Patent Grant
8777979
This disclosure relates to therapeutic implant delivery and retrieval systems and, more particularly, to a system with a member that mechanically engages an implant to be positioned in a body. The positioning includes delivering and deploying an implant at a target site, or removing an implant from the target site. The disclosure also relates to implants and, more particularly, to implants adapted to be mechanically retained by a delivery and retrieval system.
Sometimes a body cavity, such as an aneurysm, is located in a surgically remote, delicate, and torturously formed region, such as within the cerebral vasculature, that requires a specialized delivery system to navigate to the region and safely and reliably deliver a coil implant.
The positioning system includes an actuator operated by an operator, a positioner engaging the actuator, and an implant interface at the distal end of the positioner that engages a complementary portion of an implant.
The positioner provides the operator the ability to move the implant controllably through a microcatheter or delivery tube and to position the implant properly at a target site. The positioner provides a mechanical system for selectively engaging the implant, while maintaining a narrow profile and sufficient flexibility to navigate the tortuous pathways within the body that are navigated to reach the target site. While providing a small and flexible profile, the positioner has sufficient strength to allow the operator to controllably move the implant through the microcatheter, and the mechanical engagement with the implant remains functional and controllable when subjected to high tortuosity near the target site. The mechanical engagement of the positioner to the implant also maintains the proper orientation of the implant throughout the positioning procedure by allowing the implant to rotate and discharge any torsional forces induced during the movement of the implant to the target site. The positioner also allows the operator to control the movement of the positioner and implant by properly translating the control exerted by the operator into predictable and responsive movements near the target site.
The positioner achieves advantageous performance and overcomes problems believed to be limiting the performance of existing systems by providing a mechanical implant engagement system that permits free rotating movement while retaining the implant, and that provides minimal direct contact with the implant, so as to minimize the build up of torsional forces between the positioner and implant when the implant twists and rotates while moving through the microcatheter. The contact between the positioner and implant is minimized and fully rotatable so that the implant will maintain an acceptable orientation as it progresses to the target site while independently reacting to any forces acting on the implant when navigating the tortuous pathway to the target site. The minimization of contact and torsional forces between the positioner and implant improves the operator's ability to control the positioner, and improves accuracy in the positioning of the implant at the target site. The positioner also achieves advantageous performance by providing a mechanical implant engagement system that is narrow, flexible, and controllable. The positioner provides a narrow profile by employing a mechanical implant engagement system in which the implant moves in an axial direction when engaging or disengaging the positioner, without the need for transverse movement of the implant. The positioner provides improved flexibility by using a support structure that has varying flexibility along its length, with greater flexibility corresponding to more tortuous portions of the pathway to the target site. The positioner provides improved controllability by employing materials and surfaces that provide coefficients of friction selected with regard to the tortuosity of the pathway to the target site, and that are utilized in the positioner so as to correspond to the most tortuous portions of the pathway to the target site. The positioner also provides improved control by more fully and accurately communicating the control movements exerted by the operator to the movement of the positioner at the target site. The positioner also provides a system that permits the mechanical engagement or disengagement of the implant without the use of hydraulic, thermal, electrical, or chemical energy.
The implant interface allows the operator to mechanically control the engagement and disengagement of the implant to the positioner, and allows the positioner to retain the implant in a way that minimally contacts the implant, that permits movement in all directions of motion and rotationally, and that allows the implant to move axially and without radial movement when engaging and disengaging the implant interface. The implant interface provides mechanical control of the engagement and disengagement of the implant by retaining a member engaging the implant. The member is introduced into the implant interface through an opening in the positioning system, and retained at the implant interface by obstructing the opening at least in part, or fully, so as to physically prevent the complete exit of the member back through the opening. The obstructing is achieved with a movable elongate member disposed along the length of the positioning system with a distal end that obstructs the opening. By obstructing the opening and not fixedly restraining the implant, the implant remains free to move according to the limitations defined by the implant interface, which includes movement in the axial and radial directions compared to the axis of the positioning system, rotational movement about an axis of the implant, and angular movement that disposes the implant at an angle as compared to the axis of the positioning system. Furthermore, by obstructing the opening and not directly restraining the implant, the contact between the implant interface and the implant is minimized.
The therapeutic implant can be any implant that can be retained and positioned by the positioning system. The implant is retained by the implant interface with an extension engaging the implant. The extension can be a part of the implant when the implant is made, a modified portion of the manufactured implant, or attached to the implant after initial manufacturing. The extension provides an end that is disposed at a distance from the implant body, and allows the implant interface to engage and secure the implant by securing the end of the extension. The implant body itself; however, is not connected to the implant interface. The end of the extension may be a ball, but can take other forms.
The positioning system facilitates the unhindered rotation of the ball and implant, thereby avoiding the sudden or uncontrolled release of energy imparted to the system by the movement of the system to the target site. The free rotation of the implant and ball allows the implant to be deployed from the microcatheter at the target site much more gently than with existing systems having a connection that is rigid or that partly or wholly limits movement and rotation between the implant and delivery system, and the free rotation also lowers the force applied to the vasculature during deployment and positioning of the implant at the target site.
The implant interface also advantageously provides for the unrestrained axial movement of the ball within a cavity of the implant interface. The movement of the ball within the cavity is related to the longitudinal length of the cavity and the length of the rod engaging the implant and disposed in the cavity. When the implant and positioner are both advanced in the distal direction, friction against the surface of the implant will cause the ball to move axially to an extreme proximal position in the cavity and the proximal surface of the implant will abut the distal surface of positioner. When the positioner is advanced in the proximal direction, friction against the surface of the implant will cause the ball to move distally to an extreme distal position in the cavity, and that there will be minimal or no frictional contact between the positioner and implant. The differing frictional characteristics related to the axial movement of the ball in the cavity, and the degree of contact between implant and the implant interface, provides a “friction push” and a “frictionless pull” to the positioning system that is appealing to the operator because it provides an additional tactile sensation related to the movement of the system.
The axial movement of the ball in the cavity advantageously permits the implant to assume an angled orientation compared to the axis of the positioner, and articulate or pivot around the ball. That angled orientation and articulation advantageously assists in the relaxation and discharge of potential energy or spring forces in the implant, or between the implant and the positioner, as the implant is moved through the microcatheter.
The positioner also advantageously captures or recaptures an implant already located at or proximate the target site.
The actuator interface provides the operator the ability to control the movement of the implant as it is positioned by the positioning system, and to mechanically control the selective engagement and disengagement of the implant and implant interface. The actuator interface controls the movement of the implant by providing a surface upon which the operator can exert control, so that the controlling motions of the operator are accurately transferred to the implant interface and implant through the positioner. The actuator interface provides a relatively stiff proximal end of the positioner that transfers the axially-directed and rotational forces exerted on the actuator interface by the operator to the relatively flexibly distal end of the positioning system with minimal loss due to flexing and twisting of the positioning system. The actuator interface provides control of the engagement and disengagement of the implant from the implant interface with a sliding mechanism that controllably and predictably moves the implant interface between the engaged and disengaged orientations. The actuator interface also connects to an actuator that permits the operator to controllably and predictably move the slider. In addition, the actuator interface establishes and maintains a compressive biasing of the implant interface so that the implant interface remains in the engaged orientation by disposing the slider in a distally forward position.
The actuator provides a mechanism that removably engages the actuator interface and causes the controllable and predictable movement of the actuator interface. The actuator achieves this function by providing a structure that holds the outer tube in a fixed position relative to the body of the actuator, and a pawl and anvil that pinches the slider and pulls the slider in the proximal direction for a predetermined distance with a predetermined force, and then disengages from the slider to allow disengagement from the actuator. The actuator also provides a design that allows the operator to hold the actuator firmly in place, in order to maintain the position of the positioner relative to the target site, and allows the operator to utilize the actuator in a controlled manner that minimizes the movement of the positioner.
In order to minimize the force required from the operator, and to lessen the potential for failure of instrument components, the positioning system advantageously achieves improved pushability. The force applied to the proximal end of the positioner translates to an equal or near equal force at the distal end of the positioner. The positioning system also advantageously achieves improved pushability by reducing friction between the cord and the positioner, and between the positioner and the microcatheter. Advantageous force transfer ratio is achieved by reducing the average friction coefficient at the portions of the positioning system subject to the greatest tortuosity. This may be achieved by selecting specific materials and surface characteristics of mating surfaces at the portions of the positioning system subject to the greatest tortuosity.
The positioning system may achieve the appropriate level of flexibility by providing a relatively rigid structure at the proximal portion of the positioner, a relatively supple structure at the distal portion the positioner, and a transition region in the middle of the positioner that provides a change in flexibility between the proximal and distal portions. The proximal portion of the positioner may provide a flexibility (or stiffness) that remains almost constant along the length of this section of the positioner. The near-constant flexibility of the proximal portion is achieved by the use of a tube structure. The distal portion and the transition region achieve a suppleness with a combination of structural modifications to the tube structure that increases flexibility, the increase in the degree of those structural modifications along the length of the tube structure in the distal direction, and the structural support provided to the positioner by reinforcing structures. The flexibility of the distal portion increases along the length of this section, with the greatest suppleness achieved near or at the distal-most end of the positioner. The near-constant flexibility of the proximal portion is also achieved by a fully-enclosed tube structure of the positioner without the use of skiving. The variable flexibility characteristics of the distal portion and the transition region are achieved by a combination of a tube with skiving, the increase in the degree of the skiving along the length of the tube in the distal direction, and the structural support provided to the positioner by the positioner tube sleeve.
The positioning system achieves a mechanically-operated implant engagement and disengagement system with an appropriate profile, or size, by utilizing materials and surfaces with variable friction coefficients, strengths, and flexibilities appropriate for a positioner subjected to a tortuous pathway. The outer diameter of the distal end of the positioner is small enough to reach the target site while permitting the proper operation of the implant interface from a mechanical system connecting the implant interface to the proximal end of the positioning system.
The positioner avoids or minimizes the development of fatigue-related stresses at the interface between the positioner and implant by permitting the unrestrained movement of the implant relative to the positioner, within the limitations defined by the implant interface. The development of implant interface stresses is minimized or avoided because the ball, rod, and implant are able to move in the axial and radial directions compared to the axis of the positioning system, to rotate about an axis of the rod or implant, and to move angularly so that implant is at an angle as compared to the axis of the positioning system.
The positioning system does not require an additional step of preparing a coil detachment mechanism because the positioner and implant are already in an engaged orientation when removed from packaging and prior to insertion into a patient. The positioner and implant thus provide a system that is ready for use out of the package. The positioning system also provides a direct connection between the actuation of a detachment mechanism and the detachment of the implant from the delivery system, without an intermediary process to initiate and complete coil detachment. The positioning system thus achieves a fast preparatory and/or detachment time, which represents a short period of time between the opening of the packaging and the deployment of the implant. The positioning system can be prepared for use without delays relating to the preparation of the coil detachment mechanism, and can achieve detachment of the implant from the positioning system without delays resulting from an intermediate process to initiate and complete the detachment. The absence of such delays, and the connection of the detachment mechanism, provides a system that permits a fast and efficient deployment of implants at a target site. The reduction in the length of time required to prepare the positioning system advantageously increases the efficiency of the procedure because a coil detachment mechanism preparation step is not needed, thereby allowing the practitioner to attend to other duties during the invasive medical procedure. The reduced deployment time advantageously allows the length of the invasive medical procedure to be shortened because time is not needed for the detachment mechanism to achieve coil detachment. The short deployment time also allows the expended positioner to be removed soon after detachment and allow the next implant to be inserted and positioned in a given time interval.
Additional features and advantages of the subject technology will be set forth in the description below, and in part will be apparent from the description, or may be learned by practice of the subject technology. The advantages of the subject technology will be realized and attained by the structure particularly pointed out in the written description and claims hereof as well as the appended drawings.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the subject technology as claimed.
The subject technology is illustrated, for example, according to various aspects described below. Various examples of aspects of the subject technology are described as numbered clauses (1, 2, 3, etc.) for convenience. These are provided as examples, and do not limit the subject technology. It is noted that any of the dependent clauses may be combined in any combination, and placed into a respective independent clause, e.g., clause ——————. The other clauses can be presented in a similar manner.
Clause 1: An assembly for deploying an implant into an aneurysm in a vessel, comprising: a tubular member having a longitudinal axis, a wall defining a lumen along the axis, and a distal portion having an inner cross-sectional dimension and a distal end; a coil implant having an enlarged proximal end; and a core wire extending within the lumen and contacting the enlarged end at a point; wherein a length of a line segment extending from an outer surface of the enlarged end, through the point, and to an outer surface of the core wire is greater than the cross-sectional dimension, such that the enlarged end is prevented from moving within the lumen distally entirely past the distal end when the core wire and enlarged end are positioned radially adjacent each other within the lumen; and wherein at least a portion of the core wire is attached to the wall at a distal portion thereof, such that while the core wire and tubular member are attached, relative axial movement between the core wire and the tubular member is substantially prevented.
Clause 2: The assembly of clause 1, wherein the at least a portion of the core wire is attached to the wall by at least one of an adhesive, a tack weld, a circumferential weld, a pin, a crimp in the tubular member, solder, and a frangible connection.
Clause 3: The assembly of clause 1, wherein the at least a portion of the core wire is attached to the wall by an attachment that can be broken when the core wire is subjected to a predetermined force.
Clause 4: The assembly of clause 1, wherein the at least a portion of the core wire is attached to the wall at a portion proximal to a location where the core wire and enlarged end are radially adjacent each other relative to the axis.
Clause 5: The assembly of clause 1, wherein the coil implant further comprises: a coil comprising a proximal portion and a distal portion; a stretch-resistant member extending through the coil and having a proximal end and a distal end, the stretch-resistant member distal end coupled to the coil distal portion; wherein the enlarged proximal end is disposed at the proximal end of the stretch-resistant member and is otherwise free of the proximal portion of the coil.
Clause 6: The assembly of clause 1, wherein a coil of the coil implant is disposed entirely outside the lumen.
Clause 7: The assembly of clause 1, wherein the enlarged proximal end is spaced apart from a coil of the coil implant.
Clause 8: An assembly for deploying an implant into an aneurysm in a vessel, comprising: a tubular member having a longitudinal axis, a wall defining a lumen along the axis, the lumen comprising (i) a distal portion having an inner cross-sectional dimension and a distal end and (ii) a reduced portion, proximal to the distal portion, having a reduced cross-sectional dimension; a coil implant having an enlarged proximal end proximal to the distal end and distal to the reduced portion; and a core wire extending within the lumen, the core wire contacting the enlarged end at a point and having an enlarged region, proximal to the reduced portion, having an enlarged cross-sectional dimension transverse to the axis and greater than the reduced cross-sectional dimension; wherein a length of a line segment extending from an outer surface of the enlarged end, through the point, and to an outer surface of the core wire is greater than the inner cross-sectional dimension, such that the enlarged end is prevented from moving within the lumen distally entirely past the distal end when the core wire and enlarged end are positioned radially adjacent each other within the lumen; and wherein the core wire is substantially prevented from distal axial movement of the enlarged region past the reduced portion.
Clause 9: The assembly of clause 8, wherein a portion of the core wire proximal to the enlarged region is compressively biased toward the reduced portion, such that distal movement of the core wire relative to the tubular member is restricted.
Clause 10: The assembly of clause 8, wherein the enlarged region abuts the wall.
Clause 11: The assembly of clause 8, wherein the reduced portion extends through an obstructing member within the lumen.
Clause 12: An assembly for deploying an implant into an aneurysm in a vessel, comprising: a tubular member having a longitudinal axis from a proximal end to a distal end, a wall defining a lumen along the axis, and a distal portion having an inner cross-sectional dimension; a coil implant having an enlarged proximal end; and a core wire extending within the lumen and contacting the enlarged end at a point; wherein a length of a line segment extending from an outer surface of the enlarged end, through the point, and to an outer surface of the core wire is greater than the cross-sectional dimension, such that the enlarged end is prevented from moving within the lumen distally entirely past the distal end when the core wire and enlarged end are positioned radially adjacent each other within the lumen; wherein, prior to release of the coil implant from the tubular member and when the enlarged end is unable to move within the lumen distally past the tubular member distal portion, the core wire extends through the lumen and beyond the distal end.
Clause 13: The assembly of clause 12, wherein the core wire extends into the coil.
Clause 14: The assembly of clause 12, wherein the core wire extends by at least the distance from the enlarged proximal end of the coil to the distal end of the tubular member.
Clause 15: The assembly of clause 12, wherein the core wire is eccentrically positioned through the lumen.
Clause 16: The assembly of clause 12, wherein the core wire abuts the wall.
Clause 17: The assembly of clause 12, wherein the core wire extends beyond a distalmost portion of the lumen.
Clause 18: The assembly of clause 12, wherein the coil implant further comprises: a coil comprising a proximal portion and a distal portion; a stretch-resistant member extending through the coil and having a proximal end and a distal end, the stretch-resistant member distal end coupled to the coil distal portion; wherein the enlarged proximal end is disposed at the proximal end of the stretch-resistant member and is otherwise free of the proximal portion of the coil.
