Patient -Worn Medical Tube (Cannula) Holder Vest And Apparatuses
The present invention addresses the security of medical tubes (including, but not limited to, cannulae and catheters) that are inserted into a patient's internal organ or cavity and/or passed through the patient's skin. Specifically, the invention provides a patient-worn garment in the form of a vest and accompanying apparatuses which secure the tubes in order to redistribute physical and/or gravitational force away from the tube anchoring (or exit) sites (including, but not limited to, suture sites) onto the vest. This minimizes the risk of tug trauma, kinking, and accidental dislodging of the tubes. Thus the invention allows for increased patient mobility during post-operative recovery, after medical device implant(s), and during pre-organ transplant wait periods.
This nonprovisional utility patent claims the benefit of the prior filed provisional application USPTO provisional patent application No. 61/271,849 filed on Jul. 26, 2009. Note that the sections titled DESCRIPTION OF PRIOR ART and BRIEF SUMMARY OF THE INVENTION in the provisional application now appear in sequence under BRIEF SUMMARY OF THE INVENTION in this nonprovisional application.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCHNot Applicable
REFERENCE TO SEQUENCE LISTING, A TABLE, OR A COMPUTER PROGRAM LISTING COMPACT DISC APPENDIXNot Applicable
BACKGROUND OF THE INVENTIONThis invention relates generally to medical device support equipment and more specifically to a vest for securing medical tubes, especially cannulae, to a portion of a human body.
Many hospital and ICU patients require continuous medical treatment offered by medical tubes for assistance with a variety of functions including, but not limited to, cardiovascular function, blood circulation, blood withdrawal, respiration, parenteral nutrition, chemotherapy, bone marrow transplants, intravenous antibiotics, and drainage of bodily fluids (including, but not limited to, bile, urine, and gastrointestinal content) from the patient. Patients with medical tubes passing through the body, especially in the case of cannulae inserted into critical organs (i.e. the heart when using a ventricular assist device), have been traditionally confined to hospital beds during post-operative recovery, post-medical device implantation, and/or pre-organ transplant waiting periods. Medical tubes passing through the patient's body are anchored to the patient's skin or exit site in order to prevent tube dislodgment and/or unsafe discharge of vital fluids or blood. However, pumps and other devices connected to the tubes are likely to pull on the anchoring sites of the tubes. The flow of fluid and pressure within the tubes also place stress on the tube anchoring sites. Additionally, physical movement increases the risk of tug trauma at these tube anchoring sites on the patient, potentially resulting in wound infection and fatal tube dislodgment (for example, sudden blood loss due to the dislodging of a ventricular assist device cannula).
Clinical research has demonstrated that patient immobility in the hospital/ICU can adversely affect subsequent health outcomes, increase the length of stay, and raise medical costs. Patients who are safely and effectively mobilized (i.e. sitting unsupported, standing, and ambulating) regularly experience better outcomes and shorter ICU/hospital stays. Devices that minimize tug trauma and secure medical tubes to the patient can facilitate patient mobility, decrease the risks related to tube dislocation, and reduce recovery time.
BRIEF SUMMARY OF THE INVENTIONMedical tubing, when attached to convalescing patients, is frequently secured to a bed, pole mount, or a location away from the patient (U.S. Pat. No. 4,821,720, No. 5,334,186, No. 5,322,253). For example, Hadjuch U.S. Pat. No. 4,821,720 provides an apparatus for holding tubing that clamps to the patient's bed. While somewhat secure, this and similar tube-holding devices limit the patient's movement and often confine the patient to the bed. These devices also fail to protect against tube dislodgment caused by accidental movement or force affecting the tubes at their anchoring sites.
Some existing medical tube holders do attach to parts of the patient's body in order to facilitate some movement (U.S. Pat. No. 5,292,312, No. 5,300,037, No. 5,626,565, and No. 5,681,290). For example, Delk et al. U.S. Pat. No. 5,292,312 provides a medical conduit holder which is adhesively secured to the skin. However, adhesive-based tube holders can loosen from perspiration, bodily fluids, stretching of the skin, and physical movement. These adhesive tube holders may also cause skin irritation/discomfort and do not offer sufficient protection against tug trauma or accidental dislodging of the medical tubes.
