# Patent

## Title
Microcatheter system

## Abstract

A microcatheter system is disclosed which may include a microcatheter, one or more microcatheter extensions, and/or a microcatheter hub. In an embodiment, the microcatheter has a plurality of zones where the outside diameter of each zone from the distal to the proximal end has an outside diameter that is the same as or greater than the previous zone while the inside diameter is constant throughout the microcatheter length. In a further embodiment, a unique joining mechanism is employed for coupling a microcatheter to a microcatheter extension or to a microcatheter hub.

## Background
RELATED APPLICATION
The present application claims priority benefit of U.S. Provisional Application No. 62/159,543, filed 11 May 2015 and entitled “Microcatheter System”, the entirety of which is hereby incorporated herein by reference.


FIELD
This disclosure relates to a microcatheter system, including a system having a microcatheter and a microcatheter extension and/or a microcatheter hub, where a unique joining mechanism couples two of the components together.
BACKGROUND
Microcatheters, including endovascular and neuroendovascular microcatheters, are generally microtubes inserted into the body through a blood vessel such as the femoral artery and have a variety of uses. Typically, microcatheters have a distal and a proximal end, where at or close to the distal end a marker band is employed for visualization of microcatheter positioning during in vivo use. The marker band typically comprises a metal or metal alloy ring such as platinum, nitinol and/or gold rings which can be visualized via fluoroscopy.
Microcatheters are typically used to embolize the neurovasculature such as in treating arteriovenous malformations (AVMs), aneurysms, and the like in a relatively non-invasive manner. Microcatheters with sufficient flexibility and size for applications in small tortuous vessels have been developed but typically require the continuous use of a guide catheter.
A wide variety of commercially available microcatheters have been developed for insertion in the vascular system for a number of diagnostic or therapeutic applications. Certain applications, however, require a small diameter and very flexible catheter to access small tortuous vessels in situ. Guide catheters of larger diameter are usually employed to act as a conduit to help support microcatheter access. One problem associated with the removal of guide catheters is the increased risk associated with thromboembolic and vascular wall injury complications. It would be beneficial to have a microcatheter system that can remain in situ at a desired vascular location without the need for a larger diameter guide catheter to also remain in situ.
SUMMARY
An aspect of at least one of the embodiments described herein includes the realization that it is advantageous to provide microcatheters which can remain in situ at a desired vascular location without the need for a larger diameter guide catheter to also remain in situ. It is further advantageous to provide microcatheters which easily are extensible and safely detachable/attachable in situ microcatheters with a unique joining mechanism which couples, for example, a microcatheter with a microcatheter extension without requiring an increase in the diameter of the microcatheter system at the joint. The unique joining mechanism is sometimes referred to herein as an internal Luer lock mechanism. The matching parts (male (probe) and female (receptacle) portions as described in further detail below) of the unique joining mechanism may be secured together by, for example, press fitting so that the matching parts remain in place due to friction.
According to one aspect of the present disclosure, a microcatheter system is described which includes a microcatheter having a distal end and a proximal end, wherein an internal diameter is constant throughout, and wherein the microcatheter includes a plurality of zones each zone having an outside diameter that is different from the outside diameter of each of the other zones in the plurality of zones; wherein the proximal end of the microcatheter is configured as a first receptacle for receiving a first probe for connecting a first microcatheter extension or a microcatheter hub to the microcatheter, and wherein an outside diameter of the first receptacle is no greater than a largest diameter of the zones in the plurality of zones; and the first microcatheter extension having a distal end and a proximal end, wherein an internal diameter is constant throughout, and wherein an outside diameter is constant throughout, and wherein the distal end of the first microcatheter extension is configured as the first probe to be received by the first receptacle of the proximal end of the microcatheter, and wherein an outside diameter of the first probe is less than an internal diameter of the first receptacle, wherein the internal diameter of the microcatheter is the same as the internal diameter of the first microcatheter extension, and wherein an outside diameter of the first microcatheter extension is the same as the outside diameter of the largest diameter of the zones in the plurality of zones.
According to another aspect of the present disclosure, a microcatheter system is described which includes a microcatheter having a distal end and a proximal end, wherein an internal diameter is constant throughout, and wherein the microcatheter includes a plurality of zones each zone having an outside diameter that is different from the outside diameter of each of the other zones in the plurality of zones; wherein the proximal end of the microcatheter is configured as a first probe for connecting to a first receptacle for connecting a first microcatheter extension or a microcatheter hub to the microcatheter, and wherein an outside diameter of the first probe is less than an internal diameter of the first receptacle; and the first microcatheter extension having a distal end and a proximal end, wherein an internal diameter is constant throughout, and wherein an outside diameter is constant throughout, and wherein the distal end of the first microcatheter extension is configured as the first receptacle to receive the first probe of the proximal end of the microcatheter, and wherein an outside diameter of the first receptacle is no greater than a largest diameter of the zones in the plurality of zones, wherein the internal diameter of the microcatheter is the same as the internal diameter of the first microcatheter extension, and wherein an outside diameter of the first microcatheter extension is the same as the outside diameter of the largest diameter of the zones in the plurality of zones.
Numerous other advantages and features of the present disclosure will become readily apparent from the following detailed description, the accompanying drawings, and the appended claims.



