Single Operator Intracranial Medical Device Delivery Systems and Methods of Use

• US 20180207399A1
• Filed: 01/19/2018
• Published: 07/26/2018
• Est. Priority Date: 01/20/2017
• Status: Active Grant

• Current Assignee: Route 92 Medical, Inc.
• Original Assignee: Route 92 Medical, Inc.
• Inventors: Chou, Tony M., Wilson, Scott D., Valley, Kirsten, Shinsky, Vera, Evard, Philip
• Granted Patent: US 10,864,350 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/068 Modifying the blood flow model, e.g. by diffuser or deflector
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• CPC Class Codes: A61M 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 2025/0059 having means for preventing the catheter, sheath or lumens from collapsing due to outer forces, e.g. compressing forces, or caused by twisting or kinking
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2205/0222 Materials for reducing friction
• CPC Class Codes: A61M 2205/0238 the material being a coating or protective layer
• CPC Class Codes: A61M 2205/586 Ergonomic details therefor, e.g. specific ergonomics for left or right-handed users
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 2210/12 Blood circulatory system
• CPC Class Codes: A61M 25/0021 characterised by the form of the tubing A61M25/0054 takes precedence
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0052 Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0097 : characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/01 : Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0108 : using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/09 : Guide wires

Abstract

A rapid exchange microcatheter for accessing the intracranial neurovasculature. A side opening through the sidewall is located a first distance proximal to the distal-most tip. A proximal opening located proximal to the side opening is a second distance from the distal-most tip. A distal, reinforced catheter portion extends between a distal end region to a point near the side opening. A proximal, reinforced catheter portion extends a distance from a point near the side opening towards the proximal end of the catheter body. The side opening is positioned within a gap between a proximal end of the distal reinforced catheter portion and a distal end of the proximal reinforced catheter portion. A payload of a cerebral treatment device is housed within the lumen proximal to the side opening. Related devices, systems, and methods are disclosed.

Claims

1. A rapid exchange microcatheter system for accessing the intracranial neurovasculature, the microcatheter system comprising:

(i) a catheter body having;

(a) an outer diameter, an inner diameter, and a distal-most tip;

(b) an internal lumen defined by the inner diameter, the catheter body adapted to carry a payload within the internal lumen and deliver the payload from the internal lumen to a target location in the intracranial neurovasculature, wherein (i) the inner diameter is sized to allow passage of a guidewire and (ii) the outer diameter has a maximum size of less than 0.048 inch;

(c) a guidewire side opening into the internal lumen, the guidewire side opening sized to allow passage of a guidewire, the guidewire side opening located a distance between 10-20 cm from the distal-most tip of the catheter body;

(d) a proximal opening into the internal lumen, the proximal opening different and distinct from the guidewire side opening, the proximal opening located a distance greater than 20 cm from the distal-most tip;

(e) a distal, reinforced catheter portion extending between a distal end region of the catheter body to a point near the guidewire side opening; and

(f) a proximal, reinforced catheter portion extending a distance from a point near the guidewire side opening towards the proximal end of the catheter body;

wherein the guidewire side opening is positioned within a gap between a proximal end of the distal reinforced catheter portion and a distal end of the proximal, reinforced catheter portion; and

(ii) instructions for use that instruct that the payload be loaded in the internal lumen at a location proximal to the guidewire side opening prior to use of the catheter body.

2. The rapid exchange microcatheter system of claim 1, wherein the proximal, reinforced catheter portion is less flexible than the distal, reinforced catheter portion.

3. The rapid exchange microcatheter system of claim 1, wherein the distal, reinforced catheter portion has a first reinforcement structure.

4. The rapid exchange microcatheter system of claim 3, wherein the proximal, reinforced catheter portion has a second reinforcement structure.

5. The rapid exchange microcatheter system of claim 4, wherein the first reinforcement structure is coupled to the second reinforcement structure by a rigid coupler.

6. The rapid exchange microcatheter system of claim 4, wherein the first and second reinforcement structure are different in structure to one another.

7. The rapid exchange microcatheter system of claim 4, wherein the first reinforcement structure is a coil and the second reinforcement structure is a coil, wherein a pitch of the coil of the first reinforcement structure is greater than a pitch of the coil of the second reinforcement structure.

