This invention generally relates to handles to having rotational detachment mechanisms for use with medical device deployment systems that deploy implantable medical devices at target locations within a human body vessel, and methods of using the same.
The use of catheter delivery systems for positioning and deploying therapeutic devices, such as dilation balloons, stents and embolic coils, in the vasculature of the human body has become a standard procedure for treating endovascular diseases. It has been found that such devices are particularly useful in treating areas where traditional operational procedures are impossible or pose a great risk to the patient, for example in the treatment of aneurysms in cranial blood vessels. Due to the delicate tissue surrounding cranial blood vessels, especially for example brain tissue, it is very difficult and often risky to perform surgical procedures to treat defects of the cranial blood vessels. Advancements in catheter deployment systems have provided an alternative treatment in such cases. Some of the advantages of catheter delivery systems are that they provide methods for treating blood vessels by an approach that has been found to reduce the risk of trauma to the surrounding tissue, and they also allow for treatment of blood vessels that in the past would have been considered inoperable.
Typically, these procedures involve inserting the distal end of a delivery catheter into the vasculature of a patient and guiding it through the vasculature to a predetermined delivery site. An implantable medical device, such as an embolic coil or vascular stent, is attached to the end of a delivery member which pushes the medical device through the catheter and out of the distal end of the catheter into the delivery site. Some of the delivery systems associated with these procedures utilize an elongated control member, sometimes referred to as a control wire or pull wire, to activate the release and deployment of the medical device. For example, U.S. Pat. No. 5,250,071 to Palermo, which is hereby incorporated herein by reference, describes a delivery and detachment system whereby interlocking clasps of the system and the coil are held together by a control wire. The control wire is moved proximally to disengage the clasps from each other.
Additionally, U.S. patent application Ser. No. 11/461,245, filed Jul. 31, 2006, to Mitelberg, et al., which is hereby incorporated herein by reference for its disclosure of a distal-portion detachment mechanism with which the present invention may be utilized, describes a detachment system wherein a control wire engages a hook or an eyelet to attach a medical device to the deployment system. The control wire is moved in a proximal direction to disengage it from the hook and release the medical device.
There remains a need for mechanisms or methods that may be used by a medical professional to manipulate control members of various medical device deployment systems. There also remains a need for mechanisms or methods that reduce the strain on the control member, while providing a quick and timely deployment of the implantable medical device at a target location within a body vessel.
In accordance with one embodiment or aspect of the present invention, a handle is provided for use with an implantable medical device deployment system including a control member whose movement initiates the release of an implantable medical device from the deployment system. The handle includes a handle body, with a cavity having a rotatable member located within the cavity that rotates relative to the handle body. The rotatable member includes an internal threaded surface defining a lumen, wherein the internal threaded surface may be threadably connected to the control member and the lumen may receive the control member therein. The rotatable member is rotated to cause the control member to move axially and release the implantable medical device.
Alternatively, relative rotational movement between the rotatable member and the handle body can cause the handle body to move in an axial direction relative to a carrier member. The handle body may be operatively connected to the control member so that the control member moves in an axial direction with the handle body to release the medical device.
In accordance with yet another embodiment or aspect of the present invention, a deployment system is provided for delivering an implantable medical device to a target location of a body vessel. The deployment system comprises a generally elongated carrier member having a proximal end portion and a distal end portion, and an implantable medical device releasably attached to the distal end portion of the carrier member. The deployment system also includes a control member whose movement causes the release of the implantable medical device from the distal end portion of the carrier member. Additionally, the deployment system includes a handle having a handle body connected to the distal end portion of the carrier member. The handle body has a cavity in which a rotatable member is located. The rotatable member is rotatable relative to the handle body. Furthermore, the rotatable member includes an internal threaded surface defining a lumen having a proximal end portion of the control member located therein and threadably engaged with the internal threaded surface of rotatable member. The rotatable member is rotated to cause the control member to move axially to release the implantable medical device.
In accordance with a further embodiment or aspect of the present invention, a deployment system may also include a handle that has a rotatable member and a handle body. The rotatable member is rotationally coupled to the distal end portion of the carrier member and includes an internal threaded surface defining a lumen. The handle body has a threaded portion located within the lumen of the rotatable member and threadably engaged with the internal threaded surface of the rotatable member. The handle body is operatively connected to the control member so that the control member moves with the handle body. Either the rotatable member or the handle body may be rotated to cause the handle body to move in an axial direction relative to the carrier member, thereby causing movement of the control member to release the medical device.