Clause 19: An assembly for deploying an implant into an aneurysm in a vessel, comprising: a tubular member having a longitudinal axis, a wall defining a lumen along the axis, and a distal portion having an inner cross-sectional dimension and a distal end; a coil implant having an enlarged proximal end; and a core wire having a distal end, extending within the lumen, and contacting the enlarged end at a point; wherein a length of a line segment extending from an outer surface of the enlarged end, through the point, and to an outer surface of the core wire is greater than the cross-sectional dimension, such that the enlarged end is prevented from moving within the lumen distally entirely past the tubular member distal end when the core wire and enlarged end are positioned radially adjacent each other within the lumen; and wherein the core wire is compressively biased toward the tubular member distal portion, such that axial movement of the core wire relative to the tubular member is restricted.
Clause 20: The assembly of clause 19, wherein the distal end of core wire axially abuts the tubular member distal portion.
Clause 21: The assembly of clause 19, wherein the core wire is compressively biased against the tubular member distal portion, such that proximal movement of the core wire relative to the tubular member is substantially prevented until the core wire is subjected to a predetermined force.
Clause 22: The assembly of clause 19, wherein the core wire is compressively biased toward the tubular member distal portion, such that distal movement of the core wire relative to the tubular member is restricted.
Clause 23: The assembly of clause 19, wherein the coil implant further comprises: a coil comprising a proximal portion and a distal portion; a stretch-resistant member extending through the coil and having a proximal end and a distal end, the stretch-resistant member distal end coupled to the coil distal portion; wherein the enlarged proximal end is disposed at the proximal end of the stretch-resistant member and is otherwise free of the proximal portion of the coil.
Clause 24: An assembly for deploying an implant into an aneurysm in a vessel, comprising: a tubular member having a longitudinal axis, a wall defining a lumen along the axis, and a distal portion having an inner cross-sectional dimension and a distal end; a coil implant having an enlarged proximal end; a core wire extending within the lumen and contacting the enlarged end at a point; and a restraining member, disposed within the lumen proximal to the enlarged end, configured to limit non-axial translational movement of the core wire within the lumen; wherein a length of a line segment extending from an outer surface of the enlarged end, through the point, and to an outer surface of the core wire is greater than the cross-sectional dimension, such that the enlarged end is prevented from moving within the lumen distally entirely past the distal end when the core wire and enlarged end are positioned radially adjacent each other within the lumen.
Clause 25: The assembly of clause 24, wherein the core wire extends through the restraining member.
Clause 26: The assembly of clause 24, wherein the restraining member extends within the lumen a distance of a majority of a length of the tubular member.
Clause 27: The assembly of clause 24, wherein the restraining member provides an inner cross-sectional dimension less than an inner cross-sectional dimension of the tubular member.
Clause 28: The assembly of clause 24, wherein the restraining member comprises polytetrafluoroethylene.
Clause 29: An assembly for deploying an implant into an aneurysm in a vessel, comprising: a tubular member having a longitudinal axis, a wall defining a lumen along the axis, and a distal portion having an inner cross-sectional dimension and a distal end; a coil implant having an enlarged proximal end; a core wire extending within the lumen and contacting the enlarged end at a point; and a limiting member extending radially inwardly from the wall proximal to the enlarged end, the limiting member configured to receive a proximal region of the core wire and limit non-axial translational movement of the core wire within the lumen; wherein a length of a line segment extending from an outer surface of the enlarged end, through the point, and to an outer surface of the core wire is greater than the cross-sectional dimension, such that the enlarged end is prevented from moving within the lumen distally entirely past the distal end when the core wire and enlarged end are positioned radially adjacent each other within the lumen.
Clause 30: The assembly of clause 29, wherein, at the distal portion, the wall comprises at least one section extending at least partially through the wall.
Clause 31: The assembly of clause 30, wherein, the at least one section is selected from the group consisting of a skived section, a slot, a gap, a hole, a spiral cut, and a reduced thickness in the tubular wall.
Clause 32: An assembly for deploying an implant into an aneurysm in a vessel, comprising: a tubular member having a longitudinal axis, a wall defining a lumen along the axis, and a distal portion having an inner cross-sectional dimension and a distal end; a coil implant having an enlarged proximal end; and a core wire extending within the lumen and contacting the enlarged end at a point, the core wire comprising a region having a cross-section that has, in a plane transverse to the longitudinal axis and intersecting the point, a concave first side; wherein a length of a line segment extending from an outer surface of the enlarged end, through the point, and to an outer surface of the core wire is greater than the cross-sectional dimension, such that the enlarged end is prevented from moving within the lumen distally entirely past the distal end when the core wire and enlarged end are positioned radially adjacent each other within the lumen.
Clause 33: The assembly of clause 32, wherein the cross-section has a convex second side facing away from the enlarged end.
Clause 34: The assembly of clause 33, wherein the second side contacts the wall.
Clause 35: The assembly of clause 32, wherein the first side contacts the enlarged end.
Clause 36: An assembly for deploying an implant into an aneurysm in a vessel, comprising: a tubular member having a longitudinal axis, a wall defining a lumen along the axis, and a distal portion having an inner cross-sectional dimension and a distal end; a coil implant comprising: (i) a coil having an enlarged proximal end, a proximal portion, and a distal portion; (ii) a stretch-resistant member extending through the coil and having a proximal end and a distal end, the stretch-resistant member distal end coupled to the coil distal portion; (iii) an attachment member disposed at the proximal end of the stretch-resistant member and otherwise free of the proximal portion of the coil; the attachment member being disposed within the lumen, such that the coil implant is configured to at least one of (i) move axially relative to the tubular member a distance of at least a length of the attachment member and (ii) tilt about the attachment member within a range of angles relative to the longitudinal axis.
Clause 37: The assembly of clause 36, further comprising: a core wire extending within the lumen and contacting the attachment member at a point.
Clause 38: The assembly of clause 37, wherein a length of a line segment extending from an outer surface of the attachment member, through the point, and to an outer surface of the core wire is greater than the cross-sectional dimension, such that the attachment member is prevented from moving within the lumen distally entirely past the tubular member distal end when the core wire and attachment member are positioned radially adjacent each other within the lumen.
Clause 39: The assembly of clause 38, wherein the coil implant is configured to move axially relative to the tubular member the distance of at least the length of the attachment member while the core wire is contacting the attachment member at the point.
Clause 40: The assembly of clause 38, wherein the coil implant is configured to tilt about the attachment member within the range of angles relative to the longitudinal axis while the core wire is contacting the attachment member at the point.
Clause 41: The assembly of clause 36, wherein the proximal portion of the coil is spaced apart from the tubular member distal portion.
Clause 42: The assembly of clause 36, wherein the coil implant is configured to rotate about the longitudinal axis.
Clause 43: The assembly of clause 38, wherein the coil implant is configured to rotate about the longitudinal axis while the core wire is contacting the attachment member at the point.
Clause 44: The assembly of clause 36, wherein the range of angles is about 10 to about 50 degrees.
Clause 45: The assembly of clause 36, wherein the coil is disposed entirely outside the lumen.
Clause 46: The assembly of clause 36, wherein the coil implant is configured to both (i) axially move relative to the tubular member a distance of at least a length of the attachment member and (ii) tilt about the attachment member within a range of angles relative to the longitudinal axis.
Clause 47: The assembly of clause 46, wherein the coil implant is configured to rotate about the longitudinal axis.
Clause 48: An assembly for deploying an implant into an aneurysm in a vessel, comprising: a tubular member having a longitudinal axis, a wall defining a lumen along the axis, and a distal portion having an inner cross-sectional dimension and a distal end; a coil implant comprising: (i) a coil having an enlarged proximal end, a proximal portion, and a distal portion; (ii) a stretch-resistant member extending through the coil and having a proximal end and a distal end, the stretch-resistant member distal end coupled to the coil distal portion; (iii) an attachment member disposed at the proximal end of the stretch-resistant member and otherwise free of the proximal portion of the coil; the attachment member being disposed within the lumen, such that the coil implant is configured to tilt about the attachment member within a range of angles relative to the longitudinal axis.
Clause 49: The assembly of clause 48, further comprising: a core wire extending within the lumen and contacting the attachment member at a point.
Clause 50: The assembly of clause 49, wherein a length of a line segment extending from an outer surface of the attachment member, through the point, and to an outer surface of the core wire is greater than the cross-sectional dimension, such that the attachment member is prevented from moving within the lumen distally entirely past the tubular member distal end when the core wire and attachment member are positioned radially adjacent each other within the lumen.
Clause 51: The assembly of clause 50, wherein the coil implant is configured to tilt about the attachment member within the range of angles relative to the longitudinal axis while the core wire is contacting the attachment member at the point.
Clause 52: The assembly of clause 48, wherein the proximal portion of the coil is spaced apart from the tubular member distal portion.
Clause 53: The assembly of clause 48, wherein the coil implant is configured to rotate about the longitudinal axis.
Clause 54: The assembly of clause 50, wherein the coil implant is configured to rotate about the longitudinal axis while the core wire is contacting the attachment member at the point.
Clause 55: The assembly of clause 48, wherein the range of angles is about 10 to about 50 degrees.
Clause 56: The assembly of clause 48, wherein the coil is disposed entirely outside the lumen.
Clause 57: The assembly of clause 48, wherein the coil implant is configured to axially move relative to the tubular member a distance of at least a length of the attachment member.
Clause 58: The assembly of clause 50, wherein the coil implant is configured to axially move relative to the tubular member the distance of at least the length of the attachment member while the core wire is contacting the attachment member at the point.
Clause 59: An assembly for deploying an implant into an aneurysm in a vessel, comprising: a tubular member having a longitudinal axis, a wall defining a lumen along the axis, and a distal portion having an inner cross-sectional dimension and a distal end; a coil implant having an enlarged proximal end; a core wire extending within the lumen and contacting the enlarged end at a point; and wherein a length of a line segment extending from an outer surface of the enlarged end, through the point, and to an outer surface of the core wire is greater than the cross-sectional dimension, such that the enlarged end is prevented from moving within the lumen distally entirely past the distal end when the core wire and enlarged end are positioned radially adjacent each other within the lumen; and wherein, when the enlarged end is disposed within the lumen, the core wire extends distally beyond a distal end of the enlarged end to the tubular member distal portion.
Clause 60: The assembly of clause 59, wherein the core wire extends beyond a distalmost portion of the lumen.
Clause 61: The assembly of clause 59, wherein the coil implant further comprises a coil having a proximal portion and a distal portion.
Clause 62: The assembly of clause 61, wherein the coil implant further comprises a stretch-resistant member extending through the coil and having a proximal end and a distal end, the stretch-resistant member distal end coupled to the coil distal portion.
Clause 63: The assembly of clause 62, wherein the enlarged proximal end is disposed at the proximal end of the stretch-resistant member and is otherwise free of the proximal portion of the coil.
Clause 64: An assembly for deploying an implant into an aneurysm in a vessel, comprising: a tubular member having a longitudinal axis, a wall defining a lumen along the axis, and a distal portion having an inner cross-sectional dimension and a distal end; a coil implant comprising: (i) a coil; (ii) an enlarged proximal end spaced apart from the coil; a core wire extending within the lumen and contacting the enlarged end at a point; and wherein a length of a line segment extending from an outer surface of the enlarged end, through the point, and to an outer surface of the core wire is greater than the cross-sectional dimension, such that the enlarged end is prevented from moving within the lumen distally entirely past the distal end when the core wire and enlarged end are positioned radially adjacent each other within the lumen.
Clause 65: The assembly of clause 64, wherein the coil further comprises a proximal portion and a distal portion.
Clause 66: The assembly of clause 65, wherein the coil implant further comprises a stretch-resistant member extending through the coil and having a proximal end and a distal end, the stretch-resistant member distal end coupled to the coil distal portion.
Clause 67: The assembly of clause 66, wherein the enlarged proximal end is disposed at the proximal end of the stretch-resistant member and is otherwise free of the proximal portion of the coil.
Clause 68: The assembly of clause 64, wherein, when the core wire and enlarged proximal end are positioned radially adjacent each other relative to the axis, the enlarged proximal end abuts the wall.
Clause 69: The assembly of clause 64, wherein, at the distal portion, the wall comprises at least one section extending at least partially through the wall.
Clause 70: The assembly of clause 69, wherein, the at least one section is selected from the group consisting of a skived section, a slot, a gap, a hole, a spiral cut, and a reduced thickness in the tubular wall.
Clause 71: The assembly of claim 64, wherein core wire comprises at least one segment tapering from a first cross-sectional dimension to a second, smaller cross-sectional dimension.
Clause 72: An assembly for deploying an implant into an aneurysm in a vessel, comprising: a tubular member having a longitudinal axis, a wall defining a lumen along the axis, and a distal portion having an inner cross-sectional dimension and a distal end; a coil implant comprising: (i) a coil disposed entirely outside the lumen; (ii) an enlarged proximal end disposed within the lumen; a core wire extending within the lumen and contacting the enlarged end at a point; and wherein a length of a line segment extending from an outer surface of the enlarged end, through the point, and to an outer surface of the core wire is greater than the cross-sectional dimension, such that the enlarged end is prevented from moving within the lumen distally entirely past the distal end when the core wire and enlarged end are positioned radially adjacent each other within the lumen.
Clause 73: The assembly of clause 72, wherein the coil further comprises a proximal portion and a distal portion.
Clause 74: The assembly of clause 73, wherein the coil implant further comprises a stretch-resistant member extending through the coil and having a proximal end and a distal end, the stretch-resistant member distal end coupled to the coil distal portion.
Clause 75: The assembly of clause 74, wherein the enlarged proximal end is disposed at the proximal end of the stretch-resistant member and is otherwise free of the proximal portion of the coil.
Clause 76: The assembly of clause 72, wherein, when the core wire and enlarged proximal end are positioned radially adjacent each other relative to the axis, the enlarged proximal end abuts the wall.
Clause 77: The assembly of clause 72, wherein, at the distal portion, the wall comprises at least one section extending at least partially through the wall.
Clause 78: The assembly of clause 77, wherein, the at least one section is selected from the group consisting of a skived section, a slot, a gap, a hole, a spiral cut, and a reduced thickness in the tubular wall.
Clause 79: The assembly of claim 72, wherein core wire comprises at least one segment tapering from a first cross-sectional dimension to a second, smaller cross-sectional dimension.
Clause 80: An assembly for deploying an implant into an aneurysm in a vessel, comprising: a tubular member having a longitudinal axis, a wall defining a lumen along the axis, and a distal portion having an inner cross-sectional dimension and a distal end; a coil implant comprising: (i) a coil having a proximal portion and a distal portion; (ii) a stretch-resistant member extending through the coil and having a proximal end and a distal end, the stretch-resistant member distal end coupled to the coil distal portion; (iii) an enlarged proximal end disposed at the proximal end of the stretch-resistant member and otherwise free of the proximal portion of the coil; a core wire extending within the lumen and contacting the enlarged end at a point; and wherein a length of a line segment extending from an outer surface of the enlarged end, through the point, and to an outer surface of the core wire is greater than the cross-sectional dimension, such that the enlarged end is prevented from moving within the lumen distally entirely past the tubular member distal end when the core wire and enlarged end are positioned radially adjacent each other within the lumen.
Clause 81: The assembly of clause 80, wherein, when the core wire and enlarged end are positioned radially adjacent each other relative to the axis, the enlarged proximal end abuts the wall.
Clause 82: The assembly of clause 80, wherein, at the distal portion, the wall comprises at least one section extending at least partially through the wall.
Clause 83: The assembly of clause 82, wherein, the at least one section is selected from the group consisting of a skived section, a slot, a gap, a hole, a spiral cut, and a reduced thickness in the tubular wall.
Clause 84: The assembly of claim 80, wherein core wire comprises at least one segment tapering from a first cross-sectional dimension to a second, smaller cross-sectional dimension.
Clause 85: An assembly for deploying an implant into an aneurysm in a vessel, comprising: a tubular member having a longitudinal axis, a wall defining a lumen along the axis, and a distal portion having an inner cross-sectional dimension and a distal end; a coil implant having an enlarged proximal end; and a core wire extending within the lumen and contacting the enlarged end at a point, the core wire comprising a region having a cross-section that is, in a plane transverse to the longitudinal axis and intersecting the point, substantially crescent shaped; wherein a length of a line segment extending from an outer surface of the enlarged end, through the point, and to an outer surface of the core wire is greater than the cross-sectional dimension, such that the enlarged end is prevented from moving within the lumen distally entirely past the distal end when the core wire and enlarged end are positioned radially adjacent each other within the lumen.
Clause 86: The assembly of clause 85, wherein the cross-section has a concave first side facing toward the enlarged end.
Clause 87: The assembly of clause 86, wherein the first side contacts the enlarged end when the core wire contacts the enlarged end.
Clause 88: The assembly of clause 85, wherein the cross-section has a convex second side facing away from the enlarged end.
Clause 89: The assembly of clause 88, wherein the second side contacts the wall when the core wire contacts the enlarged end.
Clause 90: The assembly of claim 85, wherein core wire comprises at least one segment tapering from a first cross-sectional dimension to a second, smaller cross-sectional dimension.
