Inverted balloon neck on catheter

Abstract

A method for thermal bonding of an inverted balloon neck on a catheter, including placing an inverted balloon neck (84) on a shaft (86) of a catheter, and characterized by applying heat at an internal hollow (85) of the shaft (86) where the inverted balloon neck (84) is placed, while applying internal pressure to attach an external surface of the shaft (86) to the inverted balloon neck (84).

Description

FIELD OF THE INVENTION[0001]The present invention relates generally to devices and methods for re-entry into a blood vessel's true lumen from a subintimal space between layers of the blood vessel.BACKGROUND OF THE INVENTION[0002]Chronic Total Occlusion (CTO) is an arterial vessel blockage that impedes proper blood flow beyond the obstruction. Poor blood flow can lead to insufficient delivery of blood to muscles and vital organs. CTO can occur both in the coronary and peripheral arteries, resulting in disability and even death. The underlying cause of CTO is atherosclerosis.[0003]In order to reverse the effects of CTO, proper blood flow must be reestablished. This must be achieved by either driving through and removing the CTO or creating a bypass around the CTO. Under either scenario, the first step is to “cross” or drive a guidewire through or around the CTO. If the occlusion is relatively new, the plaque is likely to be soft and the guidewire will penetrate and cross the plaque. T...

AI Technical Summary

Benefits of technology

[0011]The present invention seeks to provide a device for reentry into a blood vessel's true lumen from an extraluminal or subintimal space of the vessel. The device eliminates the need for rotational orientation and operator direction via imaging guidance. In accordance with an embodiment of the present invention, a balloon catheter automatically bends the catheter's distal end in the direction of the true lumen. The device eliminates the need for a curved needle, and instead allows guidewire direct penetration with or without the support of a straight needle. The device of the invention can improve the technique of cardiologists, vascular surgeons, and radiologists in treating occlusions.

[0016]Folding of the internal layer with minimal or no movement from the external layer will cause the catheter distal end to bend towards the true lumen. By creating a weaker section in the catheter at the proximal base of the balloon, the device leverages the asymmetrical forces and facilitates the tilt in the radial direction for punching through the internal layer back into the true lumen without the need for any imaging system for rotational orientation.

Problems solved by technology

Poor blood flow can lead to insufficient delivery of blood to muscles and vital organs.

CTO can occur both in the coronary and peripheral arteries, resulting in disability and even death.

However, if the plaque has been lodged in the vessel for several weeks or months, the plaque can become much harder as the occlusion becomes fibrotic and calcified, making it almost impossible for a guidewire to cross.

Failure to cross the obstruction is the primary failure mode for CTO recanalization, and often leads to the abortion of the interventional procedure in favor of a surgical bypass procedure instead, with higher costs and complications.

The difficulty in many cases is to direct the guidewire back into the blood vessel's true lumen beyond the occlusion so that this new channel can be dilated and used as an internal conduit for blood supply.

The technique has limited acceptance due to technical challenges of the procedure.

Among those who perform subintimal recanalization, there is a technical failure rate of up to 30% due to the inability to reenter the distal true lumen at the specific desired location.

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