Active steerable guidewire
By combining a composite shaft design with shape memory metal, the problem of difficulty in manipulating and positioning existing medical devices in vascular systems has been solved, enabling flexible navigation and precise control of complex vascular systems, especially the successful crossing of collateral branches.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- BOSTON SCIENTIFIC SCIMED INC
- Filing Date
- 2024-09-09
- Publication Date
- 2026-06-05
Smart Images
Figure CN122161640A_ABST
Abstract
Description
Cross-reference to related applications
[0001] This application claims the benefit and priority of U.S. Provisional Patent Application Serial No. 63 / 583,015, filed September 15, 2023, the disclosure of which is incorporated herein by reference. Technical Field
[0002] This disclosure relates to medical devices. More specifically, this disclosure relates to medical devices such as guidewires. Background Technology
[0003] Various in vivo medical devices have been developed for medical applications, such as intravascular applications. Some of these devices include guidewires, catheters, etc. These devices are manufactured using any of a variety of different manufacturing methods and can be used according to any of a variety of different methods. Each of the known medical devices and methods has some advantages and disadvantages. Therefore, there is a continuous need to provide alternative medical devices and alternative methods for manufacturing and using these devices. Summary of the Invention
[0004] This disclosure relates to several alternative designs, materials, and methods of manufacturing medical device structures and components, and their uses. One example can be found in a maneuverable elongated medical device. The maneuverable elongated medical device includes a composite shaft extending from a proximal region to a distal region, the distal region being adapted to selectively bend along a first direction or an opposite second direction. The composite shaft includes: a first shaft member having a straight configuration below the transition temperature and a bent configuration above the transition temperature, the first shaft member bending the composite shaft along the first direction when in its bent configuration. The composite shaft includes a second shaft member having a straight configuration below the transition temperature and a bent configuration above the transition temperature, the second shaft member bending the composite shaft along the second direction when in its bent configuration. A spacer member separates the first shaft member and the second shaft member. The maneuverable elongated medical device includes a handle removably fixed to the proximal region. The handle includes: a housing adapted to be removably fixed to the proximal region of the composite shaft; and a knob rotatably fixed relative to the housing. The knob includes: a knob body; a first electrical contact disposed on the knob body and adapted to contact a first shaft member when the knob is rotated to a first position; and a second electrical contact disposed on the knob body and adapted to contact a second shaft member when the knob is rotated to a second position.
[0005] Alternatively or additionally, the first shaft component may be adapted to increase in temperature when current passes through it, and the second shaft component may be adapted to increase in temperature when current passes through it.
[0006] Alternatively or additionally, the first shaft component and the second shaft component may each include shape memory metal.
[0007] Alternatively or additionally, the first shaft component and the second shaft component may each include nitinol.
[0008] Alternatively or additionally, the first electrical contact may be adapted to make electrical contact with the first shaft component when the knob is rotated to the first position, and the second electrical contact may be adapted to make electrical contact with the second shaft component when the knob is rotated to the second position.
[0009] Alternatively or additionally, the knob may be adapted to rotate to a neutral position between a first position and a second position, in which neither the first electrical contact nor the second electrical contact is in electrical contact with the first shaft component or the second shaft component.
[0010] Alternatively or additionally, the knob may also include a power connector that is electrically connected to the first and second electrical contacts.
[0011] Alternatively or additionally, the steerable elongated medical device may also include a conductive member that makes electrical contact with the distal region of the first axial member and the distal region of the second axial member to form a circuit.
[0012] Alternatively or additionally, the transition temperature may be higher than 37°C.
[0013] Alternatively or additionally, the spacer may include an insulating member.
[0014] Alternatively or additionally, the spacer member may include a thermoelectric circuit adapted to selectively heat one of the first shaft component and the second shaft component.
[0015] Alternatively or additionally, the first shaft component may include a plurality of cutouts formed within the first shaft component to enhance the hinge flexibility of the first shaft component.
[0016] Alternatively or additionally, the second shaft component may include multiple cutouts formed within the second shaft component to enhance the hinge flexibility of the second shaft component.
[0017] Another example can be found in a maneuverable guidewire. The maneuverable guidewire includes a compound shaft adapted to selectively bend along a first direction or an opposite second direction. The compound shaft includes a first shaft member movable between a first configuration and a second configuration, the first shaft member being adapted to move to the second configuration upon electrical heating. The compound shaft includes a second shaft member movable between the first and second configurations, the second shaft member being adapted to move to the second configuration upon electrical heating. A handle is adapted to be removably secured to the compound shaft. The handle is selectable between: a first position, in which current is supplied to the first shaft member; a second position, in which current is supplied to the second shaft member; and a third position, in which no current is supplied.
[0018] Alternatively or additionally, the first shaft component and the second shaft component may each include shape memory metal.
