Medical device equipped with guide wire brakes

Abstract

The exemplary medical device includes a handle (15) having a distal end region (11), a proximal end region (13), and an interior chamber. The medical device (10) includes a guidewire brake (22) including an actuation member (28) coupled to a first gripping member (40a) and a second gripping member (40b). The first gripping member (40a) and the second gripping member (40b) are disposed within the interior chamber of the handle (15), and at least a portion of the actuation member (28) is disposed along an exterior surface of the handle (15). Furthermore, the first gripping member (40a) and the second gripping member (40b) are configured to shift between an unclamping configuration and a clamping configuration to clamp and unclamp the guidewire (16) between the first gripping member (40a) and the second gripping member (40b).

Description

Technical Field

[0001] The present disclosure relates to medical devices and methods of manufacturing and using medical devices. More specifically, the present disclosure relates to devices and methods for removing occluding substances from body lumens. Further, the present disclosure relates to an atherectomy device for forming a passage through an occlusion in a body lumen such as a blood vessel.

Background Art

[0002] Many patients suffer from occlusions in arteries and other blood vessels that restrict blood flow. The occlusion can be a partial occlusion that reduces blood flow through the occluded portion of the blood vessel or a complete occlusion (e.g., chronic total occlusion) that substantially blocks blood flow through the occluded blood vessel. In some cases, a stent can be placed in the treated area of the occlusion. However, restenosis can occur within the stent, and the blood vessel can become further occluded, restricting blood flow. Revascularization procedures involve creating or enlarging an opening through the occlusion using various devices that pass through the occlusion. Atherectomy is one technique for advancing a catheter having a cutting element through the occlusion to form or enlarge a passage through the occlusion. Alternative atherectomy devices for facilitating the crossing of the occlusion are still needed.

Summary of the Invention

[0003] The present disclosure provides alternative forms of design, materials, manufacturing methods, and use of medical devices. An exemplary medical device includes a handle having a distal end region, a proximal end region, and an internal chamber. The medical device also includes a guide wire brake that includes an actuating member coupled to a first gripping member and a second gripping member. The first gripping member and the second gripping member are provided within the internal chamber of the handle, and at least a portion of the actuating member is disposed along an outer surface of the handle. Further, the first gripping member and the second gripping member are configured to shift between a non-clamp configuration and a clamp configuration.

[0004] In place of or in addition to any of the above embodiments, the first gripping member includes a first gripping pad, and the second gripping member includes a second gripping pad, wherein in a non-clamp configuration, at least a portion of the first gripping pad is spaced apart from at least a portion of the second gripping pad, and in a clamp configuration, the first gripping pad is in contact with the second gripping pad.

[0005] In addition to or instead of any of the embodiments described above, in the clamp configuration, the first gripping pad and the second gripping pad are configured to clamp the guide wire between the first gripping pad and the second gripping pad.

[0006] In place of or in addition to any of the embodiments described above, the first gripping pad and the second gripping pad are configured to apply force to the guide wire such that the guide wire is prevented from shifting longitudinally, rotating, or rotating while shifting longitudinally.

[0007] In addition to or instead of any of the embodiments described above, the operating member is coupled to the first gripping member and the second gripping member via one or more link mechanisms. In addition to or instead of any of the above embodiments, the operation of the actuating member shifts the guide wire brake between a non-clamped configuration and a clamped configuration.

[0008] In addition to or instead of any of the embodiments described above, the operating member is configured to be operated manually. In place of or in addition to any of the above embodiments, the system further comprises sensors provided along the guide wire brake.

[0009] In place of or in addition to any of the above embodiments, the sensor is configured to detect when the guide wire brake is positioned in a clamp configuration. Alternatively, or in addition to any of the above embodiments, a control system provided along the handlebars is further provided, wherein a sensor is configured to transmit a signal to the control system indicating that the guide wire brake is positioned in a clamp configuration.

