Preformed Medical Devices

Abstract

A medical device is provided that includes a catheter body defining a proximal segment, a distal segment, and a lumen extending through the proximal and distal segments. [Solution] The distal segment (16) includes a pre-shaped segment having a first geometric configuration in an unloaded state and a second geometric configuration in a loaded state, and in the first geometric configuration, the pre-shaped segment includes a 180-degree arc having a radius of at least 1 mm, the center of the arc being laterally offset from the longitudinal axis of the proximal segment of the catheter body (12).

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application is a joint venture of "PRE-SHAPED MEDICA" filed on May 22, 2020. No. 63 / 028,803, entitled "DEVICES WITH MICRO-ELECTRONIC MICRO-ELECTRONIC DEVICES," Priority is claimed and is incorporated herein by reference in its entirety.

[0002] STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT Not applicable

[0003] FIELD OF THE DISCLOSURE The present disclosure relates to intravascular medical devices and methods of use thereof. [Background technology]

[0004] Intravascular catheters are used in a variety of ways to advance and position therapeutic devices at target locations within the body. It is used in a variety of different therapeutic and diagnostic procedures. Summary of the Invention [Problem to be solved by the invention]

[0005] Reaching such a target location makes access difficult for typical catheters. This includes navigating tortuous vascular pathways with extreme turns or bending dimensions. The present disclosure provides improved navigation and access to such tortuous routes. This provides an example of a preformed vascular device that is flexible and maneuverable enough to be used in a surgical procedure. [Means for solving the problem]

[0006] The present disclosure provides a proximal segment, a distal segment, and a and a catheter body defining a lumen therethrough, The device has a first geometric configuration in an unloaded state and a second geometric configuration in a loaded state. a first geometric configuration including a pre-formed segment; includes a 180 degree arc having a radius of at least 1 mm, the center of the arc being located at the catheter It is laterally offset from the longitudinal axis of the proximal segment of the body. The segment may comprise a 180 degree arc having a radius of at least 2 mm. The shaped segments were able to change from a first geometric configuration to a second geometric configuration under loads of 6gF to 14gF. The preformed segments can be transferred to the mechanical configuration under a load of 9gF to 11gF. The distal segment may transition from the first geometric configuration to the second geometric configuration. The distal segment may include an atraumatic distal tip. That's fine.

[0007] a proximal segment, a distal segment, and a lumen passing through the proximal and distal segments; and a distal segment, the distal segment being in a non-load-bearing state. and a preformed segment having a first geometric configuration in a loaded state and a second geometric configuration in a loaded state. and wherein in the first geometric configuration, the preformed segment comprises at least a 180 degree arc having a radius of 2 mm, the center of the arc being located at the proximal segment of the catheter body; The catheter body extends proximally of the distal segment. The intermediate segment may include a radius of curvature of 20 mm to 30 mm. The intermediate segment may define a diameter. The intermediate segment may have a length between 5 mm and 15 mm. The segments may have an arc length of between 30 degrees and 60 degrees. The device may transition from the first geometric configuration to the second geometric configuration under a load of 6 gF to 14 gF. stomach.

[0008] a proximal segment, a distal segment, and a lumen passing through the proximal and distal segments; Another medical device is provided that includes a catheter body defining a distal segment. a preformed structure having a first geometric configuration in a weighted state and a second geometric configuration in a loaded state; and wherein the preformed segments in a first geometric configuration are at least Each includes a 180 degree arc having a radius of 2 mm, the center of the arc being located at the proximal end of the catheter body. The catheter body is laterally offset from the longitudinal axis of the distal segment. and a middle segment extending proximally from the distal end of the stent, the middle segment having a bend of 20 mm to 30 mm. The intermediate segment may have a length of 10 mm to 20 mm. The segments may have an arc length of between 45 degrees and 90 degrees. The device may transition from the first geometric configuration to the second geometric configuration under a load of 6 gF to 14 gF. stomach.