A more versatile and secure medical tubing support device is presented by Madden et al. U.S. Pat. No. 5,244,464. This device consists of a band that secures and aligns medical tubing relative to a portion of the human body. The band is comprised of primary and secondary straps constructed to attach to each other with VELCRO®, trapping the medical tubing between straps via direct contact. Although this band is more versatile than prior inventions, it does not provide adequate protection against gravitational force or incidental pushing/pulling that may dislodge medical tubes from the patient. This is especially due to the lack of friction between the smooth tube surface and the VELCRO® surface of the strap and of the band. There is insufficient friction and fixation strength to resist a force applied to the tube (i.e. pulling vertically on the tube or accidentally lifting the tubes forward). Another problem with the band is that it can change the angle of the tube at the exit site, subsequently affecting the flow of fluid in the tube.
Villapiano U.S. Pat. No. 6,032,289 addresses some of the previous shortcomings by providing a security garment comprising of two layers with fastening means (e.g. VELCRO®) in between the layers to secure tubing. Individual VELCRO® straps can be applied to any location in between the garment layers to secure tubes. Each strap may be used to form a tension loop that is designed to protect against the tube exit site. While more versatile and secure than some of the prior inventions, this garment has several shortcomings. First, this garment is difficult to put on a patient who already has tubes exiting his/her body. Villipiano suggests cutting pieces off the garment to make way for medical tubes but this is highly inconvenient, weakens the integrity of the garment, and loosens the garment's attachment to the patient's body. Second, the tension loops, which rely on hook and loop fasteners or VELCRO®, can be pulled apart due to the limited VELCRO® contact points and the lack of friction between the tube and the VELCRO® surfaces (this is the same problem mentioned above for Madden et al.). The flat strap only has contact with the round tube surface near its highest point, which leaves a significant portion of the tube surface unfastened. The small contact point offers little friction, offering little or no protection against vertical pulling or gravitational force (if the tube is pressurized) when the patient stands up (this is the same problem mentioned above for Madden et al.). The tube can slide loosely in between the garment's layers, beneath the strap fasteners, and around tension loops. Sliding and lateral or vertical movement can stress the tube exit site and disrupt the contact points between the strap and the garment, risking loosening and dislodging of the tube.
Third, the strap fasteners and tension loops are too close to the patient's body to adequately redistribute any pulling force away from the tube exit site. Fourth, the garment's dual-layered holding mechanism, strap fasteners, and tension loops force the medical tubes to press too closely to the patient's body. This is especially harmful for tubes that cannot be weaved, curved, or bent around the patient's body, such as ventricular assist device cannulae. This fails to accommodate the practical use of many medical tubes, which typically protrude from the exit site at angles higher than 0 degrees, and also risks pressing into and stressing the tube exit site. For example, a ventricular assist device cannula should generally emerge from the patient at a 15- to 60-degree angle from the patient's body in order to ensure the unimpeded circulation of blood. Running the cannula in between the garment's layers or securing them to the garment via straps or tension loops can bend the tube, causing increased flow resistance or creating turbulence. This can dangerously interfere with fluid and blood circulation, place constant pressure on the exit sit, and risk fatal tube dislodgment. An acute angle of protrusion or kinking can also increase resistance to blood flow, create turbulence, and damage or cause trauma to the blood cells, increasing the risk of thrombosis.
Other patient-worn medical tube holders have largely been limited to headgear and other apparatuses fastened to the head, face, or neck (U.S. Pat. No. 4,906,234, No. 4,622,034, No. 4,665,566, No. 4,844,061, No. 5,345,931, No. 5,529,062, No. 5,558,090, and No. 6,578,576) without adequate application towards the security of cannulae inserted into critical organs.
The previous art does not empirically address tubes that are subject to the full tube fluid weight or to a dynamic flow typically greater than 2 L/minute with a mean pressure of greater than 50 mmHg. When the tube is filled (i.e. with blood, involving continuous flow and continuous pressure), the tension on the tube's anchoring site is significantly higher.
It is an object of the present invention to overcome the aforementioned deficiencies in the prior art.
It is another object of the invention to provide a means for supporting and protecting at least one medical tube and medical tube anchoring (or exit) site placed in any location on the torso of the body and protruding at any angle from the patient's body.
It is another object of the invention to allow the wearer of the vest to put on and remove the vest and apparatuses without disconnecting already-anchored medical tubes and without the need to cut or tailor the vest to accommodate the tube exit sites.
It is another object of the present invention to provide a means to secure medical tubes to the patient's body with the means capable of adjusting to accommodate persons of different sizes and medical tubes of different sizes and functions.
It is another object of the present invention to permit access to the medical tube exit site for maintenance and cleaning of the dressing surrounding the tube.
It is another object of the present invention to provide a reusable support for medical tubes which can be easily cleaned by machine washing and drying.
