ARTICULATING HANDLE FOR A DEFLECTABLE CATHETER AND METHOD THEREFOR
A catheter assembly includes a handle assembly, and a catheter body coupled with the handle assembly, where the catheter body extends to a deflectable distal end portion, and the deflectable distal end is controllable by a flexible element. A lever actuator member is operatively coupled with the flexible element, and movement of the actuator member provides for movement of the flexible element.
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This application is a continuation of and claims the benefit of priority under 35 U.S.C. § 120 to U.S. patent application Ser. No. 11/127,818, entitled “ARTICULATING HANDLE FOR A DEFLECTABLE CATHETER AND METHOD THEREFOR,” filed on May 12, 2005 (Attorney Docket No. 905.061US1), which is hereby incorporated by reference herein in its entirety.
TECHNICAL FIELDThe present document relates generally to deflectable catheter assemblies. More particularly, it pertains to an articulating handle assembly for a deflectable catheter.
BACKGROUNDIncrease in the use of stents, leads, and ablation techniques in branch vessels has provided an increased demand in the placement techniques for the devices. For some procedures, it is necessary to initially position a guidewire into a desired part of the lumen of a desired vessel or duct, such as a blood vessel. After the guidewire is positioned within the desired location, a catheter or other tubular device may be positioned over the guidewire and used to convey other medical instruments into the desired blood vessel or duct.
Alternatively, a guiding catheter is used to negotiate the vasculature of a patient. One example of a guiding catheter is described in U.S. Pat. No. 4,898,577 to Badger et al. The Badger guiding catheter includes a single elongate shaft that has a deflectable distal portion controllable by a pull wire. Once the distal portion is at the required deflection or location within the patient, the medical instrument is fed through the catheter.
The deflectable catheter is controlled at a proximal end of the catheter by a control handle that operates the pull wire to deflect the catheter, for example, as shown in U.S. Pat. No. 6,171,277. However, with conventional catheter steering mechanisms, it is sometimes difficult to accurately position the catheters in certain body vessels, such as branch veins. For instance, the mechanisms are awkward or require the use of two hands. Other steering mechanisms require pull wires to be wound and unwound around a rotatable cam wheel, causing increased fatigue on the pull wires, and potentially shortening the life of the device. Furthermore, some deflectable catheters involve relatively large catheter sheaths. The larger sheaths can be difficult to manipulate within a patient, particularly when using a relatively small wheel mechanism or the above-discussed handle assemblies.
What is needed is a deflectable catheter that overcomes the shortcomings of previous deflectable catheters. What is further needed is a deflectable catheter that allows for more ease positioning of the distal end of the deflectable catheter, and that is usable with a single hand.
SUMMARYA catheter assembly includes a handle assembly, and a catheter body coupled with the handle assembly, where the catheter body extends to a deflectable distal end portion, and the deflectable distal end portion is controllable by a flexible element. The catheter assembly further includes a lever actuator member operatively coupled with the flexible element, where the lever actuator member has a first lever position and a second lever position, and movement of the lever actuator member provides for movement of the flexible element and the deflectable distal end portion. The lever actuator has several options. For example, the lever actuator member can be disposed along a first surface of the handle assembly, where the lever actuator member is deflectable toward a second surface when moving from the first position to the second position, where the first surface is opposite the second surface. In another option, the lever actuator member is movable within a first plane, and the deflectable distal end portion is movable within a second plane, and the first plane is substantially non-parallel with the second plane. Several other options are further discussed below.
A method includes manipulating a catheter assembly, the catheter assembly including a handle assembly, a catheter body coupled with the handle assembly, the catheter body extending to a deflectable distal end portion, the deflectable distal end portion controllable by a flexible element and a lever actuator member mechanically associated with the flexible element, and movement of the lever actuator member provides for movement of the flexible element. The method further includes moving the lever actuator member from a first actuator position to a second actuator position including moving the lever actuator member from a position along a first surface of the handle assembly toward a second opposite surface of the handle assembly, moving the lever actuator member from the first actuator position deflects the distal end portion of the catheter body.
These and other embodiments, aspects, advantages, and features of the present invention will be set forth in part in the description which follows, and in part will become apparent to those skilled in the art by reference to the following description of the invention and referenced drawings or by practice of the invention. The aspects, advantages, and features of the invention are realized and attained by means of the instrumentalities, procedures, and combinations particularly pointed out in the appended claims and their equivalents.
In the following detailed description, reference is made to the accompanying drawings which form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the invention, and it is to be understood that other embodiments may be utilized and that structural changes may be made without departing from the scope of the present invention. Therefore, the following detailed description is not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims and their equivalents.