Clause 91: An assembly for deploying an implant into an aneurysm in a vessel, comprising: a tubular member having a longitudinal axis, a wall defining a lumen along the axis, and a distal portion having an inner cross-sectional dimension and a distal end; a coil implant having an enlarged proximal end; and a core wire extending within the lumen and contacting the enlarged end at a point; wherein a length of a line segment extending from an outer surface of the enlarged end, through the point, and to an outer surface of the core wire is greater than the cross-sectional dimension, such that the enlarged end is prevented from moving within the lumen distally entirely past the distal end when the core wire and enlarged end are positioned radially adjacent each other within the lumen; and wherein a region of the wall has a non-circular cross-sectional shape in a plane perpendicular to the longitudinal axis and intersecting the point, wherein the core wire is restrained by the wall from moving about a circumference of the lumen while the core wire is contacting the enlarged end.
Clause 92: The assembly of clause 91, wherein the region has a substantially oval cross-sectional shape in the plane.
Clause 93: The assembly of clause 91, wherein the tubular member has an outer profile with a substantially circular cross-sectional shape in the plane.
Clause 94: The assembly of clause 91, wherein a thickness of the tubular member varies at the region.
Clause 95: The assembly of clause 91, wherein the coil implant further comprises (i) a coil having a proximal portion and a distal portion and (ii) a stretch-resistant member extending through the coil and having a proximal end and a distal end, the stretch-resistant member distal end coupled to the coil distal portion, wherein the enlarged proximal end is disposed at the proximal end of the stretch-resistant member and is otherwise free of the proximal portion of the coil.
Clause 96: An assembly for deploying an implant into an aneurysm in a vessel, comprising: a tubular member having (i) a longitudinal axis, (ii) a wall defining a lumen along the axis, (iii) an aperture through the wall, (iv) an arm extending from an edge of the aperture, covering at least a portion of the aperture, and curving radially inward toward the axis, and (v) a distal portion having an inner cross-sectional dimension and a distal end; a coil implant having an enlarged proximal end; and a core wire extending within the lumen and contacting the enlarged end at a point; wherein a length of a line segment extending from an outer surface of the enlarged end, through the point, and to an outer surface of the core wire is greater than the cross-sectional dimension, such that the enlarged end is prevented from moving within the lumen distally entirely past the distal end when the core wire and enlarged end are positioned radially adjacent each other within the lumen.
Clause 97: The assembly of clause 96, wherein no part of the arm extends a radial distance from the axis greater than an outer radius of the tubular member.
Clause 98: The assembly of clause 96, wherein a portion of the arm extends inward toward the axis to a radial distance from the axis less than an outer radius of the tubular member.
Clause 99: The assembly of clause 96, wherein the arm is in contact with the enlarged end when the enlarged end is within the aperture and contacting the core wire.
Clause 100: An assembly for deploying an implant into an aneurysm in a vessel, comprising: a tubular member having a longitudinal axis, a wall defining a lumen along the axis, the lumen comprising (i) a distal portion having a cross-sectional dimension (ii) a distal end, and (iii) a reduced portion, proximal to the distal portion, having a non-circular first cross-sectional profile; a coil implant having an enlarged proximal end; and a core wire extending within the lumen through the reduced portion and contacting the enlarged end at a point, the core wire comprising an enlarged region having a second cross-sectional profile, wherein (i) travel of the enlarged region through the reduced portion is limited while in a first rotational state relative to the reduced portion and (ii) travel of the enlarged region through the reduced portion is permitted while in a second rotational state relative to the reduced portion; wherein a length of a line segment extending from an outer surface of the enlarged end, through the point, and to an outer surface of the core wire is greater than the cross-sectional dimension, such that the enlarged end is prevented from moving within the lumen distally entirely past the distal end when the core wire and enlarged end are positioned radially adjacent each other within the lumen.
Clause 101: The assembly of clause 100, wherein the second cross-sectional profile is geometrically similar to the first cross-sectional profile.
Clause 102: The assembly of clause 100, wherein the second cross-sectional profile is congruent to a uniform scaling of the first cross-sectional profile.
Clause 103: The assembly of clause 100, wherein the second cross-sectional profile has substantially the same shape as the first cross-sectional profile.
Clause 104: The assembly of clause 100, wherein the second cross-sectional profile and the first cross-sectional profile comprise non-square rectangles.
Clause 105: The assembly of clause 100, wherein a portion of the core wire proximal to the enlarged region is compressively biased toward the reduced portion, such that distal movement of the core wire relative to the tubular member is restricted while the enlarged region is in the first rotational state.
Clause 106: The assembly of clause 100, wherein the reduced portion extends through an obstructing member within the lumen.
Clause 107: The assembly of clause 106, wherein a proximal surface of the enlarged region is substantially parallel to a distal surface of the obstructing member.
Clause 108: The assembly of clause 100, wherein the first rotational state comprises a first position of rotation of the enlarged region about the longitudinal axis.
Clause 109: An assembly for deploying an implant into an aneurysm in a vessel, comprising: a tubular member having a longitudinal axis, a wall defining a lumen along the axis, an aperture through the wall, and a distal portion having an inner cross-sectional dimension and a distal end; a coil implant having an enlarged proximal end, the enlarged end having (i) a primary portion residing in the lumen and (ii) a secondary portion extending from the primary portion into the aperture and engaging an edge of the aperture; and a core wire extending within the lumen and contacting the enlarged end at a point; wherein a length of a line segment extending from an outer surface of the enlarged end, through the point, and to an outer surface of the core wire is greater than the cross-sectional dimension, such that the enlarged end is prevented from moving within the lumen distally entirely past the distal end when the core wire and enlarged end are positioned radially adjacent each other within the lumen.
Clause 110: The assembly of clause 109, wherein a distal surface of the secondary portion engages a distal surface of the edge.
Clause 111: The assembly of clause 109, wherein the primary portion is substantially spherical.
Clause 112: The assembly of clause 109, wherein the secondary portion is substantially non-spherical.
Clause 113: The assembly of clause 109, wherein the secondary portion is substantially cylindrical.
Clause 114: The assembly of clause 109, wherein a first width of the secondary portion distal to the primary portion is greater than a second width of the secondary portion proximal to the primary portion.
The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate exemplary embodiments of the disclosure, and, together with the general description given above and the detailed description given below, serve to explain the features of the disclosure.
In the following detailed description, numerous specific details are set forth to provide a full understanding of the subject technology. It will be apparent, however, to one ordinarily skilled in the art that the subject technology may be practiced without some of these specific details. In other instances, well-known structures and techniques have not been shown in detail so as not to obscure the subject technology.
A phrase such as “an aspect” does not imply that such aspect is essential to the subject technology or that such aspect applies to all configurations of the subject technology. A disclosure relating to an aspect may apply to all configurations, or one or more configurations. An aspect may provide one or more examples of the disclosure. A phrase such as “an aspect” may refer to one or more aspects and vice versa. A phrase such as “an embodiment” does not imply that such embodiment is essential to the subject technology or that such embodiment applies to all configurations of the subject technology. A disclosure relating to an embodiment may apply to all embodiments, or one or more embodiments. An embodiment may provide one or more examples of the disclosure. A phrase such “an embodiment” may refer to one or more embodiments and vice versa. A phrase such as “a configuration” does not imply that such configuration is essential to the subject technology or that such configuration applies to all configurations of the subject technology. A disclosure relating to a configuration may apply to all configurations, or one or more configurations. A configuration may provide one or more examples of the disclosure. A phrase such as “a configuration” may refer to one or more configurations and vice versa.
U.S. Pat. Nos. 5,122,136 and 5,423,829 describe some existing electrolytic delivery systems having a pusher attached to an implantable platinum coil by detachment segment that can be eroded by an electrolytic process. The coil is advanced by the pusher through a microcatheter to the desired target site within the vasculature and an electrical current is applied to the pusher at the detachment segment. The electrical current causes the electrolytic erosion of the detachment segment that results in the separation of the coil from the pusher and the release of the coil at the target site. It is believed that there are numerous drawbacks and disadvantages to such electrolytic systems. One disadvantage of this design is believed to be that the detachment segment must be positioned distally of microcatheter for release (i.e., the operator cannot “pre-release” the coil within microcatheter if desired). Another disadvantage is believed to be that these systems require electrical insulation and isolation of the detachment segment to reduce the release of metallic particles created during detachment, which may cause unwanted embolization downstream of the target site. Another disadvantage is believed to be that these systems require the practitioner to wait for an unknown amount of time, typically 10-180 seconds, until the implant coil is released, with the release monitored by feedback from a specialized system using complex electrical drivers. Yet another disadvantage is believed to be that these systems generate “false positives” quite often, at a rate of 3-10%, that falsely indicate that the coil has been released when in fact it has not. Further, as with any electrochemical reaction in solution, the system needs to be within ionic fluids to function, and it is believed that undesirable gases are formed at both the anode and the cathode. Additionally, it is believed that there are guide wire and delivery system size limitations because these systems require a constant flow of electrolytes such as saline through the microcatheter to hasten the detachment time of the coil. Because of this need for electrolytes, it is believed that the outer diameter of an electrolytic delivery system is optimized for saline flow rather than for considerations of coil deliverability, pushability, and force transfer of the pusher, and the suppleness of the distal end of the delivery system.
U.S. Pat. Nos. 6,063,100 and 6,607,538 describe hydraulic delivery systems having a pusher attached to an implantable platinum coil with a frictional fit between a pressure cuff on the distal end of the pusher and a cylindrical solid proximal end of the coil. The platinum coil is advanced through a microcatheter by the pusher into the target site. Hydraulic pressure is applied to the proximal end of the pusher, creating hydraulic pressure at the distal end of the pusher and causing the cylindrical solid proximal end of the coil to be pushed out of the pressure cuff to cause the separation of the coil from the pusher. One disadvantage of this design is believed to be that such systems require complex catheter construction and rigorous purging to avoid the delivery of air emboli. Even after purging, it is believed that some air emboli are usually left in the system and will be inevitably injected into the patient during the detachment process. Another disadvantage is believed to be that these systems are time consuming to use because of the preparation of the pusher and because of the filling and attachment of pressure syringes. These systems are believed to be less reliable than electrolytic systems and at times have either failed to release the coil or prematurely released the coil. Additionally, with this type of design, it is believed that the delivery system is optimally sized for hydraulic detachment, and not sized to facilitate coil delivery or the action of the pusher-coil interface. These delivery systems have generally hollow conduits designed for high hydraulic pressures and, as a result, are rigid. The coil-pusher interface, as well, is stiff because part of the proximal end of the coil is wedged tightly into the distal end of the pusher.
U.S. Pat. No. 5,234,437 describes a mechanical delivery system with a pusher that is attached to an implantable platinum coil by a threaded portion at the distal end of the pusher that screws into the inner winds of the coil. The coil is advanced by the pusher through a microcatheter into the target site. Once positioned, the operator twists the proximal end of the pusher a number of times to unscrew the distal end of the pusher from coil implant. A disadvantage of this design is believed to be that the system will not work well in highly tortuous anatomy due to the diminishing torque transmission of the pusher, that is, the body of the pusher itself twists with little or no rotation of the threaded portion. The unscrewing operation of the pusher is also believed to cause undesirable movement of the entire system that could cause misalignment with the target site and cause the coil to be positioned undesirably within the target vessel. Also, the screw design is believed to require the operator to hyper-extend the pusher beyond the tip of the microcatheter to effect release and is non-retrievable at that point.
U.S. Pat. No. 5,895,391 and U.S. Pat. Publ. No. 2006/0276823 describe mechanical delivery systems. U.S. Pat. No. 5,895,391 describes a mating member attached to a vaso-occlusive member that is held in an opening with an interference wire. The interference wire presses the mating member into an opening through the wall of a holding member. U.S. Pat. Publ. No. 2006/0276823 describes a mechanical interlocking mechanism with engagement member attached to a distal end of a pusher member and that extends through a retaining ring at a proximal end of an embolic device. A detachment member extends through an aperture at the distal end of the engagement member to lock the embolic device onto the pusher member.
Accordingly a need exists for an implant delivery system that is easier to use and more reliable than systems currently on the market and that requires fewer steps and faster detachment.
A further need exists for a technique for treating a vascular defect or lesion with platinum coils without creating metallic or gaseous particulates during the detachment process.
A further need exists for an implant delivery system that has increased reliability measured by fewer false positive detachments and fewer premature detachments.
A further need exists for a coil-to-pusher interface that is less rigid than those of existing systems.
A further need exists for an implant delivery system with superior pushability with a supple distal flexibility profile.
As illustrated in
In the embodiment illustrated in
Positioner
The positioner provides the operator the ability to move the implant controllably through the microcatheter and to position the implant properly at the target site. The positioner provides a mechanical system for selectively engaging the implant, while maintaining a narrow profile and sufficient flexibility to navigate the tortuous pathways within the body to reach the target site. While providing a small and flexible profile, the positioner has sufficient strength to allow the operator to controllably move the implant through the microcatheter, and the mechanical engagement with the implant remains functional and controllable when subjected to high tortuosity near the target site. The mechanical engagement of the positioner to the implant also maintains the proper orientation of the implant throughout the positioning procedure by allowing the implant to rotate and discharge any torsional forces induced during the movement of the implant to the target site. The positioner also allows the operator to control the movement of the positioner and implant by properly translating the control exerted by the operator into predictable and responsive movements near the target site.
The positioner achieves advantageous performance and overcomes problems believed to be limiting the performance of existing systems by providing a mechanical implant engagement system that permits free rotating movement while retaining the implant, and that provides minimal direct contact with the implant, so as to minimize the build up of torsional forces between the positioner and implant when the implant twists and rotates while moving through the microcatheter. The contact between the positioner and implant is minimized and fully rotatable so that the implant will maintain an acceptable orientation as it progresses to the target site while independently reacting to any forces acting on the implant when navigating the tortuous pathway to the target site. The minimization of contact and torsional forces between the positioner and implant improves the operator's ability to control the positioner, and improves accuracy in the positioning of the implant at the target site. The positioner also achieves advantageous performance by providing a mechanical implant engagement system that is narrow, flexible, and controllable. The positioner provides a narrow profile by employing a mechanical implant engagement system in which the implant moves in an axial direction when engaging or disengaging the positioner, without the need for transverse movement of the implant. The positioner provides improved flexibility by using a support structure that has varying flexibility along its length, with greater flexibility corresponding to more tortuous portions of the pathway to the target site. The positioner provides improved controllability by employing materials and surfaces that provide coefficients of friction selected with regard to the tortuosity of the pathway to the target site, and that are utilized in the positioner so as to correspond to the most tortuous portions of the pathway to the target site. The positioner also provides improved control by more fully and accurately communicating the control movements exerted by the operator to the movement of the positioner at the target site. The positioner also provides a system that permits the mechanical engagement or disengagement of the implant without the use of hydraulic, thermal, electrical, or chemical energy.
The positioner is an elongate, flexible structure that transfers the controlling force applied by the operator at the proximal end to the implant interface at the distal end. As illustrated in
As also illustrated in
At two points 62 along the length of the middle portion 58 there are areas where the wall 56 transitions from a partial wall to a full wall circumferentially enclosing the lumen 44, similar to the wall 56 in the proximal and distal ends of the positioner tube 42. Between these two points 62 is a positioner marker 64, as illustrated in
Referring to
A cord liner 68 may be disposed upon the inner surface of positioner tube 42 within the lumen 44 encloses the cord 52 to provide a sliding surface that guides the cord 52 along the axis 54. The cord liner 68 also passes through the interior of the positioner marker 64, reducing in diameter where it engages the positioner marker 64. It is advantageous to insert a low-friction material between the surface of the cord 52 and the positioner tube 42 in order to reduce the frictional drag acting on the cord 52 when moved within the positioner tube 42. It is particularly advantageous to reduce friction at the distal one third of the positioner tube 42 and the cord 52 as these distal-most portions are subject to tortuous anatomy causing additional friction between the cord 52 and the cord liner 68.