[0019] Alternatively or additionally, the first shaft component and the second shaft component may each include nitinol.
[0020] Alternatively or additionally, the first configuration of the first shaft component and the first configuration of the second shaft component may each correspond to the straight configuration of the composite shaft.
[0021] Alternatively or additionally, when the first shaft component is electrically heated while the second shaft component is not electrically heated, the first shaft component can cause the composite shaft to bend along a first direction; and when the second direction is electrically heated while the first shaft component is not electrically heated, the second shaft component can cause the composite shaft to bend along a second direction.
[0022] Alternatively or additionally, when neither the first shaft component nor the second shaft component is electrically heated, the composite shaft may have a neutral configuration.
[0023] Another example can be found in a maneuverable guidewire. The maneuverable guidewire includes a composite shaft adapted to selectively bend along a first direction or a second, opposite direction. The composite shaft includes: a first shaft member movable between a neutral configuration and a bending configuration, the first shaft member being adapted to move to the bending configuration upon electrical heating, the first shaft member comprising nitinol; and a second shaft member movable between a neutral configuration and a bending configuration, the second shaft member being adapted to move to the bending configuration upon electrical heating, the second shaft member comprising nitinol. When the first shaft member is in its bending configuration and the second shaft member is in its neutral configuration, the composite shaft is adapted to bend along the first direction. When the first shaft member is in its neutral configuration and the second shaft member is in its bending configuration, the composite shaft is adapted to bend along the opposite second direction. When the first shaft member is in its neutral configuration and the second shaft member is in its neutral configuration, the composite shaft is adapted to remain in the neutral configuration.
[0024] The foregoing summary is intended to aid in understanding the unique innovative features of this disclosure and is not intended to be a complete description. A full understanding of this disclosure can be obtained by considering the entire specification, claims, drawings, and abstract as a whole. Attached Figure Description
[0025] This disclosure can be more fully understood by taking into account the following description of various examples and the accompanying drawings, in which:
[0026] Figure 1 It is a perspective view illustrating a manipulable medical device;
[0027] Figure 2 This is a schematic diagram illustrating a composite axis, showing the possible degrees of freedom;
[0028] Figure 3 yes Figure 1 An illustrative perspective view of a manipulable medical device, in which part of the handle has been removed;
[0029] Figure 4 It is formed Figure 1 A schematic diagram of an illustrative composite shaft, a part of an illustrative manipulable medical device, wherein insulating material is assembled between two thermal shape memory materials;
[0030] Figure 5 yes Figure 1 A schematic diagram of an illustrative operable medical device showing a knob in a first position in which the first shaft component of the compound shaft is energized;
[0031] Figure 6 yes Figure 1 An illustrative diagram of a manipulable medical device showing a knob in a second position in which the second shaft component of the compound shaft is energized;
[0032] Figure 7 yes Figure 1 An illustrative diagram of a manipulable medical device shows the knob in the third position, in which neither of the two shaft components of the compound shaft is energized;
[0033] Figure 8 It is along Figure 4 The sectional view taken by line 8-8 in the middle;
[0034] Figure 9 This is a perspective view of an illustrative composite axis, showing an exemplary cutout pattern;
[0035] Figure 10 It can be used to form Figure 1 A schematic diagram of an illustrative composite shaft for an illustrative manipulable medical device, wherein a thermoelectric circuit is assembled between two thermal shape memory materials; and
[0036] Figure 11 It can be used Figure 10 A schematic diagram of an illustrative thermoelectric circuit within an illustrative composite shaft.
[0037] While this disclosure is open to various modifications and alternatives, its specific details have been illustrated by way of example in the accompanying drawings and will be described in detail. However, it should be understood that this disclosure is not intended to be limited to the specific examples described. Rather, it is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of this disclosure. Detailed Implementation
[0038] The following description should be read in conjunction with the accompanying drawings, in which similar elements in different drawings are numbered in a similar manner. The drawings are not necessarily drawn to scale and depict examples that are not intended to limit the scope of this disclosure. Although examples are shown for individual elements, those skilled in the art will recognize that many of the examples provided have suitable alternatives available.
[0039] Unless otherwise expressly stated otherwise, all numerical values in this document are considered to be modified by the term “about”. A range of numerical values expressed in terms of endpoints includes all numbers contained within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).
[0040] As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural references unless otherwise expressly stated. As used in this specification and the appended claims, the term “or” is generally used to mean “and / or” unless otherwise expressly stated.
[0041] It should be noted that references to "one embodiment," "some embodiments," "other embodiments," etc., in the specification indicate that the described embodiments may include specific features, structures, or characteristics, but not every embodiment must include that specific feature, structure, or characteristic. Furthermore, such phrases do not necessarily refer to the same embodiment. Additionally, when a specific feature, structure, or characteristic is described in connection with an embodiment, it is contemplated that such feature, structure, or characteristic may be applied to other embodiments, whether explicitly described or not, unless explicitly stated to the contrary.
