STEERABLE CATHETERS
20220226611 · 2022-07-21
Inventors
Cpc classification
A61M25/0041
HUMAN NECESSITIES
A61M2025/0175
HUMAN NECESSITIES
A61M25/0147
HUMAN NECESSITIES
International classification
Abstract
Steerable catheters may include a plurality of generally arcuate-shaped struts connected at proximal and distal ends of a handle. The handle is connected to a tubular portion at a distal end of the handle. The tubular portion includes a resilient component positioned near a distal tip of the tubular portion. The catheter includes a pull wire fixed to a point at or near the distal tip of the tubular portion. Upon manual compression of the handle, the struts are squeezed together, lengthening the handle, and extending the pull wire proximally. The proximal extension of the pull wire can cause the distal tip of the catheter to deflect. The catheter can be rotated greater than 360° around a longitudinal axis. The compressible handle can allow a user of the catheter tactile feedback and control over navigation of the catheter.
Claims
1. (canceled)
2. A steerable catheter comprising: a handle comprising: a proximal end, a distal end, an axis between the proximal end of the handle and the distal end of the handle, an intermediate point between the proximal end of the handle and the distal end of the handle, a plurality of struts extending away from the axis from the proximal end of the handle to the intermediate point and extending towards the axis from the intermediate point to the distal end of the handle, each of the plurality of struts coupled at the proximal end of the handle and at the distal end of the handle, the plurality of struts circumferentially spaced about the axis forming as a whole an arcuate shape, and a cover over the plurality of struts, the handle rotatable at least 360° about the axis during manual inward compression of the handle; an elongate body comprising: a proximal portion coupled to the distal end of the handle, a distal portion including a distal end of the elongate body, the distal portion comprising a resilient component, a first lumen extending from the proximal portion to the distal portion, and a second lumen extending from the proximal portion to the distal portion, the second lumen configured to provide a path for an endoluminal device; and a pull wire extending from the proximal end of the handle to the distal end of the elongate body through the first lumen, the pull wire configured to extend proximally upon manual inward compression of the handle, the distal portion of the elongate body configured to deflect upon manual inward compression of the handle from a straight configuration to a curved configuration, a degree of deflecting corresponding to a force applied during the manual inward compression, the pull wire configured to extend distally upon manual outward decompression of the handle, the distal portion of the elongate body configured to deflect upon manual outward decompression of the handle from the curved configuration to the straight configuration, a degree of deflecting corresponds to a force applied during the manual outward decompression.
3. The steerable catheter of claim 2, wherein the resilient component comprises a ribbon on a side of the distal portion.
4. The steerable catheter of claim 2, wherein the resilient component comprises a shape memory material.
5. The steerable catheter of claim 2, further comprising a locking mechanism configured to maintain the pull wire in a proximally retracted configuration.
6. A steerable catheter comprising: a handle comprising: a proximal end, a distal end, an axis between the proximal end of the handle and the distal end of the handle, an intermediate point between the proximal end of the handle and the distal end of the handle, a plurality of struts extending away from the axis from the proximal end of the handle to the intermediate point and extending towards the axis from the intermediate point to the distal end of the handle, the plurality of struts circumferentially spaced about the axis forming as a whole an arcuate shape, and a cover over the plurality of struts, the handle rotatable at least 360° about the axis during manual inward compression of the handle; an elongate body comprising: a proximal portion coupled to the distal end of the handle, a distal portion including a distal end of the elongate body, and a lumen extending from the proximal portion to the distal portion; and a wire extending from the proximal end of the handle to the distal end of the elongate body through the lumen, the wire configured to extend proximally upon manual inward compression of the handle, the distal portion of the elongate body configured to deflect upon manual inward compression of the handle from a straight configuration to a curved configuration, a degree of deflecting corresponding to a force applied during the manual inward compression.
7. The steerable catheter of claim 6, wherein the distal portion comprises a resilient component on a side of the distal portion.
8. The steerable catheter of claim 7, wherein the resilient component comprises a shape memory material.
9. The steerable catheter of claim 6, wherein the elongate body comprises a second lumen extending from the proximal portion to the distal portion, the second lumen configured to provide a path for an endoluminal device.
10. The steerable catheter of claim 6, wherein the wire is configured to extend distally upon manual outward decompression of the handle, the distal portion of the elongate body configured to deflect upon manual outward decompression of the handle from the curved configuration to the straight configuration, a degree of deflecting corresponding to a force applied during the manual outward decompression.
11. The steerable catheter of claim 6, further comprising a locking mechanism configured to maintain the wire in a proximally retracted configuration.