[0010] In place of or in addition to any of the above embodiments, the device further comprises a drive shaft coupled to the distal end region of the handle. In place of or in addition to any of the above embodiments, the invention further comprises an atherectomy bar coupled to the distal end of the drive shaft.

[0011] Another exemplary atherectomy apparatus includes a handle having a distal end region, a proximal end region, and an internal chamber. The apparatus includes a drive shaft coupled to the distal end region of the handle, the drive shaft including an atherectomy bar provided along the distal end of the drive shaft. The apparatus also includes a guide wire brake including an actuating member coupled to a first gripping member and a second gripping member. The first and second gripping members are provided within the internal chamber of the handle, and at least a portion of the actuating member is positioned along the outer surface of the handle. Furthermore, the first and second gripping members are configured to shift between a non-clamped configuration and a clamped configuration.

[0012] In place of or in addition to any of the above embodiments, the first gripping member includes a first gripping pad, and the second gripping member includes a second gripping pad, wherein in a non-clamp configuration, at least a portion of the first gripping pad is spaced apart from at least a portion of the second gripping pad, and in a clamp configuration, the first gripping pad is in contact with the second gripping pad.

[0013] In addition to or instead of any of the embodiments described above, in the clamp configuration, the first gripping pad and the second gripping pad are configured to clamp the guide wire between the first gripping pad and the second gripping pad.

[0014] In place of or in addition to any of the embodiments described above, the first gripping pad and the second gripping pad are configured to apply force to the guide wire such that the guide wire is prevented from shifting longitudinally, rotating, or rotating while shifting longitudinally.

[0015] In addition to or instead of any of the embodiments described above, the operating member is coupled to the first gripping member and the second gripping member via one or more link mechanisms. In addition to or instead of any of the above embodiments, the operation of the actuating member shifts the guide wire brake between a non-clamped configuration and a clamped configuration.

[0016] In addition to or instead of any of the embodiments described above, the operating member is configured to be operated manually. An exemplary method for treating a tissue lesion includes advancing an atherectomy device onto the lesion on a guidewire, the atherectomy device including a handle having a distal end region, a proximal end region, and an internal chamber. The device also includes a drive shaft coupled to the distal end of the handle and an atherectomy bar coupled to the distal end of the drive shaft. The device also includes a guidewire brake including an actuating member coupled to a first gripping member and a second gripping member, the first and second gripping members being located within the internal chamber of the handle, and at least a portion of the actuating member positioned along the outer surface of the handle. The method also includes acting the actuating member so that the first and second gripping members clamp the guidewire between the first and second gripping members and rotate the atherectomy bar.

[0017] The above summary of some embodiments is not intended to describe each of the disclosed embodiments or any implementation of this disclosure. The following figures and detailed descriptions illustrate these embodiments more specifically.

[0018] This disclosure can be understood in more detail by considering the following detailed description together with the accompanying drawings.

Brief Description of the Drawings

[0019] [Figure 1] Diagram of an exemplary medical device. [Figure 2] Diagram showing a part of the medical device shown in FIG. 1. [Figure 3] Diagram showing the guide wire brake of the medical device shown in FIG. 1. [Figure 4] Diagram showing a part of the guide wire brake shown in FIG. 3. [Figure 5] Diagram showing a part of the guide wire brake shown in FIG. 3. [Figure 6] Exploded view of the guide wire brake shown in FIG. 3.

Modes for Carrying Out the Invention

[0020] Although the present disclosure is applicable to various modified forms and alternative forms, the details are shown in the drawings as examples and are described in detail. However, it should be understood that there is no intention to limit the present disclosure to the specific embodiments described. Rather, it is intended to include all modified forms, equivalents, and alternative forms within the spirit and scope of the present disclosure.

[0021] For the terms defined below, these definitions shall apply unless different definitions are given in the claims or elsewhere in this specification. In this specification, all numerical values are assumed to be modified by the term "about", whether explicitly indicated or not. The term "about" generally refers to a range of numbers that a person skilled in the art would consider to be equal to the recited numerical value (e.g., having the same function or result). In many cases, the term "about" may include numbers rounded to the nearest significant digit.

