EXPANDABLE BODY DEVICE AND METHOD OF USE

• US 20170245864A1
• Filed: 09/17/2015
• Published: 08/31/2017
• Est. Priority Date: 09/17/2014
• Status: Active Grant

• Current Assignee: Artio Medical, Inc.
• Original Assignee: Metactive Medical, Inc.
• Inventors: FRANANO, F. Nicholas, BRUNELL, Stephen, STEPHENSON, Katherine, LOREE II, Howard M.
• Granted Patent: US 11,033,275 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12131 characterised by the type of occluding device
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/1214 Coils or wires
• CPC Class Codes: A61B 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12177 comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2017/00942 hydrophilic
• CPC Class Codes: A61B 2017/00946 malleable
• CPC Class Codes: A61B 2017/00991 Telescopic means
• CPC Class Codes: A61B 2017/12063 electrolytically detachable
• CPC Class Codes: A61B 2017/12068 detachable by heat
• CPC Class Codes: A61B 2017/12095 Threaded connection
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image

Abstract

Disclosed herein are devices, designs, methods of manufacturing and using medical devices comprising expandable bodies for treating saccular vascular aneurysms and occluding segments of blood vessels and other biological conduits. Exemplary expandable bodies include hollow gold structures that can be folded, wrapped, and compressed, joined to a delivery device, advanced to location in the body of patient in need of treatment, expanded by injection of a fluid into the central void, and separated from the delivery device, remaining in place in an open, expanded form without the addition of support structures to the central void. Other expandable bodies include coiled wires that can be loaded into delivery catheters and expelled from the delivery catheters using pusher devices. Also disclosed herein, are methods of using multiple medical devices and expandable bodies where the expandable bodies are placed adjacent to each other to occlude a saccular aneurysm.

Claims

1. A medical device comprising:

a metallic expandable body configured for permanent implantation in an artery or vein, the expandable body comprising;

a distal region, a proximal region generally opposite the distal region, an intermediate region transitioning from the distal region to the proximal region, a center axis extending proximal-distal between the proximal region and distal region;

a wall extending generally continuously through the intermediate region from the distal region to the proximal region to define an exterior surface of the expandable body and an interior surface of the expandable body, the interior surface defining a central void of the expandable body; and

a proximal neck, a distal neck, a proximal nosecone, a distal nosecone, and one or more elastomeric valves;

a triple lumen delivery catheter assembly comprising;

a longitudinally extending body further comprising a proximal end and a distal end generally opposite the proximal end, wherein the distal end of the delivery catheter is operably coupled to the proximal region of the expandable body;

a first hollow member shaft that defines a first lumen that is continuous from the proximal end to the distal end and is configured to accept a guide wire;

a second hollow member shaft that defines a second lumen to allow for passage of a fluid medium from the proximal end to the distal end and into the central void of the expandable body; and

a third hollow member shaft that defines a third lumen to allow for passage of a fluid medium from the proximal end to the distal end and into the blood vessel lumen near the location of the expandable body;

wherein the third hollow member shaft can be separated from the remainder of the delivery catheter, wherein the expanded expandable body can be separated from the delivery catheter by pulling the third hollow member shaft and the remainder of the delivery catheter assembly components apart;

wherein, the one or more elastomeric valves are configured to close a proximal neck or a distal neck when separated from the delivery catheter such that the pressure inside the central void of the expanded expandable body, after separation from the delivery catheter, is less than or equal to the pressure outside the expanded expandable body,

wherein the expandable body is configured to expand from a deliverable configuration to an expanded configuration, the expandable body is attached to the delivery catheter by a friction fit, without glue, adhesive, or a weld; and

wherein, when the expandable body is in the deliverable configuration, the wall assumes a pleated configuration comprising a plurality of pleats folded over in a clockwise direction relative to the center axis or a counter-clockwise direction relative to the center axis to form a folded-over region of the expandable body.

2. The medical device of claim 1, wherein the expanded expandable body possesses sufficient strength to maintain itself in the expanded configuration within a biological space after separation from the delivery catheter;

and wherein no solid or semi-solid material or member, not derived from the patient, is required in the interior volume of the expandable body to at least assist in causing the expandable body to assume or maintain the expanded configuration after separation of the expanded expandable body and the delivery catheter.

3. The medical device of claim 1 wherein:

the first hollow member shaft and the second hollow member shaft form a first catheter assembly with a first proximal hub, wherein the first catheter assembly is engaged to the metallic expandable body and the third hollow member shaft is a second catheter assembly with a second proximal hub;

wherein the first proximal hub and the second proximal hub are engaged in a deployment configuration; and

wherein the first proximal hub and the second proximal hub are disengaged in a detachment configuration wherein the first catheter assembly and the second catheter assembly are pulled apart, resulting in separation of the expandable body from the first catheter assembly.