It is another object of the present invention to use a three (or more) point force distribution mechanism(s) to stabilize each medical tube and redistribute force or pressure away from the exit site.
It is another object of the present invention to maintain the natural angle of each tube at the exit site without bending the tube thus avoiding the creation of turbulence within the tube and its contents.
It is another object of the present invention to increase the surface area of the contact surface and to increase the friction (e.g. grip) of the contact surface of the medical tubes and the medical tube-holding apparatuses.
It is another object of the present invention to anchor and secure tubes that have significant weight and high pressure loads.
It is another object of the present invention to secure medical tubing that functions as Ventricular Assist Device (VAD) cannulae, which the prior art does not address. These tubes (i.e. those used with VADs) require fastening mechanisms that can withstand a greater amount of weight and pressure. The use of cannulae attached to VADs increased in prevalence after 2002 and after the advent of the prior art.
The present invention provides a patient-worn vest and accompanying apparatuses that effectively secure medical tubes which pass through the patient's body, including, but not limited to, areas on the patient's chest, abdomen, flank, and back. For the purposes of the present invention, “medical tube” includes, but is not limited to cannulae and catheters. “Patient” refers to any person receiving medical attention. Furthermore, for the purposes of this invention, “vest” is a sleeveless garment covering the torso of the body.
The vest of the present invention can be made of any type of fabric, including woven or non-woven cotton, polyester, nylon, or any other fiber (synthetic or natural) suitable for making garments. The exterior surface (not in contact with the wearer) of the entire vest is covered with fastening material. The fastening means can include, but are not limited to, any conventional fastening means, such as hook and loop fasteners or VELCRO®. The inner surface (touching the wearer) is comprised of any type of fabric that is comfortable to the wearer such as cotton or Lycra®.
The upper section of the vest is comprised of two wide adjustable suspenders that are detachable from the vest. The exterior surface (facing away from and not touching the wearer) of the suspenders is comprised of strong hook fasteners which allow straps and apparatuses with loop fasteners to latch on. Each suspender has a length adjustment mechanism, allowing patients of various sizes to wear the vest comfortably yet securely.
The lower section of the vest is comprised of several anchoring sites for the suspenders, overlapping horizontal straps, and rear elastic straps. The surfaces of each of these areas, except the inner surface touching the wearer's skin, are covered in the aforementioned hook and loop fastening material. While the front of the section can remain open by disengaging the overlapping horizontal straps, the rear of the vest is comprised of a continuous region of the vest's fabric as described above.
The anchoring sites for the suspenders include large buttons, quick-lock buckle receptacles, and/or durable laces (made from strong fabric including, but not limited to nylon). They work as follows: The buttons pass through slits located near the distal ends of the suspender straps; the buckle, attached to the suspender, fastens into the receptacle, attached to the lower section of the vest; one lace, attached to the suspender, forms a tightened tie or knot with another lace, attached to the lower section of the vest. The detachability of the suspenders from the lower section of the vest allows the patient to put on the vest without having to disconnect or adjust medical tubes already attached to the body. To put on vest, the patient can simply place his or her back into the lower section of the vest and then fasten the suspenders using the aforementioned methods to the lower section of the vest.
The front of the vest consists of at least two overlapping horizontal straps or a single strap with long horizontal slits. These straps secure the front of the vest to the patient and serve as a mounting site for other apparatuses. Each side of the vest can have any number of overlapping straps (for example, three on the left, and three on the right). The straps on one side overlap and latch on to the straps on the other side with the help of hook and loop fasteners—the exterior surface of the bottom straps have hook fasteners which latch on to the loop fasteners on the inner surface (facing the bottom straps) of the top straps. The straps are separated by a horizontal gap through which the medical tubes pass (a single strap with long horizontal slits may also be used). This gap may be widened to accommodate thicker tubes by adjusting the angle of the horizontal straps when fastening them.
A button-through-slit mechanism and laces are used to further secure the overlapping straps to each other: A button on the bottom strap passes through a slit on the top strap; a lace attached securely to the top strap is tied to a lace attached securely to the bottom strap. Note that the laces are sufficiently long enough to provide more versatility than the button-through-slit mechanism, should such versatility be necessary, by having the ability to fasten the horizontal straps at varying resting positions beyond the constraints of the button-through loop mechanism.
The rear elastic straps are attached to the back of the vest and wrap around to the front of the vest, fastening to and covering the overlapping straps and/or any apparatuses attached to the straps. These straps offer additional security and ensure the vest and apparatuses are securely fastened to the patient.
