Rotatable control handles for medical devices and methods of using rotatable control handles

Rotatable control handles and methods of using rotatable control handles are described herein. An example embodiment of a rotatable control handle comprises a handle, a compressible member disposed within the handle, a cap attached to the handle, and a cannula rotatably attached between the handle and the cap. The handle comprises a first member and a second member that is releasably attachable to the first member.

FIELD

The disclosure relates generally to the field of medical devices and methods of using medical devices. More particularly, the disclosure relates to the field of control handles for medical devices, such as guidewires, and methods of using control handles.

BACKGROUND

Numerous procedures have been developed that require the percutaneous insertion of one or more medical devices into the body of a patient. Such procedures include, for example, percutaneous transluminal coronary angioplasty (PTCA), X-ray angiographic procedures, embolization procedures, and the like. The medical devices intended for use in such procedures may be introduced into the vascular system by a variety of known techniques. For example, in the widely used Seldinger technique, a surgical opening is made in a body vessel, such as an artery or vein, by a needle, and a guidewire is inserted into the body vessel through a bore in the needle. The needle is then withdrawn, leaving the guidewire in place. A dilator positioned within the lumen of an introducer device is then inserted over the guidewire and advanced into the body vessel. Once the introducer is positioned as desired within the body vessel, the dilator is withdrawn. A variety of medical devices, such as catheters, delivery systems, cardiac leads, and the like, can then be advanced through the introducer to a point of treatment in the body vessel. For example, a delivery system that includes a guidewire with an attached embolization coil can be introduced through the introducer to a point of treatment and delivered using conventional techniques (e.g., rotating the guidewire such that the embolization coil becomes free of the guidewire).

In many cases, an introducer will include one or more hemostatic valve members (also referred to as check valves) for inhibiting leakage of bodily fluids, such as blood, through the introducer as a medical device is inserted through or withdrawn from the introducer. In some cases, hemostatic valves that include a valve member, such as an elastomeric member, are used to minimize fluid leakage during these exchanges. Hemostatic valves of this type are dependent upon the ability of the valve member to seal around the interventional devices to close any gaps created upon insertion or withdrawal of the device through the valve.

The introduction and maneuvering of medical devices, such as guidewires, through a valve member of a hemostatic valve present various challenges. For example, when disposed through a valve member, a guidewire can be difficult to introduce and withdraw from the valve member and rotation of the guidewire relative to the valve member can require two hands, which increases the complexity of the procedure. In addition, the manipulation of the guidewire through the valve member sometimes results in the guidewire becoming kinked, which may result in the guidewire becoming unsuitable for continued use throughout the remainder of the procedure. Control handles for guidewires have been developed that can be used during the performance of a procedure. However, these devices fail to provide support for the guidewire through valve members and also fail to provide a mechanism for rotating the guidewire relative to a portion of the control handle when the guidewire is disposed through a valve member. Thus, there is a need for improved rotatable control handles and methods of using rotatable control handles.

BRIEF SUMMARY OF SELECTED EXAMPLE EMBODIMENTS

Rotatable control handles useful for controlling the position of a medical device are provided. An example rotatable control handle comprises a handle, a compressible member, a cap, and a cannula. The handle has a first member and a second member that is releasably attached to the first member. The handle is moveable between a first configuration in which the first member is free of attachment to the second member and a second configuration in which the first member is releasably attached to the second member. The compressible member is partially disposed within the first member and the second member and is movable between a first configuration when the handle is in the first configuration and a second configuration when the handle is in the second configuration. The compressible member has a compressible member first end, a compressible member second end, and a compressible member body that defines a base and a plurality of arms. The plurality of arms extends from the base and cooperatively defines a first inside diameter when the compressible member is in the first configuration and a second inside diameter when the compressible member is in the second configuration. The second inside diameter is less than the first inside diameter. The cap is attached to the handle and has a cap first end, a cap second end, and a cap body that defines a cap recess and a cap passageway. The cap recess extends into the cap body from the cap first end toward the cap second end. The cap passageway extends from the cap second end to the cap recess and is in communication with the cap recess. The cannula is rotatably attached to the cap and is partially disposed within the cap recess and between the second member and the cap. The cannula is disposed through the cap passageway and has a cannula first end, a cannula second end, and a cannula body that defines a cannula passageway that extends from the cannula first end to the cannula second end.

Another example rotatable control handle comprises a handle, a compressible member, a cap, a guide member, and a cannula. The handle has a first member and a second member that is releasably attached to the first member. The handle is moveable between a first configuration in which the first member is free of attachment to the second member and a second configuration in which the first member is releasably attached to the second member. The first member has a first member first end, a first member second end, and a first member body that defines a first member passageway and a first member recess. The first member passageway extends from the first member first end toward the first member second end. The first member recess extends from the first member second end toward the first member first end and is in communication with the first member passageway. The second member has a second member first end, a second member second end, and a second member body that defines a second member first recess, a second member second recess, and a second member passageway. The second member first recess extends from the second member first end toward the second member second end. The second member second recess extends from the second member second end toward the second member first end. The second member passageway extends from the second member first recess to the second member second recess and is in communication with the second member first recess and second member second recess. The compressible member is partially disposed within the first member recess and the second member first recess and is movable between a first configuration when the handle is in the first configuration and a second configuration when the handle is in the second configuration. The compressible member has a compressible member first end, a compressible member second end, and a compressible member body that defines a base, a first arm that extends from the base, a second arm that extends from the base, a third arm that extends from the base, and a fourth arm that extends from the base. The compressible member body defines a projection and a notch on each of the first arm, the second arm, the third arm, and the fourth arm. The first arm, the second arm, the third arm, and the fourth arm cooperatively define a first inside diameter when the compressible member is in the first configuration and a second inside diameter when the compressible member is in the second configuration. The second inside diameter is less than the first inside diameter. The notch defined on the first arm is disposed a first distance from the compressible member second end. The projection defined on the first arm is disposed a second distance from the compressible member second end that is different than the first distance. The cap is attached to the handle and has a cap first end, a cap second end, and a cap body that defines a cap recess and a cap passageway. The cap recess extends into the cap body from the cap first end toward the cap second end. The cap passageway extends from the cap second end to the cap recess and is in communication with the cap recess. The guide member is disposed between the second member and the cap and has a guide member first end, a guide member second end, and a guide member body that defines a guide member passageway. The guide member passageway extends from the guide member first end to the guide member second end and has a third inside diameter and a fourth inside diameter that is less than the third inside diameter. The cannula is rotatably attached to the cap and is partially disposed within the cap recess and between the second member and the guide member. The cannula is disposed through the cap passageway and has a cannula first end, a cannula second end, and a cannula body that defines a cannula passageway that extends from the cannula first end to the cannula second end.

Methods of using a rotatable control handle are also provided. An example method of using a rotatable control handle comprises the steps of: positioning a rotatable control handle on a medical device having a medical device first end and a medical device second end; moving the handle of the rotatable control handle from a first configuration to a second configuration; applying an axial force on the rotatable control handle directed toward a valve device having a housing and a valve member such that the medical device is advanced through the valve member of the valve device and the first end of the medical device is disposed on a first side of the valve member and the second end of the medical device is disposed on a second side of the valve member; continuing the application of an axial force on the rotatable control handle such that the rotatable control handle and the medical device are advanced through the valve member of the valve device and the first end of the cannula of the rotatable control handle is disposed on the second side of the valve member and the second end of the cannula is disposed on the first side of the valve member; applying torque to the handle of the rotatable control handle such that the handle and medical device rotate relative to the valve device; moving the handle of the rotatable control handle from a second configuration to a first configuration; applying axial force on the medical device such that the medical device moves relative to the handle; moving the handle of the rotatable control handle from the first configuration to the second configuration; applying an axial force on the rotatable control handle directed away from the valve device such that the rotatable control handle and the medical device are withdrawn from the valve member of the valve device, the second end of the cannula of the rotatable control handle is disposed on the second side of the valve member, and the medical device and rotatable control handle are free of the valve device.

Additional understanding of the exemplary rotatable control handles and methods of using rotatable control handles can be obtained by review of the detailed description, below, and the appended drawings.

DETAILED DESCRIPTION

The following detailed description and the appended drawings describe and illustrate various example embodiments of a rotatable control handle that can be used with various medical devices and methods of using a rotatable control handle. The description and illustration of these examples are provided to enable one skilled in the art to make and use a rotatable control handle and to practice a method of using a rotatable control handle. They are not intended to limit the scope of the claims in any manner.