8. The rapid exchange microcatheter system of claim 5, wherein the coupler has a window aligned with the side opening.

9. The rapid exchange microcatheter system of claim 1, wherein a sidewall of the catheter body comprises:

a lubricious, tubular liner;

a reinforcement layer positioned over the tubular liner that is more rigid than the tubular liner, the reinforcement layer comprising;

a first reinforcement structure extending within the distal, reinforced catheter portion, the first reinforcement structure having a proximal end; and

a second reinforcement structure extending within the proximal, reinforced catheter portion, the second reinforcement structure having a distal end,

wherein the proximal end of the first reinforcement structure is separated from the distal end of the second reinforcement structure creating the gap;

a short, tubular rigid coupler positioned over the proximal end of the first reinforcement structure and over the distal end of the second reinforcement structure, the coupler having an elongate window extending through a sidewall of the coupler; and

an outer jacket positioned over the coupler and the reinforcement layer.

10. A rapid exchange microcatheter system for accessing the intracranial neurovasculature, the microcatheter system comprising:

(i) a catheter body having;

(a) an outer diameter, an inner diameter, and a distal-most tip;

(b) an internal lumen defined by the inner diameter, the catheter body adapted to carry a payload within the internal lumen and deliver the payload from the internal lumen to a target location in the intracranial neurovasculature, wherein (i) the inner diameter is sized to allow passage of a guidewire and (ii) the outer diameter body has a maximum size of less than 0.048 inch;

(c) a guidewire side opening into the internal lumen, the guidewire side opening sized to allow passage of a guidewire, the guidewire side opening located a distance between 10-20 cm from the distal-most tip of the catheter body;

(d) a proximal opening into the internal lumen, the proximal opening different and distinct from the guidewire side opening, the proximal opening located a distance greater than 20 cm from the distal-most tip;

(e) a distal, reinforced catheter portion extending between a distal end region of the catheter body to a point near the guidewire side opening; and

(f) a proximal, reinforced catheter portion extending a distance from a point near the guidewire side opening towards the proximal end of the catheter body;

wherein the guidewire side opening is positioned within a gap between a proximal end of the distal reinforced catheter portion and a distal end of the proximal, reinforced catheter portion; and

(ii) the payload loaded in the internal lumen at a location proximal to the guidewire side opening such that the payload can be carried within and delivered from the internal lumen to a target location in the intracranial neurovasculature.

11. The rapid exchange microcatheter system of claim 10, wherein the proximal, reinforced catheter portion is less flexible than the distal, reinforced catheter portion.

12. The rapid exchange microcatheter system of claim 10, wherein the distal, reinforced catheter portion has a first reinforcement structure.

13. The rapid exchange microcatheter system of claim 12, wherein the proximal, reinforced catheter portion has a second reinforcement structure.

14. The rapid exchange microcatheter system of claim 13, wherein the first reinforcement structure is coupled to the second reinforcement structure by a rigid coupler.

15. The rapid exchange microcatheter system of claim 13, wherein the first and second reinforcement structure are different in structure to one another.

16. The rapid exchange microcatheter system of claim 13, wherein the first reinforcement structure is a coil and the second reinforcement structure is a coil, wherein a pitch of the coil of the first reinforcement structure is greater than a pitch of the coil of the second reinforcement structure.

17. The rapid exchange microcatheter system of claim 14, wherein the coupler has a window aligned with the side opening.

18. The rapid exchange microcatheter system of claim 10, wherein a sidewall of the catheter body comprises:

a lubricious, tubular liner;

a reinforcement layer positioned over the tubular liner that is more rigid than the tubular liner, the reinforcement layer comprising;

a first reinforcement structure extending within the distal, reinforced catheter portion, the first reinforcement structure having a proximal end; and

a second reinforcement structure extending within the proximal, reinforced catheter portion, the second reinforcement structure having a distal end,

wherein the proximal end of the first reinforcement structure is separated from the distal end of the second reinforcement structure creating the gap;

a short, tubular rigid coupler positioned over the proximal end of the first reinforcement structure and over the distal end of the second reinforcement structure, the coupler having an elongate window extending through a sidewall of the coupler; and

an outer jacket positioned over the coupler and the reinforcement layer.