BRIEF DESCRIPTION OF THE DRAWINGS
The present disclosure is best understood from the following detailed description when read in conjunction with the accompanying drawings. It is emphasized that, according to common practice, the various features of the drawings are not necessarily to scale. On the contrary, the dimensions of the various features are arbitrarily expanded or reduced for clarity. Like reference numerals denote like features throughout specification and drawings.
FIG. 1 is a schematic illustration of a microcatheter in accordance with one embodiment.
FIG. 2 is a schematic illustration of a microcatheter extension in accordance with one embodiment.
FIG. 3 is a schematic illustration of the connection between a microcatheter and a microcatheter extension in accordance with one embodiment.
FIG. 4 is a schematic illustration of a connection between a microcatheter and a microcatheter hub, or the connection between a microcatheter extension and a microcatheter hub in accordance with one embodiment.



DETAILED DESCRIPTION
This description of the exemplary embodiments is intended to be read in connection with the accompanying drawings, which are to be considered part of the entire written description. In the description, relative terms such as “lower,” “upper,” “horizontal,” “vertical,”, “above,” “below,” “up,” “down,” “top” and “bottom” as well as derivative thereof (e.g., “horizontally,” “downwardly,” “upwardly,” etc.) should be construed to refer to the orientation as then described or as shown in the drawing under discussion. These relative terms are for convenience of description and do not require that the apparatus be constructed or operated in a particular orientation. Terms concerning attachments, coupling and the like, such as “connected” and “interconnected,” refer to a relationship wherein structures are secured or attached to one another either directly or indirectly through intervening structures, as well as both movable or rigid attachments or relationships, unless expressly described otherwise.
FIG. 1 illustrates a notional schematic of a microcatheter according to an embodiment of the present disclosure. The microcatheter 100 is designed along standard neuroendovascular microcatheter platforms with a generally tubular body to allow for the delivery of, e.g., detachable coil systems, particulate matter injections, as well as liquid injection and infusions in either a transient and/or in situ continuous manner. The microcatheter 100 has a distal end 110, which is also marked as A, a proximal end 150, which is also marked as E, and a transition portion. The transition portion of the microcatheter 100 includes four distinct zones from 110 to 120 is zone AB, from 120 to 130 is zone BC, from 130 to 140 is zone CD, and from 140 to 150 is zone DE. In one embodiment, zone AB and zone BC are usually disposed inside a body, while zone CD and zone DE are usually disposed outside the body.
In an embodiment, the tubular body of the microcatheter 100 has an increasing outer diameter (“OD”) in the direction from the distal end to the proximal end. For example, the outer diameter of zone AB is no greater than the outer diameter of zone BC, the outer diameter of zone BC is no greater than the outer diameter of zone CD, the outer diameter of zone CD is no greater than the outer diameter of zone DE.
In another embodiment, more than four zones are employed. In another embodiment, fewer than four zones are employed. In another embodiment, more than two zones are placed inside the body. In yet another embodiment, fewer than two zones are placed inside the body.
In one embodiment, the transition in outer diameter between any two abutting zones is a step change. In another embodiment, the transition in outer diameter between any two abutting zones is a gradual change. In another embodiment, the transition in outer diameter between any two abutting zones is a taper change. In another embodiment, the transition in outer diameter between any two abutting zones is a chamfer change. In another embodiment, the transition in outer diameter between any two abutting zones is a fillet change. One of skill in the art will readily understand that the current disclosure encompasses situations where more than one type of transition occurs along the length of a microcatheter such as, for a non-limiting example, a step change occurs between a first two abutting zones and a tapering change occurs between a second two abutting zones.