[0009] a proximal segment, a distal segment, and a lumen passing through the proximal and distal segments; and a distal segment, the distal segment being in a non-load-bearing state. a nonlinear preformed structure having a first geometric configuration in a loaded state and a second geometric configuration in a loaded state; a catheter body including a distal segment having a cut pattern therein; The tube includes a cut pattern having a width of 0.03 mm to 0.05 mm. A plurality of cuts having a longitudinal gap of 0.02 mm to 0.03 mm between each of the plurality of cuts. The preformed segments are designed to withstand a load of 6gF to 14gF. The cut pattern transitions from a first geometric configuration to a second geometric configuration. A post height of 0.08 mm to 0.12 mm may be defined between each of the cuts. The turns define a pitch of 0.05mm to 0.08mm for each of the multiple cuts. Good too.

[0010] In a first geometric configuration, the pre-formed segments have a radius of at least 1 mm. The catheter body may include a 180 degree arc extending through the proximal segment of the catheter body, the center of the arc being The preformed segments may be laterally offset from the longitudinal axis. Both may include a 180 degree arc with a radius of 2 mm.

[0011] In a first geometric configuration, the pre-formed segments have a radius of at least 2 mm. The catheter body may include a 180 degree arc extending through the proximal segment of the catheter body, the center of the arc being It may be collinear with the longitudinal axis.

[0012] In a first geometric configuration, the pre-formed segments have a radius of at least 2 mm. The catheter body may include a 180 degree arc extending through the proximal segment of the catheter body, the center of the arc being It may be laterally offset from the longitudinal axis.

[0013] The preformed segments were subjected to a load of 9gF to 11gF from a first geometric configuration to a second geometric configuration. At least a portion of the distal segment may be radiopaque. The distal segment may include an atraumatic distal tip.

[0014] Proximal segment, proximal segment and distal segment, proximal segment and distal segment A medical device is provided that includes a catheter body defining a lumen through a distal segment. The component has a first geometric configuration in an unloaded state and a second geometric configuration in a loaded state. It includes linear preformed segments, the distal segment having a cut pattern therein. The cut patterns each have a width of 0.03 mm to 0.05 mm. Multiple cuts and longitudinal gaps of 0.01mm to 0.03mm between each of the multiple cuts The preformed segments are subjected to a first load of 5 gF to 7 gF. The cut pattern transitions from one geometric configuration to a second geometric configuration. The cut pattern may define a post height of 0.06 mm to 0.15 mm between each other. A pitch of 0.05 mm to 0.07 mm may be defined for each of the plurality of cuts.

[0015] The catheter body may include a first tube segment proximal to the distal segment. The first tube segment has a cut pattern therein, and the cut pattern is cut A plurality of cuts forming a spiral cut, each cut being 0.03 mm to 0.05 mm. The plurality of cuts have a width of 0.03 mm to 0.04 mm, and the distance between each of the plurality of cuts is 0.03 mm to 0.04 mm. The uncut width in the longitudinal direction is 0.08mm to 0.12m between each of the cuts. The cut pattern of the first tube segment defines a plurality of cuts. A pitch of 0.06 mm to 0.09 mm may be defined for each of the slots.

[0016] The catheter body includes a second tube segment proximal to the first tube segment. the second tube segment may have a cut pattern therein, and the cut pattern A plurality of cuts forming a segmented spiral cut, each cut being 0.03 mm A plurality of cuts having a width of 0.05 mm and 0.06 mm between each of the plurality of cuts. ~0.07mm longitudinal uncut width and 0.08mm between each of the multiple cuts~ The cut pattern for the second tube segment defines a post height of 0.12 mm. A pitch of 0.09 mm to 0.11 mm may be defined for each of the plurality of cuts.

