Guiding Catheter
Patent Information
- Application Number
- JP2024503843
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2021-07-21
- Filing Date
- 2022-07-21
- Publication Date
- 2025-08-06
AI Technical Summary
Current catheter systems face issues with reduced inner diameters that prevent equipment passage and difficulties in managing wires within the catheter control center, leading to complications during medical procedures.
A dynamic catheter system incorporating a guide catheter with a telescoping guide extension catheter and a catheter control center, featuring an integrated advancement mechanism, wire storage, and hemostasis valve, allowing for easier manipulation and control of wires without the need for separate guide extension catheters.
Enhances procedural efficiency by providing greater inner diameter for instrument passage, reducing wire mix-ups, and maintaining tactile feedback, while minimizing manufacturing costs and procedural complexity.
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Abstract
Description
[Technical field]
[0001] This application claims the benefit of priority under 35 USC § 119(e) of U.S. Provisional Patent Application No. 63 / 203,415, filed July 21, 2021, the entirety of which is incorporated by reference herein.
[0002] The embodiments described herein relate to novel dynamic catheter systems and hemostatic valves. [Background technology]
[0003] The dynamic catheter system may include a guiding catheter, a telescoping guiding extension catheter, and a catheter control center. In current catheter systems involving a guiding catheter and a guiding extension catheter, the guiding extension catheter may reduce the inner diameter of the system to such an extent that certain instruments cannot pass through the inner diameter of the system. Additionally, current systems may not include a mechanism for easily disconnecting one or more wires passing through the catheter control center. Summary of the Invention [Problem to be solved by the invention]
[0004] Thus, embodiments of the dynamic catheter system address these and other issues, thereby significantly improving the use of the system. [Means for solving the problem]
[0005] In some cases, the dynamic catheter system may include a guiding catheter and a guiding extension catheter. The guiding catheter may include a first wall. The first wall may include a distal portion with a distal end, a proximal portion with a proximal end, and an intermediate portion extending between the distal portion and the proximal portion. The distal portion may be configured to be positioned in the artery, and the proximal end is configured to interact with the valve. A first wall thickness of the first wall may vary from the proximal end to the distal end. The guiding extension catheter may include a second wall. The second wall may include a distal portion with a distal end, a proximal portion with a proximal end, and an intermediate portion extending between the distal portion and the proximal portion. The guiding extension catheter may be positioned within the guiding catheter and may be configured to extend from a distal end of the guiding catheter. A second wall thickness of the second wall may vary from the proximal end to the distal end.
[0006] The dynamic catheter system of any of the preceding paragraphs and / or any of the dynamic catheter systems disclosed herein may include one or more of the following features: The change in the first wall thickness may be inversely related to the change in the second wall thickness. The guide catheter may include a first transition region including a change in the first wall thickness. The guide extension catheter may include a second transition region including a change in the second wall thickness. The first transition region may be positioned at an intermediate portion of the guide catheter. The second transition region may be positioned at an intermediate portion of the guide catheter. The first transition region may be positioned at a distal section of the intermediate portion of the guide catheter. The second transition region may be positioned at a distal section of the intermediate portion of the guide extension catheter. The first wall thickness may decrease from a maximum wall thickness to a minimum wall thickness in a proximal to distal direction in the first transition region. The second wall thickness may decrease from a maximum wall thickness to a minimum wall thickness in a distal to proximal direction in the second transition region. The first wall thickness may include a thickness between 0.01 mm and 1.0 mm. The first wall thickness may comprise a thickness between 0.065 mm and about 0.125 mm. The second wall thickness may comprise a thickness between 0.05 mm and 1.0 mm. The second wall thickness may comprise a thickness between 0.1 mm and about 0.125 mm. The guiding extension catheter may comprise an inner diameter between 0.50 mm and 2.00 mm. The guiding extension catheter may comprise an inner diameter between 1.60 mm and 1.67 mm. The dynamic catheter system may further comprise an expanded configuration and a non-expanded configuration. The distal portion of the guiding extension catheter may extend beyond the distal end of the guiding catheter when the dynamic catheter system is in the expanded configuration. The distal end of the guiding extension catheter may not extend beyond the distal end of the guiding catheter when the dynamic catheter system is in the non-expanded configuration. The second wall thickness at the distal end of the guiding extension catheter may comprise a maximum wall thickness. The first wall thickness at the distal end of the guiding catheter may comprise a minimum wall thickness. The dynamic catheter system may further comprise a valve and a wire control mechanism. The wire control mechanism may be integral with the valve. The wire control mechanism may be configured to be removably coupled to the valve.
[0007] The dynamic catheter system may include one or more of the features described above.The method of using the dynamic catheter system may include one or more of the features described above.
[0008] In some cases, the wire control mechanism may include a distal end with a distal opening, a proximal end with a proximal opening with a first portion and a second portion, a length between the distal end and the proximal end, and one or more passageways configured to receive two or more wires, the one or more passageways including a central passageway and an exchange passageway extending radially outward from the central passageway, the central passageway extending along a length from the distal end to the proximal end, the central passageway including a distal opening at the distal end and a first portion of the proximal opening at the proximal end, the exchange passageway including a second portion of the proximal opening, , one or more passages configured to exchange the two or more wires between a first portion and a second portion of the proximal opening; and a cap configured to engage the proximal opening of the passages, the cap comprising a first notch and a second notch, the cap configured to uncover and cover the exchange passages without a user removing the two or more wires from the wire control mechanism, each of the first notch and the second notch configured to receive at least one of the two or more wires.
[0009] Any of the wire control mechanisms of any of the preceding paragraphs and / or disclosed herein may include one or more of the following features: The cap may be configured to separate a first portion of the proximal opening from a second portion of the proximal opening and separate the two or more wires when engaged with the proximal opening and covering the exchange passage. The cap may be configured to not cover the exchange passage when disengaged from the proximal opening such that a user can move the two or more wires between the first and second portions of the proximal opening through the exchange passage. The cap may have an open configuration and a closed configuration, where when the cap is in the open configuration, the cap is disengaged from the proximal opening and the exchange passage is not covered, and when the cap is in the closed configuration, the cap is engaged with the proximal opening and the exchange passage is covered. When the cap is engaged with the proximal opening, the first portion of the proximal opening may align with a first notch in the cap. When the cap is engaged with the proximal opening, the second portion of the proximal opening may align with a second notch in the cap. The distal end may be configured to be removably coupled to the hemostasis valve.The distal end may be configured to be integral with the hemostasis valve.
[0010] The wire control mechanism may include one or more of the features described above.The method of using the wire control mechanism may include one or more of the features described above.
[0011] In some cases, the dynamic catheter system includes a hemostatic valve comprising a valve and a wire control mechanism in communication with the valve, the wire control mechanism having a distal end with a distal opening, a proximal end with a proximal opening, and a length between the distal end and the proximal end, the proximal opening comprising a first portion and a second portion, and one or more passageways configured to receive two or more wires, the one or more passageways including a central passageway and an exchange passageway extending radially outward from the central passageway, the central passageway extending from the distal end to the proximal end along the length, the central passageway being connected to a first exchange passageway between the distal opening at the distal end and the proximal opening at the proximal end. the exchange passageway having a first portion of the proximal opening and the exchange passageway having a second portion of the proximal opening, the exchange passageway configured to allow two or more wires to be exchanged between the first and second portions of the proximal opening; and a cap configured to engage the proximal opening of the passageway, the cap having first and second notches, the cap configured to uncover and cover the exchange passageway without a user removing the two or more wires from the wire control mechanism, each of the first and second notches configured to receive at least one of the two or more wires.
[0012] The dynamic catheter system of any of the preceding paragraphs and / or any of the dynamic catheter systems disclosed herein may include one or more of the following features: The cap may be configured to separate a first portion of the proximal opening from a second portion of the proximal opening and separate the two or more wires when engaged with the proximal opening and covering the exchange passage. The cap may be configured to not cover the exchange passage when disengaged from the proximal opening such that a user can move the two or more wires between the first and second portions of the proximal opening through the exchange passage. The cap may have an open configuration and a closed configuration, where when the cap is in the open configuration, the cap is disengaged from the proximal opening and the exchange passage is not covered, and when the cap is in the closed configuration, the cap is engaged with the proximal opening and the exchange passage is covered. When the cap is engaged with the proximal opening, the first portion of the proximal opening may align with a first notch in the cap. When the cap is engaged with the proximal opening, the second portion of the proximal opening may align with a second notch in the cap. The valve may include a valve passage configured to align with a central passage of the wire control mechanism. The valve passage may be configured to receive two or more wires.
[0013] Disclosed herein is a valve and a wire control mechanism in communication with the valve, the wire control mechanism having a distal end with a distal opening, a proximal end with a proximal opening, and a length between the distal and proximal ends, the proximal opening comprising a first portion, a second portion, and a third portion, one or more passageways configured to receive two or more wires, the one or more passageways comprising a central passageway, a first exchange passageway, and a second exchange passageway, the first exchange passageway and the second exchange passageway extending radially outward from the central passageway, the central passageway extending from the distal end to the proximal end along the length, the central passageway comprising a distal opening at the distal end and a first portion of the proximal opening at the proximal end, the first exchange passageway comprising a second portion of the proximal opening, and the third exchange passageway comprising a distal opening at the distal end and a first portion of the proximal opening at the proximal end. and a wire control mechanism comprising: one or more passageways, the first and second exchange passageways configured to exchange two or more wires between the first, second and third portions of the proximal opening, and first and second doors configured to engage the proximal opening of the passageways, the first and second doors further configured to uncover and cover at least a portion of the first and second exchange passageways without a user removing the two or more wires from the wire control mechanism, and each of the first, second and third portions of the proximal opening is configured to receive at least one wire of the two or more wires. The valve comprises a hemostatic valve.
[0014] In some implementations, the wire control mechanism forms a single continuous structure. In some implementations, the first door is configured to separate a first portion of the proximal opening from a second portion of the proximal opening and separate the two or more wires when engaged with the proximal opening and covering at least a portion of the first exchange passage. In some implementations, the second door is configured to separate a second portion of the proximal opening from a third portion of the proximal opening and separate the two or more wires when engaged with the proximal opening and covering at least a portion of the second exchange passage. In some implementations, the first door is configured to not cover the first exchange passage when disengaged from the proximal opening to permit a user to move the two or more wires between the first and second portions of the proximal opening through the first exchange passage. In some implementations, the second door is configured to not cover the second exchange passage when the second door is disengaged from the proximal opening to allow a user to move two or more wires between the second and third portions of the proximal opening through the second exchange passage. In some implementations, the first and second doors have an open configuration and a closed configuration, and when the first and second doors are in the open configuration, the first and second doors are disengaged from the proximal opening and the first and second exchange passages are not covered, and when the first and second doors are in the closed configuration, the first and second doors are engaged with the proximal opening and the first and second exchange passages are at least partially covered. In some implementations, the valve comprises a valve passage configured to align with a central passage of the wire control mechanism. In some implementations, the valve passage is configured to receive two or more wires. In some implementations, the first and second doors are rectangular. In some implementations, the proximal end includes one or more hinges, and the ends of the first door and the second door are coupled to the one or more hinges.
[0015] Disclosed herein is a dynamic catheter system comprising any of the valve systems disclosed herein; a guiding catheter having a first wall, the first wall comprising a distal portion with a distal end, a proximal portion with a proximal end, and an intermediate portion extending between the distal and proximal portions, the distal portion configured to be positioned within the artery, the proximal end configured to interact with the valve, a first wall thickness of the first wall varying from the proximal end to the distal end; and a guiding extension catheter having a second wall, the second wall comprising a distal portion with a distal end, a proximal portion with a proximal end, and an intermediate portion extending between the distal and proximal portions, the guiding extension catheter configured to be positioned within the guiding catheter and extend from the distal end of the guiding catheter, and a second wall thickness of the second wall varying from the proximal end to the distal end.
[0016] In some implementations, the change in the first wall thickness is inversely related to the change in the second wall thickness. In some implementations, the guide catheter includes a first transition region including a change in the first wall thickness, and the guide extension catheter includes a second transition region including a change in the second wall thickness. In some implementations, the first transition region is positioned at a midsection of the guide catheter, and the second transition region is positioned at a midsection of the guide extension catheter. In some implementations, the first transition region is positioned at a distal section of the midsection of the guide catheter, and the second transition region is positioned at a distal section of the midsection of the guide extension catheter. In some implementations, the first wall thickness decreases from a maximum wall thickness to a minimum wall thickness in a proximal to distal direction in the first transition region. In some implementations, the second wall thickness decreases from a maximum wall thickness to a minimum wall thickness in a distal to proximal direction in the second transition region.
[0017] Disclosed herein is a valve and a wire control mechanism in communication with the valve, the wire control mechanism comprising: a distal end with a distal opening, a proximal end with a proximal opening, and a length between the distal end and the proximal end, the proximal opening having a first portion and a second portion; one or more passageways configured to receive two or more wires, the one or more passageways including a central passageway and an exchange passageway extending radially outward from the central passageway, the central passageway extending from the distal end to the proximal end along the length, the central passageway including a distal opening at the distal end and a first portion of the proximal opening at the proximal end; The exchange passage comprises a second portion of the proximal opening, the exchange passage being configured to exchange two or more wires between the first and second portions of the proximal opening, and a wire control mechanism comprising a door configured to engage the proximal opening of the passage, the door being further configured to uncover and cover at least a portion of the exchange passage without a user removing the two or more wires from the wire control mechanism, the first and second portions of the proximal opening being configured to receive at least one of the two or more wires.
[0018] In some implementations, the door is configured to separate a first portion of the proximal opening from a second portion of the proximal opening and separate the two or more wires when engaged with the proximal opening and covering at least a portion of the exchange passage. In some implementations, the door is configured to not cover the exchange passage when disengaged from the proximal opening to allow a user to move the two or more wires between the first and second portions of the proximal opening through the exchange passage. In some implementations, the door comprises an open configuration and a closed configuration, where when the door is in the open configuration, the door is disengaged from the proximal opening and the exchange passage is not covered, and when the door is in the closed configuration, the door is engaged with the proximal opening and the exchange passage is at least partially covered. In some implementations, the valve comprises a valve passage configured to align with a central passage of the wire control mechanism. In some implementations, the valve passage is configured to receive the two or more wires. In some implementations, the door is rectangular. In some implementations, the proximal end comprises one or more hinges, and an end of the door couples to the one or more hinges. In some implementations, the valve and wire control mechanism form a single continuous structure.
[0019] Disclosed herein is a dynamic catheter system comprising any of the valve systems disclosed herein; a guiding catheter having a first wall, the first wall comprising a distal portion with a distal end, a proximal portion with a proximal end, and an intermediate portion extending between the distal and proximal portions, the distal portion configured to be positioned within the artery, the proximal end configured to interact with the valve, a first wall thickness of the first wall varying from the proximal end to the distal end; and a guiding extension catheter having a second wall, the second wall comprising a distal portion with a distal end, a proximal portion with a proximal end, and an intermediate portion extending between the distal and proximal portions, the guiding extension catheter configured to be positioned within the guiding catheter and extend from the distal end of the guiding catheter, and a second wall thickness of the second wall varying from the proximal end to the distal end.
[0020] Disclosed herein is a valve and a wire control mechanism in communication with the valve, the wire control mechanism having a distal end with a distal opening, a proximal end with a proximal opening, and a length between the distal and proximal ends, a passageway configured to receive two or more wires, the passageway comprising a central passageway extending along a length from the distal end to the proximal end, the central passageway comprising a distal opening at the distal end and a proximal opening at the proximal end, and a disc configured to engage the proximal opening of the passageway, the disc having a first portion, a second portion, a third portion, and a wire control mechanism comprising a disc having a notch defining a proximal opening, the disc configured to cover at least a portion of the proximal opening, the disc configured to permit communication between the first portion, the second portion, and the third portion and to move two or more wires between the first portion, the second portion, and the third portion without a user removing the two or more wires from the wire control mechanism, the first portion, the second portion, and the third portion of the notch configured to receive at least one wire of the two or more wires.
[0021] In some implementations, a first bridge portion separates the first and second portions of the cutout and a second bridge portion separates the second and third portions of the cutout. In some implementations, the first bridge portion and the second bridge portion comprise seals. In some implementations, the second portion of the cutout comprises one or more slits extending from the second portion. In some implementations, the valve comprises a valve passage configured to align with a central passage of the wire control mechanism. In some implementations, the valve passage is configured to receive two or more wires. In some implementations, the disc comprises a circular shape. In some implementations, the first and third portions of the cutout comprise an arc shape and the second portion of the cutout comprises a circular shape. In some implementations, the valve and the wire control mechanism form a single continuous structure.
[0022] Disclosed herein is a dynamic catheter system comprising any of the valves disclosed herein; a guiding catheter having a first wall, the first wall comprising a distal portion having a distal end, a proximal portion having a proximal end, and an intermediate portion extending between the distal and proximal portions, the distal portion configured to be positioned within the artery, the proximal end configured to interact with the valve, a first wall thickness of the first wall varying from the proximal end to the distal end; and a guiding extension catheter having a second wall, the second wall comprising a distal portion having a distal end, a proximal portion having a proximal end, and an intermediate portion extending between the distal and proximal portions, the guiding extension catheter configured to be positioned within the guiding catheter and extend from the distal end of the guiding catheter, and a second wall thickness of the second wall varying from the proximal end to the distal end.
[0023] In some implementations, the change in the first wall thickness is inversely related to the change in the second wall thickness. In some implementations, the guide catheter includes a first transition region including a change in the first wall thickness, and the guide extension catheter includes a second transition region including a change in the second wall thickness. In some implementations, the first transition region is positioned at a midsection of the guide catheter, and the second transition region is positioned at a midsection of the guide extension catheter. In some implementations, the first transition region is positioned at a distal section of the midsection of the guide catheter, and the second transition region is positioned at a distal section of the midsection of the guide extension catheter. In some implementations, the first wall thickness decreases from a maximum wall thickness to a minimum wall thickness in a proximal to distal direction in the first transition region. In some implementations, the second wall thickness decreases from a maximum wall thickness to a minimum wall thickness in a distal to proximal direction in the second transition region.
[0024] Disclosed herein is a valve and a wire control mechanism in communication with the valve, the wire control mechanism comprising: a distal end with a distal opening, a proximal end with a proximal opening, and a length between the distal and proximal ends, the proximal opening comprising a main portion, a first notch, and a second notch, the first notch and the second notch extending from a main portion of the proximal opening; a passageway configured to receive two or more wires, the passageway comprising a central passageway extending from the distal end to the proximal end along the length, the central passageway comprising a distal opening at the distal end and a main portion of the proximal opening at the proximal end; and a sleeve configured to engage the distal end; a wire control mechanism comprising a sleeve, the sleeve being configured to uncover and cover at least a portion of the first notch and the second notch, the sleeve being configured to allow communication between the main portion, the first notch, and the second notch when the sleeve does not cover a portion of the first notch and the second notch, and configured to move two or more wires between the main portion, the first notch, and the second notch without a user removing the two or more wires from the wire control mechanism, the main portion, the first notch, and the second notch being configured to receive at least one wire of the two or more wires.
[0025] In some implementations, the sleeve includes a first position in which at least a portion of the first notch and the second notch are not covered by the sleeve. In some implementations, the sleeve includes a second position in which end portions of the first notch and the second notch are isolated from a main portion of the proximal opening by the sleeve. In some implementations, the sleeve transitions from the first position to the second position by rotating the sleeve along an axis of rotation defined by the central passage. In some implementations, the sleeve transitions from the first position to the second position by moving the sleeve along an axial axis defined by the central passage. In some implementations, the valve and the wire control mechanism form a single continuous structure.
[0026] Disclosed herein is a dynamic catheter system comprising any of the valve systems disclosed herein; a guiding catheter having a first wall, the first wall comprising a distal portion with a distal end, a proximal portion with a proximal end, and an intermediate portion extending between the distal and proximal portions, the distal portion configured to be positioned within the artery, the proximal end configured to interact with the valve, a first wall thickness of the first wall varying from the proximal end to the distal end; and a guiding extension catheter having a second wall, the second wall comprising a distal portion with a distal end, a proximal portion with a proximal end, and an intermediate portion extending between the distal and proximal portions, the guiding extension catheter configured to be positioned within the guiding catheter and extend from the distal end of the guiding catheter, and a second wall thickness of the second wall varying from the proximal end to the distal end.
[0027] In some implementations, the change in the first wall thickness is inversely related to the change in the second wall thickness. In some implementations, the guide catheter includes a first transition region including a change in the first wall thickness, and the guide extension catheter includes a second transition region including a change in the second wall thickness. In some implementations, the first transition region is positioned at a midsection of the guide catheter, and the second transition region is positioned at a midsection of the guide extension catheter. In some implementations, the first transition region is positioned at a distal section of the midsection of the guide catheter, and the second transition region is positioned at a distal section of the midsection of the guide extension catheter. In some implementations, the first wall thickness decreases from a maximum wall thickness to a minimum wall thickness in a proximal to distal direction in the first transition region. In some implementations, the second wall thickness decreases from a maximum wall thickness to a minimum wall thickness in a distal to proximal direction in the second transition region.
[0028] Disclosed herein is a valve and a wire control mechanism in communication with the valve, the wire control mechanism comprising: a distal end with a distal opening, a proximal end with a proximal opening, and a length between the distal and proximal ends, the proximal opening comprising a main portion, a first notch, and a second notch, the first notch and the second notch extending from a main portion of the proximal opening; a passageway configured to receive two or more wires, the passageway comprising a central passageway extending from the distal end to the proximal end along the length, the central passageway comprising a distal opening at the distal end and a main portion of the proximal opening at the proximal end; and a cap configured to engage the proximal end, the cap comprising a first arm and a second arm. and a wire control mechanism comprising a cap, wherein the first and second arms are configured to uncover and cover at least a portion of the first and second cutouts, and the first and second arms are configured to allow communication between the main portion, the first and second cutouts when uncovering the portions of the first and second cutouts, and configured to move two or more wires between the main portion, the first and second cutouts without a user removing the two or more wires from the wire control mechanism, and the main portion, the first and second cutouts are configured to receive at least one wire of the two or more wires. In some implementations, the valve and the wire control mechanism form a single continuous structure.
[0029] Disclosed herein is a dynamic catheter system comprising any of the valve systems disclosed herein; a guiding catheter having a first wall, the first wall comprising a distal portion with a distal end, a proximal portion with a proximal end, and an intermediate portion extending between the distal and proximal portions, the distal portion configured to be positioned within the artery, the proximal end configured to interact with the valve, a first wall thickness of the first wall varying from the proximal end to the distal end; and a guiding extension catheter having a second wall, the second wall comprising a distal portion with a distal end, a proximal portion with a proximal end, and an intermediate portion extending between the distal and proximal portions, the guiding extension catheter configured to be positioned within the guiding catheter and extend from the distal end of the guiding catheter, and a second wall thickness of the second wall varying from the proximal end to the distal end.
[0030] In some implementations, the change in the first wall thickness is inversely related to the change in the second wall thickness. In some implementations, the guide catheter includes a first transition region including a change in the first wall thickness, and the guide extension catheter includes a second transition region including a change in the second wall thickness. In some implementations, the first transition region is positioned at a midsection of the guide catheter, and the second transition region is positioned at a midsection of the guide extension catheter. In some implementations, the first transition region is positioned at a distal section of the midsection of the guide catheter, and the second transition region is positioned at a distal section of the midsection of the guide extension catheter. In some implementations, the first wall thickness decreases from a maximum wall thickness to a minimum wall thickness in a proximal to distal direction in the first transition region. In some implementations, the second wall thickness decreases from a maximum wall thickness to a minimum wall thickness in a distal to proximal direction in the second transition region.
[0031] Disclosed herein is a valve and a wire control mechanism in communication with the valve, the wire control mechanism comprising: a distal end with a distal opening, a proximal end with a proximal opening, and a length between the distal end and the proximal end, the proximal opening having a main portion and a plurality of notches, the plurality of notches extending from the main portion of the proximal opening; a passageway configured to receive two or more wires, the passageway comprising a central passageway extending from the distal end to the proximal end along the length, the central passageway configured to engage the distal opening at the distal end and the main portion of the proximal opening at the proximal end, and the plurality of notches. and a wire control mechanism comprising a plurality of sliding parts, the plurality of sliding parts being configured to uncover and to cover at least a portion of the plurality of cutouts, the plurality of sliding parts being configured to allow communication between the main part and the plurality of cutouts when uncovering a portion of the plurality of cutouts and configured to move two or more wires between the main part and the plurality of cutouts without a user removing the two or more wires from the wire control mechanism, the main part and the plurality of cutouts being configured to receive at least one wire of the two or more wires.
[0032] Disclosed herein is a dynamic catheter system comprising any of the valve systems disclosed herein; a guiding catheter having a first wall, the first wall comprising a distal portion with a distal end, a proximal portion with a proximal end, and an intermediate portion extending between the distal and proximal portions, the distal portion configured to be positioned within the artery, the proximal end configured to interact with the valve, a first wall thickness of the first wall varying from the proximal end to the distal end; and a guiding extension catheter having a second wall, the second wall comprising a distal portion with a distal end, a proximal portion with a proximal end, and an intermediate portion extending between the distal and proximal portions, the guiding extension catheter configured to be positioned within the guiding catheter and extend from the distal end of the guiding catheter, a second wall thickness of the second wall varying from the proximal end to the distal end.
[0033] In some implementations, the change in the first wall thickness is inversely related to the change in the second wall thickness. In some implementations, the guide catheter includes a first transition region including a change in the first wall thickness, and the guide extension catheter includes a second transition region including a change in the second wall thickness. In some implementations, the first transition region is positioned at a midsection of the guide catheter, and the second transition region is positioned at a midsection of the guide extension catheter. In some implementations, the first transition region is positioned at a distal section of the midsection of the guide catheter, and the second transition region is positioned at a distal section of the midsection of the guide extension catheter. In some implementations, the first wall thickness decreases from a maximum wall thickness to a minimum wall thickness in a proximal to distal direction in the first transition region. In some implementations, the second wall thickness decreases from a maximum wall thickness to a minimum wall thickness in a distal to proximal direction in the second transition region.
[0034] Disclosed herein is a valve and a wire control mechanism in communication with the valve, the wire control mechanism comprising a distal end with a distal opening, a proximal end with a proximal opening, and a length between the distal end and the proximal end, the proximal opening having a first portion and a second portion, one or more passageways configured to receive two or more wires, the one or more passageways comprising a central passageway and an exchange passageway, the exchange passageway extending radially outward from the central passageway, the central passageway extending along the length from the distal end to the proximal end, the central passageway having a distal opening at the distal end and a proximal opening at the proximal end. and a wire control mechanism comprising: one or more passages, the one or more passages configured to allow two or more wires to be exchanged between the first and second portions of the proximal opening, the exchange passage comprising a first portion of a proximal opening in the proximal opening and the second portion ... configured to allow two or more wires to be exchanged between the first and second portions of the proximal opening; and a wire control mechanism comprising a liner configured to engage the proximal end, the liner comprising a bridge portion that at least partially seals the second portion from the first portion, each of the first and second portions of the proximal opening configured to receive at least one of the two or more wires.
[0035] In some implementations, the liner is partially embedded within a portion of the second portion of the proximal opening. In some implementations, the liner partially covers the second portion of the proximal opening. In some implementations, the bridge portion comprises an opening separating the first section of the liner and the second section of the liner. In some implementations, the liner and the valve comprise a single continuous structure. In some implementations, the liner comprises a V-shape. In some implementations, the liner comprises a silicone gel.
[0036] Disclosed herein is a dynamic catheter comprising any of the valve systems disclosed herein; a guiding catheter having a first wall, the first wall comprising a distal portion with a distal end, a proximal portion with a proximal end, and an intermediate portion extending between the distal and proximal portions, the distal portion configured to be positioned within the artery, the proximal end configured to interact with the valve, a first wall thickness of the first wall varying from the proximal end to the distal end; and a guiding extension catheter having a second wall, the second wall comprising a distal portion with a distal end, a proximal portion with a proximal end, and an intermediate portion extending between the distal and proximal portions, the guiding extension catheter configured to be positioned within the guiding catheter and extend from the distal end of the guiding catheter, a second wall thickness of the second wall varying from the proximal end to the distal end.
[0037] In some implementations, the change in the first wall thickness is inversely related to the change in the second wall thickness. In some implementations, the guide catheter includes a first transition region including a change in the first wall thickness, and the guide extension catheter includes a second transition region including a change in the second wall thickness. In some implementations, the first transition region is positioned at a midsection of the guide catheter, and the second transition region is positioned at a midsection of the guide extension catheter. In some implementations, the first transition region is positioned at a distal section of the midsection of the guide catheter, and the second transition region is positioned at a distal section of the midsection of the guide extension catheter. In some implementations, the first wall thickness decreases from a maximum wall thickness to a minimum wall thickness in a proximal to distal direction in the first transition region. In some implementations, the second wall thickness decreases from a maximum wall thickness to a minimum wall thickness in a distal to proximal direction in the second transition region.
[0038] Disclosed herein is a valve and a wire control mechanism in communication with the valve, the wire control mechanism comprising a distal end with a distal opening, a proximal end with a proximal opening, and a length between the distal end and the proximal end, the proximal opening having a first portion and a second portion, one or more passageways configured to receive two or more wires, the one or more passageways comprising a central passageway and an exchange passageway, the exchange passageway extending radially outward from the central passageway, the central passageway extending along the length from the distal end to the proximal end, the central passageway having a distal opening at the distal end and a proximal opening at the proximal end. and a wire control mechanism comprising: one or more passages, the exchange passage comprising a first portion of a proximal opening in a distal end of the proximal opening and a second portion of the proximal opening in a distal end of the proximal opening, the exchange passage comprising a second portion of the proximal opening, the exchange passage configured to allow two or more wires to be exchanged between the first and second portions of the proximal opening; and an insert configured to engage the proximal end, the insert comprising a bridge portion that at least partially seals the second portion from the first portion, each of the first and second portions of the proximal opening configured to receive at least one of the two or more wires.