[0022] The description of a numerical range by endpoints includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). As used in this specification and the appended claims, the singular forms "a", "an", and "the" include the plural referents unless the context clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in the sense of "and / or" unless the context clearly dictates otherwise.

[0023] Note that references in this specification to "one embodiment", "some embodiments", "other embodiments", etc., indicate that the described embodiments may include one or more specific features, structures, and / or characteristics. However, such descriptions do not necessarily mean that all embodiments include the specific features, structures, and / or characteristics. Further, when a specific feature, structure, and / or characteristic is described in relation to one embodiment, it should be understood that such feature, structure, and / or characteristic may be used in relation to other embodiments whether or not explicitly described, unless the context clearly dictates otherwise.

[0024] The following detailed description should be read with reference to the drawings in which like elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, illustrate exemplary embodiments and are not intended to limit the scope of the present disclosure.

[0025] Many patients suffer from occlusion of arteries, other blood vessels, and / or tubules or other body lumens that can restrict the flow of bodily fluids (e.g., blood, bile, etc.). Occlusion can be partial occlusion, which reduces blood flow through the occluded portion of the vessel, or complete occlusion, which substantially blocks blood flow through the occluded vessel (e.g., chronic complete occlusion). Revascularization procedures involve creating or widening an opening through the occlusion using various devices that pass through the occlusion. Atherectomy is one technique that involves advancing a catheter with a cutting element through the occlusion to form or widen a passage through the occlusion. Ideally, the cutting element removes the occlusion without damaging the surrounding vessel wall and / or any stents previously implanted at the site of restenosis. However, in some cases, the cutting element may be manipulated and / or advanced to come into contact with the vessel wall and / or stents. Therefore, it may be desirable to use materials and / or design atherectomy devices that can remove the occlusion without damaging the surrounding vessels and / or any stents previously implanted at the site of restenosis. Furthermore, it may be desirable to design cutting elements that can effectively remove not only hard occluding materials such as calcified materials, but also softer occluding materials. The methods and systems disclosed herein may be designed to effectively excise occluding materials while overcoming at least some of the limitations of previous atherectomy devices.

[0026] Figure 1 shows an exemplary medical device system 10. The medical device system 10 may optionally include an atherectomy system. For example, the atherectomy system 10 may include a handle member 15 having a distal end region 11 and a proximal end region 13. The distal end region of the handle 15 may be coupled to a drive shaft 12. Furthermore, the system 10 may further include an end effector 14 coupled to the distal end of the drive shaft 12. The end effector 14 may optionally include an atherectomy bar.

[0027] In addition, Figure 1 shows that the medical device system 10 may include a housing 17. The housing 17 may include an internal chamber. In some examples, the medical device may also include a drive mechanism (not shown in Figure 1) located within the internal chamber of the housing 17. Furthermore, it can be understood that the drive mechanism may be adapted to rotatably operate the atherectomy bar 14 by the rotation of a drive shaft 12. For example, it can be understood that the drive mechanism may be designed to rotate the atherectomy bar 14, which is coupled to the distal end of the drive shaft 12, by rotating the drive shaft 12.

[0028] Furthermore, the atherectomy system 10 may include a control system (not shown in Figure 1) adapted to adjust the operation of the drive mechanism. In some cases, the atherectomy system 10 may include a user interface 18 that can be operationally coupled to the control system so that the user interface 18 can display information regarding the performance of the drive mechanism. This information may include one or more, for example, the instantaneous velocity of the drive mechanism, the instantaneous torque received by the atherectomy bar 14, etc. In some cases, the atherectomy system 10 may not include a user interface 18. In some cases, the atherectomy bar 14 may also be referred to as a cutting head or cutting member, or including a cutting head or cutting member, and these terms may be used interchangeably.