12. A steerable catheter comprising: a handle comprising: a proximal end, a distal end, an axis between the proximal end of the handle and the distal end of the handle, an intermediate point between the proximal end of the handle and the distal end of the handle, a plurality of struts circumferentially spaced about the axis together forming an arcuate shape, the handle rotatable at least 360° about the axis during manual inward compression of the handle; an elongate body comprising: a proximal portion coupled to the distal end of the handle, and a distal portion including a distal end of the elongate body; and a wire extending from the proximal end of the handle to the distal end of the elongate body.
13. The steerable catheter of claim 12, wherein the handle comprises a cover over the plurality of struts.
14. The steerable catheter of claim 12, wherein the wire is configured to extend proximally upon manual inward compression of the handle, and wherein the distal portion of the elongate body is configured to deflect upon manual inward compression of the handle from a straight configuration to a curved configuration.
15. The steerable catheter of claim 14, wherein a degree of deflecting corresponds to a force applied during the manual inward compression.
16. The steerable catheter of claim 12, wherein the elongate body comprises a lumen extending from the proximal portion to the distal portion, the lumen configured to provide a path for an endoluminal device.
17. The steerable catheter of claim 12, wherein the distal portion comprises a resilient component on a side of the distal portion.
18. The steerable catheter of claim 17, wherein the resilient component comprises a shape memory material.
19. The steerable catheter of claim 12, wherein the wire is configured to extend distally upon manual outward decompression of the handle, the distal portion of the elongate body configured to deflect upon manual outward decompression of the handle from a curved configuration to the straight configuration.
20. The steerable catheter of claim 19, wherein a degree of deflecting corresponds to a force applied during the manual outward decompression.
21. The steerable catheter of claim 12, further comprising a locking mechanism configured to maintain the wire in a proximally retracted configuration.
Description
BRIEF DESCRIPTION OF THE FIGURES
[0011] These and other features, aspects, and advantages of the present disclosure are described with reference to the drawings of certain embodiments, which are intended to illustrate certain embodiments and not to limit the invention.
[0012]
[0013]
[0014]
[0015]
[0016]
[0017]
[0018]
[0019]
[0020]
[0021]
[0022]
[0023]
[0024]
DETAILED DESCRIPTION
[0025] Although certain embodiments and examples are described below, those of skill in the art will appreciate that the invention extends beyond the specifically disclosed embodiments and/or uses and obvious modifications and equivalents thereof. Thus, it is intended that the scope of the invention herein disclosed should not be limited by any particular embodiments described below.
[0026] Example steerable catheters are provided, each including a handle and an elongate tubular portion. The handle includes multiple segments (e.g., strips, wires), connected at a proximal end of the handle and a distal end of the handle. The segments form a generally arcuate shape such as a sphere or an ellipse. The tubular portion is connected to the distal end of the handle. The tubular portion includes a resilient component positioned near a distal tip of the tubular portion. The resilient component can include a shape-memory material and can extend longitudinally along the tubular portion near the distal tip of the tubular portion. The catheter includes a pull wire fixed to a point near the distal tip of the tubular portion and fixed to a point near the proximal end of the handle. Upon manual compression or squeezing of the handle, the segments are squeezed together, causing the shape of the handle to flatten and lengthen. As the handle lengthens, the pull wire, fixed to the proximal end of the handle, is pulled back, away from the tubular portion. This retraction of the pull wire pulls on the distal tip of the tube portion at the point where the pull wire is fixed to the distal tip of the tubular portion, causing the distal tip of the tubular portion to deflect away from the longitudinal axis of the tubular portion. The deflection may take the form of curvature of the distal tip of the tubular portion. The amount of deflection is proportional to the amount of compression or squeezing of the handle. Increasing the squeezing or compressing of the handle increases the retraction of the pull wire and the deflection of the distal tip. Decreasing the squeezing or compressing of the handle decreases the retraction of the pull wire and the deflection of the distal tip. Upon decompression or release of the handle, the segments of the handle return towards their arcuate configuration and the pull wire moves distally. When no other forces are acting on the resilient component at the distal tip of the tubular member, the resilient component can return to its original configuration, which is usually straight but may also be curved (e.g., curved in the opposite direction to the direction of deflection), and the distal tip can follow the shape of the resilient component. The amount of rebounding is proportional to the amount of decompression or release of the handle. Increasing the decompression or release of the handle increases the distal movement of the pull wire and the amount of rebounding of the distal tip of the tubular portion. Decreasing the decompression or release of the handle decreases the distal movement of the pull wire and the amount of rebounding of the distal tip of the tubular portion. Alternative handles (e.g., including one or more compressible buttons), tubular portions, and other components are also disclosed.