[0042] Guidewires are used in many medical procedures. In many cases, guidewires can be used to access portions of anatomical structures, such as, but not limited to, the vascular system. Once the guidewire reaches the desired location, other medical devices, such as treatment devices, can be advanced along it. In some cases, reaching the desired location within the vascular system may require navigating through tortuous pathways within the system. In some cases, successfully advancing the guidewire into and through a collateral branch of the vessel may require locating and penetrating the opening of that branch. In some cases, the ability to manipulate the guidewire may facilitate successful navigation through tortuous pathways within the vascular system and successful advancement within a collateral branch.
[0043] Figure 1This is a perspective view of an illustrative, maneuverable, elongated medical device 10. The maneuverable, elongated medical device 10 can be considered, for example, a maneuverable guidewire. The maneuverable guidewire 10 includes a composite shaft 12 extending from a proximal region 14 to a distal region 16 and a handle 18 adapted to be removably secured to the proximal region 14 of the composite shaft 12. It should be understood that once the maneuverable guidewire 10 has successfully reached the desired location (e.g., a treatment site within a vascular system), the handle 18 can be removed so that other medical devices (e.g., treatment devices) can be advanced along the maneuverable guidewire 10.
[0044] Handle 18 may include a housing 20 adapted to be removably secured to a proximal region 14 of the compound shaft 12. Handle 18 may include a knob 22 rotatably secured relative to housing 20. As discussed below, the rotatable knob 22 may actuate the compound shaft 12 to bend, for example, in a first or second direction. In some cases, housing 20 may include a proximal region 24 adapted to facilitate gripping and manipulating the elongated medical device 10. Housing 20 may include a distal region 26 adapted to engage with the proximal region 14 of the compound shaft 12. In some cases, distal region 26 may be narrowed relative to the compound shaft 12. In some cases, distal region 26 may include a slot 28 formed within distal region 26 to allow distal region 26 to bend sufficiently to enable insertion (and subsequent removal) of the compound shaft 12 into handle 18.
[0045] In some cases, the chuck 30 may be disposed on the distal region 26 and may be used to compress the distal region 26 onto the proximal region 14 of the compound shaft 12. In some cases, the chuck 30 may be adapted to slide distally to the position shown after the handle 18 has been disposed on the proximal region 14 of the compound shaft 12, to secure the handle 18 in place by compressing the distal region 26 onto the proximal region 14 of the compound shaft 12. In some cases, the chuck 30 may include a first half and a second half, each having a semi-cylindrical profile and together forming a cylindrical profile. The first half and the second half may be adapted to engage together on the distal region 26 to compress the distal region 26 of the housing 20 onto the proximal region 14 of the compound shaft 12. In some cases, the chuck 30 may be threadedly engaged with the distal region 26 of the housing 20. In some cases, the handle 18 may include a power connector 32, which may be used to provide current for actuating the compound shaft 12 (as discussed below).
[0046] In some cases, the maneuverable elongated medical device 10 (including the composite shaft 12) may be adapted to facilitate passage through tortuous vascular systems, including access to collateral branches. Figure 2This is a schematic diagram of the compound shaft 12, illustrating the degrees of freedom provided by the manipulatory elongated medical device 10. The distal region 16 is adapted for vertical hinge flexibility. Shaft portion 12a, shown in dashed lines, illustrates how the distal region 16 can bend or curve in the first direction indicated by arrow 34. Shaft portion 12b, also shown in dashed lines, illustrates how the distal region 16 can bend or curve in the second direction indicated by arrow 36. The compound shaft 12 is adapted to rotate clockwise or counterclockwise, as indicated by arrows 38 and 40, respectively. The compound shaft 12 is adapted to be pushed in the direction indicated by arrow 42 and pulled in the direction indicated by arrow 44. By combining these movements, the compound shaft 12 can be navigated through tortuous vascular systems and, for example, even into collateral vessels. By rotating the compound shaft 12 and then actuating the distal region 16 in the first direction indicated by arrow 34 or the second direction indicated by arrow 36, the compound shaft 12 can be manipulated in either direction.