One advantage of the microcatheter described herein is that the substantially increased proximal outer diameter of the microcatheter and microcatheter extension increases the stability of the overall microcatheter system.
In one embodiment, the overall length of the microcatheter 100 is 150 cm and may optionally include one or two distal radio-opaque markers for visualization with detachable coil deployment. In one embodiment, the microcatheter 100 employs a nitinol braiding system throughout the entire length which enables improved stability. In one embodiment, the inner diameter of the microcatheter 100 remains constant at 0.4138 mm throughout the entire length of the microcatheter 100. In another embodiment, the inner diameter of the microcatheter 100 remains constant at approximately 0.4 mm.
In one embodiment, zone AB is 30 cm in length and 0.57 mm in outer diameter (or 1.7 Fr); zone BC is 15 cm in length, and 0.73 mm (or 2.2 Fr) in outer diameter; zone CD is 15 cm in length, and 1.17 mm (or 3.5 Fr) in outer diameter; zone DE is 90 cm in length, and 1.33 mm (or 4 Fr) in outer diameter.
As would be apparent to one of ordinary skill in the art, the exemplary length or lengths listed above for any one or more zone may be different without departing from the spirit and intent of the present disclosure. Similarly, the exemplary inner diameter may be different without departing from the spirit and intent of the present disclosure. Likewise, the exemplary outer diameters listed above for any one or more zone may be different without departing from the spirit and intent of the present disclosure.
In one embodiment, the proximal end 150 (E) of the microcatheter 100 contains a female portion of a unique joining mechanism (e.g., female internal Luer lock mechanism) by which either the microcatheter extension 200 in FIG. 2 or FIG. 3 or the detachable/attachable microcatheter hub 400 in FIG. 4 may be attached and/or detached. This unique design allows the microcatheter 100 to be utilized as a standard microcatheter or as an exchange length microcatheter. In another embodiment, the proximal end 150 (E) of the microcatheter 100 contains a unique male portion of the unique joining mechanism (e.g., male internal Luer lock mechanism) by which either the microcatheter extension 200 or the detachable/attachable microcatheter hub 400, each having a unique female internal Luer lock mechanism, may be attached and/or detached. The internal Luer lock mechanism allows the microcatheter extension 200 to be coupled to the microcatheter 100 in such a manner as to allow the safe and effective removal of commonly employed guide catheter from the parent artery, allowing for continued treatment through the microcatheter 100 for a prolonged manner and decreasing the risk associated with thromboembolic complications.
FIG. 2 illustrates a notional schematic of a microcatheter extension 200 according to an embodiment of the present disclosure. In an embodiment, this microcatheter extension 200 is similar in material and configuration in terms of inner diameter and outer diameter as zone DE of the microcatheter 100 shown in FIG. 1. In one embodiment, the overall length of the microcatheter extension 200 from 210 to 220, or A′E′ is 150 cm, the inner diameter 213 throughout remains the same as the inner diameter of the microcatheter 100, which, in an embodiment, may be 0.4138 mm, and the outer diameter throughout remains the same as the outer diameter of zone DE, which is 1.33 mm. Other lengths and diameters of the microcatheter extension 200 are contemplated in keeping with the principles of the present disclosure.