[0027]
[0028] The steerable catheter 100 comprises an elongate tubular body 112 positioned distally of the handle 102. The elongate tubular body 112 comprises a proximal portion 114 and a distal portion 116. A lumen 118 extends from the proximal portion 114 to the distal portion 116. The distal portion 116 of the tubular body 112 comprises a resilient component 120. The resilient component 120 is positioned at or near the distal end 122 of the tubular body 112. The resilient component 120 may extend proximally from a point at or near the distal end 122 of the tubular body 112. In some embodiments, the elongate tubular body 112 is more malleable towards the distal end 122 of the tubular body 112 than towards the proximal end 114 of the tubular body. This increased malleability can allow enhanced bendability around tortuous anatomy.
[0029] The steerable catheter 100 comprises a pull wire 124 extending from the proximal end 106 of the handle 102 to the distal end 122 of the tubular body 112. The pull wire 124 is connected to the handle 102 at or near the proximal end 106 of the handle and is connected to the elongate tubular body 112 at or near the distal end 122 of the body 112.
[0030]
[0031] The degree of straightening of the struts 110 may correspond to the force applied during the manual inward compression of the at least some of the resilient metal struts. For example, increasing the force applied during compression of the struts 110 can increase the degree of straightening. Conversely, decreasing the force applied during compression of the struts 110 can decrease the degree of straightening.
[0032] Compressing the handle 102 may proximally extend the proximal end 106 of the handle 102, pulling the pull wire 124 proximally, as shown by the proximally pointing arrow 132 in
[0033] Proximal extension of the pull wire 124 at the distal end 122 of the tubular body causes deflection of the distal portion 116 of the tubular body 112, shown by the arrow 134 in
[0034] The distal portion 116 that curves may be defined between the distal end 122 of the catheter 100 and the proximal end of the resilient component 120. The distal portion 116 may be capable of curving up to 180° within the plane of curvature. The plane of curvature may be a plane including the resilient portion 120 and a section extending along the tubular body 112 that is generally opposite from the resilient portion 120.
[0035]
[0036] Distal retraction of the pull wire 124 allows the distal portion 116 of the tubular body to rebound from a deflected or curved configuration towards a straighter configuration, shown by arrow 140 in
[0037] The deflection and rebounding of the distal portion 116 of the tubular body 112 can allow the catheter 100 to be navigated through tortuous sections of the anatomy (e.g., the vasculature). This ability to navigate can allow the catheter 100 to be used as a guiding catheter for use in peripheral vasculature or coronary sinus areas, implant delivery systems, and for EP mapping, among other applications. Many steerable catheters currently available use some sort of handle, lever, or motor/switch system by which they cause the distal end of the catheter to curve. Such configurations do not allow for optimal control over the steering or provide tactile feedback to the physician attempting to steer the catheter. Furthermore, some “digital” steering mechanisms do not provide any tactile feedback or allow for fine control in response to the anatomy encountered during a medical procedure. This compression and decompression can be described as “analog” because there are an infinite number of positions the pull wire can be extended to and an infinite number of curvatures that can be imparted to the distal portion. By contrast, existing structures can generally only be operated in two “digital” predetermined curvatures (one of which may be no curvature). In the case of currently available “analog” steering mechanisms, one finger or thumb is generally used to steer the catheter, which provides less than ideal tactile feedback and can be difficult to control consistently. In contrast, the steering mechanism disclosed herein is controlled by an analog, compressible handle 102 configured to be grasped by the hand (e.g., thumb, palm, and at least some fingers) of a user. Parts of the hand working together can allow for increased tactile feedback and control over currently available systems.
[0038] In some embodiments, the catheter 100 comprises more than one lumen extending from the proximal portion 114 to the distal portion 116. The pull wire may be housed within a “false” lumen. The catheter may also comprise one or more working or functional lumens. For some examples, a guidewire, other catheters, devices (e.g., endoluminal devices), therapeutic agents, or a wire for EP applications could be navigated through these working or functional lumens. The lumens may be side-by-side, coaxial, round, partially round (e.g., wedges, semicircular, crescent, etc.).
[0039] In some embodiments, the struts 110 comprise a wire. Other shapes for the struts are also possible. For example, in some embodiments, the struts 110 comprise a ribbon. In some embodiments, all of the struts 110 comprise a same shape. In other embodiments, the struts 110 comprise different shapes. For example, some of the struts 110 may comprise a wire and others of the struts 110 may comprise a ribbon.
