This invention relates generally to medical imaging, and more particularly to a medical device, which illuminates vasculature and soft tissue in the human body. The device is especially useful for efficiently identifying suitable subcutaneous veins for venipuncture and other medical procedures.
Venipuncture is a procedure performed in medicine by which a hollow needle is passed through a person's skin and into the vasculature of the body to achieve direct access to the bloodstream. The procedure is frequently utilized in a number of healthcare settings for a variety of reasons, but most venipunctures are performed for obtaining blood samples for diagnostic lab values and placing intravenous (IV) lines that deliver rapid, systemic therapies. IV lines are also frequently utilized for correcting electrolyte imbalances, infusing appropriate fluids for rehydration, performing blood transfusions, and administering pharmaceutical therapies such as chemotherapy regiments.
Due to the intrinsic role that venipuncture plays in patient care, it is critically important that the procedure is carried out as efficiently and safely as possible. Nurses, phlebotomists, and other healthcare workers traditionally identify suitable veins by touch and unaided eye. Many patient types with less superficially visible subcutaneous veins can pose difficulties for the administrators of intravenous lines, patients, and the hospital or lab. The literature suggests that there are increased risks and complications for venipuncture misses (i.e., missing the intended vein), which are more frequent in certain patient populations including, but not limited to: pediatrics, patients who experience chronic venipuncture (e.g., chemotherapy patients), obese, advanced age, dark skin pigmentation, edematous, and trauma. Other causes for difficulty locating suitable veins for venipuncture include: dehydration, hypotension, peripheral vasoconstriction, poor vein quality, telangiectasia, skin rash, IV drug use, and low skill of technician.
When venipuncture misses occur, the perforating needle can cause unwanted complications such as nerve damage, artery puncture, and other soft tissue injury. Multiple venipuncture attempts to place an IV line also increases the risk of infection. IV infection is a serious complication since patients can develop into septicemia, which dramatically worsens patient outcomes and increases morbidity rates. The cost to treat IV infections is also extremely high as hospital acquired infections are often not fully reimbursed by insurance. This leaves hospitals or clinics absorbing the cost of treating the infection. The costs of venipuncture misses also escalate when specialists or physicians need to be called in to perform the procedure. The increased amount of time it takes to find specialists and physicians holds an associated cost and introduces additional inefficiencies into patients' healthcare.
In addition to the adverse effects that venipuncture misses have on patients' quality and cost of care, they also have a profound impact on their overall perception of the care that they receive. The quality of the patient experience will play an increasingly important role in healthcare delivery as the Center for Medicare & Medicaid Services has established The Hospital Consumer Assessments of Healthcare Providers and Systems, which collects information on patients' perspectives of care and establishes a standard metric for measuring patient satisfaction. Under the Affordable Healthcare Act, these patient satisfaction scores will be used to help allocate reimbursement dollars.
One of the most impressionistic aspects for patients in charting their patient satisfaction is their venipuncture experience. Venipuncture is a critical component to the patient experience as it is one of the first procedures performed on patients visiting hospitals. It is also an experience that patients easily recall since they are usually awake when they are subjected to this often painful and stressful procedure without any numbing or prophylactic measures to lessen the pain or discomfort. Additionally, a number of patients suffer from a condition called trypanophobia, or “needle phobia,” meaning an individual has an intense fear of needles, which can result in physical responses including, but not limited to: increased heart rate, rise in blood pressure, stress hormonal release, syncope, and acute psychosomatic episode.
Illuminating patients' veins to assist in the delivery of an IV can reduce venipuncture misses, increase patient satisfaction, and reduce costs for a hospital or lab. The practice of illuminating patients' veins is known in the field. A number of technologies and manifestations of this practice are common today, but they are either prohibitively expensive for hospitals and labs, or far less effective than the present invention.
For example, solutions such as Veinlite LED (U.S. Pat No. 20120101343 A1), shown in
Existing less costly solutions are also less effective. One existing disposable patch is described in U.S. Pat. No. 7,925,332, which is depicted in
Once an IV is inserted, it is critically important to properly secure and stabilize it. Currently, IVs are secured with a wide range of products ranging from tape to aseptic dressings, such as 3M's Tegaderm™ and IV securement kits from Centurion Medical Products. These products come in many shapes and sizes, and may or may not include an aseptic material to help reduce the risk of infection. Studies have shown that catheter securement devices are far more effective at securing and stabilizing an IV line than tape, though tape is still very common. Using excess tape can block visibility of the IV site, which may block any visual signs of infection or other complication. One study estimated that between 40 and 70 percent of all Peripheral Intravenous Catheter (PIVC) insertions are caused by unscheduled restarts (i.e., replacing a failed PIVC). IV restarts require additional time for healthcare workers, and again increase risks and complications. If an IV is not secure, the patient may face an increased exposure to infection.
