Actuating element for bending a medical device - Patent application

The medical device employs a variable-sized actuating element within an elongate tube to achieve precise and adjustable bending, addressing the challenges of size restriction, mechanical issues, and unintended movement associated with manipulation wires in existing medical devices.

JP7657816B2Active Publication Date: 2025-04-07STRYKER CORP +1
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Patent Information

Application Number
JP2022553057
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2020-03-06
Filing Date
2021-03-05
Publication Date
2025-04-07
Estimated Expiration
2041-03-05

AI Technical Summary

Technical Problem

Existing medical devices, such as catheters, guidewires, and implants, face challenges in bending during use due to the need for manipulation wires, which restrict size, cause mechanical issues, and lead to unintended movement or shortening.

Method used

The medical device incorporates an elongate tube with a wall having a first opening and a variable-sized actuating element within the opening, capable of causing stress and displacement to bend the tube. This actuating element can inflate, contract, or both, and is configured to apply forces through linkages to achieve bending.

Benefits of technology

The solution allows for precise and adjustable bending of medical devices without the need for manipulation wires, enabling smaller device sizes, minimizing mechanical issues, and preventing unintended movement or shortening.

✦ Generated by Eureka AI based on patent content.

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Abstract

The medical device 100 includes an elongated tube 110 having a wall 130 defining a lumen for the elongated tube, the wall of the elongated tube having a first opening 140; and a first actuating element 120 coupled directly or indirectly to the wall of the elongated tube, wherein at least a portion of the first actuating element and the first opening in the wall are located at the same longitudinal position with respect to a longitudinal axis of the elongated tube, and the first actuating element is configured to change size to induce stress and / or displacement in the wall of the elongated tube to cause the elongated tube to bend.
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Description

[Technical field]

[0001] The field of the present application relates to medical devices, and more particularly to actuating elements for bending medical devices and medical devices having such actuating elements. [Background technology]

[0002] Many medical devices need to be bent during use. For example, catheters that deliver and / or remove materials to and from a patient need to be bent as the catheter is advanced within the patient. In many cases, bending of the catheter can be accomplished with a steering wire attached to the distal end of the catheter. However, the use of a steering wire to bend the catheter can be undesirable because it requires the steering wire to extend all the way from the distal portion of the catheter to the proximal end of the catheter. This requires the catheter to retract the steering wire, preventing the catheter from achieving a certain minimum size. The use of a steering wire can also result in the user inadvertently moving the catheter while attempting to activate the deflection. Furthermore, because the steering wire causes bending of the catheter by tensioning applied from the proximal end of the catheter, the use of the steering wire can cause compression of the catheter body, which can result in some shortening of the catheter when the catheter is in a deflected or bent state, and can result in the proximal portion of the catheter being straightened. Additionally, catheters with steering wires can have mechanical problems such as separation of the steering wire from the catheter body, the steering wire becoming stuck due to frictional contact with the catheter body, or the like.

[0003] Another type of medical device that requires bending during use is a guidewire. Guidewires are used in the medical field to access passageways inside a patient. In some cases, it may be desirable for the distal segment of the guidewire to achieve a somewhat curved shape during use. This allows the distal segment of the guidewire to access certain passageways having a particular geometry inside the patient. Generally, such guidewires have a pre-curved shape, which is assumed by the guidewire when it is in a relaxed configuration (e.g., when no force is applied to the guidewire). The guidewire may have a relatively straight configuration when confined within a delivery tube. When the guidewire is deployed out of the delivery tube inside the patient, there the guidewire automatically resumes its pre-curved shape. After the guidewire is deployed inside the patient, the curvature of the pre-curved shape of the guidewire is generally not adjustable. A pre-curved guidewire can change shape during use, making it less impactful in accessing diseased treatment sites. Additionally, the pre-bent guidewire, due to its pre-bent curvature, can have the ability to catch its tip in smaller "perforator" vessels or on a device such as a pre-deployed or deployed stent.

[0004] Another type of medical device that requires bending during use is an implant, such as a vaso-occlusive device. In some cases, the vaso-occlusive device may have a certain three-dimensional pre-curved configuration. The vaso-occlusive device may be confined within a delivery tube and may have a relatively straight configuration when inside the delivery tube. When the vaso-occlusive device is deployed out of the delivery tube inside the patient, then the vaso-occlusive device automatically resumes its three-dimensional pre-curved configuration. After the vaso-occlusive device is deployed inside the patient, the curvature of the pre-curved shape of the vaso-occlusive device is generally not adjustable. Also, the vaso-occlusive device may sometimes be difficult to advance within the delivery tube. This is because when the vaso-occlusive device is bent from its pre-curved shape to a straighter shape when confined inside the delivery tube, the vaso-occlusive device pushes against the inner wall of the delivery tube, resulting in a significant frictional force against the inner wall of the delivery tube.

[0005] Therefore, new techniques for creating flexible medical devices are desirable. Summary of the Invention

[0006] The medical device includes an elongated tube having a wall, the wall of the elongated tube having a first opening, and a first actuating element located within the first opening in the wall of the elongated tube, the first actuating element within the first opening in the wall being operable to induce stress and / or displacement in the wall of the elongated tube causing the elongated tube to bend.

[0007] Optionally, the size of the first actuating element is variable to induce stress and / or displacement in a wall of the elongate tube to cause the elongate tube to bend.

[0008] Optionally, the size of the actuation element is variable in a direction parallel to the longitudinal axis of the elongate tube.

[0009] Optionally, the size of the actuation element is variable in a direction perpendicular to the longitudinal axis of the elongate tube.

[0010] Optionally, the first actuating element is on a first side of the elongate tube and the elongate tube includes one or more slots, or other structural features, on a second side of the elongate tube, the second side being opposite the first side.

[0011] Optionally, the first actuation element is configured to inflate, to deflate, or to both inflate and deflate.

[0012] Optionally, the first actuating element is configured to expand within the first opening in the wall to cause the elongated tube to bend in a first direction, and the first actuating element is configured to contract within the opening in the wall to cause the elongated tube to bend in a second direction opposite the first direction.

[0013] Optionally, the wall of the elongate tube includes a first linkage and a second linkage coupled to respective opposing sides of the first actuating element.

[0014] Optionally, the first actuating element is configured to exert opposing forces towards the first and second linkages to induce stress and / or displacement in a wall of the elongate tube.

[0015] Optionally, the first linkage comprises a first portion of the wall and the second linkage comprises a second portion of the wall, the first and second portions of the wall being formed by laser cutting the elongated tube, etching the elongated tube, or removing material from the elongated tube.

[0016] Optionally, the first actuation element comprises a piezoelectric element, a balloon, an electroactive polymer, or a shape memory element.

[0017] Optionally, the first actuation element is actuable in response to electrical energy, radio frequency energy, a change in temperature, the delivery of a fluid, or pressure.

[0018] Optionally, the wall of the elongate tube comprises a second opening, and the medical device further comprises a second actuation element located within the second opening in the wall of the elongate tube.

[0019] Optionally, the first actuating element and the second actuating element are located on the same side of the elongate tube.

[0020] Optionally, the first actuating element and the second actuating element are located on different respective sides of the elongate tube.

[0021] Optionally, the first actuating element is configured to cause the elongate tube to bend in a first direction and the second actuating element is configured to cause the elongate tube to bend in a second direction different from the first direction.

[0022] Optionally, the elongate tube is part of a catheter.

[0023] Optionally, the elongate tube is part of a guidewire.

[0024] Optionally, the elongate tube is part of the implant.

[0025] Optionally, the implant is configured to plastically deform.

[0026] Optionally, the first actuation element and / or the elongate tube are configured to deform elastically.

[0027] Optionally, the first actuation element and / or the elongate tube are configured to plastically deform.

[0028] The medical device includes an elongated tube having a wall defining a lumen for the elongated tube, the wall of the elongated tube having a first opening, and a first actuating element coupled directly or indirectly to the wall of the elongated tube, at least a portion of the first actuating element and the first opening in the wall are located at the same longitudinal position with respect to a longitudinal axis of the elongated tube, and the first actuating element is configured to change size to induce stress and / or displacement in the wall of the elongated tube to cause the elongated tube to bend.

[0029] Optionally, the first actuation element is configured to vary a cross-sectional dimension of the first opening so as to induce stress and / or displacement in a wall of the elongate tube.

[0030] Optionally, the first actuation element is actuatable and located within a first opening in a wall of the elongate tube.

[0031] Optionally, the wall of the elongate tube includes a first linkage and a second linkage coupled to respective opposing sides of the first actuating element.