The cord 52 slides within the lumen 44 and the lumen of the cord liner 68, from the actuator interface 46 to the implant interface 80. As illustrated in
The positioner tube 42 may be made from a material that is flexible and strong enough to transfer forces applied by the operator at the proximal end to the implant interface 80, such as 304 stainless steel hypotube, polymeric extrusion, braided extrusion, or non-elongating polymeric material that has a 0.010-0.018 inch outer diameter and a 0.005-0.012 inch inner diameter, with a 10-60 cm length of the distal end of the positioner tube 42 ground to a 0.008-0.016 inch outer diameter to reduce girth and increase flexibility. The outer tube 48 may be made of 304 stainless steel hypotube, polymeric extrusion, braided extrusion, or non-elongating polymeric material with a 0.012-0.020 inch outer diameter, a 0.010-0.018 inch inner diameter, and a length of 1-15 cm, fitted over the proximal 1-50 mm of the positioner tube 42 and circumferentially welded to the positioner tube 42. The slider 50 may be made of a 304 stainless steel hypotube segment, polymeric extrusion, or steel alloys and crimped to the proximal end of the cord 52, with a 0.010-0.018 inch outer diameter, a 0.001-0.016 inch inner diameter, and a length of 1-15 cm. The end cap 82 may be made of a 0.001-0.005 inch thick 304 stainless steel, polymeric material, or steel alloy retainer ring with a 0.008-0.018 inch outer diameter and a 0.003-0.009 inch diameter port welded or bonded to the distal end of the positioner tube 42. The positioner marker 64 may be a radiopaque platinum/iridium or platinum/tungsten coil disposed in the lumen 44 and having a 0.008-0.018 inch outer diameter, a 0.005-0.015 inch inner diameter, and a 1-6 mm length. The positioner tube sleeve 66 may be made of a polytetrafluoroethylene (PTFE) or low-friction polymeric material having a friction coefficient of 0.2 or less, heat shrunk onto all or at least the distal most portion of the positioner tube 42. The cord liner 68 may be made of PTFE or other low-friction materials and has a 0.002-0.006 inch inner diameter and a 0.004-0.008 inch outer diameter. The cord 52 may be a cord, wire, rod, tube, thread or filament made of a metal or polymer with a circular cross section and a 0.001-0.005 inch outer diameter. The stopper 70 may be made of 304 stainless steel, polymeric extrusion, braided extrusion, or non-elongating polymeric material with approximately a 0.001-0.012 inch inner diameter, and is welded to the interior of the positioner tube 42. The coining area 72 may have a 0.0015-0.0120 inch width. The length of the cord 52 proximal to the stopper 70 (e.g., between the proximal end of the positioner tube 42 and the proximal end of the stopper 70) may be slightly longer than the corresponding length of the structure adjacent to the length of the cord 52 (e.g., the length of positioner tube 42 corresponding to the length of the cord 52) by 0.001-0.040 inches, thereby compressively biasing the cord 52 so that it maintains the coining area 72 against the stopper 70 until the cord 52 is moved in the proximal direction.
The positioner tube 42 may be made from 304 stainless steel hypotube and has a 0.012 inch outer diameter and a 0.007 inch inner diameter, and a 50-60 cm length of the distal end of the positioner tube 42 is ground to a 0.010 inch outer diameter to reduce girth and increase flexibility. The outer tube 48 may be made of 304 stainless steel hypotube with a 0.016 inch outer diameter, a 0.0122 inch inner diameter, and a length of 6 cm, fitted over the proximal 5 mm of the positioner tube 42 and circumferentially welded to the positioner tube 42. The slider 50 may be made of a 304 stainless steel hypotube segment crimped to the proximal end of the cord 52, with a 0.012 inch outer diameter, a 0.003 inch inner diameter, and a length of 4 cm. The end cap 82 may be a 0.002-0.003 inch thick 304 stainless steel retainer ring with an approximate 0.010 inch outer diameter and an approximate 0.0043 inch diameter port welded to the distal end of the positioner tube 42. The positioner marker 64 may be a radiopaque platinum/tungsten coil disposed in the lumen 44 and having a 0.008 inch outer diameter, a 0.006 inch inner diameter, and a 3 mm length. The positioner tube sleeve 66 may be made of PTFE heat shrunk onto most of the length of the positioner tube 42. The cord liner 68 may be made of PTFE and has a 0.003 inch inner diameter and a 0.005 inch outer diameter. The cord 52 may be a 304 stainless steel Hyten™ cord sold by Fort Wayne Metals of Indiana, with a circular cross section and a 0.00185 inch outer diameter. The stopper 70 may be made of 304 stainless steel with a 0.0022 inch inner diameter, and is welded to the interior of the positioner tube 42. The coining area 72 may have a 0.0028 inch width. The length of the cord 52 between the proximal end of the positioner tube 42 and the proximal end of the stopper 70 may be longer than the corresponding length of the positioner tube 42 by 0.027 of an inch, thereby compressively biasing the cord 52 so that it maintains the coining area 72 against the stopper 70 until the cord 52 is moved in the proximal direction.
Although specific materials, dimensions, and characteristics are described in regard to the illustrated embodiments, it is appreciated that other designs can achieve the same operational objectives of the described components and structures. For example, to control the flexibility of the positioner tube 42, instead of skived sections 60 of the wall 56 at the middle portion 58, the wall 56 can fully or partially enclose the lumen 44 and include a plurality of slots or gaps to increase the flexibility of the wall. The slots or gaps can have a depth that reaches through the entirety of the wall 56 to form holes communicating with the lumen 44, or the slots and gaps can have a depth that reaches only partially into the surface of the wall 56. The slots or gaps can be longitudinal and parallel with the axis 54, transverse or orthogonal to the axis 54, or at an angle to the axis 54. Instead of slots or gaps, the wall 56 can have circular or oval holes partially or fully through the wall 56. According to some embodiments, the middle portion 58 of the wall 56 can have a spiral cut along all or part of the length of the middle portion 58 to increase the flexibility of the wall. According to some embodiments, the thickness of all or part of the wall 56 in the middle portion 58 can be reduced to increase flexibility. In still another embodiment, instead of a tube or a skived tube, the positioner tube 42 can have a series of tubes and/or partial tubes longitudinally aligned with a stiffening member between the tubes and/or partial tubes. Likewise, the end cap 82 can be replaced by a partial or whole loop, ring, or eyelet defining a port 84, and/or carried by a stiffening member disposed at a distance from the positioner tube 42.
According to some embodiments, instead of the end cap 82, the distal end of the positioner tube 42 can be formed to have an end crimp, cone shape, or dome shape to reduce the diameter of the distal end of the positioner tube 42 and form the port 84, and to also form a surface that engages the cord 52 and implant 90 to prevent the disengagement of the implant 90 from the implant interface 80. An embodiment in which the end cap 82 is replaced with an end dome 81, made from the crimping of the distal end of the positioner tube 42, is illustrated in
According to some embodiments, instead of a positioner tube sleeve 66, the exterior of the positioner tube 42 or the interior of the microcatheter 14 can be coated with a lubricating material or a lubricant. Also, instead of being disposed on the inner surface of the lumen 44, the cord liner 68 can be disposed on a portion of the cord 52. According to some embodiments, the exterior of the cord 52 or the inner surface of lumen 44 can be coated with a lubricating material or a lubricant.
According to some embodiments, instead of the coining area 72, the outer diameter of the cord 52 at the position of the coining area 72 can be made larger than the lumen of the stopper 70 by fixing a bushing to the cord 52. According to some embodiments, instead of modifying the dimensions of the cord 52 at the coining area 72 to limit its distal movement through the lumen of the stopper 70, the cord 52 can instead be provided with a bend or twist that impedes the distal movement of the cord 52 into the lumen of the stopper 70. Yet another embodiment is for the cord 52 to be fixed in a distally forward position by an adhesive that can be broken when the cord 52 is subjected to sufficient force.
Another aspect of the compressively biased arrangement that maintains a portion of the cord 52 in a distally forward position, at coining area 72 and its various embodiments, is that the positioner tube 42 be sufficiently strong to maintain the arrangement so that the distal end of the cord does not leave its position proximate the port 84 or permit the premature release of the ball 96 from the cavity 86. The positioner tube 42 may maintain the position of the cord 52 relative to the port 84 when subjected to an elongation force of more than 3 Newtons or an elongation force of more than 2 Newtons. According to some embodiments, an enlarged proximal end (e.g., ball 96) of the coil implant 90 may be of any size, shape, or geometry. For example, the enlarged end may be a sphere, a cube, a hexahedron, another polyhedron, a cylinder, or a hook.
Implant Interface
The implant interface allows the operator to mechanically control the engagement and disengagement of the implant to the positioner, and allows the positioner to retain the implant in a way that minimally contacts the implant, that permits movement in all directions of motion and rotationally, and that allows the implant to move axially and without radial movement when engaging and disengaging the implant interface. The implant interface provides mechanical control of the engagement and disengagement of the implant by retaining a member engaging the implant. The member is introduced into the implant interface through an opening in the positioning system, and retained at the implant interface by obstructing the opening at least in part, or fully, so as to physically prevent the complete exit of the member back through the opening. The obstructing is achieved with a movable elongate member disposed along the length of the positioning system with a distal end that obstructs the opening. By obstructing the opening and not fixedly restraining the implant, the implant remains free to move according to the limitations defined by the implant interface, which includes movement in the axial and radial directions compared to the axis of the positioning system, rotational movement about an axis of the implant, and angular movement that disposes the implant at an angle as compared to the axis of the positioning system. Furthermore, by obstructing the opening and not directly restraining the implant, the contact between the implant interface and the implant is minimized.
As illustrated in
The cord 52 may have engaged and disengaged orientations illustrated, respectively, in
In an embodiment illustrated in
According to some embodiments, the cord 52 extends within the lumen or cavity 87 and contacts the ball 96 at a point. A length of a line segment extending from an outer surface of the ball 96, through the point, and to an outer surface of the cord 52 is greater than the cross-sectional dimension of a distal portion of a tubular member (e.g., end cap 82), such that the ball 96 is prevented from moving within a lumen distally entirely past the end cap 82 when the cord 52 and ball 96 are positioned radially adjacent each other within the lumen.
Implant
The implant can be any implant that can be retained and positioned by the positioning system. The implant is retained by the implant interface with an extension engaging the implant. The extension can be a part of the implant when the implant is made, a modified portion of the manufactured implant, or attached to the implant after initial manufacturing. The extension provides an end that is disposed at a distance from the implant body, and allows the implant interface to engage and secure the implant by securing the end of the extension. The implant body itself, however, is not connected to the implant interface.
According to some embodiments, as illustrated in
The neurological coil implant 90 may comprise (i) a coil 116 having a proximal portion and a distal portion; (ii) a stretch-resistant member 112 extending through the coil 116 and having a proximal end and a distal end, the stretch-resistant member 112 distal end coupled to the coil 116 distal portion; (iii) an enlarged proximal end (e.g., ball 96) disposed at the proximal end of the stretch-resistant member 112 and otherwise free of the proximal portion of the coil 116. The ball 96 may be spaced apart from the coil 116. The ball 96 may be disposed entirely within a lumen of the delivery tube, and the coil 116 may be disposed entirely outside the lumen.
As illustrated in
The freedom to rotate the ball 96 and implant 90, facilitated by the illustrated embodiment, is advantageous. It is believed that in existing systems, the implant or a portion of the implant is firmly held by the delivery system and not free to rotate and, when the implant and delivery system are advanced distally to the target site through a microcatheter, the surface of the implant (especially the helical surface of some neurological coils) can induce a torque within the implant when moved along the inner surface of a microcatheter. That torque is stored as a potential energy in a compressed spring within the implant itself and within the connection between the implant and the delivery system. When the implant then emerges from the microcatheter at the target site, it is believed that the potential energy can be released suddenly and cause the implant to twist unpredictably and deposit itself in an undesirable location. The positioning system 10 facilitates the unhindered rotation of the ball 96 and implant 90, thereby avoiding this problem that is believed to exist with existing delivery systems. The free rotation of the implant 90 and ball 96 allows the implant 90 to be deployed from the microcatheter 14 at the target site 16 much more gently than with existing systems having a connection that is rigid or that partly or wholly limits movement and rotation between the implant and delivery system, and the free rotation also lowers the force applied to the vasculature during deployment and positioning of the implant 90 at the target site 16.
The relationship between the implant interface and the implant establishes some of the dimensions of these components. The implant interface provides an opening having a first opening area and a second opening area. The implant provides an extension that is disposed in the implant interface through the opening, and that has a portion (such as the ball 96) that can pass through the first opening area but can not pass through the second opening area. The portion of the extension has an obstruction dimension that defines a structural arrangement that prevents the portion from passing through the structure defining the second opening area at the opening. The obstruction dimension also defines the structural arrangement that permits the portion to pass through the structure defining the first opening area. This relationship can be expressed as follows:
The implant interface and implant extension use this relationship by having implant interface structure that forms the second opening area to be smaller than the obstruction dimension of the implant extension, to physically block passage of the portion of the extension through the opening, and implant interface structure that forms the first opening area to be larger than the obstruction dimension, to allow passage of the portion of the extension through the opening.
In the embodiment illustrated in
p>b>(p−w) Equation (2)
where “p” is the cross-sectional dimension of the port 84, “b” is the cross-sectional dimension of the ball 96, and “p−w” is the cross-sectional dimension of the port 84 less the cross section dimension of the distal tip 88 of the cord 52. In the illustrated embodiment, the relationship of Equation (2) is applied to structures having circular cross sections. However, it is appreciated that the principles of Equation (1) can be applied to structures having non-circular geometries, such as a rod 95, with a triangular cross section, or ports 85 and 89, with a non-circular shape, as illustrated in
According to some embodiments, the ball 96 can be replaced with another structure that can effectively pass through an unobstructed port 84 but not pass through an obstructed port 84, such as a disc, hook, or ring structure. Likewise, the distal tip 88 can be modified to obstruct only selected portions of the port 84, or to more closely abut against the inner surface of positioner tube 42 within cavity 86 in order to provide a larger space for the ball 96 to freely rotate or otherwise move within the cavity 86. According to some embodiments, the distal tip 88 can have a cross-sectional shape that is noncircular. For example, as illustrated in
The illustrated embodiment advantageously provides for the unrestrained axial movement of the ball 96 within the cavity 86 of the implant interface 80. The movement of the ball 96 within the cavity 86 is related to the longitudinal length of the cavity 86 and the length of the rod 94 engaging the implant 90 into the cavity 86. As illustrated in
Also, the axial movement of the ball 96 in the cavity 86 advantageously permits the implant 90 to assume an angled orientation compared to the axis 54 of the positioner tube 42, and articulate, tilt, or pivot around the ball 96. As illustrated in
According to some embodiments, as illustrated in
The positioning system 10 of the illustrated embodiment also advantageously captures or recaptures an implant 90 already located at or proximate the target site 16. As can be appreciated in the reverse sequence of
Commercially available embolic coils suitable for use with the delivery system 10, when modified to include the ball 96 or a combination of the rod 94 and ball 96, include the Sapphire™, NXT™, and Nexus™ embolic coils, commercially available from EV3, Inc. of Plymouth, Minn. USA. Although the implant 90 of the illustrated embodiment is a neurological coil, the implant 90 can be any implant that can be inserted with a catheter, such as a stent or stent-graft 90a as illustrated in
Actuator Interface
The actuator interface provides the operator the ability to control the movement of the implant as it is positioned by the positioning system, and to mechanically control the selective engagement and disengagement of the implant and implant interface. The actuator interface controls the movement of the implant by providing a surface upon which the operator can exert control, so that the controlling motions of the operator are accurately transferred to the implant interface and implant through the positioner. The actuator interface provides a relatively stiff proximal end of the positioner that transfers the axially-directed and rotational forces exerted on the actuator interface by the operator to the relatively flexibly distal end of the positioning system with minimal loss due to flexing and twisting of the positioning system. The actuator interface provides control of the engagement and disengagement of the implant from the implant interface with a sliding mechanism or slider that controllably and predictably moves the implant interface between the engaged and disengaged orientations. The actuator interface also connects to an actuator that permits the operator to controllably and predictably move the slider. In addition, the actuator interface establishes and maintains a compressive biasing of the implant interface so that the implant interface remains in the engaged orientation by disposing the slider in a distally forward position.
The compressive biasing of the cord 52 that presses the coining area 72 distally against proximal end of the stopper 70 may be established at the actuator interface 46. In the embodiment illustrated in
According to some embodiments, the biasing, fixing, and movement of the cord 52 within the positioner 40 can be achieved with a variety of designs. The slider 50 can be threaded and received into corresponding threads of the outer tube 48, with the slider 50 axially held in place relative to the outer tube 48 by the threads, and with the biasing and movement of the slider 50 controlled by the rotational movement of the slider 50 relative to the outer tube 48. According to some embodiments, instead of the tack weld 49, the biasing of the cord 52 and the fixing of the slider 50 can be achieved with a removable locking pin fitted through a common hole through the outer tube 48 and slider 50, temporarily fixed together with an adhesive or the pin can be breakable or bendable with a force that is similar to the force applied when breaking the tack weld 49. The slider 50 can also be temporarily fixed in place by a deformable crimp in the outer tube 48 that presses the outer tube 48 against the outer surface of the slider 50, to hold the slider 50 in place relative to the outer tube 48.
According to some embodiments, as illustrated in
According to some embodiments, as illustrated in
In the embodiment illustrated in
When the implant interface 80 is in the engaged orientation, the slider 50 is disposed in a distal position within the outer tube 48 and temporarily held in place by the tack weld 104, as illustrated in
According to some embodiments, as illustrated in
Actuator
The actuator provides a mechanism that removably engages the actuator interface and causes the controllable and predictable movement of the actuator interface. The actuator achieves this function by providing a structure that holds the outer tube in a fixed position relative to the body of the actuator, and a pawl and anvil that pinches the slider and pulls the slider in the proximal direction for a predetermined distance with a predetermined force, and then disengages from the slider to allow disengagement from the actuator. The actuator also provides a design that allows the operator to hold the actuator firmly in place, in order to maintain the position of the positioner relative to the target site, and allows the operator to utilize the actuator in a controlled manner that minimizes the movement of the positioner.