[0039] In some implementations, the insert is partially embedded within a portion of the second portion of the proximal opening. In some implementations, the insert partially covers a first portion of the proximal opening. In some implementations, the bridge portion comprises an opening separating the first section of the insert and the second section of the insert. In some implementations, the insert and the valve comprise a single continuous structure. In some implementations, the insert comprises a circular shape. In some implementations, the insert comprises silicone gel.
[0040] Disclosed herein is a dynamic catheter comprising any of the valve systems disclosed herein; a guiding catheter comprising a first wall, the first wall comprising a distal portion comprising a distal end, a proximal portion comprising a proximal end, and an intermediate portion extending between the distal portion and the proximal portion, the distal portion configured to be positioned within the artery, the proximal end configured to interact with the valve, a first wall thickness of the first wall varying from the proximal end to the distal end; and a guiding extension catheter comprising a second wall, the second wall comprising a distal portion comprising a distal end, a proximal portion comprising a proximal end, and an intermediate portion extending between the distal portion and the proximal portion, the guiding extension catheter configured to be positioned within the guiding catheter and extend from the distal end of the guiding catheter, a second wall thickness of the second wall varying from the proximal end to the distal end. In some implementations, the change in the first wall thickness is inversely related to the change in the second wall thickness. In some implementations, the guide catheter includes a first transition region including a change in a first wall thickness, and the guide extension catheter includes a second transition region including a change in a second wall thickness. In some implementations, the first transition region is positioned at a midsection of the guide catheter, and the second transition region is positioned at a midsection of the guide extension catheter. In some implementations, the first transition region is positioned at a distal section of the midsection of the guide catheter, and the second transition region is positioned at a distal section of the midsection of the guide extension catheter. In some implementations, the first wall thickness decreases in the first transition region from a maximum wall thickness to a minimum wall thickness in a proximal to distal direction. In some implementations, the second wall thickness decreases in the second transition region from a maximum wall thickness to a minimum wall thickness in a distal to proximal direction.
[0041] Disclosed herein is a wire control mechanism having a distal end with a distal opening, a proximal end with a proximal opening, and a length between the distal and proximal ends, the proximal opening comprising a first portion, a second portion, and a third portion; and one or more passageways configured to receive two or more wires, the one or more passageways comprising a central passageway, a first exchange passageway, and a second exchange passageway, the first exchange passageway and the second exchange passageway extending radially outward from the central passageway, the central passageway extending from the distal end to the proximal end along the length, the central passageway comprising a distal opening at the distal end and a first portion of the proximal opening at the proximal end, the first exchange passageway comprising a second portion of the proximal opening, and the third exchange passageway. a third portion of the proximal opening, the first and second exchange passages configured to allow two or more wires to be exchanged between the first, second and third portions of the proximal opening; and first and second doors configured to engage the proximal opening of the passages, the first and second doors further configured to uncover and cover at least a portion of the first and second exchange passages without a user removing the two or more wires from the wire control mechanism, each of the first, second and third portions of the proximal opening configured to receive at least one wire of the two or more wires.
[0042] In some implementations, the first door is configured to separate a first portion of the proximal opening from a second portion of the proximal opening and separate the two or more wires when engaged with the proximal opening and covering at least a portion of the first exchange passage. In some implementations, the second door is configured to separate a second portion of the proximal opening from a third portion of the proximal opening and separate the two or more wires when engaged with the proximal opening and covering at least a portion of the second exchange passage. In some implementations, the first door is configured to not cover the first exchange passage when disengaged from the proximal opening to allow a user to move the two or more wires between the first and second portions of the proximal opening through the first exchange passage. In some implementations, the second door is configured to not cover the second exchange passage when disengaged from the proximal opening to allow a user to move the two or more wires between the second and third portions of the proximal opening through the second exchange passage. In some implementations, the first and second doors have an open configuration and a closed configuration, and when the first and second doors are in the open configuration, the first and second doors are disengaged from the proximal opening and the first and second exchange passages are uncovered, and when the first and second doors are in the closed configuration, the first and second doors are engaged with the proximal opening and the first and second exchange passages are at least partially covered. In some implementations, the first and second doors are rectangular. In some implementations, the proximal end comprises one or more hinges, and the ends of the first and second doors couple to the one or more hinges.
[0043] Disclosed herein is a wire control mechanism having a distal end with a distal opening, a proximal end with a proximal opening, and a length between the distal end and the proximal end, the proximal opening having a first portion and a second portion, and one or more passageways configured to receive two or more wires, the one or more passageways including a central passageway and an exchange passageway extending radially outward from the central passageway, the central passageway extending from the distal end to the proximal end along the length, the central passageway including a distal opening at the distal end and a first portion of the proximal opening at the proximal end. and a door configured to engage the proximal opening of the one or more passages, the exchange passage comprising a second portion of the proximal opening, the exchange passage configured to allow two or more wires to be exchanged between the first and second portions of the proximal opening, the door further configured to uncover and cover at least a portion of the exchange passage without a user removing the two or more wires from the wire control mechanism, the first and second portions of the proximal opening configured to receive at least one of the two or more wires.
[0044] In some implementations, the door is configured to separate a first portion of the proximal opening from a second portion of the proximal opening and separate the two or more wires when engaged with the proximal opening and covering at least a portion of the exchange passage. In some implementations, the door is configured to not cover the exchange passage when disengaged from the proximal opening to allow a user to move the two or more wires between the first and second portions of the proximal opening through the exchange passage. In some implementations, the door comprises an open configuration and a closed configuration, where when the door is in the open configuration, the door is disengaged from the proximal opening and the exchange passage is not covered, and when the door is in the closed configuration, the door is engaged with the proximal opening and the exchange passage is at least partially covered. In some implementations, the door is rectangular. In some implementations, the proximal end comprises one or more hinges, and the door end couples to the one or more hinges.
[0045] Disclosed herein is a wire control mechanism having a distal end with a distal opening, a proximal end with a proximal opening, and a length between the distal and proximal ends; a passageway configured to receive two or more wires, the passageway comprising a central passageway extending along a length from the distal end to the proximal end, the central passageway comprising a distal opening at the distal end and a proximal opening at the proximal end; and a disc configured to engage the proximal opening of the passageway, the disc defining a first portion, a second portion, and a third portion. and a disc configured to cover at least a portion of the proximal opening, the disc configured to permit communication between the first portion, the second portion, and the third portion and to move two or more wires between the first portion, the second portion, and the third portion without a user removing the two or more wires from the wire control mechanism, the first portion, the second portion, and the third portion of the cutout configured to receive at least one of the two or more wires.
[0046] In some implementations, a first bridge portion separates the first and second portions of the cutout and a second bridge portion separates the second and third portions of the cutout. In some implementations, the first bridge portion and the second bridge portion comprise seals. In some implementations, the second portion of the cutout comprises one or more slits extending from the second portion. In some implementations, the disc comprises a circular shape. In some implementations, the first and third portions of the cutout comprise an arc shape and the second portion of the cutout comprises a circular shape.
[0047] Disclosed herein is a wire control mechanism comprising: a distal end with a distal opening, a proximal end with a proximal opening, and a length between the distal and proximal ends, the proximal opening comprising a main portion, a first notch, and a second notch, the first notch and the second notch extending from a main portion of the proximal opening; a passageway configured to receive two or more wires, the passageway comprising a central passageway extending from the distal end to the proximal end along the length, the central passageway comprising a distal opening at the distal end and a main portion of the proximal opening at the proximal end; and a sleeve configured to engage the distal end, the sleeve. the sleeve is configured to cover and uncover at least a portion of the first notch and the second notch, the sleeve being configured to allow communication between the main part, the first notch, and the second notch when uncovering the first notch and the second notch, and configured to move two or more wires between the main part, the first notch, and the second notch without a user removing the two or more wires from the wire control mechanism, and the main part, the first notch, and the second notch are configured to receive at least one wire of the two or more wires.
[0048] In some implementations, the sleeve includes a first position in which at least a portion of the first notch and the second notch are not covered by the sleeve. In some implementations, the sleeve includes a second position in which end portions of the first notch and the second notch are isolated from a main portion of the proximal opening by the sleeve. In some implementations, the sleeve transitions from the first position to the second position by rotating the sleeve along an axis of rotation defined by the central passage. In some implementations, the sleeve transitions from the first position to the second position by moving the sleeve along an axial axis defined by the central passage.
[0049] Disclosed herein is a wire control mechanism having a distal end with a distal opening, a proximal end with a proximal opening, and a length between the distal and proximal ends, the proximal opening having a main portion, a first notch, and a second notch, the first notch and the second notch extending from a main portion of the proximal opening; a passageway configured to receive two or more wires, the passageway comprising a central passageway extending from the distal end to the proximal end along the length, the central passageway comprising a distal opening at the distal end and a main portion of the proximal opening at the proximal end; and a cap configured to engage the proximal end, the cap comprising a first arm and a second arm, the first arm of the cap. and a cap, wherein the first arm and the second arm are configured to uncover and to cover at least a portion of the first notch and the second notch, and the first arm and the second arm are configured to allow communication between the main part, the first notch, and the second notch when not covering a portion of the first notch and the second notch, and configured to move two or more wires between the main part, the first notch, and the second notch without a user removing the two or more wires from the wire control mechanism, and the main part, the first notch, and the second notch are configured to receive at least one wire of the two or more wires.
[0050] Disclosed herein is a wire control mechanism in communication with a valve, the mechanism comprising: a distal end with a distal opening, a proximal end with a proximal opening, and a length between the distal end and the proximal end, the proximal opening having a main portion and a plurality of notches, the plurality of notches extending from the main portion of the proximal opening; and a passageway configured to receive two or more wires, the passageway comprising a central passageway extending from the distal end to the proximal end along the length, the central passageway configured to engage the distal opening at the distal end and the main portion of the proximal opening at the proximal end. and a plurality of sliding parts configured to cover and not cover at least a portion of the plurality of cutouts, the plurality of sliding parts configured to allow communication between the main part and the plurality of cutouts when not covering a portion of the plurality of cutouts and configured to move two or more wires between the main part and the plurality of cutouts without a user removing the two or more wires from the wire control mechanism, the main part and the plurality of cutouts configured to receive at least one wire of the two or more wires.
[0051] Disclosed herein is a wire control mechanism in communication with a valve, the mechanism comprising: a distal end with a distal opening, a proximal end with a proximal opening, and a length between the distal end and the proximal end, the proximal opening having a first portion and a second portion; and one or more passageways configured to receive two or more wires, the one or more passageways comprising a central passageway and an exchange passageway, the exchange passageway extending radially outward from the central passageway, the central passageway extending from the distal end to the proximal end along the length, the central passageway comprising a distal opening at the distal end, and A wire control mechanism comprising: one or more passages comprising a first portion of a proximal opening at a proximal end, the exchange passage comprising a second portion of the proximal opening, the exchange passage configured to exchange two or more wires between the first and second portions of the proximal opening; and a liner configured to engage the proximal end, the liner comprising a bridge portion that at least partially seals the second portion from the first portion, each of the first and second portions of the proximal opening configured to receive at least one of the two or more wires.
[0052] In some configurations, the liner is partially embedded within a portion of the second portion of the proximal opening. In some configurations, the liner partially covers the second portion of the proximal opening. In some configurations, the bridge portion comprises an opening separating a first section of the liner and a second section of the liner. In some configurations, the liner comprises a V-shape. In some configurations, the liner comprises a silicone gel.
[0053] Disclosed herein is a wire control mechanism in communication with a valve, the mechanism comprising: a distal end with a distal opening, a proximal end with a proximal opening, and a length between the distal end and the proximal end, the proximal opening having a first portion and a second portion; and one or more passageways configured to receive two or more wires, the one or more passageways comprising a central passageway and an exchange passageway, the exchange passageway extending radially outward from the central passageway, the central passageway extending from the distal end to the proximal end along the length, the central passageway comprising a distal opening at the distal end, and A wire control mechanism comprising: one or more passages comprising a first portion of a proximal opening at a proximal end, the exchange passage comprising a second portion of the proximal opening, the exchange passage configured to exchange two or more wires between the first and second portions of the proximal opening; and an insert configured to engage the proximal end, the insert comprising a bridge portion that at least partially seals the second portion from the first portion, each of the first and second portions of the proximal opening configured to receive at least one of the two or more wires.
[0054] In some implementations, the insert is partially embedded within a portion of the second portion of the proximal opening. In some implementations, the insert partially covers a first portion of the proximal opening. In some implementations, the bridge portion comprises an opening separating the first section of the insert and the second section of the insert. In some implementations, the insert comprises a circular shape. In some implementations, the insert comprises silicone gel.
[0055] Disclosed herein is a valve system comprising a valve and a wire control mechanism in communication with the valve, the wire control mechanism having a distal end with a distal opening, a proximal end with a proximal opening, and a length between the distal end and the proximal end, the proximal opening having a first portion and a second portion, and one or more passageways configured to receive two or more wires, the one or more passageways including a central passageway and an exchange passageway extending radially outward from the central passageway, the central passageway extending from the distal end to the proximal end along the length, the central passageway being configured to exchange a first portion of the distal opening at the distal end and a second portion of the proximal opening at the proximal end. a cap configured to engage the proximal opening of the one or more passages, the cap comprising a first cutout and a second cutout, the cap configured to uncover and cover the exchange passage without a user removing the two or more wires from the wire control mechanism, the cap comprising a first cutout and a second cutout configured to receive at least one of the two or more wires.
[0056] Disclosed herein is a dynamic catheter system comprising one or more of the features described above. Also disclosed herein is a method of using a dynamic catheter system comprising one or more of the features described above. Also disclosed herein is a wire control mechanism comprising one or more of the features described above. Also disclosed herein is a method of using a wire control mechanism comprising one or more of the features described above. Also disclosed herein is a dynamic catheter system comprising one or more of the features described above for use in an interventional cardiology procedure. Also disclosed herein is a method of using a wire control mechanism comprising one or more of the features described above for use in an interventional cardiology procedure. Also disclosed herein is a wire control mechanism comprising one or more of the features described above for use in an interventional cardiology procedure.
[0057] The dynamic catheter system may include one or more of the features described above.The method of using the dynamic catheter system may include one or more of the features described above.
[0058] Any of the features, components, or details of any of the configurations or embodiments disclosed in the present application, including, without limitation, any of the guide catheter and guide extension catheter system embodiments disclosed below, may be mutually interchangeably combined with any other features, components, or details of any of the configurations or embodiments disclosed herein to form new configurations and embodiments.
[0059] Various embodiments of the presently disclosed devices and methods are described herein with reference to the drawings. [Brief description of the drawings]
[0060] [Figure 1] FIG. 1 is a diagram of a guide catheter for use in a medical procedure. [Figure 2A]FIG. 13 is a diagram of a guide catheter shaft with a telescoping guide extension catheter system. [Figure 2B] FIG. 13 is a diagram of a guide catheter shaft with a telescoping guide extension catheter system. [Figure 3A] FIG. 13 is a diagram of a guide catheter shaft with a telescoping guide extension catheter system. [Figure 3B] FIG. 13 is a diagram of a guide catheter shaft with a telescoping guide extension catheter system. [Figure 3C] FIG. 13 is a diagram of a guide catheter shaft with a telescoping guide extension catheter system. [Figure 3D] FIG. 13 is a diagram of a guide catheter shaft with a telescoping guide extension catheter system. [Figure 4A] FIG. 13 is a diagram of a guide catheter shaft with a telescoping guide extension catheter system. [Figure 4B] FIG. 13 is a diagram of a guide catheter shaft with a telescoping guide extension catheter system. [Figure 4C] FIG. 13 is a diagram of a guide catheter shaft with a telescoping guide extension catheter system. [Figure 5A] FIG. 13 is a diagram of a guide catheter shaft with a telescoping guide extension catheter system. [Figure 5B] FIG. 13 is a diagram of a guide catheter shaft with a telescoping guide extension catheter system. [Figure 5C] FIG. 13 is a diagram of a guide catheter shaft with a telescoping guide extension catheter system. [Figure 6A] FIG. 13 is a diagram of a guide catheter with a telescoping guide extension catheter incorporating a branch wire advancement mechanism. [Figure 6B] FIG. 13 is a diagram of a guide catheter with a telescoping guide extension catheter incorporating a branch wire advancement mechanism. [Figure 6C] FIG. 13 is a diagram of a guide catheter with a telescoping guide extension catheter incorporating a branch wire advancement mechanism. [Figure 6D] FIG. 13 is a diagram of a guide catheter with a telescoping guide extension catheter incorporating a branch wire advancement mechanism. [Figure 6E] FIG. 13 is a diagram of a guide catheter with a telescoping guide extension catheter incorporating a branch wire advancement mechanism. [Figure 6F] FIG. 13 is a diagram of a guide catheter with a telescoping guide extension catheter incorporating a branch wire advancement mechanism. [Figure 7A] FIG. 13 is a diagram of a wire advancement mechanism using a sliding mechanism. [Figure 7B] FIG. 13 is a diagram of a wire advancement mechanism using a sliding mechanism. [Figure 7C] FIG. 13 is a diagram of a wire advancement mechanism using a sliding mechanism. [Figure 7D] FIG. 13 is a diagram of a wire advancement mechanism using a sliding mechanism. [Figure 8A] FIG. 13 is a diagram of a wire advancement mechanism using a spool mechanism. [Figure 8B] FIG. 13 is a diagram of a wire advancement mechanism using a spool mechanism. [Figure 8C] FIG. 13 is a diagram of a wire advancement mechanism using a spool mechanism. [Figure 8D] FIG. 13 is a diagram of a wire advancement mechanism using a spool mechanism. [Figure 9A] FIG. 13 is a diagram of a wire advance mechanism using a contact wheel mechanism. [Figure 9B] FIG. 13 is a diagram of a wire advance mechanism using a contact wheel mechanism. [Figure 9C] FIG. 13 is a diagram of a wire advance mechanism using a contact wheel mechanism. [Figure 9D] FIG. 13 is a diagram of a wire advance mechanism using a contact wheel mechanism. [Figure 10A] FIG. 13 is a diagram of a wire advancement mechanism using a screw mechanism. [Figure 10B] FIG. 13 is a diagram of a wire advancement mechanism using a screw mechanism. [Figure 11A] FIG. 13 is a diagram of a wire advance mechanism using a rack and pinion mechanism. [Figure 11B] FIG. 13 is a diagram of a wire advance mechanism using a rack and pinion mechanism. [Figure 11C] FIG. 13 is a diagram of a wire advance mechanism using a rack and pinion mechanism. [Figure 11D] FIG. 13 is a diagram of a wire advance mechanism using a rack and pinion mechanism. [Figure 12A] FIG. 13 is a diagram of a wire advancement mechanism using a non-contact advancement mechanism. [Figure 12B] FIG. 13 is a diagram of a wire advancement mechanism using a non-contact advancement mechanism. [Figure 13] 11A-11C are diagrams of example handles and / or grips that can be used with either the guide extension advancement mechanism and / or the guide catheter. [Figure 14] 11A-11C are diagrams of example handles and / or grips that can be used with either the guide extension advancement mechanism and / or the guide catheter. [Figure 15] 11A-11C are diagrams of example handles and / or grips that can be used with either the guide extension advancement mechanism and / or the guide catheter. [Figure 16] 11A-11C are diagrams of example handles and / or grips that can be used with either the guide extension advancement mechanism and / or the guide catheter. [Figure 17A] 1A-1C are diagrams of an example of a dynamic catheter system with a guide extension advancement mechanism for actuating the guide extension catheter within the guide catheter. [Figure 17B] 1A-1C are diagrams of an example of a dynamic catheter system with a guide extension advancement mechanism for actuating the guide extension catheter within the guide catheter. [Figure 17C] 1A-1C are diagrams of an example of a dynamic catheter system with a guide extension advancement mechanism for actuating the guide extension catheter within the guide catheter. [Figure 17D] 1A-1C are diagrams of an example of a dynamic catheter system with a guide extension advancement mechanism for actuating the guide extension catheter within the guide catheter. [Figure 17E] 1A-1C are diagrams of an example of a dynamic catheter system with a guide extension advancement mechanism for actuating the guide extension catheter within the guide catheter. [Figure 17F] 1A-1C are diagrams of an example of a dynamic catheter system with a guide extension advancement mechanism for actuating the guide extension catheter within the guide catheter. [Figure 17G]1A-1C are diagrams of an example of a dynamic catheter system with a guide extension advancement mechanism for actuating the guide extension catheter within the guide catheter. [Figure 17H] 1A-1C are diagrams of an example of a dynamic catheter system with a guide extension advancement mechanism for actuating the guide extension catheter within the guide catheter. [Figure 18A] 1A-1C are diagrams of an example of a dynamic catheter system with a guide extension advancement mechanism for actuating the guide extension catheter within the guide catheter. [Figure 18B] 1A-1C are diagrams of an example of a dynamic catheter system with a guide extension advancement mechanism for actuating the guide extension catheter within the guide catheter. [Figure 18C] 1A-1C are diagrams of an example of a dynamic catheter system with a guide extension advancement mechanism for actuating the guide extension catheter within the guide catheter. [Figure 18D] 1A-1C are diagrams of an example of a dynamic catheter system with a guide extension advancement mechanism for actuating the guide extension catheter within the guide catheter. [Figure 18E] 1A-1C are diagrams of an example of a dynamic catheter system with a guide extension advancement mechanism for actuating the guide extension catheter within the guide catheter. [Figure 18F] 1A-1C are diagrams of an example of a dynamic catheter system with a guide extension advancement mechanism for actuating the guide extension catheter within the guide catheter. [Figure 18G] 1A-1C are diagrams of an example of a dynamic catheter system with a guide extension advancement mechanism for actuating the guide extension catheter within the guide catheter. [Figure 18H] 1A-1C are diagrams of an example of a dynamic catheter system with a guide extension advancement mechanism for actuating the guide extension catheter within the guide catheter. [Figure 19A] 1A-1C are diagrams of an example of a dynamic catheter system with a guide extension advancement mechanism for actuating the guide extension catheter within the guide catheter. [Figure 19B] 1A-1C are diagrams of an example of a dynamic catheter system with a guide extension advancement mechanism for actuating the guide extension catheter within the guide catheter. [Figure 20A] 1A-1C are diagrams of an example of a dynamic catheter system with a guide extension advancement mechanism for actuating the guide extension catheter within the guide catheter. [Figure 20B] 1A-1C are diagrams of an example of a dynamic catheter system with a guide extension advancement mechanism for actuating the guide extension catheter within the guide catheter. [Figure 21A] 1A-1C are diagrams of an example of a dynamic catheter system with a guide extension advancement mechanism for actuating the guide extension catheter within the guide catheter. [Figure 21B] 1A-1C are diagrams of an example of a dynamic catheter system with a guide extension advancement mechanism for actuating the guide extension catheter within the guide catheter. [Figure 21C] 1A-1C are diagrams of an example of a dynamic catheter system with a guide extension advancement mechanism for actuating the guide extension catheter within the guide catheter. [Figure 21D] 1A-1C are diagrams of an example of a dynamic catheter system with a guide extension advancement mechanism for actuating the guide extension catheter within the guide catheter. [Figure 21E] 1A-1C are diagrams of an example of a dynamic catheter system with a guide extension advancement mechanism for actuating the guide extension catheter within the guide catheter. [Figure 21F] 1A-1C are diagrams of an example of a dynamic catheter system with a guide extension advancement mechanism for actuating the guide extension catheter within the guide catheter. [Figure 22A] 1A-1C are diagrams of an example of a dynamic catheter system with a guide extension advancement mechanism for actuating the guide extension catheter within the guide catheter. [Figure 22B] 1A-1C are diagrams of an example of a dynamic catheter system with a guide extension advancement mechanism for actuating the guide extension catheter within the guide catheter. [Figure 23A] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 23B] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 23C] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 23D]FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 24A] FIG. 23B is a side view of the wire control mechanism shown in FIGS. 23A-23D attached to a valve of a catheter system. [Figure 24B] FIG. 23B is a side view of the wire control mechanism shown in FIGS. 23A-23D attached to a valve of a catheter system. [Figure 25A] FIG. 13 is a perspective view of an example of a wire control mechanism attached to a valve of the catheter system. [Figure 25B] FIG. 13 is a side view of an example of a wire control mechanism attached to a valve of the catheter system. [Figure 26A] FIG. 13 is a proximal view of an example of a wire control mechanism attached to a valve of a catheter system. [Figure 26B] FIG. 13 is a distal perspective view of an example of a wire control mechanism attached to a valve of a catheter system. [Figure 26C] FIG. 26C is a side view of the example wire control mechanism shown in FIGS. 26A-B attached to a valve of a catheter system. [Figure 27] FIG. 13 is a diagram of an example guiding catheter shaft with a telescoping guiding extension catheter system. [Figure 28A] 28 is a cross-sectional view of an example guiding catheter shaft with an example telescoping guiding extension catheter system and a side view of a portion of the distal end of the example guiding catheter shaft shown in FIG. 27. [Figure 28B] FIG. 28B is a view of the distal end of the guide catheter shaft shown in FIG. 28A. [Figure 28C] FIG. 28B is a view of the proximal end of the guide catheter shaft shown in FIG. 28A. [Figure 29A] 28 is a cross-sectional view of an example guiding catheter shaft with an example telescoping guiding extension catheter system and a side view of a portion of the distal end of the example guiding catheter shaft shown in FIG. 27. [Figure 29B] FIG. 29B is a view of the distal end of the guide catheter shaft shown in FIG. 29A. [Figure 29C] FIG. 29B is a view of the proximal end of the guide catheter shaft shown in FIG. 29A. [Figure 30A] 28 is a cross-sectional view of an example guiding catheter shaft with an example telescoping guiding extension catheter system and a side view of a portion of the distal end of the example guiding catheter shaft shown in FIG. 27. [Figure 30B] FIG. 30B is a view of the distal end of the guide catheter shaft shown in FIG. 30A. [Figure 30C] FIG. 30B is a view of the proximal end of the guide catheter shaft shown in FIG. 30A. [Figure 30D] FIG. 30B is a perspective view of the transition section of the guide catheter shaft shown in FIG. 30A. [Figure 30E] 30B is a cross-sectional view of the guide catheter shaft shown in FIG. 30A in a different configuration. [Figure 30F] 30B is a cross-sectional view of the guide catheter shaft shown in FIG. 30A in a different configuration. [Figure 31A] 1A-1D are various views of an example spool system. [Figure 31B] 1A-1D are various views of an example spool system. [Figure 31C] 1A-1D are various views of an example spool system. [Figure 31D] 1A-1D are various views of an example spool system. [Figure 32A] FIG. 1 is a perspective view of an example mooring system. [Figure 32B] FIG. 1 is a perspective view of an example mooring system. [Figure 32C] FIG. 1 is a perspective view of an example mooring system. [Diagram 33] 1A-1C are diagrams of various examples of storage mechanisms for catheter wires. [Figure 34A] 1A-1C are diagrams of various examples of storage mechanisms for catheter wires. [Figure 34B] 1A-1C are diagrams of various examples of storage mechanisms for catheter wires. [Diagram 35] 1A-1C are diagrams of various examples of storage mechanisms for catheter wires. [Diagram 36] 1A-1C are diagrams of various examples of storage mechanisms for catheter wires. [Figure 37]1A-1C are diagrams of various examples of storage mechanisms for catheter wires. [Figure 38A] 1A-1C are diagrams of various examples of storage mechanisms for catheter wires. [Figure 38B] 1A-1C are diagrams of various examples of storage mechanisms for catheter wires. [Figure 39] 1A-1D are diagrams of various examples of safety mechanisms for catheter systems. [Diagram 40] 1A-1D are diagrams of various examples of safety mechanisms for catheter systems. [Diagram 41] 1A-1D are diagrams of various examples of safety mechanisms for catheter systems. [Figure 42A] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 42B] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 42C] FIG. 13 is a diagram of an example of a wire control mechanism. [Fig.42D] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 42E] FIG. 13 is a diagram of an example of a wire control mechanism. [Fig.42F] FIG. 13 is a diagram of an example of a wire control mechanism. [Fig.42G] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 43A] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 43B] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 43C] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 44A] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 44B] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 44C] FIG. 13 is a diagram of an example of a wire control mechanism. [Fig.44D] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 44E] FIG. 13 is a diagram of an example of a wire control mechanism. [Fig.44F] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 45A] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 45B] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 45C] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 46A] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 46B] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 46C] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 46D] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 46E] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 46F] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 47A] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 47B] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 47C] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 48A] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 48B] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 48C] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 49A] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 49B] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 49C] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 49D] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 49E] FIG. 13 is a diagram of an example of a wire control mechanism. [Fig.49F] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 50A] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 50B] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 50C] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 50D] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 50E] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 50F] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 50G] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 51A] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 51B] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 51C] FIG. 13 is a diagram of an example of a wire control mechanism. [Fig. 51D] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 51E] FIG. 13 is a diagram of an example of a wire control mechanism. [Fig. 51F] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 52A] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 52B] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 52C] FIG. 13 is a diagram of an example of a wire control mechanism. [Fig. 52D] FIG. 13 is a diagram of an example of a wire control mechanism. [Figure 52E] FIG. 13 is a diagram of an example of a wire control mechanism. [Fig. 52F] FIG. 13 is a diagram of an example of a wire control mechanism. [Fig. 52G] FIG. 13 is a diagram of an example of a wire control mechanism. [Fig. 52H] FIG. 13 is a diagram of an example of a wire control mechanism. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0061] The embodiments described herein relate to a novel dynamic catheter system. The dynamic catheter system may include a guiding catheter, a telescopic guiding extension catheter, and a catheter control center. The catheter control center may include various elements such as an advancement mechanism, a hemostasis valve, and a wire storage chamber. The devices and methods may be used to significantly improve the use of guiding catheters and guiding extension catheters without adding significant manufacturing and / or assembly costs. The guiding catheter device and method embodiments may be particularly impactful when accessing the vasculature. In addition to coronary vascular procedures, any of the techniques described herein (i.e., the novel dynamic catheter system) may be applied to any vascular procedure, including, but not limited to, neurovascular, renal vascular, and other peripheral vascular procedures.
