The present invention relates to an apparatus and method for use of a multi-lumen catheter assembly and, more particularly, to a handle for providing relative motion to a multi-lumen catheter assembly and a method of using the handle.
In many minimally invasive surgical procedures, such as percutaneous procedures, a catheter is inserted into a patient's body to facilitate remote manipulation of surgical tools at a surgery site within the patient. For example, a user may desire to deploy an intraluminal prosthesis within a patient's vasculature, possibly with the assistance of an apparatus such as that disclosed in the commonly assigned U.S. patent application Ser. No. 11/601,075, filed Nov. 16, 2006 for APPARATUS AND METHOD FOR DELIVERING LINED INTRALUMINAL PROSTHESES. However, the user must have some way of controlling the deployment of the intraluminal prosthesis deep within the body.
Often such deployment control or other remote control during a percutaneous procedure is provided by relative motion of various structures of a catheter assembly. However, it can be difficult for a user to move multiple structures in different directions, possibly at different rates of motion, while monitoring conditions at the surgery site through remote viewing devices.
In an embodiment of the present invention, a handle for providing relative motion to a multi-lumen catheter assembly is described. An elongated handle body has a longitudinal axis. The handle body has longitudinally spaced proximal and distal handle ends. An outer catheter chuck is connected to the distal handle end and is adapted to receive an outer catheter member. An inner catheter chuck is connected to the proximal handle end and is adapted to receive an inner catheter member. A handle actuator is movably connected to the handle body. The handle actuator is adapted to receive an intermediate catheter member and to move the intermediate catheter member relative to the inner and outer catheter members. The intermediate catheter is at least partially interposed between the inner and outer catheter.
In an embodiment of the present invention, a multi-lumen catheter assembly is described. An outer catheter member has a longitudinal axis and longitudinally spaced proximal and distal outer catheter ends with a first lumen defined therebetween. An intermediate catheter member has longitudinally spaced proximal and distal intermediate catheter ends with a second lumen defined therebetween. The intermediate catheter member is at least partially located within the first lumen. An inner catheter member has longitudinally spaced proximal and distal inner catheter ends. The inner catheter member is at least partially located within the second lumen. A handle is connected to the proximal outer catheter end, the proximal intermediate catheter end, and the proximal inner catheter end. The handle is adapted to maintain the relative position of the outer and inner catheter members while providing movement of the intermediate catheter member relative thereto.
In an embodiment of the present invention, a method of providing relative motion to a multi-lumen catheter assembly is described. An outer catheter member having a longitudinal axis and longitudinally spaced proximal and distal outer catheter ends with a first lumen defined therebetween is provided. An intermediate catheter member is at least partially located within the first lumen. The intermediate catheter member has longitudinally spaced proximal and distal intermediate catheter ends with a second lumen defined therebetween. An inner catheter member is at least partially located within the second lumen. The inner catheter member has longitudinally spaced proximal and distal inner catheter ends. A handle is connected to the proximal outer catheter end, the proximal intermediate catheter end, and the proximal inner catheter end. The relative position of the outer and inner catheter members is maintained. Movement of the intermediate catheter member relative to the outer and inner catheter members is provided.
For a better understanding of the invention, reference may be made to the accompanying drawings, in which:
In accordance with the present invention,
An intermediate catheter member 112 is at least partially located within the first lumen 110. The intermediate catheter member has longitudinally spaced proximal and distal intermediate catheter ends 114 (hidden within the outer catheter member 102 in this view) and 116, respectively, with a second lumen 118 defined therebetween.
An inner catheter member 220 is at least partially located within the second lumen 118. The inner catheter member 220 is not visible in
As depicted in
One or more of the distal outer catheter end 108, the distal intermediate catheter end 116, and the distal inner catheter end 224 may be adapted for operative connection to a intraluminal prosthesis cartridge (not shown) as part of a intraluminal prosthesis delivery system (not shown). To facilitate such connection, the chosen one(s) of the distal outer catheter end 108, the distal intermediate catheter end 116, and the distal inner catheter end 224 may include a coupling or fitting member of any suitable type, such as the intermediate catheter threaded connector 228 or the inner catheter threaded connector 230 shown in
Returning to
The handle 134 is adapted to maintain the relative positioning of two or more of the outer, intermediate, and inner catheter members 102, 112, and 220 while moving the remaining one(s) of these catheter members translationally and/or rotationally relative to the maintained catheter members 102, 112, and/or 220. For clarity of discussion inn the below description, the handle 134 will be presumed to be adapted to maintain the relative position of the outer and inner catheter members 102 and 220 while providing translational movement of the intermediate catheter member 112 relative thereto.