The use of “e.g.,” “example,” and “or,” and grammatically related terms, indicate non-exclusive alternatives without limitation, unless otherwise noted. The term “diameter” refers to the length of a straight line passing from side to side through the center of a body, element, or feature, and does not impart any structural configuration on the body, element, or feature. The recitation of a first structural feature “circumferentially adjacent” to a second structural feature means that the first structural feature is the nearest first structural feature to the second structural feature when moving along an imaginary line that extends from the first structural feature to the second structural feature.

FIGS. 1, 2, 3, 4, 5, 5A, 5B, 5C, 5D, 6, 7, and 8illustrate a rotatable control handle10for use on a medical device, such as a guidewire. The control handle10has a lengthwise axis11, a first end12, a second end14, and comprises a handle16, a compressible member18, a cap20, a guide member22, and a cannula24.

As illustrated inFIG. 4, the handle16has a first member30that is releasably attachable to a second member32. The handle16is moveable between a first configuration in which the first member30is free of attachment to the second member32, and a second configuration in which the first member30is releasably attached to the second member32. The first member30has a first end34, a second end36, and a body38that defines a passageway40, a recess42, and threads44. The passageway40extends through a portion of the body38and from the first end34toward the second end36of the first member30and is in communication with the recess42. The passageway40has a passageway diameter41that is sized and configured to receive a medical device, such as a guidewire. The recess42extends into the body38from the second end36toward the first end34of the first member30. The recess42has a recess diameter43and a length45that is sized and configured to house a portion of the compressible member18, as described in more detail herein. The recess diameter43is greater than the passageway diameter41. The threads44extend from the second end36toward the first end32and are sized and configured to mate with the threads60defined by the second member32of the handle16, as described in more detail herein.

The second member32of the handle16is releasably attachable to the first member30when the handle16is in the second configuration. As illustrated inFIG. 1, the second member32is releasably attached to the first member30. The second member32has a first end46, a second end48, and a body50that defines a first recess52, a second recess54, a projection56, a passageway58, and threads60. In the illustrated embodiment, the second member32has a length that extends from the first end46to the second end48that is equal to about 18 millimeters and has a diameter at the first end46that is equal to about 14.5 millimeters. The first recess52extends into the body50from the first end46toward the second end48and has a first recess diameter53that is sized and configured to receive a portion of the first member30and a portion of the compressible member18. In the illustrated embodiment, the first recess diameter53is equal to about 6.35 millimeters and has a length that extends from the first end46to the passageway58that is equal to about 8 millimeters. The first recess52is in communication with the passageway58. The second recess54extends into the body50from the second end48toward the first end46and has a second recess diameter55that is greater than the first recess diameter53and is sized and configured to receive a portion of the cap20, guide member22, and cannula24. In the illustrated embodiment, the second recess diameter55is equal to about 11 millimeters and has a length that extends from the second end48to the passageway58that is equal to about 8 millimeters. The second recess54is in communication with the passageway58. The projection56extends into the second recess54and toward the lengthwise axis of the second member32and defines a projection diameter57within the second recess54that is less than the second recess diameter55. The projection56provides structure for rotatably attaching the cap20to the handle16, as described in more detail herein. In the illustrated embodiment, the projection diameter57is equal to about 10.3 millimeters. The passageway58extends through a portion of the body50of the second member32and from the first recess52to the second recess54such that the passageway58is in communication with each of the first recess52and the second recess54. The passageway58has a first passageway diameter59at the opening in communication with the first recess52and a second passageway diameter61at the opening in communication with the second recess54. The first passageway diameter59is greater than the second passageway diameter61. In the illustrated embodiment, the second passageway diameter61is equal to about 1.1 millimeters. The diameter of the passageway58tapers from the first passageway diameter59to the second passageway diameter61along a first portion of the length of the passageway58that extends from the first recess52toward the second recess54such that the wall of the passageway58along the first portion of the length of the passageway58is disposed at an angle equal to about 30 degrees relative to the lengthwise axis of the second member32. The passageway58is sized and configured to receive a medical device, such as a guidewire. In the illustrated embodiment, the first portion of the passageway58has a length that extends from the first recess52to a second portion of the passageway that is equal to about 0.9 millimeters.

While the handle16has been illustrated as having a particular structural configuration and having particular dimensions, a handle included in a rotatable control handle can have any suitable structural configuration and can have any suitable dimensions. Selection of a suitable structural configuration and dimensions for a handle can be based on various considerations, such as the structural configuration of a compressible member included in the rotatable control handle and/or the material(s) that forms the medical device on which the handle is intended to be disposed. For example, the first member and/or second member of a handle can define one or more recesses and/or projections on an exterior surface that are sized and configured to provide tactile feedback as to the movement of the member during use. Alternative to the configuration illustrated inFIGS. 1, 2, 3, and 4, a handle can omit the inclusion of the projection and/or the handle included in a rotatable control handle can define a compressible member (e.g., collet) such that the handle can be directly attached to a medical device, such as a guidewire, without the inclusion of a separate component (e.g., compressible member18).

While the first member30has been illustrated as being attached to the second member32using a threaded connection, a first member can be releasably attached to a second member using any technique or method of attachment considered suitable for a particular embodiment. Selection of a suitable technique or method of attachment between a first member and a second member can be based on various considerations, such as the material(s) that forms a first member to which a second member is intended to be attached. Examples of techniques and methods of attachment considered suitable between a first member and a second member include snap fit configurations, threaded connections, and any other technique or method of attachment considered suitable for a particular embodiment. For example, alternative to the first member defining threads on an exterior surface and the second member defining threads within a recess, a first member can define threads within a recess that are sized and configured to mate with threads defined on an exterior surface of a second member. In this alternative configuration, the first member defines a recess sized and configured to receive a portion of the second member and a portion of the compressible member and the second member defines a recess that is sized and configured to receive a portion of the compressible member.

In the illustrated embodiment, the compressible member18has a lengthwise axis63, a first end64, a second end66, a length67, and a body68that defines a base70, a passageway72, a first arm74, a second arm76, a third arm78, and a fourth arm80. The compressible member18is moveable between a first configuration, as shown inFIGS. 5, 5A, and 5B, and a second configuration, as shown inFIGS. 5C and 5D. The compressible member18is in the first configuration when the handle16is in the first configuration and the compressible member18is in the second configuration when the handle16is in the second configuration. The length67of the compressible member18extends from the first end64to the second end66and is greater than the length45of the recess42defined by the first member30. The base70has an outside diameter71, a first end82, and a second end84. The outside diameter71of the base70is sized and configured to be received by the recess42defined by the first member30. The passageway72extends through the base70from a first opening defined on the first end82of the base70to a second opening defined on the second end84of the base70. The passageway72is sized and configured to receive a medical device, such as a guidewire, and, when the rotatable medical device10is assembled as illustrated inFIG. 1, is coaxial with the passageway40defined by the first member30and the passageway58defined by the second member32.

Each of the arms74,76,78,80extends from the base70to the second end66of the compressible member18and is moveable between a first position, as illustrated inFIGS. 5, 5A, and5B, and a second position, as illustrated inFIGS. 5C and 5D. Each of the arms74,76,78,80is in the first position when the compressible member18is in the first configuration and each of the arms74,76,78,80is in the second position when the compressible member18is in the second configuration. Each of the arms74,76,78,80has a first end86attached to the base70, a second end88, a length89, a shaft90, and a head92. The length89extends from the first end86to the second end88and, in the illustrated embodiment, is equal to about 8.8 millimeters. The shaft90extends from a first end attached to the base70to a second end attached to the head92such that the shaft90is disposed between the base70and the head92. The head92extends from the shaft90to the second end66of the compressible member18. The body68of the compressible member18defines a notch94and a projection96on the head92of each of the arms74,76,78,80. The notch94of each arm74,76,78,80is sized and configured to receive a projection of a circumferentially adjacent arm when the compressible member18is in the second configuration, as illustrated inFIGS. 5C and 5D. In the illustrated embodiment, the notch94is a triangular prismatic notch that extends into the arm a length equal to about 0.9 millimeters and the projection96is a triangular prismatic projection that extends from the arm a length equal to about 0.7 millimeters. The notch94is positioned on a first side of the head92and the projection96is positioned on a second side of the head92such that a portion of the notch94is disposed on a first plane and a portion of the projection96is disposed on a second plane that is positioned orthogonal to the first plane. In the illustrated embodiment, when the compressible member18is in the first configuration, the projection96is partially disposed in the notch94of a circumferentially adjacent arm a length equal to about 0.1 millimeters.