FIG. 3 illustrates a notional schematic of the internal Luer lock mechanism connection 300 according to an embodiment of the present disclosure. In one embodiment, at the distal end 210 of the microcatheter extension 200 (A′) is a unique male internal Luer lock mechanism 211 which allows for connection to the proximal end 150 of either the microcatheter 100 or another microcatheter extension 200. At the proximal end 150 of the microcatheter 100 is a unique female internal Luer lock mechanism 151. At the proximal end 220 of the microcatheter extension (E′) is a unique female internal Luer lock mechanism which is identical in design to the mechanism found at the proximal end 150 of the microcatheter 100 (as shown at E in FIG. 3). This allows for connection with either an additional microcatheter extension 200 or detachable/attachable microcatheter hub 400 (FIG. 4). Internal diameter 153 is constant as described above.
In an alternate embodiment, the respective male and female portions are swapped between the connecting components. For example, at the distal end of the microcatheter extension 210 (A′) is a unique female internal Luer Lock mechanism which allows for connection to the proximal end 150 of either the microcatheter 100 or microcatheter extension 200. At the proximal end 220 of the microcatheter extension 200 (E′) is a unique male internal Luer lock mechanism which is identical in design to the mechanism found at the proximal end 150 of the microcatheter 100.
One advantage of the microcatheters described herein is that the unique Luer lock mechanism permits attachment and detachment of the microcatheter extension in tandem and/or with a microcatheter hub. Effectively creating an extended microcatheter with a detachable hub permits the safe and effective removal of a standard guiding catheter in standard exchange technique. This also allows the microcatheter described herein to be used as a standard endovascular/neuroendovascular microcatheter for standard, commonly employed procedures as well as increased utility when coupled with other components of the system.
FIG. 4 illustrates a notional schematic of the internal Luer lock connection between a microcatheter 100, or a microcatheter extension 200, and a microcatheter hub 400 having a distal end 410 and a proximal end 420, according to an embodiment of the present disclosure. In an embodiment, the microcatheter hub 400 is similar in design and composition to the standard endovascular microcatheter proximal aspect; a standard female Luer lock mechanism permits connection with standard Luer lock syringes, connectors, and intravenous tubing. In an embodiment, the detachable/attachable microcatheter hub 400 distal aspect 411 is unique in that it possess a unique male internal Luer lock system which permits connection to either the proximal aspect 151 of either the microcatheter 100 or microcatheter extension 200. The proximal end 420 of the microcatheter hub 400 is designed on a similar platform to the standard microcatheter hubs, e.g., having a standard Luer lock receptacle 421, which allows for connection with standard Luer lock syringes, additional adapters such as three-way connectors and rotating hemostatic valves, as well as intravenous tubing to permit passage of detachable coil systems, particular matter, continuous liquid infusions, as well as syringe injections. Internal diameter 412 may be constant throughout as described above.
In another embodiment, the detachable/attachable microcatheter hub 400 distal aspect is unique in that it possess a unique female internal Luer lock system which permits connection to either the proximal aspect 150 of either the microcatheter 100 or microcatheter extension 200. The ability to attach or detach the detachable/attachable microcatheter hub 400 permits the use of the microcatheter 100 as either a standard endovascular, or neuroendovascular microcatheter and/or as an exchange length microcatheter. The detachable/attachable microcatheter hub 400 is compatible with Dimethyl-Sulfoxide, and possess a pressure rating identical to the standard endovascular or neuroendovascular microcatheters.
One advantage of the microcatheters described herein is the improved performance of the microcatheters and increased safety with the exchange technique.
Although the subject matter has been described in terms of exemplary embodiments, it is not limited thereto. Rather, the appended claims should be construed broadly, to include other variants and embodiments, which may be made by those skilled in the art.