[0062] The dynamic catheter system described herein can eliminate the need to place a guiding extension catheter during the course of a procedure. The dynamic catheter system can allow for easier movement of the guiding extension catheter. The dynamic catheter system can reduce wire tangles and wire wraps, and the extension wire can be neatly contained within the catheter control center and / or advancement mechanism. In some cases, the guiding extension catheter can be easy to move forward, maintain tactile feedback, and the guiding extension wire can avoid wrapping with other wires. The dynamic catheter system can allow for easier hand placement for the practitioner, and can allow for more control and ease of use for the practitioner compared to existing guiding catheter and guiding extension catheter products. The dynamic catheter system creates an opportunity for improved guiding catheter and guiding extension catheter design and performance. For example, a dynamic catheter system with an integrated guiding extension catheter and / or advancement mechanism can allow for a guiding extension catheter tip that can be softer than existing guiding catheter extensions. In some cases, the improved guiding extension catheter can have an outer surface that allows for easier movement within the guiding catheter and vasculature without adding significant manufacturing and / or assembly costs. In other example embodiments, the dynamic catheter system can allow for an increased inner diameter of the guiding extension catheter to allow more space for the passage of instruments, and the integrated guiding extension catheter can allow for easier placement of the guiding catheter by creating more stiffness in the guiding catheter.
[0063] Current guide catheters can be used to facilitate easier entry into blood vessels with other devices or instruments. Guide catheters can be used to facilitate placement of balloons and stents for angioplasty and stenting, or other procedures.
[0064] A current guiding extension catheter is a separate catheter that is placed into the guiding catheter and can be used during a medical procedure. The guiding extension catheter can be inserted through the catheter past the hemostatic valve in coordination with other wires or devices delivered through the catheter. The guiding extension catheter can often help provide greater support to the guiding catheter, making it easier to deliver devices such as stents and / or balloons to the target area. Prior to inserting the current guiding extension catheter, other devices used during the procedure may need to be adjusted or removed. The wire portion of the current guiding extension catheter that is used to advance or retract the guiding extension catheter can have a uniform cross-sectional shape and can also exit through the hemostatic valve after insertion. The uniform cross-sectional shape of the wire can be rectangular and can be bulky (flat wire). As a result, the current guiding extension catheter wire can be in a way that makes other wires difficult to handle within the guiding catheter and challenging to insert during the procedure.
[0065] The procedure to deliver the device for percutaneous coronary intervention may include various steps. The radial or femoral artery may be accessed and a sheath may be placed. A diagnostic angiogram may be performed using the diagnostic catheter showing the lesion in a specific area (e.g., the mid-right coronary artery [RCA]). The diagnostic catheter may be removed and the operator may prepare for percutaneous coronary intervention. A Tuohy-Borst valve or similar hemostatic valve device may be connected to the back of the guiding catheter, and then a manifold may be connected to the hemostatic valve and the guiding catheter may be flushed. A standard J-tip guidewire (typically 0.035-0.038 inch diameter) may then be fed into the hemostatic valve and guiding catheter. The hemostatic valve may be opened slightly to allow the wire to slide in. The wire may be advanced in the vessel into the ascending aorta, taking the guiding catheter with it. Once the guiding catheter is near the aortic root, the wire may be removed and the operator may aspirate and flush the catheter.
[0066] The right coronary ostium may be engaged with a guide catheter. A standard 0.014 inch coronary guidewire may be advanced to the hemostatic valve, advanced into the guide catheter, and advanced past the mid-RCA lesion into the distal vessel. If the operator is able, a flexible balloon may be advanced over the coronary guidewire into the lesion and inflated to pre-dilatate the lesion. The balloon may then be removed and the operator may assess that it has adequately dilated the lesion. If possible, the operator may advance a stent into the lesion. However, in some cases, the operator may be unable to deliver the device due to the calcified and / or tortuous nature of the lesion / vessel, or lack of adequate guide catheter support.
[0067] In this regard, the operator may insert a guiding extension catheter for additional support after initially removing the stent (or balloon). After inserting the guiding extension catheter over the coronary guidewire, the stent or balloon may then be advanced again over the coronary guidewire. With existing guiding extension catheter devices, the operator is encouraged to slide the guiding extension catheter over the shaft of the balloon or stent delivery system in the coronary artery to provide a portion of the rail and reduce the risk of injuring the proximal vessel. In some circumstances, the operator may find it less than ideal to have to insert the guiding extension catheter as a separate device due to the need to remove the balloon / stent with multiple wires exiting the hemostasis valve, and cost considerations. Thus, the operator may try several alternative techniques to avoid the use of the guiding extension catheter. The decision may be based on the operator's comfort and experience, time, and cost. As previously described, the dynamic catheter system described herein may help enable a single device that can provide the guiding catheter, the guiding extension catheter, and / or an advancement mechanism that can provide control of the dynamic catheter system and routing of the wires and devices within the dynamic catheter system.
[0068] Dynamic Catheter System It would be beneficial to have a dynamic catheter system utilizing a guide catheter, a telescoping guide extension catheter, and a catheter control center that may include an integrated control center with an advancement mechanism, a wire storage and / or retention device, and an integrated hemostasis valve.
[0069] It may be beneficial to have a guiding catheter that utilizes an integrated guiding extension catheter that can allow for easy deployment of the guiding extension catheter when needed. In such cases, the procedure would follow the steps above, but if the operator is unable to deliver the instrument due to the calcified / tortuous nature of the lesion / vessel, the operator can utilize the integrated guiding extension catheter for additional support. In such cases, the guiding extension catheter portion of the device can be advanced over the coronary guidewire and the balloon or stent. The balloon or stent can then be advanced to the lesion. The guiding extension catheter portion can often be helpful as it provides greater support from the guiding catheter, making it easier to deliver the instrument. In conventional cases, if the stent does not intersect with the lesion, the operator may need to remove the stent and re-advance and re-inflate the non-compliant or compliant balloon. With an integrated guiding extension catheter device as described in more detail below, the operator may still have the option of a buddy wire or wiggle wire. In other cases, the operator can bring the balloon (compliant) beyond the lesion and inflate it at a lower pressure (approximately 4 atm) to anchor the guiding catheter. The operator can then slide the guiding extension catheter past the lesion, remove the balloon, and advance the stent. The operator can then unsheath the stent at the lesion.
[0070] An integrated guiding extension catheter can provide additional support without the need for additional equipment (i.e., a separate guiding extension catheter). An integrated guiding extension catheter can also allow for a wire advancement mechanism that does not pass through a hemostasis valve, so it may be easier to identify, navigate, and maintain separation from the coronary wire and / or the balloon or stent wire. An integrated guiding extension catheter can have design differences that can allow for less trauma to the proximal vessel and more support in the subclavian region, etc. An integrated guiding extension catheter can also save steps and time during the procedure. In some cases, an integrated guiding extension catheter device can allow for easier guiding catheter engagement as opposed to using a guiding catheter, which is more difficult to engage with the coronary artery. For example, for the RCA, the operator may choose to use a Judkins Right 4 (JR4) guide catheter with an integrated guide extension catheter rather than an Amplatz Left 0.75 guide catheter, which offers greater support than the JR4 but is more difficult to engage and carries a higher risk of proximal vessel dissection. This may be important in acute emergency situations. It may also be useful for engaging the coronary arteries after transcatheter aortic valve implantation, which may be difficult with currently available guide catheters.
[0071] The dynamic catheter system devices described herein may include a guide catheter that is placed into a person's artery for vascular (including but not exclusively coronary, peripheral, or neurovascular) procedures to act as a guide for more efficient support and delivery of devices such as stents and balloons to the artery (e.g., in the coronary artery) through the guide catheter. The dynamic catheter system may include two key elements: a guide catheter design that includes a plastic tube inside, or a guide extension catheter that can retract in and out of the distal end of the guide catheter. The guide catheter may include a telescopic feature for the guide extension catheter. In some cases, the guide catheter with an integrated guide extension catheter can be used for percutaneous coronary intervention or coronary angioplasty. The dynamic catheter system may include a catheter control center that is integral with the guide catheter and can house an advancement mechanism including a guide catheter wire and a hemostasis valve, which may include or be configured to couple to a wire control mechanism, as described in more detail below.
[0072] Guiding Catheter A standard guiding catheter 100 is shown in FIG. 1. The guiding catheter may be a round hollow plastic tube. The plastic may be braided with metal for additional stability. The hollow tube may be percutaneously inserted into the artery, for example through the wrist or groin, and guided to an opening in the coronary artery where the distal end of the guiding catheter and / or guiding extension catheter can be seated. The guiding catheter and / or guiding extension catheter may therefore be very small in diameter, ranging from about 0.05 to 0.10 inches in diameter. The guiding catheter may be used as a conduit or protective replacement to facilitate the delivery of other materials to the coronary artery. For example, a thin metal wire (or coronary wire) may be placed midway through the guiding catheter, over which one or more stents or balloons may be passed within the inner diameter of the guiding catheter.
[0073] Guiding Extension Catheter Current guiding extension catheter designs may be inserted into the guiding catheter after the guiding catheter is already seated in the coronary artery. The distal section of the guiding extension catheter may be pushed beyond the distal end of the guiding catheter into the tortuous and / or heavily calcified artery to provide additional support for balloon / stent delivery, thereby extending the support provided by the guiding catheter. However, as described herein, the use of a separate guiding extension catheter device may create additional complications and difficulties throughout the medical procedure. As such, a separate guiding extension catheter device inserted during the procedure may not be ideal.
[0074] The guide catheters and telescoping guide extension catheters described herein may incorporate a guide extension catheter into a guide catheter device.
[0075] Current guiding extension catheters used with guiding catheters must be threaded through a hemostasis valve through the guiding catheter In contrast, an integrated guiding extension catheter is integrated into the guiding catheter and therefore does not need to be threaded through a hemostasis valve.
[0076] The guiding extension catheter may have a distal end and a proximal end. The guiding extension catheter may be positioned to extend from the distal end of the guiding catheter into the required vasculature, such as an artery. The proximal end of the guiding extension catheter may be in communication with the proximal end of the guiding catheter and / or with any actuation device that may be used to move or actuate the guiding extension catheter.
[0077] 2A shows a cross-sectional view of an embodiment of a guiding catheter shaft 210 with a telescoping guiding extension catheter 212 disposed in a proximal to distal configuration. As shown in FIG. 2A, the guiding extension catheter 212 may comprise a cylindrical portion 214 and a wire portion 216. The wire portion 216 is at the proximal portion of the guiding extension catheter. The wire portion 216 may allow for control and steering of the guiding extension catheter. In some cases, the wire portion may be a flat wire. The guiding extension catheter 212 may be incorporated into the guiding catheter 210 such that the guiding extension catheter may be moved in the proximal to distal direction and the distal to proximal direction within the inner diameter of the guiding catheter.
[0078] As shown in FIG. 2A, the guiding extension catheter 212 may have a proximal section 216 with a smaller diameter and a distal section 214 with larger inner and outer diameters than current guiding extension catheters. In some cases, the guiding catheter 210 and the distal section 214 of the guiding extension catheter 212 may be concentric. In some cases, the outer diameter of the distal section 214 of the guiding extension catheter 212 may be sized to fit within the inner diameter of the guiding catheter 210. In some cases, the outer diameter of the distal section 214 of the guiding extension catheter 212 may be sized to be small enough to allow movement of the guiding extension catheter 212 within the guiding catheter, but large enough to allow the inner diameter of the guiding extension catheter to allow delivery of an instrument or other device. The outer diameter of the distal section 214 of the guiding extension catheter 212 need only be smaller than the inner diameter of the guiding catheter. For example, in some cases, the guiding catheter may have an inner diameter of about 2 cm. In some cases, the inner diameter of the distal portion 214 of the guiding extension catheter 212 may be about 2 cm or less.
[0079] The dynamic catheter system can integrate the guiding catheter and the guiding extension catheter device. This pre-procedure integration can improve the design of the guiding catheter and the guiding catheter extension. For example, the guiding extension catheter in the dynamic catheter system can have the largest possible inner diameter, considering that the guiding extension catheter does not need to be passed from the most proximal to the most distal portion of the guiding catheter after the guiding catheter is already positioned inside the patient's body. In some cases, the guiding catheter and the guiding extension catheter can have different sizes, and the inner diameter of the guiding extension catheter can be similar to the inner diameter of an equivalently sized guiding catheter.
[0080] In some cases, considering that the guiding catheter and the guiding extension catheter are preloaded together, both of them can be made with thinner walls to achieve the same guiding catheter behavior. As a result, there is a larger inner diameter in the guiding extension catheter, which provides additional space for the practitioner over current guiding extension catheters. The smaller wall thickness can be achieved by various means, such as using a smaller mesh pattern or using modern materials made specifically for thin-walled catheters (e.g., Teflon liners, thermoplastic overextrusions, and high tensile wires). The guiding extension catheter 212 can have a transition section 218 between the proximal section 216 and the distal section 214. The transition section 218 can transition from the smaller diameter wire of the proximal section 216 to the larger diameter wire of the distal section 214. In some cases, the inner wall of the distal section 214 of the guiding extension catheter 212 can be thinner than conventional guiding extension catheter devices, making the guiding extension catheter 212 softer.
[0081] Figure 2B shows an embodiment of a guide catheter shaft 210 with several portions of the guide catheter cut away to show a guide extension catheter 212 within the guide catheter 210. Figure 2A shows a horizontal cross section through line 2A-2A shown in Figure 2B.
[0082] In some cases, the distal portion of the guiding extension catheter can be designed to be made of a softer material or reshaped to facilitate functionality. For example, the distal tip of the guiding extension catheter can be made of materials such as thermoplastic nylon and Pebax. In some cases, the guiding extension catheter can be made of polytetrafluoroethylene (PTFE). In some cases, the guiding extension catheter can have a hydrophilic coating to aid in deliverability. In some cases, the transition portion 218 of the barrel of the guiding extension catheter can be stiffer (more tightly braided) to facilitate control / movement (to combine with the softer distal portion). In some cases, the guiding extension catheter can be a coil reinforced device that provides flexibility and kink resistance during delivery through the vessel.
[0083] In some cases, the guiding catheter may include a rail or passageway along which the guiding extension catheter may move within the guiding catheter. The rail or passageway may provide a path for the guiding extension catheter to move along to prevent kinking or entanglement of the guiding extension wire and / or guiding extension catheter during movement within the guiding catheter.
[0084] In some cases, the mother / child design of the guiding catheter and guiding extension catheter system can provide additional benefits. The ease of placing and maintaining the position of the guiding catheter can be improved. For example, the overall stiffness of the mother / child combination can be higher than the guiding catheter alone. In other embodiments, adding stiffness to the guiding catheter can provide critical support. The portion of the guiding catheter that crosses the subclavian artery can have additional braids that create a stiffer component. In some cases, pre-loading or integration of the guiding extension catheter can change the properties of the guiding catheter as it enters the aorta and cardiac tissue. When the guiding extension catheter is integrated with the guiding catheter, the distal end of the guiding extension catheter can be able to be softer than a conventional guiding extension catheter because it does not have to go over a wire, through a hemostasis valve, and / or up the aorta. However, the guiding extension catheter and the distal tip of the guiding extension catheter may still need to maintain a somewhat similar level of thickness to provide support.
[0085] In some cases, the device can provide tactile feedback that allows the operator to feel the movement of the guiding extension catheter and pressure feedback. Tactile feedback can be important and allows for easy use by the operator. In some cases, a wire-based mechanism in the proximal portion 216 of the guiding extension catheter can be used to provide this tactile feedback. An actuator mechanism that allows for similar feedback may be used. For example, the advancement mechanism described herein for sliding or moving the guiding extension catheter forward (e.g., a sliding knob mechanism described in detail below) can provide the same desirable tactile feedback that operators are accustomed to with atherectomy devices (rotational and orbital atherectomy) and can provide a familiar feel to the operator. In some embodiments, instead of or in addition to an advancement mechanism in the catheter control center, the guiding extension catheter proximal portion wire itself can be adjusted to allow for greater control and tactile feedback.
[0086] 3A-5C show a guiding catheter and a guiding extension catheter. As shown in FIG. 3A-3D, the guiding extension catheter 212 may include a proximal section 216 including a guiding extension wire and a distal section 214 with a cylindrical braided section. FIG. 3A shows a view of a transition section 218 of the guiding extension catheter 212 that allows a transition feature between the proximal section 216 including the guiding extension wire and the distal section 214 with a cylindrical braided section. FIG. 3B-3C show a view of the guiding extension catheter 212. FIG. 3D shows a cross section of the guiding catheter 210 and the guiding extension catheter 212, taken along line 3D-3D in FIG. 3C. FIG. 3D shows the concentric nature of the guiding extension catheter 212 within the guiding catheter 210. As shown in FIG. 3D, the inner diameter of the guiding catheter is sized to match the outer diameter of the guiding extension catheter as close as possible to the inner diameter of the guiding catheter. This arrangement can allow for a close fitting concentric arrangement as shown in FIG. 3D, while still allowing the guiding extension catheter to be advanced within the guiding catheter without resistance.
[0087] Figures 4A-4C show a device comprising a guide catheter 210 and a concentric guiding extension catheter 212. Figure 4C shows a cross section through the guide catheter 210 and the guiding extension catheter 212 taken along line 4C-4C in Figure 4B.
[0088] Figures 5A-5C show an embodiment of a guiding extension catheter with a flat wire, with Figure 5C showing a cross section through the guiding catheter 210 and the guiding extension catheter 212 taken along line 5C-5C in Figure 5B.
[0089] Catheter Control Center As described herein, a dynamic catheter system may include a catheter control center that may incorporate an advancement mechanism, a guiding extension catheter wire, and / or a hemostasis valve. In some cases, the catheter control center may incorporate one or more of these components into a housing or other enclosure that provides a user-friendly device that may be controlled and steered by the operator. The distal end of the catheter control center may be attached to the proximal end of the guiding catheter and the guiding extension catheter, and the guiding extension catheter wire may move in a proximal-to-distal or distal-to-proximal direction within both the guiding catheter and the catheter control center.
[0090] Advance mechanism The dynamic catheter system can incorporate an actuator for advancing and / or retracting the telescoping guiding extension catheter. The actuator at the proximal end of the guiding catheter can incorporate a variety of actuation features. The actuator can be incorporated into the catheter control center. In some embodiments, the catheter control center can incorporate an advancement mechanism that uses an actuation device or mechanism that can provide distal and proximal movement, preserve tactile feedback, prevent wire wrapping, require little modification to existing components, and allow for simple manufacture and setup.
[0091] In some cases, the valve in communication with the advancement mechanism for extending or actuating the telescopic guide extension catheter within the guiding catheter and the hemostatic valve are not incorporated into the same housing. In these cases, the valve may be positioned as a pre-hemostatic valve or a post-hemostatic valve, depending on the positioning of the hemostatic valve relative to the positioning of the advancement mechanism. The pre-hemostatic valve may include a device with a secondary or branching valve positioned proximal to the hemostatic valve. This configuration may facilitate the use of a guide extension catheter that may be easier to use, allowing the guide catheter, guide extension catheter, and advancement mechanism to be incorporated into one piece, allowing for no interruptions. The branching valve configuration may eliminate the need for a seal in the mechanism, but in some cases may require the addition of a second valve adjustment step, since there are two valves in two locations. In other cases, the pre-hemostatic valve may include a wrapping mechanism that is enclosed within the guiding catheter device and positioned proximal to the hemostatic valve. The wrapping mechanism may not require a separate open / close mechanism of the valve to advance the guide extension catheter. In some cases, the wrapping mechanism may reduce tactile feedback.
[0092] In some cases, the guide catheter can incorporate a retractable guide extension catheter that uses a valve incorporated distal to the hemostasis valve or the post-hemostasis valve. The post-hemostasis valve can be formed from two pieces, can require a setting assembly, and / or can interfere with wire steering areas for other devices.
[0093] In some cases, the guiding extension catheter wire can have multiple cross-sectional shapes and sizes. For example, the distal portion of the wire can have a rectangular cross-section (i.e., a flat wire) and the proximal portion of the wire can have a circular cross-section (i.e., a round wire). The proximal portion of the wire is near or inside the catheter control center. Customizing the proximal portion of the wire maximizes the ability of the catheter control center to store the wire, actuate the guiding extension catheter, and optimize feedback for the practitioner. Customizing the distal portion of the wire allows for optimal wire bending characteristics inside the guiding catheter, which affects the advancement and retraction behavior of the guiding extension catheter.
[0094] 6A-6E show an embodiment of a guide catheter with a telescoping guide extension catheter incorporating a guide extension advancement mechanism. In some cases, the guide extension advancement mechanism may be a bifurcated wire advancement mechanism that may include a bifurcated slide.
[0095] FIG. 6B illustrates a bifurcated device 601 with a 20 degree bifurcation. A first bifurcation 602 of the bifurcated device can include a hemostasis valve 606. A second bifurcation 604 can include a guide extension advancement mechanism 608. For example, as shown in FIGS. 6A-6F, the guide extension advancement mechanism 608 can be a slide mechanism 620 capable of actuating a guide extension catheter. In some cases, the slide mechanism 620 can have a slide advancement distance of about 5-10 cm per slide movement. In some cases, the complete travel of the slide (over one or more slide movements) can be 5 cm, 10 cm, 15 cm, 20 cm, 25 cm, 30 cm, 35 cm, 40 cm, 45 cm, 50 cm, 55 cm, 60 cm, 65 cm, 70 cm, or more (about 5 cm, about 10 cm, about 15 cm, about 20 cm, about 25 cm, about 30 cm, about 35 cm, about 40 cm, about 45 cm, about 50 cm, about 55 cm, about 60 cm, about 65 cm, about 70 cm, or more). In some cases, the complete travel of the slide (over one or more slide movements) may be between about 5 cm and about 70 cm, between about 10 cm and about 65 cm, between about 15 cm and about 60 cm, between about 20 cm and about 55 cm, between about 25 cm and about 50 cm, between about 30 cm and about 45 cm, or between about 35 cm and about 40 cm. In some cases, the complete travel of the slide (over one or more slide movements) may be at least 25 cm (about at least 25 cm), or longer. In some cases, the slide mechanism 620 may have a diameter of 15.5 mm, or any diameter that is comfortable for the operator to hold and / or manipulate. FIG. 6C shows a wire 626 for manual pushing or longer advancement. FIGS. 6D-6F show cross-sectional views of the branched wire guide catheter device 601. The branched wire guide catheter device 601 may have a silicone retaining collar 622 for additional support between the first and second branches of the device. In some cases, the sliding mechanism 620 may include a wire clamping portion 624 as shown in FIG. 6F.
[0096] 7A-7B show an embodiment of a guide extension advancement mechanism 700 that uses a sliding mechanism 702. The sliding mechanism 702 may comprise an actuator that can be moved along a horizontal axis that extends in a proximal to distal direction of the sliding mechanism 702. The sliding mechanism 702 may be attached to a wire 704 to actuate the wire 704 within the guide catheter. When the sliding mechanism 702 is moved along the horizontal axis, the wire 704 is moved along the horizontal axis in a distal to proximal direction and a proximal to distal direction. FIG. 7A shows a first position of the sliding mechanism 702 in which the wire is retracted into the mechanism in a proximal-most direction. FIG. 7B shows a second position of the sliding mechanism 702 in which the wire 704 is extended to a position distal to the first position, allowing the guide extension catheter to be extended in a distal direction. The sliding mechanism may comprise a casing 706 that forms an enclosure structure that surrounds the wire 704. The sliding mechanism 702 can provide tactile feedback to the operator. The guide extension advancement mechanism 700 can require a specific grip that can be used with the thumb to move the sliding mechanism 702. In some cases, if the sliding mechanism 702 needs to be moved beyond the length of the thumb, the operator may need to readjust the grip on the device.
[0097] 7C-7D show guide extension advancement mechanisms that may be used. FIG. 7C shows an O-ring sliding cylinder that may be used in guide extension advancement mechanism 700. The O-ring sliding cylinder of guide extension advancement mechanism 700 may include a sliding mechanism 702 and a wire 704 that may be moved in a proximal to distal direction or a distal to proximal direction by movement of the sliding mechanism 702. FIG. 7D shows another example of a guide extension advancement mechanism 700 with a sliding mechanism 702 that may be used and does not require a seal. The guide extension advancement mechanism 700 may include a sliding mechanism 702 and a wire 704 that may be moved in a proximal to distal direction or a distal to proximal direction by movement of the sliding mechanism 702.
[0098] The guide extension advancing mechanism 700 using the sliding mechanism 702 of Figures 7A-7D can be used in the system described with reference to Figures 6A-6F and can be used in place of the guide extension advancing mechanism 608 in Figures 6A-6F.
[0099] 8A-8B show an embodiment of a guide extension advancement mechanism 800 that uses a spool mechanism 802. The guide extension advancement mechanism 800 with the spool mechanism 802 can be actuated with a grip that is fixed with one hand. A wire 804 coupled to the guide extension catheter can be wound around the spool, and the spool can be actuated to move the guide extension catheter from a proximal to a distal configuration and from a distal to a proximal configuration. FIG. 8A shows a first position of the spool mechanism 802 in which the wire 804 is retracted into the mechanism in a proximal-most direction. FIG. 8B shows a second position of the spool mechanism 802 in which the wire 804 is extended to a position distal to the first position. The guide extension advancement mechanism 800 with the spool mechanism 802 can provide a compact length because the wire is wound around the spool 806 instead of extending from the proximal end of the guide extension advancement mechanism.
[0100] 8C-8D show exploded views of the guide extension advancement mechanism with spool mechanism 802. FIG. 8C shows the components of the spool mechanism 802 in a guide catheter device in a location distal to a hemostasis valve 806. The wire 804 can be wrapped around a wheel 832 and a cap 834 with a groove can be used to actuate the wire 804 by moving the wheel 832. The spool mechanism features can include a seal at the distal end to prevent fluid from entering the spool mechanism.
[0101] 9A-9B show an embodiment of a guide extension advancement mechanism 900 that uses a contact wheel mechanism 902. The contact wheel mechanism 902 can include two wheels 932, 934, where one or both wheels can move to allow for movement of the wire 904 and movement of the guide extension catheter at the distal end of the wire. The contact wheel mechanism 902 can allow for a convenient, one-handed, fixed grip that can be more compact than other devices and simplify operation for the operator. The wire is positioned to move in a proximal-to-distal direction and a distal-to-proximal direction within the two wheels, which can move the guide extension catheter within the guide catheter and / or artery. In some cases, the region of the wire that is positioned to move between the wheels can be thicker than the rest of the wire or can be formed from a material with additional grips to allow the wire to better contact the wheels. FIG. 9A shows a first position of the contact wheel mechanism 902 with the wire 904 in a first position. FIG. 9B illustrates a second position of the contact wheel mechanism 902 with the wires 904 extended to a position distal to the first position.
[0102] 9C-9D show another example of a guide extension advancement mechanism 900 with a contact wheel mechanism 902. The contact wheel mechanism 902 in FIGS. 9C-9D is similar to the contact wheel mechanism 902 in FIGS. 9A-9B. However, the contact wheel mechanism 902 is enclosed within a housing 906. A first wheel 934 can be positioned within the housing and a second wheel 932 can be positioned partially within the housing 906. As shown in FIGS. 9C and 9D, the second wheel 932 can rotate and can be used to move the wire 904 within the contact wheel mechanism 902.
[0103] 10A-10B show an embodiment of a guide extension advancement mechanism 1000 that uses a screw mechanism 1002. The screw mechanism can be in communication with a housing 1006 and a wire 1004 that can be attached to the guide extension catheter to move the guide extension catheter within the guide catheter. The screw mechanism 1002 can be designed with a threaded screw-like device 1032 that can move along a complementary thread in the inner diameter of the housing 1006. When the screw 1032 is moved in a proximal to distal direction or a distal to proximal direction, the wire and the guide extension catheter are also moved in a proximal to distal direction or a distal to proximal direction. FIG. 10A shows a first position of the screw mechanism 1002 with the wire 1004 in a first position. FIG. 10B shows a second position of the screw mechanism 1002 where the wire 1004 is extended to a position distal to the first position. The guide extension advancement mechanism 1000 using a screw mechanism 1002 can allow for a fixed grip because the operator can twist the proximal end 1008 of the screw 1032 to move the screw within the housing, thereby moving the wire 1004 and guide extension catheter. In some cases, the wire can be attached to a point in the housing or run along a guide or rail to prevent the wire from twisting when the screw is turned.