4. The medical device of claim 1, wherein the first lumen is located centrally in the delivery catheter and is continuous from the proximal end to the distal end.

5. The medical device of claim 1, wherein the second lumen is defined by an annular gap between an inner wall of the second hollow member shaft and an outer wall of the first hollow member shaft and enables a fluid communication between the proximal hub of the delivery catheter and a central void or space of the expandable body.

6. The medical device of claim 1, wherein the third lumen is defined by an annular gap between an inner wall of the third hollow member shaft and an outer wall of the second hollow member shaft and enables a fluid communication between a proximal hub of the delivery device and a blood vessel segment lumen near the location of the metallic expandable body.

7. The medical device of claim 1, wherein the first hollow member shaft comprises:

an outer layer comprising a polymer, such as polyimide;

a middle layer comprising a braided metal;

wherein the middle layer is disposed between the outer layer and an inner layer; and

,

the inner layer comprising a lubricious coating, a lubricious polymer such as PTFE, or a polyimide/PTFE composite.

8. The medical device of claim 1, wherein the second hollow member shaft comprises:

one layer comprising a polymer, such as polyimide; and

a second layer comprising a braided metal;

wherein the middle layer is disposed between the outer layer and an inner layer;

9. The medical device of claim 1, wherein the third hollow member shaft comprises:

a lubricious outer surface coating;

an outer layer comprising a polymer, such as polyimide or Pebax,

a middle layer comprising a coiled metal wire, wherein the middle layer is disposed between the outer layer and an inner layer; and

an inner layer comprising a lubricious coating, a lubricious polymer such as PTFE, or a polyimide/PTFE composite.

10. The medical device of claim 9, wherein the wall of the third hollow member shaft comprises a material with a Shore durometer hardness equal to or greater than 55 Shore D.

11-264. -264. (canceled)

265. A method for treating a peripheral blood vessel with a medical device, the method comprising:

providing a single-lobed metallic expandable body with one or more elastomeric valves, wherein the expandable body is engaged by a friction fit with a delivery catheter disposed within a multi-lumen delivery catheter assembly, wherein the expandable body is configured to expand from a deliverable configuration to an expanded configuration;

delivering the expandable body into the biological space of the patient in a deliverable configuration via the delivery catheter assembly;

wherein the delivery catheter, disposed with in the delivery catheter assembly, defines a first lumen of the detachment catheter assembly, wherein the delivery catheter is engaged to a proximal region of the expandable body by the friction fit;

delivering a fluid medium into the interior volume of the expandable body via a second lumen of the delivery catheter assembly to cause the expandable body to assume the expanded configuration;

decoupling the expandable from the delivery catheter assembly by disengaging the friction fit; and

obstructing the flow of blood within the interior volume of the expanded expandable body with the one or more elastomeric valves.

266. The method of claim 265, wherein decoupling the expandable from the delivery catheter assembly comprises retracting the delivery catheter such that a portion of the expandable body in the expanded configuration contacts a distal region of the delivery catheter assembly.

267. The method of claim 265, wherein decoupling the expandable from the delivery catheter assembly comprises advancing the delivery catheter assembly while holding the delivery catheter steady such that a portion of the expandable body in the expanded configuration contacts a distal region of the delivery catheter assembly thereby.

268. The method of claim 265, further comprising:

injecting a fluid contrast agent through a second lumen of the delivery catheter assembly.

269. The method of claim 268, wherein the fluid contrast agent is injected after expansion of the expandable body.

270. The method of claim 268, wherein the fluid contrast agent is injected after expansion of the expandable body prior to expansion of the expandable body.

271. The method of claim 268, wherein the fluid contrast agent is injected after expansion of the expandable body prior to expansion of the expandable body after detachment of the expandable body.

272. The method of claim 265, wherein the peripheral blood vessel is an artery or a vein.

273. The method of claim 265, wherein the expanded expandable body alone is maintained in the expanded configuration within the biological space after separation from the delivery catheter.

274. The method of claim 265, further comprising delivering a solid material to the interior volume of the expandable body, wherein the expandable body is at least partially filled with the solid material.

275. The method of claim 274, wherein the solid material comprises a support structure.

276. The method of claim 275, wherein the support structure is selected from a group consisting of metallic or polymeric coils or wires, metallic or polymeric expansile structures, beads, balls, microspheres, a bioresorbable material, or combinations thereof.