[0017] A more complete understanding of the present disclosure and its attendant advantages and features may be obtained by reading the following detailed description in conjunction with the accompanying drawings. With this in mind, it will be more readily understood by reference to the following detailed description. [Brief explanation of the drawings]

[0018] [Figure 1A] FIG. 1A is a perspective view of a distal segment of one example of a medical device constructed in accordance with the principles of the present disclosure. [Figure 1B] FIG. 1B is a side view of the medical device shown in FIG. 1A. [Figure 2A] FIG. 2A is a perspective view of a distal segment of an example medical device constructed in accordance with the principles of the present disclosure. [Figure 2B] FIG. 2B is a side view of the medical device shown in FIG. 2A. [Figure 3A] FIG. 3A is a perspective view of a distal segment of an example medical device constructed in accordance with the principles of the present disclosure. [Figure 3B] FIG. 3B is a side view of the medical device shown in FIG. 3A. [Figure 4A] FIG. 4A is a perspective view of a distal segment of an example medical device constructed in accordance with the principles of the present disclosure. [Figure 4B] FIG. 4B is a side view of the medical device shown in FIG. 4A. [Figure 5]FIG. 5 is a perspective view of a distal segment of an example medical device constructed in accordance with the principles of the present disclosure. [Figure 6A] FIG. 6A illustrates an example of a portion of a catheter body structure in accordance with the principles of the present disclosure. [Figure 6B] FIG. 6B is a more detailed view of the catheter body of FIG. 6A. [Figure 6C] FIG. 6C is another view of the catheter body shown in FIG. 6A. [Figure 7A] FIG. 7A illustrates an example of use of a medical device constructed in accordance with the principles of the present disclosure. [Figure 7B] FIG. 7B illustrates an example of use of a medical device constructed in accordance with the principles of the present disclosure. [Figure 7C] FIG. 7C illustrates an example of use of a medical device constructed in accordance with the principles of the present disclosure. [Figure 7D] FIG. 7D illustrates an example of use of a medical device constructed in accordance with the principles of the present disclosure. [Figure 7E] FIG. 7E illustrates an example of use of a medical device constructed in accordance with the principles of the present disclosure. [Figure 8A] FIG. 8A illustrates an example of use of a medical device constructed in accordance with the principles of the present disclosure. [Figure 8B] FIG. 8B illustrates an example of use of a medical device constructed in accordance with the principles of the present disclosure. [Figure 9A] FIG. 9A illustrates an example of use of a medical device constructed in accordance with the principles of the present disclosure. [Figure 9B] FIG. 9B illustrates an example of use of a medical device constructed in accordance with the principles of the present disclosure. [Figure 10] FIG. 10 is a diagram illustrating an example radiopaque coating region of an example medical device constructed in accordance with the principles of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0019] The present disclosure provides intravascular medical devices and methods of use thereof. In particular, the present disclosure provides access to vascular side branches or other vascular passageways that have sharp turns and / or small radii due to the possibility of The present invention provides a preformed medical device that can assist in access and crossing.

[0020] Referring now to the drawings, FIGS. 1A-5B show a method for manufacturing a semiconductor device in accordance with the principles and advantages disclosed herein. 1 shows an example of an intravascular medical device 10, such as a catheter, configured with a catheter. used in interventional cardiology to evaluate and / or treat vascular defects or conditions and intravenously in combination with one or more other devices as disclosed herein. The device 10 is generally a minimally invasive device that can be introduced and operated from outside the patient. sufficient to be manipulated, traverse the vasculature, and be positioned in proximity to the area to be evaluated or treated. The catheter includes an elongated catheter body 12 having length, flexibility, and torque characteristics. Body 12 generally connects to and / or is connected to a hub or other component external to the patient (not shown). The catheter includes a proximal segment 14 that can terminate at a distal end, and a distal segment 16. The distal body 12 further includes a lumen 18 extending therethrough and exiting the distal segment 16. The lumen 18 may include or define a guidewire and / or catheter body. 12 has a diameter sufficient to allow introduction of one or more other medical instruments or devices therethrough.

[0021] An additional feature of the device 10 and catheter body 12 is the "MODULAR VASCULAR" No. 15 / 726,024, entitled "U.S. Patent Application No. 15 / 726,024" (U.S. Patent Application No. 15 / 726,024), Publication No. 2018 / 0093070) and "VARIABLE FLEXIBILIT U.S. Patent Application No. 16 / 2009 entitled "Y CATHETER SUPPORT FRAME" No. 55,141 (U.S. Patent Application Publication No. 2019 / 0160259), the entire contents of which are incorporated herein by reference.

