Suture Ring for Implantable Medical Device Migration Control
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Solution Overview
Problem
Implantable medical devices (IMDs) face challenges in maintaining stable placement, particularly due to migration issues that can compromise the efficacy of therapies and sensing accuracy, especially for devices like implantable cardioverter defibrillators (ICDs), which require precise positioning to deliver effective defibrillation shocks and sense cardiac signals.
Innovation Solution
The integration of a suture ring coupled to the IMD housing, aligned with the gravitational axis, to prevent migration and rotation by using a metallic or biocompatible material wire forming an annular loop with legs extending to opposing ends, which securely holds sutures or staples, thereby maintaining the device's position relative to the heart.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the IMD housing is made smooth and rounded to promote patient comfort, then patient comfort is improved, but the structural complexity for securing the device increases
Solution Approach 1:
The housing is segmented into a main body and a separate suture ring component. The suture ring is a distinct element that can be attached to the housing, allowing the main housing to remain smooth and rounded for patient comfort while the suture ring provides the necessary structural features for securing the device.
Solution Approach 2:
The suture ring is nested within or integrated into the housing structure. The suture ring can be positioned within a recess in the housing or attached to the housing surface, combining the smooth housing exterior with the functional suture retention features.
2Ease of operation
If the IMD housing size is minimized to promote patient comfort, then patient comfort is improved, but the reliability of device placement stability deteriorates
Solution Approach 1:
The placement stability function is segmented from the main housing by using a separate suture ring component. This allows the housing to remain small for patient comfort while the suture ring provides dedicated structures for secure anchoring through sutures or staples.
Solution Approach 2:
The suture ring acts as an intermediary element between the small IMD housing and the securing sutures or staples. It provides attachment points and structural features that enable reliable fixation without requiring the housing itself to be large or complex.
3Ease of manufacture
If the IMD housing is made simple to minimize manufacturing cost, then manufacturing cost is reduced, but the ability to prevent migration and rotation deteriorates
Solution Approach 1:
The migration prevention function is segmented into a separate suture ring component that can be manufactured independently using simple, cost-effective processes. The main housing remains simple and inexpensive to manufacture, while the suture ring provides the necessary geometric features for preventing migration and rotation.
Solution Approach 2:
The suture ring serves multiple functions: it provides attachment points for sutures, prevents migration, prevents rotation, and can be manufactured using simple processes. This multi-functional element addresses several requirements without complicating the main housing design or manufacturing.
4Ease of operation
If the IMD housing is made smooth and rounded to promote patient comfort, then patient comfort is improved, but the effectiveness of defibrillation therapy deteriorates due to migration
Solution Approach 1:
The therapy effectiveness is protected by segmenting the housing into a smooth main body and a separate suture ring. The smooth housing promotes patient comfort, while the suture ring provides secure anchoring that prevents migration and maintains the critical shock vector for effective defibrillation therapy.
Solution Approach 2:
The suture ring is attached to the housing before implantation, establishing the device's position and orientation in advance. This preliminary action ensures that the device maintains its desired position relative to the heart, preserving the effectiveness of defibrillation therapy throughout the patient's life.
Data Source
AI summary
An implantable medical device housing has an outer surface and an inner surface that defines an interior cavity. A wire is coupled to the housing outer surface. The wire wholly defines an open aperture for receiving a fixation member. The wire includes a first wire end, a second wire end, and an annular loop between the first and second ends. A cover extends over at least the first end and the second end of the wire.