[0029] As shown in Figure 1, the distal end of the atherectomy bar 14 may optionally include an aperture (not shown in Figure 1) configured to allow the guidewire 16 to extend, and an internal cavity (e.g., lumen) of the atherectomy bar 14. Furthermore, the guidewire 16 may be able to extend through the lumen of the drive shaft 12 and enter the inner chamber of the housing 17. Furthermore, Figure 1 shows that the guidewire can extend through the inner chamber of the housing 17 and exit from the proximal end region 13 of the housing through an aperture 20 that penetrates the wall of the housing 17. In other words, the aperture 20 may extend across the wall of the housing 17 (from a position outside the handle 15 to a position inside the inner chamber of the housing 17).

[0030] As described above, atherectomy is a medical procedure that involves advancing a rotating cutting element (e.g., an atherectomy bar 14) through an occlusion to form or enlarge a passage through the occlusion. In some cases, it may be understood that a guidewire 16 can be positioned adjacent to the occlusion before the atherectomy bar 14 is advanced through the occlusion. For example, a clinician may manipulate the guidewire 16 so that it is positioned adjacent to the occlusion before the rotating atherectomy bar 14 is advanced through the occlusion. In other examples, a clinician may manipulate the guidewire 16 so that it is positioned across the occlusion. However, after the guidewire 16 is positioned (but before the rotating atherectomy bar 14 is advanced across the occlusion), the clinician may need to "lock" (e.g., fix) the guidewire 16 so that it cannot move (rotatably or longitudinally) relative to the handle 15. Preventing the guidewire 16 from moving (rotating or longitudinally) relative to the handle 15 may be necessary because it can provide a more stable guidewire passage through which the drive shaft 12 can advance. For patient safety, it may be necessary to lock the guidewire to prevent rotation. The rotating atherectomy bur through which the guidewire passes may rotate at speeds exceeding 200,000 revolutions per minute. If the guidewire is not securely locked and rotates with the atherectomy bur, the guidewire may begin to "bend," potentially causing damage (e.g., puncture or tear) to a vein or artery through which the atherectomy bur is rotating.

[0031] For this purpose, Figure 2 shows the proximal end region 13 of the handle 15 (for clarity, Figure 2 shows the handle 15 with the housing 17 removed, thereby exposing the internal components arranged along the proximal end region 13 of the handle 15). As shown in Figure 2, one of the components located within the inner chamber of the housing 17 may include a guide wire brake 22 (in some cases, it may be understood that the guide wire brake 22 may be called a guide wire lock or guide wire clamp). Figure 2 further shows a guide wire 16 extending through an aperture 21a located in the guide wire brake 22. It may be understood that the aperture 21a may be aligned with the aperture 20 described above with respect to Figure 1. As described above, the guide wire brake 22 may be located inside the handle 15 (e.g., within the inner chamber of the handle 15) and may be configured to reversibly clamp the guide wire 16 to prevent the guide wire 16 from moving during the operation of the atherectomy system 10.

[0032] As will be described in more detail below, the guide wire brake 22 may be designed to shift between an open (e.g., non-clamped) configuration and a closed (e.g., clamped) configuration. Furthermore, shifting the guide wire brake 22 between a clamped configuration (where the guide wire 16 is fixed and prevented from rotating and moving longitudinally) and a non-clamped configuration (where the guide wire 16 is free and can rotate and move longitudinally) can be achieved by sliding the actuarial member 28 along the top surface 29 of the guide wire brake 22. In other words, the guide wire brake 22 may be designed to operate (e.g., shift) between a non-clamped configuration and a clamped configuration.

[0033] Furthermore, in some examples, it may be understood that shifting the guide wire brake 22 between a non-clamped configuration and a clamped configuration may involve manually operating the actuator 28. In other words, the clinician operating the medical device 10 may manually shift (e.g., slide) the actuator from left to right or vice versa (e.g., with their own hands). This manual operation of the actuator 28 allows the guide wire brake 22 to be shifted between a non-clamped configuration and a clamped configuration. Designing the guide wire brake 22 to include a manual actuator 28 may be desirable because it allows the clinician to operate the brake independently of power. In other words, the clinician may be able to apply or release the brake 22 regardless of whether power is supplied to the medical device 10. If the clinician needs to detach the medical device 10 from the guide wire 16, the clinician can release the guide wire brake 22 from the guide wire 16 by manually operating the actuator 28.