## Claims

1. A microcatheter system comprising:
a microcatheter having a distal end and a proximal end, a plurality of zones, a passage and a first receptacle, wherein an internal diameter of the passage is constant throughout the plurality of zones, and wherein each zone having an outside diameter constant across the respective zone that is progressively greater than an immediately adjacent and more distal zone; wherein the proximal end of said microcatheter is configured with the first receptacle receiving a first probe connecting a first microcatheter extension or a microcatheter hub to said microcatheter, and wherein an outside diameter of the first receptacle is no greater than a largest diameter of the zones in the plurality of zones; and
said first microcatheter extension having a distal end and a proximal end, a second passage, a first portion and the first probe, wherein an internal diameter of the second passage is constant throughout the first portion and the first probe, and wherein an outside diameter of the first portion is constant throughout, and wherein the distal end of said first microcatheter extension is configured with the first probe to be received by the first receptacle of the proximal end of said microcatheter, and wherein an outside diameter of the first probe is constant and less than an internal diameter of the first receptacle,
wherein the internal diameter of the passage of the plurality of zones of said microcatheter is the same as the internal diameter of the second passage of said first microcatheter extension, and
wherein an outside diameter of said first portion of the first microcatheter extension is the same as the outside diameter of the largest diameter of the zones in the plurality of zones.

2. The microcatheter system of claim 1 wherein the proximal end of said first microcatheter extension is configured as a second receptacle for receiving a second probe for connecting a second microcatheter extension or said microcatheter hub to said first microcatheter extension, and wherein an outside diameter of the second receptacle is no greater than the outside diameter of said first portion of the first microcatheter extension.

3. The microcatheter system of claim 2 further comprising said microcatheter hub having a distal end and a proximal end, wherein a portion of an internal diameter of a third passage of said microcatheter hub is the same as the internal diameter of the second passage of said first microcatheter extension, and wherein the distal end of said microcatheter hub is configured as the second probe to be received by the second receptacle, and wherein an outside diameter of the second probe is less than an internal diameter of the second receptacle.

4. The microcatheter system of claim 3 wherein the proximal end of said microcatheter hub comprises a Luer lock receptacle.

5. The microcatheter system of claim 1 wherein said microcatheter comprises nitinol braiding.

6. The microcatheter system of claim 1 wherein said first microcatheter extension comprises nitinol braiding.

7. The microcatheter system of claim 1 wherein a number of zones in the plurality of zones is four.

8. The microcatheter system of claim 7 wherein a length of a first zone is approximately 30 cm, the length of a second zone is approximately 15 cm, the length of a third zone is approximately 15 cm, and the length of a fourth zone is approximately 90 cm, and wherein the first zone is at the distal end of said microcatheter and the fourth zone is at the proximal end of said microcatheter.

9. The microcatheter system of claim 8 wherein the internal diameter of the passage is 0.4138 mm.

10. The microcatheter system of claim 8 wherein the internal diameter of the passage is approximately 0.4 mm.

11. The microcatheter system of claim 9 wherein the outside diameter of the first zone is approximately 1.7 Fr, the outside diameter of the second zone is approximately 2.2 Fr, the outside diameter of the third zone is approximately 3.5 Fr, and the outside diameter of the fourth zone is approximately 4 Fr, where Fr=3D where D is the outside diameter of said microcatheter in mm.