[0104] 11A-11B show an embodiment of a guide extension advancement mechanism 1100 that uses a rack and pinion mechanism 1102. The rack and pinion mechanism 1102 can be used to move a wire 1104 and can be attached to a guide extension catheter within the guide catheter. The rack and pinion mechanism 1102 can include a circular gear 1132 (pinion) that engages a linear gear 1134 (rack), which can operate to convert rotational motion of the circular gear 1132 into linear motion. An operator can move the circular gear 1132. Rotation of the circular gear 1132 can move the linear gear 1134 in a proximal to distal direction or a distal to proximal direction. Thus, movement of the linear gear 1134 can move the wire 1104, which can move the guide extension catheter in a proximal to distal direction or a distal to proximal direction. FIG. 11A shows a first position of the rack and pinion mechanism 1102 with the wire 1104 in the first position. FIG. 11B shows a second position of the rack and pinion mechanism 1102 with the wire 1104 extended to a position distal to the first position. FIGS. 11C-11D show another example of a guide extension advancement mechanism 1100 using a rack and pinion mechanism 1102. FIG. 11C shows a rack and pinion mechanism 1102 with a finger wheel that allows the operator to move the circular gear 1132 with their finger. FIG. 11D shows a rack and pinion mechanism 1102 with a thumb wheel that allows the operator to move the circular gear 1132 with their finger.
[0105] As shown in Figures 11A-11D, at least a portion of the linear gear 1134 can be positioned within the housing 1106 and the circular gear 1132 can extend from the housing 1106. The operator can rotate the circular gear 1132 extending from the housing 1106, thereby moving the linear gear 1134 and the wire / guiding extension catheter in a proximal to distal direction or a distal to proximal direction. The rack and pinion mechanism 1102 can use a conveniently constrained path to prevent the wire from buckling. The rack and pinion mechanism 1102 can be a fixed gripping device that can be actuated by the operator's finger or thumb.
[0106] 12A-12B show an embodiment of a guide extension advancement mechanism 1200 that uses a non-contact advancement mechanism 1202. In some cases, the non-contact advancement mechanism can use a magnet. The non-contact advancement mechanism 1202 can operate the guide extension advancement mechanism 1200 in a closed system, where the housing 1206 encloses the internal component 1232 and the wire 1204, while the external component 1234 can be positioned outside of the housing 1206. FIG. 12A shows a first position of the non-contact advancement mechanism 1202 with the wire 1204 in the first position. FIG. 12B shows a second position of the non-contact advancement mechanism 1202 where the wire 1204 is extended to a position distal to the first position.
[0107] 13-16 show various handles and / or grips that can be used with any of the guide extension advancement mechanisms and / or guide catheters described herein. Various grips can be used, including but not limited to ball grips, bike handle grips, trigger handle grips, and / or pencil grips. FIG. 13 shows an example of a guide extension advancement mechanism with a thumb wheel. The thumb wheel allows the operator to hold the handle of the guide extension advancement mechanism in a natural grip in their hand. FIG. 14 shows an example of a guide extension advancement mechanism with a finger wheel. The finger wheel allows the operator to hold the handle in their hand while moving the wheel with their fingers to actuate the wire and guide extension catheter. FIG. 15 shows a handle grip that allows the housing to be pressed against the hand grip while still being under physical control. FIG. 16 shows a handle grip that can be rotated with a thumb or finger. For example, as shown in FIG. 16, the operator's thumb can be used to rotate the handle 180 degrees by pressing a tab to move the wire and associated components such as a guiding extension catheter.
[0108] 17A-22B show examples of dynamic catheter systems involving a guiding catheter, a guiding extension catheter, and a catheter control center incorporating a guiding extension advancement mechanism for actuating the guiding extension catheter and wire, the guiding extension catheter wire, and a hemostatic valve within the guiding catheter. As described herein, the guiding extension catheter can be designed to be incorporated into the guiding catheter as it is inserted into the patient and passed through the artery.
[0109] 17A-17H show a dynamic catheter system 1700 with a guide extension advancement mechanism 1702 for actuating a guide extension catheter (not shown) within a guide catheter (not shown). The guide extension advancement mechanism 1702 may include a housing 1706 with a finger pinch wire advancement portion 1732 used to advance or actuate a guide extension catheter wire 1704. FIGS. 17A-17B show a side view of the dynamic catheter system 1700, with FIG. 17B showing the housing 1706 in transparent form to allow visualization of the internal components. The proximal end 1736 of the guide extension catheter wire 1704 may be folded or bent within a wire passageway 1780 within the housing, as shown in FIG. 17B. In some cases, the guide extension catheter wire 1704 may have different properties or characteristics throughout the length of the wire. For example, the guiding extension catheter wire 1704 may have a different diameter at the proximal end where it is folded or bent in the passageway 1780 than the diameter of the more distal portion of the guiding extension catheter wire 1704 that is passed through the guiding catheter. In some cases, the guiding extension catheter wire 1704 may be more malleable or flexible at the proximal end where it is folded or bent in the passageway 1780 to allow the wire to move, fold or bend within the passageway. In contrast, the guiding extension catheter wire 1704 may be less flexible in the more distal portion that is extended through the guiding catheter to prevent the guiding extension catheter wire 1704 from kinking, tangling, or bending, or to prevent other unwanted movement of the guiding extension catheter wire 1704 within the guiding catheter. In some cases, the proximal end of the guiding extension catheter wire 1704 may be shaped differently than the guiding extension catheter wire 1704 at the more distal end. In other cases, the guiding extension catheter wire 1704 at the proximal end is the same shape and material as the guiding extension catheter wire 1704 at the more distal end of the device.
[0110] The guide extension advancement mechanism 1702 may also have a seal 1734 in the housing 1706 to prevent fluids or other contaminants from entering the guide extension advancement mechanism 1702. In some cases, the seal 1734 may be a double seal or any seal necessary to prevent fluid ingress into the housing or any component of the mechanism. The dynamic catheter system 1700 may include a hemostasis valve 1710 positioned proximal to the guide extension advancement mechanism 1702 and a swivel-type valve 1712 positioned between the hemostasis valve 1710 and the guide extension advancement mechanism 1702. The hemostasis valve 1710 may be used to deliver instruments or other wires through the guide catheter and / or the guide extension catheter to a target area, as described herein.
[0111] In some cases, the hemostasis valve 1710 and / or valve 1712 can be integrated into the guide extension advancement mechanism 1702 itself and formed as a unitary piece. For example, the valve 1712 can be positioned at a distal end of the guide extension advancement mechanism 1702 and the hemostasis valve 1710 can be positioned at a proximal end of the guide extension advancement mechanism 1702. This arrangement can allow the dynamic catheter system 1700 to have the guide extension advancement mechanism 1702 with the hemostasis valve 1710 and / or valve 1712 integrated in one component to allow for component lengths that are similar to the lengths of existing hemostasis valve systems.
[0112] 17C-17D show a front view of the dynamic catheter system 1700 with the guide extension advancement mechanism 1702 with the guide extension catheter wire 1704 extending distally out of the device (out of the page). FIG. 17D shows the housing 1706 in transparency to allow visualization of the internal components. As shown in FIG. 17C-17D, the finger pinch advancement mechanism 1732 can have two tabs (described in more detail with reference to FIG. 20A-20B) that can be pressed together at the top 1738 by the operator to pinch the guide extension catheter wire 1704 and move the guide extension catheter wire 1704. For example, when the tabs are pressed together at the top 1738, the bottom portion 1739 can pinch the guide extension catheter wire 1704 and move the wire in a proximal to distal or distal to proximal direction. When the tabs are not pressed together (left apart) at the upper portion 1738 , the upper and lower portions 1739 can be in a rest state where the tabs are bent outward and exert no force on the guiding extension catheter wire 1704 .
[0113] 17E-17F show a top view of the dynamic catheter system 1700 with the guide extension advancement mechanism 1702 with the guide extension catheter wire 1704 extending distally out of the device and the finger pinch wire advancement portion 1732 extending out of the page. FIG. 17F shows the housing 1706 as transparent to allow visualization of the internal components.
[0114] 17G-17H show perspective views of a dynamic catheter system 1700 with a guide extension advancement mechanism 1702. FIG. 17H shows the housing 1706 transparent to allow visualization of the internal components of the device. In some cases, the guide extension catheter wire can be advanced between about 5 cm and about 20 cm, between about 10 cm and about 15 cm, or about 7 cm. In some cases, the storage capacity of the bent or folded wire within the housing can be between about 5 cm and about 40 cm, between about 10 cm and about 35 cm, between about 15 cm and about 30 cm, between about 20 cm and about 25 cm, or about 20 cm of wire. In some cases, the guide extension advancement mechanism 1702 can comprise a length between about 5 cm and about 30 cm, between about 10 cm and about 25 cm, or between about 15 cm and about 20 cm. In some cases, the guide extension advancement mechanism 1702 may comprise a width between about 1 cm and about 20 cm, or between about 5 cm and about 15 cm. In some cases, the guide extension advancement mechanism 1702 may comprise a height between about 1 cm and about 20 cm, or between about 5 cm and about 15 cm.
[0115] 18A-18H show a dynamic catheter system 1800 with a guide extension advancement mechanism 1802 for actuating a guiding extension catheter (not shown) within a guiding catheter (not shown). The dynamic catheter system 1800 of FIGS. 18A-18H is similar to the dynamic catheter system 1700 of FIGS. 17A-17H. However, the dynamic catheter system 1800 of FIGS. 18A-18H may use a spool mechanism 1840 to store a proximal end portion of a guiding extension catheter wire 1804. The guiding extension catheter wire 1804 is actuated to extend the guiding extension catheter wire 1804 and a corresponding guiding extension catheter (not shown) at the distal end of the guiding extension catheter wire 1804. When the finger pinch advancement mechanism 1832 is pressed together at the top portion 1838, the guide extension catheter wire 1804 is pinched and the finger pinch advancement mechanism 1832 can be moved distally and the guide extension catheter wire is unwound from the spool mechanism 1840 to distally extend the guide extension catheter wire 1804. In some cases, the spool may be used passively with the finger advancement.
[0116] In some cases, the guide extension catheter wire can be advanced between about 5 cm and about 20 cm, between about 10 cm and about 15 cm, or about 6 cm. In some cases, the spooling mechanism can store between about 5 cm and about 60 cm, between about 10 cm and about 55 cm, between about 15 cm and about 50 cm, between about 20 cm and about 45 cm, between about 25 cm and about 40 cm, between about 30 cm and about 35 cm, or about 36 cm of wire. In some cases, the guide extension advancement mechanism 1802 can comprise a length between about 1 cm and about 30 cm, between about 5 cm and about 25 cm, or between about 10 cm and about 20 cm. In some cases, the guide extension advancement mechanism 1802 can comprise a width between about 1 cm and about 20 cm, or between about 5 cm and about 15 cm. In some cases, the guide extension advancement mechanism 1802 may comprise a height of between about 1 cm and about 20 cm, or between about 5 cm and about 15 cm.
[0117] 19A-19B show an embodiment of the interior of the guide extension advancement mechanism 1902. As shown in FIG. 19A-19B, the guide extension advancement mechanism 1902 may include a dual seal system. The guide extension advancement mechanism 1902 may have a first seal 1946 positioned on the exterior surface of the main passageway 1947 between the main passageway 1947 and the guide extension catheter wire passageway 1948 to seal the opening through which the guide extension catheter wire 1904 passes. The first seal 1946 may prevent fluids or other contaminants from entering the guide extension catheter wire passageway 1948. The guide extension advancement mechanism 1902 may have a second seal 1949 positioned in the guide extension catheter wire passageway 1948. The second seal 1949 may be perpendicular to the guide extension catheter wire 1904. The second seal 1949 may be a dynamic radial seal that seals against the guide extension catheter wire 1904. The main passageway 1947 may include a passive filter 1950 that may be used to prevent accumulation of fluid or other contaminants at the junction between the main passageway 1947 and the guiding extension catheter wire passageway 1948 .
[0118] 20A-20B show an enlarged view of the finger pinch wire advancement portion 2032. The finger pinch wire advancement portion 2032 can be a flexible, plastic finger pinch grip. As shown in FIG. 20A, the resting state of the finger pinch wire advancement portion 2032 is such that the tabs 2052, 2054 are bent outward (as indicated by the arrows in FIG. 20A). When the tabs 2052, 2054 are pushed inward as shown in FIG. 20B, the wire 2004 can be pinched by the lower portion 2039 of the finger pinch wire advancement portion 2032. The finger pinch wire advancement portion 2032 can be moved distally along the track 2056, which will also move the wire 2004 that is pinched by the finger pinch wire advancement portion 2032. The finger pinch wire advancement portion 2032 can then be released and moved back to the resting state. The wire advancement can be repeated as needed to move the guiding extension catheter wire in a distal to proximal or proximal to distal direction within the dynamic catheter system.
[0119] Figures 21A-21F show a dynamic catheter system 2100 with a guide extension advancement mechanism 2102 for actuating a guide extension catheter (not shown) within a guide catheter (not shown). The dynamic catheter system 2100 of Figures 21A-21F is similar to the dynamic catheter systems 1700, 1800 of Figures 17A-17H and 18A-18H. However, the dynamic catheter system 2100 of Figures 21A-21F may use a finger knob advancement mechanism 2132 to actuate the guide extension catheter wire 2104 (shown in Figures 21C and 21D).
[0120] The guiding extension catheter wire 2104 is actuated to extend the guiding extension catheter wire 2104 and a corresponding guiding extension catheter 2152 at the distal end of the guiding catheter 2150 from the distal end of the guiding extension catheter wire 2104. The dynamic catheter system 2100 of FIGS. 21A-21F also incorporates the functionality of a hemostasis valve 2110. Additionally, the dynamic catheter system 2100 of FIGS. 21A-21F incorporates a rotating coupler 2136 into the catheter control center housing 2106 of the finger knob advancement mechanism 2132. The rotating coupler 2136 allows the guiding catheter 2150 to rotate independently from the remainder of the dynamic catheter system 2100. This feature allows the guiding catheter to rotate independently from the catheter control center components, allowing movement of the guiding catheter during and after insertion. This feature also allows the practitioner to rotate the catheter control center without moving the guide catheter, resulting in greater flexibility in instrument positioning throughout highly critical procedures.
[0121] The integration of hemostasis valve 2110 and valve 2136 within the catheter control center housing 2106 can allow for an integrated, easy to use device that the surgeon can control during use.
[0122] 21A-21B show diagrams of the dynamic catheter system 2100 with a finger knob advancement mechanism 2132. FIGS. 21C-21D show side views of the dynamic catheter system 2100 with a finger knob advancement mechanism 2132. The housing 2106 is shown transparent to allow for viewing of the internal components within the housing 2106. The housing 2106 may have two components, a guiding extension catheter wire component 2192 and a main valve component 2194. The guiding extension catheter wire 2104 may be seen with two bends within the guiding extension catheter wire component 2192 of the housing 2106 as described with reference to FIGS. 17A-17H. The guiding extension catheter wire component 2192 may house the guiding extension catheter wire 2104 and the advancement mechanism 2132. In some cases, the main valve component 2194 can act similarly to the hemostasis valve described herein and can allow all other wires and / or devices to pass from the valve through the main valve component 2194 to the guide catheter. In some embodiments, the guiding extension catheter wire component 2192 and the main valve component 2194 can be coupled by a seal 2134. The seal 2134 can prevent fluid from entering the guiding extension catheter wire component 2192.
[0123] 21E-21F show a top view of the dynamic catheter system 2100 with a finger knob advancement mechanism 2132. The finger knob advancement mechanism 2132 can move along a track 2156 as shown in FIG. 21E-21F to actuate the guiding extension catheter wire 2104 (shown in FIG. 21C and FIG. 21D) and the guiding extension catheter 2152 (shown in FIG. 21A-21B). FIG. 21E-21F show a side port 2154 that can be incorporated into the housing 2106. The side port 2154 can be used to provide additional support. For example, the side port 2154 can be used to flush the catheter, to attach a manifold, and / or to measure pressure or take other measurements. Although the side port 2154 is shown on the side of the housing 2106, the port 2154 can be positioned on any portion of the housing 2106. Also, the hemostasis valve 2110 is shown at the proximal end of the housing 2106. However, the hemostasis valve 2110 can be positioned in any portion of the housing 2106 that allows an instrument or other device to be delivered through the valve and / or into the guide catheter 2150.
[0124] 22A-22B show a finger knob advancement mechanism 2232 that can be used to actuate the guide extension catheter wire 2104 (shown in FIGS. 21C and 21D) and move the guide extension catheter 2152. The finger knob advancement mechanism 2232 is depressed at the top portion 2238 to move the finger knob advancement mechanism 2232 along the track 2156. For example, the finger knob advancement mechanism 2232 can be depressed to move distally along the track 2156 and the guide extension catheter wire can be moved within the housing to extend the guide extension catheter wire distally. The finger knob advancement mechanism 2232 can have a round knob slider with a spring loaded push button as shown in FIGS. 22A-22B. In the default state (released or not depressed), the finger knob advancement mechanism 2232 does not pinch the guide extension catheter wire. When the top portion 2238 is depressed, the finger knob advancement mechanism 2232 can pinch and grip the guide extension catheter wire for advancing or retracting the guide extension catheter wire. In some cases, the catheter control center profile can be designed to be placed or pressed against a table and to facilitate grasping or maneuvering by the operator. The catheter control center can be easily grasped with one hand so that the second hand can be used to hold other devices or is otherwise free. In some cases, the dynamic catheter system can include finger notches to instruct the operator how to hold the device. In some cases, the catheter control center can be weighted on the main valve chamber side to encourage a particular orientation. In some cases, the dynamic catheter system can have catheter control center feet or an adhesive or sticky underside to keep the catheter control center in place.
[0125] Wire Control Mechanism It may be beneficial to have a wire control mechanism that can separate and / or combine two or more wires at the beginning, during, or end of a procedure so that the user can easily identify and navigate the wires. For example, the wire control mechanism can keep the guide wire separate from the device wire. Any of the wire control mechanisms described herein can be integral with or attached to a valve (e.g., a hemostasis valve). For example, the wire control mechanism and valve can be part of a unibody (e.g., of a single structure) device such that they are not detachable from one another. The unibody wire control mechanism and valve can be integral with or attached to any of the dynamic catheter systems described herein, or can be used with any other catheter system, device, or procedure that utilizes one or more wires. Any feature of the wire control mechanism may be integral with or attached to the valve, including, but not limited to, the doors (e.g., 4916a, 4916b, 5016), discs (e.g., 5116), liners (e.g., 5216), inserts (e.g., 5316), sleeves (e.g., 5416, 5516), caps (e.g., 2316, 5616), and / or sliding pieces (e.g., 5716a-5716d). Valves described herein may include Tuohy Force valves, Tuohy valve systems, hemostasis valves, y-connector valves, or any other valve system used with or without a catheter system.
[0126] 23A-26C show example wire control mechanisms that may be integral with or attached to the proximal end of a dynamic catheter system. For example, the wire control mechanism may be coupled to or integral with a valve at the proximal end of a dynamic catheter system, such as one of the dynamic catheter systems 1700, 1800, 2100 previously described. Additionally, the dynamic catheter system may include a guide catheter, a guide extension catheter, and a hemostatic valve that incorporates the wire control mechanism. In some cases, a catheter control system is not required. Although the wire control mechanism is described as being used with a dynamic catheter system, it may be used in any device or procedure that utilizes one or more wires. For example, all hemostatic valves in use today may benefit from the incorporation of a wire control mechanism as described herein.
[0127] 23A-24B illustrate an implementation of a wire control mechanism 2300. The wire control mechanism 2300 may include a distal end 2302, a proximal end 2304, and a passageway 2306 (shown in FIG. 24A ) extending between the distal end 2302 and the proximal end 2304. The wire control mechanism 2300 may include a cap 2316 configured to separate two or more wires. For example, the cap 2316 may include a hinge such that the cap 2316 may include a closed configuration in which the cap 2316 is coupled to the proximal end 2304, and an open configuration in which the cap 2316 is detached from the proximal end 2304. When the cap 2316 is in the closed configuration, the cap 2316 may separate two or more wires without removing the two or more wires from the wire control mechanism 2300 and without removing the wire control mechanism 2300 from the catheter system, as described further below. In other configurations, the cap 2316 may include a rotatable mechanism, a pivotable mechanism, or any other mechanism that allows for separation of two or more wires without removing the wire control mechanism 2300 from the dynamic catheter system.
[0128] As shown in FIGS. 24A-24B, the distal end 2302 may be integral with the proximal end 2412 of the dynamic catheter system or may be configured to be removably coupled to the proximal end 2412. For example, FIGS. 24A-24B show the valve 2410 of the dynamic catheter system as transparent to show the internal components. The dynamic catheter system may include a valve 2410, such as a hemostasis valve, at the proximal end 2412 configured to couple to the distal end 2302 of the wire control mechanism 2300. In some configurations, the valve 2410 may include or be integral with the wire control mechanism 2300. The valve 2410 may be the same or similar to any of the valves 1710, 1712, 1810, 2110 described herein and may be used with or without the actuation mechanism and / or catheter control center described herein. The valve 2410 may include any valve, such as a hemostasis valve. For example, the valve 2410 may comprise a rotatable part configured to open or close a seal of the valve 2410. In some configurations, the valve 2410 may comprise a button configured to be pressed to open or close a seal of the valve 2410. In some embodiments, the valve 2410 may comprise a rotatable part and a button configured to open or close a seal of the valve 2410.
[0129] The distal end 2302 of the wire control mechanism 2300 may be configured to receive or be received by the proximal end 2412 of the valve 2410. During a procedure, a user may couple the wire control mechanism 2300 to the valve 2410 or may detach the wire control mechanism 2300 from the valve 2410. For example, a user may determine that a guiding extension catheter is needed during a procedure. A user may insert the guiding extension catheter into the guiding catheter and may couple the wire control mechanism 2300 to separate the wires during a procedure. Additionally, a user may couple the wire control mechanism 2300 to the valve 2410 prior to a procedure. In some configurations, the distal end 2302 may be integral with the valve 2410. The illustrated configuration shows a distal end 2302 with a larger diameter than the proximal end 2412 of the valve 2410 such that the proximal end 2412 of the valve 2410 can be received by the distal end 2302 of the wire control mechanism 2300. The distal end 2302 of the wire control mechanism 2300 can be coupled to the valve 2410 via a push-in engagement, a threaded engagement, a snap-fit engagement, or any suitable releasable coupling.
[0130] As shown in FIGS. 23A-23D, the proximal end 2304 can include an opening 2308. The opening 2308 can be aligned with the passageway 2306 such that the opening can be in communication with the valve 2410 and / or the internal passageway of the dynamic catheter system. In some configurations, the proximal end 2304 can include multiple openings (e.g., two, three, four, five). The opening 2308 can include a first portion 2312 and a second portion 2310. In some embodiments, the opening 2308 can include only one portion, or three or more portions (e.g., three, four, five, six). The first portion 2312 can be aligned with the passageway 2306 and the second portion 2310 can be angled from the passageway 2306. The angle between the second portion 2310 and the first portion 2312 can be between about 5 degrees and about 60 degrees, between about 10 degrees and about 50 degrees, between about 20 degrees and about 40 degrees, or about 15 degrees. This angle can control the distance between two or more wires extending through the wire control mechanism 2300, as described further below. The second portion 2310 can extend from the first portion 2312 such that an exchange passage 2314 extends between the first portion 2312 and the second portion 2310. The exchange passage 2314 can extend from the opening 2308 to the passage 2306 such that the exchange passage 2314 can be in communication with the passage 2306. The exchange passage 2314 can be configured to move two or more wires between the first portion 2312 and the second portion 2310, as described further below. In some configurations, the wire control mechanism 2300 can include multiple passages (e.g., two, three, four, five). In some embodiments, each of the multiple passageways can be opened and closed independently.
[0131] The wire control mechanism 2300 may include a cap 2316 configured to engage with the proximal end 2304 of the wire control mechanism 2300. The cap 2316 may be attached to the proximal end 2304 (e.g., via a hinge) or the cap 2316 may be completely removable from the proximal end 2304. The cap 2316 may include a first notch 2318 and a second notch 2320. In some embodiments, the cap 2316 may include only one notch, or three or more notches (e.g., three, four, five, six). In some configurations, the first notch 2318 may be larger than the second notch 2320. In other configurations, the first notch 2318 may be smaller than or the same size as the second notch 2320. In some configurations, the first cutout 2318 and / or the second cutout 2320 can include a seal. For example, the first cutout 2318 and / or the second cutout 2320 can include a silicone gel that can partially seal the cutouts 2318, 2320 such that one or more wires or other devices can be pushed through the silicone gel. The first cutout 2318 and / or the second cutout 2320 can include materials other than silicone gel, including flexible materials, that allow one or more wires or other devices to be pushed through the material.
[0132] 23A, 23C, and 24A show the cap 2316 in an open configuration, while FIGS. 23B, 23D, and 24B show the cap 2316 in a closed configuration. In the open configuration, the cap 2316 can be disengaged from the proximal end 2304 such that the wire control mechanism 2300 includes a single passageway, and a user can freely move one or more wires between the first portion 2312 and the second portion 2310 of the opening 2308 via the exchange passageway 2314. For example, FIGS. 23C and 24A show two wires extending through the wire control mechanism 2300 while the cap 2316 is in the open configuration. A user can move one or both of the wires between the first portion 2312 and the second portion 2310 of the opening 2308 via the exchange passageway 2314. A user can also insert more wires into the opening 2308 while the cap 2316 is in the open configuration.
[0133] In the closed configuration, the cap 2316 can be coupled to the proximal end 2304 of the wire control mechanism 2300 such that the exchange passageway 2314 can be covered, with the cap 2316 forming two passageways via the first notch 2318 and the second notch 2320. For example, the cap 2316 can be removably coupled to the proximal end 2304 of the wire control mechanism 2300 via a push-fit engagement, a threaded engagement, a snap-fit engagement, or any suitable releasable coupling that allows a user to easily open and close the cap 2316 as needed. For example, a first wire can extend through the first notch 2318 and a second wire can extend through the second notch 2320. A user can open the cap 2316 and move the first and second wires through the exchange passageway 2314 such that the first wire can extend through the second notch 2320 and the second wire can extend through the first notch 2318 when the user closes the cap 2316. Advantageously, the wires and wire control mechanism 2300 do not need to be removed from the catheter system for the user to move each wire to a different notch 2318, 2320. As shown in FIG. 23B and FIG. 23D, while in the closed configuration, the first notch 2318 can align with the first portion 2312 of the opening 2308 and the second notch 2320 can align with the second portion 2310 of the opening 2308. The cap 2316 can separate two or more wires while in the closed configuration. For example, as shown in Figures 23D and 24B, a first wire can extend through a first notch 2318 and a second wire can extend through a second notch 2320. Advantageously, this arrangement can separate two or more wires during a procedure to allow a user to easily identify and navigate the wires (e.g., guidewire and device wire).
[0134] In other embodiments, no cap or no notch is required. The exchange passageway separating the sections can be opened and closed using a rotating mechanism, a push button mechanism, or any other well known design technique. For example, the wire control mechanism depicted in Figures 23A-23D can be configured to rotate a proximal portion of the wire control mechanism 2300 to block or unblock the exchange passageway 2314. An additional push button can be added to the wire control mechanism 2300 to block or unblock the exchange passageway 2314.
[0135] In further embodiments, the wire control mechanism 2300 may include a wire tether. The wire tether may be used to prevent the wire from moving in any direction, which may be advantageous in many situations for the user. The wire tether may be located on the cap or may be located on the main body of the wire control mechanism. For example, the wire tether may consist of a rotating mechanism that tightens around the wire (at any portion or notch). In other embodiments, the wire tether may be a push button mechanism, a sliding mechanism, a pinching mechanism, or any other well known mechanism. The wire tether provides additional control functionality to the wire control mechanism beyond the separation of the wire.
[0136] 25A-25B depict other configurations of example wire control mechanism 2500 and valve 2610 as transparent to show internal components. Wire control mechanism 2500 can be the same as or similar to wire control mechanism 2300, and valve 2610 can be the same as or similar to valve 2410 described above in connection with Figures 23A-24B, except as described below. Reference numbers for like or substantially like features may share the same last two digits.
[0137] The proximal end 2504 of the wire control mechanism 2500 may include an opening (not shown) that may be covered by a cap 2516. The cap 2516 may be any shape, including circular, oval, square, rectangular, or any suitable shape. The illustrated cap 2516 shown in FIGS. 25A-B has a circular shape. The cap 2516 may include a first notch 2518 spaced apart from a second notch 2520. The first notch 2518 and the second notch 2520 may include any shape, including circular, oval, square, rectangular, or any suitable shape. The first notch 2518 and the second notch 2520 may include the same shape or different shapes. For example, the first notch 2518 and the second notch 2520 may both have a circular shape. In some configurations, the cap 2516 may be integral with the proximal end 2504 of the wire control mechanism 2500. In some configurations, the cap 2516 may be removable from the proximal end 2504 of the wire control mechanism 2500.
[0138] Figures 26A-26C show other configurations of an example wire control mechanism 2700 and valve 2810. The wire control mechanism 2700 can be the same as or similar to the wire control mechanisms 2300, 2500, and the valve 2810 can be the same as or similar to the valves 2410, 2610 described above in connection with Figures 23A-25B, except as described below. Reference numbers for the same or substantially the same features may share the same last two digits.
[0139] 26A-B show a proximal view and a distal perspective view of a cap 2716 of the wire control mechanism 2700. The cap 2716 may include a thickness measured in a distal to proximal direction such that a first notch 2718 and a second notch 2720 of the cap 2716 are positioned proximal to the proximal end 2704 of the wire control mechanism 2700. In some configurations, the cap 2716 may have a funnel-like shape such that a distal end of the cap 2716 has a larger diameter than a proximal end of the cap 2716.