[0034] Figure 3 shows the guide wire brake 22 described above. The guide wire brake 22 may include a first housing 26a, which is coupled to a second housing 26b. In some cases, the first housing 26a may be coupled to the second housing 26b in a clamshell configuration. The first housing 26a can be fixed to the second housing 26b by one or more pins, screws, bolts, etc.

[0035] As described above, the guide wire brake 22 may further include an actuation member 28 provided between the first housing 26a and the second housing 26b. The actuation member 28 may be designed to shift (e.g., slide, traverse, actuate, etc.) within a trajectory formed between the first housing member 26a and the second housing member 26b. As can be seen from Figure 1, the actuation member 28 may extend outside the housing 17 of the handle member 15. Placing the actuation member 28 outside the housing may allow a clinician to manually shift the actuation member 28 between a clamped configuration and an unclamped configuration as described above.

[0036] As described above, Figure 3 shows an aperture 21a extending into the first housing member 26a. In particular, Figure 3 shows an aperture 21a extending through the base portion 32a of the first housing member 26a. The base portion 32a may be designed so that when the base portion 32a is positioned within the inner chamber of the handle 15, the aperture 21a can be aligned with the aperture 20 extending through the housing 17.

[0037] Figure 3 further illustrates that in some examples, the guide wire brake 22 may include a sensor 24. The sensor 24 may be coupled to the guide wire brake 22 via a sensor housing 30. In other words, a portion of the sensor 24 may be located within the sensor housing 30, which is coupled to a first housing member 26a and a second housing member 26b. The sensor 24 may include a variety of different sensor configurations. For example, the sensor 24 may include a contact sensor, a pressure sensor, a force sensor, a light sensor, or any other suitable type of sensor.

[0038] Furthermore, it can be understood that the sensor 24 may be designed to communicate with a control system located within the handle 15. In some examples, the sensor 24 may be able to detect the state of the guide wire brake 22 and send a signal to the control system indicating whether the guide wire brake 22 is in a clamped or unclamped configuration. Furthermore, it can be understood that the user interface 18 may provide a visual display of the state of the guide wire brake 22.

[0039] Figure 4 shows a front view of the guide wire brake 22 with the first housing member 26a removed, exposing the internal components of the guide wire brake 22. It can be understood that Figure 4 shows the guide wire brake 22 in a non-clamped configuration. For example, Figure 4 shows the actuation member 28 sliding to its leftmost position relative to the second housing member 26b. In this position, the first gripping member 40a (including the first gripping pad 42a provided in the distal end region of the first gripping member 40a) can be separated from the second gripping member 40b (including the second gripping pad 42b provided in the distal end region of the second gripping member), thereby creating a space between at least a portion of the first gripping pad 42a and at least a portion of the second gripping pad 42b, which can allow the guide wire 16 to move freely between the first gripping pad 42a and the second gripping pad 42b. As described above, Figure 4 further shows a portion of the sensor 24 positioned between the second housing member 26b and the sensor housing 30.

[0040] In addition, it can be seen from Figure 4 that the guide wire 16 may extend through aperture 21b located within the second housing member 26b. Furthermore, aperture 21b may be aligned with aperture 21a (located in the first housing member 26a) and aperture 20 extending through the housing 17 (as described above). Aperture 21b may be positioned to perpendicularly align the guide wire 16 within the vertical plane of the first gripping pad 42a and the second gripping pad 42b. For example, it can be seen that the guide wire 16 may extend through the internal cavity of the housing 17, through aperture 21b, between the first gripping pad 42a and the second gripping pad 42b, and through both aperture 21a and aperture 20. As described above, apertures 21b, 21a, and 20 may be designed to position the guide wire 16 within the vertical plane between the first gripping member 42a and the second gripping member 42b.