Crucial to the function of the vest are four apparatuses (labeled A, B, C, and D for explanatory purposes) and the use of a hook and loop fastener fabric adhered to each medical tube. Apparatus A consists of long straps that attach to the suspenders of the vest. Each strap is designed to hold on securely to the suspenders while forming a cruciated loop around a designated medical tube. The cruciated loop is essential to ensuring 360 degrees of contact around the surface of the tube; holding the tube circumferentially increases the friction between the strap and the tube, providing extra security. Any number of straps and cruciated loops may be used on each medical tube. The strap is lined with hook fasters on one side and loop fasteners on the other, allowing the strap to fasten to the vest, itself, and any other hook and loop fastener enabled apparatus. The strap is also sufficiently long enough for one end to attach to the suspenders, for the strap to form a cruciated loop around a medical tube at any location on the torso, and for the other end to reach back and fasten on to the suspenders once the loop is formed. The proximal end of each strap can fasten to the suspenders via a button-through-slit mechanism or quick-lock buckle mechanism. The distal end also contains one of the aforementioned fastening mechanisms that attach to the suspenders. This fastening mechanism is used in addition to hook and loop fasteners to prevent the strap from coming off the vest when pulled.
Before the distal end fastens to the suspender, the strap must form a cruciated loop around the medical tube. The cruciated loop is formed by passing part of the strap through a slit located on the strap. Each strap contains a slightly wider region along the length of the strap. The slightly wider region on the strap contains a slit that is sufficiently long and wide enough to allow the remainder of the strap to pass through and form a cruciated loop. The location of this slit and cruciated loop may be adjusted from both the proximal and the distal ends via length adjuster mechanisms located near both ends of each strap. Each adjustment mechanism also adjusts the length of the entire strap, allowing the apparatus to accommodate tubes at different locations. The medical tube passes through and is held by this loop. In order to ensure the hold of this loop, a fabric containing hook or loop fasteners is adhered to the surface of the tube at the region where the loop is formed. Adhesives used to attach the fabric to the tube include, but are not limited to, glue and rubber cement. The fabric prevents the tube from sliding vertically through the loop.
Once the loop is formed securely around the medical tube, the distal end of an apparatus A strap is attached to the suspender opposite the proximate end's suspender. This helps redistribute physical and/or gravitational force away from the medical tube exit site while preserving the tube's angle of protrusion from the patient's body. If the tube is pulled, the points at which apparatus A joins the suspenders will be pulled on rather than the exit site. Because both suspenders secure apparatus A, the force is evenly distributed between the shoulders.
Apparatus B is polygon-shaped medical tube holder comprised of a firm but flexible material (including, but not limited to, semi-rigid foam, rubber, and silicone) and attaches to the vest via a base and/or platform lined with hook-and-loop fasteners. This apparatus secures medical tubes to the vest by holding each tube inside one of any number of cylindrical passageways that run through the apparatus. The apparatus can be produced to have varying lengths, widths, and heights. The passageways inside the apparatus can have varying lengths and diameters. Each passageway is accessible via a slit/gap that flexibly opens to make way for a medical tube but closes once the tube has passed through. The slit/gap is sufficiently flexible enough to let a tube through but less wide than the tube's width, preventing the tube from falling out of the passageway. This allows tubes of varying diameters to fit securely into the apparatus. The surface of the apparatus, including the walls of the passageways, is lined with hook-and-loop fasteners. As with apparatus A, a hook and loop fastener fabric is adhered to the surface of the medical tube in the area of the tube inserted into the apparatus to increase friction and ensure the tube doesn't slide. Different versions of this apparatus can be produced to provide different sized cylindrical passageways to accommodate an even wider variety of tube diameters.
Apparatus C is a variant of Apparatus B with a polygonal shape that is also comprised of the aforementioned firm but flexible material and attaches to the vest via a base and/or platform lined with hook and loop fasteners. This apparatus secures medical tubes to the vest via semi-cylindrical passageways and straps. The apparatus can be produced, without limitation, to have semi-cylindrical passageways of varying lengths and diameters. These passageways are located on the outer surface of the apparatus, which is lined with hook-and-loop fasteners. Each medical tube rests in one of these passageways and, as with the previous apparatuses, a hook and loop fastener fabric is adhered to the surface of the tube in order to increase friction and to prevent sliding. Any number of fastening straps lined with hook and loop fasteners can be placed over each passageway to further secure each tube.