[0047] Figure 3 This is a perspective view of an illustrative, maneuverable, elongated medical device 10, with a portion of the housing 20 removed. It can be seen that the proximal region 14 of the compound shaft 12 extends sufficiently into the distal region 26 of the housing 20. In some cases, the compound shaft 12 has a proximal end 46 positioned adjacent to the knob 22. As discussed below, positioning the proximal end 46 of the compound shaft 12 near the knob 22 allows selective actuation of the compound shaft 12 to bend or curve in the direction indicated by arrow 34, bend or curve in the direction indicated by arrow 36, or remain in a neutral configuration in which the compound shaft 12 may bend due to the vascular system in which the maneuverable, elongated medical device 10 is placed, but will remain straight or substantially straight (defined as within ten percent of a straight line) without other constraints. The knob 22 includes a knob body 48. A first gripping member 50 extends radially outward from the knob body 48 in a first direction, and a second gripping member 52 extends radially outward from the knob body 48 in the opposite second direction. The combination of the first gripper 50 and the second gripper 52 allows the user to easily rotate the knob 22 to selectively actuate the compound shaft 12.
[0048] Figure 4 This is a schematic perspective view of a portion of a composite shaft 12. The composite shaft 12 includes a first shaft member 54 and a second shaft member 56. The first shaft member 54 is adapted to have a first or straight configuration below the transition temperature and a second or bent configuration above the transition temperature. When the first shaft member 54 is in its bent configuration, it bends the composite shaft 12 along a first direction. The first or straight configuration may correspond to a neutral configuration. For example, in… Figure 2In this configuration, the composite shaft 12 is bent or curved along the first direction indicated by arrow 34, as shown in the shaft portion 12a (shown in dashed lines). In some cases, the first shaft component 54 may be configured to move from a first or straight configuration to a second or curved configuration due to electrical heating by flowing current through the first shaft component 54. In some cases, the first shaft component 54 may comprise a shape memory material. In some cases, the first shaft component 54 may have a shape memory configuration corresponding to the second or curved configuration. In some cases, the first shaft component 54 may be made of nitinol.
[0049] The second shaft member 56 is adapted to have a first or straight configuration below the transition temperature and a second or bent configuration above the transition temperature. When the second shaft member 56 is in its bent configuration, it bends the composite shaft 12 along a second direction. The first or straight configuration may correspond to a neutral configuration. For example, in Figure 2 In this configuration, the composite shaft 12 has been bent or curved along the second direction indicated by arrow 36, as shown in the shaft portion 12b (shown in dashed lines). In some cases, the second shaft component 56 may be configured to move from a first or straight configuration to a second or curved configuration due to electrical heating by flowing current through the second shaft component 56. In some cases, the second shaft component 56 may comprise a shape memory material. In some cases, the second shaft component 56 may have a shape memory configuration corresponding to the second or curved configuration. In some cases, the second shaft component 56 may be made of nitinol.
[0050] In some cases, the transition temperature may correspond to a temperature above body temperature. The transition temperature may be above 37°C, for example. The transition temperature may be above 40°C, or above 42°C. This means that the composite shaft 12 may have a neutral configuration at lower temperatures (e.g., ambient temperature or even normal body temperature). When the first shaft component 54 is heated above the transition temperature, the first shaft component 54 will recover its memory configuration, which causes the composite shaft 12 to bend along a first direction. When the second shaft component 56 is heated above the transition temperature, the second shaft component 56 will recover its memory configuration, which causes the composite shaft 12 to bend along a second direction. In some cases, the first shaft component 54 and the second shaft component 56 may remain forgeable below the transition temperature. In some cases, the first shaft component 54 and the second shaft component 56 may each become hyperelastic due to electrical heating.
[0051] The composite shaft 12 includes a spacer member 58 disposed between a first shaft member 54 and a second shaft member 56. In some cases, the spacer member 58 may have insulating properties. In some cases, the spacer member 58 may be adapted to be electrically insulating, such that current flowing through one of the first shaft member 54 and the second shaft member 56 will not enter the other of the first shaft member 54 and the second shaft member 56. In some cases, the spacer member 58 may be thermally insulating, such that temperature rise within one of the first shaft member 54 and the second shaft member 56 will not heat the other of the first shaft member 54 and the second shaft member 56. The spacer member 58 may be formed of a variety of different polymer materials, for example. The spacer member 58 may include or be made of PTFE (polytetrafluoroethylene), Pebax®, PVC (polyvinyl chloride), or any type of foam.
[0052] In some cases, knob 22 can rotate between a first position, a second position, and a third position, supplying current to the first shaft component 54 in the first position, supplying current to the second shaft component 56 in the second position, and supplying no current in the third position. In some cases, handle 18 can be considered selectable between the first position, the second position, and the third position. Figure 5 The knob 22 is shown in the first position. Figure 6 The knob 22 is shown in the second position. Figure 7 The knob 22 is shown in the third position. In some cases, the knob 22 can move freely between the first, second, and third positions, and can be adapted to remain in any position to which the knob 22 is turned. In some cases, the knob 22 can be biased to the third position, for example, and will only remain in the first or second position if someone holds the knob 22 in the first or second position respectively.
