Devices and methods for treating heart failure
First Claim
1. An implantable medical device comprising a braided structure, wherein the braided structure is unitary in construction, a shunt portion comprising a distal end, proximal end, and a tubular body, a distal retention flange comprising a free end and a fixed end, wherein in a deployed profile of the implantable medical device, the fixed end of the distal retention flange connects to the distal end of the shunt portion and the free end of the distal retention flange extends radially outwardly from the fixed end of the distal retention flange and is the most radially outward portion of the distal retention flange, a proximal retention flange comprising a free end and a fixed end, wherein the fixed end of the proximal retention flange connects to the proximal end of the shunt portion, and the free end of the proximal retention flange extends radially outwardly from the fixed end of the proximal retention flange, the distal and proximal retention flanges comprising a diameter of at least 1.2 times that of the shunt portion, and wherein the shunt portion comprises a diameter of about 5-30 mm, and wherein the implantable medical device also comprises a delivery profile in which the shunt portion comprises a first braid angle, the distal retention flange comprises a second braid angle, and the proximal retention flange comprises a third braid angle, wherein the first braid angle is greater than the second and third braid angles, wherein the shunt portion is configured to be positioned within an aperture in an atrial septum, and wherein the shunt portion comprises a hoop strength sufficient to keep the aperture open and allow blood flow from the left atrium to reduce elevated pressure.
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Accused Products
Abstract
The present teachings provide a device and methods of making and using thereof. Specifically, one aspect of the present teachings provides a self-expandable device with a braided structure comprising a shunt, a distal retention flange, and a proximal retention flange. Upon the device being deployed at a treatment location, the distal retention flange or the proximal retention flange transitions to have a diameter that is greater than the diameter of the shunt portion. And the shunt portion has a braid angle θ. Another aspect of the present teachings provide that the ratio of flange/shunt diameter equals or greater than 1/sin θ. Yet another aspect of the present teachings provides an axial constraining mechanism to reinforce the shunt portion.
397 Citations
19 Claims
- 1. An implantable medical device comprising a braided structure, wherein the braided structure is unitary in construction, a shunt portion comprising a distal end, proximal end, and a tubular body, a distal retention flange comprising a free end and a fixed end, wherein in a deployed profile of the implantable medical device, the fixed end of the distal retention flange connects to the distal end of the shunt portion and the free end of the distal retention flange extends radially outwardly from the fixed end of the distal retention flange and is the most radially outward portion of the distal retention flange, a proximal retention flange comprising a free end and a fixed end, wherein the fixed end of the proximal retention flange connects to the proximal end of the shunt portion, and the free end of the proximal retention flange extends radially outwardly from the fixed end of the proximal retention flange, the distal and proximal retention flanges comprising a diameter of at least 1.2 times that of the shunt portion, and wherein the shunt portion comprises a diameter of about 5-30 mm, and wherein the implantable medical device also comprises a delivery profile in which the shunt portion comprises a first braid angle, the distal retention flange comprises a second braid angle, and the proximal retention flange comprises a third braid angle, wherein the first braid angle is greater than the second and third braid angles, wherein the shunt portion is configured to be positioned within an aperture in an atrial septum, and wherein the shunt portion comprises a hoop strength sufficient to keep the aperture open and allow blood flow from the left atrium to reduce elevated pressure.
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17. A method of treating heart failure with an implantable medical device, wherein the implantable medical device comprises a braided structure, wherein the braided structure is unitary in construction;
- wherein the implantable medical device comprises a shunt portion comprising a distal end, a proximal end, and a tubular body, a distal retention flange comprising a free end, a fixed end, and an inner tubular surface, wherein the fixed end of the distal retention flange connects to the distal end of the shunt portion, and a proximal retention flange comprising a free end and a fixed end, wherein the fixed end of the proximal retention flange connects to the proximal end of the shunt portion, and wherein the shunt portion comprises a first braid angle, the distal retention flange comprises a second braid angle, and the proximal retention flange comprises a third braid angle, wherein the first braid angle is greater than the second and third braid angles, and wherein the shunt portion is configured to be positioned in an aperture in an atrial septum of a patient and comprising a hoop strength sufficient to keep the aperture open and allow blood flow from the left atrium to reduce elevated pressure, and wherein the distal and proximal retention flanges comprise a diameter of at least 1.2 times that of the shunt portion, and wherein the shunt portion comprises a diameter of about 5-30 mm; and
wherein the implantable medical device comprises a delivery profile and a deployed profile;
the method comprising advancing the distal retention flange of the implantable medical device at its delivery profile through the atrial septum into the left atrium in which the free end of the distal retention flange is the distal most portion of the implantable medical device, and transitioning the free end of the distal retention flange to a generally disc-like shape wherein the free end of the distal retention flange extends radially outwardly from the fixed end of the distal retention flange and is the most radially outward portion of the distal retention flange and the inner tubular surface transitions to form a surface facing away from the shunt portion. - View Dependent Claims (18)
- wherein the implantable medical device comprises a shunt portion comprising a distal end, a proximal end, and a tubular body, a distal retention flange comprising a free end, a fixed end, and an inner tubular surface, wherein the fixed end of the distal retention flange connects to the distal end of the shunt portion, and a proximal retention flange comprising a free end and a fixed end, wherein the fixed end of the proximal retention flange connects to the proximal end of the shunt portion, and wherein the shunt portion comprises a first braid angle, the distal retention flange comprises a second braid angle, and the proximal retention flange comprises a third braid angle, wherein the first braid angle is greater than the second and third braid angles, and wherein the shunt portion is configured to be positioned in an aperture in an atrial septum of a patient and comprising a hoop strength sufficient to keep the aperture open and allow blood flow from the left atrium to reduce elevated pressure, and wherein the distal and proximal retention flanges comprise a diameter of at least 1.2 times that of the shunt portion, and wherein the shunt portion comprises a diameter of about 5-30 mm; and
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19. A device comprising an implantable medical device and a catheter, wherein the catheter comprises a distal end, a proximal end, and a lumen extends proximally from the distal end;
- the implantable medical device comprises a braided structure, wherein the braided structure is unitary in construction, a shunt portion configured to be positioned in an aperture in an atrial septum of a patient and comprising a hoop strength sufficient to keep the aperture open and allow blood flow from the left atrium to reduce elevated pressure, the shunt portion comprising a distal end, a proximal end, and a tubular body, a distal retention flange comprising a free end and a fixed end, wherein in a deployed profile of the implantable medical device, the fixed end of the distal retention flange connects to the distal end of the shunt portion and the free end of the distal retention flange extends radially outwardly from the fixed end of the distal retention flange and is the most radially outward portion of the distal retention flange, a proximal retention flange comprising a free end and a fixed end, wherein the fixed end of the proximal retention flange connects to the proximal end of the shunt portion, wherein the distal and proximal retention flanges comprise a diameter of at least 1.2 times that of the shunt portion, and wherein the shunt portion comprises a diameter of about 5-30 mm, and wherein implantable medical device comprises a delivery profile in which the shunt portion comprises a first braid angle, the distal retention flange comprises a second braid angle, and the proximal retention flange comprises a third braid angle, wherein the first braid angle is greater than the second and third braid angles.
Specification