[0032] Optionally, the first actuating element is configured to exert opposing forces towards the first and second linkages to induce stress and / or displacement in a wall of the elongate tube.

[0033] Optionally, the wall of the elongate tube comprises a second opening, and the medical device further comprises a second actuation element located within the second opening in the wall of the elongate tube.

[0034] Optionally, the first actuating element is configured to cause the elongate tube to bend in a first direction and the second actuating element is configured to cause the elongate tube to bend in a second direction that is the same as the first direction or different from the first direction.

[0035] Optionally, the first actuation element extends across a first opening in a wall of the elongate tube.

[0036] Optionally, the first actuation element is coupled to an outer surface of the elongate tube.

[0037] Optionally, the first actuation element is coupled to an inner surface of the elongate tube.

[0038] Optionally, the wall of the elongate tube further comprises a second opening, and the first actuation element also extends across the second opening in the wall of the elongate tube.

[0039] Optionally, the elongate tube comprises a distal end and a proximal end, and the first actuation element is located between the distal and proximal ends of the elongate tube.

[0040] Optionally, the medical device further includes a structural member coupled between opposing sides of the first opening, the first actuating element being located within the lumen of the elongate tube and configured to apply a force towards the structural member.

[0041] Optionally, the structural member has a length that is greater than a dimension of the opening.

[0042] Optionally, the first actuation element is configured to apply a force in a direction that is perpendicular to a longitudinal axis of the elongate tube.

[0043] Optionally, the first actuating element is on a first side of the elongate tube and the elongate tube includes one or more slots, or other structural features, on a second side of the elongate tube, the second side being opposite the first side.

[0044] Optionally, the first actuation element is configured to inflate, to deflate, or to both inflate and deflate.

[0045] Optionally, the first actuation element comprises a piezoelectric element, a balloon, an electroactive polymer, or a shape memory element.

[0046] Optionally, the first actuation element is actuable in response to electrical energy, radio frequency energy, a change in temperature, the delivery of a fluid, or pressure.

[0047] Optionally, the elongate tube is part of a catheter, part of a guidewire, or part of an implant.

[0048] Optionally, the implant is configured to plastically deform.

[0049] Optionally, the first actuation element and / or the elongate tube are configured to deform elastically.

[0050] Optionally, the first actuation element and / or the elongate tube are configured to plastically deform.

[0051] Other and further aspects and features will become apparent from a reading of the following detailed description. [Brief description of the drawings]

[0052] The drawings illustrate the design and utility of the embodiments, and like elements are referred to by common reference numerals. The drawings are not necessarily drawn to scale. For a better understanding of the manner in which the above-mentioned and other advantages and objects are obtained, a more detailed description of the embodiments is provided, which is illustrated in the accompanying drawings. These drawings are merely illustrative of exemplary embodiments, and therefore should not be considered as limiting the scope of the claims.

[0053] [Figure 1] 1A-1D illustrate a medical device having a tube and an actuation element for bending the tube according to some embodiments. [Diagram 2] FIG. 2 is a side view of the medical device of FIG. 1. [Diagram 3] 2A-2D are force and motion diagrams for the medical device of FIG. 1. [Figure 4A] 13A-13C show another embodiment of a tube and a medical device having multiple actuating elements for bending the tube. [Figure 4B] 13A-13C show another embodiment of a tube and a medical device having multiple actuating elements for bending the tube. [Figure 4C] 13A-13C show another embodiment of a tube and a medical device having multiple actuating elements for bending the tube. [Figure 5A] 13A-13C show another embodiment of a tube and a medical device having multiple actuating elements for bending the tube. [Figure 5B] 13A-13C show another embodiment of a tube and a medical device having multiple actuating elements for bending the tube. [Figure 5C] 13A-13C show another embodiment of a tube and a medical device having multiple actuating elements for bending the tube. [Figure 5D]13A-13C show another embodiment of a tube and a medical device having multiple actuating elements for bending the tube. [Figure 6A] 13A-13C show a medical device having a tube and an actuation element for bending the tube according to another embodiment. [Figure 6B] 13A-13C show another embodiment of a tube and a medical device having multiple actuating elements for bending the tube. [Figure 6C] 13A-13C show another embodiment of a tube and a medical device having multiple actuating elements for bending the tube. [Figure 6D] 13A-13C show another embodiment of a tube and a medical device having multiple actuating elements for bending the tube. [Figure 7A] 13A-13C show a medical device having a tube and an actuation element for bending the tube according to another embodiment. [Figure 7B] FIG. 7B is a side view of the medical device of FIG. 7A. [Figure 8] 1 illustrates a catheter according to some embodiments. [Figure 9] 1 illustrates a guidewire according to some embodiments. [Figure 10] FIG. 1 illustrates an implant according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0054] Various embodiments are described below with reference to the figures. It should be noted that the drawings are not to scale and that elements of similar structure or function are represented by the same reference numerals throughout the drawings. It should also be noted that the drawings are only intended to facilitate the description of the embodiments. They are not intended as an exhaustive description of the invention or as a limitation of the scope of the invention. Furthermore, an illustrated embodiment need not have all the aspects or advantages shown. An aspect or advantage described in conjunction with a particular embodiment is not necessarily limited to that embodiment and can be implemented in any other embodiment even if not so shown or so explicitly described.

[0055] 1-2 illustrate a medical device 100 having an elongated tube 110 and an actuating element 120 for bending the elongated tube 110 according to some embodiments. The elongated tube 110 has a wall 130 that defines a lumen 168 for the elongated tube 110, the wall 130 of the elongated tube including a first opening 140. The medical device 100 also includes an actuating element (first actuating element) 120 located within the first opening 140 of the wall 130 of the elongated tube 110. The first actuating element 120 within the first opening 140 of the wall 130 is operable to induce stress and / or displacement in the wall 130 of the elongated tube 110 causing the elongated tube 110 to bend.

[0056] In the illustrated embodiment, the size of the first actuating element 120 is variable to induce stress and / or displacement in the wall 130 of the elongate tube 110 to bend the elongate tube 110. The size of the actuating element 120 can be variable in a direction parallel to the longitudinal axis 170 of the elongate tube 130, variable in a direction perpendicular to the longitudinal axis 170 of the elongate tube 130, or variable in both directions parallel to the longitudinal axis 170 and perpendicular to the longitudinal axis 170.

[0057] In some embodiments, the first actuating element 120 is configured to expand within the first opening 140 in the wall 130 of the elongated tube 110 to cause the elongated tube 110 to bend. In other embodiments, the first actuating element 120 is configured to contract within the first opening 140 in the wall 130 of the elongated tube 110 to cause the elongated tube 110 to bend. In further embodiments, the first actuating element 120 is configured to both expand and contract. In such cases, expansion of the first actuating element 120 causes the elongated tube 110 to bend in a first direction, and contraction of the first actuating element 120 causes the elongated tube 110 to bend in a second direction that is opposite the first direction.

[0058] 1, the wall 130 of the elongated tube 110 includes a first linkage 150a and a second linkage 150b coupled to respective opposing sides of the first actuating element 120. The first linkage 150a includes a first structural member 160a and a second structural member 162a configured to transmit forces caused by the first actuating element 120 to the wall 130 of the elongated tube 110. The first structural member 160a and the second structural member 162a are both connected to a joint member 164, which is configured to transmit forces from the first and second structural members 160a, 162a to the wall 130 of the elongated tube 110. Similarly, the second linkage 150b includes a first structural member 160b and a second structural member 162b configured to transmit forces caused by the first actuating element 120 to the wall 130 of the elongated tube 110. Both the first structural member 160b and the second structural member 162b are connected to a joint member 166, which is configured to transfer forces from the first and second structural members 160b, 162b to the wall 130 of the elongated tube 110.

[0059] In the illustrated embodiment, the first linkage 150a includes a first portion of the wall 130 and the second linkage 150b includes a second portion of the wall 130. The first and second portions of the wall 130 that make up the first and second linkages 150a, 150b may be formed by laser cutting or otherwise removing material from the elongated tube 110. The joining members 164, 166 also include a portion of the wall 130 of the elongated tube 110. The joining members 164, 166 may also be formed by laser cutting or otherwise removing material from the elongated tube 110.