In accordance with another embodiment or aspect of the present invention, an actuator is provided for use with an implantable medical device deployment system that includes a control member which initiates the release of an implantable medical device from the deployment system upon movement of the control member. The actuator comprises an actuator body which may be operatively connected to the control member. The actuator body includes a threaded portion that may be threadably connected to the deployment system so that rotational movement of the actuator body causes the actuator and the control member connected therewith to move relative to the deployment system to release the medical device. The threaded portion of the actuator body includes a pitch that has at least a first pitch size and a second pitch size wherein the first and second pitch sizes are different from each other.
In accordance with further embodiment or aspect of the present invention, a deployment system for delivering an implantable medical device to a target location of a body vessel is provided. The deployment system comprises a generally elongated carrier member having a proximal end portion and a distal end portion and an implantable medical device releasably attached to the distal end portion of the carrier member. The deployment system also includes a control member whose movement causes the release of the implantable medical device from the distal end portion of the carrier member. Additionally, the deployment system also includes an actuator having a threaded portion that is threadably connected to a corresponding threaded portion of the carrier member located at the proximal end portion of the carrier member. The control member is connected to the actuator, and rotational movement of the actuator causes the actuator to move in an axial direction relative to the carrier member, thereby causing movement of the control member in an axial direction to release the medical device form the distal end portion of the carrier member. Further, one of the threaded portion of the actuator and the threaded portion of the carrier member includes a pitch that has at least a first pitch size and a second pitch size wherein the first pitch size and said second pitch size are different from each other.
In accordance with yet another embodiment or aspect of the present invention, a deployment system delivers an implantable medical device to a target location of a body vessel. The deployment system comprises a generally elongated carrier member having a proximal end portion and a distal end portion and an implantable medical device releasably attached to the distal end portion of the carrier member. The deployment system also includes a control member whose movement causes the release of the implantable medical device from the distal end portion of the carrier member. Additionally, the deployment system includes an actuator movably connected to the proximal end portion of the carrier member wherein the actuator is moveable in an axial direction relative to the carrier member. The control member is connected to the actuator, and movement of the actuator relative to the carrier member causes movement of the control member to release the medical device from the distal end portion of the carrier member. Further, the deployment system includes a regulator that changes the rate of relative axial movement between the actuator and the carrier member.
In accordance with another embodiment or aspect of the present invention, a method is provided for deploying an implantable medical device to a target location of a body vessel. The method comprises providing a deployment system that has a generally elongated carrier member having a proximal end portion and a distal end portion and an implantable medical device releasably secured to the distal end portion of the carrier member. The deployment system also has a control member whose movement causes the release of the implantable medical device from the distal end portion of the carrier member. Additionally, the deployment system also has a handle that has a handle body connected to the distal end portion of the carrier member. The handle body includes a cavity having a rotatable member located within the cavity. The rotatable member includes an internal threaded surface defining a lumen having a proximal end portion of the control member located within the lumen and threadably engaged with the internal threaded surface of rotatable member. Rotation of rotatable member causes the control member to move axially. The method further includes positioning the implantable medical device generally adjacent to a target location with a body vessel, and rotating the rotatable member to cause the control member to move axially, thereby releasing the medical device.
In accordance with a further embodiment or aspect of the present invention, a method is provided for deploying an implantable medical device to a target location of a body vessel. The method comprises providing a deployment system including a carrier member having a proximal end portion and a distal end portion and an implantable medical device releasably connected to the distal end portion of the carrier member. The medical device is released from the distal end portion of the carrier member upon movement of a control member. The deployment system also includes an actuator threadably connected to the proximal end portion of the carrier member. The actuator includes a thread that has at least two different pitch sizes. The control member is connected to and moveable with the actuator. The method further comprises positioning the implantable medical device generally adjacent to a target location within the body vessel. Rotating the actuator relative to the carrier member to cause axial movement of the actuator relative to the carrier member, thereby moving the control member and releasing the implantable medical device.
The following description of the preferred embodiments of the present invention is merely illustrative in nature, and as such it does not limit in any way the present invention, its application, or uses. Numerous modifications may be made by those skilled in the art without departing from the true spirit and scope of the invention.
The deployment system 10 is comprised of a generally hollow elongated carrier member or pusher 14 having a distal end portion 16 and a proximal end portion 18. Preferably, the carrier member 14 is a hypotube that may be comprised of a biocompatible material, such as stainless steel. The hypotube typically will have a diameter of between about 0.010 inch (0.254 mm) and about 0.015 inch (0.381 mm), a preferred tube having a diameter of approximately 0.013 inch (0.330 mm). Such a carrier member 14 is suitable for delivering and deploying implantable medical devices, such as embolic coils, vascular stents or the like, to target locations, typically aneurysms, within the neurovasculature, but differently sized carrier members comprised of other materials may be useful for different applications.