[0140] 26C shows a side view of the wire control mechanism 2700 attached to a valve 2810, with the wire control mechanism 2700 and valve 2810 transparent to show the internal components. The configuration shown has a distal end 2702 of the wire control mechanism 2700 having a larger diameter than the proximal end 2812 of the valve 2810 such that the proximal end 2812 of the valve 2810 can be received by the distal end 2702 of the wire control mechanism 2700. In some configurations, the cap 2716 may be integral with the proximal end 2704 of the wire control mechanism 2700. In some configurations, the cap 2716 may be removable from the proximal end 2704 of the wire control mechanism 2700.
[0141] In some configurations, the wire control mechanism 2700 may include a blocking mechanism 2722, such as a button or lever, configured to block the passageway 2706. For example, the blocking mechanism 2722 may be positioned at the proximal end 2704 of the wire control mechanism 2700 adjacent the cap 2716 when the cap 2716 is attached to the proximal end 2704. When a user engages the blocking mechanism 2722 (e.g., when a button is pressed), the blocking mechanism 2722 moves to partially or fully block the passageway 2706. When a user disengages the blocking mechanism 2722 (e.g., when a button is moved outward), the blocking mechanism 2722 moves to partially or fully open the passageway 2706. In use, for example, a user can move the blocking mechanism 2722 to partially block the passageway 2706 such that the first notch 2718 is not in communication with the passageway 2706, thereby allowing a user to load a guidewire into the passageway 2706 through the second notch 2720. A user can move the blocking mechanism 2722 such that the passageway 2706 is open, allowing a user to load a device wire into the passageway 2706 through the first notch 2718.
[0142] In some configurations, the wire control mechanism 2700 can be configured to be pushed or depressed distally to open the seal of the valve 2810 to allow fluids, such as blood, to exit the valve 2810 and / or to allow a user to insert or remove an instrument. When the wire control mechanism 2700 is released, the seal of the valve 2810 can close.
[0143] Integrated catheter design for maximum space, support and function The dynamic catheter system allows for optimal guide catheter and guide extension catheter design. By integrating the guide catheter and the guide extension catheter into a single system, the dynamic catheter system reveals a whole new set of design options to maximize space and guide support. For practitioners, the internal diameter space within the catheter system can be important because it can dictate the type of advanced equipment that can be used while keeping the catheter in place. Stents, balloons, intravascular ultrasound (IVUS) equipment, and optical coherence tomography (OCT) equipment are some examples of equipment used by interventional cardiology. A larger internal diameter space can be a considerable advantage. For example, an internal diameter space between 0.03 mm and 0.30 mm (approximately 0.03 mm to 0.30 mm) can be beneficial.
[0144] Balancing the inner diameter space with the ability of the guiding and guiding extension catheters to retain their configuration can be difficult. Thinner walls and less material can result in a reduction in the strength of the catheter wall, but can allow more space for instruments to pass. An integrated catheter approach can allow the guiding extension catheter to act as a built in support for the guiding catheter, thereby allowing unique flexibility to redesign each catheter for optimal functionality.
[0145] 27 shows cross-sectional views of three example configurations of guiding catheter shafts 2910, 3010, 3110 with telescopic guiding extension catheters 2912, 3012, 3112. The guiding catheter shafts 2910, 3010, 3110 and telescopic guiding extension catheters 2912, 3012, 3112 can be the same as or similar to any of the guiding catheter shafts and telescopic guiding extension catheters as described herein. The guiding catheter shafts 2910, 3010, 3110 can be used in the arteries of any vessel. As described herein, the entirety or almost the entirety of the guiding catheter shaft (and the guiding extension catheter shaft) can be positioned within the artery during the procedure. The guide catheter shaft 2910, 3010, 3110 may have a distal end 2904, 3004, 3104 (or leading end) that is initially introduced into and extends through the artery, and a proximal end 2906, 3006, 3106 (or trailing end) that transitions into the guide catheter wire.
[0146] The integrated catheter approach allows for more space by reducing the wall thickness of either (or both) catheter shafts. FIGS. 28A-C show an example implementation of an integrated guide catheter shaft 2910 with a telescoping guide extension catheter 2912. In this implementation, the wall thickness of the guide catheter 2910 is reduced slightly, while the wall thickness of the guide extension catheter 2912 is reduced to a greater extent. The guide catheter 2910 may have a constant wall thickness extending from the distal end 2904 to the proximal end 2906. In an example embodiment, the wall thickness of this guide catheter 2910 is anywhere from 5-15% less than a commercially available comparably sized guide catheter. The reduction in wall thickness may be achieved, for example, by changes to coating layers, knitting patterns, or material selection. Depending on the French size of the integrated catheter system (e.g., 4F, 5F, 6F, etc.), the wall thickness of each catheter may range from about 0.1 mm to about 3 mm, about 0.5 mm to about 2.5 mm, about 1.0 mm to about 2.0 mm, or about 0.125 mm. Depending on the French size of the integrated catheter system, the wall thickness of the guide catheter may be greater or less than the sizes described herein. The guiding extension catheter 2912 may have a constant wall thickness extending from the distal end 2914 of the shaft of the guiding extension catheter 2912 to the proximal end 2916 of the shaft of the guiding extension catheter 2912. In an example embodiment, the guiding extension catheter 2912 is 15-30% thinner at any location than a commercially available comparably sized guiding extension catheter. Depending on the French size of the integrated catheter system (e.g., 4F, 5F, 6F, etc.), the wall thickness may be between about 0.05 mm and about 3 mm, between about 0.5 mm and about 2.5 mm, between about 1.0 mm and about 2.0 mm, or about 0.1 mm. Depending on the French size of the integrated catheter system, the wall thickness of the guiding extension catheters may be greater or less than those described herein. In the illustrated configuration, the wall thickness of the guiding catheter 2910 may be greater than the wall thickness of the guiding extension catheter 2912. In other configurations, the wall thickness of the guiding catheter 2910 may be less than the wall thickness of the guiding extension catheter 2912.
[0147] In some configurations, the guiding extension catheter 2912 may have a diameter smaller than the inner diameter of the guiding catheter 2910 such that it may be positioned within the guiding catheter 2910. For example, the inner diameter of the guiding extension catheter 2912 may be between about 0.5 mm and about 5 mm, between about 1.0 mm and about 4.5 mm, between about 1.5 mm and about 4.0 mm, between about 2.0 mm and about 3.5 mm, or between about 2.5 mm and about 3.0 mm. In some configurations, the inner diameter of the guiding extension catheter 2912 may be about 1.17 mm, about 1.45 mm, about 1.6 mm, or about 1.80 mm.
[0148] In some embodiments, the guiding extension catheter 2912 can include a transition region 2918. At the transition region 2918, the wire of the guiding extension catheter 2912 can transition into the shaft of the guiding extension catheter 2912.
[0149] 29A-29C show an example implementation of a guide catheter shaft 3010 integrated with a telescoping guide extension catheter 3012. In this implementation, the wall thickness of the guide catheter 3010 is greatly reduced, while the wall thickness of the guide extension catheter 3012 is only slightly reduced. The guide catheter 3010 may have a constant wall thickness extending from the distal end 3004 to the proximal end 3006. In an example embodiment, the wall thickness of the guide catheter 3010 is anywhere from 15-40% less than a commercially available comparably sized guide catheter. For example, the wall thickness may be between about 0.01 mm and about 3 mm, between about 0.5 mm and about 2.5 mm, between about 1.0 mm and about 2.0 mm, or about 0.065 mm. Depending on the French size of the integrated catheter system, the wall thickness of the guide catheter may be greater or less than the sizes described herein. The guiding extension catheter 3012 may have a constant wall thickness extending from the distal end 3014 of the shaft of the guiding extension catheter 3012 to the proximal end 3016 of the shaft of the guiding extension catheter 3012. In example embodiments, the guiding extension catheter 2912 is anywhere from 5-15% thinner than a commercially available comparably sized guiding extension catheter. For example, the wall thickness may be between about 0.05 mm and about 3 mm, between about 0.5 mm and about 2.5 mm, between about 1.0 mm and about 2.0 mm, or about 0.125 mm. Depending on the French size of the integrated catheter system, the wall thickness of the guiding extension catheter may be greater or less than the sizes described herein. In some configurations, the wall thickness of the guiding catheter 3010 may be greater than the wall thickness of the guiding extension catheter 3012. In the illustrated configuration, the wall thickness of the guiding catheter 3010 may be less than the wall thickness of the guiding extension catheter 3012.
[0150] In some configurations, the guiding extension catheter 3012 may have a diameter smaller than the inner diameter of the guiding catheter 3010 so that it can be positioned within the guiding catheter 3010. For example, the inner diameter of the guiding extension catheter 3012 may be between about 0.5 mm and about 5 mm, between about 1.0 mm and about 4.5 mm, between about 1.5 mm and about 4.0 mm, between about 2.0 mm and about 3.5 mm, or between about 2.5 mm and about 3.0 mm. In some configurations, the inner diameter of the guiding extension catheter 3012 may be about 1.17 mm, about 1.45 mm, about 1.67 mm, or about 1.80 mm. In some configurations, the length of the guiding extension catheter shaft may be extended to provide additional support to the guiding catheter. For example, for use in a coronary artery, the length of the guiding extension catheter may range from 15 cm to 200 cm, depending on the additional support desired.
[0151] 27, the guiding extension catheter 3012 may include a transition region 3018. At the transition region 3018, the wire of the guiding extension catheter 3012 may transition into the shaft of the guiding extension catheter 3012.
[0152] 30A-30F show an example implementation of an integrated catheter system with catheters made with variable wall thickness. The variable wall thickness provides to further optimize inner diameter space and guiding support. As shown in FIG. 27, the guiding catheter shaft 3110 and the guiding extension catheter 3112 can each have a distal portion with distal ends 3104, 3114, a proximal portion with proximal ends 3106, 3116, and an intermediate portion 3105, 3115 extending between the ends 3104, 3106, 3114, 3116. In this implementation, the guiding catheter 3110 and the guiding extension catheter 3112 can each have a wall thickness that varies through the length of the device. The wall thickness can result in either a variable inner diameter or a variable outer diameter of each catheter in the integrated catheter system. For example, as shown in FIG. 30A-30F, the system can include a guiding catheter 3110 with a constant outer diameter and a variable inner diameter. The system may further include a guiding extension catheter 3112 with a constant inner diameter and a variable outer diameter. A critical dimension for the practitioner's space may be the inner diameter of the guiding extension catheter 3112, considering that this is the minimum dimension that may limit space for instruments to pass through.
[0153] 30A-30F further depict examples of wall thickness transitions. The guide catheter 3110 transitions from maximum to minimum wall thickness in the proximal to distal direction, while the guide extension catheter 3112 has the opposite wall thickness transition. As shown in FIG. 30A and 30D-30F, the guide catheter 3110 and the guide extension catheter 3112 can have first transition regions 3120a, 3120b, respectively. For example, as shown in FIG. 30D, the first transition regions 3120a, 3120b can overlap when the guide catheter 3110 and the guide extension catheter 3112 are in a closed or unexpanded configuration, as described further below in connection with FIG. 30F.
[0154] In some configurations, the maximum wall thickness of the guide catheter 3110 may be between about 0.01 mm and about 3 mm, between about 0.5 mm and about 2.5 mm, between about 1.0 mm and about 2.0 mm, or about 0.125 mm. The minimum wall thickness of the guide catheter 3110 may be between about 0.01 mm and about 3 mm, between about 0.5 mm and about 2.5 mm, between about 1.0 mm and about 2.0 mm, or about 0.085 mm. For example, the maximum wall thickness of the guide extension catheter 3112 may be between about 0.01 mm and about 3 mm, between about 0.5 mm and about 2.5 mm, between about 1.0 mm and about 2.0 mm, or about 0.125 mm. The minimum wall thickness of the guiding extension catheter 3112 can be between about 0.01 mm and about 3 mm, between about 0.5 mm and about 2.5 mm, between about 1.0 mm and about 2.0 mm, or about 0.085 mm. In one embodiment, the maximum wall thickness of the guiding extension catheter 3112 can be about 0.125 mm, and the minimum wall thickness of the guiding extension catheter 3112 can be about 0.085 mm.
[0155] In some configurations, the varying wall thicknesses of the guiding catheter 3110 and the guiding extension catheter 3112 may be inversely related. For example, the wall thickness of the guiding catheter 3110 may decrease from a maximum wall thickness to a minimum wall thickness in a distal to proximal direction, while the wall thickness of the guiding extension catheter 3112 may decrease from a maximum wall thickness to a minimum wall thickness in a proximal to distal direction. There are at least two distinct properties of these configurations. First, the catheter space 3120 between each catheter may be optimized and may be constant. In some embodiments, the catheter space 3120 is up to 20% smaller than the catheter space when non-integrated catheters are used in series. The catheter space 3120 may be important in determining the frictional interaction between the catheters and in affecting the optimal inner diameter of the guiding extension catheter 3112. Second, the overall combined thickness of the catheters remains constant (in the closed position, as described with reference to the closed position, as opposed to the extended position described herein).
[0156] In some configurations, the guiding extension catheter 3112 may have a diameter smaller than the inner diameter of the guiding catheter 3110 such that it can be positioned within the guiding catheter 3110. For example, the inner diameter of the guiding extension catheter 3112 may be between about 0.5 mm and about 5 mm, between about 1.0 mm and about 4.5 mm, between about 1.5 mm and about 4.0 mm, between about 2.0 mm and about 3.5 mm, or between about 2.5 mm and about 3.0 mm. In some configurations, the inner diameter of the guiding extension catheter 3112 may be about 1.17 mm, about 1.45 mm, about 1.63 mm, or about 1.80 mm. Advantageously, the increased inner diameter of the guiding extension catheter 3112 may allow a user to insert larger tools or instruments through the guiding extension catheter 3112 without having to remove the guiding extension catheter 3112 from the guiding catheter 3110.
[0157] 27, the guiding extension catheter 3112 may include a second transition region 3118. At the transition region 3118, the wire of the guiding extension catheter 3112 may transition into the shaft of the guiding extension catheter 3112.
[0158] 30F illustrates a closed or unexpanded configuration in which the distal end 3114 of the guiding extension catheter 3112 is positioned concentrically in the guiding catheter 3110 and is flush with and does not extend beyond the distal end 3104 of the guiding catheter 3110. In some configurations, the first transition regions 3120a, 3120b may be positioned in the intermediate portions 3105, 3115 (FIG. 27) of the guiding catheter 3110 and the guiding extension catheter 3112, respectively. For example, the intermediate portions 3105, 3115 (FIG. 27) may include the distal section 3102 (FIGS. 30D-30F), and the first transition regions 3120a, 3120b may be positioned in the distal section 3102 when the guiding catheter 3110 and the guiding extension catheter 3112 are in the closed or unexpanded configuration. When in the closed or unexpanded configuration, the maximum wall thickness of the guiding extension catheter 3112 can be concentrically located distal to the distal section 3102, as well as the minimum wall thickness of the guiding catheter 3110 at the distal ends 3104, 3114 of the guiding catheter 3110 and the guiding extension catheter 3112. The minimum wall thickness of the guiding extension catheter 3112 can also be concentrically located distal to the distal section 3102, as well as the maximum wall thickness of the guiding catheter 3110 proximal to the distal section 3102.
[0159] 30E illustrates an extended or expanded configuration in which the distal end 3114 of the guiding extension catheter 3112 extends beyond the distal end 3104 of the guiding catheter 3110. In the extended or expanded configuration, the maximum wall thickness of the guiding extension catheter 3112 may extend beyond the distal end 3104 of the guiding catheter 3110 such that the minimum wall thickness of the guiding extension catheter 3112 is concentrically positioned at the minimum wall thickness of the guiding catheter 3110. The maximum wall thickness of the guiding extension catheter 3112 may provide support for any tools or other objects inserted through the guiding extension catheter 3112 while in the extended or expanded configuration. Additionally, the alignment of the minimum wall thicknesses for both the guiding catheter 3110 and the guiding extension catheter 3112 provides a double wall arrangement to support the thinner walled sections of the guiding catheter 3110 and the guiding extension catheter 3112 during use. Also, in the extended or expanded configuration, the maximum wall thickness of the guide catheter 3110 is proximal to the double wall arrangement, and the maximum wall thickness of the guide catheter 3110 may be sufficient to provide support to the proximal end of the catheter system. Advantageously, all portions of the guide catheter 3110 and the guiding extension catheter 3112 in the extended or expanded configuration may provide support for any tools or other objects inserted through the catheter system. Also, varying the wall thickness along the length of the guide catheter 3110 and the guiding extension catheter 3112 maximizes the inner diameter of the guide catheter 3110 and the guiding extension catheter 3112 through which tools or other objects may be inserted, while maintaining a small overall diameter so that the guide catheter 3110 may be maneuvered through the artery. During a procedure, a length of the guide catheter 3110 may extend through the arterial tortuosity of the blood vessel, and the guide extension catheter 3112 may extend from the distal end 3104 of the guide catheter 3110 when the distal end 3104 of the guide catheter 3110 is adjacent the treatment site.
[0160] There are various advantages of an integrated catheter system that results in a more dynamic catheter system. An integrated guiding catheter and guiding extension catheter eliminates the need for a guiding extension catheter 3112 to be placed during the procedure. For example, in a typical percutaneous coronary intervention with a non-integrated catheter, the practitioner must push the guiding extension catheter through a hemostasis valve and into a tortuous guiding catheter that is already placed. This process can cause various problems. First, the practitioner must remove other equipment to make room for the guiding extension catheter to be placed. Second, the guiding extension catheter must be designed to pass through the valve and through the entire guiding catheter, which imposes limitations on material selection, wall thickness, shaft length, and wire design.
[0161] In the integrated catheter system described herein, the guiding extension catheter 3112 can be preloaded into the guiding catheter 3110 and configured to be flush with the guiding catheter 3110 at its most distal end. This allows the practitioner to begin the case by placing the integrated catheter system into the patient once and then simply extending the guiding extension catheter 3112 when needed. This advantage allows for a wider selection of materials, braids, coatings, wall thicknesses, shaft lengths, and wire designs for the guiding extension catheter to broaden the use, function, safety, and effectiveness of the combined catheter. For example, for percutaneous coronary intervention procedures, a soft guiding extension catheter tip may be preferred to avoid dissections in the artery and allow devices such as balloons to easily exit the catheter. With the integrated catheter system described herein, the tip material and dimensions can be customized to a greater degree.
[0162] The integrated catheter system can be more dynamic in that it can be used for a variety of vessels beyond extending the catheter into the coronary arteries. Given the flexibility in design, the dynamic catheter system can be used in a variety of peripheral vascular procedures throughout the body. For example, the dynamic catheter system described herein can be used in sheathless procedures. The dynamic catheter system described herein can be used to extend the guide catheter 3110 in the aorta or other arteries where larger guide catheter support (not necessary in smaller arteries) may be needed. The smaller size of the guide catheter can be manufactured and utilized with confidence, which can result in safer and faster procedures, and ultimately better patient outcomes.
[0163] Different configurations of the wire storage mechanism In some embodiments, the dynamic catheter system can be replaced with an additional wire port in the hemostasis valve for the guiding extension catheter wire. The wire port can keep the guiding extension catheter and / or the guiding catheter wire separate to reduce wire entanglement and tangling. The wire port can be constructed distal or proximal to the hemostasis valve seal. If the wire port is distal to the valve seal, the same (or equivalent) sealing technique discussed above can be applied. If the wire port is proximal to the valve seal, no additional sealing is required. The guiding extension catheter wire port can be configured to accept the guiding extension catheter wire and maximize the efficiency of the wire movement. In some embodiments, the dynamic catheter system can consist of a wire storage mechanism as well as an additional wire port in the hemostasis valve described above. Figures 31A-38B show different configurations of the wire storage mechanism and matching accessories. This embodiment can prevent excess wires from cluttering the limited space for the practitioner. As discussed further below with reference to Figures 32A-32C, the anchoring portion 4006 provides the practitioner with the option of anchoring the guide extension catheter wire to the table, thereby preventing unintended movement of the guide extension wire.
[0164] 31A-31D show a compact spool mechanism 4000 configured to store a wire 4002. The compact spool mechanism 4000 may have a bend radius of between about 2 mm and about 20 mm, between about 5 mm and about 15 mm, or about 10 mm. The compact spool mechanism 4000 may have an overall diameter of between about 0.5 inches and about 5 inches, between about 1 inch and about 4 inches, or between about 2 inches and about 3 inches. The compact spool mechanism 4000 may have friction openings 4004 configured to increase resistance in the wire 4002 as it is pulled through the openings 4004 or retracted through the openings 4004. During use, the wire 4002 may be stored in the spool mechanism 4000 (FIG. 31B). When a user needs more length, the wire 4002 may be pulled from the spool mechanism 4000 (FIG. 31C). When no pulling force is applied to the wire 4002 , the wire 4002 can retract into the spool mechanism 4000 .
[0165] 32A-32C show an example anchoring portion 4006. The anchoring portion 4006 may include a friction pad on a bottom surface of the anchoring portion 4006. The anchoring portion 4006 may be configured to weight the spooling mechanism 4000 against a surface during use. Advantageously, the anchoring portion 4006 allows a user to pull the wire 4002 from the spooling mechanism 4000 without having to hold or otherwise handle the spooling mechanism 4000. In some configurations, the anchoring portion 4006 may include one or more protrusions 4008a, 4008b. The illustrated configuration of the anchoring portion 4006 has two protrusions 4008a, 4008b. As shown in FIG. 32B, the spooling mechanism 4000 may be attached to the anchoring portion 4006. For example, the spooling mechanism 4000 may include an opening 4001. In some embodiments, the opening 4001 can be configured to receive one or more protrusions 4008a, 4008b. Alternatively, as shown in FIG. 32C, the wire 4002 can be pulled through a portion of the tether 4006. In some embodiments, the protrusions 4008a, 4008b are configured to be movable. For example, the protrusions 4008a, 4008b can be moved toward each other to tighten their grip on the wire 4002. Alternatively, the protrusions 4008a, 4008b can be moved apart to loosen their grip on the wire 4002.
[0166] FIG. 33 illustrates a configuration of the spooling mechanism 4100. Similar to the spooling mechanism 4000, the spooling mechanism 4100 can be configured to store the wire 4102. The spooling mechanism 4100 can include a housing 4106. The housing 4106 can have a length of between about 5 cm and about 20 cm, between about 10 cm and about 15 cm, or about 8 cm. The housing 4106 can have a width of between about 5 cm and about 20 cm, between about 10 cm and about 15 cm, or about 8 cm. The housing 4106 can include a friction opening 4104 configured to maintain the wire 4102 in place when the user is not pulling on the wire 4102 or when the wire 4102 is not retracted into the spooling mechanism 4100. The wire 4102 can form a single loop within the housing 4106. For example, the loop can have a diameter of between about 1 cm and about 20 cm, between about 5 cm and about 15 cm, or about 4 cm. In some configurations, the wire 4102 can form multiple loops within the housing 4106 .
[0167] 34A-34B show configurations of a spool mechanism 4200. The spool mechanism 4200 may include a housing 4206 configured to be opened (FIG. 34A) and closed (FIG. 34B). The spool mechanism 4200 may include a spool 4208 stored within the housing 4206. The spool 4208 may be configured to store the wire 4202. During use, the wire 4202 may be pulled through an opening 4204 in the housing 4206. When a user pulls the wire 4202 from the housing 4206, the spool 4208 may rotate in a first direction. When the wire 4202 is retracted into the housing 4206, the spool 4208 may rotate in the opposite direction. In some configurations, the spool 4208 may be disposable. Advantageously, the housing 4206 may be opened and closed for ease of loading a new spool 4208 and removing an old spool 4208. In some configurations, the spool 4208 may be reusable.
[0168] 35 shows a spool base 4210. The spool base 4210 can be used to combine multiple spool mechanisms 4200. For example, the configuration shown shows three spool mechanisms 4200. In some configurations, the spool base 4210 can hold two spool mechanisms 4200 or more than four spool mechanisms 4200 (e.g., four, five, six, seven).
[0169] 36 shows a configuration of the spool mechanism 4300. The spool mechanism 4300 may include a spool 4304, a sliding guide 4306, a sliding rail 4310, and a pulley 4308. A wire 4302 may be wrapped around the spool 4304 and pulled through the sliding guide 4306 and across the pulley 4308. The sliding guide 4306 may be positioned on the sliding rail 4310 such that it may move along the length of the sliding rail 4310.
[0170] 37 illustrates a configuration of a spool mechanism 4400. The spool mechanism 4400 may include a spool 4404 and a base 4408. The spool 4404 may be configured to store the wire 4402. The base 4408 may include a motor 4406 with a mounting portion 4410. The spool 4404 may be configured to mount to the mounting portion 4410 of the motor 4406. The motor 4406 may be configured to provide retraction and adjustable drag when the wire 4402 is being pulled from the spool 4404. In some configurations, the base 4408 may be configured to be reusable. In some configurations, the spool 4404 may be configured to be disposable.
[0171] 38A and 38B show a configuration of the spool mechanism 4500. The spool mechanism 4500 may include a spool 4504, a base 4512, a ratchet 4506, and a ratchet wheel 4514. One end of the wire 4502 may be received by a wire stop 4508 of the spool 4504 and may be wound around the spool 4504. The ratchet 4506 and the ratchet wheel 4514 may be positioned radially inward of the wire 4502. The spool mechanism 4500 may be configured to pull the wire 4502 in one direction. The base 4512 may include a release button 4510 configured to disengage the ratchet 4506 from the ratchet wheel 4514 so that the wire 4502 can be wound around the spool 4504. In some configurations, the spool mechanism 4500 may include a spring configured to provide a force to the spool 4504 such that the wire 4502 retracts (i.e., wraps around the spool 4504) when the release button 4510 is actuated.
[0172] Safety mechanism configuration 39-41 show a safety mechanism arrangement configured to attach to a valve (e.g., a hemostasis valve) and allow a user to manually steer the guiding extension catheter wire if the actuation mechanism fails. The safety mechanism can be used with the actuation mechanisms and catheter control centers described herein. For example, the safety mechanism can be configured to release the actuation mechanism if a user needs to manually steer the guiding extension catheter wire. Additionally, the safety mechanism can be configured to allow a user to remove the guiding extension catheter from the guiding catheter if the guiding extension catheter becomes clogged, if more space is needed in the guiding catheter, or for other reasons. FIG. 39 shows a safety mechanism 4600 arrangement for use in a clamshell actuation mechanism. The actuation mechanism 4600 can include a first portion 4602 and a second portion 4604. The first portion 4602 can be coupled to the second portion 4604 via a hinge 4606 at a first end of the actuation mechanism 4600. The first portion 4602 and the second portion 4604 may be releasably coupled via a coupling mechanism 4608. A user may disengage the coupling mechanism 4608 so that the first portion 4602 and the second portion 4604 may be separated if the user needs to manually manipulate the wire 4610. As shown in FIG. 39, the coupling mechanism 4608 may be a button that may be twisted or unscrewed to uncouple the first portion 4602 and the second portion 4604. In some configurations, the coupling mechanism 4608 may be configured to move the guiding extension catheter proximally and distally within the guiding catheter.
[0173] 40 illustrates a configuration of a safety mechanism 4700. The safety mechanism 4700 may include a first portion 4702 and a second portion 4704 configured to be separable from the first portion 4702. The first portion 4702 and the second portion 4704 may be releasably coupled via a coupling mechanism 4708 (e.g., a screw). If a user needs to manually manipulate the wire 4710, the user may disengage (e.g., unscrew) the coupling mechanism 4708 such that the first portion 4702 and the second portion 4704 may be separated. The safety mechanism 4700 may include an actuation mechanism 4712 configured to move the guiding extension catheter proximally and distally within the guiding catheter.
[0174] 41 illustrates a configuration of a safety mechanism 4800. The safety mechanism 4800 may include an actuation mechanism with a first portion 4802 and a second portion 4804 configured to be separable from the first portion 4802. For example, the second portion 4804 may include a cap 4804 and the first portion 4802 may include a threaded portion configured to engage with the cap 4804. A user may disengage and remove the cap of the second portion 4804 from the first portion 4802 if manual manipulation of the wire is required (not shown).
[0175] Different wire control mechanisms A wire control mechanism as described herein may be used to allow a user to control and steer two or more wires used in the systems described herein. As described herein, it may be beneficial to have a wire control mechanism that can separate and / or combine two or more wires at the beginning, during, or end of a procedure so that the user can easily identify and steer the wires. For example, the wire control mechanism may keep a guide wire separate from a device wire.
[0176] 23A-26C show example wire control mechanisms that may be integral with or attached to the proximal end of a dynamic catheter system, as described above. The wire control mechanisms described in FIGS. 42A-52H may also be integral with or attached to the proximal end of a dynamic catheter system. Any of the wire control mechanisms described herein may be integral with or attached to a valve (e.g., a hemostasis valve). For example, the wire control mechanism and valve may be part of a unibody (e.g., of a single structure) device such that they are not detachable from one another. The unibody wire control mechanism and valve may be integral with or attached to any of the dynamic catheter systems described herein, or may be used with any other catheter system, device, or procedure that utilizes one or more wires. Any feature of the wire control mechanism may be integral with or attached to the valve, including, but not limited to, the doors (e.g., 4916a, 4916b, 5016), discs (e.g., 5116), liners (e.g., 5216), inserts (e.g., 5316), sleeves (e.g., 5416, 5516), caps (e.g., 5616), and / or sliders (e.g., 5716a-5716d). Valves described herein may include Tuohy Force valves, Tuohy valve systems, hemostasis valves, y-connector valves, or any other valve system used with or without a catheter system.