[0022] The distal segment 16 of the device 10 may be configured to aid in accessing or traversing certain vasculature. The method includes one or more pre-formed segments to provide the desired geometry for the When the device 10 is in a "neutral" or no-load configuration / state, it may and may include or define preformed segments of, as described herein. , for example, routing one or more medical devices or instruments through the device 10. When placed under a certain threshold force level of load or strain, which may include It may be transitionable to a configuration / state or shape.

[0023] In the example shown in FIGS. 1A-1B, the distal segment 16 is substantially the length of the catheter body 12. having a center of radius "R" offset from the longitudinal axis 20 of the straight portion substantially This pre-shaped distal segment 16 defines a semi-circular shape. %) radius and / or an arc length of about 180 degrees (+ / - 15%). can be provided.

[0024] In the example shown in FIGS. 2A-2B, the distal segment 16 is substantially the length of the catheter body 12. having a center of radius "R" offset from the longitudinal axis 20 of the straight portion substantially This pre-shaped distal segment 16 defines a semi-circular shape. %) radius and / or an arc length of about 180 degrees (+ / - 15%). can be provided.

[0025] In the example shown in FIGS. 3A-3B, the distal segment 16 is substantially A substantially semicircular shape having a center of radius "R" substantially coaxial with the longitudinal axis 20 of the straight portion This pre-shaped distal segment 16 defines a shape of approximately 2 mm (+ / - 15%). and / or provide an arc length of about 180 degrees (+ / - 15%). The device 10 may be implemented between the center of curvature of the segment 16 and the longitudinal axis 20. curved from the longitudinal axis 20 to provide qualitatively collinear alignment; Alternatively, it may include an intermediate segment 19 that is at least partially offset. The segment 19 can have a length of, for example, about 5 mm to about 15 mm, and can be about 20 mm. It can define a radius of curvature of about 30 mm and / or an arc length of about 30 degrees to about 60 degrees. It may have a thickness.

[0026] In the example shown in FIGS. 4A-4B, the distal segment 16 is substantially having a center of radius "R" offset from the longitudinal axis 20 of the straight portion substantially The distal tip or end 22 of the device 10 defines a semicircular shape such that the distal tip or end 22 of the device 10 is The preformed distal segment is substantially collinear or coaxial with the axis 20. The ridge 16 may define a radius of about 2 mm (+ / - 15%) and / or a radius of about 18 mm. The device 10 can provide an arc length of 0 degrees (+ / - 15%). longitudinal axis 20 to provide substantially collinear alignment with longitudinal axis 2 intermediate segment 19 that is curved or at least partially offset from 0 The intermediate segment 19 may have a length of, for example, about 10 mm to about 20 mm. and may define a radius of curvature of about 20 mm to about 30 mm, and / or may define an angle of about 45 degrees to about It may have an arc length of about 90 degrees.

[0027] In the example shown in FIG. 5, the distal segment 16 is a substantially straight portion of the catheter body 12. Define a substantially semicircular shape having a center of radius "R" substantially coaxial with the longitudinal axis 20 The preformed first segment 16a has a first segment 16a. It is possible to define a radius R1 of about 0.5-3 mm, preferably 2 mm (+ / - 15%). , and / or may provide an arc length of about 180 degrees (+ / - 15%). The segment 16 also includes a second segment 16b extending from the first segment 16a. The second segment 16b may be about 0.25 mm to 6 mm, preferably 3 mm (+ + / - 15%) and / or define a radius R2 of about 10 degrees to 60 degrees (+ / - 15%). The apparatus 10 defines an arc shape that may provide an arc length of 16a. To provide substantially collinear alignment between the center of gravity and the longitudinal axis 20, A middle segment that is curved or at least partially offset from the manual axis 20 The intermediate segment 19 may include a length of, for example, about 5 mm to about 15 mm. and may define a radius of curvature of about 20 mm to about 30 mm; and / Or it may have an arc length of about 30 degrees to about 60 degrees.

