Balloon encapsulation and isovolumetric suction thrombectomy catheter and methods thereof

Abstract

The disclosure provides for an adjustable catheter system with isovolumetric suction and restoration of fluid for the removal of a thrombus and a method of use thereof. The catheter system includes an inner catheter and an outer sheath surrounding at least a portion of the inner catheter. The inner catheter may include at least three lumina extending from the proximal end to the distal end of the inner catheter, at least one infusion fenestration along the infusion segment, and a distal encapsulation balloon at the distal end. The outer sheath may include at least three lumina extending from the proximal end to the distal end of the outer sheath and a proximal encapsulation balloon at the distal end. The catheter system may further include an agitator for mechanical morcellation of the thrombus.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]This application claims priority to U.S. Provisional Application No. 62 / 842,975, filed May 3, 2019, and U.S. Provisional Application No. 62 / 736,890, filed Sep. 26, 2018, the contents of which are entirely incorporated by reference herein.FIELD[0002]The present disclosure is directed to a balloon encapsulation suction thrombectomy catheter and methods of use thereof.BACKGROUND[0003]Over the past two decades the incidence and prevalence of deep vein thrombosis (DVTs) and pulmonary embolism (PE) have increased due to higher use of indwelling central venous catheters (CVCs), inferior vena cava (IVC) filters, and venous stent implantations. The most common risk factors for DVT and / or PE include age, obesity, pregnancy, pharmacological contraception, malignant disease, and immobility. The etiological factors of DVTs and PEs are found among Virchow's triad of venous blood stasis, venous injury, and hypercoagulability. Under these circumstances, ...

AI Technical Summary

Benefits of technology

The patent text describes a method for treating blockages in blood vessels using an infusion solution containing tPA and a negative suction applied for about 2 minutes. The blockage is mechanically cleared by advancing and retracting an agitator over the catheter lumen, or by rotating the agitator. The method can restore greater than about 90% luminal patency of the treatment area.

Problems solved by technology

Incomplete resolution can lead to further thrombus propagation, instability, fragmentation, chronic thromboembolic pulmonary hypertension (CTEPH), and venous thromboembolism (VTE).

However, even when thrombus is stabilized and propagation is prevented, the resultant residual obstructive chronic DVT within the venous structure can lead to post-thrombotic syndrome (PTS).

However, all have limited efficacy in the treatment of PE.

There are currently no endovascular devices that are specifically designed for the treatment of massive (PE causing hemodynamic compromise) and sub-massive PEs (PE causing cardiac dysfunction).

Additionally, recent evidence from various large multicenter randomized controlled trials has questioned the efficacy of CDT endovascular devices.

In particular, existing technologies have the following limitations: lack of a clot removal device tailored for the iliocaval venous system, ineffective localized thrombolysis leading to systemic dispersal, ineffective encapsulation of clot during lysis to avoid VTE, and atraumatic thrombectomy to avoid venous wall damage and long-term PTS.

Images