[0041] Figure 4 further illustrates that the actuator 28 may be coupled to the first gripping pad 42a and the second gripping pad 42b via a series of linkage mechanisms. For example, Figure 4 shows that the actuator 28 may be coupled to the central link 34. As shown in Figure 4, the actuator 28 may include a slit 50, which may be configured to receive a pin 52 extending through it. The pin 52 may be coupled to the central link 34. As shown in Figure 4, the slit 50 is positioned at an angle to the horizontal axis of the central link 34, so that the actuator 28 can be operated from left to right (e.g., slide) to push the central link 34 downward. Furthermore, the pin 52 may also extend to a vertical channel 46 formed in the second housing member 26b, so that the central link 34 may be restricted to vertical movement. Thus, the actuator 28 can be operated from left to right (e.g., slide) to push the central link 34 vertically downward.

[0042] For this purpose, the central link 34 may be coupled to the first gripping member 40a and the second gripping member 40b via a series of linkage mechanisms 36a / 36b / 38a / 38b. It may be understood that the distal end regions of each first gripping member 40a and the second gripping member 40b may be coupled to a first gripping pad 42a and a second gripping pad 42b, respectively. Furthermore, each first gripping member 40a and the second gripping member 40b may be maintained under tension by a first spring 44a and a second spring 44b. In a clamp configuration, it may be understood that the first spring 44a and the second spring 44b provide an outward force which is converted into a compressive force applied to the guide wire 16 via the first gripping pad 42a and the second gripping pad 42b.

[0043] Figure 5 shows the guide wire brake 22 after the actuation member 28 has shifted (e.g., slid) from left to right relative to the second housing member 26b (in the direction indicated by arrow 48). Note that the actuation member 28 is shifted from left to right when viewed from the proximal end of the guide wire brake 22 (for example, when viewed from the proximal end when the guide wire brake 22 is positioned within the handle 15).

[0044] When the operating member 28 is slid from left to right, the central link mechanism 34 is pushed vertically downward (as described above), thereby causing the first gripping pad 42a to move toward the second gripping pad 42b via a series of link mechanisms 36a / 36b / 38a / 38b connected to both the first gripping member 40a and the second gripping member 40b. Although the guide wire 16 is not shown in Figure 5, it should be noted that Figure 5 shows the clamp configuration of the guide wire brake 22, and it should be understood that this clamp configuration positions the guide wire 16 between the first gripping pad 42a and the second gripping pad 42b.

[0045] Furthermore, it can be understood that Figure 5 shows that in the second configuration, the distal end 37b of the link mechanism 36b may contact the sensor 24. This point-to-point contact between the distal end 37b of the link mechanism 36b and the sensor 24 can be detected by the sensor 24. After detecting the contact, the sensor 24 can transmit a signal to the control system of the medical device 10. The signal may indicate that the guide wire brake 22 is positioned in a clamp configuration. Furthermore, this information may be displayed on the user interface 18 (shown in Figure 1).

[0046] Figure 6 shows an exploded view of the guide wire brake 22 described above. For example, Figure 6 shows a first housing member 26a, a second housing member 26b, an operating member 28, a central link mechanism 34, a sensor 24, a sensor housing 30, a first gripping member 40a, a second gripping member 40b, a first spring 44a, a second spring 44b, a first gripping pad 42a, a second gripping pad 42b, and connecting link mechanisms 36a / 36b / 38a / 38b. Furthermore, it can be understood that the aforementioned components can be connected to each other via a plurality of pins 60, clips 66, a first bolt 62, and a second bolt 64.

[0047] Materials that may be used in the medical device 10 or components of the medical device 10 disclosed herein may generally include those related to medical devices. For the sake of simplicity, the following description will refer to the medical device 10 or components of the medical device 10. However, this is not intended to limit the devices and methods described herein, and the description may apply to other similar devices disclosed herein.