An engagement member 20 is associated with the distal end portion 16 of the carrier member 14. The engagement member 20 may comprise a distal end length of an elongated wire loosely bent in half to define an opening 22 (
In an alternative embodiment, the engagement member 20 may comprise a flat ribbon defining the opening 22 at a distal portion thereof. In either embodiment, the engagement member 20 typically is preferably deformable to the up-turned condition illustrated in
The deployment system 10 further includes a control member 26, such as a control wire or pull wire, received within the lumen 28 of the carrier member 14 and movable with respect to the engagement member 20. The control member 26 stretches beyond the proximal end portion 18 of the carrier member 14 and is operatively connected to the handle 12. The control member 26 may be a wire comprised of any of a number of materials, including nitinol. The function of the control member 26 will be described in greater detail herein.
As shown in
To connect the implantable medical device 30 to the distal end portion 16 of the carrier member 14, an aperture-containing proximal end portion 32 of the implantable medical device 30 is placed adjacent to opening 22 of the engagement member 20, which is then deformed to the up-turned condition of
As described herein, the engagement member 20 may be elastically deformable to the up-turned condition of
The handle 12 can include a handle body 34 having a proximal end portion 36 and a distal end portion 38 wherein the distal end portion 38 is connected to the proximal end portion 18 of the carrier member 14. The handle body 34 may be comprised of a proximal wall 40 and a circumferential wall 42 that define a cavity 44. The cavity 44 communicates with the lumen 28 of the carrier member 14 and accepts a proximal end portion 46 of the control member 26. The circumferential wall 42 may be a continuous arcuate wall which forms a handle body having a generally circular cross-section, such as a generally cylindrically shaped handle body, or the circumferential wall could be comprises of a series of panels or sub-walls which form a handle having a rectangular cross-section.
A rotatable member 48, such as the illustrated generally cylindrical rotational sleeve, is located within a portion of the cavity 44 that is configured to house the rotatable member and allow the rotatable member to rotate relative to the handle body 34, the carrier member 14 and the control member 26. Preferably, the rotatable member 48 may rotate in the direction of “A” or the direction of “B” (
The rotatable member 48 includes an internal threaded surface 50 (perhaps best shown in
As the rotatable member 48 is rotated relative to the control member 26, the threaded engagement between the internal surface 50 of the rotatable member 48 and the proximal end portion 46 of the control member 26 causes the control member to move in a proximal or distal direction depending on the direction of rotational movement of the rotatable member 48. If the rotatable member 48 is rotated such that the control member 26 moves in a proximal direction, the cavity 44 of the handle may include a through port 54 at a location that is proximal the rotatable member. The through port 54 accepts the proximal end portion 46 of the control member 26 as the control member is moved proximally out of the proximal end of the rotatable member 48. To prevent over-threading of the control member 26 or to limit the amount of axial movement of the control member 26 in either the proximal or distal direction, the control member 26 may include stops 56a, 56b that contact the rotatable member 48 and prevent further movement of the control member 26 in a particular direction. For example, as illustrated in
The handle body 34 and rotatable member 48 are preferably configured so that the rotatable member 48 may be rotated by hand, but both may also be configured to be rotated by instrument. Referring to
In the illustrated embodiment, the medical device 30 may be attached to the deployment system 10 as described above and as illustrated in
According to one method of delivering the medical device 30, a tubular catheter (not shown) is fed into a body vessel until a distal end thereof is adjacent to a target location. Thereafter, the deployment system 10 and associated implantable medical device 30 are advanced through the catheter, using procedures and techniques known in the art, until the device 30 is itself generally adjacent to the target location. Alternatively, the deployment system 10 and associated device 30 may be pre-loaded in the catheter, with the combination being fed through a body vessel to a target location. Other methods of positioning the implantable medical device 30 generally adjacent to a target location may also be practiced without departing from the scope of the present invention.
To more accurately position the engaged device 30, radiopaque markers (not illustrated) may be attached to the carrier member 14 or the device 30 itself.
When the engaged device 30 has been properly positioned and oriented, the rotatable member 48 is rotated, preferably by hand through window 58 in wall 42 of the handle body, relative to the control member 26. Referring to
When the implantable medical device 30 is disengaged from the engagement member 20, the deployment system 10 may be removed from the patient alone or in conjunction with the catheter.
In the illustrated embodiment, the rotatable member 64 includes an internal threaded surface 66 which defines a lumen 68. The proximal end portion 18a of the carrier member 14a is located within the lumen 68, and a rim 70 extending radially form the proximal end portion 18a of the carrier member 14a is located within a groove 72 of the rotatable member 64 to mechanically and rotatably connect the rotatable member 64 to the carrier member 14a.