As shown schematically in
A handle actuator 144 is affixed to the proximal intermediate catheter end 114 and is movably connected to the handle body 136. The handle actuator 144 may be movable in as many degrees of freedom as desired, and is adapted for both selective axial rotation and selective longitudinal translation relative to the handle body 136 in the depicted embodiment of the present invention. The handle actuator 144 is selectively movable relative to the handle body 136 to move the attached intermediate catheter member 112 longitudinally relative to the outer and inner catheter members 102 and 220.
The handle actuator 144 may have any suitable mechanical connection with the handle body 136. For example, bearings associated with either or both of the handle actuator 144 and the handle body 136 could provide a rolling interface between the two. As another example, the handle actuator 144 may simply be slidably connected to the handle body 136. The relative materials, dimensions, and other properties of both the handle actuator 144 and the handle body 136 may be chosen to optimize frictional forces therebetween for a desired mechanical result. For example, when there is a relatively tight fit between the handle actuator 144 and the handle body 136, a resulting frictional engagement may help to retain the handle actuator in a desired position along the handle body, while a looser fit may be preferable when ease of motion is more desirable than frictional retention.
Because the inner catheter chuck 448 is connected to the proximal handle end 138 and to the inner catheter member 220, the inner catheter member extends longitudinally through at least a portion of the handle body 136 when received by the inner catheter chuck. For example, the inner catheter member 220 could extend through at least a portion of the handle lumen 142, as depicted in
When the inner catheter member 220 includes the optional third lumen 226, the proximal handle end 138 may include an inner catheter adapter 450, as shown in
The handle actuator 144 is adapted to receive the intermediate catheter member 112 and to move the intermediate catheter member relative to the outer and inner catheter members 102 and 220. As a consequence, the handle actuator 144 is adapted to move the distal intermediate catheter end 116 longitudinally relative to the distal outer and inner catheter ends 108 and 224 and thereby to place the distal intermediate catheter end into a desired position at the surgery side within the patient's body while maintaining the position of the distal outer and inner catheter ends relative to the distal intermediate catheter end.
For example, the multi-lumen catheter assembly 100 may be arranged so that the handle actuator 144 is selectively movable relative to the handle body 136 to move the distal intermediate catheter end 116 longitudinally between the distal inner catheter end 224 and the distal outer catheter end 108. Alternatively or additionally, the handle actuator 144 may be selectively movable relative to the handle body 136 to extend the distal intermediate catheter end 116 longitudinally beyond the distal inner catheter end 224. One of ordinary skill in the art can readily choose the relative sizes of any or all structures of the multi-lumen catheter assembly 100 in order to achieve relative movement between any or all of the outer, intermediate, and inner catheter members 102, 112, and 220 as desired for a particular application of the present invention. For example, the lengths of the outer, intermediate, and inner catheter members 102, 112, and 220 may be chosen to provide desired arrangements and spacing between two or more of the distal outer, intermediate, and inner catheter ends 108, 116, and 224 during operation of the multi-lumen catheter assembly.
An actuator detent mechanism 452, such as the spring-loaded pin shown in
For example, the actuator detent mechanism 452 may be designed to lightly hold the handle actuator 144 in an initial position, such that a user can readily overcome the actuator detent mechanism by a slight motion of, or firm grasp upon, the handle actuator. In contrast, the actuator detent mechanism 452 may instead provide a “safing” function, in which the user is required to perform some affirmative action, such as releasing a latch or breaking a seal, before the handle actuator 144 can be moved axially and/or longitudinally with respect to the handle body 136.
Operation of the multi-lumen catheter assembly 100 is shown in the sequence of
In
A detent slot 662, extending substantially circumferentially around a portion of the handle body 136, is visible in
Optionally, and regardless of the configuration or presence of the detent slot 662, the actuator detent mechanism 452 may be operative to selectively resist movement of the handle actuator 144 between the first and second actuator rotation positions.
In the transition from
From the second condition of
As can also be seen in
The actuator stub 660, protruding from the handle actuator 144, is depicted and described herein as interacting with the opening 658 in the handle body 136 to guide both rotational and translational movement of the handle actuator relative to the handle body. However, it is intuitively obvious that a protrusion (not shown) from the handle body 136 could instead interact with an opening (not shown) in the handle actuator 144 to provide either or both of the rotational and translational relative movements. Additionally, any other suitable structure(s), whether or not a protrusion/opening pair, could be used to guide the rotational and/or translational movement of the handle actuator 144 relative to the handle body 136.
