Background & Project Scope
Foley catheters are widely used in the current healthcare environment for treatments ranging from surgical operations to end-of-life care. Their primary use is to drain urine from the bladder of patients who do not have voluntary control over urinary function.
A typical Foley catheter consists of three principal components – a long, flexible tube (commonly made of latex or silicone), an inflatable balloon, and a sterile bag. The tube is first lubricated and inserted into the urethra of the patient. Once the catheter has been placed completely through the urethra and into the bladder, a balloon is inflated such that the tubing will not easily slip out from the bladder. The end of the tubing (inside of the bladder) is open such that urine can drainthrough the tubing and into the sterile bag, which is placed external to the body.
The Foley catheter market is large from both a domestic and international perspective. Every year, approximately 30 million catheters are utilized in the United States alone. Given the large quantity of catheters utilized on an annual basis, l\the market has become substantially lucrative. It has been estimated that the global market for indwelling urinary catheters has a current value of $1.38 billion.. While this market is already very large, it also has significant room for growth. Between now and 2021, the value of this market is expected to grow by an annual rate of 4.1%, leading to a future market value of $1.76 billion. It is clear from this research that this market is widely used, lucrative, and growing.
In certain instances, such as postoperative recovery from surgery, a patient may be confused or disoriented due to the effects of anesthesia/medications. Further, a Foley catheter may be inserted while the patient is unconscious, leaving them with no recollection of the event. Because of this, the patient may try to forcibly remove the catheter from their bladder without proper deflation of the balloon. In doing so, the inflated balloon (which can as large as 75.0 cubic centimeters)1 would be forced through the urethra, thereby causing significant traumatic damage to the bladder, urethra, and urethral sphincter. This can lead to further pain, bleeding, and scarring.
Additionally, there are many patients that require long-term/permanent use of Foley catheters, such as rehabilitation patients and those who suffer from urinary incontinence. Such patients typically keep the urine collection bag connected to the catheter, requiring that the bag be with them at all times. One of the chief complaints from these patients is embarrassment regarding the presence of their urine collection bag - it may even become so severe that they refrain from having family/friends visit them in the hospital.
Given both the health risks and body image issues associated with Foley catheter use, the scope of the project is two-fold. First, we seek to add an additional safety measure to the standard Foley catheter that will prevent traumatic injuries due to forced balloon removal. Further, we seek to provide a method by which long-term catheter users can disconnect the urine collection bag, impede the flow of urine, and drain their bladder when it is full in a regular bathroom. We hope to market our device and in the future, capture the large foley catheter market.
A typical Foley catheter consists of three principal components – a long, flexible tube (commonly made of latex or silicone), an inflatable balloon, and a sterile bag. The tube is first lubricated and inserted into the urethra of the patient. Once the catheter has been placed completely through the urethra and into the bladder, a balloon is inflated such that the tubing will not easily slip out from the bladder. The end of the tubing (inside of the bladder) is open such that urine can drainthrough the tubing and into the sterile bag, which is placed external to the body.
The Foley catheter market is large from both a domestic and international perspective. Every year, approximately 30 million catheters are utilized in the United States alone. Given the large quantity of catheters utilized on an annual basis, l\the market has become substantially lucrative. It has been estimated that the global market for indwelling urinary catheters has a current value of $1.38 billion.. While this market is already very large, it also has significant room for growth. Between now and 2021, the value of this market is expected to grow by an annual rate of 4.1%, leading to a future market value of $1.76 billion. It is clear from this research that this market is widely used, lucrative, and growing.
In certain instances, such as postoperative recovery from surgery, a patient may be confused or disoriented due to the effects of anesthesia/medications. Further, a Foley catheter may be inserted while the patient is unconscious, leaving them with no recollection of the event. Because of this, the patient may try to forcibly remove the catheter from their bladder without proper deflation of the balloon. In doing so, the inflated balloon (which can as large as 75.0 cubic centimeters)1 would be forced through the urethra, thereby causing significant traumatic damage to the bladder, urethra, and urethral sphincter. This can lead to further pain, bleeding, and scarring.