The handle body 62 includes a threaded portion 74 and a gripping portion 76 extending from the threaded portion 74. The threaded portion 74 is located within the lumen 68 of the rotatable member 64 and includes a threaded surface 78 corresponding to and engaging the threaded internal surface 66 of the rotatable member 64. The threaded engagement between the threaded portion 74 of the handle body 62 and the internal threaded surface 66 of the rotatable member 64 may be any suitable threaded engagement. In the illustrated embodiment, the threaded surface 78 of the threaded portion 74 includes a grooved thread 80, and the threaded surface 66 of the rotatable member 64 includes at least one projection 82 that follows along the groove 80 as the hand body 62 and rotatable member 64 are rotated relative to one another.
When the handle body 62 and the rotatable member 64 are rotated relative to one another, the threaded engagement between the handle body 62 and the rotatable member 64 causes the handle body 62 to move axially in a proximal or distal direction depending on the direction of relative rotation and the desired use. The proximal end 46a of the control member 26a is operatively connected to the handle body 62 so that the control member 26a moves proximally and distally with the handle body 62.
The handle body 62 and rotatable member 64 may be rotated relative to one another by a variety of methods. For example, the gripping portion 76 of the handle body 62 may be grasped to hold the handle body 62 in a rotationally stationary position, and the rotatable member 64 may be rotated relative to the handle body 62. In another method, the rotatable member 64 may be held in a rotationally stationary position, and the handle body 62 may be rotated relative to the rotatable member 64. Further, the rotatable member 64 could be rotated in one direction and the handle body 62 could be rotated in the other direction.
As illustrated in
In another embodiment illustrated in
The actuator 112 is moveably connected to the proximal end portion 118 of the carrier member 114 and can move axially in a proximal direction from the position shown in
The actuator 112 includes a gripping portion 134 and a threaded portion 136. The gripping portion 134 can be configured to be gasped by hand, medical instrument or both. Preferably, the gripping portion 134 functions as a percutaneous handle and has a gripping surface, such as a knarled surface or protruding wings.
The threaded portion 136 of the actuator 112 is configured to threadable engage a corresponding threaded portion 138 of the proximal end portion 118 of the carrier member 114. The threaded engagement between the actuator 112 and the carrier member 114 can be any suitable threaded connection. In the illustrated embodiment, the threading of the threaded portion 136 of the actuator 112 comprises a groove 40 and the threading of the corresponding threaded portion 138 of the proximal end portion 118 of the carrier member 114 comprises one or protrusions 142 which engage and follow the groove 140 as the actuator 112 is rotated relative to the carrier member 114. In an alternative embodiment, the outer surface of the proximal end 18 of the carrier member 114 could include threading in the form of a groove, and the threaded portion of the actuator 112 could include a protrusion that engages and follows the groove.
When the actuator 112 is threadably engaged with the carrier member 114, rotation of the actuator relative to the carrier member 114 causes the actuator 112 to move proximally or distally in an axial direction depending on the direction of relative rotation between the actuator and carrier member.
Referring to
Referring to
The rate of axial movement of actuator 112 can be controlled by the speed at which the actuator is rotated relative to the carrier member and the size of the pitch of the threading of the actuator. For example, at a constant speed of actuator rotation relative to the carrier member, a smaller or finer pitch size will result in relatively slower axial movement of the actuator relative to the carrier member, and a larger or coarser pitch size will result in relatively faster axial movement of the actuator relative to the carrier member. Thus, the size of the pitch can be tailored to the desired use.
As discussed above, the control member 126 is connected to the actuator 112. Accordingly, as the actuator 112 is moved axially relative to the carrier member 114, the control member 126 is also moved axially, in the same direction and at the same rate as the actuator 112, relative to the carrier member 14. Therefore, in the illustrated deployment system 110 of
Referring to
When the engaged device 130 has been properly positioned and oriented, the actuator 112 is grasped by hand or instrument at the gripping portion 134 and rotated relative to the carrier member 114. As the actuator 112 is rotated, the actuator and control member 126 initially move relatively slowly in a proximal direction as a result of the fine or short pitch size associated with the proximal end portion 144 of the threaded portion 136 of the actuator 112. As the actuator 112 is further rotated, the actuator 112 and control member 126 move proximally at a more accelerated rate, as a result of the coarse or larger pitch distance associated with the distal end portion 144 of the threaded portions 136 of the actuator 112. Referring to
It will be understood that the embodiments of the present invention which have been described are illustrative of some of the applications of the principles of the present invention. Numerous modifications may be made by those skilled in the art without departing from the true spirit and scope of the invention, including those combinations of features that are individually disclosed or claimed herein.
This patent application is a continuation which claims the benefit of (i) U.S. Provisional Patent Application No. 60/749,784, filed Dec. 13, 2005, and PCT/US2006/61916 filed Dec. 12, 2006; and (ii) U.S. Provisional Patent Application No. 60/749,838, filed Dec. 13, 2005 and PCT/US2006/61925 filed Dec. 12, 2006, which are hereby incorporated herein by reference.