A deflectable catheter assembly is disclosed herein and includes a handle assembly, and a catheter body coupled with the handle assembly, where the catheter body extends to a deflectable distal end portion, and the deflectable distal end portion is controllable by a flexible element. The catheter assembly further includes a lever actuator member operatively coupled with the flexible element, where the lever actuator member has a first lever position and a second lever position, and movement of the lever actuator member provides for movement of the flexible element and the deflectable distal end portion. The catheter assembly will be described in more detail along with the illustrations.
The catheter body 110 comprises, in one option, an elongate tubular construction that is flexible yet substantially non-compressible along its length. The deflectable catheter body 110 extends from a proximal end portion 102 to a distal end portion 104, where the distal end portion 104 is disposed within a patient. At the distal end 104 is a distal tip 105. At the proximal end 102, the physician controls the deflection of the deflectable catheter body 110 with the handle assembly 150 and a pull wire 120 (
The catheter body 110 includes a pull wire anchor that is secured to, for example, a distal portion of the catheter body 110. The pull wire 120 is mechanically secured to the pull wire anchor, for example, by welding the pull wire 120 to the pull wire anchor. It should be noted that the pull wire can be secured to the distal end 104 of the catheter body 110 in other manners. In one option, the catheter body 110 includes a stiffening member embedded therein, such as a braided stainless steel member. The stiffening member facilitates rotation of the distal end 104 from the proximal end 102, and also assists in preventing the catheter body 110 from collapsing.
The deflectable catheter body 110 includes a deflectable end portion 104 that is deflectable, for example, from a first position, as illustrated in
Several examples of the handle assembly 150 are shown in
The handle housing 152 includes a handle lumen 158 therein. The handle lumen 158 is co-operatively aligned or connected with the delivery lumen of the catheter body 110 (
The housing 152 and delivery lumen are adapted to receive a medical instrument, such as, but not limited to, a guidewire, a lead, an ablating device, etc., through the second end of the housing 152. In one option, a valve 130 (
The handle assembly 150 includes therein the actuator assembly 170 that is operatively coupled with and moves the pull wire 120 (
The lever actuator member 174 extends from a first member end 176 (
The lever actuator member 174 is designed to be used by a single handed operation. For example, the user can squeeze the lever actuator member 174 and manipulate the distal end 104 of the catheter assembly. The lever actuator member 174 is resiliently coupled within the handle assembly such that squeezing the lever actuator member 174 deflects the distal end 104, for example, in a first direction, and releasing the lever actuator member 174 allows for the resilient member, discussed further below, to actuate or deflect the distal end 104 in a second direction. Further options which facilitate single-handed operation include the relative proportions of the lever actuator member 174. For example, the lever extends along the housing where the lever member 174 has a length greater than at least half a length of the handle length.
Further options are illustrated in
The handle assembly 150 further includes an internal mechanism for translating the movement of the actuator member 174 to movement of the flexible element, such as, but not limited to, pull wire 120, resulting in deflection of the distal end of the catheter assembly.
The linkage 190 includes a distal link 192, a proximal link 194, a lever member roller 196, and a handle roller 198. The distal link 192 is rotatably coupled with the housing 152 at a first end 193 and is rotatably coupled with the member roller 196 at a second end 195. The proximal link 194 is coupled with the member roller 196 at a first end 191 and with a pull wire assembly 121 at a second end 189. The pull wire assembly 121 moves within a portion of the housing 152 as the lever member actuates the linkage 190. The pull wire assembly 121 is mechanically fixed with the pull wire 120, such that as the pull wire assembly 121 is moved, the pull wire 120 is moved.
The handle housing 152 includes a projection 149 extending from an internal portion of the housing 152. The projection 149 obstructs the path of the pull wire 120 when the pull wire 120 and/or anchor 123 are moved relative to the projection 149. For example, the actuator member 174 is moved from a first position to a second position, and the anchor 123 is moved therewith. The anchor movement moves the pull wire 120 and extends it over the projection 149, increasing the amount of pull wire 120 disposed within the handle housing 152, and decreasing the amount of pull wire 120 in the catheter body. This causes tension in the pull wire 120 and causes the distal end of the catheter body to deflect. When the lever actuator member 174 is released, the tension in the pull wire 120 is released, and the deflection in the distal end is released. It should be noted that the projection 149 and anchor 123 are one example of an internal mechanism where the length of the pull wire 120 is displaced, however, other variations are possible. For example, the projection 149 can be disposed on the lever actuator member 174, and the anchor can be disposed on the housing 152. In another option, the projection 149 could have a pulley or roller so the pullwire is not dragged across its surface.