In the illustrated embodiment, the first arm74defines the notch94a first distance from the second end66of the compressible member18and the projection96a second distance from the second end66of the compressible member18that is greater than the first distance. The second arm76defines the notch94a third distance from the second end66of the compressible member18and the projection96a fourth distance from the second end66of the compressible member18that is less than the third distance. The third distance is equal to the second distance. The third arm78defines the notch94a fifth distance from the second end66of the compressible member18and the projection96a sixth distance from the second end66of the compressible member18that is greater than the third distance. The fifth distance is equal to the fourth distance. The fourth arm80defines the notch94a seventh distance from the second end66of the compressible member18and the projection96an eighth distance from the second end66of the compressible member18that is less than the third distance. The seventh distance is equal to the sixth distance and the eighth distance is equal to the first distance. In the illustrated embodiment, the first distance, the fourth distance, the fifth distance, and the eighth distance are equal to one another and equal to about 1.22 millimeters and the second distance, third distance, sixth distance, and seventh distance are equal to one another and equal to about 1.82 millimeters. While the notch and projection of each arm have been described as being disposed at different distances from the second end of the compressible member, a compressible member can alternatively define a notch and projection at equal distances from the second end of the compressible member.

The first arm74is circumferentially adjacent to the second arm76and the fourth arm80. The second arm76is circumferentially adjacent to the first arm74and the third arm78. The third arm78is circumferentially adjacent to the second arm76and the fourth arm80. The fourth arm80is circumferentially adjacent to the third arm78and the first arm74. As illustrated inFIG. 5A, each of the arms74,76,78,80is separated from a circumferentially adjacent arm a distance73when the compressible member18is in the first configuration. In the illustrated embodiment, the distance73between each arm when the compressible member18is in the first configuration is equal to about 0.6 millimeters and the end of the slot formed between each arm has a radius of curvature equal to about 0.3 millimeters. The arms74,76,78,80cooperatively define a first outside diameter75, a second outside diameter77, and a first inside diameter79when the compressible member18is in the first configuration. The first outside diameter75is disposed along the length of the shafts90and is measured on a plane that is orthogonal to the lengthwise axis63of the compressible member18. The second outside diameter77is disposed along the length of the heads92and is measured on a plane that is orthogonal to the lengthwise axis63of the compressible member18. The first outside diameter75is less than the second outside diameter77and is sized and configured to be received by the recess42defined by the first member30. The second outside diameter77is greater than the first outside diameter75and is less than the diameter53of the first recess52defined by the second member32such that the second end66of the compressible member18is sized and configured to be received by the first recess52defined by the second member32. The second outside diameter77is greater than the diameter43of the recess42defined by the first member30. The outside diameter of the compressible member18tapers from the second outside diameter77to the first outside diameter75along a portion87of the length67of the compressible member18. This structural configuration provides a mechanism for moving the compressible member18between its first configuration when the first member30of the handle16is free of the second member32of the handle16and its second configuration when the first member30of the handle16is releasably attached to the second member32of the handle16. The first inside diameter79is measured on a plane that is orthogonal to the lengthwise axis63and is sized and configured to receive a medical device, such as a guidewire, and allow a portion of the medical device to pass through the passageway72.

The arms74,76,78,80cooperatively define a third outside diameter81, a fourth outside diameter83, and a second inside diameter85when the compressible member18is in the second configuration, as illustrated inFIGS. 5C and 5D. In use, the compressible member18is in the second configuration when it is disposed within the handle16and the first member30is attached to the second member32. The third outside diameter81is disposed along the length of the shafts90and is measured on a plane that is orthogonal to the lengthwise axis63. The fourth outside diameter83is disposed along the length of the heads92and is measured on a plane that is orthogonal to the lengthwise axis63. The third outside diameter81is less than the first outside diameter75. The fourth outside diameter83is greater than the third outside diameter81and is less than the second outside diameter77. The fourth outside diameter83is greater than the diameter43of the recess42defined by the first member30such that when the compressible member18is in the second configuration a portion of the head92of each arm is disposed outside of the recess42defined by the first member30. The second inside diameter85is measured on a plane that is orthogonal to the lengthwise axis63and is sized and configured to receive a portion of a medical device, such as a guidewire, such that the compressible member18contacts the medical device along a portion of the shafts90and/or heads92and the medical device is releasably attached to the compressible member18and the handle16.

In use, the first end64of the compressible member18is partially positioned within the recess42defined by the first member30and the second end66of the compressible member18is advanced into the first recess52defined by the second member32of the handle16. The threads44of the first member30are mated with the threads60of the second member32such that the application of torque on the first member30while the position of the second member32is maintained, or vice versa, advances the second end36of the first member30toward the second end48of the second member32. Alternatively, torque can be applied to both the first member30and the second member32such that the second end36of the first member30is advanced toward the second end48of the second member32. This results in the handle16moving from the first configuration to the second configuration and the exterior surface of the tapered portion87of the compressible member18contacting the first end34of the first member30such that continued advancement of the first member30into the second member32moves the compressible member18from the first configuration to the second configuration.

While the compressible member18has been illustrated as a separate component releasably attached to the handle16, a portion of a handle of a rotatable control handle can alternatively form a compressible member. For example, each arm of a compressible member can be formed by a first member or second member of a handle and adapted to move between first and second configurations, as described herein. In addition, while the compressible member18has been illustrated as having a particular structural configuration and particular dimensions, a compressible member included in a rotatable control handle can have any suitable structural configuration and can have any suitable dimensions. Selection of a suitable structural configuration and dimensions for a compressible member can be based on various considerations, such as the structural configuration of the medical device intended to be used with the rotatable control handle. For example, a compressible member can define a curved, rounded, or blunt surface that is directed toward the lengthwise axis of the compressible member such that damage to any medical device disposed through a rotatable control handle can be prevented during use. In addition, while the compressible member18has been illustrated as having a first end64disposed within the first member30of a handle16and a second end66disposed within the second member32of a handle16, a handle can include structure that allows for a compressible member to be positioned within the handle in the opposite configuration. For example, the body of the first member of a handle can define a recess that extends from the second end toward the first end that is sized and configured to receive the second end of a compressible member (e.g., has a structural arrangement that mirrors the first recess52defined by the second member32) and the body of the second member of the handle can define a first recess that extends from the first end toward the second end that is sized and configured to receive the first end of the compressible member (e.g., has a structural configuration that mirrors the recess42defined by the first member30). In addition, while the compressible member18has been illustrated as having a first arm74, a second arm76, a third arm78, and a fourth arm80and each arm has been illustrated as defining a triangular prismatic notch94and a triangular prismatic projection96, a compressible member can include any suitable number of arms and the notch and/or projection of an arm can have any suitable structural arrangement. Examples of numbers of arms considered suitable for a compressible member to define include one, at least one, two, a plurality, three, four, five, six, and any other number considered suitable for a particular embodiment. Examples of structural configurations considered suitable for a notch and/or projection included on an arm include triangular prisms, rectangular prisms, cubes, partial cylinders, and any other structural configuration considered suitable for a particular embodiment. Alternatively, a compressible member can omit the inclusion of a notch and/or projection on each arm or one or more arms defined by the compressible member.

In the illustrated embodiment, the cap20is rotatably attached to the handle16and, as illustrated inFIG. 6, has a lengthwise axis101, a first end102, a second end104, a length105, and a body106that defines an exterior surface108, a recess110, a first opening112, a second opening114, and a passageway116. The length105extends from the first end102to the second end104and is greater than the length of the second recess54defined by the second member32. In the illustrated embodiment, the length105of the cap20is equal to about 15.7 millimeters and the outside diameter of the cap20at the first end102is equal to about 11 millimeters. The recess110extends into the body106of the cap20from the exterior surface108toward the lengthwise axis101of the cap20and is sized and configured to receive a portion of the projection56defined by the second member32such that the cap20can be releasably, and rotatably, attached to the handle16and the cap20can rotate relative to the handle16.

The first opening112has a first inside diameter113and the second opening114has a second inside diameter115that is less than the first inside diameter113. The first inside diameter113is equal to about 8 millimeters and the second opening is equal to about 3.2 millimeters. The passageway116extends from the first opening112to the second opening114and has proximal portion118, an intermediate portion120, and a distal portion122. Each of the first opening112, second opening114, and passageway116is sized and configured to receive the guide member22and medical device (e.g., guidewire), as described in more detail herein. The proximal portion118has a constant inside diameter that is equal to the first inside diameter113. The proximal portion118has a length that extends from the first end102to the intermediate portion120that is equal to about 4 millimeters. The distal portion122has a constant inside diameter that is equal to the second inside diameter115. The intermediate portion120has a diameter that tapers from the first inside diameter113to the second inside diameter115and from the proximal portion118to the distal portion122such that the wall of the intermediate portion120is disposed at angle equal to about 45 degrees relative to the lengthwise axis101. In the illustrated embodiment, the distal portion122has a length that is greater than the length of the proximal portion118and the length of the intermediate portion120.

