Engineering the Next Generation of Artificial Hearts

PADT Medical is helping SynCardia Systems Inc. meet the anticipated demand for its artificial heart medical device. SynCardia, a Tucson-based company, manufactures the CardioWest™ temporary Total Artificial Heart (TAH-t). The TAH-t is the only temporary total artificial heart in the world that has both FDA and CE approval for the treatment of severely ill patients with end-stage biventricular failure. SynCardia anticipates increased demand for the TAH-t upon FDA approval of its portable driver technology. Recent shifts in reimbursement policy by the Centers for Medicare and Medicaid Services (CMS) are also anticipated to increase demand for the TAH-t.

SynCardia has contracted PADT to provide engineering services on the development of the next-generation of implants. According to Mike Gaul, Chief Operating Officer of SynCardia;

“PADT is providing engineering expertise to help us develop our next-generation of total artificial hearts. Their medical device testing and CFD fluid-flow modeling capabilities are providing valuable insight into the performance of these products.”

SynCardia has a small 50cc TAH-t, under development, which is targeted for patients with a body surface area (BSA) of 1.0 to 1.7, to complement the existing 70cc TAH-t, which is generally used for patients with a BSA of 1.7 or greater. In addition, SynCardia is developing Pediatric Ventricular Assist Devices (VADs). The 10cc and 30cc VADs are intended to be short term devices that in some cases allows the native heart to fully recover.

PADT is well equipped to develop innovative cardiovascular medical devices. These devices have a host of challenging design requirements including biocompatibility, fluid dynamics, and difficult geometric constraints. PADT’s experience with these challenges is proving valuable to customers like SynCardia. Contact us for more information about PADT’s expertise in the development of cardiovascular related medical devices.

Join us for the next Council Connect event on Rapid Prototyping at PADT on 2/26/2009

Here is the Agenda:

7:30AM – Registration & Continental Breakfast
8:00AM – Welcome & Introductions
Steven G Zylstra, President & CEO, Arizona Technology Council
8:10AM - Presentation: Rapid Prototyping Product Innovation
Presenter: Eric Miller, Principal, Director, Analysis & Design Technologies (PADT)
9:00 – Panelist Questions
Moderator: Eric Miller, Principal, Director, Analysis & Design Technologies (PADT)
Panelist: Rey Chu, Director of Rapid Manufacturing Technologies, PADT, Inc.
Panelist: Brad Palumbo, RP Expert, PADT Inc.
Panelist: Renee Palacios, FORTUS Channel Manager, Stratasys, Inc.
9:15AM - Tour of Rapid Prototyping Systems
9:30AM – Conference ends, Steven G Zylstra

Click here for more information and to register for the event.

Shape Setting Nitinol for a Medical Device Prototype

This week I enjoyed the excitement and frustration of shape setting Nitinol tubing for a prototype medical device used for a demonstration. I obtained samples from NDC and Memry . Both provided free samples within days. Nitinol is commonly used in medical devices because of its superelastic or shape-memory characteristics. In my application, I am taking advantage of the superelastic properties.

Shape setting Nitinol is a quick and easy process provided you have the appropriate equipment. To shape set the Nitinol, I created a fixture to securely hold the Nitinol to the desired shape. I then pre-heated an oven to 500-550°C. Next, I placed the part in the oven for 1 minute. I then removed the part and immediately quenched it in water. If you overheat the part it will reduce its superelastic properties.

The key to designing parts with Nitinol is to obtain material and start testing as soon as possible. Nitinol is NOT an easy material to design with because it does not have a linear stress-strain curve like stainless steels. Hence, most design formulas are not applicable. This week I learned that even though think-walled Nitinol tubes are flexible, they will splinter when compressed axially.

By Margaret Koga

PADT is Celebrating 15 Years of Service

PADT is celebrating 15 years of service by inviting all who are interested to join us on March 12th for an open house and celebration. Here's a flyer. Come and celebrate with us!

Posted by: Scott Klopfenstein

Developing Next-Generation Surgical Devices

PADT Medical has a growing expertise in the development of "non-invasive" and Natural Orifice Transluminal Endoscopic Surgury (NOTES) medical devices. PADT Medical was contracted to by SafeStitch Medical Devices to develop and deliver a transoral sugical device for the treatment of obesity (shown below).




This device is patented by SafeStitch Medical Devices. SafeStich offers the following description on there website about this device:

The Obesity Device is introduced through the mouth and esophagus and works by suctioning two sides of the stomach lining into position for suturing, impaling the mucosa or stomach lining, placing a row of sutures through the two sides of the stomach, as commonly done during gastric surgery, injecting adrenaline into the mucosa to elevate it for excision, excising the top layer of the entrapped stomach wall, releasing this tissue, removing the device and tightening the sutures. [link]

Here is a news article that provides additional discussion and links on the future of surgery using NOTES techniques and medical devices.

Posted By: Scott Klopfenstein