Apparatus D is comprised of any number of cylindrical clamps via a base and/or platform lined with hook and loop fasteners. This apparatus secures medical tubes to the vest by using any number of clamp and strap mechanisms. Each clamp can be made to provide sufficient space for a medical tube of any size to pass through. The clamps can be produced without limitation, to have varying lengths and diameters. The size of the clamp's opening can be adjusted by strap fastening mechanism attached to the arms of the clamp. The clamp's arms join at an angle that allows the arms at the distal end to adjust position and tightness of grip. The inside of each clamp is lined with hook-and-loop fasteners. A hook and loop fastener fabric is adhered to the surface of the medical tube placed inside the clamp, preventing the tube from sliding.
In addition to apparatus A, apparatuses B, C, and D further secure a medical tube and redirect any pulling/gravitational forces onto the vest away from the tube anchoring (or exit) site. They also help preserve the tube's level of elevation from the patient in order to maintain a safe angle of protrusion. The level of elevation may be adjusted by padding the area between the apparatus and the vest with a hook and loop fastened platform or pad.
It is necessary to use apparatus A in conjunction with the vest and at least one of the other three apparatuses in order to fulfill the function of the present invention (especially the function of securing tubes with weight and pressure such as VAD cannulae). Apparatus A alone, while providing security and some assistance for a medical tube's exit angle; requires the help of apparatus B, C, or D further along the length of the tube in order to maintain the natural angle and elevation of the tube and further secure the tube to the patient via a three (or more) points of fixation. While the hook and loop fasteners securing apparatus A to the vest offers resistance against gravity and vertical pulling of the tube or the patient bending in extreme directions that are inimical to the tube's position, apparatuses B, C, and D prevent the tube from being pulled horizontally or upwards. A combination of apparatuses A and B, A and C, or A and D provides an effective three-point triangular hold on the tube and offers maximum security and stability in holding the medical tube. Once these apparatuses are used, securing the rear straps around them will enclose the medical tubes, effectively making the apparatuses A, B, C, and/or D a collective bloc and part of the patient's body. This combination offers maximum resistance to incidental pulling, gravity, kinking, and/or bending of the tubes.
Holding the application of apparatus A constant, apparatuses B, C, and D may be used in conjunction with each other or independently, depending on the nature of the medical treatment and/or medical tubes. Apparatus B may be more preferable for tubes that need to be protected from accidental pressure. Apparatus C may be more preferable because it is faster to engage (no need to press tubes through a slit/gap). Apparatus D may be more preferable to preserve space on the vest for other clamps and apparatuses.
Crucial to the functionality of all apparatuses is the use of a hook and loop fastener fabric adhered to the surface of a medical tube at the region where the apparatuses secure the tube. This prevents the tube from sliding, especially since a strap, passageway, or clamp alone does not sufficiently grip the smooth surface of the tube.
The present invention redistributes physical and/or gravitational force away from the medical tube anchoring (or exit) sites in/on the patient's body. The physical and/or gravitational force affecting each medical tube is redistributed onto the vest via strap mechanisms and tube holder apparatuses that are attached to the vest, which is tightly fastened to the patient's body. A combination of at least two apparatuses and the rear straps fully secures the medical tubes against gravity or pulling. In addition, the apparatuses grip the medical tube around its entire circumference, providing security and stability superior to that of the prior art in this field. Any number of other clamps or medical tube holders may be attached to the vest via hook and loop fasteners to further secure the medical tubes. Non-angled or and non-elevated tubes may be secured by a hook and loop fastener strap attaching the tube to the vest. Unlike prior inventions in this field, a hook and loop fastener fabric is adhered to the medical tube at the location where it is fastened to the apparatus to increase friction and prevent sliding. Thus, the vest allows for increased patient mobility while reducing the risk of tug trauma, tube kinking, and accidental tube dislocation.
For the purposes of the present invention, “fastener” or “fastening mechanism” includes any device which fastens one portion of the vest to another portion of the vest, to hold the vest in place on the patient, or to hold any apparatus to the vest. Such fastening means can include, but is not limited to, hook and loop fasteners, hook and eye fasteners, adhesives (including reusable adhesives), adhesive tape, zippers, buttons, laces, quick-lock buckles, snaps, pins, stitching, clamps, and the like. These fastening means are provided merely by way of illustration and are not intended to be limited to the specific examples presented.
For purposes of the present invention, “medical tubes” or “medical tubing” refers to cannulae, catheters, feeding tubes, surgical drains, and any other type of tubing or wiring which is implanted in a patient's body and which exits the patient's body through an opening in the skin. The terms used place no limitation on the particular use of the medical tubes or medical tubing. Unless specified, these terms are interchangeable and include all variations of the terms.