[0060] In the illustrated embodiment, the first actuating element 120 is configured to apply opposing forces towards the first and second linkages 150a, 150b to induce stress and / or displacement in the wall 130 of the elongated tube 110. FIG. 3 shows a force and motion diagram for the medical device of FIG. 1. As represented by the arrows 200 in the diagram, the first actuating element 120 can be configured to expand and / or contract within the first opening 140 of the wall 130 of the elongated tube 110. The expansion of the first actuating element 120 pushes the first and second linkages 150a, 150b away from each other, inducing tension in the first and second structural members 160a, 162a of the first linkage 150a as well as tension in the first and second structural members 160b, 162b of the second linkage 150b. This causes the joint members 164, 166 to be pulled toward one another (as represented by arrow 202), thereby shortening the distance between the joint members 164, 166. As a result, the elongate tube 110 bends toward the side of the elongate tube 110 where the first actuating element 120 is located.

[0061] Conversely, contraction of first actuating element 120 pulls first and second linkages 150a, 150b toward one another, causing compression in first and second structural members 160a, 162a of first linkage 150a and also in first and second structural members 160b, 162b of second linkage 150b. This causes junction members 164, 166 to be pulled away from one another, thereby shortening the distance between junction members 164, 166. As a result, elongated tube 110 bends toward the side of elongated tube 110 opposite the side on which first actuating element 120 is located.

[0062] It should be noted that the technique of using the actuating element 120 to vary the distance between two points on the wall 130 of the elongate tube 110 is advantageous because a small movement or displacement by the actuating element 120 can result in a large deflection at the tip of the elongate tube 110. The linkages and structural members can be configured to amplify the displacement of the actuating element 120 to various degrees by changing the angle of the structural members relative to the axis of expansion or contraction of the actuating element.

[0063] 1-2 , the first actuating element 120 is on a first side of the elongated tube 110, and the elongated tube 110 also includes one or more slots 180, or other structural features, on a second side of the elongated tube 110, the second side being opposite the first side. The slots 180 or structural features of the elongated tube 110 allow the elongated tube 110 to be more easily bent by the first actuating element 120.

[0064] The first actuating element 120 may be implemented using different techniques in different embodiments. In some embodiments, the first actuating element 120 may be a piezoelectric (piezo) element. In such cases, the medical device 100 may include wires connected to the first actuating element 120 to apply energy (e.g., current, voltage, etc.) to drive the piezoelectric element and cause it to change size and / or shape. In other embodiments, the first actuating element 120 may be a shape memory (e.g., Nitinol or NiTi) element. In such cases, the medical device 100 may include wires connected to a shape memory element to apply current to cause the shape memory element to change size and / or shape. In some embodiments, the shape memory element may heat up due to resistive heating caused by current, which causes the shape memory element to change size and / or shape. In other embodiments, other means of changing the temperature of the shape memory element may be used, such as delivery of a fluid to the element at high temperature, contact by or near the element to a hot surface, or use of radio frequency energy to induce eddy currents in the shape memory element, thereby increasing its temperature and causing a change in shape. In further embodiments, the first actuating element 120 may be made of one or more electroactive polymers that can exhibit a change in size and / or shape when stimulated by an electric field or current. In such cases, the medical device 100 may include an electrical wire connected to the first actuating element 120 to apply an electrical current to cause the first actuating element 120 to change size and / or shape. In yet further embodiments, the first actuating element 120 may be a balloon. In such cases, the medical device 100 may include a fluid delivery channel to inflate the balloon to cause the balloon to change size and / or shape.

[0065] In the above examples, the first actuating element 120 is described as being operable in response to electrical energy (e.g., current or voltage) or fluid energy. In other embodiments, the first actuating element 120 may be operable in response to radio frequency energy. In such cases, the first actuating element 120 may include a receiver configured to receive radio frequency energy and a converter configured to convert the radio frequency energy into electrical energy (e.g., current or voltage). The electrical energy (e.g., current or voltage) may then be utilized by the first actuating element 120 to change its size and / or shape. In some embodiments, the radio frequency energy may be one or more radio frequency signals transmitted from a controller. The controller may comprise a user interface configured to allow a user to provide an input for providing the radio frequency signal. In further embodiments, the actuating element 120 may be operable in response to other forms of energy, such as light energy, ultrasonic energy, etc., that are not mechanical energy associated with tensioning of the operating wire. Also, in some embodiments, the actuating element 120 may be operable in response to delivery of a fluid that provides a volumetric displacement and / or fluid pressure. In other embodiments, the actuation element 120 may be actuable in response to mechanical displacement and / or mechanical pressure.

[0066] In the above embodiment, the medical device 100 has one actuating element (first actuating element) 120. In other embodiments, the medical device 100 can have multiple actuating elements 120. For example, in other embodiments, instead of having one actuating element 120 in the wall opening 140, the medical device 100 may have multiple actuating elements 120 stacked in the opening 140. Such a configuration allows for various degrees of deflection by selectively activating one of the multiple actuating elements or multiple actuating elements simultaneously.

[0067] In further embodiments, instead of having multiple actuating elements 120 all located within the same opening 140 of the wall 130, multiple actuating elements 120 may be located within different respective openings 140. For example, as shown in FIG. 4A, in other embodiments, the wall 130 of the elongated tube 110 may include a first opening 140a and a second opening 140b. In such a case, the medical device 100 includes a first actuating element 120a located within the first opening 140a and a second actuating element 120b located within the second opening 140b of the wall 130 of the elongated tube 110. As shown in the figure, both the first actuating element 120a and the second actuating element 120b are located on the same side of the elongated tube 110. This configuration allows the actuating elements 120a, 120b to bend different segments of the elongated tube 110 towards the same side of the elongated tube 110 (i.e., in the same bending plane).

[0068] In other embodiments, the first actuating element 120a and the second actuating element 120b can be located on different respective sides of the elongated tube 110 (FIG. 4B). This configuration allows the actuating elements 120a, 120b to bend the elongated tube 110 in different bending planes. For example, the first actuating element 120a can be configured to cause the elongated tube 110 to bend in a first direction in a first bending plane, and the second actuating element 120b can be configured to cause the elongated tube 110 to bend in a second direction (in a second bending plane) that is different from the first direction.

[0069] In further embodiments, the medical device 100 may include three or more actuating elements 120. FIG. 4C illustrates a medical device 100 having an elongated tube 110 and multiple actuating elements 120 for bending the elongated tube 110 according to another embodiment. The medical device 100 is the same as that illustrated in FIG. 4A, except that the wall 130 of the elongated tube 100 further includes a third opening 140c and a third actuating element 120c located within the third opening 140c. The third actuating element 120c has the same configuration as that of the first actuating element 120a. As illustrated in the figure, the first and second actuating elements 120a, 120b are located at the same circumferential position with respect to the longitudinal axis 170 of the elongated tube 110, and the third actuating element 120c is located at a different circumferential position with respect to the longitudinal axis 170 than that of the first and second actuating elements 120a, 120b. Such a configuration allows the first and second actuating elements 120a, 120b to bend the elongated tube 110 in a first bending plane, and the third actuating element 120c to bend the elongated tube 110 in a second bending plane that is different from the first bending plane. The first and second actuating elements 120a, 120b allow bending of different segments along the length of the elongated tube 110. In further embodiments, the medical device 100 can optionally include a fourth opening and a fourth actuating element located at the fourth opening. The third and fourth actuating elements can be located at the same circumferential location with respect to the longitudinal axis 170 of the elongated tube 110. This allows the third and fourth actuating elements to bend different segments of the elongated tube 110 in the same bending plane.

[0070] In the above embodiment, the medical device 100 is shown as having an elongated tube 110 with a continuous surface along the longitudinal axis 170 of the elongated tube 110. In other embodiments, the elongated tube 110 of the medical device 100 can be a slotted tube with multiple slots along the longitudinal axis 170 of the elongated tube 110. FIG. 5A shows a medical device 100 having a tube 110 and multiple actuating elements 120 for bending the tube, according to other embodiments. As shown in the figure, the actuating elements 120 are located in respective openings 140 defined by the wall 130 of the elongated tube 110. The openings 140 are elongated slots that extend circumferentially with respect to the longitudinal axis 170 of the elongated tube 110. The slots divide the elongated tube 110 into multiple ring-like elements aligned along the longitudinal axis 170. In the illustrated embodiment, the actuating elements 120 are in groups 500 and aligned longitudinally in series. Each actuating element 120 can be implemented using any of the techniques described with reference to the embodiment of Fig. 1. Unlike the embodiment of Fig. 1, the elongated tube 110 of Fig. 5A does not include linkages 160a, 160b, 162a, 162b. Instead, in the embodiment of Fig. 5A, each actuating element 120 is configured to directly abut two adjacent ring-shaped elements of the elongated tube 110 and vary in size to directly exert opposing forces on the two adjacent ring-shaped elements of the elongated tube 110.