[0177] The wire control mechanism may be coupled to or integral with a valve at the proximal end of a dynamic catheter system, such as one of the dynamic catheter systems 1700, 1800, 2100 described above. Additionally, the dynamic catheter system may include a guide catheter, a guide extension catheter, and a hemostatic valve incorporating the wire control mechanism. In some cases, a catheter control system is not required. Although the wire control mechanism is described as being used with a dynamic catheter system, it can be used in any catheter system, device, or procedure that utilizes one or more wires. For example, any hemostatic valve or valves in use today can benefit from the incorporation of a wire control mechanism as described herein.
[0178] The wire control mechanism shown in Figures 42A-43C may be similar to wire control mechanism 2300 shown in Figures 23A-24B. The wire control mechanism shown in Figures 42A-43C may include an angle between the second portion 2310 and the first portion 2312 that is greater than the angle between the second portion 2310 and the first portion 2312. For example, wire control mechanism 2300 may include an angle of about 35 degrees between the second portion 2310 and the first portion 2312, while the wire control mechanism shown in Figures 42A-43C may include an angle of about 45 degrees between the second portion 2310 and the first portion 2312.
[0179] Figures 42F-G and 43B-C show a first wire W1 passing through a first portion of the aperture and a second wire W2 passing through a second portion of the aperture. The wires W1, W2 can be moved from one portion of the aperture to another as previously described. The wire control mechanism can accommodate one wire or three or more wires simultaneously.
[0180] 44A-D show other configurations of an example wire control mechanism 4900. The wire control mechanism 4900 may include a distal end 4902, a proximal end 4904, and a passageway 4906 extending between the distal end 4902 and the proximal end 4904. The wire control mechanism 4900 may include a first door 4916a and a second door 4916b configured to separate two or more wires. The doors 4916a, 4916b may include a first end and a second end opposite the first end. For example, the first door 4916a and the second door 4916b may be attached or coupled to the proximal end 4904 via a hinge such that one or both of the first door 4916a and the second door 4916b may include a closed configuration when attached such that the second ends of the doors 4916a, 4916b are coupled to the edge 4905 of the proximal end 4904, and may include an open configuration when the second ends of the doors 4916a, 4916b are detached from the edge 4905 of the proximal end 4904. In some cases, the doors 4916a, 4916b are generally rectangular. However, the doors 4916a, 4916b may include other shapes, including square, circular, or any other suitable shape. The first door 4916a and the second door 4916b may comprise the same or substantially the same shape, size, and / or volume, or different shapes, sizes, and / or volumes.
[0181] As shown in FIG. 44C and FIG. 44D, the distal end 4902 may be integral with the proximal end 4912 of the dynamic catheter system or may be configured to be removably coupled to the proximal end 4912. For example, FIG. 44C and FIG. 44D show a valve 4910 of the dynamic catheter system. The dynamic catheter system may include a valve 4910, such as a hemostasis valve, at the proximal end 4912 configured to couple to the distal end 4902 of the wire control mechanism 4900. In some configurations, the valve 4910 may include or be integral with the wire control mechanism 4900. The valve 4910 may be the same as or similar to any of the valves 1710, 1712, 1810, 2110 described herein and may be used with or without the actuation mechanism and / or catheter control center described herein. The valve 4910 may include any valve, such as a hemostasis valve. For example, the valve 4910 may comprise a rotatable part configured to open or close a seal of the valve 4910. In some configurations, the valve 4910 may comprise a button configured to be pressed to open or close a seal of the valve 4910. In some embodiments, the valve 4910 may comprise a rotatable part and a button configured to open or close a seal of the valve 4910.
[0182] The distal end 4902 of the wire control mechanism 4900 may be configured to receive or be received by the proximal end 4912 of the valve 4910. During a procedure, a user may couple the wire control mechanism 4900 to the valve 4910 or detach the wire control mechanism 4900 from the valve 4910. For example, a user may determine that a guiding extension catheter is needed during a procedure. A user may insert the guiding extension catheter into the guiding catheter and couple the wire control mechanism 4900 to separate the wires during a procedure. Additionally, a user may couple the wire control mechanism 4900 to the valve 4910 prior to a procedure. In some configurations, the distal end 4902 may be integral with the valve 4910. For example, the distal end 4902 and the valve 4910 may be part of a unibody (e.g., single structure) device such that they are not detachable from one another. The unibody wire control mechanism and valve can be attached to a dynamic catheter system described herein or any other catheter system, device, or procedure utilizing one or more wires. The illustrated configuration shows the proximal end 4912 of the valve 4910 with a larger diameter than the distal end 4902 such that the distal end 4902 of the wire control mechanism 4900 can be received by the proximal end 4912 of the valve 4910. The distal end 4902 of the wire control mechanism 4900 can be coupled to the valve 4910 via a push-in engagement, a threaded engagement, a snap-fit engagement, or any suitable releasable coupling.
[0183] As shown in FIGS. 44A-44D, the proximal end 4904 can include an opening 4908. The opening 4908 can be aligned with the passageway 4906 such that the opening can be in communication with the valve 4910 and / or the internal passageway of the dynamic catheter system. In some configurations, the proximal end 4904 can include multiple openings (e.g., two, three, four, five). The opening 4908 can include a first portion 4912a, a second portion 4912b, and a third portion 4912c. In some cases, the opening 4908 can include only one portion, two portions, or four or more portions (e.g., four, five, six). The second portion 4912b can be aligned with the passageway 4906, and the first portion 4912a and the third portion 4912c can be angled from the passageway 4906. The angle between the first portion 4912a or the third portion 4912c and the second portion 4912b can be between about 5 degrees and about 60 degrees, between about 5 degrees and about 80 degrees, between about 10 degrees and about 50 degrees, between about 20 degrees and about 40 degrees, or about 15 degrees. This angle can control the distance between two or more wires extending through the wire control mechanism 4900, as described further below. The first portion 4912a and the third portion 4912c can extend from the second portion 4912b such that an exchange passage 4914a extends between the first portion 4912a and the second portion 4912b, and such that an exchange passage 4914b extends between the second portion 4912b and the third portion 4912c. The width of the exchange passageway 4914a, 4914b, the first portion 4912a, and the third portion 4912c may be less than the width of the second portion 4912b. In some cases, the first portion 4912a and the third portion 4912c may extend radially at an angle to the passageway 4906. The exchange passageways 4914a and 4914b may extend from the opening 4908 to the passageway 4906 such that they may be in communication with the passageway 4906. The exchange passageways 4914a and 4914b may be configured to move two or more wires between the first portion 4912a, the second portion 4912b, and the third portion 4912c, as described further below. In some configurations, the wire control mechanism 4900 may include multiple passageways (e.g., two, three, four, five).In some embodiments, each of the multiple passageways can be opened and closed independently.
[0184] The wire control mechanism 4900 may include a first door 4916a and a second door 4916b configured to engage a proximal end 4904 of the wire control mechanism 4900. The first door 4916a and the second door 4916b may be attached to the proximal end 4904 (e.g., via hinges), or the first door 4916a may be attached and the second door 4916b may be completely removable from the proximal end 4904.
[0185] FIG. 44E illustrates the wire control mechanism 4900 with both the first door 4916a and the second door 4916b in an open configuration, and FIG. 44F illustrates the wire control mechanism 4900 with both the first door 4916a and the second door 4916b in a closed configuration. In the open configuration, the first door 4916a and the second door 4916b can be disengaged from the proximal end 4904 such that the wire control mechanism 4900 includes a single passageway, and a user can freely move one or more wires between the first portion 4912a, the second portion 4912b, and the third portion 4912c of the opening 4908 via the exchange passageway 4914a or the exchange passageway 4914b. For example, three wires can extend through the wire control mechanism 4900 while the first door 4916a and the second door 4916b are in the open configuration. A user can move one or more of the wires between the first portion 4912a, the second portion 4912b, and the third portion 4912c of the opening 4908 via the exchange passage 4914a or the exchange passage 4914b. A user can also insert more wires into the opening 4908 when the first door 4916a or the second door 4916b is in the open configuration.
[0186] In the closed configuration, the first door 4916a or the second door 4916b can be coupled to the proximal end 4904 of the wire control mechanism 4900 such that at least a portion of the exchange passage 4914a or the exchange passage 4914b can be covered and such that the first door 4916a and the second door 4916b can separate the three portions 4912a, 4912b, 4912c of the opening 4908. For example, the first door 4916a and the second door 4916b can be removably coupled to the proximal end 4904 of the wire control mechanism 4900 via a push-in engagement, a screw engagement, a snap-fit engagement, or any suitable releasable coupling that allows a user to easily open and close the first door 4916a or the second door 4916b as needed. For example, a first wire can extend through a first portion 4912a of the opening 4908, a second wire can extend through a second portion 4912b of the opening 4908, and a third wire can extend through a third portion 4912c of the opening 4908. A user can open the first door 4916a or the second door 4916b, and when the user closes the first door 4916a and the second door 4916b, the first, second, and / or third wires can be moved through the first exchange passage 4914a and the second exchange passage 4914b such that the first wire can extend through the second portion 4912b of the opening 4908, the second wire can extend through the third portion 4912c of the opening 4908, and the third wire can extend through the first portion 4912a of the opening 4908. Advantageously, the wires and wire control mechanism 4900 do not need to be removed from the catheter system for a user to move each wire to a different portion 4912a, 4912b, 4912c of the opening 4908. The first door 4916a and the second door 4916b can separate two or more wires while in the closed configuration. For example, a first wire can extend through the first portion 4912a of the opening 4908, a second wire can extend through the second portion 4912b of the opening 4908, and a third wire can extend through the third portion 4912c of the opening 4908.Advantageously, this arrangement allows for separation of two or more wires during a procedure to allow the user to easily identify and navigate the wires (eg, guidewire and device wire).
[0187] FIG. 44E shows a first wire W1 passing through the first portion 4912a, a second wire W2 passing through the second portion 4912b, and a third wire W3 passing through the third portion 4912c when the first door 4916a and the second door 4916b are in an open configuration. The wires W1, W2, and W3 can be moved from one portion to another as previously described. The wire control mechanism 4900 can accommodate one wire, two wires, or four or more wires simultaneously. FIG. 44F shows a first wire W1 passing through the first portion 4912a, a second wire W2 passing through the second portion 4912b, and a third wire W3 passing through the third portion 4912c when the first door 4916a and the second door 4916b are in a closed configuration.
[0188] In other embodiments, no cap or door is required. The exchange passageway separating the sections can be opened and closed using a rotating mechanism, a push button mechanism, or any other well known design technique. For example, the wire control mechanism can be configured to rotate a proximal portion of the wire control mechanism 4900 to block or unblock the exchange passageway. Additional push buttons may be added to the wire control mechanism 4900 to block or unblock the exchange passageway 4914a and / or 4914b.
[0189] In further embodiments, the wire control mechanism 4900 may include a wire tether. The wire tether may be used to prevent the wire from moving in any direction, which may be advantageous in many situations for the user. The wire tether may be located on the cap or may be located on the main body of the wire control mechanism. For example, the wire tether may consist of a rotating mechanism that tightens around the wire (at any portion or notch). In other embodiments, the wire tether may be a push button mechanism, a sliding mechanism, a pinching mechanism, or any other well known mechanism. The wire tether provides additional control functionality to the wire control mechanism beyond the separation of the wire.
[0190] 45A-45C show other configurations of an example wire control mechanism 5000. The wire control mechanism 5000 may include a distal end 5002, a proximal end 5004, and a passageway 5006 extending between the distal end 5002 and the proximal end 5004. The wire control mechanism 5000 may include a door 5016 configured to separate two or more wires. The door 5016 may include a first end and a second end opposite the first end. For example, the first end of the door 5016 may be attached or coupled to the proximal end 5004 via a hinge such that the second end of the door 5016 can include a closed configuration when coupled to the edge 5005 of the proximal end 5004 and can include an open configuration when the second end of the door 5016 is detached from the edge 5005 of the proximal end 5004. In some cases, the door 5016 is generally rectangular. However, the door 5016 may include other shapes, including square, circular, or any other suitable shape. When the door 5016 is in a closed configuration, it can separate two or more wires without removing the two or more wires from the wire control mechanism 5000 and without removing the wire control mechanism 5000 from the catheter system, as described further below. In other configurations, the door 5016 can include a rotatable mechanism, a pivotable mechanism, or any other mechanism that can separate two or more wires without removing the wire control mechanism 5000 from the dynamic catheter system.
[0191] The distal end 5002 may be integral with the proximal end 5012 of the dynamic catheter system or may be configured to be removably coupled to the proximal end 5012. For example, FIG. 45 illustrates a valve 5010 of the dynamic catheter system. The dynamic catheter system may include a valve 5010, such as a hemostatic valve, at the proximal end 5012 configured to couple to the distal end 5002 of the wire control mechanism 5000. In some configurations, the valve 5010 may include the wire control mechanism 5000 and may be integral with the wire control mechanism 5000. The valve 5010 may be the same as or similar to any of the valves 1710, 1712, 1810, 2110 described herein and may be used with or without the actuation mechanism and / or catheter control center described herein. The valve 5010 may include any valve, such as a hemostatic valve. For example, the valve 5010 may include a rotatable part configured to open or close a seal of the valve 5010. In some configurations, the valve 5010 may include a button configured to be pressed to open or close a seal of the valve 5010. In some embodiments, the valve 5010 may include a rotatable part and a button configured to open or close a seal of the valve 5010.
[0192] The distal end 5002 of the wire control mechanism 5000 may be configured to receive or be received by the proximal end 5012 of the valve 5010. During a procedure, a user may couple the wire control mechanism 5000 to the valve 5010 or may detach the wire control mechanism 5000 from the valve 5010. For example, a user may determine that a guiding extension catheter is needed during a procedure. A user may insert the guiding extension catheter into the guiding catheter and may couple the wire control mechanism 5000 to separate the wires during a procedure. Additionally, a user may couple the wire control mechanism 5000 to the valve 5010 prior to a procedure. In some configurations, the distal end 5002 may be integral with the valve 5010. For example, the distal end 5002 and the valve 5010 may be part of a unibody (e.g., single structure) device such that they are not detachable from one another. The illustrated configuration shows a distal end 5002 with a larger diameter than the proximal end 5012 of the valve 5010 such that the proximal end 5012 of the valve 5010 can be received by the distal end 5002 of the wire control mechanism 5000. The distal end 5002 of the wire control mechanism 5000 can be coupled to the valve 5010 via a push-in engagement, a threaded engagement, a snap-fit engagement, or any suitable releasable coupling.
[0193] The proximal end 5004 can include an opening 5008. The opening 5008 can be aligned with the passageway 5006 such that the opening can be in communication with the valve 5010 and / or the internal passageway of the dynamic catheter system. In some configurations, the proximal end 5004 can include multiple openings (e.g., two, three, four, five). The opening 5008 can include a first portion 5012a and a second portion 5012b. In some embodiments, the opening 5008 can include only one portion, two portions, three portions, or four or more portions (e.g., four, five, six). The first portion 5012a can be aligned with the passageway 5006 and the second portion 5012b can be angled from the passageway 5006. The angle between the first portion 5012a and the second portion 5012b can be between about 5 degrees and about 60 degrees, between about 10 degrees and about 50 degrees, between about 20 degrees and about 40 degrees, or about 15 degrees. This angle can control the distance between two or more wires extending through the wire control mechanism 5000, as described further below. The second portion 5012b can extend from the first portion 5012a such that the exchange passage 5014 extends between the first portion 5012a and the second portion 5012b. The width of the exchange passage 5014 and the second portion 5012b can be less than the width of the first portion 5012a. In some cases, the second portion 5012b can extend radially at an angle relative to the passage 5006. The exchange passage 5014 can extend from the opening 5008 into the passage 5006 such that the exchange passage 5014 can be in communication with the passage 5006. The exchange passageway 5014 may be configured to move two or more wires between the first portion 5012a and the second portion 5012b, as described further below. In some configurations, the wire control mechanism 5000 may include multiple passageways (e.g., two, three, four, five). In some embodiments, each of the multiple passageways may be independently opened and closed.
[0194] The wire control mechanism 5000 may include a door 5016 configured to engage with a proximal end 5004 of the wire control mechanism 5000. The door 5016 may be attached to the proximal end 5004 (e.g., via a hinge) or the door 5016 may be completely removable from the proximal end 5004.
[0195] In the open configuration, the door 5016 can be disengaged from the proximal end 5004 such that the wire control mechanism 5000 includes a single passageway, and a user can freely move one or more wires between the first and second portions 5012a, 5012b of the opening 5008 via the exchange passageway 5014. A user can move one or more of the wires between the first and second portions 5012a, 5012b of the opening 5008 via the exchange passageway 5014. A user can also insert more wires into the opening 5008 while the door 5016 is in the open configuration.
[0196] In a closed configuration, the door 5016 can be coupled to the proximal end 5004 of the wire control mechanism 5000 such that at least a portion of the exchange passage 5014 can be covered and such that the door 5016 can separate the portions 5012a, 5012b of the opening 5008. For example, the door 5016 can be removably coupled to the proximal end 5004 of the wire control mechanism 5000 via a push-fit engagement, a screw engagement, a snap-fit engagement, or any suitable releasable coupling that allows a user to easily open and close the door 5016 as needed. For example, a first wire can extend through the first portion 5012a of the opening 5008 and a second wire can extend through the second portion 5012b of the opening 5008. A user can open the door 5016 and move the first wire and the second wire through the exchange passage 5014 such that when the user closes the door 5016, the first wire can extend through the second portion 5012b of the opening 5008 and the second wire can extend through the first portion 5012a of the opening 5008. Advantageously, the wire and wire control mechanism 5000 do not need to be removed from the catheter system for the user to move each wire to a different portion 5012a, 5012b of the opening 5008. The door 5016 can separate two or more wires while in the closed configuration. The first wire can extend through the first portion 5012a of the opening 5008 and the second wire can extend through the second portion 5012b of the opening 5008. Advantageously, this arrangement can separate two or more wires during a procedure to allow the user to easily identify and navigate the wires (e.g., guidewire and device wire).
[0197] When the door 5016 is in the closed configuration, the door 5016 can cover only a portion of the second portion 5012b and / or the exchange passage 5014. In some cases, the uncovered space along the portions 5012a, 5012b and the exchange passage 5014 when the door 5016 is in the closed configuration is greater than the uncovered space along the portions 2310, 2312 (of the wire control mechanism 2300) when the cap 2316 is attached. Beneficially, the additional uncovered space along the portions 5012a, 5012b and the exchange passage 5014 provides a user with more space to maneuver one or more wires along the portions 5012a, 5012b and the exchange passage 5014.
[0198] FIG. 45B shows the first wire W1 passing through the first portion 5012a and the second wire W2 passing through the second portion 5012b when the door 5016 is in a closed configuration. The wires W1, W2 can be moved from one portion to another as previously described. The wire control mechanism 5000 can accommodate one wire or three or more wires simultaneously. FIG. 45C shows the first wire W1 passing through the first portion 5012a and the second wire W2 passing through the second portion 5012b when the door 5016 is in an open configuration.
[0199] In other embodiments, no cap or door is required. The exchange passageway separating the sections can be opened and closed using a rotating mechanism, a push button mechanism, or any other well known design technique. For example, the wire control mechanism can be configured to rotate a proximal portion of the wire control mechanism 5000 to block or unblock the exchange passageway. An additional push button can be added to the wire control mechanism 5000 to block or unblock the exchange passageway 5014.
[0200] In further embodiments, the wire control mechanism 5000 may include a wire tether. The wire tether may be used to prevent the wire from moving in any direction, which may be advantageous in many situations for the user. The wire tether may be located on the cap or may be located on the main body of the wire control mechanism. For example, the wire tether may consist of a rotating mechanism that tightens around the wire (at any portion or notch). In other embodiments, the wire tether may be a push button mechanism, a sliding mechanism, a pinching mechanism, or any other well-known mechanism. The wire tether provides additional control functionality to the wire control mechanism beyond the separation of the wire.
[0201] Figures 46A-46F show other configurations of example wire control mechanism 5100 and valve 5110. Wire control mechanism 5100 can be the same as or similar to wire control mechanism 2300, 4900, or 5000, and valve 5110 can be the same as or similar to valve 2410, 4910, or 5010 described above in connection with Figures 23A-24B, except as described below. Reference numbers for like or substantially like features may share the same last two digits.
[0202] The proximal end 5104 of the wire control mechanism 5100 may include an opening 5108 that may be at least partially covered by a disc portion 5116. The disc portion 5116 may be any shape, including circular, elliptical, square, rectangular, or any suitable shape. The illustrated disc portion 5116 shown in FIGS. 46A-E has a circular shape. The disc portion 5116 may include a notch 5118 that defines a continuous opening that includes a first region 5118a, a second region 5118b, and a third region 5118c. The first region 5118a and the third region 5118c may include an arc shape. However, in some cases, the first region 5118a and the third region 5118c may include any shape, including circular, elliptical, square, rectangular, or any suitable shape. The second region 5118b may include a substantially circular shape with two slits 5118d, 5118d extending outward from opposite positions of the circle as shown in FIGS. 46A-46E. However, in some cases, any number of slits or formations at any position may be used to provide flexibility to the cap components. In some cases, the second region 5118b may include any shape, including an oval, a square, a rectangle, or any suitable shape. The first region 5118a, the second region 5118b, and the third region 5118c may include the same or different shapes. In some configurations, the disc portion 5116 may be integral with the proximal end 5104 of the wire control mechanism 5100. In some configurations, the disc portion 5116 may be detachable from the proximal end 5104 of the wire control mechanism 5100.
[0203] In some configurations, the first region 5118a, the second region 5118b, and the third region 5118c may be separated by a seal. For example, the first bridge portion 5150a separating the first region 5118a and the second region 5118b may include a silicone gel with slits or openings that may partially seal the first region 5118a from the second region 5118b (and the second region 5118b from the first region 5118a), but still allow a user to move one or more wires or other devices between the regions by pushing one or more wires or other devices through the slits or openings in the silicone gel. Similarly, the second bridge portion 5150b separating the second region 5118b and the third region 5118c may include a silicone gel with slits or openings that may partially seal the second region 5118b from the third region 5118c (and the third region 5118c from the second region 5118b), but the user may still move one or more wires or other devices between the regions by pushing one or more wires or other devices through the slits or openings in the silicone gel. In some cases, the bridge portion does not include silicone gel. For example, the length of the first bridge portion 5150a and the second bridge portion 5150b may allow the free ends of the first bridge portion 5150a and the second bridge portion 5150b to touch or nearly touch each other, requiring the user to exert a minimum threshold force when moving a wire from one region to the other. Beneficially, this can prevent accidental or unintended switching of the wire from one region to another. Although silicone gel or intimate contact has been described as being used to prevent accidental or unintended switching of the wire from one region to another, any other mechanism can be used to separate or substantially separate the passageways but still allow the openings to provide selective communication between the passageways.
[0204] When the disc portion 5116 is attached to the proximal end 5104 of the wire control mechanism 5100, the disc portion 5116 can separate two or more wires without removing the two or more wires from the wire control mechanism 5100 and without removing the wire control mechanism 5100 from the catheter system. In other configurations, the disc portion 5116 can include a rotatable mechanism, a pivotable mechanism, or any other mechanism that can separate two or more wires without removing the wire control mechanism 5100 from the dynamic catheter system.
[0205] The distal end 5102 of the wire control mechanism 5100 may be integral with or configured to be removably coupled to the proximal end 5112 of the dynamic catheter system. For example, FIG. 46E illustrates a valve 5110 of a dynamic catheter system. The dynamic catheter system may include a valve 5110, such as a hemostasis valve, at the proximal end 5112 configured to couple to the distal end 5102 of the wire control mechanism 5100. In some configurations, the valve 5110 may include the wire control mechanism 5100 or may be integral with the wire control mechanism 5100. The valve 5110 may be the same as or similar to any of the valves 1710, 1712, 1810, 2110, 4910, 5010 described herein and may be used with or without the actuation mechanism and / or catheter control center described herein. The valve 5110 may include any valve, such as a hemostasis valve. For example, the valve 5110 may include a rotatable part configured to open or close a seal of the valve 5110. In some configurations, the valve 5110 may include a button configured to be pressed to open or close a seal of the valve 5110. In some cases, the valve 5110 may include a rotatable part and a button configured to open or close a seal of the valve 5110.
[0206] The distal end 5102 of the wire control mechanism 5100 may be configured to receive or be received by the proximal end 5112 of the valve 5110. During a procedure, a user may couple the wire control mechanism 5100 to the valve 5110 or may detach the wire control mechanism 5100 from the valve 5110. For example, a user may determine that a guiding extension catheter is needed during a procedure. A user may insert the guiding extension catheter into the guiding catheter and may couple the wire control mechanism 5100 to separate the wires during a procedure. Additionally, a user may couple the wire control mechanism 5100 to the valve 5110 prior to a procedure. In some configurations, the distal end 5102 may be integral with the valve 5110. For example, the distal end 5102 and the valve 5110 may be part of a unibody (e.g., single structure) device such that they are not detachable from one another. The illustrated configuration shows a distal end 5102 with a larger diameter than the proximal end 5112 of the valve 5110 such that the proximal end 5112 of the valve 5110 can be received by the distal end 5102 of the wire control mechanism 5100. The distal end 5102 of the wire control mechanism 5100 can be coupled to the valve 5110 via a push-in engagement, a threaded engagement, a snap-fit engagement, or any suitable releasable coupling.
[0207] The wire control mechanism 5100 may include a disc portion 5116 configured to engage with the proximal end 5104 of the wire control mechanism 5100. The disc portion 5116 may be attached to the proximal end 5104, or the disc portion 5116 may be completely removable from the proximal end 5104.
[0208] When the disc portion 5116 is not attached to the proximal end 5104 of the wire control mechanism 5100, the wire control mechanism 5100 includes a single passageway through which a user can freely move one or more wires. For example, three wires can extend through the wire control mechanism 5100 while the disc portion 5116 is not attached to the proximal end 5104 of the wire control mechanism 5100. A user can move one or more of the wires along the single passageway. A user can also insert more wires into the single passageway while the disc portion 5116 is not attached to the proximal end 5104 of the wire control mechanism 5100.
[0209] When the disc portion 5116 is attached to the proximal end 5104 of the wire control mechanism 5100, at least a portion of the passageway is covered. The disc portion 5116 can be removably coupled to the proximal end 5104 of the wire control mechanism 5100 via a push-in engagement, a threaded engagement, a snap-fit engagement, or any suitable releasable coupling that allows a user to easily attach and remove the disc portion 5116 as needed. When the disc portion 5116 is attached, a first wire can extend through the first region 5118a, a second wire can extend through the second region 5118b, and a third wire can extend through the third region 5118c. A user can move one or more of the first, second, and third wires to different regions by pushing the first, second, and / or third wires through the first bridge portion 5150a or the second bridge portion 5150b. For example, to move a first wire from the first region 5118a to the second region 5118b, a user can push the first wire from the first region 5118a through the first bridge portion 5150a to the second region 5118b. Similarly, to move a third wire from the third region 5118c to the second region 5118b, a user can push the third wire from the third region 5118c through the second bridge portion 5150b to the second region 5118b. The wires and wire control mechanism 5100 do not need to be removed from the catheter system for a user to move each wire to a different region 5118a, 5118b, 5118c. The disc portion 5116 can separate two or more wires while attached to the proximal end 5104 of the wire control mechanism 5100. A first wire can extend through the first region 5118a, a second wire can extend through the second region 5118b, and a third wire can extend through the third region 5118c. Advantageously, this arrangement can separate two or more wires during a procedure to allow a user to easily identify and navigate the wires (e.g., guidewire and device wire).
[0210] 46F shows a first wire W1 passing through the first region 5118a, a second wire W2 passing through the second region 5118b, and a third wire W3 passing through the third region 5118c. The wires W1, W2 can be moved from one region to another as previously described. The wire control mechanism 5100 can accommodate one wire, two wires, or four or more wires simultaneously.
[0211] In further embodiments, the wire control mechanism 5100 may include a wire tether. The wire tether may be used to prevent the wire from moving in any direction, which may be advantageous in many situations for the user. The wire tether may be located on the cap, or may be located on the main body of the wire control mechanism. For example, the wire tether may consist of a rotating mechanism that tightens around the wire (at any portion or notch). In other embodiments, the wire tether may be a push button mechanism, a sliding mechanism, a pinching mechanism, or any other well-known mechanism. The wire tether provides additional control functionality to the wire control mechanism beyond the isolation of the wire.