Attachment of the cap20to the handle16can be accomplished by first inserting the guide member22into the passageway116defined by the cap20, then inserting the cannula24into the passageway142defined by the guide member22, contacting the first end102of the cap20to the second end48of the second member32, and applying an axial force on the cap20directed toward the second member32until the projection56defined by the second member32is disposed within the recess110defined by the cap20. Alternative embodiments can include a cap that defines a projection that is sized and configured to be received within a recess defined by the second member of a housing. The projection defined by the cap can extend from the exterior surface of the cap and away from the lengthwise axis of the cap and the recess defined by the second member can extend from an interior surface of the second member and away from the lengthwise axis of the second member.

While the cap20has been illustrated as having a particular structural configuration and having particular dimensions, a cap included in a rotatable control handle can have any suitable structural configuration and can have any suitable dimensions. Selection of a suitable structural configuration and dimensions for a cap can be based on various considerations, such as the structural configuration of a handle included in the rotatable control handle and/or the material(s) that forms the medical device on which the rotatable control handle is intended to be disposed. In addition, while the cap20has been illustrated as being attached to the handle16using a snap fit configuration, a cap can be releasably attached to a handle using any suitable technique or method of attachment considered suitable for a particular embodiment. Selection of a suitable technique or method of attachment between a cap and a handle can be based on various considerations, such as the material(s) that forms the handle to which the cap is intended to be attached. Examples of techniques and methods of attachment considered suitable between a cap and a handle include snap fit configurations, threaded connections (e.g., a second member of the handle defines threads that are sized and configured to mate with threads defined by a cap), fusing, welding, using adhesives, and any other technique or method of attachment considered suitable for a particular embodiment. For example, a cap can be fixedly attached to a handle (e.g., using adhesive, fusing) such that it is not rotatable relative to the handle. In this alternative embodiment, only the cannula is rotatable relative to the cap and handle or a combination of the cannula and the guide member is rotatable relative to the cap and the handle.

As illustrated inFIG. 7, the guide member22has a lengthwise axis129, a first end130, a second end132, a length133, and a body134that defines an exterior surface136, a first opening138, a second opening140, and a passageway142. The length133extends from the first end130to the second end132and is equal to the length105of the cap20. The exterior surface136of the guide member22has a structural configuration that corresponds to the structural configuration of the passageway116defined by the cap20such that the guide member22can be positioned within the passageway116and attached to the cap20. The exterior surface136of the guide member22has a proximal portion144, an intermediate portion146, and a distal portion148. The proximal portion144has a first outside diameter145that is less than the first inside diameter113of the passageway116. In the illustrated embodiment, the first outside diameter145is equal to about 7.9 millimeters and the length of the proximal portion144that extends from the first end130to the intermediate portion146is equal to about 3.9 millimeters. The distal portion148has a second outside diameter149that is less than the second inside diameter115of the passageway116. In the illustrated embodiment, the second outside diameter149is equal to about 3.17 millimeters and the sum of the length of the intermediate portion146and the distal portion148from the proximal portion144to the second end132is equal to about 11.7 millimeters. The intermediate portion146has an outside diameter that tapers from the first outside diameter145to the second diameter149and from the proximal portion144to the distal portion148. In the illustrated embodiment, the intermediate portion146tapers from the proximal portion144to the distal portion148such that the wall of the intermediate portion146is disposed at an angle that is equal to about 45 degrees relative to the lengthwise axis129of the guide member22.

The first opening138has a first inside diameter139and the second opening140has a second inside diameter141that is less than the first inside diameter139. The passageway142extends from the first opening138to the second opening140and has proximal portion150, a first intermediate portion152, a second intermediate portion154, a third intermediate portion156, a fourth intermediate portion158, and a distal portion160. Each of the first opening138, the second opening140, and the passageway142is sized and configured to receive a portion of the cannula24and a medical device, as described in more detail herein. The proximal portion150has a diameter equal to the first inside diameter139, the first intermediate portion152has a third inside diameter153, the second intermediate portion154has a diameter that tapers from the first intermediate portion152to the third intermediate portion156, the third intermediate portion156has a fourth inside diameter157, the fourth intermediate portion158has a fifth inside diameter159, and the distal portion160has a diameter that increases from the fourth intermediate portion158to the second inside diameter141at the second end132of the guide member22. The third inside diameter153is greater than the first inside diameter139. The fourth inside diameter157is less than the third inside diameter153and the fifth inside diameter159. The fourth inside diameter157is sized and configured to allow the cannula24to be rotatably disposed through the guide member22and the cap20and prevent fluid from passing between the guide member22and cannula24during use.

In the illustrated embodiment, the first inside diameter139is equal to about 4.7 millimeters, the second inside diameter141is equal to about 2.2 millimeters, the third inside diameter153is equal to about 6.2 millimeters, the inside diameter of the second intermediate portion154adjacent to the first intermediate portion152is equal to about 3.3 millimeters, the fourth inside diameter157is equal to about 0.9 millimeters, and the fifth inside diameter159is equal to about 1.2 millimeters. In addition, the second intermediate portion154tapers from the first intermediate portion152to the third intermediate portion156such that the wall of the second intermediate portion154is disposed at an angle equal to about 30 degrees relative to the lengthwise axis129. Furthermore, the distal portion160increases in diameter from the fourth intermediate portion158to the second end132such that the wall of the distal portion160is disposed at an angle equal to about 30 degrees relative to the lengthwise axis129. The sum of the lengths of the proximal portion150and the first intermediate portion152from the first end130to the second intermediate portion154is equal to about 3.2 millimeters. The length of the first intermediate portion152from the proximal portion150to the second intermediate portion154is equal to about 2 millimeters. The sum of the lengths of the fourth intermediate portion158and the distal portion160from the third intermediate portion156to the second end132is equal to about 9.7 millimeters.

In the illustrated embodiment, the guide member22is adhesively attached to the cap20. However, alternative techniques and methods of attachment can be used to attach a guide member to a cap. Examples of techniques and methods of attachment considered suitable between a guide member and a cap included using adhesives, threaded connections, friction fit connections, fusing a portion of the guide member to the cap, forming the guide member as a portion of a cap, snap fit configurations, and any other technique or method of attachment considered suitable for a particular embodiment. For example, alternative embodiments can include a guide member that is rotatably attached to a cap. While the guide member22has been illustrated as having a particular structural configuration and having particular dimensions, a guide member included in a rotatable control handle can have any suitable structural configuration and can have any suitable dimensions. Selection of a suitable structural configuration and dimensions for a guide member can be based on various considerations, such as the structural configuration of a cap included in the rotatable control handle and/or the material(s) that forms the medical device on which the rotatable control handle is intended to be disposed. Alternative embodiments can omit the inclusion of a guide member and a cap can define structure that is sized and configured to correspond with a portion of the structure of a cannula.

While the guide member22has been illustrated as having a proximal portion144that has a first outside diameter145that is less than the first inside diameter113of the passageway116defined by the cap20and a distal portion148that has a second outside diameter149that is less than the second inside diameter115of the passageway116defined by the cap20, a guide member can have any suitable structural arrangement. For example, a guide member can have a proximal portion that has a first outside diameter that is equal to, or greater than, the first inside diameter of the passageway defined by a cap and/or a distal portion that has a second outside diameter that is equal to, or greater than, the second inside diameter of the passageway defined by a cap such that the guide member can be attached to the cap using a friction fit.

As illustrated inFIG. 8, the cannula24has a lengthwise axis165, a first end166, a second end168, a length169, and a body170that defines an exterior surface172, a first opening174, a second opening176, and a passageway178. The length169extends from the first end166to the second end168and is sized and configured to pass through a portion of the guide member22, cap20, and through a medical device, such as a valve device (e.g., hemostatic valve, introducer). A portion of the exterior surface172of the cannula24has a structural configuration that corresponds to a portion of the structural configuration of the passageway142defined by the guide member22such that the cannula24can be positioned, and rotate, within the guide member22. The exterior surface172of the cannula24has a proximal portion180and a distal portion182. The proximal portion180has a first outside diameter181that is greater than the fourth inside diameter157of the passageway142defined by the guide member22. The distal portion182has a second outside diameter183that is less than the first outside diameter181and is sized and configured to be passed through the third intermediate portion156of the passageway142defined by the guide member22. Thus, the second outside diameter183is less than the fourth inside diameter157. This structural arrangement provides a mechanism for passing the cannula24through the passageway142defined by the guide member22until the exterior surface172of the cannula24along the proximal portion180contacts the interior surface of the guide member22along the second intermediate portion154. Alternatively, the second outside diameter of a cannula can be equal to the fourth inside diameter of a guide member such that a friction fit between the cannula and guide member can be accomplished.