[0028] The above-described example medical device 10 and associated dimensions may vary depending on different anatomies and / or different May be modified for different uses to accommodate and / or suit use in patients. can.

[0029] The preformed segment(s) described herein may be formed in the disclosed geometries. The present invention can be configured in a variety of ways to provide the above configurations and variations thereof. For example: The distal segment may be primarily or alternatively made of a shape memory alloy such as a nickel-titanium alloy or other material. It may be partially constructed and may be heat treated to form one or more parts of the device as desired. Accordingly, one or more varying degrees of flexibility and / or set configurations along the length of the device 10 may be provided. Such structures may also and / or alternatively provide, for example, one or more A plurality of patterns may be cut into the metal tube to form one or more patterns in the catheter body 12. providing varying degrees of flexibility and / or shape along the length of the device 10 as desired; This may include:

[0030] When subjected to forces or loads associated with intravascular or other medical procedures and procedures, the medical device 10 Contains sufficient stiffness along its length to substantially resist axial compression and elastic deformation. The pre-shaped or geometrically biased configuration of the device 10 may also be "neutral." or from its primary pre-formed configuration when in an unloaded state / configuration, within a certain threshold. Secondary altered geometric configuration or shape when placed under a force level load or strain The threshold force level can be, for example, determined by one or more medical devices via the device 10. The force may include the force that the medical device 10 is subjected to when routing a medical device or instrument. 1, the preformed configuration of the medical device 10 allows for routing of a guidewire through the lumen 18 of the device. 10, thereby providing the device 10 with the contour (or lack thereof) of a guidewire extending therethrough. This can be overcome by removing the preformed portion(s) of the medical device 10. The segment is preformed so that the guidewire routed through the device 10 is It may be flexible enough to overcome the configuration, but may also have pre-(one or more) The shaped segments allow manipulation of the proximal end of the device 10 by the physician to accommodate a sudden turn of the patient. or be rigid enough to be able to navigate tortuous anatomical structures. It must be.

[0031] In one example, the preformed segment(s) of the medical device 10 may be approximately 6 grams. The shape retention threshold can be between about 14 gF and 10 gF. The force or load exceeds the predetermined value, causing the preformed segment to change shape, i.e., The shaped configuration is transitioned to a substantially linear shape or otherwise.

[0032] The desired stiffness of the medical device may be determined by one or more of the device's parameters, including, for example, wall thickness, cut pattern, etc. This can be achieved by varying several properties.

[0033] The cut pattern for the catheter body and preformed segment(s) is , including a plurality of cuts 24 that are substantially uniform along one or more lengths or zones thereof. Examples of such a cut pattern are shown in FIGS. 6A and 6B. a longitudinal uncut width 28 between the slot segments to form an interrupted helical configuration; and / or the strut height 30 between cuts to connect the uncut portions of the pattern (e.g. , the uncut length between successive partial spiral cuts), as well as the pitch distance 3 2 (e.g., the cut traverses to complete one revolution around the circumference of the catheter body, The length along the longitudinal axis of the catheter body 12 may also include the length of the catheter body 12.

[0034] Referring now to FIG. 6C, the catheter body 12 of the medical device 10 may be configured to vary the flexibility of the device. One or more cuts may be included along the length of the catheter body 12 to provide a uniform For example, the catheter body may include a distal segment 16 and a distal A first zone ("Zone 1") may include the edge 22. A second zone ("Zone 2") may include the edge 22. ") may extend proximally from Zone 1, and a third zone ("Zone 3") may extend proximally from Zone 2 and may include a proximal segment 14. The zones of the catheter body 12 are: It is possible to provide an increase in flexibility from the proximal segment 14 to the distal segment 16, and each The zones provide the desired torque, flexibility, and pre-shaped characteristics described herein. To achieve this, multiple cuts (e.g., cut width, uncut width, pitch) are required compared to other zones. This may include variations in the characteristics of the device (e.g., temperature).