[0053] exist Figure 5 In this configuration, knob 22 has been rotated, causing the first gripper 50 to move distally and position closer to the composite shaft 12, while the second gripper 52 moves proximally and positions further away from the composite shaft 12. In some cases, the relative positions of the first gripper 50 and the second gripper 52 provide a visual indication of the knob 22's position, thus indicating which shaft component (if any) is being heated. Knob 22 includes a first electrical contact 60 that rotates with knob 22. In some cases, the first electrical contact 60 is biased in an outward direction, for example by a spring (not shown). In the illustrated position, the first electrical contact 60 is in electrical contact with the first shaft component 54. As a result, current is supplied to flow through the first shaft component 54, and the resistance of the first shaft component 54 causes its temperature to rise. As the temperature of the first shaft component 54 rises above its transition temperature, the first shaft component 54 will recover its memory shape and bend or flex. This will cause the composite shaft 12 to bend or flex in a first direction, as indicated by arrow 34. Figure 2).
[0054] exist Figure 6 In this configuration, knob 22 has been rotated such that the first gripper 50 moves proximally and positions further away from the composite shaft 12, while the second gripper 52 moves distally and positions closer to the composite shaft 12. In some cases, the relative positions of the first gripper 50 and the second gripper 52 provide a visual indication of the knob 22's position, thus indicating which shaft component (if any) is being heated. Knob 22 includes a second electrical contact 62 that rotates with knob 22. In some cases, the second electrical contact 62 is biased in an outward direction, for example by a spring (not shown). In the illustrated position, the second electrical contact 62 is in electrical contact with the second shaft component 56. As a result, current is supplied to flow through the second shaft component 56, and the resistance of the second shaft component 56 causes its temperature to rise. As the temperature of the second shaft component 56 rises above its transition temperature, the second shaft component 56 will recover its memory shape and bend or flex. This will cause the composite shaft 12 to bend or flex in a second direction, as indicated by arrow 36. Figure 2 ).
[0055] exist Figure 7 In this configuration, knob 22 has been rotated such that the first gripper member 50 and the second gripper member 52 are positioned vertically. In some cases, the relative positions of the first gripper member 50 and the second gripper member 52 provide a visual indication of the position of knob 22, thereby indicating which shaft component (if any) is being heated. When knob 22 is in this position, the first electrical contact 60 is held away from contact with the first shaft component 54, and the second electrical contact 62 is held away from contact with the second shaft component 56. As a result, no current flows through either the first shaft component 54 or the second shaft component 56. This means that both the first shaft component 54 and the second shaft component 56 will remain in their first or linear configuration, and the composite shaft 12 will also remain in a straight configuration, except for any incidental bending of the composite shaft 12 due to the constraint of the vascular wall affecting the composite shaft 12.
[0056] Brief Reference Figure 4 The composite shaft 12 includes an outer layer 70. In some cases, the outer layer 70 may be a polymer extrusion that provides electrical and thermal insulation to the composite shaft 12. In some cases, the outer layer 70 may be formed from Pebax or PTFE extrusion. In some cases, the outer layer 70 may provide additional shaft stiffness and may therefore include one or more reinforcing layers, such as, for example, coils or braids. In some cases, the outer layer 70 may include several different layers, such as two or more polymer insulating layers sandwiching a conductive layer that extends to the distal region 16 of the composite shaft 12 to provide an electrical conductor in electrical contact with the distal portions of the first shaft member 54 and the second shaft member 56, thereby forming a circuit that allows current to flow.
[0057] Figure 8 It is along Figure 4 The sectional view taken from line 8-8. From Figure 8 As can be seen, the first insulating layer 72 is disposed directly on the first shaft member 54. A conductive layer 74 is disposed on the first insulating layer 72. In some cases, the conductive layer 74 may extend further than the first insulating layer 72, and thus the conductive layer 74 may be in electrical contact with both the first shaft member 54 (as shown) and the second shaft member 56, thereby serving as a return path for the current selectively supplied to the first shaft member 54 and the second shaft member 56. A second insulating layer 76 may be disposed on the conductive layer 74 to electrically insulate the conductive layer 74. Although a three-layer configuration is shown, it should be understood that this is merely illustrative, and the composite shaft 12 may include any number of insulating polymer layers. Alternative examples of the composite shaft 12 including an electrical conductor extending to the distal end 46 of the composite shaft 12 are possible. For example, the composite shaft 12 may simply include a conductive wire extending the length of the composite shaft 12.