[0071] During use, one or more of the actuating elements 120 can be actuated to cause the elongated tube 110 to bend. In particular, each actuating element 120 is configured to change size, thereby causing the elongated tube 110 to bend. The actuating elements 120 can expand to increase a dimension (measured along the longitudinal axis 170) of the opening 140 on one side of the elongated tube 110, can contract to decrease a dimension of the opening 140, or can both expand and contract. When the actuating element 120 expands to increase a dimension of the opening 140 on one side of the elongated tube 110 (or the spacing between adjacent ring-like elements of the elongated tube 110), it causes an extension of that side of the elongated tube 110, thereby bending the elongated tube 110 in a direction that is opposite that side of the elongated tube 110. On the other hand, when the actuating element 120 contracts to reduce the dimension of the opening 140 on one side of the elongate tube 110 (or the spacing between adjacent ring-like elements of the elongate tube 110), it causes shortening of that side of the elongate tube 110, thereby bending the elongate tube 110 in the direction toward that side of the elongate tube 110. The actuating element 120 can be implemented using any of the techniques described with reference to the embodiment of FIG.

[0072] In some cases, the degree of bending of the elongated tube 110 may correspond to the number of actuating elements 120 that are actuated. For example, if a slight bending of the elongated tube 110 is desired, only one of the actuating elements 120 may be actuated. On the other hand, if more bending (e.g., greater curvature) of the elongated tube 110 is desired, more actuating elements 120 may be actuated. In the illustrated embodiment, the actuating elements 120 are aligned on the same side of the elongated tube 110, so that actuation of one or more of the actuating elements 120 causes the elongated tube 110 to bend within the same bending plane.

[0073] In the above embodiment, the medical device 100 has one group 500 on the actuating elements 120. In other embodiments, the medical device 100 can have multiple groups 500 on the actuating elements 120.

[0074] 5B, in other embodiments, the medical device 100 comprises a first group 500a of actuating elements 120 located within respective openings 140 in the wall 130 of the elongated tube 110, and a second group 500b of actuating elements 120 located within the respective openings. As shown in the figure, the first group 500a of actuating elements 120 and the second group 500b of actuating elements 120 are both located on the same side of the elongated tube 110. This configuration allows the two groups 500a, 500b of actuating elements 120 to bend different segments of the elongated tube 110 towards the same side of the elongated tube 110 (i.e., in the same bending plane).

[0075] In other embodiments, the first group 500a of actuating elements and the second group 500b of actuating elements 120 can be located on different respective sides of the elongated tube 110 (FIG. 5C). This configuration allows the groups 500a, 500b of actuating elements 120 to bend the elongated tube 110 in different bending planes. For example, the first group 500a of actuating elements 120 may be configured to cause the elongated tube 110 to bend in a first direction in a first bending plane, and the second group 500b of actuating elements 120 may be configured to cause the elongated tube 110 to bend in a second direction (in a second bending plane) that is different from the first direction.

[0076] In further embodiments, the medical device 100 may include more than two groups 500 of actuating elements 120. FIG. 5D illustrates a medical device 100 having an elongated tube 110 and a plurality of actuating elements 120 for bending the elongated tube 110, according to another embodiment. The medical device 100 is the same as that illustrated in FIG. 5B, except that the medical device 100 further includes a third group 500c of actuating elements 120. The third group 500c of actuating elements 120 has the same configuration as that of the first group 500a of actuating elements 120. As illustrated in the figure, the first and second groups 500a, 500b of actuating elements 120 are located at the same circumferential position with respect to the longitudinal axis 170 of the elongated tube 110, and the third group 500c of actuating elements 120 is located at a different circumferential position with respect to the longitudinal axis 170 than that of the first and second groups 500a, 500b of actuating elements 120. Such a configuration allows the first and second groups 500a, 500b of actuating elements 120 to bend the elongated tube 110 in a first bending plane, and the third group 500c of actuating elements 120 to bend the elongated tube 110 in a second bending plane that is different from the first bending plane. The first and second groups 500a, 500b of actuating elements 120 allow bending of different segments along the length of the elongated tube 110. In further embodiments, the medical device 100 can optionally include a fourth group of actuating elements. The third and fourth groups of actuating elements 120 can be located at the same circumferential position with respect to the longitudinal axis 170 of the elongated tube 110. This allows the third and fourth groups of actuating elements 120 to bend different segments of the elongated tube 110 in the same bending plane.

[0077] In the above embodiment, the actuating element 120 has been described as being located within the opening 140 in the wall 130 of the elongated tube 110. In other embodiments, one or more actuating elements 120 can be located outside of the opening 140 in the wall 130 of the elongated tube 110.

[0078] 6A illustrates a medical device having an elongated tube 110 and an actuating element 120 for bending the elongated tube 110, according to another embodiment. In the illustrated embodiment, the elongated tube 110 has a plurality of openings 140 in the form of elongated slots extending circumferentially about a longitudinal axis 170 of the elongated tube 110. The slots divide the elongated tube 110 into a plurality of ring-like elements aligned along the longitudinal axis 170. As shown in the figure, the actuating element 120 is coupled to an outer surface of the elongated tube 110 and extends across a plurality of the openings 140. In other embodiments, the actuating element 120 can extend across only one of the openings 140.

[0079] The actuating element 120 is configured to change size, thereby causing the elongated tube 110 to bend. In particular, the actuating element 120 can expand to increase a dimension (measured along the longitudinal axis 170) of the opening 140 on one side of the elongated tube 110, can contract to decrease a dimension of the opening 140, or can both expand and contract. When the actuating element 120 expands to increase a dimension of the opening 140 on one side of the elongated tube 110, it causes an elongation of that side of the elongated tube 110, thereby bending the elongated tube 110 in a direction that is opposite that side of the elongated tube 110. On the other hand, when the actuating element 120 contracts to decrease a dimension of the opening 140 on one side of the elongated tube 110, it causes a shortening of that side of the elongated tube 110, thereby bending the elongated tube 110 in a direction toward that side of the elongated tube 110. The actuation element 120 may be implemented using any of the techniques described with reference to the embodiment of FIG.

[0080] In the above embodiment of FIG. 6A, the medical device 100 has one actuating element (first actuating element) 120. In other embodiments, the medical device 100 can have multiple actuating elements 120. For example, as shown in FIG. 6B, in other embodiments, the medical device 100 can include a first actuating element 120a and a second actuating element 120b coupled to an outer surface of the wall 130 of the elongated tube 110. As shown in the figure, the first actuating element 120a and the second actuating element 120b are both located on the same side of the elongated tube 110. This configuration allows the actuating elements 120a, 120b to bend different segments of the elongated tube 110 toward the same side of the elongated tube 110 (i.e., in the same bending plane).

[0081] In other embodiments, the first actuating element 120a and the second actuating element 120b can be located on different respective sides of the elongated tube 110 (FIG. 6C). This configuration allows the actuating elements 120a, 120b to bend the elongated tube 110 in different bending planes. For example, the first actuating element 120a may be configured to cause the elongated tube 110 to bend in a first direction in a first bending plane, and the second actuating element 120b may be configured to cause the elongated tube 110 to bend in a second direction (in a second bending plane) that is different from the first direction.

[0082] In further embodiments, the medical device 100 may include more than two actuating elements 120. Figure 6D illustrates a medical device 100 having an elongated tube 110 and multiple actuating elements 120 for bending the elongated tube 110, according to another embodiment. The medical device 100 is the same as that illustrated in Figure 6B, except that the medical device 100 further includes a third actuating element 120c coupled to an outer surface of the wall 130 of the elongated tube 110. The third actuating element 120c has the same configuration as that of the first actuating element 120a. As illustrated in the figure, the first and second actuating elements 120a, 120b are located at the same circumferential position with respect to the longitudinal axis 170 of the elongated tube 110, and the third actuating element 120c is located at a different circumferential position with respect to the longitudinal axis 170 than that of the first and second actuating elements 120a, 120b. Such a configuration allows the first and second actuating elements 120a, 120b to bend the elongated tube 110 in a first bending plane, and the third actuating element 120c to bend the elongated tube 110 in a second bending plane that is different from the first bending plane. The first and second actuating elements 120a, 120b allow bending of different segments along the length of the elongated tube 110. In further embodiments, the medical device 100 can optionally include a fourth opening and a fourth actuating element located at the fourth opening. The third and fourth actuating elements can be located at the same circumferential location with respect to the longitudinal axis 170 of the elongated tube 110. This allows the third and fourth actuating elements to bend different segments of the elongated tube 110 in the same bending plane.