[0035] In one example, the medical device 10 has a cut width 26 of about 0.03 mm to about 0.05 mm. A catheter having a first zone with a plurality of cuts 24 characterized by intermittent spiral cuts. The first zone may include a thermocouple body 12, preferably about 0.04 mm. The plurality of cuts 24 includes an uncut width 28 of between about 0.02 mm and about 0.03 mm. The first zone may have a thickness of about 0.024 mm, preferably about 0.024 mm. 4 may include a post height 30 between about 0.08 mm and about 0.12 mm, preferably The plurality of cuts 24 in the first zone may be about 0.05 mm. The pitch 32 may be between about 0.08 mm and about 0.064 mm, preferably about 0.064 mm. This first zone may have a shape retention threshold of about 9 gF to about 11 gF.

[0036] Continuing with this example of an exemplary medical device, the second zone having a plurality of cuts 24 is approximately The cut width 26 is between 0.03 mm and about 0.05 mm. The thickness of the second zone may be approximately 0.04 mm. The number of cuts 24 includes an uncut width 28 between about 0.03 mm and about 0.04 mm. The plurality of cuts 24 in the second zone may be about 0.036 mm, preferably about 0.036 mm. may include a post height 30 between about 0.08 mm and about 0.12 mm, preferably The plurality of cuts 24 in the first zone may be about 0.06 mm. The pitch 32 may be about 0.09 mm or less, and preferably about 0.076 mm or less. good.

[0037] The third zone having a plurality of cuts 24 has cuts of about 0.03 mm to about 0.05 mm. It may feature an intermittent spiral cut having a width 26, preferably about 0.04 m The plurality of cuts 24 in the third zone may be about 0.06 mm to The uncut width 28 may be between about 0.07 mm and preferably about 0.062 mm. The plurality of cuts 24 in the third zone may be about 0.08 mm to about 0.1 The post height 30 may be between 2 mm and preferably about 0.105 mm. The plurality of cuts 24 in the third zone have a pitch 32 of about 0.09 mm to about 0.11 mm. It may include, and may preferably be about 0.102 mm.

[0038] In another example, the medical device 10 has a cut width 26 of about 0.03 mm to about 0.05 mm. The cutter has a first zone having a plurality of cuts 24 characterized by intermittent spiral cuts. The catheter body 12 may be preferably about 0.04 mm. The plurality of cuts 24 in the groove are uncut between about 0.01 mm and about 0.03 mm. The plurality of cuts 24 in the first zone may include a width 28. The plurality of cuts 24 in the first zone may include a width 28 of about 0.06 mm to about 0. The plurality of cuts 24 in the first zone may include a post height 30 of between about 0.15 mm. The first region may include a pitch 32 between 0.05 mm and about 0.07 mm. It may have a shape retention threshold of 5 gF to about 7 gF.

[0039] Continuing with this example of an exemplary medical device, the second zone having a plurality of cuts 24 is approximately The cut width 26 is between 0.03 mm and about 0.05 mm. The thickness of the second zone may be approximately 0.04 mm. The number of cuts 24 includes an uncut width 28 between about 0.03 mm and about 0.04 mm. The plurality of cuts 24 in the second zone may be about 0.036 mm, preferably about 0.036 mm. may include a post height 30 between about 0.08 mm and about 0.12 mm, preferably The plurality of cuts 24 in the first zone may be about 0.06 mm. The pitch 32 may be about 0.09 mm or less, and preferably about 0.076 mm or less. good.

[0040] The third zone having a plurality of cuts 24 has cuts of about 0.03 mm to about 0.05 mm. It may feature an intermittent spiral cut having a width 26, preferably about 0.04 m The plurality of cuts 24 in the third zone may be about 0.06 mm to The uncut width 28 may be between about 0.07 mm and preferably about 0.062 mm. The plurality of cuts 24 in the third zone may be about 0.08 mm to about 0.1 The post height 30 may be between 2 mm and preferably about 0.105 mm. The plurality of cuts 24 in the third zone have a pitch 32 of about 0.09 mm to about 0.11 mm. It may include, and may preferably be about 0.102 mm.