[0058] In some cases, the first shaft component 54 and / or the second shaft component 56 may include slit patterns formed within the first shaft component 54 and / or the second shaft component 56. In some cases, forming slit patterns can make each of the first shaft component 54 and / or the second shaft component 56 more flexible. When one of the first shaft component 54 and the second shaft component 56 is heated, the heated shaft component transforms into its memory shape. The unheated shaft component remains forgeable, so the heated shaft component is able to overcome the shape of the unheated component, thereby allowing the composite shaft 12 to bend or flex. Figure 9 A composite shaft 12 is shown, wherein a cut pattern 80 is formed on the outer surface of the second shaft member 56. The cut pattern 80 improves the hinge flexibility of the first shaft member 54 and the second shaft member 56. This is just one example, and any of a variety of different cut patterns can be used. In some cases, the composite shaft 12 may be adapted to bend equally along the first and second directions. In some cases, the composite shaft 12 may be adapted to bend preferentially along one direction rather than the other. The relative cut patterns for each of the first shaft member 54 and the second shaft member 56 may reflect the desired bending characteristics of the composite shaft 12.
[0059] Figure 10This is a schematic perspective view of a portion of a composite shaft 112. The composite shaft 112 includes a first shaft component 154 and a second shaft component 156. The first shaft component 154 is adapted to have a first or straight configuration below the transition temperature and a second or bent configuration above the transition temperature. When the first shaft component 154 is in its bent configuration, it bends the composite shaft 112 along a first direction. The first or straight configuration may correspond to a neutral configuration. In some cases, the first shaft component 154 may be configured to move from the first or straight configuration to the second or bent configuration due to heating. In some cases, the first shaft component 154 may comprise a shape memory material. In some cases, the first shaft component 154 may have a shape memory configuration corresponding to the second or bent configuration. In some cases, the first shaft component 154 may be made of nitinol.
[0060] The second shaft member 156 is adapted to have a first or straight configuration below the transition temperature and a second or bent configuration above the transition temperature. When the second shaft member 156 is in its bent configuration, it causes the composite shaft 112 to bend along a second direction. The first or straight configuration may correspond to a neutral configuration. In some cases, the second shaft member 156 may be configured to move from the first or straight configuration to the second or bent configuration due to heating. In some cases, the second shaft member 156 may comprise a shape memory material. In some cases, the second shaft member 156 may have a shape memory configuration corresponding to the second or bent configuration. In some cases, the second shaft member 156 may be made of nitinol.
[0061] In some cases, the transformation temperature may correspond to a temperature above body temperature. The transformation temperature may be above 37°C, for example. The transformation temperature may be above 40°C, or above 42°C. This means that the composite shaft 112 may have a neutral configuration at lower temperatures (e.g., ambient temperature or even normal body temperature). When the first shaft component 154 is heated above the transformation temperature, the first shaft component 154 will recover its memory configuration, which causes the composite shaft 112 to bend along a first direction. When the second shaft component 156 is heated above the transformation temperature, the second shaft component 156 will recover its memory configuration, which causes the composite shaft 112 to bend along a second direction. In some cases, the first shaft component 154 and the second shaft component 156 may remain forgeable below the transformation temperature. In some cases, the first shaft component 154 and the second shaft component 156 may each become hyperelastic due to heating.
[0062] The composite shaft 112 includes a spacer member 158 disposed between a first shaft member 154 and a second shaft member 156. In some cases, the spacer member 158 may be a thermoelectric circuit adapted to selectively heat one of the first shaft member 154 and the second shaft member 156. In some cases, the thermoelectric circuit may comprise materials with different Seebeck coefficients (p-doped and n-doped semiconductors) configured as thermoelectric generators. The composite shaft 112 includes an outer layer 170, which may include, for example, a polymer insulating layer.
[0063] Figure 11 This is a schematic diagram showing thermoelectric circuit 158. Thermoelectric circuit 158 includes an n-doped semiconductor 160 and a p-doped semiconductor 162. Applying current will cause a cooling surface 164 and a heating surface 166. Depending on the direction of current flow (which can be controlled), which surface is heated and which surface is cooled can be reversed. If the cooling surface 164 corresponds to the first shaft member 154 and the heating surface 166 corresponds to the second shaft member 156, then the second shaft member 156 will be heated and bent, causing the composite shaft 112 to bend in the direction indicated by the memory shape of the second shaft member 156. Alternatively, if the cooling surface 164 corresponds to the second shaft member 156 and the heating surface 166 corresponds to the first shaft member 154, then the first shaft member 154 will be heated and bent, causing the composite shaft 112 to bend in the direction indicated by the memory shape of the first shaft member 154.
[0064] Materials that can be used for various components of the medical device described herein may include those typically associated with medical devices. The medical device and its various components described herein may be made of metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, or other suitable materials. Some examples of suitable metals and metal alloys include: stainless steels such as 304, 304V, 304L, 316, 316LV, 303, 410, and 416 stainless steels; nickel-titanium alloys such as linear elastic and / or hyperelastic nickel-titanium; cobalt-nickel-chromium-molybdenum alloys (e.g., UNS: R30035, such as MP35N®, etc.), nickel-molybdenum alloys (e.g., UNS: N10665, such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as ELGILOY®, PHYNOX®, etc.); brass such as C360, C260, C280, C693, C768, C87850, etc.; platinum-rich stainless steels; combinations thereof; or any other suitable material.