[0083] In other embodiments, instead of coupling the actuating elements 120 to an outer surface of the elongate tube 110 as in those depicted in Figures 6A-6D, the actuating elements 120 may be coupled to an inner surface of the elongate tube 110. For example, one or more actuating elements 120 may be coupled to an inner surface of the wall 130 of the elongate tube 110.

[0084] 6A-6D, the actuating element 120 can have any length, which may differ from the example shown. For example, in some embodiments, the actuating element 120 may be relatively long to achieve a relatively large overall bending movement and bent profile.

[0085] It should be understood that in the embodiment of Figures 5-6, the medical device 100 is not limited to having one opening 140 (e.g., slot) per longitudinal plane, and in other embodiments, the medical device 100 may have more than one opening 140 (e.g., two or more slots) per longitudinal plane. The openings 140 (e.g., slots) do not have to be equal in size within a given longitudinal plane and / or in other parallel planes. In some embodiments, the openings 140 can be slots that collectively form a spiral or other pattern around the tube 110, with the actuating elements 120 following the same spiral, thereby forming the spiral or other pattern.

[0086] It should also be noted that the medical device 100 is not limited to the described example, and the medical device 100 may have other configurations in other embodiments. For example, in other embodiments, the medical device 100 may include one or more actuating elements 120 located within the lumen 168 of the elongated tube 100. FIGS. 7A-7B show another medical device 100 having a bendable elongated tube 110 according to another embodiment. The elongated tube 110 has a wall 130 with an opening 140. The elongated tube 110 also includes a structural member 700 (FIG. 7B) located within the opening 140. In the illustrated embodiment, the structural member 700 is coupled between opposing sides of the opening 140. The structural member 700 has a length that is longer than a dimension of the opening 140. As shown in FIG. 7B, the medical device 100 further includes an actuating element 120 disposed within the lumen 168 of the elongated tube 110. The actuating element 120 is configured to exert a force toward the structural member 700. In the illustrated embodiment, the actuating element 120 is configured to expand to apply a force in a direction that is perpendicular to the longitudinal axis 170 of the elongate tube 110. In particular, the expansion of the actuating element 120 pushes a middle or central portion of the structural member 700 into the opening 140 in a direction away from the lumen 168 of the elongate tube 110. This results in the opposing ends of the opening 140 being pushed away from each other by the structural member 700 (because the structural member 700 is longer than the dimensions of the opening 140), causing the elongate tube 110 to bend in a direction that is opposite the pushing force exerted by the actuating element 120.

[0087] Different techniques may be used to create the structural member 700 such that it is longer than the dimensions of the opening 140. As shown in FIG. 7A, in the illustrated embodiment, the portions 701, 702 of the structural member 700 may be created by cutting the elongated tube 110 (e.g., using laser cutting). As shown in the figure, the portions 701, 702 are created such that they are not connected together and there is a gap 710 between the portions 701, 702. The portions 701, 702 are then bent inwardly toward the lumen 168 such that the portions 701, 702 form respective non-zero angles with respect to the longitudinal axis 170 of the elongated tube 110 (as shown in FIGS. 7A-7B). In some embodiments, the bending of the portions 701, 702 may involve plastically deforming or heat setting the portions 701, 702. A bridge element 720 may then be placed between the portions 701, 702, thereby connecting the portions 701, 702 together. The bridge element 720 may be any rigid element. The bridge element 720 may be secured to the portions 701, 702 using glue, adhesives, welding, or any other technique known in the art. The portions 701, 702 and the bridge element 720 together form the structural member 700. In other embodiments, the opening 140 may be created without the portions 701, 702. In such a case, after the opening 140 is created, the structural member 700 may be placed within the opening 140 with both opposing ends secured to opposing sides of the opening 140. In such an embodiment, the structural member 700 may be a unitary component, such as a strip of material having a curved configuration. In other embodiments, the bridge element 720 may be a single, integral element bridging from one end of the opening to the opposite end, and the bridge element 720 may be plastically deformed (stretched) inwardly into the lumen 168 of the elongate tube 110.

[0088] In other embodiments, the structural member 700 can have a length that is the same as the dimension of the opening 140. In such cases, the actuating element 120 can be configured to contract to pull at least a portion of the structural member 700 away from the opening 140 in a direction toward the lumen 168 of the elongate tube 110. This results in opposing ends of the opening 140 being pulled toward each other, causing the elongate tube 110 to bend in a direction that is opposite the pulling force exerted on the actuating element 120.

[0089] In some embodiments, the actuating element 120 may be in the form of a ring with a central opening. Such a configuration allows material or objects within the lumen 168 of the elongate tube 110 to pass therethrough. In other embodiments, the actuating element 120 may have other shapes. For example, in other embodiments, the actuating element 120 may have a block-like configuration that does not completely fill the lumen 168. In further embodiments, the actuating element 120 may completely fill the lumen 168. The actuating element 120 may be implemented using any of the techniques described with reference to FIG. 1.

[0090] In the illustrated embodiment, the portions 701, 702 have their respective major lengths oriented in a direction parallel to the longitudinal axis 170 of the elongate tube 110. In other embodiments, the portions 701, 702 can extend circumferentially rather than longitudinally, as shown. In still further embodiments, the medical device 100 of FIG. 7A may optionally include a linkage, such as the linkages 60a, 62a, 60b, 62b described with reference to FIG. 1, to amplify the deflection. In such a case, the linkage may be coupled to the structural member 700 that receives the force exerted by the structural member 700 upon actuation of the actuation element 120.

[0091] 7A, the medical device 100 includes only one actuating element 120. In other embodiments, the medical device 100 can include multiple actuating elements 120 disposed at different longitudinal positions relative to the longitudinal axis 170 of the elongated tube 110. For example, in other embodiments, the medical device 100 can include a first actuating element 120 and a second actuating element 120 located within respective openings 140 in the wall 130 of the elongated tube 110. The first actuating element 120 and the actuating element 120 can be configured to push and / or pull respective structural members 700 located on the same side of the elongated tube 110. This configuration allows the actuating elements 120 to bend different segments of the elongated tube 110 toward the same side of the elongated tube 110 (i.e., in the same bending plane).

[0092] In other embodiments, the first actuating element 120 and the second actuating element 120 may be configured to push and / or pull respective structural members 700 located on different respective sides of the elongated tube 110. This configuration allows the actuating elements 120 to bend the elongated tube 110 in different bending planes. For example, the first actuating element 120 may be configured to cause the elongated tube 110 to bend in a first direction in a first bending plane, and the second actuating element 120 may be configured to cause the elongated tube 110 to bend in a second direction (in a second bending plane) that is different from the first direction.

[0093] In further embodiments, the medical device 100 may include three or more actuation elements 120 configured to push and / or pull respective structural members 700 disposed on different segments of the elongate tube 110 .

[0094] In any of the embodiments described herein, the actuating element 120 may be actuable to impart different degrees of bending. For example, if the actuating element 120 is actuable in response to energy, the amount of energy may be variable to cause the actuating element 120 to impart different degrees of bending to the elongated tube 110. In other embodiments, the actuating element 120 may be bimodal in that it can simply be turned on or off. In such cases, the actuating element 120 does not impart different degrees of bending, but rather a predetermined degree of bending. Similarly, if the medical device 100 includes multiple such actuating elements 120 (where the degree of expansion / contraction of each actuating element 120 is bimodal (on / off) rather than incrementally controllable), different numbers and / or combinations of the actuating elements 120 may be selectively actuated to achieve different degrees of bending for the elongated tube 110.

[0095] In any of the embodiments described herein, the elongate tube 110 may be part of a catheter, a guidewire, or an implant. Thus, any of the actuating elements 120 described herein may be implemented as a catheter component for bending a catheter, a guidewire component for bending a guidewire, or an implant component for bending an implant.

[0096] FIG. 8 illustrates an elongated tube 110 that is part of a catheter according to some embodiments. The medical device 100, which in the illustrated embodiment is a catheter, includes a catheter body 804 having a distal end 800 and a proximal end 802. The medical device 100 also includes a handle 810 coupled to the proximal end 802 of the catheter body 804 and a user interface 820 configured to allow a user to control bending of the catheter body 804. Although the user interface 820 is shown implemented in the handle 810, in other embodiments, the user interface 820 may be implemented as a separate device that is separate from the handle 810. For example, in other embodiments, the user interface 820 may be a computer or any electronic device (e.g., a cell phone, tablet, etc.) capable of generating electrical and / or radio frequency signals. As shown in the figure, the catheter body 804 includes an actuating element 120, which may be any of the embodiments of the actuating element 120 described herein. The actuating elements 120 are actuable in response to electrical or radio frequency signals provided by the user interface 820, thereby bending the catheter body 804. In other embodiments, the catheter body 804 may include multiple actuating elements 120. The user interface 820 may include one or more controls to allow a user to activate the actuating elements 120 on the catheter body 804, thereby bending the catheter body 804. In some embodiments, the one or more controls may be one or more physical buttons, knobs, switches, etc. In other embodiments, the one or more controls may be a touch screen having graphical elements configured to allow a user to activate the actuating elements 120 on the catheter body 804.