[0212] The wire control mechanism 5200 shown in FIGS. 47A-47C may be similar to any of the wire control mechanisms described herein and may include one or more, or all, of the features of those wire control mechanisms. In some cases, the wire control mechanism 5200 may include a liner 5216 configured to separate two or more wires. The liner 5216 may include a bridge portion 5250 separating the first passageway 5212a and the second passageway 5212b. The bridge portion 5250 may be a slit extending along at least a portion of the liner 5216. The width of the bridge portion 5250 may allow a user to move one or more wires from the first passageway 5212a to the second passageway 5212b. The width of the bridge portion 5250 may be substantially the same as or smaller than the width of the one or more wires and may require a user to exert a minimum threshold force to move the wires from one portion to another. This can prevent a user from accidentally or unintentionally moving one wire from one section to another. The width of the bridge section 5250 can increase while the user threads the wire through the opening in the bridge section, thereby allowing a wire of a certain width to be threaded through the opening or slit in the bridge section 5250. The liner 5216 can separate two or more wires without removing the two or more wires from the wire control mechanism 5200 and without removing the wire control mechanism 5200 from the catheter system. The liner 5216 can be attached to the proximal surface 5215b of the wire control mechanism 5200. In some cases, the liner 5216 can be positioned within at least a portion of the second passageway 5212b. The liner 5216 can also be embedded within a portion of the proximal surface 5215b. In some cases, the liner 5216 can be made of a silicone material. However, the liner 5216 may be made from any material or any flexible material that allows the opening in the bridge portion to expand when a user is threading a wire through the bridge portion 5250. The features of the wire control mechanism 5200 should not be limited to the particular shapes and proportions depicted in Figures 47A-47C.In some embodiments, the size, shape, and location of the first passageway 5212a, the second passageway 5212b, the bridge portion 5250, and / or the liner 5216 can vary. For example, the bridge portion 5250 that widens into the larger second passageway 5212b can be narrower (such as a smooth slit covered by the liner 5216). In those embodiments, the two passageways are significantly larger than the bridge portion 5250 to accommodate movement of the wire when positioned in each passageway while still maintaining the desired separation between the passageways through the bridge portion 5250.
[0213] 47B shows a first wire W1 passing through a first passage 5212a and a second wire W2 passing through a second passage 5212b. The wires W1, W2 can be moved from one passage to another as previously described. The wire control mechanism can accommodate one wire or more than two wires simultaneously.
[0214] 48A-C show other configurations of an example wire control mechanism 5300. The wire control mechanism 5300 may include a distal end 5302, a proximal end 5304, and a passageway 5306 extending between the distal end 5302 and the proximal end 5304. The wire control mechanism 5300 may include an insert 5316 configured to separate two or more wires. The insert 5316 may be any shape, including circular, oval, square, rectangular, or any suitable shape. The illustrated insert 5316 shown in FIGS. 48A-C has a circular shape.
[0215] As shown in FIGS. 48A-48C, the distal end 5302 may be integral with the proximal end 5312 of the dynamic catheter system or may be configured to be removably coupled to the proximal end 5312. For example, FIGS. 48A-48C show a valve 5310 of the dynamic catheter system. The dynamic catheter system may include a valve 5310, such as a hemostasis valve, at the proximal end 5312 configured to couple to the distal end 5302 of the wire control mechanism 5300. In some configurations, the valve 5310 may include the wire control mechanism 5300 or may be integral with the wire control mechanism 5300. The valve 5310 may be the same as or similar to any of the valves 1710, 1712, 1810, 2110, 4910, 5010, 5110, 5210 described herein and may be used with or without the actuation mechanism and / or catheter control center described herein. The valve 5310 may include any valve, such as a hemostasis valve. For example, the valve 5310 may comprise a rotatable part configured to open or close a seal of the valve 5310. In some configurations, the valve 5310 may comprise a button configured to be pressed to open or close a seal of the valve 5310. In some embodiments, the valve 5310 may comprise a rotatable part and a button configured to open or close a seal of the valve 5310.
[0216] The distal end 5302 of the wire control mechanism 5300 may be configured to receive or be received by the proximal end 5312 of the valve 5310. During a procedure, a user may couple the wire control mechanism 5300 to the valve 5310 or may detach the wire control mechanism 5300 from the valve 5310. For example, a user may determine that a guiding extension catheter is needed during a procedure. A user may insert the guiding extension catheter into the guiding catheter and may couple the wire control mechanism 5300 to separate the wires during a procedure. Additionally, a user may couple the wire control mechanism 5300 to the valve 5310 prior to a procedure. In some configurations, the distal end 5302 may be integral with the valve 5310. For example, the distal end 5302 and the valve 5310 may be part of a unibody (e.g., single structure) device such that they are not detachable from one another. The illustrated configuration shows the proximal end 5312 of the valve 5310 with a larger diameter than the distal end 5302 such that the distal end 5302 of the wire control mechanism 5300 can be received by the proximal end 5312 of the valve 5310. The distal end 5302 of the wire control mechanism 5300 can be coupled to the valve 5310 via a push-in engagement, a threaded engagement, a snap-fit engagement, or any suitable releasable coupling.
[0217] The proximal end 5304 can include an opening 5308. The opening 5308 can be aligned with the passageway 5306 such that the opening can be in communication with the valve 5310 and / or the internal passageway of the dynamic catheter system. In some configurations, the proximal end 5304 can include multiple openings (e.g., two, three, four, five). The opening 5308 can include a first portion 5312a and a second portion 5312b. In some cases, the opening 5308 can include only one portion, or three or more portions. The first portion 5312a can be aligned with the passageway 5306 and the second portion 5312b can be angled from the passageway 5306. The angle between the first portion 5312a and the second portion 5312b can be between about 5 degrees and about 60 degrees, between about 10 degrees and about 50 degrees, between about 20 degrees and about 40 degrees, or about 15 degrees. This angle can control the distance between two or more wires extending through the wire control mechanism 5300, as described further below. The second portion 5312b can extend from the first portion 5312a such that the exchange passage 5314 extends between the first portion 5312a and the second portion 5312b. The exchange passage 5314 can extend from the opening 5308 to the passage 5306 such that it can be in communication with the passage 5306. The exchange passage 5314 can be configured to move two or more wires between the first portion 5312a and the second portion 5312b, as described further below. In some configurations, the wire control mechanism 5300 can include multiple passages (e.g., two, three, four, five). In some cases, each of the multiple passages can be opened and closed independently.
[0218] The wire control mechanism 5300 may include an insert 5316 configured to be embedded within an internal pocket of the proximal end 5304 of the wire control mechanism 5300. In some configurations, the insert 5316 can be attached to the proximal end 5304 or the insert 5316 can be completely removable from the proximal end 5304.
[0219] When the insert 5316 is not embedded in the inner pocket of the proximal end 5304 of the wire control mechanism 5300 or attached to the proximal end 5304, the wire control mechanism 5300 includes a single passageway and a user can freely move one or more wires between the first portion 5312a and the second portion 5312b of the opening 5308 via the exchange passageway 5314. For example, while the insert 5316 is not embedded in the inner pocket of the proximal end 5304 of the wire control mechanism 5300 or attached to the proximal end 5304, two wires can extend through the wire control mechanism 5300. A user can move one or more of the wires between the first portion 5312a and the second portion 5312b of the opening 5308 via the exchange passageway 5314. The user can also insert more wire into the opening 5308 while the insert 5316 is not embedded in the inner pocket of the proximal end 5304 of the wire control mechanism 5300 or attached to the proximal end 5304.
[0220] When the insert 5316 is embedded in an inner pocket of or attached to the proximal end 5304 of the wire control mechanism 5300, the insert 5316 can separate two or more wires without removing the two or more wires from the wire control mechanism 5300 and without removing the wire control mechanism 5300 from the catheter system. In other configurations, the insert 5316 can include a rotatable mechanism, a pivotable mechanism, or any other mechanism that can separate two or more wires without removing the wire control mechanism 5300 from the dynamic catheter system.
[0221] In some configurations, the first portion 5312a and the second portion 5312b may be separated by a seal. The insert 5316 may include a bridge portion 5350 configured to separate the first portion 5312a from the second portion 5312b (and separate the second portion 5312b from the first portion 5312a). The bridge portion 5350 may be a slit or an opening extending along at least a portion of the insert 5316. The width of the bridge portion 5350 may allow a user to move one or more wires from the first portion 5312a to the second portion 5312b. The width of the bridge portion 5350 may be substantially the same as or smaller than the width of the one or more wires, requiring the user to exert a minimum threshold force to move the wires from one portion to another. Beneficially, this may prevent a user from accidentally or unintentionally moving one wire from one portion to another. The width of the bridge portion 5350 can increase while the user threads the wire through the opening of the bridge portion, thereby allowing a wire of a certain width to be threaded through the opening or slit of the bridge portion 5350. The insert 5316 can be attached to the proximal surface 5315b of the wire control mechanism 5300. The insert 5316 can also be embedded into a portion of the proximal surface 5315b. In some cases, the insert 5316 can be made from a silicone material. However, the insert 5316 can be made from any material that causes the opening of the bridge portion to expand when the user is threading the wire through the bridge portion 5350. The features of the wire control mechanism 5300 should not be limited to the particular shapes and proportions depicted in FIGS. 48A-48C. In some embodiments, the size, shape, and location of the first passageway 5312a, the second passageway 5312b, the bridge portion 5350, and / or the insert 5316 can vary. For example, the bridge portion 5350 that spans the larger second passageway 5312b can be narrower (such as a smooth slit covered by the insert 5316). In these embodiments, the two passageways are larger than the bridge portion 5350 to accommodate movement of the wires when positioned in each passageway while still maintaining the desired separation between the passageways through the bridge portion 5350.
[0222] Although silicone gel or intimate contact has been described as being used to prevent accidental or unintentional switching of the wire from one region to another, any other mechanism can be used to separate or substantially separate the passageways while still allowing the openings to provide selective communication between the regions.
[0223] When the insert 5316 is embedded in an inner pocket of the proximal end 5304 of the wire control mechanism 5300 or attached to the proximal end 5304, the first wire can extend through the first portion 5312a and the second wire can extend through the second portion 5312b. A user can move one or more of the first and second wires to different regions by pushing the first and / or second wires through the bridge portion 5350. For example, to move the first wire from the first portion 5312a to the second portion 5312b, a user can push the first wire from the first portion 5312a through the bridge portion 5350 to the second portion 5312b via the exchange passage 5314. Similarly, to move the second wire from the second portion 5312b to the first portion 5312a, the user can push the second wire from the second portion 5312b through the bridge portion 5350 to the first region 5312a through the exchange passage 5314. Advantageously, the wire and wire control mechanism 5300 do not need to be removed from the catheter system for the user to move each wire to a different region 5312a, 5312b. While the insert 5316 is embedded in an inner pocket of the proximal end 5304 of the wire control mechanism 5300 or attached to the proximal end 5304, the insert 5316 can separate two or more wires. For example, the first wire can extend through the first portion 5312a and the second wire can extend through the second portion 5312b. Advantageously, this arrangement allows for separation of two or more wires during a procedure to allow the user to easily identify and navigate the wires (eg, guidewire and device wire).
[0224] In further embodiments, the wire control mechanism 5300 may include a wire tether. The wire tether may be used to prevent the wire from moving in any direction, which may be advantageous in many situations for the user. The wire tether may be located on the insert or may be located on the main body of the wire control mechanism. For example, the wire tether may consist of a rotating mechanism that tightens around the wire (at any portion or notch). In other embodiments, the wire tether may be a push button mechanism, a sliding mechanism, a pinching mechanism, or any other well-known mechanism. The wire tether provides additional control functionality to the wire control mechanism beyond the isolation of the wire.
[0225] 49A-49F show an implementation of a wire control mechanism 5400. The wire control mechanism 5400 may include a distal end 5402, a proximal end 5404, and a passageway 5406 extending between the distal end 5402 and the proximal end 5404. The wire control mechanism 5400 may include a main body 5415 and a sleeve 5416 configured to separate two or more wires. The main body 5415 of the wire control mechanism may include a distal end 5415a and a proximal end 5415b. The sleeve 5416 may include a distal end 5416a and a proximal end 5416b. The sleeve 5416 may be removably coupled to the main body 5415. For example, the distal end 5415a of the main body 5415 may be configured to receive or be received by the proximal end 5416b of the sleeve 5416. The sleeve 5416, when coupled to the main body 5415, as described further below, can separate two or more wires without removing the two or more wires from the wire control mechanism 5400 and without removing the wire control mechanism 5400 from the catheter system. In other configurations, the sleeve 5416 can include a rotatable mechanism, a pivotable mechanism, or any other mechanism that can separate two or more wires without removing the wire control mechanism 5400 from the dynamic catheter system.
[0226] As shown in FIG. 49D and FIG. 49E, the distal end 5402 of the wire control mechanism 5400 may be integral with or configured to be removably coupled to the proximal end 5412 of the dynamic catheter system. For example, FIG. 49D illustrates a valve 5410 of the dynamic catheter system. The dynamic catheter system may include a valve 5410, such as a hemostasis valve, at the proximal end 5412 configured to couple to the distal end 5402 of the wire control mechanism 5400. In some configurations, the valve 5410 may include or be integral with the wire control mechanism 5400. The valve 5410 may be the same as or similar to any of the valves 1710, 1712, 1810, 2110, 4900, 5000, 5100, 5200, 5300 described herein and may be used with or without the actuation mechanisms and / or catheter control centers described herein. The valve 5410 may include any valve, such as a hemostatic valve. For example, the valve 5410 may include a rotatable part configured to open or close a seal of the valve 5410. In some configurations, the valve 5410 may include a button configured to be pressed to open or close a seal of the valve 5410. In some embodiments, the valve 5410 may include a rotatable part and a button configured to open or close a seal of the valve 5410.
[0227] The distal end 5402 of the wire control mechanism 5400 may be configured to receive or be received by the proximal end 5412 of the valve 5410. During a procedure, a user may couple the wire control mechanism 5400 to the valve 5410 or may detach the wire control mechanism 5400 from the valve 5410. For example, a user may determine that a guiding extension catheter is needed during a procedure. A user may insert the guiding extension catheter into the guiding catheter and may couple the wire control mechanism 5400 to separate the wires during a procedure. Additionally, a user may couple the wire control mechanism 5400 to the valve 5410 prior to a procedure. In some configurations, the distal end 5402 may be integral with the valve 5410. For example, the distal end 5402 and the valve 5410 may be part of a unibody (e.g., single structure) device such that they are not detachable from one another. The illustrated configuration shows the proximal end 5412 of the valve 5410 with a larger diameter than the distal end 5402 such that the distal end 5402 of the wire control mechanism 5400 can be received by the proximal end 5412 of the valve 5410. The distal end 5402 of the wire control mechanism 5400 can be coupled to the valve 5410 via a push-in engagement, a threaded engagement, a snap-fit engagement, or any suitable releasable coupling.
[0228] The proximal end 5415b of the main body 5415 may include an opening 5408. The opening 5408 may align with the passageway 5406 such that the opening 5408 may communicate with the valve 5410 and / or the internal passageway of the dynamic catheter system. In some configurations, the main body 5415 may include multiple cutouts (e.g., 2, 3, 4, 5) in a sidewall of the main body 5415. For example, the main body 5415 may include a first cutout 5417a and a second cutout 5417b. Each cutout 5417a, 5417b may include a bridge portion 5417c, 5417d and an end portion 5417e, 5417f. The cutouts 5417a, 5417b can extend from the proximal end 5415b of the main body 5415 along the sidewall of the main body 5415 to end portions 5417e, 5417f. The bridge portions 5417c, 5417d can be positioned between the end portions 5417e, 5417f and the portions where the cutouts 5417a, 5417b extend from the proximal end 5415b. The cutouts 5417a, 5417b can comprise a U-shape or a C-shape. However, in some cases, the cutouts 5417a, 5417b can comprise other shapes. Each of the cutouts 5417a, 5417b can comprise the same shape or a different shape from one another. In some cases, the opening 5408 may include only one portion, or three or more portions (e.g., three, four, five, six). The shape, length, and size of the first notch 5417a and the second notch 5417b may be substantially the same or may be different. The opening 5408 may be configured to allow two or more wires to move between the first notch 5417a and the second notch 5417b, as described further below.
[0229] The wire control mechanism 5400 may include a sleeve 5416 configured to engage a distal end 5415a of the main body 5415. The sleeve 5416 may be attached to the main body 5415, for example, by inserting the distal end 5415a of the main body 5415 through an opening 5419 in the sleeve 5416. The sleeve 5416 may be completely removable from the main body 5415. In some cases, the sleeve 5416 may be coupled to the main body 5415 and may be movable along the length of the main body, but is not removable from the main body 5415. The length of the main body 5415 may extend along the axis as the passageway 5406. The main body 5415 may include a first notch 5417a and a second notch 5417b. In some cases, the main body 5415 may include only one passageway, or more passageways (e.g., three, four, five, six). In some configurations, the first cutout 5417a can be larger than the second cutout 5417b. In other configurations, the first cutout 5417a can be smaller than or the same size as the second cutout 5417b. In some configurations, the first cutout 5417a and / or the second cutout 5417b can include a seal. For example, the first cutout 5417a and / or the second cutout 5417b can include a silicone gel with a slit or opening that can partially seal the cutouts 5417a, 5417b so that one or more wires or other devices can be pushed through the slit or opening in the silicone gel. The first cutout 5417a and / or the second cutout 5417b can include any material other than silicone gel that allows one or more wires or other devices to be pushed through the material, including a flexible material. Beneficially, this can prevent a user from accidentally or unintentionally moving one wire from one passageway to the other. In some cases, however, the cutouts 5417a, 5417b may not include silicone gel and may include a different seal or no seal at all.
[0230] 49C and 49E show the sleeve 5416 attached to the main body 5415. When the sleeve 5416 is attached to the main body 5415, the sleeve 5416 can be moved between at least a first position and a second position. The sleeve 5416 can be moved between the first position and the second position by sliding the sleeve 5416 axially along the main body 5415 in a direction going from the distal end 5415a to the proximal end 5415b or from the proximal end 5415b to the distal end 5415a, as shown by arrow 5421. In some cases, the sleeve 5416 can rotate along an axis of rotation that extends along the passageway 5406. In some cases, the first position can include any position in which the sleeve 5416 completely blocks the bridge portion 5417c and the bridge portion 5417d. In some cases, the second position of the sleeve 5416 may include any position in which at least a portion of the bridge portions 5417c and 5417d are not blocked by the sleeve 5416. When the sleeve 5416 is in the first position, the wire control mechanism includes a single passageway formed by the opening 5408, the first notch 5417a, and the second notch 5417b, and a user can freely move one or more wires between the opening 5408, the first notch 5417a, and the second notch 5417b. For example, two wires can extend through the wire control mechanism 5400 while the sleeve 5416 is in the first position. A user can move one or both of the wires between the first notch 5417a and the second notch 5417b through the opening 5408. The user may also insert more wire into the opening 5408, the first notch 5417a, or the second notch 5417b while the sleeve 5416 is in the first position.
[0231] As shown in Figures 49C and 49E, when the sleeve 5416 is in the second position, the wire control mechanism includes three passages formed by the opening 5408, the end 5417e of the first notch 5417a, and the end 5417f of the second notch 5417b. When the sleeve 5416 is in the second position, the first wire can extend through the end 5417e of the first notch 5417a, and the second wire can extend through the end 5417f of the second notch 5417b. When the sleeve 5416 is in the second position, the sleeve 5416 blocks the bridge portions 5417c, 5417d, so that the first wire and the second wire cannot move beyond the bridge portions 5417c and 5417d. Advantageously, this arrangement allows for separation of two or more wires during a procedure to allow a user to easily identify and navigate the wires (e.g., guidewire and device wire). In some cases, when the sleeve 5416 is in the second position, a first wire can extend through the end 5417e of the first notch 5417a or the end 5417f of the second notch 5417b, and a second wire can extend through the opening 5408. If three wires are used, when the sleeve 5416 is in the second position, a first wire can extend through the end 5417e of the first notch 5417a, a second wire can extend through the end 5417f of the second notch 5417b, and a third wire can extend through the opening 5408. A user can transition the sleeve 5416 from a first position to a second position and move the first and second wires to different notches through the area of the opening 5408. For example, while the sleeve is in the first position, a user can move the first wire from the first notch 5417a to the second notch 5417b by moving the first wire from end 5417e through bridge portion 5417c and opening 5408 to end 5417f.Similarly, while the sleeve is in the first position, the user can move the second wire from the second notch 5417b to the first notch 5417a by moving the second wire from end 5417f through the bridge portion 5417d and the opening 5408 to end 5417e. After moving the first and second wires, the user can transition the sleeve 5416 to the second position such that the first wire can extend through end 5417f of the second notch 5417b and the second wire can extend through end 5417e of the first notch 5417a. Advantageously, the wires and wire control mechanism 5400 do not need to be removed from the catheter system in order for the user to move each wire to a different notch 5417a, 5417b.
[0232] 49F shows a first wire W1 passing through end portion 5417e of first cutout 5417a and a second wire W2 passing through end portion 5417f of second cutout 5417b. Wires W1, W2 can be moved from one end portion to the other as previously described. Wire control mechanism 5400 can accommodate one wire or more than two wires simultaneously.
[0233] In further embodiments, the wire control mechanism 5400 may include a wire tether. The wire tether may be used to prevent the wire from moving in any direction, which may be advantageous in many situations for the user. The wire tether may be located on the cap or may be located on the main body of the wire control mechanism. For example, the wire tether may consist of a rotating mechanism that tightens around the wire (at any portion or notch). In other embodiments, the wire tether may be a push button mechanism, a sliding mechanism, a pinching mechanism, or any other well-known mechanism. The wire tether provides additional control functionality to the wire control mechanism beyond the separation of the wire.
[0234] 50A-50G show an implementation of a wire control mechanism 5500. The wire control mechanism 5500 may include a distal end 5502, a proximal end 5504, and a passageway 5506 extending between the distal end 5502 and the proximal end 5504. The wire control mechanism 5500 may include a main body 5515 and a sleeve 5516 configured to separate two or more wires. The main body 5515 of the wire control mechanism may include a distal end 5515a and a proximal end 5515b. The sleeve 5516 may include a distal end 5516a and a proximal end 5516b. The sleeve 5516 may be removably coupled to the main body 5515. For example, the distal end 5515a of the main body 5515 may be configured to receive or be received by the proximal end 5516b of the sleeve 5516. The sleeve 5516, when coupled to the main body 5515, as described further below, can separate two or more wires without removing the two or more wires from the wire control mechanism 5500 and without removing the wire control mechanism 5500 from the catheter system. In other configurations, the sleeve 5516 can include a rotatable mechanism, a pivotable mechanism, or any other mechanism that can separate two or more wires without removing the wire control mechanism 5500 from the dynamic catheter system.
[0235] As shown in FIG. 50F, the distal end 5502 of the wire control mechanism 5500 may be integral with the proximal end 5512 of the dynamic catheter system or may be configured to be removably coupled to the proximal end 5512. For example, FIG. 50D illustrates a valve 5510 of a dynamic catheter system, as in FIG. 49D. The dynamic catheter system may include a valve 5510, such as a hemostasis valve, at the proximal end 5512 configured to couple to the distal end 5502 of the wire control mechanism 5500. In some configurations, the valve 5510 may include the wire control mechanism 5500 or may be integral with the wire control mechanism 5500. The valve 5510 may be the same or similar to any of the valves 1710, 1712, 1810, 2110, 4900, 5000, 5100, 5200, 5300, 5400 described herein and may be used with or without the actuation mechanisms and / or catheter control centers described herein. The valve 5510 may include any valve, such as a hemostasis valve. For example, the valve 5510 may include a rotatable part configured to open or close a seal of the valve 5510. In some configurations, the valve 5510 may include a button configured to be pressed to open or close a seal of the valve 5510. In some cases, the valve 5510 may include a rotatable part and a button configured to open or close a seal of the valve 5510.
[0236] The distal end 5502 of the wire control mechanism 5500 may be configured to receive or be received by the proximal end 5512 of the valve 5510. During a procedure, a user may couple the wire control mechanism 5500 to the valve 5510 or may detach the wire control mechanism 5500 from the valve 5510. For example, a user may determine that a guiding extension catheter is needed during a procedure. A user may insert the guiding extension catheter into the guiding catheter and may couple the wire control mechanism 5500 to separate the wires during a procedure. Additionally, a user may couple the wire control mechanism 5500 to the valve 5510 prior to a procedure. In some configurations, the distal end 5502 may be integral with the valve 5510. For example, the distal end 5502 and the valve 5510 may be part of a unibody (e.g., single structure) device such that they are not detachable from one another. The illustrated configuration shows the proximal end 5512 of the valve 5510 with a larger diameter than the distal end 5502 such that the distal end 5502 of the wire control mechanism 5500 can be received by the proximal end 5512 of the valve 5510. The distal end 5502 of the wire control mechanism 5500 can be coupled to the valve 5510 via a push-in engagement, a threaded engagement, a snap-fit engagement, or any suitable releasable coupling.
[0237] As shown in FIG. 50C, the proximal end 5515b of the main body 5515 can include an opening 5508. The opening 5508 can be aligned with the passageway 5506 such that the opening 5508 can be in communication with the valve 5510 and / or the internal passageway of the dynamic catheter system. In some configurations, the main body 5515 can include multiple notches (e.g., two, three, four, five) extending in a sidewall of the main body 5515. For example, the main body 5515 can include a first notch 5517a and a second notch 5517b. Each of the notches 5517a, 5517b can include an end portion 5517e, 5517f. The notches 5517a, 5517b can extend from the proximal end 5515b of the main body 5515 along the sidewall of the main body 5515 to the end portions 5517e, 5517f. The bridge portions 5517c, 5517d may be positioned at the open ends of the cutouts 5517a, 5517b (e.g., where the cutouts 5517a, 5517b first extend from the proximal end 5515b). The cutouts 5517a, 5517b may comprise an L-shape. However, in some cases, the cutouts 5517a, 5517b may comprise other shapes. Each of the cutouts 5517a, 5517b may comprise the same shape or a different shape from each other. In some cases, the opening 5508 may comprise two or more portions (e.g., two, three, four, five, six). The shape, length, and size of the first cutout 5517a and the second cutout 5517b may be substantially the same or different. The opening 5508 can be configured to allow two or more wires to travel between the first notch 5517a and the second notch 5517b, as described further below.
[0238] The wire control mechanism 5500 may include a sleeve 5516 configured to engage a distal end 5515a of the main body 5515. The sleeve 5516 may be attached to the main body 5515, for example, by inserting the distal end 5515a of the main body 5515 through an opening 5519 in the sleeve 5516. The sleeve 5516 may be completely removable from the main body 5515. The main body 5515 may include a first notch 5517a and a second notch 5517b. In some cases, the main body 5515 may include only one passageway, or three or more passageways (e.g., three, four, five, six). In some configurations, the first notch 5517a may be larger than the second notch 5517b. In other configurations, the first notch 5517a can be smaller than the second notch 5517b or can be the same size. In some configurations, the first notch 5517a and / or the second notch 5517b can include a seal. For example, the first notch 5517a and / or the second notch 5517b can include a silicone gel with a slit or opening that can partially seal the notches 5517a, 5517b so that one or more wires or other devices can be pushed through the slit or opening in the silicone gel. The first notch 5517a and / or the second notch 5517b can include materials other than silicone gel that allow one or more wires or other devices to be pushed through the material, including flexible materials. Beneficially, this can prevent a user from accidentally or unintentionally moving one wire from one passage to another. However, in some cases, the cutouts 5517a, 5517b do not include silicone gel and may include a different seal or no seal at all.
[0239] 50C, 50D, and 50F show the sleeve 5516 attached to the main body 5515. When the sleeve 5516 is attached to the main body 5515, the sleeve 5516 can move between at least a first position and a second position. The sleeve 5516 can move between the first position and the second position by rotating the sleeve 5516 clockwise or counterclockwise, as indicated by the arrow 5521, along an axis of rotation that extends along the passageway 5506. In some cases, the sleeve 5516 can slide axially along the main body 5515 in a direction going from the distal end 5515a to the proximal end 5515b. In some cases, a coil 5580 can be disposed between the sleeve 5516 and the main body 5515. As shown in FIG. 50B, the coil 5580 can be wrapped around the main body 5515. In some cases, the coil 5580 may be configured to maintain the sleeve 5516 in a first or second position when the user is not actively rotating the sleeve 5516. In some cases, the first position may include any position in which the access ports 5590a, 5590b of the sleeve 5516 are aligned with at least one bridge portion 5517c, 5517d of the main body. In some cases, the second position of the sleeve 5516 may include any position in which the bridge portions 5517c and 5517d are not aligned with the access ports 5590a, 5590b. When the sleeve 5516 is in the first position, the wire control mechanism includes a single passageway formed by the opening 5508, the first bridge portion 5517c of the first cutout 5517a, and the second bridge portion 5517d of the second cutout 5517b, allowing the user to freely move one or more wires between these positions. In the first position, the access ports 5590a, 5590b can be aligned with the bridge portions 5517c, 5517d. For example, while the sleeve 5516 is in the first position, two wires can extend through the wire control mechanism 5500. A user can move one or both of the wires through the opening 5508 between a portion of the first cutout 5517a and a portion of the second cutout 5517b.The user may also insert more wire into the opening 5508 and into a portion of the first notch 5517a or the second notch 5517b while the sleeve 5516 is in the first position.
[0240] As shown in Figures 50C, 50D, and 50F, when the sleeve 5516 is in the second position, the wire control mechanism includes three passages formed by the opening 5508, the end 5517e of the first notch 5517a, and the end 5517f of the second notch 5517b. In the second position, the access ports 5590a, 5590b can be aligned with the end portions 5517e, 5517f. Transitioning the sleeve 5516 from the first position to the second position can move wires positioned at or near the first bridge portion 5517c and the second bridge portion 5517d to the end portions 5517e, 5517f. When the sleeve 5516 is in the second position, the first wire can extend through the end 5517e of the first notch 5517a, and the second wire can extend through the end 5517f of the second notch 5517b. When the sleeve 5516 is in the second position, the sleeve 5516 blocks the bridge portions 5517c, 5517d, so that the first wire and the second wire do not move beyond the bridge portions 5517c and 5517d. Advantageously, this arrangement can separate two or more wires during a procedure to allow a user to easily identify and navigate the wires (e.g., guide wires and device wires). The user can transition the sleeve 5516 from the first position to the second position and move the first wire and the second wire to different paths through the area of the opening 5508. For example, while the sleeve is in the first position, a user can move a first wire from first notch 5517a to second notch 5517b by moving the first wire from end 5517e through opening 5508 to end 5517f. Similarly, while the sleeve is in the first position, a user can move a second wire from second notch 5517b to first notch 5517a by moving the second wire from end 5517f through opening 5508 to end 5517e.After moving the first and second wires, the user can transition the sleeve 5516 to a second position such that the first wire can extend through the end 5517f of the second cutout 5517b and the second wire can extend through the end 5517e of the first cutout 5517a. Advantageously, the wires and wire control mechanism 5500 do not need to be removed from the catheter system for the user to move each wire to a different cutout 5517a, 5517b. If three wires are used, when the sleeve 5516 is in the second position, the first wire can extend through the end 5517e of the first cutout 5517a, the second wire can extend through the end 5517f of the second cutout 5517b, and the third wire can extend through the opening 5508.