[0065] The medical device described herein, and its parts and components, may be made of the same material along its length, or in some embodiments, may include parts or sections made of different materials. In some embodiments, materials may be selected to impart different flexibility and stiffness properties to different parts. For example, different parts of a component (e.g., proximal and distal sections) may be formed of different materials, such as materials with different elastic moduli, resulting in differences in flexibility. In some embodiments, the material used to construct the proximal section may be relatively stiff to have good pushability and torque transmission, while the material used to construct the distal section may be relatively softer in comparison to have better lateral tracking and maneuverability. For example, the proximal section may be formed from straightened 304V stainless steel wire or strip, while the distal section may be formed from straightened hyperelastic or linearly elastic alloys (e.g., nickel-titanium alloy wire or strip).
[0066] In embodiments of the medical device described herein, where different parts are made of different materials, the different parts can be connected using suitable connection techniques and / or connectors. For example, the different parts can be connected using welding (including laser welding), soldering, brazing, adhesives, or combinations thereof. These techniques can be utilized regardless of whether connectors are used. An example of a connector is a structure such as a hypotube or a spiral coil, having an inner diameter of appropriate size to accommodate and connect to the ends of the proximal and distal portions.
[0067] A sheath or cover (not shown) may be provided on part or all of the medical device described herein. However, in other embodiments, such a sheath or cover may be absent. The sheath may be made of a polymer or other suitable material. Some examples of suitable polymers may include: polytetrafluoroethylene (PTFE), ethylene-tetrafluoroethylene copolymer (ETFE), fluorinated ethylene-propylene copolymer (FEP), polyoxymethylene (POM, e.g., DuPont's DELRIN®), polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., DSM Engineering Plastics' ARNITEL®), ether-based or ester-based copolymers (e.g., polybutylene terephthalate-polytetramethylene ether glycol copolymer and / or other polyester elastomers, such as DuPont's HYTREL®), polyamides (e.g., Bayer's DURETHAN® or Elf). Atochem's CRISTAMID®, elastomer polyamides, block polyamides / ethers, polyether block amides (PEBA, e.g., sold under the trade name PEBAX®), ethylene-vinyl acetate copolymers (EVA), silicone resins, polyethylene (PE), Marlex® high-density polyethylene, Marlex® low-density polyethylene, linear low-density polyethylene (e.g., REXELL®), polyesters, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polypropylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene ether (PPO), poly(p-phenylene terephthalamide) (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (e.g., EMS American) Grilon's GRILAMID®, perfluoro(propyl vinyl ether) (PFA), ethylene-vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites thereof. In some embodiments, the sheath may be blended with a liquid crystal polymer (LCP). For example, the blend may contain up to about 6% LCP. The sheath may include braided yarns along a portion or all of its axial length, for example...
[0068] In some embodiments, the outer surface of the medical device described herein may be subjected to sandblasting, bead blasting, sodium bicarbonate blasting, electropolishing, etc. In these and some other embodiments, a coating, such as a lubricating, hydrophilic, protective, or other type of coating, may be applied to part or all of the medical device described herein. Alternatively, the sheath may include a lubricating, hydrophilic, protective, or other type of coating. Hydrophobic coatings (such as fluoropolymers) provide dry lubrication, which improves guidewire manipulation and device exchange. Lubricating coatings improve maneuverability and lesion crossing ability. Suitable lubricating polymers are known in the art and may include silicone resins, hydrophilic polymers such as high-density polyethylene (HDPE), polytetrafluoroethylene (PTFE), polyaryl oxides, polyvinylpyrrolidone, polyvinyl alcohol, hydroxyalkyl cellulose, alginates, sugars, caprolactone, etc., and mixtures and combinations thereof. Hydrophilic polymers may be blended with each other or with formulated amounts of water-insoluble compounds (including some polymers) to produce a coating with suitable lubricity, adhesion, and solubility. Other examples of such coatings, as well as materials and methods for manufacturing such coatings, can be found in U.S. Patent Nos. 6,139,510 and 5,772,609, which are incorporated herein by reference.
[0069] Having described several illustrative embodiments of this disclosure, those skilled in the art will readily understand that other embodiments can be made and used within the scope of the appended claims. However, it should be understood that this disclosure is illustrative in many respects only. Changes may be made in detail, particularly in terms of shape, size, arrangement of components, and exclusion and order of steps, without departing from the scope of this disclosure. The scope of this disclosure is, of course, defined by the language of the appended claims.
