Modular Catheter Solutions for Smarter and More Efficient Catheter Storage
All physicians performing Peripheral Vascular (PV) interventional procedures know that having appropriate devices is critical to success. The medical device industry has responded by commercializing an increased number of specialized balloons, stents, grafts, and other device catheters. Many of these catheter types require dozens or perhaps even hundreds of stock-keeping units (SKUs) to be a viable product solution.
Managing the all the SKUs required can be a problem for hospital systems and other care settings, like an office-based lab (OBL). The necessary variety of balloons, stents, grafts, and other devices has created an explosion in SKU complexity and a physical catheter storage issue.
Dr. Michael Bacharach, Director of Vascular Interventions at North Central Heart in Sioux Falls, describes the situation at his institution: “I mean we got balloons everywhere. We got closets full of stuff. I get asked almost daily, ‘why do you need that? Can we get rid of this? Is there a different catheter device you can leverage instead?’ This is a real issue.”
“I mean we got balloons everywhere. We got closets full of stuff. I get asked almost daily, ‘why do you need that? Can we get rid of this? Is there a different catheter device you can leverage instead?’ This is a real issue.”, Dr. Michael Bacharach
To deal with the boom in balloon and catheter devices, some hospitals and OBLs have moved their catheter products out of the Cath Lab and into remote storage areas to accommodate an expanded catheter product footprint and increased SKU complexity. Over time, this shift in catheter storage has resulted in workflow inefficiencies that may not even be fully appreciated. For example, there are several problems with NOT having Catheter Solutions in the Cath Lab and NOT visible to the physician.
- One, they must wait for balloons and catheters to be fetched from a remote location, which disrupts the flow and prolongs the procedure.
- Two, they can’t see precisely which catheter products are available, so there is some guesswork and ambiguity in getting the next catheter device, meaning the technician may not bring back the correct device.
- Three, they must weigh the downside of the extra time to fetch a catheter device versus having the optimal catheter solution.
Dr. Michael Lichtenberg, Chief Medical Officer of the Angiology Department at the Vascular Centre Clinic in Arnsberg, Germany, describes the situation at his institution this way: “Say I need this particular balloon. It’s not the Cath Lab where I am operating. We have three Cath labs, so I send a technician off to find it in one of the other two Cath Labs. They try one, and it’s not there. They then try the third; maybe it’s there, and then they bring it to me. That can add up to real-time wasted, minute by minute passing where I am just waiting.”
“Say I need this particular balloon. It’s not the Cath Lab where I am operating. We have three Cath labs, so I send a technician off to find it in one of the other two Cath Labs. They try one, and it’s not there. They then try the third; maybe it’s there, and then they bring it to me. That can add up to real-time wasted, minute by minute passing where I am just waiting.”, Dr. Michael Lichtenberg
The increased inventory SKU complexity and shift in catheter device storage can prolong procedure times that physicians and staff may not fully realize. For example, Dr. Gary Ansel, pioneering interventional cardiologist and President of Healthcare Insights, didn’t fully appreciate it until he was editing live taped cases for educational presentations.
“I noticed this because when I was editing live taped cases, I would edit out all the times I said, ‘go get me this…’. Suddenly, we noticed that took up to 15 to 20 minutes out of a 90-minute case. That is a significant time savings”, Dr. Gary Ansel.
“I noticed this because when I was editing live taped cases, I would edit out all the times I said, ‘go get me this…’. Suddenly, we noticed that took up to 15 to 20 minutes out of a 90-minute case. That is a significant time savings”, Dr. Gary Ansel
This is a classic example of unintentionally creating a new problem with the introduction of new technologies. The new and varied catheter products to expand access and improve outcomes in PV interventions have unintentionally extended procedure times.
There is no going backward, no one wants to eliminate therapeutic and catheter options, innovation drives better access and outcomes, so what is the solution?
Solutions through a new catheter architecture
Covellus, a medical device technology company, has looked to other product solutions in different industries for inspiration.