As illustrated in
As illustrated in
The receiving section 22 also includes a detent 32 fixed in a channel directed radially into the receiving section 22 and into the central lumen 31. The detent 32 includes a ball positioned in the channel that is biased towards the central lumen 31 by an internal spring. A portion of the ball of the detent 32 is pressed into the central lumen 31 by the internal spring and, when the actuator interface 46 is inserted into the central lumen 31, the ball presses against the outer surface of the outer tube 48 and frictionally retains the outer tube 48 in the central lumen 31.
Slidably disposed in the interior of the body 21 is the sliding frame 26. The proximal portion 26a of the sliding frame 26 is sized to conform to the interior surface of the body 21, to align and guide the movement of the sliding frame 26 within the body 21. The sliding frame 26 is biased in the body 21 to move in the distal direction by the slide return spring 25. The distal portion 26b of the sliding frame 26 engages the proximal portion 26a (behind the pawl 23 and the anvil 24 in the cross-sectional views presented in
A hinge 33 also is disposed on the flat surface of the sliding frame distal portion 26b (between the two opposing members of the sliding frame distal portion 26b) and engages the pawl 23, and the pawl spring 30 biases the proximal end of the pawl 23 away from the sliding frame proximal portion 26a rotatably around the hinge 33, and presses the proximal end of the pawl 23 against the proximal end of the receiver section 22. The anvil 24 is carried by the flat surface of the sliding frame distal portion 26b (between the two opposing members of the sliding frame distal portion 26b) and, in the deactivated position illustrated in
Referring to
The receiver section 22 may be made of polycarbonate or ABS, and the pawl 23, the anvil 24, the slide return spring 25, and the pawl spring 30 are made of steel. The funnel of the receiver section 22 may be a cone with an angle of 10-120 degrees, and the central lumen 31 has a diameter of 0.010-0.030 of an inch to receive the outer tube 48 and a diameter of 0.006-0.026 of an inch to receive the slider 50.
The receiver section 22 may be made of polycarbonate, and the pawl 23, the anvil 24, the slide return spring 25, and the pawl spring 30 are made of stainless steel. The funnel of the receiver section 22 may be a cone with an angle of 30 degrees, and the central lumen 31 has a diameter of 0.018 of an inch to receive the outer tube 48 and a diameter of 0.014 of an inch to receive the slider 50.
The operator-manipulated interface surface used by the operator to move the actuator 20 from the deactivated position, illustrated in
Pushability
The vasculature of the brain is more tortuous than the vasculature leading to the brain from the groin, a typical access point into a patient's body. An instrument disposed in a patient's body between the groin and the brain thus experiences the most tortuous pathway at the distal end of the instrument. This tortuous pathway forces the instrument to bend and subjects the instrument body to increased stresses. Also, any sliding member slidably moved within the instrument, such as a cord, is subjected to greater frictional forces against the sides of the instrument when the instrument is bent or curved. These increased frictional forces require the operator of the instrument to exert additional force to move the sliding member through the instrument, and the increased stresses on the instrument from bends or curves can cause permanent deformation of the instrument or failure of the instrument body or sliding member. Also, high frictional forces at the distal end of the instrument body can impede the movement of the instrument through a catheter, or the movement of a cord through the instrument. Namely, high frictional forces at the distal end of the instrument can cause the middle and proximal portions of the sliding member or cord to buckle, i.e., to have the axial movement of the sliding member or cord redirected in a undesirable non-axial or radial direction instead of a desired axial direction, or form kinks in the sliding member or cord.
In order to minimize the force required from the operator, and to lessen the potential for failure of instrument components, the positioning system advantageously achieves improved “pushability.” Specifically, pushability can be characterized by a ratio of the force applied to the positioner or cord by the operator at the proximal end of the system (“F1”) and the force observed at the distal end of the system (“F2”). Ideally, when the ratio of F1 to F2 approaches unity, this indicates that the force applied to the proximal end translates to an equal or near equal force at the distal end. As can be appreciated, buckling or kinking of the positioner or cord would produce a ratio of F1 to F2 that is not at or not near unity. The ratio of F1 to F2 can also be represented as a percentage, indicating that a certain percentage of the force at the proximal end was observed at the distal end. As shown in Table 1, the positioning system 10 may provide a pushability that is nearer to unity (100%) than that observed with an existing delivery system (“Nexus/NXT Pusher” refers to a pusher used with the Nexus™ and NXT™ coils, commercially available from EV3, Inc. of Plymouth, Minn. USA).
The positioning system also advantageously achieves improved “pushability” or “slidability” by reducing friction between the cord 52 and the positioner tube 42, and between the positioner tube 42 and the microcatheter 14. The following equation is a characterization of the frictional forces relating to a flexible inner cylindrical member enclosed within a flexible outer cylindrical member, with the outer member conforming to a curved surface defining a tortuous path, and with the inner member slidably moved within the outer member:
F1/F2=eμΘ Equation (3)
where,
The smallest force transfer ratio (F1/F2) possible is desired so that there is only a small frictional loss related to the movement between the inner and outer tubes. As it is well known that e0=1, it can be appreciated that, in order for the force transfer ratio to be as small as possible, the product of μ and Θ will likewise be a small value.
When the principles of Equation (3) and knowledge of vasculature anatomy are applied in the various embodiments, an advantageous force transfer ratio is achieved by reducing the average friction coefficient at the portions of the positioning system 10 subject to the greatest tortuosity. This may be achieved by selecting specific materials and surface characteristics of mating surfaces at the portions of the positioning system 10 subject to the greatest tortuosity, for example in the distal-most third of the positioner 40. The positioning system 10 may perform within a range of tortuosity of 900-4000 degrees, with a force transfer ratio of 16 or less, and an average friction coefficient of 0.045 or less over the length of the 4000-degree tortuous path. The positioning system 10 may perform within a range of tortuosity of 2000-4000 degrees, with a force transfer ratio of 16 or less, and an average friction coefficient of 0.045 or less over the length of the 4000-degree tortuous path.
Materials capable of providing a friction coefficient of 0.045 or less are limited. The cord 52 may be a stainless steel cord with a roughness of less than 50 microinches and the cord liner 68 is a polymer with a roughness of less than 200 microinches, the cord liner 68 and the cord 52 has a hydrophilic coating, or the space between the cord liner 68 and the cord 52 is loaded with a liquid polysiloxane containing a concentration of stearic acid in the range of 2-10%. The cord 52 may be a 304 stainless steel cord with a roughness of less than 50 microinches and the cord liner 68 is PTFE with a roughness of less than 200 microinches.
The materials for the cord 52 and the cord liner 68 may be used for the entire lengths of the cord and cord liner. However, the preferred materials may be provided in the portions of the positioner 40 that are subjected to the 4000 degrees of tortuosity, which is mostly the distal third of the positioner 40. For the proximal two thirds of the positioner 40, a wider selection of materials is available because this portion of the positioner 40 is subjected to less tortuosity (less than 2000 degrees) than the distal third of the positioner 40. For the proximal two thirds of the positioner 40, the positioner 40 may perform with a force transfer ratio of 15 or less and an average friction coefficient of 0.11 or less over the length of a 2000 or less-degree tortuous path in the proximal two thirds of the positioner 40. The materials capable of providing a friction coefficient of 0.11 or less are not as limited as with the distal third of the positioner 40. Preferable materials suitable for use in the proximal two thirds of the positioner 40 include polyethylene, acetal, or fluoropolymer for the cord liner 68, and a steel or polymer material with a surface roughness of less than 50 microinches for the cord 52. Materials may be polyethylene for the cord liner 68 and steel with a surface roughness of less than 50 microinches for the cord 52.
An advantageous force transfer ratio is also achieved at another mating surface of the positioning system 10, i.e., where the positioner tube sleeve 66 slidably moves within the microcatheter 14. Applying the same principles of Equation (3) as described above for the cord 52 and the cord liner 68, the preferred material for the positioner tube sleeve 66 is a PTFE heat shrunk material and the preferred material for the microcatheter 14 is a polymer with a relatively smoother surface.
Flexibility
The flexibility of the positioning system along the length of the system can affect system design and performance, as the flexibility of the system relates to the ability of the operator to control the positioner and the “feel” of the system from the proximal end manipulated by the operator. Also, the suppleness of the distal tip of the positioner relates to the ability of the operator to direct the positioner into the desired position. Maintaining the desired flexibility of a system with a mechanical implant engagement and disengagement system is particularly difficult because the length of the system provides a mechanical connection between the proximal and distal ends of the system that is both small in size but strong enough to cause the engagement and disengagement of the implant from the system.
The positioning system may achieve the appropriate level of flexibility by providing a relatively rigid structure at the proximal portion of the positioner, a relatively supple structure at the distal portion the positioner, and a transition region in the middle of the positioner that provides a change in flexibility between the proximal and distal portions.
The proximal portion of the positioner may provide a flexibility (or stiffness) that remains almost constant along the length of this section of the positioner. The near-constant flexibility of the proximal portion is achieved by the use of a tube structure. The distal portion and the transition region achieve a degree of suppleness with a combination of structural modifications to the tube structure that increases flexibility, the increase in the degree of those structural modifications along the length of the tube structure in the distal direction, and the structural support provided to the positioner by reinforcing structures. The flexibility of the distal portion increases along the length of this section, with the greatest suppleness achieved near or at the distal-most end of the positioner. The near-constant flexibility of the proximal portion may be achieved by a fully-enclosed tube structure of the positioner without the use of skiving. The variable flexibility characteristics of the distal portion and the transition region are achieved by a combination of a tube with skiving, the increase in the degree of the skiving along the length of the tube in the distal direction, and the structural support provided to the positioner by the positioner tube sleeve.
When subjected to a 20° deflection, the positioner 40 resists the deflection, which corresponds to flexibility, by generating a moment. As illustrated in
As also illustrated in
As further illustrated in
As illustrated in
The flexibility of the tip of the positioner 40 may be important to proper positioning of the implant 90 at the target site 16. The distal tip flexibility of the embodiment illustrated in
Profile
A mechanically-operated positioning system can be flexible and small enough to reach the target site, but remain strong enough to permit the operator to control the positioning and mechanical operation of the implant interface. The positioning system achieves a mechanically-operated implant engagement and disengagement system with an appropriate profile, or size, by utilizing materials and surfaces with variable friction coefficients, strengths, and flexibilities appropriate for a positioner subjected to a tortuous pathway. The outer diameter of the distal end of the positioner 40, at the distal end of the pusher tube 42, may be small enough to reach the target site 16 while permitting the proper operation of the implant interface 80 from a mechanical system connecting the implant interface 80 to the proximal end of the positioning system 10. The outer diameter of the distal end of the positioner 40, at the distal end of the pusher tube 42, may have a 0.008-0.018 inch outer diameter, for 304 stainless steel hypotube or steel alloy. The outer diameter of the distal end of the positioner 40, at the distal end of the pusher tube 42, may have a 0.012 inch outer diameter, for 304 stainless steel hypotube.
Fatigue Resistance
When implanting multiple neurological coils in an aneurysm, it is believed that a common practice is to place multiple coils within the aneurysm sufficient to occupy the void created by the aneurysm and to promote the formation of thrombi. It is also believed that a satisfactory result can be achieved when an aneurysm accommodates as many coils as possible, within the discretion of the operator. However, in such a procedure, it is possible that the coil or coils implanted first can interfere with or impeded the placement of subsequent coils. Also, this interference from already-implanted coils can possibly make it difficult for the operator to determine whether the aneurysm can accommodate additional coils. The placement of too few coils can possibly affect performance, and the placement of too many coils could possibly result in the rupture of the aneurysm or the dislodgement of a coil from a desired position at the target site.
It is further believed that when positioning an additional coil at the target site, the operator may repeatedly move the additional coil back and forth (by moving the delivery system) in order to nest the coil within the aneurysm between the already-implanted coils, and to evaluate whether the aneurysm can accommodate the implantation of more coils. It is also believed that the repeated movement of the delivery system and additional coil causes the system and coil to experience friction where the system and coil slidably move within a delivery catheter and where the additional coil contacts already-implanted coils. It is believed that the friction from the repeated movement of the system and coil can cause the connection point between the system and coil to experience significant stresses and, when combined with the repeated back-and-forth movement, possibly cause material fatigue and the fracture of the connection point, resulting in the premature disengagement of the coil from the system. It is further believed that existing delivery systems that rigidly or firmly engage the additional coil, or that impede the free movement or rotation of the coil relative to the system, permit the development of the stresses relating to the repeated back-and-forth movement of the system and coil.
The positioner of the various embodiments avoids or minimizes the development of stresses at the interface between the positioner and implant by permitting the unrestrained movement of the implant relative to the positioner, within the limitations defined by the implant interface. The development of implant interface stresses is minimized or avoided because the ball, rod, and implant are able to move in the axial and radial directions compared to the axis of the positioning system, to rotate about an axis of the rod or implant, and to move angularly so that implant is at an angle as compared to the axis of the positioning system.
Referring to
Referring to
As shown in Table 3, when measured, it has been observed that the engagement between the rod 94 and the positioner 40 can withstand greater tensile force than the interfaces between the implants connected to existing systems (“Positioner/Implant Interface” refers to the described embodiment, “Sapphire/NXT/Nexus” refer to the Sapphire™, NXT™, and Nexus™ products commercially available from EV3, Inc. of Plymouth, Minn. USA, and “GDC” refers to the Guglielmi Detachable Coil or GDC® Detachable Coil commercially available from Boston Scientific Corporation of Natick, Mass., USA).
Detachment Time
The embodiment illustrated in at least
The embodiment illustrated in at least
It is believed that preparatory and detachment times of the illustrated embodiment provide a system that permits a fast and efficient deployment of implants at a target site. The advantageous preparatory and detachment times reduce the length of time required to prepare the positioning system and advantageously increases the efficiency of the procedure, thereby allowing the practitioner to attend to other duties during the invasive medical procedure.
Side Wall Aperture
Reference is made to U.S. Pat. Pub. No. 2010/0174269, published on Jul. 8, 2010, and corresponding to U.S. application Ser. No. 12/498,752, filed on Jul. 7, 2009, the entirety of which is incorporated by reference, as if fully set forth herein.
Also cut or otherwise configured or disposed upon a side wall 204 is alignment member 228, shown in the example of
In preparation for deploying system 200, pull wire 226 is loaded through alignment member 228, through lumen 208, until it reaches ball 232, or as far as coil 206. Prior to loading coil 206, pull wire 226, which may be tapered, may be threaded through the distal end of insertion tool 214 to permit loading of ball 232, and then retracted or advanced to releasably retain coil 206. When positioned within distal tip 218 via alignment member 228 and occupying lumen 208, pull wire 226 urges ball 232 against paddle 240, and ball 232 has freedom of movement within aperture 244. Partial aperture 244 permits paddle 240 to be urged slightly out of the plane of sidewall 204, and paddle 240 in turn places some pressure on ball 232. Axial motion of ball 232 in a distal direction is prevented by shoulder 246, thereby preventing ball 232 from exiting the distal tip 218. Though ball 232 is retained within distal tip of insertion tool 214 prior to deployment of system 200, ball 232 advantageously has axial, rotational, and pivotal freedom of movement within the distal tip 218 of insertion tool 214 prior to retraction of pull wire 226 by an operator.
As shown in
According to embodiments, in preparation for deploying system 300, pull wire 326 is loaded through alignment member 328 until it reaches attachment member 332, as far as coil 306, or beyond coil 306. Pull wire 326 urges attachment member 332 against paddle 340 or into recess (not shown). Axial motion of attachment member 332 in a distal direction is prevented by a portion of the tube distal to paddle 340 or recess, thereby preventing attachment member 332 from exiting the distal end of the tube. During deployment of detachment system 300, pull wire 326 is retracted proximal of attachment member 332. Axial movement of attachment member 332 is then no longer restricted in a distal direction, and attachment member 332 (and in some embodiments coil 306) is free to exit the tube.
Lumen Cross-Sectional Profile
According to some embodiments, as shown in
According to some embodiments, wall thickness of a distal tip 218 may be varied. For example, as shown in
According to some embodiments, as shown in
According to some embodiments, as shown in
Alternatively, as shown in
According to some embodiments, an inner wall defining a lumen of a tube 216 may be shaped to receive a ball 232 and a pull wire 226 having a region of a crescent or other non-circular cross-sectional shape. For example, the lumen of the tube 216 may provide a lumen size and shape to which the ball 232 and the pull wire 226 conform when placed together within the lumen.
According to some embodiments, an inner wall defining a lumen of a tube 216 having non-circular cross-sectional geometry may reduce or eliminate voids in lumen of tube 216 around and between pull wire 226 and ball 232. This configuration reduces lateral motion of pull wire 226, especially lateral motion due to limitations of manufacturing tolerances, and thereby reduces unintended premature release of ball 232.