[0097] During use of the catheter, the catheter body 804 is inserted into the patient's body. As the catheter body 804 is advanced inside the patient, the user interface 820 can be manipulated by a user to actuate the actuation element 120 to cause the distal segment of the catheter body 804 to bend in a desired manner. Bending the catheter body 804 allows the distal end 800 of the catheter body 804 to be manipulated along the patient's interior passageway (e.g., blood vessel) through different curvatures. In some embodiments, the catheter body 804 can be rotated about its longitudinal axis to allow bending to occur in different bending planes. Also, in some embodiments, the degree of bending (e.g., curvature, angle, etc.) of the catheter body 804 can be adjusted by varying the amount of energy (e.g., current or voltage) or displacement applied by the user interface 820. In some examples, bending of the catheter body can also act to position the catheter tip in a desired position or orientation or to hold the catheter in a particular orientation or position within the patient. Additionally, bending or straightening of the catheter body can act to modify the shape of the passageway (e.g., blood vessel) through which the catheter body is deployed.

[0098] After the distal end 800 of the catheter body 804 is desirably positioned within a patient, the catheter body 804 may then be utilized in a medical procedure to diagnose and / or treat the patient. For example, in different embodiments, the catheter body 804 may be used to deliver substances (e.g., drugs, medications, contrast agents, saline, etc.), deploy devices (e.g., implants, tissue dissectors, imaging scopes, therapeutic energy sources, etc.), or perform other functions.

[0099] FIG. 9 illustrates an elongated tube 110 that is part of a guidewire according to some embodiments. The medical device 100, which in the illustrated embodiment is a guidewire, includes a guidewire body 904 having a distal end 900 and a proximal end 902. The medical device 100 also includes a handle 910 coupled to the proximal end 902 of the guidewire body 904 and a user interface 920 configured to allow a user to control bending of the guidewire body 904. Although the user interface 920 is shown implemented on the handle 910, in other embodiments, the user interface 920 may be implemented as a separate device that is separate from the handle 910. For example, in other embodiments, the user interface 920 may be a computer or any electronic device (e.g., a cell phone, tablet, etc.) capable of generating electrical and / or radio frequency signals. As shown in the figure, the guidewire body 904 includes an actuating element 120, which may be any of the embodiments of the actuating element 120 described herein. The actuating elements 120 are actuable in response to an electrical or radio frequency signal provided by the user interface 920, thereby bending the guidewire body 904. In other embodiments, the guidewire body 904 may include multiple actuating elements 120. The user interface 820 may include one or more controls to allow a user to activate the actuating elements 120 in the guidewire body 904, thereby bending the guidewire body 904. In some embodiments, the one or more controls may be one or more physical buttons, knobs, switches, etc. In other embodiments, the one or more controls may be a touch screen having graphical elements configured to allow a user to activate the actuating elements 120 in the guidewire body 904.

[0100] During use of the guidewire, the guidewire body 904 is inserted into the patient's body. As the guidewire body 904 is advanced inside the patient, the user interface 920 can be manipulated by a user to actuate the actuation element 120 to cause the distal segment of the guidewire body 904 to bend in a desired manner. The bending of the guidewire body 904 allows the distal end 900 of the guidewire body 904 to be manipulated along the patient's interior passageway (e.g., blood vessel) through different curvatures. In some embodiments, the guidewire body 904 can be rotated about its longitudinal axis to allow bending to occur in different bending planes. Also, in some embodiments, the degree of bending (e.g., curvature, angle, etc.) of the guidewire body 904 can be adjusted by varying the amount of energy (e.g., current or voltage) or displacement applied by the user interface 820. In some examples, the bending of the guidewire body can also act to place the guidewire tip in a desired position or orientation or to hold the guidewire in a particular orientation or position within the patient. Additionally, bending or straightening the guidewire body can act to modify the shape of the passageway (eg, blood vessel) through which the catheter body is deployed.

[0101] After the distal end 900 of the guidewire body 904 is desirably positioned within the patient, the guidewire body 904 may then be utilized in a medical procedure. For example, another device (which may be a diagnostic or therapeutic device) inserted by the guidewire body 904 may be advanced within the patient using the guidewire body 904 as a guide to reach a target location within the patient.

[0102] FIG. 10 illustrates an elongated tube 110 that is part of an implant according to some embodiments. The medical device 100, which in the illustrated embodiment is an implant, includes a distal end 1000, a proximal end 1002, and an implant body 1004 extending between the distal end 1000 and the proximal end 1002. In the illustrated example, the implant 100 is a vascular occlusion implant configured to be delivered within a blood vessel until it reaches an artery to treat an aneurysm. In other examples, the implant 100 may be other types of implants, such as a stent. As shown in the figure, the proximal end 1002 of the implant 100 is removably coupled to a delivery wire 1200. The implant 100 with the delivery wire 1200 may be housed within a delivery tube 1220 during use. The delivery tube 1220 includes a distal end 1222 and a proximal end 1224. The proximal end 1224 of the delivery tube 1220 is attached to a handle 1230 that includes a user interface 1240. The user interface 1240 may be implemented to have the same features as those described with reference to FIGS. 8 and 9. The user interface 1240 may be configured to allow a user to control the bending of the implant 100. Although the user interface 1240 is shown as being implemented on the handle 1230, in other embodiments, the user interface 1240 may be implemented as a separate device that is separate from the handle 1230. For example, in other embodiments, the user interface 1240 may be a computer or any electronic device (e.g., a cell phone, tablet, etc.) capable of generating electrical and / or radio frequency signals. As shown in the figures, the implant 100 includes actuating elements 120, each of which may be any of the embodiments of the actuating elements 120 described herein. The actuating elements 120 are actuable in response to electrical or radio frequency signals provided by the user interface 1240, thereby bending the implant 100.

[0103] In use, the implant 100 and delivery wire 1200 are housed within a delivery tube 1220. The delivery tube 1220 is inserted into a patient's blood vessel and advanced until it reaches a target site, such as an aneurysm. If the delivery tube 1220 has steering capabilities, such as any of the bending techniques described herein, or if the delivery tube 1220 has a steering wire, the delivery tube 1220 can be bent to navigate through the patient's internal blood vessels. After the delivery tube 1220 reaches the aneurysm, the delivery wire 1200 can be advanced relative to the delivery tube 1220 to deploy the implant 100 from the delivery tube 1220 into the aneurysm. As the implant 100 is being deployed into the aneurysm, or after the implant 100 has been deployed into the aneurysm, the user interface 1240 can be manipulated by a user to actuate the actuating element 120 to cause portions of the implant 100 to bend in a desired manner. The bending of the implant 100 allows the implant 100 to have a certain geometry (e.g., size and / or shape) that fits inside the aneurysm in a desired manner. Also, in some embodiments, the degree of bending (e.g., curvature, angle, etc.) of the implant 100 can be adjusted by varying the amount of energy (e.g., current, voltage, or another type of energy) provided by the user interface 1240. Furthermore, in some embodiments, the implant 100 can have a pre-bent configuration that includes a series of loops. In such a case, the implant 100 can have the actuating elements 120 disposed between adjacent loops and / or can have the actuating elements 120 disposed along segments of the loops. The pre-bent configuration of the implant 100 provides the implant 100 with a certain loose three-dimensional configuration, and the actuating elements 120 can be selectively actuated to adjust such loose three-dimensional configuration. Alternatively, the position of a particular loop of the implant can be adjusted during deployment of the implant, thereby optimizing the placement of the implant loops for occlusion of the aneurysm.In other embodiments, the pre-curved implant can be delivered in a relatively straight configuration and is allowed to tighten its structure by regaining its pre-curved shape upon interruption of the actuation signal. This can improve packing density and interlocking with other occlusion devices inside the aneurysm, thus improving occlusion. In other embodiments, the implant 100 may not have any pre-curved configuration. Instead, the implant 100 can have a relatively straight, loose profile. In such cases, the implant 100 can have multiple actuating elements 120 disposed along a majority of its length. As the implant 100 is being delivered into the aneurysm, the user interface 1240 can be operated to selectively bend some segments of the implant 100 to form a three-dimensional configuration in situ. When the actuation signal is interrupted, the implant attempts to regain its relatively straight, loose profile, but may be constrained from doing so sufficiently by a constraining membrane or structure, such as an intrasaccular device.

