Intravascular flow restrictor

• US 7,001,409 B2
• Filed: 04/07/2003
• Issued: 02/21/2006
• Est. Priority Date: 03/01/2002
• Status: Expired due to Term

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Original Assignee: AGA Medical Corporation (Abbott Laboratories)
• Inventors: Amplatz, Kurt
• Primary Examiner(s): Woo, Julian W.
• Assistant Examiner(s): NGUYEN, VI X
• Application Number:
  US10/408,805
• Publication Number:
  US 20030171772A1
• Time in Patent Office: 1,051 Days
• Field of Search: 606/151, 606/157, 606191-200, 606/213, 606/104, 606/105, 606/107, 128/898, 623/1.51, 623/901
• US Class Current: 606/213
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/068 Modifying the blood flow model, e.g. by diffuser or deflector

Abstract

An intravascular flow restrictor comprises a braided tubular structure designed to be placed in the main pulmonary artery for limiting blood pressure in the lungs. The braided structure is designed to be collapsed for placement in a delivery catheter but when ejected from the delivery catheter, assumes a substantially larger diameter disk shaped device having one or more longitudinal channels or passways therethrough.

Claims

1. A method for reducing blood pressure to which the lungs of a patient having a septal defect are exposed, comprising the steps of:

(a) providing a tubular, braided flow restrictor device exhibiting an expanded state sized to span the patient'"'"'s pulmonary artery and an elongated, stretched state sized to fit within a lumen of a tubular loading member;

(b) assembling the flow restrictor device to a distal end of a pusher device;

(c) inserting the pusher device into the lumen of a tubular loading member and drawing the flow restrictor device into the lumen of the loading member by applying a pulling force to the proximal end of the pusher device;

(d) routing a guide catheter intravascularly until the distal end of the guiding catheter has entered the ostium of the pulmonary artery;

(e) attaching the loading member to the guiding catheter and pushing the flow restrictor with the pusher device to a desired location in a pulmonary artery;

(f) expelling the flow restrictor device from the distal end of the guiding catheter, the flow restrictor device self-expanding to its expanded state to lodge in the pulmonary artery; and

(g) uncoupling the pusher device from the flow restrictor device and withdrawing the pusher device and guiding catheter form the patient'"'"'s body.

2. The method of claim 1 wherein the pulmonary artery is one of a main pulmonary artery, a right pulmonary artery and a left pulmonary artery.

3. A method for treating a patient having TGA comprising the steps of:

(a) performing the Rashkind procedure for creating an enlargement of a natural opening in the atrial septum; and

(b) installing an implantable medical device in the enlarged opening created by step (a) where said implantable medical device comprises a plurality of metal strands woven into a woven metal fabric having a proximal end and a distal end, each end having a means for securing each end attached to said woven metal fabric, thereby gathering said strands and inhibiting unraveling of the strands, said woven metal fabric having an expanded preset configuration shaped to create a restriction in a blood vessel, said expanded preset configuration being in a shape of a cylindrical disk of a predetermined thickness having at least one lumen extending through the thickness dimension of said disk and deformable to a lesser cross-sectional dimension for delivery through a channel in a patient'"'"'s body, the woven metal fabric having a memory property whereby the medical device tends to return to said expanded preset configuration when unconstrained.

4. A method for treating a patient having portal hypertension comprising the steps of:

(a) creating a shunt path between the right hepatic vein and the portal vein; and

(b) installing an implantable medical device in the shunt path created in step (a) where said implantable medical device comprise a plurality of metal strands woven into a woven metal fabric having a proximal end and a distal end, each end having a means for securing each end attached to said woven metal fabric, thereby gathering said strands and inhibiting unraveling of the strands, said woven metal fabric having an expanded preset configuration shaped to create a restriction in a blood vessel, said expanded preset configuration being in a shape of a cylindrical disk of a predetermined thickness having at least one lumen extending through the thickness dimension of said disk and deformable to a lesser cross-sectional dimension for delivery through a channel in a patient'"'"'s body, the woven metal fabric having a memory property whereby the medical device tends to return to said expanded preset configuration when unconstrained.

5. A method for treating patients to reduce protein-losing enteropathy following a Fontan operation comprising the steps of:

(a)forming a fenestration in a surgically-created Fontan channel; and

(b)installing an implantable medical device in the fenestration where said implantable medical device comprises a plurality of metal strands woven into a woven metal fabric having a proximal end and a distal end, each end having a means for securing each end attached to said woven metal fabric, thereby gathering said strands and inhibiting unraveling of the strands, said woven metal fabric having an expanded preset configuration shaped to create a restriction in a blood vessel, said expanded preset configuration being in a shape of a cylindrical disk of a predetermined thickness having at least one lumen extending through the thickness dimension of said disk and deformable to a lesser cross-sectional dimension for delivery through a channel in a patient'"'"'s body, the woven metal fabric having a memory property whereby the medical device tends to return to said expanded preset configuration when unconstrained.