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. 2022 May 6:2022:7500175.
doi: 10.1155/2022/7500175. eCollection 2022.

The Cobra Catheter: A Novel Concept and Device for the Thru-Septal Myocardium Approach

Min-Ku Chon  1 , Dong-Hoon Shin  2 , Su-Jin Jung  3 , June-Hong Kim  1
Affiliations

The Cobra Catheter: A Novel Concept and Device for the Thru-Septal Myocardium Approach

Min-Ku Chon et al. J Interv Cardiol. .

Abstract

Objectives: In our previous study, we suggested the novel septal traversing technique as effective and safe in catheter-based approach for septal myocardium. However, it is limited by its dependence on the septal perforator vein. This study aimed to evaluate the Cobra catheter as a backup catheter to overcome this limitation in swine.

Methods: We designed the guiding Cobra catheter. It consisted of three major parts (the external pull-wire steerable distal tip, the C-shaped shaft, and the steering adjustment handle). We tested the difference in force between the guidewire passing through the muscle and the vessel wall using a push-pull gauge. We performed a septal wire engage procedure in swine using the Cobra catheter. The guidewire engagement of the septal vein and Cobra catheter were compared visually and histopathologically.

Results: A total of ten swine were enrolled in this study. The success rate was 100% under fluoroscopy. The experiments confirmed the medical potential of the septal approach even in a location irrelevant to the septal perforator vein anatomy and confirmed that the wire passed well in the target direction in the harvested heart. There was no serious physical damage or pathological abnormalities in the vessel wall and myocardium.

Conclusion: These results showed that the novel Cobra catheter with a septal vein-independent trans-septal approach may be a safe and effective alternative for the treatment of structural heart diseases.

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Conflict of interest statement

June-Hong Kim has intellectual property of the Cobra catheter, stock of Tau-PNU, and is currently working as the clinical director of Tau-PNU MEDICAL Co., Ltd. Su-Jin Jung is currently working in the R&D Department of Tau-PNU MEDICAL Co., Ltd and participated in the device development. The other authors declare that they have no conflicts of interest regarding the publication of this paper.

Figures

Figure 1
Figure 1
The conceptual illustration of (a) the guidewire engaging the myocardium of patients through the septal vein and (b) the role of the Cobra catheter in patients without a septal vein.
Figure 2
Figure 2
The Cobra catheter design. (a) The distal tip of the Cobra catheter is oblique-shaped to establish complete contact with the vessel wall. The wire outside the sheath creates a bending moment when the wire is pulled by the rotating handle. (b) The preshaped catheter shaft provides an appropriate degree of angulation and torquability to guide the guidewire towards the desired direction. The curve matches the prospective shape of the coronary sinus. (c) This design provides an adequate backup force to directly engage the guidewire through the punctured vessel structure.
Figure 3
Figure 3
Procedural steps and wire positioning results. (a) The guidewire naturally passing through the myocardium with a force of 0.04 N (4.08 gf). (b) The guidewire requiring a force of 0.45 N (45.89 gf) to traverse the vessel wall and penetrate the myocardium.
Figure 4
Figure 4
Procedural steps and wire positioning results. (a) Fluoroscopy confirms the anatomy without the septal vein. (b) The guidewire engages the Cobra catheter. (c) The Cobra catheter distal tip angulation towards the direction of the guidewire. (d) The guidewire in the septum.
Figure 5
Figure 5
Visual inspection and pathology. Successfully engagement of the guidewire into the septal myocardium in both (a) the Thru-Septal approach and (b) by a direct myocardial puncture with the Cobra catheter. (c, d) Visible hemorrhagic lesion and foci with no ischemic change or necrosis. Slight hemorrhage without muscle damage in the posterior portions of the ventricle.
See this image and copyright information in PMC

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