In one aspect, the invention features a device for locating blood vessels of a patient including at least one illumination strip having a top surface and a bottom surface. There is a securing device connected to the at least one illumination strip and configured to affix the bottom surface to the patient's skin. There is a light source disposed along the at least one illumination strip and directed toward an area on the patient's skin adjacent to the at least one illumination strip to illuminate the area on the patient's skin and enhance visibility of the patient's blood vessels.
In other aspects of the invention one or more of the following features may be included. There may be a plurality of interconnected illumination strips. The plurality of interconnected illumination strips may form a frame which defines a central aperture about the area on the patient's skin and the plurality of interconnected illumination strips may each include a light source directed toward the central aperture. The securing device may comprise an adhesive disposed on the bottom surface of at least one illumination strip to affix the device to the patient's skin. The securing device may comprise an adhesive disposed on the bottom surfaces of the illumination strips to affix the device to the patient's skin. The securing device may comprise a strap configured to be disposed about a limb of the patient and secured by a fastener to affix the device to the patient's skin. There may be included a membrane hinged to a first portion of the frame and configured to be folded between an open position and a closed position to cover the central aperture and secure an intravenous line in place after insertion of the intravenous line into the patient's blood vessel through the central aperture. There may be a power source configured to provide power to said light source. There may be a switch interconnected between the power source and the light source to activate the light source and illuminate the area on the patient's skin. The power source may comprise a battery activated by a pull tab. The battery may be affixed to a portion of at least one illumination strip and the battery may include a top surface on which a label is disposed to record patient information.
In further aspects of the invention one or more of the following features may be included. The light source may comprise a plurality of light emitting diodes and the light emitting diodes may comprise printed strips of near infrared and other wavelengths of light emitting diodes. The light source may comprise a plurality of light emitting diodes disposed about the border of the frame. The at least one illumination strip may comprise a fluorescent filter to enhance illumination. The bottom surfaces of the plurality of illumination strips may contain an aseptic agent. The aseptic agent may include one or more of chlorhexidine gluconate, silver and zinc particles, and iodine. The membrane may contain an aseptic agent and the aseptic agent may include one or more of chlorhexidine gluconate, silver and zinc particles, and iodine. The frame may be rectangular in shape. The at least one illumination strip may be in the form of a band which wraps around a limb of the patient. The light source may be disposed above the top surface of the illumination strip. There may further be included at least one additional illumination strip which extends across the central aperture. The at least one illumination strip which extends across the central aperture may be curved in shape. There may further be included a sterile package which encompasses the device. The device of claim 1 further including a bumper disposed on the bottom surface of the at least one illumination strip to acts as a tourniquet to pool blood in the blood vessels.
In other aspects of the invention one or more of the following features may be included. There may be further included a fluorescent filter to enhance illumination of the light source. There may be included an ambient light filter. The light source may emit light a first wavelength suited to penetrate the skin and a second wavelength which allows the blood vessels to absorb the light. There may further be included a filter comprising materials to enhance viewing of the the second wavelength.
Referring to the drawing, wherein like numerals represent like parts throughout the several views:
The present invention provides an improved configuration applicable to many clinical settings. The invention provides a medical illumination device 10 as shown in
One notable deficiency of such devices is that they are often cumbersome to use. As many are in a handheld format, they may require the assistance of an extra healthcare worker to hold to the device while a different worker inserts the IV. Other solutions can be clipped onto patient's beds or are a part of a larger platform on wheels. Some solutions require the use of a computer monitor to project the images of the subcutaneous veins taken with a camera. These solutions are often very expensive, and frequently this cost can prohibit the purchase for a hospital or clinical lab. Finally, these solutions require ongoing maintenance and service if there are any technical issues. If the device were to malfunction, it would be unusable until the supplying company could service it. Additionally, many of these devices must be charged, require the continued refreshing of batteries, or require access to an AC power source during use, which can limit the locations and times where it may be utilized.