[0048] The medical device 10 or its components may be made from 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 polymers include polytetrafluoroethylene (PTFE), ethylenetetrafluoroethylene (ETFE), fluoroethylene propylene (FEP), polyoxymethylene (POM, e.g., Delrin® available from DuPont), polyether block esters, polyurethane (e.g., Polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., Arnitel® available from DSM Engineering Plastics), ether or ester copolymers (e.g., butylene / poly(alkylene ether) phthalates and / or other polyester elastomers such as Hytrel® available from DuPont), polyamides (e.g., Durethan® or Elf Atochem available from Bayer).Available from Atochem: Cristamid®, elastomer polyamide, block polyamide / ether, polyether block amide (PEBA, available under the trade name PEBAX®, e.g.), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low-density polyethylene (e.g., REXELL®). Polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly-p-phenylene terephthalamide (e.g., Kevlar®), polysulfone, nylon, nylon-12 (EMS), American Glylon (EMS) Examples of suitable materials include Grilamid (registered trademark) available from American Grilon, perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials or mixtures, combinations, copolymers, polymer / metal composites thereof. In some embodiments, liquid crystal polymers (LCPs) can be blended into the sheath. For example, this mixture may contain up to about 6 percent LCP.

[0049] Some examples of suitable metals and metal alloys include stainless steels such as 304V, 304L, and 316LV stainless steel; mild steel; nickel-titanium alloys such as linear elastic and / or superelastic Nitinol; nickel-chromium-molybdenum alloys (e.g., UNS:N06625 such as Inconel® 625, UNS:N06022 such as Hastelloy® C-22, Hastelloy® C276, and other Hastelloy ( HASTELLOY (registered trademark) alloys, etc. (UNS:N10276), nickel-copper alloys (e.g., MONEL (registered trademark) 400, NICKELVAC (registered trademark) 400, NICORROS (registered trademark) 400, etc., UNS:N04400), nickel-cobalt-chromium-molybdenum alloys (e.g., MP35-N (registered trademark) etc., UNS:R30035), nickel-molybdenum alloys (e.g., HASTELLOY (registered trademark) alloy B2 (ALLOY Other nickel alloys such as UNS:N10665) (registered trademark B2), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS:R30003, such as ELGILOY (registered trademark), PHYNOX (registered trademark), etc.); platinum-enriched stainless steel; titanium; combinations thereof, etc., or any other suitable materials.

[0050] In at least some embodiments, part or all of the medical device 10 may also be imbued with radiopaque material, be fabricated from radiopaque material, or otherwise contain radiopaque material. Radiopaque material is understood to be a material that can produce a relatively high-intensity image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively high-intensity image helps the user of the medical device 10 to locate its position. Some examples of radiopaque materials include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, and polymer materials loaded with radiopaque fillers. Furthermore, other radiopaque marker bands and / or coils may also be incorporated into the design of the medical device 10 or its components to achieve the same result.

[0051] In some embodiments, a certain degree of magnetic resonance imaging (MRI) compatibility is imparted to the medical device 10 or its components. For example, the medical device 10 or a part thereof may be made of a material that does not substantially distort the image and does not produce substantial artifacts (e.g., gaps in the image). For example, certain ferromagnetic materials may not be suitable because they can produce artifacts in MRI images. The medical device 10 or a part thereof may also be made from materials that can be imaged by an MRI machine. Some materials exhibiting these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS:R30003 such as ELGILOY® and PHYNOX®), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035 such as MP35-N®), nitinol, and others.

[0052] It should be understood that this disclosure is illustrative in many respects. Modifications in detail, particularly in terms of shape, size, and process arrangement, may be made without exceeding the scope of this disclosure. This may include, to an appropriate degree, the use of any of the features of one exemplary embodiment used in other embodiments. The scope of this disclosure is, of course, defined in the language in which the appended claims are expressed.