For the purposes of the present invention, “patient” and “wearer” are used interchangeably to mean the person wearing the vest and to whom the medical tubes are attached.
For the purposes of the present invention, the orientations “right” and “left” are used in a relative sense, meaning any configuration using these terms may be reversed.
For the purposes of the present invention, “fabric” may include, but is not limited to, textiles used in clothes such as VELCRO®-based fabrics, nylon, polyester, cotton, Lycra®, leather, wool, and their variants.
For the purposes of the present invention, “button” or “buttons” when used in the context of a fastening mechanism involving buttons passing through slits (button-through-slit) can also refer to laces that are tied together. The use of laces is necessary in cases when the slit being used cannot accommodate buttons positioned too far away. These laces can be made from a variety of materials, including, but not limited to, nylon, polyester, cotton, leather, wool, and their variants.
For the purposes of the present invention, “adhesives” may include, but are not limited to, glue and rubber cement.
For the purposes of the present invention, “vest” is comprised of a sleeveless garment with all the components described below.
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Presented in the following section are four apparatuses (labeled A, B, C, and D in the description and visually represented by numerical labels 15, 17, 20, and 23 respectively) that are used as part of the vest to help secure medical tubes to the vest. It is necessary to use apparatus A in conjunction with the vest (including the rear strap 19, as demonstrated in
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The use of apparatus A in conjunction with apparatus C (labeled 20 in the illustration) is demonstrated in
In order to fulfill the objects of the present invention, it is necessary use apparatus A in conjunction with apparatus B, apparatus C, or apparatus D in addition to the rear elastic straps. To ensure the proper function of the present invention, all hook-and-loop fastener mechanisms and button-through slit mechanisms should be secured.
The advantages of the present invention include, without limitation, the securing of medical tubes to the patient, the minimization of tug trauma risk and tube dislocation risk, the increase in patient mobility, and the reduction of patient recovery times. Unlike previous medical tube holders, the present invention directs physical and gravitational forces away from the medical tube anchoring sites onto the vest, which is fastened to and supported by the patient's body. Tugging forces that would normally dislodge a vital medical tube would instead meet resistance from the rear elastic straps, the apparatuses, the vest, and ultimately, the patient's body weight. The present invention is comparatively advantageous to prior art for several reasons. First, the vest and apparatuses are highly versatile—the prevalence of hook and loop fastener junctions on the vest allows apparatuses and straps to secure medical tubes of varying sizes at varying locations on the torso and allow tubes to be routed to a desired location without the risk of being squeezed or dislodged. The hook-and-loop fasteners on the vest allow for the use of any number of tube holder apparatuses at any location of the vest where the medical tubes may be located. Second, the vest is easily worn and removed by patients of various sizes because of the combined use of detachable suspenders and horizontal overlapping straps. Unlike adhesive-based tube holders, the present invention does not risk loosening from the patient's body because of perspiration or body fluids, nor does the invention irritate the patient's skin. The adjustable hook-and-loop fastener straps on multiple sides of the vest allow the patient to adjust the tightness of the vest for security and for comfort. Third, the horizontal straps leave gaps through which the medical tubes protrude, providing easy access to the medical tube exit site for maintenance and cleaning of the dressing surrounding the tube. Fourth, the vest is made of washable fabric that can be easily cleaned by machine washing and drying. Fifth, the combined use of the vest, apparatuses, and rear elastic straps provide a three-(or more) point force distribution mechanism to stabilize each medical tube and redistribute force or pressure away from the medical tubes and their exit sites. These mechanisms help anchor and secure medical tubes with significant weight and high pressure loads. Sixth, unlike prior art, the present invention maintains the natural angle of each tube at the exit site with the help of apparatuses A, B, C, and D without bending the tube, avoiding the creation of fluid turbulence within the tube. Seventh, the present invention increases the surface contact area and grip medical tube holders have on medical tubes by incorporating the use of a hook and loop fastener fabric adhered to the circumference of each medical tube where the holder and the fabric meet. Lastly, the combined advantages from above allow the present invention to be used with VAD cannulae, which require fastening mechanisms that can withstand a greater amount of weight and pressure that the prior art cannot handle.