[0104] In some embodiments, the implant can have one or more actuating elements that incorporate plastic deformation, such that the implant is bent during or after deployment and retains the bent configuration after removal of the actuating signal. One application of such a configuration is to ensure that the proximal end of the implant, e.g., a vaso-occlusive coil, remains inside the aneurysm in which it is deployed, rather than protruding into the parent vessel.

[0105] In some embodiments, one technique for bending selected portions of the implant is to use shape memory elements as actuators. The shape memory elements can be resistively heated by application of electrical current before detachment from the delivery wire. Alternatively, the shape memory elements may be inductively heated by radio frequency energy generated within the delivery catheter or by a separate device (e.g., a guidewire), by contact with or near a hot surface, or by delivery of a fluid at elevated temperature. This approach allows the implant to have multiple actuator elements, but gives the physician the option of activating some, none, or all of the actuators depending on the state of deployment of the particular implant.

[0106] In any of the embodiments described herein, the elongated tube 110 can be made of any material, such as a polymer, metal, alloy, and the like. In some embodiments, the elongated tube 110 can be a hypotube. Also, in any of the embodiments described herein, the medical device 100 can further include an outer tubular layer disposed over the elongated tube 110. The outer tubular layer can be attached directly or indirectly to the outer surface of the wall 130 of the elongated tube 110. The outer tubular layer can function to accommodate the actuating element 120 and / or achieve a smooth surface covering the area where the opening 140 is located. Also, in any of the embodiments described herein, the medical device 100 can include an inner tubular layer disposed within the lumen 168 of the elongated tube 110. The inner tubular layer can be attached directly or indirectly to the inner surface of the wall 130 of the elongated tube 110. The inner tubular layer can function to cover the opening 140. The outer tubular layer and the inner tubular layer may be made from a material that is softer than the material of the elongated tube 110 so that they do not interfere with the bending of the elongated tube 110 .

[0107] It should be noted that the medical device 100 described herein can have other features and configurations in other embodiments. For example, in other embodiments, the geometry (e.g., size, orientation, shape, etc.) of the opening 140 and / or the configuration of the actuating element 120 may be adapted to achieve a certain deflection of the elongated tube 110. In further embodiments, if the medical device 100 includes a linkage (e.g., the linkages 160, 162 described with reference to the embodiment of FIG. 1), the linkage may be adapted to achieve a certain deflection of the elongated tube 110. Also, in other embodiments, the direction of the pushing or pulling force applied by the actuating element 120 may be selectively configured to be in any direction different from the examples described herein. Furthermore, in other embodiments, the geometry of the opening 140, the configuration of the actuating element 120, the linkage, or any combination of the foregoing may be selectively adapted to achieve a certain force amplification or amplitude amplification. In force amplification, a certain force applied by the actuating element 120 results in a certain amount of bending force. In amplitude amplification, a certain amplitude of movement of the actuating element 120 (due to a change in size of the actuating element 120 ) results in a certain amount of displacement at the tip of the elongate tube 110 .

[0108] In some embodiments, the geometry of the openings 140, the configuration of the actuating elements 120, the linkage, the material properties of the elongated tube 110, or any combination of the foregoing, may be selectively adapted to achieve elastic deformation of the elements 120 and / or the elongated tube 110 (and thus reversible bending of the elongated tube 110), such that when the energy source is turned off, the elongated tube 110 resumes its original shape. In other embodiments, the geometry of the openings 140, the configuration of the actuating elements 120, the linkage, the material properties of the elongated tube 110, or any combination of the foregoing, may be selectively adapted to achieve plastic deformation of the elements 120 and / or the elongated tube 110 (and thus irreversible bending of the elongated tube 110), such that when the energy source is turned off, the elongated tube 110 does not resume its original shape. In further embodiments, the medical device 100 may incorporate both elastic and plastic deformation at different degrees and rates. For example, in some embodiments, the geometry of the opening 140, the configuration of the actuating element 120, the material properties of the elongated tube 110, or any combination of the foregoing, may be selectively adapted to achieve both elastic and plastic deformation to different degrees and rates at one or more locations within the medical device 100.

[0109] The techniques for bending the elongated tube 110 described herein are advantageous because they allow for selective bending of the elongated tube 110 while the elongated tube 110 is disposed inside the patient without the use of a manipulation wire. Unlike a manipulation wire that extends all the way from the distal end to the proximal end of the medical device, the actuation element 120 described herein does not extend to the proximal end of the medical device 100. Instead, the extent of the actuation element 120 remains localized within an area in a segment of the elongated tube 110. As shown, in the above embodiment, at least a portion of the actuation element 120 and the corresponding opening 140 in the wall 130 are located at the same longitudinal position with respect to the longitudinal axis 170 of the elongated tube 110. Because a manipulation wire is not required, the elongated tube 110 and the medical device 100 comprising such elongated tube 110 can be made smaller. A similar medical device 100 is desirable because it can navigate and reach smaller spaces inside the patient. For example, if the medical device 100 is a catheter, guidewire, or implant, such a medical device 100 can reach a target area in a narrower vessel, such as a target area in a patient's brain. Also, since the bending of the medical device 100 does not require any steering wire (such as a pull wire), there is minimal or zero net shortening of the medical device 100 in its deflected or bent state, and there is no tendency to straighten the proximal portion of the medical device 100 (which may occur due to tensioning exerted on the pull wire). Furthermore, since the medical device 100 does not have a pull wire, there is no risk of the medical device 100 being inadvertently moved by the user while attempting to actuate the deflection of the medical device 100. Furthermore, since the medical device 100 does not require any steering wire, there are no mechanical problems associated with the use of such steering wire, such as detachment of the steering wire from the catheter body, clogging of the steering wire due to frictional contact with the catheter body, etc.

[0110] The bending techniques described herein are also advantageous because they allow for the creation of sharp bends in the medical device 100. In the case where the medical device 100 is a catheter or guidewire, this feature allows the medical device 100 to navigate through sharp bends in the patient's vasculature.

[0111] Furthermore, for cases where the medical device 100 is a guidewire or implant (e.g., a vaso-occlusive device), the techniques for bending the elongated tube 110 described herein are also advantageous for these applications because the lack of a steering wire allows the guidewire or implant to be made smaller. The techniques for bending the guidewire or implant described herein allow the guidewire or implant to be selectively bent in one or more directions while the guidewire or implant is inside the patient. Furthermore, because the guidewire or implant can be selectively bent in one or more directions even after they are delivered inside the patient, the guidewire / implant can have a relatively straight profile that corresponds to the profile of the delivery tube that houses such guidewire or implant. This allows the guidewire or implant to be advanced inside the delivery tube with minimal friction.

[0112] The following items are exemplary features of the embodiments described herein. Each clause may be an embodiment in itself or may be part of an embodiment. One or more items described below may be combined with other items in an embodiment.

[0113] Clause 1: A medical device includes an elongated tube having a wall, the wall of the elongated tube having a first opening, and a first actuating element located within the first opening in the wall of the elongated tube, the first actuating element within the first opening in the wall being operable to induce stress and / or displacement in the wall of the elongated tube causing the elongated tube to bend.

[0114] Clause 2: The size of the first actuating element is variable to induce stress and / or displacement in the wall of the elongated tube to cause the elongated tube to bend.

[0115] Clause 3: The size of the actuating element is variable in a direction parallel to the longitudinal axis of the elongate tube.

[0116] Clause 4: The size of the actuating element is variable in a direction perpendicular to the longitudinal axis of the elongate tube.

[0117] Clause 5: The first actuating element is on a first side of the elongated tube, and the elongated tube has one or more slots, or other structural features, on a second side of the elongated tube, the second side being opposite the first side.

[0118] Clause 6: The first actuation element is configured to inflate, to deflate, or to both inflate and deflate.

[0119] Clause 7: The first actuating element is configured to expand within the first opening in the wall to cause the elongated tube to bend in a first direction, and the first actuating element is configured to contract within the opening in the wall to cause the elongated tube to bend in a second direction that is opposite to the first direction.

[0120] Clause 8: The wall of the elongated tube includes a first linkage and a second linkage coupled to respective opposing sides of the first actuation element.

[0121] Clause 9: The first actuating element is configured to exert opposing forces towards the first and second linkages to induce stress and / or displacement in a wall of the elongated tube.

[0122] Clause 10: The first linkage comprises a first portion of the wall and the second linkage comprises a second portion of the wall, the first and second portions of the wall being formed by laser cutting the elongated tube, etching the elongated tube, or removing material from the elongated tube.

