Abiomed

Overview:

Abiomed specializes in the Impella technology. The Impella is a minimally invasive ventricular assist device that is inserted into the patient percutaneously. The Impella product line is designed to let the heart rest by improving blood flow and/or performing the pumping of the heart. As a part of the access and closure team, our goal was to come up with novel accessories to aide in the minimally invasive implantation of the Impella product line (Device Animation). These devices, used to create a pathway between the skin level and the arterial/venous system, are commonly called introducer sheaths, or just indtroducers.

Abiomed Introducer Sheath & Dilator - design & manufacture

Project/Role:

To avoid the continued need of physicians to use off-the-shelf introducers, that only marginally worked for the Impella product line, the access team worked to design an Abiomed/Impella custom system.

Action:

Use feedback from physicians on what aspects of current off-the-shelf products are beneficial or not. Incorporated feedback with Impella specific features.

Minimized introducer sheath tip profile
Long-taper dilator design to diminish need for multiple size dilators
Material selection to enable stiffness for insertion, but flexibility to navigate tortuous anatomy
Work with vendor to design tooling and initial manufacturing procedure for tip molding
Worked with vendors to come up with lubricious coatings durable enough withstand all product use

Result:

Created initial manufacturing procedures using in-house equipment to prove design feasibility and efficient tip manufacturing processes. Built 50 'prototype' assemblies in house using overmolding, RF thermoforming, and 3D printing. Ran feasibility testing on N=10+ samples proving improved performance over current product. Full drawing package for assembly.

Hemostasis Valve

Project/Role:

As a part of a new the Impella CP Introducer sheath system I developed the hemostasis valve, the valve hub, and the cap that seals the valve into the hub. The hemostasis valve must allow various sized devices to pass easily through it, yet maintain full hemostasis with the pressurized vessel (no blood leakage).

Action:

Novel o-ring valve design creating robust & reliable valve compression to hub/hub-cap - straightforward molding
New hub/hub-cap design simplified product assembly - straightforward molding
New design incorporates features for ultrasonic welding assembly

Result:

Successfully molded valves, hubs, and caps with prototype and long-term vendors. Established repeatable assembly procedures. Completed successful feasibility testing - device insertion/removal force and short term leak performance with all applicable devices. Began simulated aging testing. Patent in Application.

specifics on design sensitive to Abiomed, hence limited details and photos

a)Hub b)Hub-cap c)Valve O-ring seal

O-ring of valve compressed between the hub and hub-cap when the 3 parts are assembled via ultrasonic welding between the hub and hub-cap

a)Ultrasonic weld joint b)Hub-cap / sonotrode interfacing surface feature

Shear/mash joint ultrasonic weld design. Idea to minimize the overall part profile while maintaining a robust connection.

Simulated Femoral Access Model

Project/Role:

Create a benchtop setup that can simulate a physicians experience when inserted an introducer sheath. To use as a repeatable model for feasibility testing prior to an animal/cadaver model (expensive, lot of work to schedule).

Action:

Find simulated vessel, subcutaneous tissue, and skin to represent a patients
- Porcine aorta, pork tenderloin, synthetic skin
Created an assembly method to effectively 'sandwich' the layers together in a representative way
Design and manufacture a complete fixture to allow simulated insertion into a pressurized vessel
- CNC & manual mill/lathe, outside machine shop vendors

Result:

Successfully created a fixture to closely simulate the feeling of inserting an introducer sheath assembly into a pateints anatomy. After proving the concept, produced a total of 5 of the fixtures that were used for product feasibility, verification, and validation on multiple projects. Released full drawings of fixture and completed IQ/OQ's.

3D Printing Station

Project/Role:

Team using 3D printing contractors (e.g. protolabs) weekly if not daily. Access team goal to bring some of these capabilities in house.

Action:

Work with team members to identify 3D printing technology best suited for our uses (small platform SLA).
Purchase 3D printer & accessories (Formlabs, Form 2)
Setup printers/station and learn best practices for printing with various materials and complex geometries
Establish general procedures for printing, washing, curing, and general post processing of parts

Result:

Successfully brought 3D printing to Abiomed as a core competency. After proving the value of in-house printing, lead team expansion to 3 printers. Aided 2 additional Abiomed teams in purchase and setup of printers and ancillary products. Ran multiple training sessions to inform co-workers on general usage of printers and best practices.

Miscelaneous

Plastic Part Design for Injection Molding Seminar: UMASS Lowell
- Worked with professor to customize course content for Abiomed team: 2 day lecture, 1 day lab work

Plastic Extrusion Processing Seminar: UMASS Lowell
- 1 day lecture, 1 day lab work

Advanced Solidworks Part Modeling Training: TriMech
- 3 day class. Topics: multibody solids, sweeping, lofting, guide curves, multi-thickness shelling, helical sweeps, 3D sketching, etc.