Pull Wire Geometry
According to some embodiments, as shown in
Crescent cross section shaped wire can be formed for example by swaging, crimping, stamping, forging, plating, EDM, welding, grinding, or other techniques. According to some embodiments, a distal portion of the pull wire 226 has a non-circular cross section, and a proximal portion of the pull wire 226 has a substantially circular cross section. According to some embodiments, an entire length of the pull wire 226 has a non-circular cross section. In some embodiments, the radius of curvature of the concave side can correspond to the radius of curvature of the ball 232. In some embodiments, to reduce friction of pull wire 226 against ball 232, the radius of curvature of the concave side can be smaller than the radius of curvature of the ball 232 such that contact between the two is limited to two lines or points rather than having contact over the entire concave surface of pull wire 226. In some embodiments, to reduce friction of pull wire 226 against ball 232, the radius of curvature of the concave side can be greater than the radius of curvature of the ball 232 such that contact between the two is limited to a point rather than having contact over the entire concave surface of pull wire 226.
According to some embodiments, a pull wire 226 having non-circular cross-sectional geometry may reduce or eliminate voids in lumen of tube 216 around and between pull wire 226 and ball 232. This configuration reduces lateral motion of pull wire 226, especially lateral motion due to limitations of manufacturing tolerances, and thereby reduces unintended premature release of ball 232.
Atraumatic Paddle
According to some embodiments, the paddle 240 may be curved inward toward the central axis of the tube 216 by means of overbending the paddle 240 beyond the elastic limit of the material from which the paddle 240 is made so that the paddle 240 acquires a permanent set in a curved inwards position. As shown in
According to some embodiments, the paddle 240 can be heat set into a curved inwards position by applying heat to at least the paddle portion 240 of the tube 216 while the paddle portion 240 is at or near the desired curved inwards position. Local application of heat can be applied using for example laser energy, CO2 laser energy, heated dies, RF heating, or other techniques. The amount of bending applied can be controlled by means of heated dies, thermally conductive molds, or other techniques, optionally in conjunction with use of an internal mandrel during manufacturing. Materials which have shape memory properties, such as Nitinol, are particularly suitable for heat setting techniques.
Rotatable Stopper
According to some embodiments, as shown in
According to some embodiments, a pull wire 226 may extend within a lumen through a reduced portion 229 of the lumen. Pull wire 226 may be aligned within reduced portion 229 to allow portions of pull wire 226 to be disposed against a side wall of tube 216 or away from a side wall of tube 216. Pull wire 226 may extend any length within tube 216, and contact ball 232, which may be within or near an aperture or otherwise disposed within a lumen of tube 216. The reduced portion 229 may be formed by an alignment member 228 extending from a wall of tube 216 (e.g., tubular distal tip 218). Alternatively or in combination, the reduced portion 229 may be a portion of a lumen of tube 216 having a tapered or reduced cross-sectional dimension relative to other portions of the lumen. According to some embodiments, a stopper 226A may be disposed on pull wire 226 distal to the reduced portion 229. The pull wire 226 may have a cross-sectional profile along a portion proximal or distal to the stopper 226A, wherein the stopper 226A has a different cross-sectional profile. For example, pull wire 226 may have a substantially circular cross-sectional profile along a portion proximal or distal to the stopper 226A, and the stopper 226A may have a non-circular cross-sectional profile along its length. The reduced portion 229 may have a cross-sectional profile that corresponds to the cross-sectional profile of the stopper 226A. For example, the cross-sectional profile of the reduced portion 229 may be geometrically similar to the cross-sectional profile of stopper 226A. By further example, the cross-sectional profile of the reduced portion 229 may have substantially the same shape as the cross-sectional profile of stopper 226A.
The second cross-sectional profile of the stopper 226A may have at least one cross-sectional dimension that exceeds at least one cross-sectional dimension of a proximal portion of pull wire 226. The second cross-sectional profile of the stopper 226A may have at least one cross-sectional dimension that exceeds at least one cross-sectional dimension of the reduced portion 229 through which pull wire 226 extends.
According to some embodiments, as shown in
A stopper 226A can be formed by adding material to the pull wire 226, such as by welding, electrodeposition, attaching a tubular component for example by welding, brazing, soldering, or adhering, or by other means. Alternatively or in combination, a stopper 226A can be formed by removing material from the pull wire 226, such as by grinding, swaging, crimping, EDM, or other means. A stopper 226A can be formed by sliding a supplemental component over the pull wire 226, followed by swaging or crimping the supplemental component to form a frictional connection (e.g., interference fit) between the two. A stopper 226A can be formed by coining a region of the pull wire 226 so as to flatten the pull wire 226 such that stopper 226A is wider than the wire diameter in a direction normal to the wire axis and also narrower than the wire diameter in a different direction normal to the wire axis.
According to some embodiments, as shown in
Aperture Interface
According to some embodiments, as shown in
A projection 232A can be formed by adding material to the ball 232, such as by welding, electrodeposition, attaching a tubular component for example by welding, brazing, soldering, or adhering, or by other means. Alternatively or in combination, a projection 232A can be formed by removing material from the ball 232, such as by grinding, swaging, crimping, EDM, or other means. A projection 232A can be formed by coining a region of a ball 232 so as to raise the projection from the surface of the ball. In some embodiments fabrication of the projection 232A will deform the ball 232 such that the ball 232, without considering the projection 232A, is no longer spherical, but rather has a flattened shape, an egg shape, or other shapes.
According to some embodiments, as shown in
To the extent that the term “include,” “have,” or the like is used in the description or the claims, such term is intended to be inclusive in a manner similar to the term “comprise” as “comprise” is interpreted when employed as a transitional word in a claim.
The word “exemplary” is used herein to mean “serving as an example, instance, or illustration.” Any embodiment described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments.
A reference to an element in the singular is not intended to mean “one and only one” unless specifically stated, but rather “one or more.” Pronouns in the masculine (e.g., his) include the feminine and neuter gender (e.g., her and its) and vice versa. The term “some” refers to one or more. Underlined and/or italicized headings and subheadings are used for convenience only, do not limit the subject technology, and are not referred to in connection with the interpretation of the description of the subject technology. All structural and functional equivalents to the elements of the various configurations described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and intended to be encompassed by the subject technology. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the above description.
While certain aspects and embodiments of the invention have been described, these have been presented by way of example only, and are not intended to limit the scope of the invention. Indeed, the novel methods and systems described herein may be embodied in a variety of other forms without departing from the spirit thereof. The accompanying claims and their equivalents are intended to cover such forms or modifications as would fall within the scope and spirit of the invention.
This application is a continuation-in-part of U.S. patent application Ser. No. 12/297,419, filed Jul. 9, 2009, which is a national stage entry of PCT patent application Ser. No. PCT/US07/66722, filed Apr. 16, 2007, and which claims priority benefit of U.S. Provisional Application Nos. 60/792,414, filed Apr. 17, 2006, and 60/894,589, filed Mar. 13, 2007, each of which are incorporated by reference in their entireties, as if fully set forth herein.
| Number | Name | Date | Kind |
|---|---|---|---|
| 3334629 | Colm | Aug 1967 | A |
| 3834394 | Hunter et al. | Sep 1974 | A |
| 4085757 | Pevsner | Apr 1978 | A |
| 4282875 | Serbinenko et al. | Aug 1981 | A |
| 4311146 | Wonder | Jan 1982 | A |
| 4327734 | White, Jr. | May 1982 | A |
| 4341218 | U | Jul 1982 | A |
| 4346712 | Handa et al. | Aug 1982 | A |
| 4364392 | Strother et al. | Dec 1982 | A |
| 4402319 | Handa et al. | Sep 1983 | A |
| 4441495 | Hicswa | Apr 1984 | A |
| 4494531 | Gianturco | Jan 1985 | A |
| 4517979 | Pecenka | May 1985 | A |
| 4545367 | Tucci | Oct 1985 | A |
| 4638803 | Rand | Jan 1987 | A |
| 4735201 | O'Reilly | Apr 1988 | A |
| 4781177 | Lebigot | Nov 1988 | A |
| 4787899 | Lazarus | Nov 1988 | A |
| 4819637 | Dormandy, Jr. et al. | Apr 1989 | A |
| 4832055 | Palestrant | May 1989 | A |
| 4944746 | Iwata et al. | Jul 1990 | A |
| 4957501 | Lahille et al. | Sep 1990 | A |
| 4990155 | Wilkoff | Feb 1991 | A |
| 4994069 | Ritchart et al. | Feb 1991 | A |
| 5002556 | Ishida et al. | Mar 1991 | A |
| 5026377 | Burton et al. | Jun 1991 | A |
| 5035706 | Giantureo et al. | Jul 1991 | A |
| 5037427 | Harada et al. | Aug 1991 | A |
| 5062829 | Pryor et al. | Nov 1991 | A |
| 5104399 | Lazarus | Apr 1992 | A |
| 5108407 | Geremia et al. | Apr 1992 | A |
| 5109867 | Twyford, Jr. | May 1992 | A |
| 5122136 | Guglielmi et al. | Jun 1992 | A |
| 5133731 | Butler et al. | Jul 1992 | A |
| 5133732 | Wiktor | Jul 1992 | A |
| 5147370 | McNamara et al. | Sep 1992 | A |
| 5167624 | Butler et al. | Dec 1992 | A |
| 5181921 | Makita et al. | Jan 1993 | A |
| 5192301 | Kamiya et al. | Mar 1993 | A |
| 5211658 | Clouse | May 1993 | A |
| 5217484 | Marks | Jun 1993 | A |
| 5222970 | Reeves | Jun 1993 | A |
| 5224953 | Morgentaler | Jul 1993 | A |
| 5226911 | Chee et al. | Jul 1993 | A |
| 5234437 | Sepetka | Aug 1993 | A |
| 5250071 | Palermo | Oct 1993 | A |
| 5256146 | Ensminger et al. | Oct 1993 | A |
| 5261916 | Engelson | Nov 1993 | A |
| 5263964 | Purdy | Nov 1993 | A |
| 5282806 | Haber et al. | Feb 1994 | A |
| 5304194 | Chee et al. | Apr 1994 | A |
| 5304195 | Twyford et al. | Apr 1994 | A |
| 5312415 | Palermo | May 1994 | A |
| 5314472 | Fontaine | May 1994 | A |
| 5334210 | Gianturco | Aug 1994 | A |
| 5350397 | Palermo et al. | Sep 1994 | A |
| 5354295 | Guglielmi et al. | Oct 1994 | A |
| 5368592 | Stern et al. | Nov 1994 | A |
| 5382259 | Phelps et al. | Jan 1995 | A |
| 5382260 | Dormandy, Jr. et al. | Jan 1995 | A |
| 5382261 | Palmaz | Jan 1995 | A |
| 5397345 | Lazarus | Mar 1995 | A |
| 5417708 | Hall | May 1995 | A |
| 5423829 | Pham et al. | Jun 1995 | A |
| 5423849 | Engelson et al. | Jun 1995 | A |
| 5443454 | Tanabe et al. | Aug 1995 | A |
| 5443478 | Purdy | Aug 1995 | A |
| 5456693 | Conston et al. | Oct 1995 | A |
| 5476472 | Dormandy, Jr. et al. | Dec 1995 | A |
| 5480382 | Hammerslag et al. | Jan 1996 | A |
| 5490859 | Mische et al. | Feb 1996 | A |
| 5498227 | Mawad | Mar 1996 | A |
| 5499985 | Hein et al. | Mar 1996 | A |
| 5507769 | Marin et al. | Apr 1996 | A |
| 5522822 | Phelps et al. | Jun 1996 | A |
| 5522836 | Palermo | Jun 1996 | A |
| 5527338 | Purdy | Jun 1996 | A |
| 5536274 | Neuss | Jul 1996 | A |
| 5540680 | Guglielmi et al. | Jul 1996 | A |
| 5549624 | Mirigian et al. | Aug 1996 | A |
| 5562698 | Parker | Oct 1996 | A |
| 5569245 | Guglielmi et al. | Oct 1996 | A |
| 5573520 | Schwartz et al. | Nov 1996 | A |
| 5578074 | Mirigian | Nov 1996 | A |
| 5582619 | Ken | Dec 1996 | A |
| 5601600 | Ton | Feb 1997 | A |
| 5624449 | Pham et al. | Apr 1997 | A |
| 5624461 | Mariant | Apr 1997 | A |
| 5626599 | Bourne et al. | May 1997 | A |
| 5634928 | Fischell et al. | Jun 1997 | A |
| 5639277 | Mariant et al. | Jun 1997 | A |
| 5643254 | Scheldrup et al. | Jul 1997 | A |
| 5645558 | Horton | Jul 1997 | A |
| 5645564 | Northrup et al. | Jul 1997 | A |