One example of the invention's advantages involves the use of external ventricular assist devices (VADs). External VADs are typical short-term solutions for patients with weak hearts recovering after heart surgery or heart attack and for patients waiting for a more permanent heart pump implant or heart transplant. VADs are responsible for supplementing or replacing the functionality of a damaged or non-functioning left or right ventricle. An external VAD, comprised of a pump located outside the patient's body, connects to the patient's heart chambers via cannulae that pass through the patient's body. Blood that leaves the heart (e.g. blood from the left atrium) is drained through a cannula ranging from 16-42 Fr in diameter, where 1 Fr=⅓ mm) into the VAD which then pumps the blood to a major artery (e.g. the aorta) via another cannula. These two (or more) cannulae pass through the patient's body and are anchored to the patient's heart and skin. These cannulae are filled with blood with a mean pressure of 60 mmHg and flow at >2 L/min. The fluid weight in the cannulae coupled with the high speed blood flow and pressure exert force/pressure on the tube anchoring/exit sites. The present invention is currently the only invention that can specifically address this demand—the use of cannulae attached to VADs increased in prevalence after 2002 and after the advent of the prior art. Accidental tugging or physical movement risks over-stressing these anchor sites and dislodging the cannulae. The VAD cannulae exit the body generally at a 15-60 degree angle. Any prior art used with VAD cannulae would change this angle. The present invention is the only device designed to maintain the angle while securing the cannulae. The vest and apparatuses of the present invention minimizes the risk of tube dislodgment by redirecting physical or gravitational force away from the anchoring site and onto the vest and the patient's body. Therefore, the present invention facilitates safe patient transport, body position change, and allows patients to perform moderate physical exercise during recovery periods, decreasing complications related to bed-ridden hospital/ICU stays, reducing recovery time, lowering hospital costs, and improving the quality of the convalescent period.
Claims
1. A medical vest for a patient to wear, the vest comprising:
- (a) a fabric shaped and sized to fit the patient's torso and back
- (b) an exterior surface of said fabric facing away from the patient's body consisting entirely of hook-and-loop fasteners
- (c) two length-adjustable shoulder strap suspenders extending from the upper portion of said fabric
- (d) three pairs of horizontal straps, one strap from each pair extending from a lateral side of the fabric opposite the other strap from the same pair
- (e) two rear elastic straps, extending laterally from the fabric at the rear of the patient's torso, that wrap around said fabric and said horizontal straps; and
- (f) four length-adjustable straps that latch on to said shoulder strap suspenders.
2. The medical vest of claim 1 wherein all said straps attached to the fabric consist of hook-and-loop fasteners on the exterior surface facing away from the patient's body and hook-and-loop fasteners on the interior surface facing the patient's body capable of latching on to the said hook-and-loop fasteners on the exterior surface of both the fabric and of other straps.
3. The medical vest of claim 1 wherein each length-adjustable shoulder strap suspender removably attaches to said fabric via fastening mechanisms.
4. The medical vest of claim 1 wherein three of the horizontal straps extending from the same lateral side overlap and fasten on, to the other three horizontal straps via fastening mechanisms.
5. The medical vest of claim 1 wherein the overlapping horizontal straps close the front of the vest when completely fastened and open the front of the vest when completely unfastened.
6. The medical vest of claim 1 wherein each pair of overlapping horizontal straps is flexible enough and far enough from an adjacent pair of overlapping horizontal straps to allow medical tubes to pass through gaps between each pair of overlapping horizontal straps.
7. The medical vest of claim 1 wherein each of the length adjustable straps removably attaches to the shoulder strap suspenders via fastening mechanisms.
8. The medical vest of claim 1 wherein each of the four length adjustable straps consists of a slightly wider region along the length of the strap with a slit long and wide enough to allow the remainder of the strap to pass through and form a cruciated loop.
9. The medical vest of claim 1 wherein each of the four length adjustable straps fastens on to one of the shoulder strap suspenders via one distal end, forms a cruciated loop around a medical tube attached to the patient's body, and fastens on to the other shoulder strap suspender via the other distal end.
10. A medical tube-holding apparatus that fastens on to a medical vest via hook-and-loop fasteners comprising:
- (a) a platform lined with hook-and-loop fasteners
- (b) a polygon-shaped solid in the form of a three-dimensional trapezoid attached to said platform wherein the two parallel sides of the trapezoid are perpendicular to said platform as well as one of the non-parallel sides and wherein the remaining non-parallel side slopes at an angle that matches the angle of exit for a protruding medical tube;
- (c) said polygon-shaped solid consisting of cylindrical and semi-cylindrical passageways through which medical tubes can pass
- (d) cylindrical clamps with arms wide enough to hold medical tubes attached to said platform with fastening straps.