The first opening174has a first inside diameter175and the second opening176has a second inside diameter177that is less than the first inside diameter175. The passageway178extends from the first opening174to the second opening176and has proximal portion184and a distal portion186. Each of the first opening174, second opening176, and passageway178is sized and configured to receive a portion of a medical device, such as a guidewire. The inside diameter of the proximal portion184tapers from the first inside diameter175at the first opening174to the second inside diameter177along a portion of the length169of the cannula24.

In the illustrated embodiment, when assembled, as illustrated inFIG. 1, the length of the rotatable control handle10from the first end12to the second end14is equal to about 9 centimeters. In addition, the cap20is rotatable relative to the handle16and the cannula24is rotatable relative to the cap20and the handle16. This arrangement provides a mechanism for allowing a first medical device, such as a guidewire, that has been passed through and attached to the rotatable control handle10, to be passed through a second medical device, such as a valve device (e.g., hemostatic valve, introducer), such that the first medical device can be rotated relative to the second medical device during use. For example, when delivering an embolization coil, a delivery system that includes a guidewire on which the embolization coil is attached can be attached to the rotatable control handle10such that the rotatable control handle10is attached to the guidewire between the embolization coil and the proximal end of the guidewire. Subsequently, the rotatable control handle10and the attached guidewire can be advanced through a valve device such that the cannula24of the rotatable control handle10contacts a portion of a valve member attached to the valve device and is partially disposed through the valve member. The handle16and guidewire can then be rotated relative to the valve device since the friction applied by the valve member on the cannula24of the rotatable control handle10maintains the position of the cannula24. Depending on the structural configuration of a rotatable control handle, a cap and cannula can rotate relative to the valve device during use (e.g., in embodiments in which the guide member and/or cap are attached (e.g., soldered) to a cannula).

In use, the rotatable control handle10is positioned on a medical device and attached to the medical device such that the rotatable control handle provides a mechanism for manipulating the position of the medical device during use. The rotatable control handles described herein can be used in combination with, and attached to, any suitable medical device and selection of a suitable medical device to use in combination with a rotatable control handle can be based on various considerations, such as the procedure intended to be performed by the medical device. For example, a rotatable control handle according to an embodiment can be attached to a guidewire, embolization device, probe, lithotripsy probe, delivery device, delivery systems that include a guidewire with an attached embolization coil, embolization coil delivery device, an optic, fiber optic, fiber, laser fiber, suction device, irrigation device, basket, stone basket, grasper, forceps, grasping forceps, drill, catheter, balloon catheter, and any other medical device considered suitable for a particular embodiment.

Each of the handle16(e.g., first member30, second member32), compressible member18, cap20, guide member22, and cannula24can be formed of any suitable material and can be fabricated using any suitable method or technique. Selection of a suitable material to form a handle, compressible member, cap, guide member, and/or cannula and a suitable method or technique to fabricate a handle, compressible member, cap, guide member, and/or cannula according to a particular embodiment can be based on various considerations, including the material(s) that forms a medical device that is intended to be used with a rotatable control handle of which the handle, compressible member, cap, guide member, and/or cannula is a component. Examples of materials considered suitable to form a handle, compressible member, cap, guide member, and/or cannula include biocompatible materials, materials that can be made biocompatible, metals such as stainless steel, titanium, brass, nickel-titanium alloys (e.g., Nitinol), polymers, Pebax (Pebax is a registered trademark of AtoChimie Corporation of Allee des Vosges, Courbevoie, France), nylon, polyethylene, polyurethane, silicone, combinations of the materials described herein, and any other material considered suitable for a particular application. Examples of methods and techniques considered suitable to fabricate a handle, compressible member, cap, guide member, and/or cannula include extrusion processes, molding processes, injection molding processes, casting processes, and any other method or technique considered suitable for a particular embodiment.

In the illustrated embodiment, each of the handle16(e.g., first member30, second member32), the cap20, and the guide member22is formed of a polymer and each of the compressible member18and cannula25is formed of a metal. However, in alternative embodiments, a handle can be formed of a first material (e.g., metal) and a compressible member can be entirely formed, or partially formed, of a second material (e.g., polymer) such that the compressible member is relatively more flexible than the handle. This alternative arrangement provides a mechanism for preventing damage to a medical device (e.g., guidewire) that is disposed through the compressible member and the handle.

FIG. 9illustrates an alternative compressible member218suitable for use in a rotatable control handle according to an embodiment. The compressible member218is similar to the compressible member18illustrated inFIGS. 1, 2, 3, 5, 5A, 5B, 5C, and 5D, and described above, except as detailed below. The compressible member218has a lengthwise axis263, a first end264, a second end266, a length267, and a body268that defines a base270, a passageway272, a first arm274, a second arm276, and a third arm278.

In the illustrated embodiment, the base270is formed of a first material and each of the first arm274, second arm276, and third arm278is formed of a second material that is different than the first material. The second material is relatively more flexible than the first material such that damage to a medical device disposed through the compressible member218is prevented during use. Alternative to, or in combination with, forming each of the arms of a compressible member of a material that is different than the material that forms the base of the compressible member, a compressible member, such as one that is entirely formed of the same material, can include a localized coating on each of the arms that is disposed on a surface that is directed toward the lengthwise axis of the compressible member (e.g., surfaces that are intended to contact a medical device, such as a guidewire). For example, the coating can be disposed on each arm on any surface that contacts a medical device positioned through the compressible member when the compressible member is in the second configuration. The coating can be formed of a material that is different than the material that forms the compressible member and be relatively more flexible than the material that forms the compressible member. Examples of materials considered suitable to form a coating include polymers, rubber, metals, alloys, and any other material considered suitable for a particular embodiment.

FIG. 10illustrates an alternative cap420suitable for use in a rotatable control handle according to an embodiment. The cap420is similar to the cap20illustrated inFIGS. 1, 2, 3, and6, and described above, except as detailed below. In the illustrated embodiment, the cap420forms a structural configuration similar to the guide member22, illustrated inFIGS. 1, 2, 3, and 7, and described above. The cap420comprises a lengthwise axis501, a first end502, a second end504, a length505, and a body506that defines an exterior surface508, a first opening538, a second opening540, and a passageway542.

In the illustrated embodiment, the cap420omits the inclusion of a recess (e.g.,110) and can be fixedly attached to a handle using an adhesive. The first opening538has a first inside diameter539and the second opening540has a second inside diameter541that is less than the first inside diameter539. The passageway542extends from the first opening538to the second opening540and has proximal portion550, a first intermediate portion552, a second intermediate portion554, a third intermediate portion556, a fourth intermediate portion558, and a distal portion560. Each of the first opening538, the second opening540, and the passageway542is sized and configured to receive a portion of a cannula and a medical device, such as a guidewire, as described in more detail herein. The proximal portion550has a diameter equal to the first inside diameter539, the first intermediate portion552has a third inside diameter553, the second intermediate portion554has a diameter that tapers from the first intermediate portion552to the third intermediate portion556, the third intermediate portion556has a fourth inside diameter557, the fourth intermediate portion558has a fifth inside diameter559, and the distal portion560has a diameter that increases from the fourth intermediate portion558to the second inside diameter541at the second end504of the cap420. The third inside diameter553is greater than the first inside diameter539. The fourth inside diameter557is less than the third inside diameter553and the fifth inside diameter559. The fourth inside diameter557is sized and configured to allow a cannula to be passed through the cap420such that it is rotatably attached to the cap420.

Methods of using a rotatable control handle are described herein. While the methods described herein are shown and described as a series of acts, it is to be understood and appreciated that the methods are not limited by the order of acts described and illustrated, as some acts may in accordance with these methods, be omitted, be repeated, or occur in different orders and/or concurrently with other acts described herein. While some steps, optional steps, and/or alternative steps are exemplified by using a rotatable control handle on a guidewire, the methods, steps, optional steps, and/or alternative steps described herein can be used on any suitable medical device and to perform any suitable method of using a rotatable control handle, or method of treatment. Selection of a suitable structure on which to use a rotatable control handle according to an embodiment and perform the methods, steps, optional steps, and/or alternative steps described herein can be based on various considerations, such as the method of using a rotatable control handle, or method of treatment, intended to be performed.

FIG. 11is a schematic illustration of an example method600of using a rotatable control handle.