In another option, the handle assembly 150 further includes a locking mechanism 202 associated therewith, as illustrated in
One example is illustrated in
The portion 212 can have a larger cross-sectional area than the rotatable part of the knob such that additional frictional forces can be placed on the pull wire assembly. The rotation of the knob 210 causes the portion 212 to move relative to the pull wire 220, however, the portion 212 may or may not rotate when the knob is rotated. In another option, a high friction member 214 is disposed along portion 212, providing additional frictional forces to the pullwire assembly 222.
In another embodiment, a method comprises manipulating a catheter assembly, the catheter assembly including a handle assembly, a catheter body controllable by a flexible element coupled with the handle assembly. An actuator member is coupled with the flexible element, where movement of the lever actuator member provides for movement of the flexible element and deflection of the distal end. The method includes moving the lever actuator member from a first actuator position to a second actuator position. The method further optionally includes moving the lever actuator member from a position along a first surface of the handle assembly toward a second opposite surface of the handle assembly, where moving the lever actuator member from the first actuator position deflects the distal end portion of the catheter body.
As the lever actuator is moved or manipulated, for example, with one hand, the internal mechanisms are manipulated, as discussed above. For example, internal linkages are manipulated, for example, by rotation. Alternatively, the pull wire length is displaced within the housing by a projection. It should be noted that a combination of these examples are also possible. Further options include locking the flexible element from movement, for example, relative to the housing.
Advantageously, the above-described deflectable catheter allows for increased control of the distal deflectable catheter end. The catheter allows for single-handed use of the device, and allows for a grip force to be exerted on the handle assembly. A large force can be produced by the user with grip force, and the device is useful for use with larger catheter shafts or thick-walled catheter shafts which are otherwise difficult to manipulate, or require a complicated mechanism to multiply force of the user.
It is to be understood that the above description is intended to be illustrative, and not restrictive. Many other embodiments will be apparent to those of skill in the art upon reading and understanding the above description. It should be noted that embodiments discussed in different portions of the description or referred to in different drawings can be combined to form additional embodiments of the present invention. The scope of the invention should, therefore, be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.
Claims
1. A catheter assembly, comprising:
- a handle assembly, including a handle housing;
- a catheter body coupled with the handle assembly, the catheter body extends to a deflectable distal end portion;
- a pull wire anchor disposed within the handle assembly;
- a pull wire, extending through a portion of the handle assembly, the pull wire is coupled to the anchor and operably coupled to the deflectable distal end portion, wherein the pull wire includes first and second pull wire segments disposed substantially within the handle assembly, and a third pull wire segment disposed substantially within the catheter body;
- a projection disposed within the handle housing, the projection extends from an internal portion of the handle assembly, and the projection engages with and deflects the pull wire into the first and second pull wire segments between the catheter body and the anchor; and
- a lever actuator member operatively coupled with the pull wire, the lever actuator member movable from a first lever position to a second lever position, wherein: in the first lever position, the first pull wire segment is a first initial length and the third pull wire segment is a second initial length; and in the second lever position, the first pull wire segment is a greater length than the first initial length and the third pull wire segment is a lesser length than the second initial length.
2. The catheter assembly of claim 1, wherein a length of the second pull wire segment disposed substantially within the handle assembly is substantially the same when the lever actuator member is in the first lever position and when the lever actuator member is in the second lever position.
3. The catheter assembly of claim 1, wherein the first pull wire segment disposed substantially within the handle assembly is disposed substantially between the pull wire anchor and the projection.
4. The catheter assembly of claim 1, wherein the second pull wire segment disposed substantially within the handle assembly is disposed substantially between the projection and the catheter body.
5. The catheter assembly of claim 1, wherein the lever actuator member is configured to displace at least one of the pull wire anchor or the projection to increase the length of the pull wire disposed within the handle housing and decrease the length of the pull wire disposed within the catheter body.
6. The catheter assembly of claim 1, wherein the handle assembly is configured for single-handed manipulation.
7. The catheter assembly of claim 1, wherein the pull wire anchor disposed within the handle assembly is fixedly coupled to the lever actuator member.
8. The catheter assembly of claim 1, wherein the projection disposed within the handle housing is fixedly coupled to the lever actuator member.
9. The catheter assembly of claim 1, wherein the projection disposed within the handle housing includes a roller, the roller is movably coupled to the pull wire.
