Tunneling Device for Defibrillator Implantation and Transseptal Puncture

PAGE TITLE

Overview

PAGE SUMMARY

A Drexel University clinician has developed a new medical tunneling device concept that can be used for faster, easier defibrillator implantation and for a range of surgical procedures requiring transseptal puncture.

The current standard of care (SOC) for implantation of a cardioverter defibrillator involves using a guide device to first tunnel beneath the skin from an incision at the side of the chest below the armpit to a second incision at the bottom of the breastbone (sternum). The defibrillator wires are then tunneled to a third incision at the top of the breastbone near the collarbone. Although a routine procedure, these implantations can be difficult as the tools currently used are unable to change direction easily through soft tissue, yet implantation requires significant manipulation of a lead wire and electrode to make a 90 degree turn directly under the skin. As such, the implantation of a cardioverter defibrillator requires multiple incisions, adding surgical complexity and time.

Performing a transseptal puncture to gain access to the left heart, for procedures including mitral valve repair/replacement, pulmonary vein isolation, left atrial appendage occlusion, and implantation of a percutaneous left ventricular assist device, requires traversing similarly complex changes in direction. The current strategy requires multiple attempts at aligning an intravenous catheter with the target puncture zone (fossa ovalis) to access the left atrium from the right atrium. Each failed attempt at this alignment can risk injury, add expense/time, and require additional equipment.

Cardiothoracic surgeon Dr. Randy Stevens has developed a new, directable tunneling device that can overcome these challenges during implantation of a subcutaneous defibrillator and transseptal puncture. This tunneling device can accommodate changes in direction without the need for additional incisions and procedures, reducing the time, complexity, and equipment needed for these interventional procedures.

ADVANTAGES
TITLE:Key Advantages

Facilitates insertion of subcutaneous defibrillator with fewer incisions (from 3 to 1)

Enhances precision and maneuverability during transseptal puncture, which requires precise angle creation

Reduces surgical equipment needed and saves time

Problem Solved
TITLE:Problems Solved

Simplifies implantation of subcutaneous devices through ability to change direction up to 90 degrees

Reduces risk during challenging process of inserting subcutaneous implants in pediatric and neonatal patients

Eliminates need for multiple incisions and extensive tissue manipulation during defibrillator insertion, decreasing infection risk

Easily aligns intravenous catheter with target puncture zone during transseptal puncture (eliminating SOC multiple attempts that increase injury risk, expense, and equipment)

APPLICATIONS
TITLE: Market Applications

Implantation of subcutaneous cardioverter defibrillators in adult, pediatric, and neonatal patients

Value added device for transseptal puncture during transcatheter mitral valve repair/replacement, pulmonary vein isolation, and treating left atrium appendage occlusion

IP STATUS

Intellectual Property and Commercialization Opportunities

Published PCT Application WO 2022/240660 A1

https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2022240660&_cid=P20-LASNG7-63507-1

Available for licensing, please contact us to see visual descriptions for applications of referenced surgical procedures.

Figure 1

Figure 1 Caption:

Figure 1: New device inserted via femoral access introducer sheath and easily lines up with target puncture zone for transseptal puncture to access left atrium.

Figure 2