[0123] Clause 11: The first actuation element comprises a piezoelectric element, a balloon, an electroactive polymer, or a shape memory element.

[0124] Clause 12: The first actuation element is actuable in response to electrical energy, radio frequency energy, thermal energy, delivery of a fluid, or pressure.

[0125] Clause 13: The wall of the elongate tube comprises a second opening, and the medical device further comprises a second actuation element located within the second opening in the wall of the elongate tube.

[0126] Clause 14: The first actuating element and the second actuating element are located on the same side of the elongated tube.

[0127] Clause 15: The first actuating element and the second actuating element are located on different respective sides of the elongated tube.

[0128] Clause 16: The first actuating element is configured to cause the elongated tube to bend in a first direction, and the second actuating element is configured to cause the elongated tube to bend in a second direction different from the first direction.

[0129] Clause 17: The elongated tube is part of a catheter.

[0130] Clause 18: The elongated tube is part of a guidewire.

[0131] Clause 19: The elongated tube is part of the implant.

[0132] Clause 20: The implant is configured to plastically deform.

[0133] Clause 21: The first actuation element and / or the elongate tube are configured to be elastically deformable.

[0134] Clause 22: The first actuation element and / or the elongate tube are configured to plastically deform.

[0135] Clause 23: A medical device includes an elongated tube having a wall defining an internal lumen for the elongated tube, the wall of the elongated tube having a first opening, and a first actuating element coupled directly or indirectly to the wall of the elongated tube, at least a portion of the first actuating element and the first opening in the wall are located at the same longitudinal position with respect to a longitudinal axis of the elongated tube, and the first actuating element is configured to change size to induce stress and / or displacement in the wall of the elongated tube to cause the elongated tube to bend.

[0136] Clause 24: The first actuating element is configured to vary a cross-sectional dimension of the first opening to induce stress and / or displacement in a wall of the elongated tube.

[0137] Clause 25: A first actuation element is actuable and located within the first opening in the wall of the elongated tube.

[0138] Clause 26: The wall of the elongated tube includes a first linkage and a second linkage coupled to respective opposing sides of the first actuation element.

[0139] Clause 27: The first actuating element is configured to exert opposing forces towards the first and second linkages to induce stress and / or displacement in a wall of the elongated tube.

[0140] Clause 28: The wall of the elongate tube comprises a second opening, and the medical device further comprises a second actuation element located within the second opening in the wall of the elongate tube.

[0141] Clause 29: The first actuating element is configured to cause the elongated tube to bend in a first direction and the second actuating element is configured to cause the elongated tube to bend in a second direction that is the same as the first direction or different from the first direction.

[0142] Clause 30: The first actuation element extends across a first opening in a wall of the elongated tube.

[0143] Clause 31: A first actuating element is coupled to an outer surface of the elongated tube.

[0144] Clause 32: A first actuating element is coupled to an inner surface of the elongated tube.

[0145] Clause 33: The wall of the elongate tube further comprises a second opening, and the first actuation element also extends across the second opening in the wall of the elongate tube.

[0146] Clause 34: The elongated tube has a distal end and a proximal end, and the first actuating element is located between the distal end and the proximal end of the elongated tube.

[0147] Clause 35: The medical device further includes a structural member coupled between opposing sides of the first opening, the first actuating element being located within the lumen of the elongated tube and configured to apply a force toward the structural member.

[0148] Clause 36: The structural member has a length greater than the dimension of the opening.

[0149] Clause 37: The first actuation element is configured to apply a force in a direction that is perpendicular to a longitudinal axis of the elongate tube.

[0150] Clause 38: The first actuating element is on a first side of the elongated tube, and the elongated tube has one or more slots, or other structural features, on a second side of the elongated tube, the second side being opposite the first side.

[0151] Clause 39: The first actuation element is configured to inflate, to deflate, or to both inflate and deflate.

[0152] Clause 40: The first actuation element comprises a piezoelectric element, a balloon, an electroactive polymer, or a shape memory element.

[0153] Clause 41: The first actuating element is actuable in response to electrical energy, radio frequency energy, thermal energy, delivery of a fluid, or pressure.

[0154] Clause 42: The elongate tube is part of a catheter, part of a guidewire, or part of an implant.

[0155] Clause 43: The implant is configured to plastically deform.

[0156] Clause 44: The first actuation element and / or the elongate tube are configured to be elastically deformable.

[0157] Clause 45: The first actuation element and / or the elongate tube are configured to plastically deform. [Explanation of symbols]

[0158] 100 Medical Devices 110 Long and thin tube 120 Operating element (first operating element) 120a First operating element 120b Second operating element 120c Third operating element 130 Wall, thin tube 140 First opening, opening 140a First opening 140b Second opening 140c Third opening 150a First Linkage 150b Second Linkage 160a First structural member, linkage 160b First structural member, linkage 162a Second structural member, linkage 162b Second structural member, linkage 164 Joint Materials 166 Joint Materials 168 Lumen 170 Longitudinal axis 180 Slots 500 Groups 500a 1st group 500b Second Group 500c 3rd group 700 Structural members 701 parts 702 parts 710 interval 720 Bridge elements 800 Distal end 802 Proximal end 804 Catheter body 810 Handle 820 User Interface 900 Distal end 902 Proximal end 904 Guidewire body 910 Handle 920 User Interface 1000 Distal end 1002 Proximal end 1004 Implant body 1010 Handle 1020 User Interface 1200 Shipping Wire 1220 Delivery pipe 1222 Distal end 1224 Proximal end 1230 Handle 1240 User Interface

Claims

1. A medical device, the medical device comprising: an elongated tube having a wall, the wall of the elongated tube having a first opening, the first opening being a notch extending through the wall; a first actuating element located within the first opening in the wall of the elongated tube; Equipped with the first actuating element within the first opening in the wall is operable to induce stress and / or displacement in the wall of the elongate tube to cause the elongate tube to bend; the medical device further comprises a first structural member and a second structural member, the first structural member being part of a first linkage and the second structural member being part of a second linkage, the first linkage and the second linkage being coupled to respective opposite sides of the first actuating element; A medical device, wherein the first actuating element in a notch through the wall has a surface configured to apply a force to the first structural member.

2. 10. The medical device of claim 1, wherein the size of the first actuating element is variable to induce the stress and / or the displacement in the wall of the elongated tube to cause the elongated tube to bend.

3. The medical device of claim 2 , wherein the size of the actuating element is variable in a direction parallel to a longitudinal axis of the elongate tube.

4. The medical device of claim 2 , wherein the size of the actuation element is variable in a direction perpendicular to a longitudinal axis of the elongate tube.

5. 10. The medical device of claim 1, wherein the first actuating element is on a first side of the elongated tube and the elongated tube comprises one or more slots or other structural features on a second side of the elongated tube, the second side being opposite the first side.

6. The medical device of claim 1 , wherein the first actuating element is configured to expand, contract, or both expand and contract.

7. 7. The medical device of claim 6, wherein the first actuating element is configured to expand within the first opening in the wall to cause the elongated tube to bend in a first direction, and the first actuating element is configured to contract within the opening in the wall to cause the elongated tube to bend in a second direction opposite the first direction.

8. 2. The medical device of claim 1, wherein the first actuating element is configured to exert opposing forces toward the first and second linkages to cause the stress and / or displacement in the wall of the elongate tube.

9. 2. The medical device of claim 1, wherein the first linkage comprises a first portion of the wall and the second linkage comprises a second portion of the wall, the first and second portions of the wall being formed by laser cutting the elongated tube, etching the elongated tube, or removing material from the elongated tube.

10. The medical device of claim 1 , wherein the first actuating element comprises a piezoelectric element, a balloon, an electroactive polymer, or a shape memory element.

11. The medical device of claim 1 , wherein the first actuating element is actuable in response to electrical energy, radio frequency energy, temperature change, fluid delivery, or pressure.

12. 12. The medical device of claim 1 , wherein the wall of the elongated tube includes a second opening, and the medical device further includes a second operating element located within the second opening in the wall of the elongated tube.

13. The medical device of claim 12 , wherein the first and second working elements are located on the same side of the elongate tube.

14. 13. The medical device of claim 12, wherein the first and second actuating elements are located on different respective sides of the elongated tube, the first actuating element configured to cause the elongated tube to bend in a first direction and the second actuating element configured to cause the elongated tube to bend in a second direction different from the first direction.

15. The medical device of claim 1 , wherein the elongated tube is part of a catheter, a guidewire, or an implant.

Citation Information

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