Claims

1. It is a medical device, A handle having a distal end region, a proximal end region, and an internal chamber, A guide wire brake including an operating member coupled to a first gripping member and a second gripping member, the guide wire brake being configured to shift between a non-clamp configuration and a clamp configuration, A sensor coupled to the guide wire brake, configured to detect whether the guide wire brake is in the non-clamped configuration or the clamped configuration, Equipped with, The first gripping member and the second gripping member are provided within the internal chamber of the handle. At least a portion of the operating member is arranged along the outer surface of the handle, The first gripping member is connected to the operating member by a rotatable first link mechanism, and the second gripping member is connected to the operating member by a rotatable second link mechanism different from the rotatable first link mechanism. The first gripping member and the second gripping member are configured to shift between the non-clamp configuration and the clamp configuration. A medical device in which the operating member is coupled to a central link, and the central link is coupled to the first gripping member and the second gripping member, respectively, via a series of linkage mechanisms.

2. The medical device according to claim 1, wherein the first gripping member includes a first gripping pad, and the second gripping member includes a second gripping pad, and in the non-clamp configuration, at least a portion of the first gripping pad is spaced apart from at least a portion of the second gripping pad, and in the clamp configuration, the first gripping pad is in contact with the second gripping pad.

3. The medical device according to claim 2, wherein the clamp configuration is configured such that the first gripping pad and the second gripping pad clamp a guide wire between the first gripping pad and the second gripping pad.

4. The medical device according to claim 2 or 3, wherein the first gripping pad and the second gripping pad are configured to apply force to the guide wire such that the guide wire is prevented from shifting and rotating in the longitudinal direction, or from shifting and rotating in the longitudinal direction.

5. The medical device according to any one of claims 1 to 4, wherein the operation of the operating member shifts the guide wire brake between the non-clamp configuration and the clamp configuration.

6. The medical device according to any one of claims 1 to 5, wherein the operating member is configured to be operated manually.

7. The medical device according to claim 1, further comprising a control system provided along the handle, wherein the sensor is configured to transmit a signal to the control system indicating that the guide wire brake is positioned in the clamp configuration.

8. The medical device according to any one of claims 1 to 7, further comprising a drive shaft coupled to the distal end region of the handle.

9. The medical device according to claim 8, further comprising an atherectomy bar coupled to the distal end of the drive shaft.

10. It is an atherectomy device, The atherectomy apparatus comprises a handle having a distal end region, a proximal end region, and an internal chamber. The atherectomy apparatus comprises a drive shaft coupled to the distal end region of the handle, the drive shaft includes an atherectomy bar provided along the distal end of the drive shaft, The atherectomy apparatus includes a guide wire brake, which includes an actuating member coupled to a first gripping member and a second gripping member, and the guide wire brake is configured to shift between a non-clamped configuration and a clamped configuration. The atherectomy device includes a sensor coupled to the guide wire brake, the sensor being configured to detect whether the guide wire brake is in the non-clamped configuration or the clamped configuration. The first gripping member and the second gripping member are provided within the internal chamber of the handle. The first gripping member is connected to the operating member by a rotatable first link mechanism, and the second gripping member is connected to the operating member by a rotatable second link mechanism different from the rotatable first link mechanism. At least a portion of the operating member is arranged along the outer surface of the handle, The first gripping member and the second gripping member are configured to shift between the non-clamp configuration and the clamp configuration. An atherectomy apparatus in which the operating member is coupled to a central link, and the central link is coupled to the first gripping member and the second gripping member, respectively, via a series of linkage mechanisms.

11. The atherectomy apparatus according to claim 10, wherein the first gripping member includes a first gripping pad, and the second gripping member includes a second gripping pad, and in the non-clamp configuration, at least a portion of the first gripping pad is spaced apart from at least a portion of the second gripping pad, and in the clamp configuration, the first gripping pad is in contact with the second gripping pad.

12. The atherectomy apparatus according to claim 11, wherein the clamp configuration is configured such that the first gripping pad and the second gripping pad clamp a guide wire between the first gripping pad and the second gripping pad.

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