A step602comprises moving the handle of a rotatable control handle from a second configuration to a first configuration. Another step604comprises positioning the rotatable control handle on a medical device. The medical device comprises a first end, a second end, and a length that extends from the first end to the second end. Another step606comprises positioning the rotatable control handle at a predetermined location on the medical device. Another step608comprises moving the handle of the rotatable control handle from a first configuration to a second configuration. Another step610comprises applying an axial force on the rotatable control handle directed toward a valve device such that the medical device is advanced through a valve member of the valve device and the first end of the medical device is disposed on a first side of the valve member and the second end of the medical device is disposed on a second side of the valve member. The valve device comprises a housing, a valve member, and a sheath. Another step612comprises continuing the application of an axial force on the rotatable control handle such that the rotatable control handle and the medical device are advanced through the valve member of the valve device and the first end of the cannula is disposed on the second side of the valve member and the second end of the cannula is disposed on the first side of the valve member. Another step614comprises applying torque to the handle of the rotatable control handle such that the handle and medical device rotate relative to the valve device. Another step616comprises moving the handle of the rotatable control handle from a second configuration to a first configuration. Another step618comprises applying axial force on the medical device such that the medical device moves relative to the handle. Another step620comprises moving the handle of the rotatable control handle from a first configuration to a second configuration. Another step622comprises applying an axial force on the rotatable control handle directed away from the valve device such that the rotatable control handle and the medical device are withdrawn from the valve member of the valve device, the second end of the cannula is disposed on the second side of the valve member, and the medical device and rotatable control handle are free of the valve device. Another step624comprises moving the handle of the rotatable control handle from the second configuration to the first configuration. Another step626comprises withdrawing the medical device from the first member and the second member of the handle of the rotatable control handle.

Step602can be accomplished using any suitable rotatable control handle according to an embodiment, such as rotatable control handle10, variations thereof, and any other rotatable control handle considered suitable for a particular method of using a rotatable control handle or method of treatment. An example rotatable control handle that can be used to accomplish the methods, steps, alternative steps, and/or optional steps described herein is illustrated and described with respect toFIGS. 1, 2, 3, 4, 5, 5A, 5B, 5C, 5D, 6, 7, and 8, and comprises a handle16, a compressible member18, a cap20, a guide member22, and a cannula24.

Step602can be accomplished by applying torque on the first member30while maintaining the position of the second member32such that the second end36of the first member30advances away from the second end48of the second member32, the first member30becomes free of the second member32, and the compressible member18moves from the second configuration to the first configuration. Alternatively, step602can be accomplished by applying torque on the first member30while maintaining the position of the second member32until the second end36of the first member30advances away from the second end48of the second member32and the compressible member18moves from the second configuration to the first configuration while the first member30and second member32are still in contact with one another. For example, in the second configuration the first member first end is disposed a first distance from the second member second end and in the first configuration the first member first end first end is disposed a second distance from the second member second end that is greater than the first distance. Alternatively, step602can be accomplished by applying torque on the second member32while maintaining the position of the first member30such that the second end48of the second member32advances away from the second end36of the first member30, the first member30becomes free of the second member32, and the compressible member18moves from the second configuration to the first configuration. Alternatively, step602can be accomplished by applying torque on the second member32while maintaining the position of the first member30until the second end48of the second member32advances away from the second end36of the first member30and the compressible member18moves from the second configuration to the first configuration while the first member30and second member32are still in contact with one another. Alternatively, step602can be accomplished by applying torque on the second member32while concurrently applying torque on the first member30such that the second end48of the second member32advances away from the second end36of the first member30, the first member30becomes free of the second member32, and the compressible member18moves from the second configuration to the first configuration. Alternatively, step602can be accomplished by applying torque on the second member32while concurrently applying torque on the first member30until the second end48of the second member32advances away from the second end36of the first member30and the compressible member18moves from the second configuration to the first configuration while the first member30and second member32are still in contact with one another. Alternatively, step602can be omitted from method600if the rotatable control handle10is provided in the first configuration.

Step604can be accomplished by positioning the rotatable control handle10on any suitable medical device and selection of a suitable medical device to use in combination with a rotatable control handle can be based on various considerations, such as the method of using a rotatable control handle or method of treatment intended to be performed. Example medical devices on which it is considered suitable to position a rotatable control handle include guidewires, embolization devices, probes, lithotripsy probes, delivery devices, delivery systems that include a guidewire with an attached embolization coil, optics, fiber optics, fibers, laser fibers, suction devices, irrigation devices, baskets, stone baskets, graspers, forceps, grasping forceps, drills, catheters, balloon catheters, and any other device considered suitable for a particular application. It is considered advantageous to position a rotatable control handle on a medical device at least because it provides a mechanism for providing fine motor control over the medical device, it provides a mechanical stop to the distal advancement of the medical device through a second medical device (e.g., valve device, hemostatic valve), and provides a mechanism for manipulating the medical device through a second medical device (e.g., valve device, hemostatic valve) through which it is disposed. For example, if a medical device702is advanced through a valve device704, as shown inFIGS. 12 and 13, the cannula24of the rotatable control handle10will contact the valve member708of the valve device704instead of the medical device702to prevent damage (e.g., kinking) to the medical device702during use and increase the maneuverability of the medical device702through the valve member708. When the method600of using a rotatable control handle is being performed as part of a method of treatment, it is considered advantageous to position a rotatable control handle on a medical device at least because it provides a mechanism for providing fine motor control over the medical device, it provides a mechanical stop to the distal advancement of the medical device within a bodily passage, and provides a mechanism for manipulating the medical device through a second medical device (e.g., valve device, hemostatic valve) through which it is disposed. In embodiments in which a rotatable control handle is positioned on a guidewire, the rotatable control handle can be positioned on any suitable guidewire, formed of any suitable material and having any suitable structural arrangement, and selection of a suitable guidewire can be based on various considerations, such as the treatment intended to be performed. Examples of materials considered suitable to form a guidewire disposed through a rotatable control handle include guidewires that are formed of biocompatible materials, materials that can be made biocompatible, metals such as stainless steel, titanium, brass, nickel-titanium alloys (e.g., Nitinol), polymers, Pebax, nylon, polyethylene, polyurethane, silicone, combinations of the materials described herein, and any other material considered suitable for a particular embodiment.

Step604can be accomplished by applying an axial force on a medical device directed toward the rotatable control handle10while maintaining the position of the handle16such that the first end or second end of the medical device is advanced through the passageway40and recess42defined by the first member30, the passageway72defined by compressible member18, between the arms74,76,78,80of the compressible member18, the first recess52, second recess54, and passageway58defined by the second member32, the passageway142defined by the guide member22, and the passageway178defined by the cannula24. Alternatively, step604can be accomplished by maintaining the position of the medical device and applying an axial force on the first member30and second member32of the rotatable control handle10directed toward the medical device such that the first end or second end of the medical device is advanced through the passageway40and recess42defined by the first member30, the passageway72defined by the compressible member18, between the arms74,76,78,80of the compressible member18, the first recess52, second recess54, and passageway58defined by the second member32, the passageway142defined by the guide member22, and the passageway178defined by the cannula24. Alternatively, in embodiments that omit the inclusion of a guide member, the medical device is passed through the passageway defined by a cap and into the passageway defined by the cannula.

Step606can be accomplished based upon various measured factors, and selection of a suitable measurement to base the positioning of a rotatable control handle on a medical device according to a particular embodiment can be based on various considerations, including the method of using a rotatable control handle intended to be performed. Examples of measurements considered suitable to base the positioning of a rotatable control handle on a medical device include the structural arrangement of a second medical device (e.g., valve device, hemostatic valve), an estimate as to the length of the medical device desired to be passed through a second medical device (e.g., valve device, hemostatic valve), and any other measurement considered suitable for a particular application. Alternatively, a rotatable control handle can be positioned on a medical device at any suitable location between the first end and the second end of the medical device. When the method600of using a rotatable control handle is being performed as part of a method of treatment, step606can alternatively be accomplished based upon various measured and/or physiological factors, and selection of a suitable measurement and/or physiological factor to base the positioning of a rotatable control handle on a medical device according to a particular embodiment can be based on various considerations, including the treatment intended to be performed. Examples of measurements and/or physiological factors considered suitable to base the positioning of a rotatable control handle on a medical device when performing a method of treatment include the structural arrangement of a bodily passage, an estimate as to the length of the medical device desired to be introduced into a bodily passage, the location of a point of treatment within a bodily passage, a previously determined measurement (e.g., the location desired to place an embolization coil within a bodily passage), and any other measurement and/or physiological factor considered suitable for a particular application. Alternative embodiments can omit the inclusion of step606.