Though the handle actuator 144 and other structures of the multi-lumen catheter assembly 100 are shown in certain positions (e.g., the first and second actuator rotation positions and the first, second, and third actuator translation positions) for ease of description, the so-described structures are not limited to these discrete positions and may be located in any number of intermediate positions between those depicted. Likewise, the described and depicted structures need not progress between the depicted positions in the order shown, but may be selectively moved from one position to another in any desired order and following any desired timing sequence. For example, the handle actuator 144 could start in the second actuator translation position, be moved to the first actuator translation position, and then pass through the second actuator translation position (and many other intermediate positions) en route to the third actuator translation position. Alternatively, a “one way” mechanism or structure could be provided to restrict the handle actuator 144 to a certain sequential motion, such as only from the first to second actuator rotation position and/or only from the first to second actuator translation position. Sequential restriction of this type could be especially useful when the multi-lumen catheter assembly 100 is used to release a compressed stent and reversal of the deployment operation could damage the previously released stent.
It is contemplated that the outer and inner catheter chucks 446 and 448 and the handle actuator 144 may each hold the respective ones of the outer, inner, and intermediate catheter members 102, 220, and 112 in any desired manner, through the use of means such as, but not limited to: chemically and/or physically adhesive materials; screws, nails, staples, or other penetrating fasteners; a mechanically interlocking/engaging structure, such as a threaded or barbed fit; a magnetically interlocking/engaging structure; a structure adapted for frictional engagement (an “interference fit”) or a compression fit; or any combination thereof.
It is also contemplated that the handle actuator 144 or another structure of the multi-lumen catheter assembly 100 may include a mechanical advantage device (not shown) operative to change the relative motion ratio between the handle actuator 144 and the intermediate catheter member 112 from the 1:1 relationship provided by the depicted multi-lumen catheter assembly to a greater or lesser ratio, thus providing desired movement of the intermediate catheter member relative to one or both of the outer and inner catheter members 102 and 220.
Finally, it is contemplated that the actuator detent mechanism 452 could include any desired mechanism or combination of reversible or unidirectional/one-time-only mechanisms adapted to prevent one or both of longitudinal translation and axial rotation of the handle actuator 144 with respect to the handle body 136. For example, chemical or physical adhesives, captured-ball, spring-pin, piezoelectric, cantilevered latch, magnetic, perforated structures, a lockout of an actuating motor, a compliant interference (e.g., a rubberized structure), a ratchet, a deflecting member (e.g., a flat spring), or any other suitable means may be used to provide the actuator detent mechanism 452.
While aspects of the present invention have been particularly shown and described with reference to the preferred embodiment above, it will be understood by those of ordinary skill in the art that various additional embodiments may be contemplated without departing from the spirit and scope of the present invention. For example, all structures of the multi-lumen catheter assembly 100 may be formed from any material, or combination of materials, as suitable to provide the finished multi-lumen catheter assembly with desired properties (e.g., the handle actuator 144 could be formed of or coated with a nonslip material for ease of grasping and operation by the user). The first, second, and third lumens 110, 118, and 226 need not extend completely between the proximal and distal ends of the outer, intermediate, and inner catheter members 102, 112, and 220, respectively. The handle 134 may be designed in an ergonomic manner, for ease of gripping and operation by the user. The outer, intermediate, and inner catheter members 102, 112, and 220 may each be of any desired lengths. One or more of the outer, intermediate, and inner catheter members could be omitted from the multi-lumen catheter assembly 100. The outer and inner catheter chucks 446 and 448 may be at least partially formed integrally with the handle 134 or any other structure of the multi-lumen catheter assembly 100, or may be provided separately therefrom. The handle lumen 142 could be smaller than depicted and/or the inner catheter member 220 could be larger than depicted, so that the inner catheter member substantially fills the handle lumen. The handle actuator 144 may be moved manually by the user, with or without an automatic assistance mechanism such as, but not limited to, a stepper motor, a pneumatic or hydraulic piston, a pulley system, or the like, or any combination thereof. The first, second, and third conditions of the multi-lumen catheter assembly 100 are defined and depicted as examples only, and are neither intended nor operative to restrict the order, direction, or sequence in which certain structures of the claimed invention interact. The detent slot 662 is depicted as extending from the opening 658, but may be separate from the opening. A device or method incorporating any of these features should be understood to fall under the scope of the present invention as determined based upon the claims below and any equivalents thereof.
Other aspects, objects, and advantages of the present invention can be obtained from a study of the drawings, the disclosure, and the appended claims.
This application claims the benefit of U.S. Provisional Patent Application Ser. No. 60/959,736, filed Jul. 16, 2007 which is incorporated herein by reference.
Number | Date | Country | |
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60959736 | Jul 2007 | US |