| 5649949 | Wallace et al. | Jul 1997 | A |
| 5658308 | Snyder | Aug 1997 | A |
| 5662700 | Lazarus | Sep 1997 | A |
| 5669905 | Scheldrup et al. | Sep 1997 | A |
| 5669931 | Kupiecki et al. | Sep 1997 | A |
| 5690666 | Berenstein et al. | Nov 1997 | A |
| 5690667 | Gia | Nov 1997 | A |
| 5690671 | McGurk et al. | Nov 1997 | A |
| 5693067 | Purdy | Dec 1997 | A |
| 5695517 | Marin et al. | Dec 1997 | A |
| 5700258 | Mirigian et al. | Dec 1997 | A |
| 5702361 | Evans et al. | Dec 1997 | A |
| 5718711 | Berenstein et al. | Feb 1998 | A |
| 5725534 | Rasmussen | Mar 1998 | A |
| 5725546 | Samson | Mar 1998 | A |
| 5725552 | Kotula et al. | Mar 1998 | A |
| 5728129 | Summers | Mar 1998 | A |
| 5733329 | Wallace et al. | Mar 1998 | A |
| 5743905 | Eder et al. | Apr 1998 | A |
| 5746734 | Dormandy, Jr. et al. | May 1998 | A |
| 5746769 | Ton et al. | May 1998 | A |
| 5749891 | Ken et al. | May 1998 | A |
| 5749894 | Engelson | May 1998 | A |
| 5749918 | Hogendijk et al. | May 1998 | A |
| 5759161 | Ogawa et al. | Jun 1998 | A |
| 5766219 | Horton | Jun 1998 | A |
| 5797953 | Tekulve | Aug 1998 | A |
| 5800426 | Taki et al. | Sep 1998 | A |
| 5800453 | Gia | Sep 1998 | A |
| 5800455 | Palermo et al. | Sep 1998 | A |
| 5814062 | Sepetka et al. | Sep 1998 | A |
| 5830230 | Berryman et al. | Nov 1998 | A |
| 5833705 | Ken et al. | Nov 1998 | A |
| 5843118 | Sepetka et al. | Dec 1998 | A |
| 5846210 | Ogawa et al. | Dec 1998 | A |
| 5851206 | Guglielmi et al. | Dec 1998 | A |
| 5853418 | Ken et al. | Dec 1998 | A |
| 5855578 | Guglielmi et al. | Jan 1999 | A |
| 5891058 | Taki et al. | Apr 1999 | A |
| 5891128 | Gia et al. | Apr 1999 | A |
| 5891130 | Palermo et al. | Apr 1999 | A |
| 5891155 | Irie | Apr 1999 | A |
| 5891192 | Murayama et al. | Apr 1999 | A |
| 5895385 | Guglielmi et al. | Apr 1999 | A |
| 5895391 | Farnholtz | Apr 1999 | A |
| 5895410 | Forber et al. | Apr 1999 | A |
| 5895411 | Irie | Apr 1999 | A |
| 5911731 | Pham et al. | Jun 1999 | A |
| 5911737 | Lee et al. | Jun 1999 | A |
| 5916235 | Guglielmi | Jun 1999 | A |
| 5919187 | Guglielmi et al. | Jul 1999 | A |
| 5925037 | Guglielmi et al. | Jul 1999 | A |
| 5925059 | Palermo et al. | Jul 1999 | A |
| 5925060 | Forber | Jul 1999 | A |
| 5925062 | Purdy | Jul 1999 | A |
| 5928226 | Guglielmi et al. | Jul 1999 | A |
| 5935145 | Villar et al. | Aug 1999 | A |
| 5935148 | Villar et al. | Aug 1999 | A |
| 5941249 | Maynard | Aug 1999 | A |
| 5941888 | Wallace et al. | Aug 1999 | A |
| 5944714 | Guglielmi et al. | Aug 1999 | A |
| 5944733 | Engelson | Aug 1999 | A |
| 5947962 | Guglielmi et al. | Sep 1999 | A |
| 5947963 | Guglielmi | Sep 1999 | A |
| 5957948 | Mariant | Sep 1999 | A |
| 5964797 | Ho | Oct 1999 | A |
| 5972019 | Engelson et al. | Oct 1999 | A |
| 5976126 | Guglielmi | Nov 1999 | A |
| 5976131 | Guglielmi et al. | Nov 1999 | A |
| 5976152 | Regan et al. | Nov 1999 | A |
| 5976162 | Doan et al. | Nov 1999 | A |
| 5980514 | Kupiecki et al. | Nov 1999 | A |
| 5980550 | Eder et al. | Nov 1999 | A |
| 5980554 | Lenker et al. | Nov 1999 | A |
| 5984929 | Bashiri et al. | Nov 1999 | A |
| 5984944 | Forber | Nov 1999 | A |
| 5989242 | Saadat et al. | Nov 1999 | A |
| 6001092 | Mirigian et al. | Dec 1999 | A |
| 6004338 | Ken et al. | Dec 1999 | A |
| 6010498 | Guglielmi | Jan 2000 | A |
| 6013084 | Ken et al. | Jan 2000 | A |
| 6015424 | Rosenbluth et al. | Jan 2000 | A |
| 6017364 | Lazarus | Jan 2000 | A |
| 6017977 | Evans et al. | Jan 2000 | A |
| 6019757 | Scheldrup | Feb 2000 | A |
| 6022369 | Jacobsen et al. | Feb 2000 | A |
| 6024754 | Engelson | Feb 2000 | A |
| 6024765 | Wallace et al. | Feb 2000 | A |
| 6030413 | Lazarus | Feb 2000 | A |
| 6033423 | Ken et al. | Mar 2000 | A |
| 6039744 | Forber | Mar 2000 | A |
| 6039749 | Marin et al. | Mar 2000 | A |
| 6056770 | Epstein et al. | May 2000 | A |
| 6059779 | Mills | May 2000 | A |
| 6059815 | Lee et al. | May 2000 | A |
| 6063070 | Eder | May 2000 | A |
| 6063100 | Diaz et al. | May 2000 | A |
| 6063104 | Villar et al. | May 2000 | A |
| 6066133 | Guglielmi et al. | May 2000 | A |
| 6066149 | Samson et al. | May 2000 | A |
| 6068644 | Lulo et al. | May 2000 | A |
| 6074407 | Levine et al. | Jun 2000 | A |
| 6077260 | Wheelock et al. | Jun 2000 | A |
| D427680 | Mariant et al. | Jul 2000 | S |
| 6083220 | Guglielmi et al. | Jul 2000 | A |
| 6086577 | Ken et al. | Jul 2000 | A |
| 6090125 | Horton | Jul 2000 | A |
| 6093199 | Brown et al. | Jul 2000 | A |
| 6096034 | Kupiecki et al. | Aug 2000 | A |
| 6096546 | Raskin | Aug 2000 | A |
| 6102917 | Maitland et al. | Aug 2000 | A |
| 6102932 | Kurz | Aug 2000 | A |
| 6102933 | Lee et al. | Aug 2000 | A |
| 6113622 | Hieshima | Sep 2000 | A |
| 6117142 | Goodson et al. | Sep 2000 | A |
| 6123714 | Gia et al. | Sep 2000 | A |
| 6126672 | Berryman et al. | Oct 2000 | A |
| 6136015 | Kurz et al. | Oct 2000 | A |
| 6143007 | Mariant et al. | Nov 2000 | A |
| 6146373 | Cragg et al. | Nov 2000 | A |
| 6149644 | Xie | Nov 2000 | A |
| 6149681 | Houser et al. | Nov 2000 | A |
| 6152947 | Ambrisco et al. | Nov 2000 | A |
| 6156061 | Wallace et al. | Dec 2000 | A |
| 6159165 | Ferrera et al. | Dec 2000 | A |
| 6159206 | Ogawa | Dec 2000 | A |
| 6165178 | Bashiri et al. | Dec 2000 | A |
| 6165193 | Greene, Jr. et al. | Dec 2000 | A |
| 6165198 | McGurk et al. | Dec 2000 | A |
| 6168570 | Ferrera | Jan 2001 | B1 |
| 6168592 | Kupiecki et al. | Jan 2001 | B1 |
| 6168610 | Marin et al. | Jan 2001 | B1 |
| 6168615 | Ken et al. | Jan 2001 | B1 |
| 6168622 | Mazzocchi | Jan 2001 | B1 |
| 6171326 | Ferrera et al. | Jan 2001 | B1 |
| 6183491 | Lulo | Feb 2001 | B1 |
| 6183495 | Lenker et al. | Feb 2001 | B1 |
| 6187024 | Boock et al. | Feb 2001 | B1 |
| 6187027 | Mariant et al. | Feb 2001 | B1 |
| 6190373 | Palermo et al. | Feb 2001 | B1 |
| 6193708 | Ken et al. | Feb 2001 | B1 |
| 6193728 | Ken et al. | Feb 2001 | B1 |
| RE37117 | Palermo | Mar 2001 | E |
| 6202261 | Moore et al. | Mar 2001 | B1 |
| 6203547 | Nguyen et al. | Mar 2001 | B1 |
| 6221066 | Ferrera et al. | Apr 2001 | B1 |
| 6221086 | Forber | Apr 2001 | B1 |
| 6224610 | Ferrera | May 2001 | B1 |
| 6231573 | Amor et al. | May 2001 | B1 |
| 6231586 | Mariant | May 2001 | B1 |
| 6231590 | Slaikeu et al. | May 2001 | B1 |
| 6231597 | Deem et al. | May 2001 | B1 |
| 6238403 | Greene, Jr. et al. | May 2001 | B1 |
| 6238415 | Sepetka et al. | May 2001 | B1 |
| 6241691 | Ferrera et al. | Jun 2001 | B1 |
| 6254592 | Samson et al. | Jul 2001 | B1 |
| 6270495 | Palermo | Aug 2001 | B1 |
| 6270508 | Klieman et al. | Aug 2001 | B1 |
| 6277125 | Barry et al. | Aug 2001 | B1 |
| 6277126 | Barry et al. | Aug 2001 | B1 |
| 6280457 | Wallace et al. | Aug 2001 | B1 |
| 6281263 | Evans et al. | Aug 2001 | B1 |
| 6287315 | Wijeratne et al. | Sep 2001 | B1 |
| 6287318 | Villar et al. | Sep 2001 | B1 |
| 6293960 | Ken | Sep 2001 | B1 |
| 6296622 | Kurz et al. | Oct 2001 | B1 |
| 6299619 | Greene, Jr. et al. | Oct 2001 | B1 |
| 6299627 | Eder et al. | Oct 2001 | B1 |
| 6306153 | Kurz et al. | Oct 2001 | B1 |
| 6312405 | Meyer et al. | Nov 2001 | B1 |
| 6312421 | Boock | Nov 2001 | B1 |
| 6315709 | Garibaldi et al. | Nov 2001 | B1 |
| 6319267 | Kurz | Nov 2001 | B1 |
| 6322576 | Wallace et al. | Nov 2001 | B1 |
| 6331184 | Abrams | Dec 2001 | B1 |
| 6335384 | Evans et al. | Jan 2002 | B1 |
| 6344041 | Kupiecki et al. | Feb 2002 | B1 |
| 6344048 | Chin et al. | Feb 2002 | B1 |
| 6346091 | Jacobsen et al. | Feb 2002 | B1 |
| 6348041 | Klint | Feb 2002 | B1 |
| 6361547 | Hieshima | Mar 2002 | B1 |
| 6364823 | Garibaldi et al. | Apr 2002 | B1 |
| 6368338 | Konya et al. | Apr 2002 | B1 |
| 6371972 | Wallace et al. | Apr 2002 | B1 |
| 6375606 | Garibaldi et al. | Apr 2002 | B1 |
| 6375628 | Zadno-Azizi et al. | Apr 2002 | B1 |
| 6375668 | Gifford et al. | Apr 2002 | B1 |
| 6375669 | Rosenbluth et al. | Apr 2002 | B1 |
| 6379329 | Naglreiter et al. | Apr 2002 | B1 |
| 6379374 | Hieshima et al. | Apr 2002 | B1 |
| 6383146 | Klint | May 2002 | B1 |
| 6383174 | Eder | May 2002 | B1 |
| 6383204 | Ferrera et al. | May 2002 | B1 |
| 6383205 | Samson et al. | May 2002 | B1 |
| 6397850 | Scheldrup et al. | Jun 2002 | B1 |
| 6409721 | Wheelock et al. | Jun 2002 | B1 |
| 6416535 | Lazarus | Jul 2002 | B1 |
| 6416541 | Denardo | Jul 2002 | B2 |
| 6423085 | Murayama et al. | Jul 2002 | B1 |
| 6425893 | Guglielmi | Jul 2002 | B1 |
| 6425914 | Wallace et al. | Jul 2002 | B1 |
| 6428557 | Hilaire | Aug 2002 | B1 |
| 6428558 | Jones et al. | Aug 2002 | B1 |
| 6454780 | Wallace | Sep 2002 | B1 |
| 6458119 | Berenstein et al. | Oct 2002 | B1 |
| 6458127 | Truckai et al. | Oct 2002 | B1 |
| 6458137 | Klint | Oct 2002 | B1 |
| 6464699 | Swanson | Oct 2002 | B1 |
| 6468266 | Bashiri et al. | Oct 2002 | B1 |
| 6475169 | Ferrera | Nov 2002 | B2 |
| 6475227 | Burke et al. | Nov 2002 | B2 |
| 6478773 | Gandhi et al. | Nov 2002 | B1 |
| 6485524 | Strecker | Nov 2002 | B2 |
| 6494884 | Gifford, III et al. | Dec 2002 | B2 |
| 6500149 | Gandhi et al. | Dec 2002 | B2 |
| 6500190 | Greene, Jr. et al. | Dec 2002 | B2 |
| 6506204 | Mazzocchi | Jan 2003 | B2 |
| 6511468 | Cragg et al. | Jan 2003 | B1 |
| 6514264 | Naglreiter | Feb 2003 | B1 |
| 6530934 | Jacobsen et al. | Mar 2003 | B1 |
| 6533801 | Wallace et al. | Mar 2003 | B2 |
| 6537293 | Berryman et al. | Mar 2003 | B1 |
| 6540657 | Cross, III et al. | Apr 2003 | B2 |
| 6544163 | Wallace et al. | Apr 2003 | B2 |
| 6544225 | Lulo et al. | Apr 2003 | B1 |
| 6544268 | Lazarus | Apr 2003 | B1 |
| 6544275 | Teoh | Apr 2003 | B1 |
| 6547804 | Porter et al. | Apr 2003 | B2 |
| 6551305 | Ferrera et al. | Apr 2003 | B2 |
| 6551340 | Konya et al. | Apr 2003 | B1 |
| 6554849 | Jones et al. | Apr 2003 | B1 |
| 6558367 | Cragg et al. | May 2003 | B1 |
| 6569179 | Teoh et al. | May 2003 | B2 |
| 6572628 | Dominguez et al. | Jun 2003 | B2 |
| 6575994 | Marin et al. | Jun 2003 | B1 |
| 6585748 | Jeffree | Jul 2003 | B1 |
| 6585754 | Wallace et al. | Jul 2003 | B2 |
| 6589227 | Sonderskov | Jul 2003 | B2 |
| 6589230 | Gia et al. | Jul 2003 | B2 |
| 6589236 | Wheelock et al. | Jul 2003 | B2 |
| 6589251 | Yee et al. | Jul 2003 | B2 |
| 6589265 | Palmer et al. | Jul 2003 | B1 |
| 6592605 | Lenker et al. | Jul 2003 | B2 |
| 6602261 | Greene, Jr. et al. | Aug 2003 | B2 |
| 6602269 | Wallace et al. | Aug 2003 | B2 |
| 6603994 | Wallace et al. | Aug 2003 | B2 |
| 6605101 | Schaefer et al. | Aug 2003 | B1 |
| 6607538 | Ferrera et al. | Aug 2003 | B1 |
| 6607539 | Hayashi et al. | Aug 2003 | B1 |
| 6610085 | Lazarus | Aug 2003 | B1 |
| 6613074 | Mitelberg et al. | Sep 2003 | B1 |
| 6616617 | Ferrera et al. | Sep 2003 | B1 |
| 6620152 | Guglielmi | Sep 2003 | B2 |
| 6623493 | Wallace et al. | Sep 2003 | B2 |
| 6632241 | Hancock et al. | Oct 2003 | B1 |
| 6635068 | Dubrul et al. | Oct 2003 | B1 |
| 6635069 | Teoh et al. | Oct 2003 | B1 |
| 6638291 | Ferrera et al. | Oct 2003 | B1 |
| 6638293 | Makower et al. | Oct 2003 | B1 |
| 6656173 | Palermo | Dec 2003 | B1 |
| 6656201 | Ferrera et al. | Dec 2003 | B2 |
| 6656218 | Denardo et al. | Dec 2003 | B1 |
| 6656351 | Boyle | Dec 2003 | B2 |
| 6660020 | Wallace et al. | Dec 2003 | B2 |
| 6663607 | Slaikeu et al. | Dec 2003 | B2 |
| 6679903 | Kurz | Jan 2004 | B2 |
| 6685653 | Ehr et al. | Feb 2004 | B2 |
| 6689141 | Ferrera et al. | Feb 2004 | B2 |
| 6692510 | West | Feb 2004 | B2 |
| 6702844 | Lazarus | Mar 2004 | B1 |
| 6716238 | Elliott | Apr 2004 | B2 |
| 6723112 | Ho et al. | Apr 2004 | B2 |
| 6743236 | Barry et al. | Jun 2004 | B2 |
| 6743251 | Eder | Jun 2004 | B1 |
| 6767358 | Leonhardt et al. | Jul 2004 | B2 |
| 6811561 | Diaz et al. | Nov 2004 | B2 |
| 6814748 | Baker et al. | Nov 2004 | B1 |
| 6835185 | Ramzipoor et al. | Dec 2004 | B2 |
| 6849081 | Sepetka et al. | Feb 2005 | B2 |
| 6852116 | Leonhardt et al. | Feb 2005 | B2 |
| 6853418 | Suzuki et al. | Feb 2005 | B2 |
| 6855153 | Saadat | Feb 2005 | B2 |
| 6855155 | Denardo et al. | Feb 2005 | B2 |
| 6860893 | Wallace et al. | Mar 2005 | B2 |
| 6860901 | Baker et al. | Mar 2005 | B1 |
| 6872218 | Ferrera et al. | Mar 2005 | B2 |
| 6878163 | Denardo et al. | Apr 2005 | B2 |
| 6905503 | Gifford, III et al. | Jun 2005 | B2 |
| 6913618 | Denardo et al. | Jul 2005 | B2 |
| 6929654 | Teoh et al. | Aug 2005 | B2 |
| 6945956 | Waldhauser et al. | Sep 2005 | B2 |
| 6958061 | Truckai et al. | Oct 2005 | B2 |
| 6958068 | Hieshima | Oct 2005 | B2 |
| 6964657 | Cragg et al. | Nov 2005 | B2 |
| 6966892 | Gandhi et al. | Nov 2005 | B2 |
| 6994689 | Zadno-Azizi et al. | Feb 2006 | B1 |
| 6994711 | Hieshima et al. | Feb 2006 | B2 |
| 7014645 | Greene, Jr. et al. | Mar 2006 | B2 |
| 7022133 | Yee et al. | Apr 2006 | B2 |
| 7029486 | Schaefer et al. | Apr 2006 | B2 |
| 7029487 | Greene, Jr. et al. | Apr 2006 | B2 |
| 7033374 | Schaefer et al. | Apr 2006 | B2 |