Step608can be accomplished by applying torque on the first member30while maintaining the position of the second member32such that the second end36of the first member30advances toward the second end48of the second member32, the first member30becomes releasably attached to the second member32, and the compressible member18moves from the first configuration to the second configuration. For example, in the first configuration the first member first end is disposed a first distance from the second member second end and in the second configuration the first member first end first end is disposed a second distance from the second member second end that is less than the first distance and the first member is releasably attached to the second member. Alternatively, step608can be accomplished by applying torque on the second member32while maintaining the position of the first member30such that the second end48of the second member32advances toward the second end36of the first member30, the first member30becomes releasably attached to the second member32, and the compressible member18moves from the first configuration to the second configuration. Alternatively, step608can be accomplished by applying torque on the first member30while concurrently applying torque on the second member32such that the second end48of the second member32advances toward the second end36of the first member30, the first member30becomes releasably attached to the second member32, and the compressible member18moves from the first configuration to the second configuration.

Step610can be accomplished by applying an axial force on any suitable portion of the rotatable control handle10(e.g., handle16) directed toward the valve device such that the medical device is advanced through the valve member.FIG. 12illustrates a guidewire702positioned through a valve device704that has a housing706, a valve member708, and a sheath710such that the first end of the guidewire702is disposed on a first side712of the valve member708and the second end of the guidewire702is disposed on a second side714of the valve member708. In embodiments in which the first end of the guidewire is disposed within the passageway178defined by the cannula24, step610can be omitted from method600.

Alternatively, step610can comprise applying an axial force on the medical device directed toward a valve device such that the medical device is advanced through the valve member of the valve device and the first end of the medical device is disposed on a first side of the valve member and the second end of the medical device is disposed on a second side of the valve member. This alternative step can be accomplished by applying an axial force on any suitable portion of the medical device directed toward the valve device such that the medical device is advanced through the valve member. During performance of method600, the sheath of the valve device can optionally be free of any other device or partially disposed within a third medical device (e.g., model of a bodily passage, such as a model of a venous valve).

While method600has been described as a method of using a rotatable control handle, method600, and the alternative steps and/or optional steps described with respect to method600, can be accomplished as part of any suitable method that uses a rotatable control handle. For example, method600, and the alternative steps and/or optional steps described with respect to method600, can alternatively be used as a method of treatment, or as part of a method of treatment, as a method of demonstrating use of a rotatable control handle, or as part of a method of demonstrating use of a rotatable control handle, as a method of controlling a medical device, or as part of a method of controlling a medical device, as a method of positioning a medical device (e.g., guidewire) within a rotatable control handle, or as part of a method of positioning a medical device (e.g., guidewire) within a rotatable control handle. When the method600is being performed as part of a method of treatment, the sheath of the valve device can optionally be partially disposed within a bodily passage or can be entirely disposed outside of a bodily passage. When the method600is being performed as part of a method of treatment, optional steps that can be completed comprise creating a surgical opening in a bodily passage (e.g., body vessel) using a needle; applying an axial force on a guidewire directed toward the needle such that the guidewire is passed through a bore of the needle and is partially disposed within the bodily passage; applying an axial force on a valve device directed toward the guidewire such that the valve device is advanced over the guidewire and is partially disposed within the bodily passage, the valve device has a housing, a valve member, a sheath, and a dilator; applying an axial force on the dilator directed away from the bodily passage such that the dilator is removed from the valve device and is free of the guidewire; applying an axial force directed toward a bodily passage on any suitable portion of a valve device such that the sheath is partially disposed within the bodily passage; and/or applying an axial force on the guidewire directed away from the bodily passage such that the guidewire is removed from the valve device and is free of the bodily passage. When the method600is being performed as part of a method of treatment, the steps, alternative steps, and/or optional steps described herein can be accomplished with respect to treating any suitable condition within any suitable bodily passage including, but not limited to, a salivary duct, the urinary tract, a portion of the vascular system, an artery, a vein, and any other bodily passage considered suitable for a particular application.

Step612can be accomplished by applying an axial force on any suitable portion of the rotatable control handle10(e.g., handle16) directed toward the valve device such that the cannula24is advanced through the valve member.FIG. 13illustrates the cannula24of a rotatable control handle10positioned through a valve device704that has a housing706, a valve member708, and a sheath710such that the second end168of the cannula24is disposed on the first side712of the valve member708and the first end166of the cannula24is disposed on the second side714of the valve member708. Alternatively, when method600is being performed as a method of treatment, step612can comprise continuing the application of an axial force on the rotatable control handle such that the rotatable control handle and the medical device are advanced through the valve member of the valve device, the first end of the cannula is disposed on the second side of the valve member, the second end of the cannula is disposed on the first side of the valve member, and the second end of the medical device is disposed at a point of treatment (e.g., the desired location to deliver an embolization coil).

Step614can be accomplished by applying a torque on any suitable portion of the rotatable control handle10(e.g., handle16) in a clockwise or counterclockwise direction such that the handle16and medical device rotate relative to the valve device. As illustrated inFIG. 13, the application of a force in the counterclockwise direction, as illustrated by arrows722, will result in rotation of the guidewire702and the handle16in a counterclockwise direction. Since the cannula24is disposed through the valve member708of the valve device704, the position of the cannula24will be fixed, or substantially fixed, during rotational movement of the handle16and guidewire702. Optionally, depending on the method of using a rotatable control handle being performed, step614can be omitted from method600. For example, when the method600is being performed as part of a method of treatment, the medical device on which the rotatable control is disposed can comprise a delivery system that includes a guidewire with an attached embolization coil disposed on the second end of the guidewire and an optional step that can be included in the method of treatment comprises continuing the application of torque on the handle until the embolization coil has been delivered at a point of treatment. This optional step can be accomplished as described with respect to step614. Also, when method600is being performed as a method of treatment, another optional step comprises confirming placement of the embolization coil. This optional step can be accomplished using any suitable visualization technique or method, such as x-ray, fluoroscopy, and any other visualization technique or method considered suitable for a particular embodiment.

Step616can be accomplished as described herein with respect to step602. Optionally, step616can be accomplished while the cannula24is disposed through the valve member of a valve device.

Step618can be accomplished by applying an axial force on any suitable portion of the medical device directed toward, or away from, the valve device such that the medical device is advanced through, or partially withdrawn from, the valve member. When method600is being performed as a method of treatment, an optional step comprises continuing the application of an axial force on the medical device until the second end of the medical device is disposed at a point of treatment. This optional step can be accomplished by applying an axial force on any suitable portion of the medical device directed toward, or away from, the valve device such that the medical device is advanced through, or partially withdrawn from, the valve member and the second end is advanced toward, or positioned at, a point of treatment. Optionally, step618, and the optional step described above, can be accomplished while the cannula24is disposed through the valve member of a valve device. It is considered advantageous to advance, withdraw, and rotate a medical device, such as a guidewire, that is disposed through the valve member of a valve device, or other medical device, through a rotatable control handle that is in contact with the valve member to prevent kinking of the medical device and provide a mechanism to reduce the force required to advance, withdraw, and rotate the medical device. For example, when using a rotatable control handle, a medical device, such as a guidewire, can be advanced, withdrawn, and rotated within a second medical device, such as a valve device, using only one hand.

Step620can be accomplished as described herein with respect to step608. Optionally, step620can be accomplished while the cannula24is disposed within the valve member.

Alternatively, depending on the method of using a rotatable control handle being performed, each of step616, step618, and/or step620can be omitted from method600or repeated. For example, when method600is being performed as a method of treatment, each of step616,618, and/or step620can be omitted from method600or repeated.

Step622can be accomplished by applying an axial force on any suitable portion of the rotatable control handle10(e.g., handle16) directed away from the valve device such that the medical device is withdrawn from the valve member. Alternatively, step622can comprise applying an axial force on the medical device directed away from the valve device such that the rotatable control handle and medical device are withdrawn from the valve member of the valve device, the second end of the cannula is disposed on the second side of the valve member, and the medical device and rotatable control handle are free of the valve device. This alternative step can be accomplished by applying an axial force on any suitable portion of the medical device directed away from the valve device such that the medical device and rotatable control handle are withdrawn from the valve member.

Step624can be accomplished as described herein with respect to step602. Optionally, step624can be omitted from method600.