Additionally, there are many patients that require long-term/permanent use of Foley catheters, such as rehabilitation patients and those who suffer from urinary incontinence. Such patients typically keep the urine collection bag connected to the catheter, requiring that the bag be with them at all times. One of the chief complaints from these patients is embarrassment regarding the presence of their urine collection bag - it may even become so severe that they refrain from having family/friends visit them in the hospital.
Given both the health risks and body image issues associated with Foley catheter use, the scope of the project is two-fold. First, we seek to add an additional safety measure to the standard Foley catheter that will prevent traumatic injuries due to forced balloon removal. Further, we seek to provide a method by which long-term catheter users can disconnect the urine collection bag, impede the flow of urine, and drain their bladder when it is full in a regular bathroom. We hope to market our device and in the future, capture the large foley catheter market.
Design Specifications
A majority of our specifications are in place in order to preserve the primary function of the urinary catheter; such specifications include balloon volume, tubing radius, bag capacity, length, inflation resistance, and urine collection rate, among others. These specifications will be the same as foley catheters that are currently in use. In order to function properly, the rate of removal from the bladder must be able to exceed the rate of urine production, ensuring the bladder is emptied.
Because our project is concerned with the consequences of forcibly removing the catheter tubing and inflated balloon, we must determine how much force is required to pull out the Foley while the balloon is inflated. Our device must activate when 75-85% of this force is applied, thereby allowing prevention of traumatic injury and ensuring that accidental activations of the safety measure are minimal. Due to the high sensitivity of the anatomical area where Foley Catheters are placed, we aim to minimize the weight of the safety mechanism that we put in place. For example, if the weight is too large, a torque could be produced about the urethral exit, causing discomfort to patients. The material used is another safety consideration. Any material that is utilized should not cause allergic reactions or be abrasive such that the patient is not harmed. There should also not be any electronic components in the device in order to decrease both the risk of injury and potential malfunction.
Foley catheters are used by hospitals in large quantities; given the increasing regulation and cost of treating patients, healthcare systems cannot afford to spend more money for basic devices like IVs and catheters. For this reason, the price of the catheter we develop should not exceed 110% of the existing market price. In addition, if the safety device is activated, it should not render the catheter unusable. Just as hospitals cannot afford expensive catheters, it would be ideal to not require new purchases whenever the safety mechanism is deployed. Furthermore, this makes re-catheterization much more convenient for the healthcare provider. Finally, the number of distinct parts should be kept to a maximum of 3 in order to maintain ease of use for the attending caretaker. Hospitals are a setting in which time is highly valued; as such, ensuring ease of use is of upmost importance.
Because our project is concerned with the consequences of forcibly removing the catheter tubing and inflated balloon, we must determine how much force is required to pull out the Foley while the balloon is inflated. Our device must activate when 75-85% of this force is applied, thereby allowing prevention of traumatic injury and ensuring that accidental activations of the safety measure are minimal. Due to the high sensitivity of the anatomical area where Foley Catheters are placed, we aim to minimize the weight of the safety mechanism that we put in place. For example, if the weight is too large, a torque could be produced about the urethral exit, causing discomfort to patients. The material used is another safety consideration. Any material that is utilized should not cause allergic reactions or be abrasive such that the patient is not harmed. There should also not be any electronic components in the device in order to decrease both the risk of injury and potential malfunction.
Foley catheters are used by hospitals in large quantities; given the increasing regulation and cost of treating patients, healthcare systems cannot afford to spend more money for basic devices like IVs and catheters. For this reason, the price of the catheter we develop should not exceed 110% of the existing market price. In addition, if the safety device is activated, it should not render the catheter unusable. Just as hospitals cannot afford expensive catheters, it would be ideal to not require new purchases whenever the safety mechanism is deployed. Furthermore, this makes re-catheterization much more convenient for the healthcare provider. Finally, the number of distinct parts should be kept to a maximum of 3 in order to maintain ease of use for the attending caretaker. Hospitals are a setting in which time is highly valued; as such, ensuring ease of use is of upmost importance.