{"id":69362,"date":"2022-03-25T12:21:12","date_gmt":"2022-03-25T16:21:12","guid":{"rendered":"https:\/\/seniordesign.digitalscholar.rochester.edu\/spring2022\/?p=284"},"modified":"2022-09-12T10:29:40","modified_gmt":"2022-09-12T14:29:40","slug":"cardio1","status":"publish","type":"post","link":"https:\/\/www.hajim.rochester.edu\/senior-design-day\/cardio1\/","title":{"rendered":"CalCatch"},"content":{"rendered":"\n
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Designed for Cardiac Surgeons.
Dedicated to Catching Calcium.<\/em><\/p>Meeting the needs of our customer while
delivering innovative solutions aimed for our patients.<\/cite><\/blockquote>\n\n\n\n

Meet the Team<\/span><\/h2>\n\n\n\n
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Nandita Bhowmik<\/a><\/p>\n\n\n\n

BS in BME \u201921, University of Rochester<\/p>\n\n\n\n

MS in BME \u201822, University of Rochester<\/p>\n<\/div><\/div>\n\n\n\n

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Bahie Ezzat<\/a><\/p>\n\n\n\n

BS in BME \u201920, University of Rochester<\/p>\n\n\n\n

MS in BME \u201822, University of Rochester<\/p>\n\n\n\n

MD Candidate \u201826, Mount Sinai<\/p>\n<\/div><\/div>\n\n\n\n

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Our Mission<\/span><\/h2>\n\n\n\n

Our mission is to significantly reduce<\/strong> post-surgical SAVR life-threatening complications<\/strong> caused by calcified debris – a  major risk factor for embolic events like stroke. CalCatch envisions that the Calcium Catcher will transform the outcomes of surgical aortic valve replacement (SAVR) procedures, resulting in a considerable reduction in mortality and other high-risk events caused by calcified debris remaining in the heart due to inadequate techniques being used today.<\/p>\n\n\n\n

Biodesign Statement<\/span><\/h2>\n\n\n\n

A device for cardiothoracic surgeons<\/strong> to capture embolic debris<\/strong> from falling into the left ventricle during surgical aortic valve replacements (SAVR) to reduce the number of particulates<\/strong> left behind and mitigate their associated risk of stroke. <\/p>\n\n\n\n

Problem<\/span><\/h2>\n\n\n\n

The leading cause of surgical aortic valve replacements (SAVR) is the build-up of calcium on the aortic valve, requiring the excision and debridement of the valvular leaflets before placing a new prosthetic valve. SAVR is expected to be a common procedure as the geriatric population expands and the number of Americans living with severe stenosis exceeds 1.5 million. CalCatch is introducing an embolic protection device for SAVR. During this procedure, calcified debris may fall into the left ventricle, as shown in Figure 1. Hence, when blood flow is restored, the embolic debris can enter the systemic circulation and cause embolic events such as stroke or cardiac arrest. As a result of the indirect causal relationship between dislodged debris and stroke rates, our team has developed a device currently not available in the medical device market, which addresses this unmet clinical need. This has been validated by our Key Opinion Leader for SAVR, Dr. Peter Knight, Chief of Cardiothoracic Surgery at the University of Rochester Medical Center (URMC). Our product was also endorsed by numerous URMC residents, including Dr. Clauden Louis and Dr. Nicholas Searcy, as well as the URMC Director of Value Analysis and Chief of Quality.<\/p>\n\n\n\n

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Figure 1. A top-view image when the aortic valve leaflets are excised. This image portrays how the calcified debris from the annulus (not shown) can easily fall into the left ventricular outflow tract (LVOT). <\/em><\/strong><\/figcaption><\/figure><\/div>\n\n\n\n

<\/span>Current Solutions and their drawbacks<\/span><\/h2>\n\n\n\n

The Calcium Catcher does not have competing, commercially available technologies that capture calcified debris in SAVR procedures. Surgeons currently address this need with two approaches. The first is repeated use of suction while the other technique is the off-brand use of a surgical sponge doused in saline. The sponge gets packed into the left ventricle with no particular form or structure. Essentially, the goal for both of these techniques is to capture and remove most of the calcified debris. This is a vital component of the surgery because once the patient is taken off of the cardiopulmonary bypass (CPB) machine, the restored blood flow can dislodge any remaining debris into the circulatory system, which results in a stroke. However, how effective are these surgical techniques for ensuring that calcified debris is removed?<\/p>\n\n\n\n