[0040] The struts 110 comprise a resilient and flexible material. In some embodiments, the struts 110 comprise a shape memory material. In some embodiments, the struts 110 comprise a metal. The struts 110 may comprise a nickel-titanium alloy (e.g., Nitinol). In some embodiments, the struts 110 comprise a polymer (e.g., carbon fiber). Other resilient and flexible materials are also possible. In some embodiments, the struts 110 comprise the same material. In some embodiments, the struts 110 comprise different materials. For example, some (e.g., half) of the struts may comprise Nitinol, and the remaining struts 110 may comprise carbon fiber, stainless steel, etc. For another example, one strut of the plurality of struts 110 may comprise Nitinol, and the remainder of the struts 110 may comprise carbon fiber, stainless steel, etc.
[0041] In some embodiments, the handle 102 comprises a cover over the plurality of struts 110. A cover positioned over the handle 102 can enhance the ease of use and comfort of the handle 102 for a user. For example, the cover can prevent pinching of the user's hands upon movement of the strips. The cover can also provide a textured surface that is easier to manipulate than the strips. In some embodiments, the cover comprises silicone. Other materials (e.g., other polymers and plastics) are also possible.
[0042] In some embodiments, the resilient component 120 comprises a shape memory material. For example, the resilient component 120 can comprise a nickel titanium alloy (e.g., Nitinol). In some embodiments, the resilient component 120 comprises a ribbon. Other shapes are also possible. For example, the resilient component 120 can comprise a wire. Other materials comprising rebound tensile strength (e.g., springs) are also possible. In some embodiments, the resilient component 120 is continuous along a portion of the tubular body 112. In some embodiments, the resilient component comprises multiple discrete components within the tubular body 112. In some embodiments, the catheter 100 comprises multiple resilient components 120. In some embodiments, a number, shape, and material of resilient components can be used to affect a rigidity of the catheter 100. For example, multiple resilient components or a more rigid material in the resilient component can involve a greater compressive force on the handle of the catheter to deflect the distal portion 116 of the catheter 100.
[0043] In some embodiments, the resilient portion 120 is pre-curved in a first direction by curving the resilient component 120. In such embodiments, compressing the handle 102 causes the distal portion 116 of the catheter to curve in a second direction, which may be opposite to the first direction. In embodiments comprising a pre-curved resilient portion 120, curvature of the distal portion 116 up to 360° within the plane of curvature may be possible.
[0044]
[0045] A finger may be used to depress the bump 404. For example, the thumb or index finger may be used to depress the bump 404, which may allow for greater accuracy and tactile feedback than using other fingers or an entire hand.
[0046]
[0047] Release of the bump 404 can cause distal retraction of the pull wire 424 and allow rebounding of the distal portion 416 of the catheter 400, for example as described above with respect to the catheter 100. Distal retraction of the pull wire 424 decreases the deflecting force applied to the resilient component 420. With less deflecting force acting upon the resilient component 420, it rebounds to its original (e.g., straight) position. In some embodiments, the catheter 400 comprises a resilient component (e.g., a spring) below the bump 404. In such an embodiment, the downward extension of the bump 404 may cause proximal extension of the pull wire 424, as described above. Upon release of the bump 404, the resilient component may cause the bump 404 to rebound towards its original position, which may retract the pull wire 424 and may cause the distal portion 416 to return to a straighter configuration. In certain such embodiments, the catheter 400 optionally does not include a resilient component at its distal end, as the resilient component at the bump 404 may control the rebounding.
[0048] In some embodiments, the catheters disclosed herein comprise multiple pull wires. For example the catheters can comprise 1, 2, 3, 4, or more pull wires. The pull wires can be connected to pull wire fix points near or at the distal end of the catheter. In some embodiments, the pull wire fix points can be spaced circumferentially around a circumference of the tubular body (e.g., 112 proximate to the distal end 122 of the tubular body 112). In such embodiments, the different pull wires may be used to deflect the catheter in different directions.
[0049]
[0050] As shown in
[0051] Releasing the bump 604 causes the pull wire 624 to move upwards around the pulley 606, and can cause distal retraction of the pull wire 624. The distal retraction of the pull wire 624 can cause the distal portion 616 of the catheter 600 to rebound towards a straighter configuration. The rebounding may be caused by a resilient component positioned at the distal portion 616 of the catheter 600. In some embodiments, the rebounding may be caused by a resilient component under the bump 604. In some embodiments, the rebounding may be caused by deflecting the pull wire 624 in a different direction by pressing the bump 605, as described below.