| 7058456 | Pierce | Jun 2006 | B2 |
| 7060083 | Gerberding | Jun 2006 | B2 |
| 7070607 | Murayama et al. | Jul 2006 | B2 |
| 7147618 | Kurz | Dec 2006 | B2 |
| 7169161 | Bonnette et al. | Jan 2007 | B2 |
| 7182774 | Barry et al. | Feb 2007 | B2 |
| 7198613 | Gandhi et al. | Apr 2007 | B2 |
| 7238194 | Monstadt et al. | Jul 2007 | B2 |
| 7294146 | Chew et al. | Nov 2007 | B2 |
| 7300458 | Henkes et al. | Nov 2007 | B2 |
| 7316701 | Ferrera et al. | Jan 2008 | B2 |
| 7323000 | Monstdt et al. | Jan 2008 | B2 |
| 7331973 | Gesswein et al. | Feb 2008 | B2 |
| 7344558 | Lorenzo et al. | Mar 2008 | B2 |
| 7377932 | Mitelberg et al. | May 2008 | B2 |
| 7410482 | Murphy et al. | Aug 2008 | B2 |
| 7419501 | Chiu et al. | Sep 2008 | B2 |
| 7473266 | Glaser | Jan 2009 | B2 |
| 7485122 | Teoh | Feb 2009 | B2 |
| 7485317 | Murayama et al. | Feb 2009 | B1 |
| 7524322 | Monstdt et al. | Apr 2009 | B2 |
| 7575582 | Gandhi et al. | Aug 2009 | B2 |
| 7578826 | Gandhi et al. | Aug 2009 | B2 |
| 7591829 | Gibson et al. | Sep 2009 | B2 |
| RE41029 | Guglielmi et al. | Dec 2009 | E |
| 7691124 | Balgobin | Apr 2010 | B2 |
| 7708755 | Davis, III et al. | May 2010 | B2 |
| 7722636 | Farnan | May 2010 | B2 |
| 7722637 | Barry et al. | May 2010 | B2 |
| 7811305 | Balgobin et al. | Oct 2010 | B2 |
| 7879064 | Monstadt et al. | Feb 2011 | B2 |
| 7896899 | Patterson et al. | Mar 2011 | B2 |
| 7901444 | Slazas | Mar 2011 | B2 |
| 7918872 | Mitelberg et al. | Apr 2011 | B2 |
| 8007509 | Buiser et al. | Aug 2011 | B2 |
| RE42758 | Ken et al. | Sep 2011 | E |
| 8016852 | Ho et al. | Sep 2011 | B2 |
| 8029466 | Wilson et al. | Oct 2011 | B2 |
| 8034073 | Davis, III et al. | Oct 2011 | B2 |
| 8100918 | Gandhi et al. | Jan 2012 | B2 |
| 8142456 | Rosqueta et al. | Mar 2012 | B2 |
| 8333796 | Tompkins et al. | Dec 2012 | B2 |
| 20010037141 | Yee et al. | Nov 2001 | A1 |
| 20020010481 | Jayaraman | Jan 2002 | A1 |
| 20020065529 | Laurent et al. | May 2002 | A1 |
| 20020072712 | Nool et al. | Jun 2002 | A1 |
| 20020072791 | Eder et al. | Jun 2002 | A1 |
| 20020082620 | Lee | Jun 2002 | A1 |
| 20020087184 | Eder et al. | Jul 2002 | A1 |
| 20020116024 | Goldberg et al. | Aug 2002 | A1 |
| 20020120297 | Shadduck | Aug 2002 | A1 |
| 20020128671 | Wallace et al. | Sep 2002 | A1 |
| 20020138095 | Mazzocchi et al. | Sep 2002 | A1 |
| 20020143349 | Gifford et al. | Oct 2002 | A1 |
| 20020169473 | Sepetka et al. | Nov 2002 | A1 |
| 20030014073 | Bashiri et al. | Jan 2003 | A1 |
| 20030040733 | Cragg et al. | Feb 2003 | A1 |
| 20030083676 | Wallace | May 2003 | A1 |
| 20030130689 | Wallace et al. | Jul 2003 | A1 |
| 20030169473 | Cotter et al. | Sep 2003 | A1 |
| 20030171770 | Kusleika et al. | Sep 2003 | A1 |
| 20030176857 | Lee | Sep 2003 | A1 |
| 20030181927 | Wallace | Sep 2003 | A1 |
| 20030199966 | Shiu et al. | Oct 2003 | A1 |
| 20030225365 | Greff et al. | Dec 2003 | A1 |
| 20040002731 | Aganon et al. | Jan 2004 | A1 |
| 20040002732 | Teoh et al. | Jan 2004 | A1 |
| 20040002733 | Teoh | Jan 2004 | A1 |
| 20040024394 | Wallace et al. | Feb 2004 | A1 |
| 20040034363 | Wilson et al. | Feb 2004 | A1 |
| 20040106946 | Ferrera et al. | Jun 2004 | A1 |
| 20040181256 | Glaser | Sep 2004 | A1 |
| 20040193178 | Nikolchev | Sep 2004 | A1 |
| 20040193206 | Gerberding et al. | Sep 2004 | A1 |
| 20040220563 | Eder | Nov 2004 | A1 |
| 20040220585 | Nikolchev | Nov 2004 | A1 |
| 20040225279 | Raymond | Nov 2004 | A1 |
| 20040243228 | Kowalsky et al. | Dec 2004 | A1 |
| 20050021023 | Guglielmi et al. | Jan 2005 | A1 |
| 20050079196 | Henkes et al. | Apr 2005 | A1 |
| 20060025792 | Gibson et al. | Feb 2006 | A1 |
| 20060025801 | Lulo et al. | Feb 2006 | A1 |
| 20060025802 | Sowers | Feb 2006 | A1 |
| 20060036281 | Patterson et al. | Feb 2006 | A1 |
| 20060079926 | Desai et al. | Apr 2006 | A1 |
| 20060106417 | Tessmer et al. | May 2006 | A1 |
| 20060116714 | Sepetka et al. | Jun 2006 | A1 |
| 20060271097 | Ramzipoor et al. | Nov 2006 | A1 |
| 20060276823 | Mitelberg et al. | Dec 2006 | A1 |
| 20060276824 | Mitelberg et al. | Dec 2006 | A1 |
| 20060278680 | Viola et al. | Dec 2006 | A1 |
| 20070055302 | Henry et al. | Mar 2007 | A1 |
| 20070173757 | Levine et al. | Jul 2007 | A1 |
| 20070179520 | West | Aug 2007 | A1 |
| 20070185524 | Diaz et al. | Aug 2007 | A1 |
| 20070239193 | Simon et al. | Oct 2007 | A1 |
| 20070267281 | Smith | Nov 2007 | A1 |
| 20070270936 | Andreas et al. | Nov 2007 | A1 |
| 20080045922 | Cragg et al. | Feb 2008 | A1 |
| 20080045997 | Balgobin et al. | Feb 2008 | A1 |
| 20080051803 | Monjtadt et al. | Feb 2008 | A1 |
| 20080097462 | Mitelberg et al. | Apr 2008 | A1 |
| 20080103585 | Monstadt et al. | May 2008 | A1 |
| 20080125855 | Henkes et al. | May 2008 | A1 |
| 20080228215 | Strauss et al. | Sep 2008 | A1 |
| 20080228216 | Strauss et al. | Sep 2008 | A1 |
| 20080243106 | Coe et al. | Oct 2008 | A1 |
| 20080255542 | Nimgaard et al. | Oct 2008 | A1 |
| 20080300616 | Que et al. | Dec 2008 | A1 |
| 20080306504 | Win et al. | Dec 2008 | A1 |
| 20080319532 | Monstadt et al. | Dec 2008 | A1 |
| 20090012554 | Makower et al. | Jan 2009 | A1 |
| 20090018653 | Bashiri et al. | Jan 2009 | A1 |
| 20090024154 | Williams et al. | Jan 2009 | A1 |
| 20090062812 | Fitz et al. | Mar 2009 | A1 |
| 20090088832 | Chew et al. | Apr 2009 | A1 |
| 20090138036 | Nardone et al. | May 2009 | A1 |
| 20090163780 | Tieu | Jun 2009 | A1 |
| 20090163986 | Tieu et al. | Jun 2009 | A1 |
| 20090177261 | Teoh et al. | Jul 2009 | A1 |
| 20090182268 | Thielen et al. | Jul 2009 | A1 |
| 20090254111 | Monstadt et al. | Oct 2009 | A1 |
| 20090254169 | Spenser et al. | Oct 2009 | A1 |
| 20090270877 | Johnson et al. | Oct 2009 | A1 |
| 20090287291 | Becking et al. | Nov 2009 | A1 |
| 20090312748 | Johnson et al. | Dec 2009 | A1 |
| 20100004673 | Denison et al. | Jan 2010 | A1 |
| 20100023105 | Levy et al. | Jan 2010 | A1 |
| 20100030200 | Strauss et al. | Feb 2010 | A1 |
| 20100049165 | Sutherland et al. | Feb 2010 | A1 |
| 20100076479 | Monstadt | Mar 2010 | A1 |
| 20100094395 | Kellett | Apr 2010 | A1 |
| 20100174269 | Tompkins et al. | Jul 2010 | A1 |
| 20100234872 | Guo et al. | Sep 2010 | A1 |
| 20100256666 | Chen et al. | Oct 2010 | A1 |
| 20100268204 | Tieu et al. | Oct 2010 | A1 |
| 20100268251 | Chen et al. | Oct 2010 | A1 |
| 20100268252 | Chen et al. | Oct 2010 | A1 |
| 20110022003 | Tekulve | Jan 2011 | A1 |
| 20110098814 | Monstadt et al. | Apr 2011 | A1 |
| 20110106098 | Williams | May 2011 | A1 |
| 20110106128 | Chen | May 2011 | A1 |
| 20110118772 | Chen et al. | May 2011 | A1 |
| 20110118776 | Chen et al. | May 2011 | A1 |
| 20110118777 | Patterson et al. | May 2011 | A1 |
| 20110172700 | Bose et al. | Jul 2011 | A1 |
| 20110202085 | Loganathan | Aug 2011 | A1 |
| 20110208227 | Becking | Aug 2011 | A1 |
| 20110265943 | Rosqueta et al. | Nov 2011 | A1 |
| 20110282380 | Davis et al. | Nov 2011 | A1 |
| 20110301686 | Bowman et al. | Dec 2011 | A1 |
| 20110313447 | Strauss | Dec 2011 | A1 |
| 20120041472 | Tan et al. | Feb 2012 | A1 |
| 20120046687 | Trommeter et al. | Feb 2012 | A1 |
| 20120065720 | Strauss | Mar 2012 | A1 |
| 20120226305 | Strauss | Sep 2012 | A1 |
| 20120313447 | Park et al. | Dec 2012 | A1 |
| 20120316598 | Becking et al. | Dec 2012 | A1 |
| 20120330347 | Becking et al. | Dec 2012 | A1 |
| 20130066360 | Becking et al. | Mar 2013 | A1 |
| 20130085520 | Liang | Apr 2013 | A1 |
| 20130085521 | Lim | Apr 2013 | A1 |
| 20130085522 | Becking et al. | Apr 2013 | A1 |
| 20130123830 | Becking et al. | May 2013 | A1 |
| 20130138136 | Beckham | May 2013 | A1 |
| 20130211495 | Halden | Aug 2013 | A1 |
| Number | Date | Country |
|---|---|---|
| 1668250 | Sep 2005 | CN |
| 4445715 | Jun 1996 | DE |
| 69627243 | Jan 1997 | DE |
| 19547617 | Sep 1997 | DE |
| 19607451 | Sep 1997 | DE |
| 19610333 | Sep 1997 | DE |
| 19647280 | May 2001 | DE |
| 19952387 | May 2001 | DE |
| 10010840 | Sep 2001 | DE |
| 10118017 | Oct 2002 | DE |
| 10155191 | May 2003 | DE |
| 707830 | Apr 1996 | EP |
| 711 532 | May 1996 | EP |
| 717969 | Jun 1996 | EP |
| 702 838 | Jul 1996 | EP |
| 765636 | Jul 1997 | EP |
| 820 726 | Jan 1998 | EP |
| 830 873 | Mar 1998 | EP |
| 829236 | Mar 1998 | EP |
| 853 955 | Jul 1998 | EP |
| 865 773 | Sep 1998 | EP |
| 882 428 | Sep 1998 | EP |
| 904 737 | Mar 1999 | EP |
| 914 807 | May 1999 | EP |
| 941 700 | Sep 1999 | EP |
| 941 701 | Sep 1999 | EP |
| 992 220 | Apr 2000 | EP |
| 996372 | May 2000 | EP |
| 996372 | May 2000 | EP |
| 1005837 | Jun 2000 | EP |
| 1 120 088 | Aug 2001 | EP |
| 1 125 553 | Aug 2001 | EP |
| 1 129 666 | Sep 2001 | EP |
| 1 142 535 | Oct 2001 | EP |
| 1 169 969 | Jan 2002 | EP |
| 1 188 413 | Mar 2002 | EP |
| 1 188 414 | Mar 2002 | EP |
| 1 312 312 | May 2003 | EP |
| 1 316 293 | Jun 2003 | EP |
| 1 258 850 | Nov 2003 | EP |
| 1400208 | Mar 2004 | EP |
| 1487526 | Dec 2004 | EP |
| 1487526 | Dec 2004 | EP |
| 1 669 032 | Jun 2006 | EP |
| 1738698 | Jan 2007 | EP |
| 832 607 | Apr 2008 | EP |
| 6-246004 | Sep 1994 | JP |
| 7-155331 | Jun 1995 | JP |
| 7-265431 | Oct 1995 | JP |
| 7-284534 | Oct 1995 | JP |
| 09-149904 | Jun 1997 | JP |
| 9-168541 | Jun 1997 | JP |
| 10-127646 | May 1998 | JP |
| 10-201766 | Aug 1998 | JP |
| 11-47138 | Feb 1999 | JP |
| 11-76249 | Mar 1999 | JP |
| 2001-513389 | Sep 2001 | JP |
| 2002-523172 | Jul 2002 | JP |
| 2004-500929 | Jan 2004 | JP |
| 2004073874 | Mar 2004 | JP |
| 2004-267749 | Sep 2004 | JP |
| 2006-051349 | Feb 2006 | JP |
| 2008-525113 | Jul 2008 | JP |
| 2009-533202 | Sep 2009 | JP |
| WO-8803817 | Jun 1988 | WO |
| WO-8906984 | Aug 1989 | WO |
| WO-9012616 | Nov 1990 | WO |
| WO-9113592 | Sep 1991 | WO |
| WO-9214408 | Sep 1992 | WO |
| WO-9221400 | Dec 1992 | WO |
| WO-9311719 | Jun 1993 | WO |
| WO-9316650 | Sep 1993 | WO |
| WO-9406502 | Mar 1994 | WO |
| WO-9406503 | Mar 1994 | WO |
| WO-9410936 | May 1994 | WO |
| WO-9411051 | May 1994 | WO |
| WO-9426175 | Nov 1994 | WO |
| WO-9512367 | May 1995 | WO |
| WO-9618343 | Jun 1996 | WO |
| WO-9632153 | Oct 1996 | WO |
| WO-9639950 | Dec 1996 | WO |
| WO-9727888 | Aug 1997 | WO |
| WO-9742881 | Nov 1997 | WO |
| WO-9809570 | Mar 1998 | WO |
| WO-9817183 | Apr 1998 | WO |
| WO-9833452 | Aug 1998 | WO |
| WO-9834546 | Aug 1998 | WO |
| WO-9839048 | Sep 1998 | WO |
| WO-9858590 | Dec 1998 | WO |
| WO-9902094 | Jan 1999 | WO |
| WO-9905977 | Feb 1999 | WO |
| WO-9907292 | Feb 1999 | WO |
| WO-9909893 | Mar 1999 | WO |
| WO-9932037 | Jul 1999 | WO |
| WO-9942038 | Aug 1999 | WO |
| WO-9944538 | Sep 1999 | WO |
| WO 9949812 | Oct 1999 | WO |
| WO-9956636 | Nov 1999 | WO |
| WO-0012016 | Mar 2000 | WO |
| WO-0013593 | Mar 2000 | WO |
| WO-0025680 | May 2000 | WO |
| WO-0044306 | Aug 2000 | WO |
| WO-0072781 | Dec 2000 | WO |
| WO-0132085 | May 2001 | WO |
| WO-0156500 | Aug 2001 | WO |
| WO-0158365 | Aug 2001 | WO |
| WO-0158382 | Aug 2001 | WO |
| WO-0187184 | Nov 2001 | WO |
| WO-0193937 | Dec 2001 | WO |
| WO-0202018 | Jan 2002 | WO |
| WO-0213705 | Feb 2002 | WO |
| WO-0213706 | Feb 2002 | WO |
| WO-0232496 | Apr 2002 | WO |
| WO-0239911 | May 2002 | WO |
| WO-0241753 | May 2002 | WO |
| WO-0245596 | Jun 2002 | WO |
| WO-02054943 | Jul 2002 | WO |
| WO-02054980 | Jul 2002 | WO |
| WO-02072168 | Sep 2002 | WO |
| WO-02087449 | Nov 2002 | WO |
| WO-02087651 | Nov 2002 | WO |
| WO-02089676 | Nov 2002 | WO |
| WO-02096273 | Dec 2002 | WO |
| WO-02096301 | Dec 2002 | WO |
| WO-03001970 | Jan 2003 | WO |
| WO-03007823 | Jan 2003 | WO |
| WO-03017852 | Mar 2003 | WO |
| WO-03034927 | May 2003 | WO |
| WO-03039624 | May 2003 | WO |
| WO-03041615 | May 2003 | WO |
| WO-03053257 | Jul 2003 | WO |
| WO-03053281 | Jul 2003 | WO |
| WO-03073914 | Sep 2003 | WO |
| WO-03077776 | Sep 2003 | WO |
| WO-03077984 | Sep 2003 | WO |
| WO-03082128 | Oct 2003 | WO |
| WO-03086240 | Oct 2003 | WO |
| WO-03092547 | Nov 2003 | WO |
| WO-03099370 | Dec 2003 | WO |
| WO-2004008974 | Jan 2004 | WO |
| WO-2004014239 | Feb 2004 | WO |
| WO-2004069059 | Aug 2004 | WO |
| WO-2004069538 | Aug 2004 | WO |
| WO-2004073529 | Sep 2004 | WO |
| WO-2006069123 | Jun 2006 | WO |
| WO-2007070797 | Jun 2007 | WO |
| WO-2007121405 | Oct 2007 | WO |
| WO-2008112435 | Sep 2008 | WO |
| WO-2008112436 | Sep 2008 | WO |
| WO-2010009019 | Jan 2010 | WO |
| WO-2010117883 | Oct 2010 | WO |
| WO-2010123821 | Oct 2010 | WO |
| Entry |
|---|
| U.S. Appl. No. 13/308,476, filed Nov. 30, 2011. |
| U.S. Appl. No. 13/685,754, filed Nov. 27, 2012. |
| US 6,056,761, 05/2000, Gia et al. (withdrawn). |
| Number | Date | Country | |
|---|---|---|---|
| 20120041470 A1 | Feb 2012 | US |
| Number | Date | Country | |
|---|---|---|---|
| 60792414 | Apr 2006 | US | |
| 60894589 | Mar 2007 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 12297419 | US | |
| Child | 13251021 | US |