When observing the procedure in the operating room, the sponge is taken out in a manner that lends itself to dislodging some debris back into the left ventricle if not, at least, the microscopic level ones. The exact number of incidences of calcium embolization caused by any open-heart surgery is unknown. Sometimes the translocation of emboli to places other than the heart, brain, and kidneys is asymptomatic, which makes it difficult to determine the source of a stroke after such surgeries. Nonetheless, multiple attendings and fellows stated that a surgeon would always prefer to use a way to reduce chances for peri-operative stroke, which is strongly associated with calcium. Therefore, this is an unmet clinical need that still requires a device that would effectively catch calcified, stroke-inducing debris.<\/p>\n\n\n\n

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Table 1<\/em>. A list of existing surgical techniques attempts to address the problem listed and similar devices that are no longer on the market.<\/em><\/figcaption><\/figure><\/div>\n\n\n\n

Our Product: <\/span>
Calcium catcher<\/span><\/h2>\n\n\n\n

With the Calcium Catcher, cardiothoracic surgeons will now enhance patient-centered care with a novel device designed to mitigate the risk of stroke. The Calcium Catcher is a solution for cardiothoracic surgeons to limit the number of embolic calcium particles remaining behind in the heart following SAVR. Given its robust cylindrical design, the Calcium Catcher helps capture any calcium that falls from the aortic valve with its tapered top and optimized fifty-micron mesh (shown in Figures 2 and 3). The device\u2019s balloon inflation mechanism offers surgeons a secure placement after deployment and better stability throughout usage. <\/p>\n\n\n\n

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Figure 2. The device is placed with the inflated balloon in the LVOT under the aortic valve (not showing the associated tubing extending from the device).<\/em><\/strong><\/figcaption><\/figure><\/div>\n\n\n\n
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Figure 3. These two images are 3D models of the device’s internal structure where the balloon is fitted at the center of the body with O-rings at each ridge.<\/em><\/strong><\/figcaption><\/figure><\/div>\n\n\n\n

Testing Plan<\/span><\/h2>\n\n\n\n
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Test #1:<\/span><\/strong> Does the device stay in place?<\/summary>
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Objective:<\/strong><\/p>\n\n\n\n

Determine how much CC of air (volume) is needed for the balloon to remain inflated and stay in place while supporting a weight of 55g.<\/p>\n\n\n\n

Specification Tested:<\/strong><\/p>\n\n\n\n

The device shall maintain its position after deployment once inflated with less than 20 CCs of air. <\/p>\n\n\n\n

Variable:<\/strong><\/p>\n\n\n\n

Record the amount of air needed to keep the device in place that can hold the weight of a 30mL cylinder (55g) for 10 seconds at least.<\/p>\n\n\n\n

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Output from JMP to conclude the following results:<\/em><\/figcaption><\/figure>\n\n\n\n

Results:<\/strong>
The final device needs at least 11 <\/strong>CCs with a 95% confidence interval of air to inflate the balloon such that the device can stay in place while supporting 55g in the air for at least 10s. The appropriate range is within 11-12 CC (rounded to the nearest whole number), which influences the choice of syringe that will come with the device.<\/p>\n\n\n\n

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Figure 3. Image of Set-Up for Test 1<\/p>\n<\/div><\/details><\/div>\n\n\n\n

Test #2:<\/span><\/strong> What percent of the calcium is caught in the device?<\/summary>
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Objective: <\/strong>
Determine how much calcium can be caught by the device to suggest its effectiveness through the benchtop model indicated in Figure 4.
Specification Tested: <\/strong>
The device can catch at least 90% of calcium debris (size ranging upwards of 0.77 mm).
Variable: <\/strong>
Record the amount of calcium that was not captured in the device (fell into the box or on the rims of the benchtop model) to calculate the percentage of calcium captured by the device. <\/p>\n\n\n\n

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Outputs from JMP with a t-test to compare the data collected by the two different users indicate no significant difference (on the left), so the data could be pooled for further analysis to determine the range of percentage of calcium caught by our device (on the right). <\/em><\/figcaption><\/figure><\/div>\n\n\n\n

Results:<\/strong>
The range of the percent of calcium caught by the device is 94-97% with a confidence level of 95%, so this has exceeded the minimum specification value of 90%. <\/p>\n\n\n\n