Step626can be accomplished by applying an axial force on the medical device directed away from the rotatable control handle10while maintaining the position of the handle16such that the first end or second end of the medical device is withdrawn from the passageway40and recess42defined by the first member30, the passageway72defined by the compressible member18, between the arms74,76,78,80of the compressible member18, the first recess52, second recess54, and passageway58defined by the second member32, the passageway142defined by the guide member22, and the passageway178defined by the cannula24. Alternatively, step626can be accomplished by maintaining the position of the medical device and applying an axial force on the first member30and second member32of the rotatable control handle10directed away from the medical device such that the first end or second end of the medical device is advanced through the passageway40and recess42defined by the first member30, the passageway72defined by the compressible member18, between the arms74,76,78,80of the compressible member18, the first recess52, second recess54, and passageway58defined by the second member32, the passageway142defined by the guide member22, and the passageway178defined by the cannula24. Alternatively, in embodiments that omit the inclusion of a guide member, the medical device is passed through the passageway defined by a cap and into the passageway defined by the cannula. Optionally, step626can be omitted from method600.

While step602, step608, step616, step620, and step624have been described as being accomplished by applying torque to a portion of a handle, depending on the structural arrangement of a handle of a rotatable control handle, each of these steps can be accomplished by applying an axial force on a portion of a rotatable control handle. For example, in embodiments in which the first member of a handle is releasably attachable to a second member using a snap fit attachment, step602, step616, and step624can be accomplished by applying an axial force on the first member directed away from the second member while maintaining the position of the second member until the first member is free of attachment to the second member. Alternatively, in embodiments in which the first member of a handle is releasably attachable to a second member using a snap fit attachment, step602, step616, and step624can be accomplished by applying an axial force on the second member directed away from the first member while maintaining the position of the first member until the first member is free of attachment to the second member. Alternatively, in embodiments in which the first member of a handle is releasably attachable to a second member using a snap fit attachment, step602, step616, and step624can be accomplished by applying an axial force on the first member directed away from the second member while concurrently applying an axial force on the second member directed away from the first member until the first member is free of attachment to the second member.

In embodiments in which the first member of a handle is releasably attachable to a second member using a snap fit attachment, step608and step620can be accomplished by applying an axial force on the first member directed toward the second member while maintaining the position of the second member until the first member is releasably attached to the second member. Alternatively, in embodiments in which the first member of a handle is releasably attachable to a second member using a snap fit attachment, step608and step620can be accomplished by applying an axial force on the second member directed toward the first member while maintaining the position of the first member until the first member is releasably attached to the second member. Alternatively, in embodiments in which the first member of a handle is releasably attachable to a second member using a snap fit attachment, step608and step620can be accomplished by applying an axial force on the second member directed toward the first member while concurrently applying an axial force on the first member directed toward the second member until the first member is releasably attached to the second member.

FIGS. 14 and 15illustrate an alternative compressible member818suitable for use in a rotatable control handle according to an embodiment. The compressible member818is similar to the compressible member18illustrated inFIGS. 1, 2, 3, 5, 5A, 5B, 5C, and 5D, and described above, except as detailed below. The compressible member818has a lengthwise axis863, a first end864, a second end866, a length867, and a body868that defines a base870, a passageway872, a first arm874, a second arm876, a third arm878, and a fourth arm880.

In the illustrated embodiment, the body868of the compressible member818defines a continuous surface894on the head892of each of the arms874,876,878,880(e.g., each arm omits a recess and projection), a conical recess896, and the compressible member818includes a inner tubular member1010that is formed of a material that is different than the material that forms the compressible member818. The conical recess896extends from the first end864toward the second end866and provides a mechanism for directing any medical device passed through the compressible member818into passageway872.

The inner tubular member1010is partially disposed within the passageway872defined by the compressible member818and is attached to the compressible member818using an adhesive. The inner tubular member1010has a first end1012, a second end1014, a length1013that extends from the first end1012to the second end1014, an outside diameter1015, and a body1016that defines a first notch1018and a second notch1020. The length1013of the inner tubular member1010is less than the length867of the compressible member818and the inner tubular member1010is partially disposed within passageway872such that the first end1012is disposed within passageway872and the second end1014is disposed outside of passageway872. Each of the notches1018,1020extends from the second end1014of the inner tubular member1010toward the first end1012of the inner tubular member1010. Each of the notches1018,1020has a width1019that is less than the radius of the inner tubular member1010and provides a mechanism from moving the inner tubular member1010between a first configuration and a second configuration. The inner tubular member1010is in the first configuration when the compressible member818is in the first configuration and the inner tubular member1010is in the second configuration when the compressible member818is in the second configuration. In the first configuration, the inner tubular member1010has a first inside diameter and in the second configuration the inner tubular member1010has a second inside diameter that is less than the first inside diameter.

In the illustrated embodiment, the inner tubular member1010is formed of a first material that has a first hardness and the compressible member818is formed of a second material that has a second hardness that is greater than the first hardness. For example, the first material can have a first durometer hardness that is less than the durometer hardness of the second material. The inclusion of an inner tubular member having a hardness that is less than the hardness of the compressible member is considered advantageous at least because it provides a mechanism for reducing any damage to a medical device that is disposed through a rotatable control handle that includes compressible member818.

While the inner tubular member1010has been illustrated as being partially disposed within compressible member818, as being formed of a first material that is different than the second material forming the compressible member818, as having a particular structural arrangement, and as being attached to the compressible member using an adhesive, an inner tubular member included in a compressible member can be formed of any suitable material, have any suitable structural arrangement, and be attached to a compressible member using any suitable technique or method of attachment. Selection of a suitable material to form an inner tubular member, a structural arrangement for an inner member, and a technique or method of attachment between an inner tubular member and a compressible member can be based on various considerations, including the materials forming a compressible member of which the inner tubular member is a component. Examples of materials considered suitable to form an inner tubular member include biocompatible materials, materials that can be made biocompatible, metals such as stainless steel, titanium, brass, nickel-titanium alloys (e.g., Nitinol), polymers, Pebax, nylon, polyethylene, polyurethane, silicone, combinations of the materials described herein, and any other material considered suitable for a particular application. Examples of suitable lengths of an inner tubular member to position within a passageway defined by a compressible member include partial lengths, entire lengths, and any other length considered suitable for a particular embodiment. Examples of structural arrangements considered suitable for an inner tubular member include arrangements that omit the inclusion of a notch, that include more than two notches, that include one or more notches that extends along a portion of the length of the tubular member, and any other structural arrangement considered suitable for a particular embodiment. Examples of techniques and methods of attachment considered suitable between an inner tubular member and a compressible member include using an adhesive, welding, fusing, and any other technique or method considered suitable for a particular embodiment.

FIGS. 16, 17A, and 17Billustrate an alternative compressible member1118suitable for use in a rotatable control handle according to an embodiment. The compressible member1118is similar to the compressible member1018illustrated inFIGS. 14 and 15, and described above, except as detailed below. The compressible member1118has a lengthwise axis1163, a first end1164, a second end1166, a length1167, and a body1168that defines a base1170, a passageway1172, a first arm1174, a second arm1176, a third arm1178, and a fourth arm1180.

In the illustrated embodiment, the body1168of the compressible member1118defines a continuous surface1194on the head1192of each of the arms1174,1176,1178,1180(e.g., each arm omits a recess and projection), a first conical recess1196, and a second conical recess1197when the compressible member1118is in the first configuration. The first conical recess1196extends from the first end1164toward the second end1166and provides a mechanism for directing any medical device passed through the compressible member1118into the passageway1172. The second conical recess1197extends from the second end1166toward the first end1164and provides a mechanism for increasing the surface area that contacts a medical device passed through the compressible member1118during use and when the compressible member1118is in the second configuration, as shown inFIG. 17B. The inclusion of a second conical recess1197is considered advantageous at least because it increases the fixation between the compressible member1118and any medical device disposed through the compressible member1118, which provides an increase in the amount of torque that can be applied on the medical device during use.

While the compressible member1118has been illustrates as having two conical recesses1196,1197, a compressible member can include any suitable number of recesses, having any suitable structural arrangement, and formed using any suitable technique. Selection of a suitable number of recesses to include on a compressible member, suitable structural arrangement for a recess, and technique to form a recess can be based on various considerations, including the material that forms the compressible member. Examples of numbers of recess to include on a compressible member include zero, one, at least one, two, a plurality, and any other number of recesses considered suitable for a particular embodiment. Examples of structural arrangements for a recess included on a compressible member include conical, frustoconical, cylindrical, and any other structural arrangement considered suitable for a particular embodiment. An example technique considered suitable to form a recess includes moving a compressible member to the second configuration forming the structure of the recess (e.g., using a drill or other tool) and then allowing the compressible member to return to the first configuration.

Those with ordinary skill in the art will appreciate that various modifications and alternatives for the described and illustrated embodiments can be developed in light of the overall teachings of the disclosure. Accordingly, the particular arrangements disclosed are intended to be illustrative only and not limiting as to the scope of the invention, which is to be given the full breadth of the appended claims and any and all equivalents thereof.