- (e) surface areas within said cylindrical passageways, semi-cylindrical passageways, and cylindrical clamps consisting of hook-and-loop fasteners
- (f) removable elevation-altering padding affixed to said platform
11. The medical tube-holding apparatus of claim 10 wherein the polygon-shaped solid contains hollow cylindrical passageways and semi-cylindrical passageways large enough to contain a medical are oriented at the same angle as the sloping non-perpendicular, non-parallel side of said trapezoid.
12. The medical tube-holding apparatus of claim 10 wherein the cylindrical passageways of the polygon-shaped solid are accessed by medical tubes via a gap in the sloping non-perpendicular, non-parallel side of said trapezoid.
13. The medical tube-holding apparatus of claim 10 wherein the external surface of sloping non-perpendicular, non-parallel-side consists of fastening straps that tight around the medical tube and keep the medical tube in the semi-cylindrical passageway from shifting position.
14. The medical tube-holding apparatus of claim 10 wherein the cylindrical clamps are tightened around medical tubes running through the inside of the clamps' arms via fastening straps affixed to outside of the clamps' arms.
15. The medical tube-holding apparatus of claim 10 wherein hook-and-loop fasteners in the surface areas within said cylindrical passageways, semi-cylindrical passageways, and cylindrical clamps fastens to hook-and-loop fastener fabric affixed to the surface of the medical tube.
16. A method for wearing a medical vest to hold medical tubes steady, said vest comprising a fabric shaped and sized to fit the patient's torso and back, an exterior surface of said fabric facing away from the patient's body consisting entirely of hook-and-loop fasteners, two detachable, length-adjustable shoulder strap suspenders extending from the upper portion of said fabric, three pairs of horizontal straps, one strap from each pair extending from a lateral side of the fabric opposite the other strap from the same pair, two rear elastic straps, extending laterally from the fabric at the rear of the patient's torso, that wrap around said fabric and said horizontal straps, and four length-adjustable straps that latch on to said shoulder strap suspenders, and utilizing the medical tube-holding apparatus that fastens on to the medical vest, said medical tube-holding apparatus comprising of a platform lined with hook-and-loop fasteners, a polygon-shaped solid in the form of a three-dimensional trapezoid attached to said platform wherein the two parallel sides of the trapezoid are perpendicular to said platform as well as one of the non-parallel sides and wherein the remaining non-parallel side slopes at an angle that matches the angle of exit for a protruding medical tube, said polygon-shaped solid consisting of cylindrical and semi-cylindrical passageways through which medical tubes can pass, cylindrical clamps with arms wide enough to hold medical tubes attached to said platform with fastening straps, surface areas within said cylindrical passageways, semi-cylindrical passageways, and cylindrical clamps consisting of hook-and-loop fasteners, removable elevation-altering padding affixed to said platform, the method comprising the steps of:
- (a) affixing hook-and-loop fastening fabric to the medical tube's contact points with the medical vest's straps and apparatuses
- (b) fastening one end of the length-adjustable strap to one shoulder strap Suspender, securing the medical tube with the length-adjustable strap with a cruciated loop, and fastening the other end of the length-adjustable strap to the other shoulder strap suspender
- (c) further securing the medical tubes by passing the medical tube through the medical tube-holding apparatus fastened to the vest—this can be through the cylindrical passageways of the polygonal solid, semi-cylindrical pathways of the polygonal solid, or the cylindrical clamps.
- (d) adding or removing the removable elevation-altering padding in order to allow the medical tube-holding apparatus to reach the medical tube; and
- (e) adjusting the medical tube-holding apparatus in order to maintain a medical tube's original angle of exit from the patient's body.
- (f) adjusting the medical tube-holding apparatus to support the position of a medical tube with a full tube fluid weight or dynamic flow greater than 0 L/minute with a mean pressure greater than 0 mmHg.
17. A method for wearing the medical vest of claim 1 that involves adjusting the vest to maintain a medical tube's original angle of exit from the patient's body and to maintain a position of a medical tube with a full tube fluid weight or dynamic flow greater than 0 L/minute with a mean pressure greater than 0 mmHg.
18. A method for wearing the medical tube-holding apparatus of claim 10 that involves adjusting the apparatus to maintain a medical tube's original angle of exit from the patient's body and to maintain a position of a medical tube with a full tube fluid weight or dynamic flow greater than 0 L/minute with a mean pressure greater than 0 mmHg.
Type: Application
Filed: Jul 26, 2010
Publication Date: Feb 3, 2011
Inventor: Henry Zhendong Liao (Edina, MN)
Application Number: 12/843,846