The invention presents an alternative to these existing vein illumination solutions through a versatile, cheaper, easier-to-use, and hands-free patch that is placed on the patient's arm via an adhesive, while providing additional capabilities. The invention allows the medical worker to insert the IV while the patch is adhered to the patient. The worker may insert the IV either within a ring of light, or adjacent to the light source, into an illuminated vein. Once the patch is placed on the arm and the LEDs are switched on (powered by a small, low-powered battery), the IV insertion process begins. The worker inserts the IV inside the LED illumination frame patch perimeter into a now-illuminated vein. Upon completion of the IV insertion, the LEDs are switched off. One version of the embodiment is a dual patch system which has an illumination component, but also a securement dressing which can be folded over the IV (and illumination frame patch) to secure the IV. The invention may be kept on the patient so long as the IV must be present. Another embodiment of the invention allows for an antiseptic solution on the securement patch to keep the area clean. When the IV is ready to be removed, the invention can be removed and disposed of. This is an ideal attribute of the enclosed invention as it allows for easy use and concurrently reduces the risk for spreading microbes and other unwanted microorganisms which can lead to infection.
The invention provides a simple yet effective mechanism for illuminating subcutaneous veins, or at least significantly enhancing the visualization of such veins, leading to improved venipuncture access, patient satisfaction, and decreased risks and complications. Improving venipuncture stick success rates will lower the costs associated with venipuncture escalations. Using the enclosed medical illumination invention cuts cost and will also produce higher patient satisfactions scores for hospitals. The present invention is more versatile than current solutions. Given the lower cost and smaller size of the invention, as compared to current illumination solutions, it can be placed in many areas of a hospital or lab that may require assistance during IV insertion. Current solutions can only be used in one place, at one time, and must be carried or wheeled to a patient (or the patient must travel to that location if the facility uses an immobile solution). Current solutions must also be sterilized before and after use which presents maintenance and upkeep requirements. It also increases the risk of spreading infection. The enclosed invention is useful in ambulatory or other field medicine settings.
Referring to
The invention's illumination technology may be comprised of printed or non-printed LED lights 14 in the form of strips, which may be layered into the membrane (formed of a translucent plastic or other suitable material) of the illumination frame 16. In this embodiment, the illumination frame 16 is in the form of a rectangle but other shapes, some of which are described below, may be used. The light source may emit a range of light of selected wavelengths (e.g. infrared and/or visible light) which are absorbed by the vasculature (specifically the hemoglobin contained within a blood cell) whereas the surrounding body tissues does not absorb the light. This effectively allows for visualization of the vasculature as it becomes illuminated allowing for the vasculature to be differentiated from the surrounding body tissues. The light source may be layered into the membrane of the illumination frame in a configuration by which the light source is attached to the membrane on the bottom surface or top surface. Another embodiment for the light source attachment to the membrane includes a configuration where the light source is embedded into the membrane with portions of the light source diode visible on the bottom and upper surfaces of the membrane. The light source (LED or other light sources) may be constructed into the membrane of the illumination patch in a fashion where the light emission (i.e. light diode or light bulb) has a directionality that is angled or aimed downward towards the skin. Furthermore, the light emission from the light source can also be angled or aimed in a myriad of directional planes including, but not limited to: oblique, lateral, medial, superior, and inferior directionality and/or any combination thereof that may enhance the visualization of vasculature. The membrane illumination frame 16 may be coated with a fluorescent filter to maximize vein illumination potential. The LED lights are powered by a small battery 26 which may be operated by a simple pull-tab switch. In this embodiment label 24 covers the battery 26 and allows healthcare workers to efficiently chart initials, IV insertion date, and any other documentation.
Additional embodiments may include, but are not limited to hose depicted in
The invention includes a device for locating blood vessels of a patient, and is depicted in
There may be a plurality of interconnected illumination strips forming such as frame 16 in
The device may include an illumination device 32,
As shown in
In
In
Illumination frame 90,
In one embodiment, as shown in
In another embodiment, as shown in
In any of the above described embodiments, there may be included features to enhance illumination and/or visibility of the veins. This may include using a fluorescent filter to enhance illumination of the LEDs which may be included as part of the securement member 18 of
While preferred embodiments of the present invention have been shown and described herein, various modifications may be made thereto without departing from the inventive idea of the present invention. Accordingly, it is to be understood the present invention has been described by way of illustration and not limitation. Other embodiments are within the scope of the following claims.
This application claims priority to U.S. Provisional Application No. 62/143,358, filed on Apr. 6, 2015, the contents of which are hereby incorporated by reference in its entirety.
Number | Date | Country | |
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62143358 | Apr 2015 | US |