12. The microcatheter system of claim 11 wherein a length of said first microcatheter extension is approximately 150 cm.

13. A microcatheter system comprising:
a microcatheter having a distal end and a proximal end, a passage, a plurality of zones and a first probe, wherein an internal diameter of the passage is constant throughout, and wherein each zone having an outside diameter constant across the respective zone that is progressively greater than an immediately adjacent and more distal zone; wherein the proximal end of said microcatheter is configured as the first probe connecting to a first receptacle a first microcatheter extension or a microcatheter hub to said microcatheter, and wherein an outside diameter of the first probe is constant and less than an internal diameter of the first receptacle; and
said first microcatheter extension having a distal end and a proximal end, a second passage, a first portion and the first receptacle, wherein an internal diameter of the second passage is constant throughout, and wherein an outside diameter of the first portion is constant throughout, and wherein the distal end of said first microcatheter extension is configured as the first receptacle to receive the first probe of the proximal end of said microcatheter, and wherein an outside diameter of the first receptacle is no greater than a largest diameter of the zones in the plurality of zones,
wherein the internal diameter of the passage of said microcatheter is the same as the internal diameter of the second passage of said first microcatheter extension, and
wherein an outside diameter of the first portion of said first microcatheter extension is the same as the outside diameter of the largest diameter of the zones in the plurality of zones.

14. The microcatheter system of claim 13 wherein the proximal end of said first microcatheter extension is configured as a second probe for connecting to a second receptacle for connecting a second microcatheter extension or said microcatheter hub to said first microcatheter extension, and wherein an outside diameter of the second probe is less than an internal diameter of the second receptacle.

15. The microcatheter system of claim 14 further comprising said microcatheter hub having a distal end and a proximal end and a third passage, wherein a portion of an internal diameter of the third passage of said microcatheter hub is the same as the internal diameter of the second passage of said first microcatheter extension, and wherein the distal end of said microcatheter hub is configured as the second receptacle for connecting to the second probe, and wherein an outside diameter of the second receptacle is no greater than a largest diameter of the zones in the plurality of zones.

16. The microcatheter system of claim 15 wherein the proximal end of said microcatheter hub comprises a Luer lock receptacle.

17. The microcatheter system of claim 13 wherein said microcatheter comprises nitinol braiding.

18. The microcatheter system of claim 13 wherein said first microcatheter extension comprises nitinol braiding.

19. The microcatheter system of claim 13 wherein a number of zones in the plurality of zones is four.

20. The microcatheter system of claim 19 wherein a length of a first zone is approximately 30 cm, the length of a second zone is approximately 15 cm, the length of a third zone is approximately 15 cm, and the length of a fourth zone is approximately 90 cm, and wherein the first zone is at the distal end of said microcatheter and the fourth zone is at the proximal end of said microcatheter.

21. The microcatheter system of claim 20 wherein the internal diameter of the passage is 0.4138 mm.

22. The microcatheter system of claim 20 wherein the internal diameter of the passage is approximately 0.4 mm.

23. The microcatheter system of claim 21 wherein the outside diameter of the first zone is approximately 1.7 Fr, the outside diameter of the second zone is approximately 2.2 Fr, the outside diameter of the third zone is approximately 3.5 Fr, and the outside diameter of the fourth zone is approximately 4 Fr, where Fr=3D where D is the outside diameter of said microcatheter in mm.

24. The microcatheter system of claim 23 wherein a length of said first microcatheter extension is approximately 150 cm.

25. A microcatheter assembly comprising:
a microcatheter body having an external surface, an internal passage, a distal end, and a proximal end; the microcatheter body divided into a plurality of zones, wherein the external surface of each of the zones has an outer diameter that is progressively greater than an immediately adjacent and distal zone and the respective outer diameter is substantially constant across each zone;
an extension body having a second external surface, a second internal passage, a distal end, and a proximal end, the second external surface at the distal end having an outer diameter equal to the largest outer diameter of the microcatheter body;
a connection assembly comprising a probe received within a receptacle, the probe having an external surface with an outer diameter in contact with an internal surface of the receptacle, the connection assembly having an outer diameter equal to the largest outer diameter of the microcatheter body; wherein the probe includes a third internal passage and wherein the probe is integral with one of the microcatheter body and the extension body and the receptacle is integral with the other of the microcatheter body and the extension body;
the connection assembly positioned at the proximal end of the microcatheter body and the distal end of the extension body and the internal passage, second internal passage and third internal passage define a continuous constant diameter passage between the distal end of the microcatheter body and the proximal end of the extension body.