[0241] 50G shows a first wire W1 passing through end portion 5517e of first notch 5517a and access port 5590a, and a second wire W2 passing through second portion 5517f of second notch 5517b and access port 5590b when the sleeve is in a second position. Wires W1, W2 can be moved from one end portion to the other as previously described. Wire control mechanism 5500 can accommodate one wire or three or more wires simultaneously.
[0242] In further embodiments, the wire control mechanism 5500 may include a wire tether. The wire tether may be used to prevent the wire from moving in any direction, which may be advantageous in many situations for the user. The wire tether may be located on the cap or may be located on the main body of the wire control mechanism. For example, the wire tether may consist of a rotating mechanism that tightens around the wire (at any portion or notch). In other embodiments, the wire tether may be a push button mechanism, a sliding mechanism, a pinching mechanism, or any other well-known mechanism. The wire tether provides additional control functionality to the wire control mechanism beyond the separation of the wire.
[0243] 51A-51F show an implementation of a wire control mechanism 5600. The wire control mechanism 5600 may include a distal end 5602, a proximal end 5604, and a passageway 5606 extending between the distal end 5602 and the proximal end 5604. The wire control mechanism 5600 may include a main body 5615 and a cap 5616 configured to separate two or more wires. The main body 5615 of the wire control mechanism 5600 may include a distal end 5615a and a proximal end 5615b. The cap 5616 may include one or more arms 5650. Each of the one or more arms 5650 may include a notch 5652. The cap 5616 may be removably coupled to the main body 5615. For example, the distal end 5615a of the main body 5615 may be configured to receive or be received by the cap 5616. 51C and 51E. When coupled to the main body 5615, the cap 5616 can separate two or more wires without removing the two or more wires from the wire control mechanism 5600 and without removing the wire control mechanism 5600 from the catheter system, as described further below. In other configurations, the cap 5616 can include a rotatable mechanism, a pivotable mechanism, or any other mechanism that can separate two or more wires without removing the wire control mechanism 5600 from the dynamic catheter system.
[0244] As shown in Figures 51D and 51E, the distal end 5602 of the wire control mechanism 5600 may be integral with the proximal end 5612 of the dynamic catheter system or may be configured to be removably coupled to the proximal end 5612. For example, Figure 51D illustrates a valve 5610 of a dynamic catheter system. The dynamic catheter system may include a valve 5610, such as a hemostasis valve, at the proximal end 5612 configured to couple to the distal end 5602 of the wire control mechanism 5600. In some configurations, the valve 5610 may include the wire control mechanism 5600 or may be integral with the wire control mechanism 5600. The valve 5610 may be the same as or similar to any of the valves 1710, 1712, 1810, 2110, 4900, 5000, 5100, 5200, 5300, 5400, 5500 described herein and may be used with or without the actuation mechanisms and / or catheter control centers described herein. The valve 5610 may include any valve, such as a hemostatic valve. For example, the valve 5610 may include a rotatable part configured to open or close a seal of the valve 5610. In some configurations, the valve 5610 may include a button configured to be pressed to open or close a seal of the valve 5610. In some cases, the valve 5610 may include a rotatable part and a button configured to open or close a seal of the valve 5610.
[0245] The distal end 5602 of the wire control mechanism 5600 may be configured to receive or be received by the proximal end 5612 of the valve 5610. During a procedure, a user may couple the wire control mechanism 5600 to the valve 5610 or may detach the wire control mechanism 5600 from the valve 5610. For example, a user may determine that a guiding extension catheter is needed during a procedure. A user may insert the guiding extension catheter into the guiding catheter and may couple the wire control mechanism 5600 to separate the wires during a procedure. Additionally, a user may couple the wire control mechanism 5600 to the valve 5610 prior to a procedure. In some configurations, the distal end 5602 may be integral with the valve 5610. For example, the distal end 5602 and the valve 5610 may be part of a unibody (e.g., single structure) device such that they are not detachable from one another. The illustrated configuration shows the proximal end 5612 of the valve 5610 with a larger diameter than the distal end 5602 such that the distal end 5602 of the wire control mechanism 5600 can be received by the proximal end 5612 of the valve 5610. The distal end 5602 of the wire control mechanism 5600 can be coupled to the valve 5610 via a push-in engagement, a threaded engagement, a snap-fit engagement, or any suitable releasable coupling.
[0246] As shown in FIG. 51A, the proximal end 5615b of the main body 5615 can include an opening 5608. The opening 5608 can be aligned with the passageway 5606 such that the opening 5608 can be in communication with the valve 5610 and / or the internal passageway of the dynamic catheter system. In some configurations, the main body 5615 can include multiple cutouts (e.g., two, three, four, five) in a sidewall of the main body 5615. For example, the main body 5615 can include a first notch 5617a and a second notch 5617b. The notches 5617a, 5617b can extend from the proximal end 5615b of the main body 5615 along the sidewall of the main body 5615 to end portions 5617e, 5617f. The bridge portions 5617c, 5617d can be positioned at the open ends of the cutouts 5617a, 5617b (e.g., where the cutouts 5617a, 5617b first extend from the proximal end 5615b). The cutouts 5617a, 5617b can include an L-shape. However, in some cases, the cutouts 5617a, 5617b can include other shapes. Each of the cutouts 5617a, 5617b can include the same shape or a different shape from each other. Each of the passages 5627a, 5627b can include end portions 5617e, 5617f. In some cases, the opening 5608 can include one passageway, or three or more passageways (e.g., three, four, five, six). The shape, length, and size of the first cutout 5617a and the second cutout 5617b can be substantially the same or different. The opening 5608 can be configured to allow two or more wires to move between the first cutout 5617a and the second cutout 5617b, as described further below.
[0247] The wire control mechanism 5600 may include a cap 5616 configured to engage the proximal end 5615b of the main body 5615. The cap 5616 may be attached to the main body 5615, such as by aligning an arm 5650 of the cap 5616 with the main body 5615 and pushing the cap 5616 axially toward the main body 5615, as shown in FIG. 51C and FIG. 51E. The cap 5616 may be fully removable from the main body 5615. The main body 5615 may include a first notch 5617a and a second notch 5617b. In some cases, the main body 5615 may include only one passageway, or three or more passageways (e.g., three, four, five, six). In some configurations, the first notch 5617a may be larger than the second notch 5617b. In other configurations, the first notch 5617a can be smaller than or the same size as the second notch 5617b. In some configurations, the first notch 5617a and / or the second notch 5617b can include a seal. For example, the first notch 5617a and / or the second notch 5617b can include a silicone gel with a slit or opening that can partially seal the notches 5617a, 5617b so that one or more wires or other devices can be pushed through the slit or opening in the silicone gel. The first notch 5617a and / or the second notch 5617b can include materials other than silicone gel that allow one or more wires or other devices to be pushed through the material, including flexible materials. Beneficially, this can prevent a user from accidentally or unintentionally moving one wire from one passage to another.
[0248] 51C and 51E show the cap 5616 attached to the main body 5615. When the cap 5616 is attached to the main body 5615, the cap 5616 can be moved between at least a first position and a second position. The cap 5616 can be moved between the first position and the second position by rotating the cap 5616 clockwise or counterclockwise, as shown by the arrow 5621, along an axis of rotation that extends along the passageway 5606. In some cases, the first position can include any position in which the arm 5650 of the cap 5616 completely blocks the bridge portion 5617c and the bridge portion 5617d. In some cases, the second position of the cap 5616 can include any position in which at least a portion of the bridge portions 5617c and 5617d are not blocked by the arm 5650. When the cap 5616 is in the first position, the wire control mechanism includes a single passageway formed by the opening 5608, the first bridge portion 5617c, and the second bridge portion 5617d, and a user can freely move one or more wires between the opening 5608, the first bridge portion 5617c, and the second bridge portion 5617d. In the first position, the notches 5652 can be aligned with the bridge portions 5617c, 5617d. For example, two wires can extend through the wire control mechanism 5600 while the cap 5616 is in the first position. A user can move one or both of the wires between the first notch 5617a and the second notch 5617b through the opening 5608. The user can also insert more wire into the opening 5608, the first notch 5617a, or the second notch 5617b while the cap 5616 is in the first position.
[0249] When the cap 5616 is in the second position, the wire control mechanism 5600 includes three passages formed by the opening 5608, the end 5617e of the first notch 5617a, and the end 5617f of the second notch 5617b. In the second position, the notch 5652 can be aligned with the end portions 5617e, 5617f. Transitioning the cap 5616 from the first position to the second position can move the wires positioned at or near the first bridge portion 5617c and the second bridge portion 5617d to the end portions 5617e, 5617f. When the cap 5616 is in the second position, the first wire can extend through the end 5617e of the first notch 5617a and the second wire can extend through the end 5617f of the second notch 5617b. When the cap 5616 is in the second position, the cap 5616 blocks the bridge portions 5617c, 5617d, so that the first wire and the second wire do not move beyond the bridge portions 5617c and 5617d. Advantageously, this arrangement can separate two or more wires during a procedure to allow a user to easily identify and navigate the wires (e.g., guide wires and device wires). The user can transition the cap 5616 from the first position to the second position and move the first wire and the second wire to different paths through the opening 5608. For example, while the cap is in the first position, the user can move the first wire from the first notch 5617a to the second notch 5617b by moving the first wire from the end 5617e through the opening 5608 to the end 5617f. Similarly, while the cap is in the first position, the user can move the second wire from the second notch 5617b to the first notch 5617a by moving the second wire from end 5617f through opening 5608 to end 5617e.After moving the first and second wires, the user can transition the cap 5616 to a second position such that the first wire extends through the end 5617f of the second notch 5617b and one of the notches 5652, and the second wire extends through the end 5417e of the first notch 5617a and the other notch 5652. Advantageously, the wires and wire control mechanism 5600 do not need to be removed from the catheter system for the user to move each wire to a different notch 5617a, 5617b. If three wires are used, when the cap 5616 is in the second position, the first wire can extend through the end 5617e of the first notch 5617a, the second wire can extend through the end 5617f of the second notch 5617b, and the third wire can extend through the opening 5608.
[0250] 51F shows wire W1 passing through notch 5652 and end portion 5617e when cap 5616 is in a second position. Wire W1 can be moved from one portion to another as previously described. The wire control mechanism can accommodate two or more wires simultaneously.
[0251] In further embodiments, the wire control mechanism 5600 may include a wire tether. The wire tether may be used to prevent the wire from moving in any direction, which may be advantageous in many situations for the user. The wire tether may be located on the cap, or may be located on the main body of the wire control mechanism. For example, the wire tether may consist of a rotating mechanism that tightens around the wire (at any portion or notch). In other embodiments, the wire tether may be a push button mechanism, a sliding mechanism, a pinching mechanism, or any other well-known mechanism. The wire tether provides additional control functionality to the wire control mechanism beyond the separation of the wire.
[0252] 52A-52H show an implementation of a wire control mechanism 5700. The wire control mechanism 5700 may include a distal end 5702, a proximal end 5704, and a passageway 5706 extending between the distal end 5702 and the proximal end 5704. The wire control mechanism 5700 may include a main body 5715 and a plurality of sliding pieces 5716a, 5716b, 5716c, 5716d configured to separate two or more wires. The plurality of sliding pieces may include passageways 5719a, 5719b, 5719c, 5719d, respectively, extending from a proximal portion of the sliding piece to a distal portion of the sliding piece. The main body 5715 of the wire control mechanism 5700 may include a distal end 5715a and a proximal end 5715b. The plurality of sliding parts 5716a, 5716b, 5716c, 5716d can be removably coupled to the main body 5715. The plurality of sliding parts 5716a, 5716b, 5716c, 5716d can be configured to attach to the main body 5715, as shown in Figures 52C and 52E-G. When at least one of the plurality of sliding parts 5716a, 5716b, 5716c, 5716d is coupled to the main body 5715, as described further below, the plurality of sliding parts 5716a, 5716b, 5716c, 5716d can separate the two or more wires without removing the two or more wires from the wire control mechanism 5700 and without removing the wire control mechanism 5700 from the catheter system.
[0253] 52D and 52E, the distal end 5702 of the wire control mechanism 5700 may be integral with or configured to be removably coupled to the proximal end 5712 of the dynamic catheter system. For example, FIG. 52D shows a valve 5710 of the dynamic catheter system. The dynamic catheter system may include a valve 5710, such as a hemostasis valve, at the proximal end 5712 configured to couple to the distal end 5702 of the wire control mechanism 5700. In some configurations, the valve 5710 may include or be integral with the wire control mechanism 5700. The valve 5710 can be the same as or similar to any of the valves 1710, 1712, 1810, 2110, 4900, 5000, 5100, 5200, 5300, 5400, 5500, 5600 described herein and can be used with or without the actuation mechanisms and / or catheter control centers described herein. The valve 5710 can include any valve, such as a hemostasis valve. For example, the valve 5710 can include a rotatable part configured to open or close a seal of the valve 5710. In some configurations, the valve 5710 can include a button configured to be pressed to open or close a seal of the valve 5710. In some cases, the valve 5710 can include a rotatable part and a button configured to open or close a seal of the valve 5710.
[0254] The distal end 5702 of the wire control mechanism 5700 may be configured to receive or be received by the proximal end 5712 of the valve 5710. During a procedure, a user may couple the wire control mechanism 5700 to the valve 5710 or may detach the wire control mechanism 5700 from the valve 5710. For example, a user may determine that a guiding extension catheter is needed during a procedure. A user may insert the guiding extension catheter into the guiding catheter and may couple the wire control mechanism 5700 to separate the wires during a procedure. Additionally, a user may couple the wire control mechanism 5700 to the valve 5710 prior to a procedure. In some configurations, the distal end 5702 may be integral with the valve 5710. For example, the distal end 5702 and the valve 5710 may be part of a unibody (e.g., single structure) device such that they are not detachable from one another. The illustrated configuration shows the proximal end 5712 of the valve 5710 with a larger diameter than the distal end 5702 such that the distal end 5702 of the wire control mechanism 5700 can be received by the proximal end 5712 of the valve 5710. The distal end 5702 of the wire control mechanism 5700 can be coupled to the valve 5710 via a push-in engagement, a threaded engagement, a snap-fit engagement, or any suitable releasable coupling.
[0255] 52A, the proximal end 5715b of the main body 5715 can include an opening 5708. The opening 5708 can be aligned with the passageway 5706 such that the opening 5708 can be in communication with the valve 5710 and / or the internal passageway of the dynamic catheter system. In some configurations, the main body 5715 can include multiple cutouts (e.g., two, three, four, five) in a sidewall of the main body 5715. For example, the main body 5715 can include a first cutout 5717a, a second cutout 5717b, a third cutout 5717c, and a fourth cutout 5717d. The cutouts 5717a, 5717b, 5717c, 5717d can extend from the proximal end 5715b of the main body 5715 along a sidewall of the main body 5715. The notches 5717a, 5717b, 5717c, 5717d may have a linear shape. However, in some cases, the notches 5717a, 5717b, 5717c, 5717d may have other shapes. Each of the notches 5717a, 5717b, 5717c, 5717d may have the same shape or a different shape from each other. Each of the notches 5717a, 5717b, 5717c, 5717d may have an end portion. In some cases, the opening 5708 may have only one passageway, or three or more passageways (e.g., three, four, five, six). The shapes, lengths, and sizes of the notches 5717a, 5717b, 5717c, 5717d may be substantially the same or may be different. The opening 5708 can be configured to allow two or more wires to move between the notches 5717a, 5717b, 5717c, 5717d, as described further below.
[0256] The wire control mechanism 5700 can include a plurality of slide parts 5716a, 5716b, 5716c, 5716d configured to engage the main body 5715. The plurality of slide parts 5716a, 5716b, 5716c, 5716d can be attached to the main body 5715, for example, by aligning each of the plurality of slide parts 5716a, 5716b, 5716c, 5716d with the notches 5717a, 5717b, 5717c, 5717d as shown in Figures 52C and 52E, and pushing the plurality of slide parts 5716a, 5716b, 5716c, 5716d axially toward the main body 5715. The plurality of slide parts 5716a, 5716b, 5716c, 5716d can be completely removable from the main body 5715. The main body 5715 may include multiple notches 5717a, 5717b, 5717c, 5717d. In some cases, the main body 5715 may include only one passageway, or more than two passageways (e.g., three, four, five, six). The dimensions of each notch 5717a, 5717b, 5717c, 5717d may be different or the same. For example, in some configurations, the first notch 5717a may be larger than the second notch 5717b. In other configurations, the first notch 5717a may be smaller than or the same size as the second notch 5717b. In some configurations, the notches 5717a, 5717b, 5717c, 5717d may include a seal. For example, the cutouts 5717a, 5717b, 5717c, 5717d can include a silicone gel with slits or openings that can partially seal the cutouts 5717a, 5717b, 5717c, 5717d so that one or more wires or other devices can be pushed through the slits or openings in the silicone gel. The cutouts 5717a, 5717b, 5717c, 5717d can include materials other than silicone gel that allow one or more wires or other devices to be pushed through the material, including flexible materials. Beneficially, this can prevent a user from accidentally or unintentionally moving a wire from one passageway to another.
[0257] 52C and 52G show all of the slide pieces 5716a, 5716b, 5716c, 5716d attached to the main body 5715. Not all slide pieces 5716a, 5716b, 5716c, 5716d need to be used at the same time. For example, a user may attach only two or three slide pieces, as shown in FIG. 52E and FIG. 52F. When the slide pieces are attached to the main body 5715, each of the slide pieces can move between at least a first position and a second position. Each of the slide pieces can move between a first position and a second position by axially moving each slide piece in a direction from the distal end 5715a to the proximal end 5715b or from the proximal end 5715b to the distal end 5715a, as shown by arrow 5721. In some cases, the first position may include any position where the sliding parts completely block the bridge portions 5718a, 5718b, 5718c, 5718d, thereby allowing the wires to exit the wire control mechanism 5700 only through the sliding door passages 5719a-5719d. In some cases, the second position of the plurality of sliding parts may include any position where at least a portion of the bridge portions 5718a-5718d are not blocked by the plurality of sliding parts. When all of the plurality of sliding parts are in the first position, the wire control mechanism includes a single passage formed by the opening 5408 and the notches 5717a, 5717b, 5717c, 5717d, allowing a user to freely move one or more wires between the opening 5708 and the notches 5717a, 5717b, 5717c, 5717d. For example, four wires can extend through the wire control mechanism 5700 while the first sliding piece 5716a is in the second position and the second, third, and fourth sliding pieces 5716b-5716d are in the first position. When the sliding pieces are in the first position, a user can move one or more of the wires between the opening 5708 and the passageway. For example, referring to FIG. 52G, a user can move one or more of the wires between the opening 5708 and the notches 5717b, 5716c, 5716d.The user can also insert more wires into any notches where the opening 5708 and associated sliding piece is in the first position.
[0258] The wire control mechanism 5700 includes two separate passages when one slide part is in the second position, three separate passages when two slide parts are in the second position, four separate passages when three slide parts are in the second position, and five separate passages when all four slide parts are in the second position. For example, when all four slide parts 5716a, 5716b, 5716c, 5716d are in the second position, a first wire can extend through the notch 5717a, a second wire can extend through the notch 5717b, a third wire can extend through the notch 5717c, and a fourth wire can extend through the notch 5717d. The plurality of sliding pieces 5716a-5716d, when in the second position, block the bridge portions 5718a-5718d so that the first, second, third, and fourth wires do not move beyond the bridge portions 5718a-5718d. Advantageously, this arrangement can separate two or more wires during a procedure to allow a user to easily identify and navigate the wires (e.g., guide wires and device wires). A user can transition each of the plurality of sliding pieces from a first position to a second position and move two or more wires through the opening 5708 to different paths. For example, while the sliding pieces 5716a, 5716b are in the first position, a user can move a first wire from the first notch 5717a to the second notch 5717b by moving the first wire from the notch 5717a through the opening 5708 to the notch 5717b. Additionally, the user can move the second wire from the second notch 5717b to the first notch 5717a by moving the second wire from the notch 5717b through the opening 5708 to the notch 5717a. After moving the first and second wires, the user can transition the sliding pieces 5716a, 5716b to a second position such that the first wire extends through the second passageway 5719b and the second wire extends through the first passageway 5719a. Advantageously, the wires and wire control mechanism 5700 do not need to be removed from the catheter system in order for the user to move each wire to a different passageway.
[0259] 52H shows a first wire W1 passing through passage 5719a when first sliding piece 5716a is in the second position, a second wire W2 passing through passage 5719b, a third wire W3 passing through passage 5719c, and a fourth wire W4 passing through passage 5719d when sliding pieces 5716b, 5716c, and 5716d are in the first position. Wires W1, W2, W3, W4 can be moved from one passage to another as previously described. Wire control mechanism 5700 can accommodate one wire, two wires, three wires, or more than four wires simultaneously.
[0260] In further embodiments, the wire control mechanism 5700 may include a wire tether. The wire tether may be used to prevent the wire from moving in any direction, which may be advantageous in many situations for the user. The wire tether may be located on the cap or may be located on the main body of the wire control mechanism. For example, the wire tether may consist of a rotating mechanism that tightens around the wire (at any portion or notch). In other embodiments, the wire tether may be a push button mechanism, a sliding mechanism, a pinching mechanism, or any other well-known mechanism. The wire tether provides additional control functionality to the wire control mechanism beyond the isolation of the wire.
[0261] All of the features disclosed herein (including any accompanying documents, claims, abstracts, and drawings) and / or all of the steps of any method or process so disclosed may be combined in any combination, except combinations in which at least some of such features and / or steps are mutually exclusive. The disclosure is not limited to the details of any of the foregoing embodiments. The disclosure extends to any novel or any novel combination of features disclosed herein (including any accompanying claims, abstracts, and drawings) or to any novel or any novel combination of steps of any method or process so disclosed.
[0262] Various modifications to the implementations described in this disclosure will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other implementations without departing from the spirit or scope of the disclosure. Thus, the disclosure is not intended to be limited to the implementations shown herein, but is to be accorded the widest scope consistent with the principles and features disclosed herein. Particular embodiments of the disclosure are covered or will be presented in the following claims. [Explanation of symbols]
[0263] 100 Guide catheter 210 Guide catheter shaft 212 Telescopic Guiding Extension Catheter 214 Distal part 216 Proximal part 218 Transition 601 Branched Wire Guiding Catheter Device 602 First Branch 604 Second Branch 606 Hemostasis valve 608 Guide extension advance mechanism 620 Sliding mechanism 622 Silicone Retaining Ring 626 Wire 700 Guide extension advance mechanism 702 Sliding mechanism 704 Wire 706 Casing 800 Guide extension advancement mechanism 802 Spool mechanism 806 Hemostasis valve 832 Wheels 834 Cap 900 Guide extension advance mechanism 902 Contact Wheel Mechanism 904 Wire 906 Case 932 Second Wheel 934 First Wheel 1000 Guide extension advance mechanism 1002 Screw mechanism 1004 Wire 1006 Case 1032 Screw-like device 1100 Guide extension advance mechanism 1102 Rack and pinion mechanism 1104 Wire 1106 Case 1132 Circular gears, pinions 1134 Linear gears, racks 1200 Guide extension advance mechanism 1202 Non-contact advancement mechanism 1204 Wire 1206 Case 1232 Internal Components 1234 External Components 1700 Dynamic Catheter System 1702 Guide extension advance mechanism 1704 Guiding extension catheter wire 1706 Case 1710 Hemostasis valve 1712 Swivel valve 1732 Finger-pinched wire advancement part, finger-pinched wire advancement mechanism 1734 Seal 1736 Proximal end 1738 Top 1780 Wire passage 1800 Dynamic Catheter System 1802 Guide extension advance mechanism 1804 Guiding extension catheter wire 1810 Valve 1832 Finger pinch advance mechanism 1838 upper part 1840 Spool mechanism 1902 Guide extension advance mechanism 1904 Guiding extension catheter wire 1946 First Seal 1947 Main aisle 1948 Guiding extension catheter wire passage 1949 Second Seal 1950 Passive Filter 2032 Finger-clasping wire advancement part 2039 Lower part Tabs 2052 and 2054 2056 orbit 2100 Dynamic Catheter System 2102 Guide extension advance mechanism 2104 Guiding extension catheter wire 2106 Case 2110 Hemostasis valve 2132 Finger knob advance mechanism 2134 Seal 2136 Rotary Coupler 2150 Guiding catheter 2152 Guiding extension catheter 2154 Side Port 2156 orbit 2192 Guiding extension catheter wire components 2194 Main valve components 2232 Finger knob advance mechanism 2238 Upper part 2300 Wire control mechanism 2302 Distal end 2304 Proximal end 2306 Passage 2308 Aperture 2310 Second Part 2312 First Part 2314 Exchange aisle 2316 Cap 2318 First notch 2320 Second notch 2410 Valve 2412 Proximal end 2500 Wire control mechanism 2504 Proximal end 2516 Cap 2518 First notch 2520 Second notch 2610 Valve 2700 Wire control mechanism 2702 Distal end 2704 Proximal end 2706 Passage 2716 Cap 2718 First notch 2720 Second notch 2722 Cut-off mechanism 2810 V...
Claims
**Claim 1** A guiding catheter comprising a first wall, wherein the first wall comprises a distal portion having a distal end, a proximal portion having a proximal end, and an intermediate portion extending between the distal portion and the proximal portion, the distal portion being configured to be positioned within an artery, the proximal end being configured to interact with a valve, and the first wall thickness of the first wall varying from the proximal end to the distal end, and a guiding catheter; A guiding extension catheter comprising a second wall, wherein the second wall comprises a distal portion having a distal end, a proximal portion having a proximal end, and an intermediate portion extending between the distal portion and the proximal portion, the guiding extension catheter being positioned within the guiding catheter and configured to extend from the distal end of the guiding catheter, and the second wall thickness of the second wall varying from the proximal end to the distal end, and a guiding extension catheter; A dynamic catheter system comprising the same. **Claim 2** The dynamic catheter system according to claim 1, wherein the change in the first wall thickness has an inverse relationship with the change in the second wall thickness. **Claim 3** The dynamic catheter system according to claim 1 or 2, wherein the guiding catheter comprises a first transition region including a change in the first wall thickness, and the guiding extension catheter comprises a second transition region including a change in the second wall thickness. **Claim 4** The dynamic catheter system according to claim 3, wherein the first transition region is positioned in the intermediate portion of the guiding catheter, and the second transition region is positioned in the intermediate portion of the guiding extension catheter. **Claim 5** The dynamic catheter system according to claim 3 or 4, wherein the first transition region is positioned in a distal region of the intermediate portion of the guiding catheter, and the second transition region is positioned in a distal region of the intermediate portion of the guiding extension catheter. **Claim 6** The dynamic catheter system according to any one of claims 3 to 5, wherein the first wall thickness decreases from a maximum wall thickness to a minimum wall thickness in a proximal-to-distal direction within the first transition region. **Claim 7** The dynamic catheter system according to any one of claims 3 to 6, wherein the second wall thickness decreases from a maximum wall thickness to a minimum wall thickness in a distal-to-proximal direction within the second transition region. **Claim 8** The dynamic catheter system according to any one of claims 1 to 7, wherein the first wall thickness has a thickness between 0.01 mm and 1.0 mm.
9. The dynamic catheter system according to any one of claims 1 to 8, wherein the first wall thickness has a thickness between 0.065 mm and about 0.125 mm.
10. The dynamic catheter system according to any one of claims 1 to 9, wherein the second wall thickness has a thickness between 0.05 mm and 1.0 mm.
11. The dynamic catheter system according to any one of claims 1 to 10, wherein the second wall thickness has a thickness between 0.1 mm and about 0.125 mm.
12. The dynamic catheter system according to any one of claims 1 to 11, wherein the guide extension catheter has an inner diameter between 0.50 mm and 2.00 mm.
13. The dynamic catheter system according to any one of claims 1 to 12, wherein the guide extension catheter has an inner diameter between 1.60 mm and 1.67 mm.
14. The dynamic catheter system according to any one of claims 1 to 12, wherein the guide extension catheter has an inner diameter between 1.17 mm and 1.30 mm.
15. The dynamic catheter system according to any one of claims 1 to 12, wherein the guide extension catheter has an inner diameter between 1.42 mm and 1.45 mm.
16. The dynamic catheter system according to any one of claims 1 to 12, wherein the guide extension catheter has an inner diameter between 1.57 mm and 1.60 mm.
17. The dynamic catheter system according to any one of claims 1 to 12, wherein the guide extension catheter has an inner diameter between 1.80 mm and 1.83 mm.
18. The dynamic catheter system according to any one of claims 1 to 17, further comprising an expanded configuration and a non-expanded configuration.