[0052]
[0053] In some embodiments, the catheter comprises more than two bumps and two pull wires, which can allow the distal end of the catheter to be steered by deflecting the distal portion in additional directions without rotation of the catheter. It will be appreciated that the bumps can comprise different shapes than those shown in
[0054]
[0055] The steerable catheter comprises an outer elongate body 812 and an inner elongate body 813. A proximal end of the outer elongate tubular body 812 may be connected to the proximal end 806 of the handle 802. A proximal end of the inner elongate tubular body 813 may be connected to the distal end 804 of the handle 802. The outer elongate tubular body 812 may include slits (not shown) that allow the struts 810 to be connected to the inner elongate tubular body through the outer body 812. A distal portion 816 of the inner body 813 may be pre-shaped in a particular configuration (e.g., curved). The distal portion 816 of the tubular body 813 may comprise a resilient component (not shown), for example similar to any of the resilient components 120, 420, 620, that has been pre-shaped. The distal portion 816 may be housed within the straight outer body 812.
[0056]
[0057] Decompression of the handle 802 allows the proximal end 806 of the handle 802 to retract distally. Decompression of the handle 802 causes at least some of the struts 810 to return to a straighter configuration. Some of the struts 810 returning to a straighter configuration can cause the proximal end 806 of the handle 802 to retract distally. The distal retraction of the proximal end 806 of the handle 802 causes the outer tubular body 812 to retract distally. The distal retraction of the outer tubular body causes the inner tubular body 813 to be sheathed within the outer tubular body 812, causing the distal portion 816 to return to a straight configuration.
[0058] Configurations for the pull wire and sleeve other than those shown in
[0059]
[0060]
[0061] In some embodiments, the catheter is sufficiently rigid for the distal tip 1004 of the catheter to equally match the rotation of the handle 1002. In some embodiments, the distal tip 1004 of the catheter 1000 does not rotate at the same rate as the handle 1002.
[0062]
[0063]
[0064] The steerable catheter 1100 comprises an elongate tubular body 1112 positioned distally of the handle 1102. The elongate tubular body 1112 comprises a proximal portion 1114 and a distal portion 1116. A lumen 1118 extends from the proximal portion 1114 to the distal portion 1116. The distal portion 1116 of the tubular body 1112 comprises a resilient component 1120. The resilient component 1120 is positioned at or near the distal end 1122 of the tubular body 1112. The resilient component 1120 may extend proximally from a point at or near the distal end 1122 of the tubular body 1112. In some embodiments, the elongate tubular body 1112 is more malleable towards the distal end 1122 of the tubular body 1112 than towards the proximal end 1114 of the tubular body.
[0065] The steerable catheter 1100 comprises a pull wire 1124 extending from the proximal end 1106 of the handle 1102 to the distal end 1122 of the tubular body 1112. The pull wire 1124 is connected to the handle 1102 at or near the proximal end 1106 of the handle and is connected to the elongate tubular body 1112 at or near the distal end 1122 of the body 1112.
[0066] The catheter 1100 comprises a first disk 1140 and a second disk 1144 at or near the distal end 1104 of the handle 1102. The first disk 1140 comprises a latch 1142. In some embodiments, the first disk 1140 comprises a greater diameter than the second disk 1144. In some embodiments, the disks 1140, 1144 have the same diameter. In some embodiments, the first disk 1140 comprises a smaller diameter than the second disk 1144.
[0067]
[0068]
[0069] After the distal tip 1116 of the catheter has been deflected, as described above with respect to
[0070] The first disk 1140 is rotatable relative to the second disk 1144. The second disk 1144 may be fixed in position relative to the catheter 1100, or a portion of the catheter 1000. In some embodiments, both disks 1140, 1144 may be rotatable. Other means for locking the pull wire 1124 in position are also possible For example, the catheter 1100 may comprise a collar positionable around the handle 1102. For another example, the pull wire 1124 may comprise hook-like structures that may engage with other hook like structures of the catheter 1100 (e.g., at the distal end 1104 of the handle 1102).
[0071] Although this invention has been disclosed in the context of certain embodiments and examples, it will be understood by those skilled in the art that the invention extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the invention and obvious modifications and equivalents thereof. In addition, while several variations of the embodiments of the invention have been shown and described in detail, other modifications, which are within the scope of this invention, will be readily apparent to those of skill in the art based upon this disclosure. It is also contemplated that various combinations or sub-combinations of the specific features and aspects of the embodiments may be made and still fall within the scope of the invention. It should be understood that various features and aspects of the disclosed embodiments can be combined with, or substituted for, one another in order to form varying modes of the embodiments of the disclosed invention. Thus, it is intended that the scope of the invention herein disclosed should not be limited by the particular embodiments described above.