10. A catheter assembly comprising:
- a handle assembly, including a handle housing;
- a catheter body having a catheter body axis, the catheter body extends to a deflectable distal end portion, the deflectable distal end portion is movable from a distal portion first position to a distal portion second position;
- a pull wire, operatively coupled with the handle assembly and the deflectable distal end portion, a pull wire first segment laterally exits the catheter body away from the catheter body axis;
- a lever actuator member operatively coupled with the pull wire, the lever actuator member is continuously variable from a first lever position to a second lever position, and movement of the lever actuator member provides for movement of the pull wire and the deflectable distal end portion;
- a pull wire anchor disposed within the handle assembly and fixedly coupled to the pull wire and at least one of the lever actuator member or the handle housing; and
- a projection disposed within the handle housing, the projection extends from an internal portion of at least one of the handle housing or the lever actuator member, and the projection engages with and deflects the pull wire first segment, wherein a proximal portion of the pull wire first segment extends between the projection and the pull wire anchor, and wherein a distal portion of the pull wire first segment extends between the projection and the catheter body.
11. The catheter assembly of claim 10, wherein the lever actuator member is configured to displace at least one of the anchor or the projection to increase the amount of the pull wire disposed within the handle housing.
12. The catheter assembly of claim 11, wherein the proximal portion of the pull wire first segment has a first length in the first lever position and the proximal portion of the pull wire first segment has a second length in the second lever position; and
- wherein the second length is different than the first length.
13. The catheter assembly of claim 10, wherein the projection disposed within the handle housing includes a roller, the roller movably coupled to the pull wire.
14. The catheter assembly of claim 10, wherein the lever actuator member is configured to displace at least one of the pull wire anchor or the projection to increase the length of the pull wire first segment.
15. The catheter assembly of claim 10, wherein the handle assembly is configured to receive a grip force.
16. The catheter assembly of claim 10, wherein the projection extends from an internal portion of the handle housing; and
- wherein the pull wire anchor is fixedly coupled to the lever actuator member.
17. The catheter assembly of claim 10, wherein the projection extends from an internal portion of the lever actuator member; and
- wherein the pull wire anchor is fixedly coupled to the handle housing.
18. The catheter assembly of claim 10, wherein the lever actuator member is operatively coupled to the handle assembly at a fulcrum.
19. The catheter assembly of claim 10, including a locking mechanism associated with the deflectable distal end portion to secure the deflectable distal end portion in an intermediate position between the distal portion first position and the distal portion second position.
20. The catheter assembly of claim 10, wherein the deflectable distal end portion is displaced from the distal portion first position toward the distal portion second position by an amount proportional to a displacement of the lever actuator member.
21. A method of manipulating a catheter assembly, comprising:
- deflecting a catheter pull wire with a projection disposed within a catheter handle assembly, the projection engages the pull wire between first and second pull wire segments, and the catheter pull wire is operably coupled to a deflectable distal end portion of the catheter assembly;
- moving a lever actuator member from a first actuator position to a second actuator position, wherein moving the lever actuator member changes a length of the first pull wire segment; and
- deflecting the distal end portion from a first position to a second position according to the movement of the lever actuator member and the change in length of the first pull wire segment.
22. The method of claim 21, including moving the lever actuator member from the second actuator position to the first actuator position to deflect the distal end portion in a second direction, wherein moving the lever actuator member from the second actuator position to the first actuator position decreases a length of the first pull wire segment.
23. The method of claim 21, wherein the moving the lever actuator member includes using a grip force to engage a first portion of the lever actuator member and forcibly position a second opposed portion of the lever actuator member inside the housing assembly, including moving the lever actuator member from a position along a first surface of the handle assembly toward a second opposite surface of the handle assembly.
24. The method of claim 21, comprising moving the lever actuator member along a first plane and moving the deflectable distal end portion along a second plane, wherein the first plane and the second plane are non-parallel.
25. The method of claim 21, wherein the moving the lever actuator member includes moving the projection, wherein the projection is fixedly coupled to the lever actuator member.
26. The method of claim 21, wherein the moving the lever actuator member includes moving a pull wire anchor, wherein the pull wire anchor is fixedly coupled to the lever actuator member.
27. The method of claim 21, wherein the moving the lever actuator member includes moving the pull wire over a roller coupled to the projection.
28. The method of claim 21, further comprising securing the distal end portion in a deflected position.
Type: Application
Filed: Apr 21, 2011
Publication Date: Aug 11, 2011
Applicant: Greatbatch, Ltd. (Clarence, NY)
Inventors: Brian Fischer (Minneapolis, MN), Brian Honebrink (Stillwater, MN)
Application Number: 13/091,187
International Classification: A61M 25/01 (20060101);