OCCLUSION ACCESS SYSTEM

• US 20140142418A1
• Filed: 11/19/2012
• Published: 05/22/2014
• Est. Priority Date: 02/09/2012
• Status: Active Grant

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Therix Medical Development Ltd. Co.
• Inventors: Gurley, John, Trautman, Joseph Creagan, Baldwin, Clayton, de La Menardiere, Brice Arnault
• Granted Patent: US 10,092,726 B2
• Time in Patent Office: Days
• US Class Current: 600/424
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61B 2017/22095 accessing a blood vessel true lumen from the sub-intimal space
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 5/064 using markers A61B5/062 takes precedence
• CPC Class Codes: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 2025/0089 Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 2025/0166 Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided
• CPC Class Codes: A61M 2029/025 characterised by the guiding element
• CPC Class Codes: A61M 2205/0266 Shape memory materials
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A catheter system for accessing the central venous system through an occlusion in the neck region.

Claims

1. A catheter system for use by a user for gaining access to the central venous system of a patient through an occlusion in a large vessel in the upper chest region of said patient, the catheter system comprising:

a radiopaque target applied to the exterior of said patient near the clavicle defining a desired exit point;

an elongate working catheter having a proximal end and a distal end;

a user manipulated handle coupled to said proximal end of said working catheter;

said working catheter having a working section proximate said working catheter distal end;

said working section terminating in a blunt dissection tip,

said working catheter having sufficient stiffness push-ability and torque-ability to permit said blunt dissection tip to enter into an occlusion via forces supplied by a user applied to said handle;

whereby the rotation of said handle by said user rotates said blunt dissection tip and defines a rotational position, and translation of said handle defines a distal end location;

a departure angle guide tube in said distal tip near but proximal of said blunt dissection tip, said departure angle guide tube having a shape memory section formed as a curve, and adapted to emerge from a side port in response to a setting on said handle thereby defining a stationary departure angle for a needle wire, and defining the needle wire exit plane;

whereby said working section and target are visualized together to permit a determination of a desirable departure angle, and exit plane and end location, selected together to aim said needle wire at said target;

said needle wire contained and located within said departure angle guide tube and adapted for relative motion with respect to said departure angle guide tube, and passing through said handle where it may be manipulated by said user;

said needle wire having a sharp dissection tip,

whereby the user may force said sharp dissection tip through the occlusion, the vessel wall intervening tissue and skin to exteriorize at the surface of the patient at said target location.

2. The catheter system of claim 1 wherein said blunt dissection tip includes:

a radiopaque feature that varies in contrast under x-ray as a function of the angle of rotation of the tip,

whereby the user can aim and orient the exit plane under fluoroscopic guidance.

3. The catheter system of claim 2 wherein said radiopaque feature is an aperture formed within the body of said distal tip.

4. The catheter system of claim 1 further including:

a knob located on said handle adapted for rotation with respect to said handle said knob turning a captive nut;

a screw form assembly attached to said departure angle guide tube, and operated by said captive nut such that rotation of the knob controls the advancement and retraction of said guide tube.

5. The catheter system of claim 4 further including:

a scale for reading the relative position of said departure angle guide tube with resect to said distal tip.