“We saw the root cause for this problem as the conventional way catheter products are designed, explains Bradley Beach, CEO of Covellus. “Conventional catheter products are designed as a unitary assembly or one-piece construction with no avenue for customization by the physician users. This conventional approach to designing catheter products necessitates dozens or hundreds of SKUs for each feature configuration of a balloon, stent, or stent-graft catheter family.”
Continuing, Beach explains that “from our perspective, the medical device catheter industry has largely overlooked certain aspects of modular design theory. Specifically, the benefits of user customization through a modular design architecture. Consider that in most other product categories, user customization is a desirable feature with many benefits. Plus, once customization is adopted, there is often no going back. For instance, are you going to throw away your smartphone and go back to a flip phone? Of course not. Modular applications are here to stay.”
The Covellus innovation is a “two-piece (dual module)” modular catheter architecture, combining two modules with independent features at the distal end. Located at the distal end of the catheter are the essential features that impact an intervention. With Covellus Modular Catheter Systems, a physician combines features on the back table during a procedure to customize a base parent catheter (base module) with smaller Adapter modules, creating a unique Catheter Solution.
A good example of this architecture and how it can solve the catheter storage issue of increased SKU complexity is the Modular Balloon System, the first Covellus product.
The Modular Balloon Solution
Percutaneous Transluminal Angioplasty (PTA) balloons have been around since the inception of modern endovascular surgery 40 years ago. PTA balloons are not perfect, but they are easy to use and have become the backbone for many vascular therapies and interventional techniques. Nowadays, balloon catheter types span many configurations and with many features. For example,
- different guidewire compatibilities (.014”, .018” and .035”),
- Over the Wire (OTW) and Rapid Exchange (RX) configurations
- inclusion of scoring and cutting features
- as a drug delivery platform (drug-coated balloon, DCB)
- reinforced balloons for high-pressure applications
- and even as a structure to deliver lithotripsy energy
Each of the balloon types above may require several dozen SKUs to make it a viable product solution. This is because each balloon type must come in many combinations of balloon diameters, balloon lengths, and catheter lengths for it to be of value to a physician. There is no one size fits all balloon. Given the conventional design approach, one can see how SKU complexity can explode to the point where catheter storage is an issue and a source of procedural inefficiencies.
Using its Modular Catheter Architecture, Covellus has developed the Modular Balloon System, the industry’s first modular catheter system, to address this issue.
The Covellus Modular Balloon System empowers physicians to combine a Parent .035” PTA Balloon catheter (base module) with a Distal Adapter module at the distal end of the Parent .035” PTA Balloon when needed during a procedure. This is a dramatic shift from the conventional balloon design approach.
Physicians can use the Parent Balloon in two ways:
- either with an 0.035” guidewire in the typical or standard fashion for PTA
- or attach a Distal Adapter to create one of the other balloon configurations they might need or even feature configurations that are not available as a conventional commercial catheter.
With the Covellus Modular Balloon System, a single Distal Adapter (SKU) can transform the Parent Balloon in the following ways:
- be converted from an over-the-wire system to a monorail (rapid exchange) system.
- facilitate crossing a tight lesion by adding a crossing tip.
- be combined with an IVUS Adapter to add enhanced real-time imaging diagnostics.
- be converted to a scoring device by adding a Scoring Adapter.
- be converted to a drug-coated balloon by adding a Drug Delivery Adapter.
- be adapted for compatibility with smaller guidewires
- be combined with a focal high-pressure balloon
- be combined with intravascular lithotripsy
- among other feature combinations.
The idea is that by replacing the dozens of SKUs for many of the necessary balloon catheter types with a single SKU, hospital systems, and other care settings can bring more of the desired Balloon Solutions back into the Cath Lab and in easy reach of the physician during a procedure. In addition, the reduced SKU complexity of a modular design architecture enables hospital systems to implement smarter and more efficient catheter storage.
The Covellus Modular Architecture is just one example of a larger trend toward modular thinking in healthcare. From catheters to robotic surgeries, many forward-thinking companies are using the theory of modularity to bring customizable solutions to hospitals and physicians. The innovative hospital systems and care providers who implement these new solutions will lead the way in creating smarter and more efficient healthcare for the future.