Claims
1. A maneuverable, elongated medical device, comprising: A composite shaft extending from a proximal region to a distal region, the distal region being adapted to selectively bend along a first direction or an opposite second direction, the composite shaft comprising: A first shaft component has a straight configuration below the transition temperature and a bent configuration above the transition temperature. When the first shaft component is in its bent configuration, the first shaft component causes the composite shaft to bend along the first direction. A second shaft component, having a straight configuration below the transition temperature and a bent configuration above the transition temperature, wherein when the second shaft component is in its bent configuration, the second shaft component causes the composite shaft to bend along the second direction; and A spacer member separating the first shaft component and the second shaft component; and A handle, removably secured to the proximal region, the handle comprising: A housing adapted to be removably secured to the proximal region of the composite shaft; and A knob that can be rotatably fixed relative to the housing, the knob comprising: Knob body; A first electrical contact, disposed on the knob body and adapted to contact the first shaft component when the knob is rotated to a first position; and A second electrical contact is disposed on the knob body and adapted to contact the second shaft component when the knob is rotated to the second position.
2. The steerable elongated medical device according to claim 1, wherein: The first shaft component is adapted to increase in temperature when current passes through it; and The second shaft component is adapted to increase in temperature when current passes through it.
3. The maneuverable elongated medical device according to claim 1 or 2, wherein the first shaft component and the second shaft component each comprise shape memory metal.
4. The maneuverable elongated medical device according to any one of claims 1 to 3, wherein the first shaft component and the second shaft component each comprise nitinol.
5. The steerable elongated medical device according to any one of claims 1 to 4, wherein: The first electrical contact is adapted to make electrical contact with the first shaft component when the knob is rotated to the first position; and The second electrical contact is adapted to make electrical contact with the second shaft component when the knob is rotated to the second position.
6. The operable elongated medical device according to any one of claims 1 to 5, wherein the knob is adapted to rotate to a neutral position between the first position and the second position, wherein in the neutral position neither the first electrical contact nor the second electrical contact is in electrical contact with the first shaft component or the second shaft component.
7. The operable elongated medical device according to any one of claims 1 to 6, wherein the knob further comprises a power connector electrically connected to the first electrical contact and the second electrical contact.
8. The steerable elongated medical device according to any one of claims 1 to 7, further comprising a conductive member that is in electrical contact with the distal regions of the first shaft member and the second shaft member to form a circuit.
9. The steerable elongated medical device according to any one of claims 1 to 8, wherein the transition temperature is above 37°C.
10. The steerable elongated medical device according to any one of claims 1 to 9, wherein the spacer member comprises an insulating member.
11. The steerable elongated medical device of claim 1, wherein the spacer member includes a thermoelectric circuit adapted to selectively heat one of the first shaft member and the second shaft member.
12. The steerable elongated medical device according to any one of claims 1 to 11, wherein the first shaft component and / or the second shaft component includes a plurality of slits formed within the first shaft component and / or the second shaft component to enhance the hinge flexibility of the first shaft component and / or the second shaft component.
13. A steerable guidewire, comprising: A composite shaft, adapted to selectively bend along a first direction or an opposite second direction, the composite shaft comprising: A first shaft component, movable between a first configuration and a second configuration, adapted to move to the second configuration upon electric heating; and A second shaft component, movable between a first configuration and a second configuration, adapted to move to the second configuration upon electric heating; and A handle, adapted to be removably fixed to the composite shaft, the handle being selectable between the following positions: In the first position, current is supplied to the first shaft component; In the second position, current is supplied to the second shaft component; and The third position, in which no current is supplied.
14. The steerable guidewire according to claim 13, wherein: When the first shaft component is electrically heated while the second shaft component is not electrically heated, the first shaft component causes the composite shaft to bend along the first direction; and When the second shaft component is electrically heated while the first shaft component is not electrically heated, the second shaft component causes the composite shaft to bend along the second direction.
15. A maneuverable guidewire, comprising: A composite shaft, adapted to bend selectively along a first direction or an opposite second direction, the composite shaft comprising: A first shaft component, movable between a neutral configuration and a curved configuration, adapted to move into the curved configuration upon electric heating, the first shaft component comprising nitinol; and A second shaft component, the second shaft component being movable between a neutral configuration and a curved configuration, the second shaft component being adapted to move to the curved configuration upon electric heating, the second shaft component comprising nitinol; Wherein, when the first shaft component is in its bent configuration and the second shaft component is in its neutral configuration, the composite shaft is adapted to bend along the first direction; Wherein, when the first shaft component is in its neutral configuration and the second shaft component is in its bent configuration, the composite shaft is adapted to bend along the opposite second direction; and Wherein, when the first shaft component is in a neutral configuration and the second shaft component is in a neutral configuration, the composite shaft is adapted to remain in a neutral configuration.