[0041] In another example, the medical device 10 has a cut width 26 of about 0.03 mm to about 0.05 mm. The cutter has a first zone having a plurality of cuts 24 characterized by intermittent spiral cuts. The catheter body 12 may be preferably about 0.04 mm. The plurality of cuts 24 in the groove are uncut between about 0.01 mm and about 0.03 mm. The plurality of cuts 24 in the first zone may have a width 28. The plurality of cuts 24 in the first zone may have a width 28 of from about 0.059 mm to about 0. The plurality of cuts 24 in the first zone may include a post height 30 between about 0.14 mm. The first region may include a pitch 32 of between 0.05 mm and about 0.07 mm. It may have a shape retention threshold of about 6 gF to about 8 gF.

[0042] Continuing with this example of an exemplary medical device, the second zone having a plurality of cuts 24 is approximately The cut width 26 is between 0.03 mm and about 0.05 mm. The thickness of the second zone may be approximately 0.04 mm. The number of cuts 24 includes an uncut width 28 between about 0.03 mm and about 0.04 mm. The plurality of cuts 24 in the second zone may be about 0.036 mm, preferably about 0.036 mm. may include a post height 30 between about 0.08 mm and about 0.12 mm, preferably The plurality of cuts 24 in the first zone may be about 0.06 mm. The pitch 32 may be about 0.09 mm or less, and preferably about 0.076 mm or less. good.

[0043] The third zone having a plurality of cuts 24 has cuts of about 0.03 mm to about 0.05 mm. It may feature an intermittent spiral cut having a width 26, preferably about 0.04 m The plurality of cuts 24 in the third zone may be about 0.06 mm to The uncut width 28 may be between about 0.07 mm and preferably about 0.062 mm. The plurality of cuts 24 in the third zone may be about 0.08 mm to about 0.1 The post height 30 may be between 2 mm and preferably about 0.105 mm. The plurality of cuts 24 in the third zone have a pitch 32 of about 0.09 mm to about 0.11 mm. It may include, and may preferably be about 0.102 mm.

[0044] The device 10 may be round and / or may be constructed from a relatively soft or pliable material. The device 10 may include a distal tip having a tapered, atraumatic profile. Portions may be radiopaque and / or aid in medical imaging of the device during the procedure. The radiopaque features may include, for example, tangential Inclusion of tungsten, bismuth, and / or barium sulfate in one or more components of the device This can be achieved by injecting the device 10 with the following: It may include one or more polymer liners or coatings on its surface.

[0045] 7A-7E, an exemplary method of use of device 10 is shown. For example, FIG. 6A illustrates a primary pathway 5, which may include a blood tube segment or other physiological pathway. 1 shows the distal segment 16 of the device 10 positioned at the distal end of the guidewire 52. 0 and extends from the distal end of the device 10. The distal segment 16 of the device 10 contours to the curvature (or lack thereof) of the guidewire. As such, it is sufficient to overcome the pre-formed biased geometry of the medical device 10.

[0046] The device 10 and guidewire 52 then make a "U" turn by manipulating the guidewire 52. or other sharp corners that may exceed 90 degrees. blood tubing with small radii or other angled approaches that are inaccessible to the The second pathway 54, which may include a segment or other physiological pathway, is accessed. can be made.

[0047] For further routing or access of guidewires and medical devices, the device 10 and When the guide wire 52 is positioned adjacent to the second passage 54, the guide wire 52 is As shown in Figures 6B-6D, the pre-shaped distal segment 16 of the device 10 rotates its shape. It may be possible to retreat a sufficient distance within the device 10 to allow recovery. The preformed curve of the distal segment 16 then guides the guidewire 14 through the distal segment 16, as shown in FIG. 6E. 10 into the second path 54 a sufficient distance to extend the wire from the device 10 into the second path 54. The device 10 may then be removed from the guidewire 52. Other devices may be routed in a second path along guidewire 52, and / or other The device is passed through the lumen 18 of the device 10 into a second passageway 54 for subsequent use. That's fine.

[0048] 8A-8B, an exemplary use of the example of device 10 shown in FIGS. 3A-4B is shown. In the illustrated example, the intermediate segment 19 and the distal segment 20 of the device 10 are The geometry of the port 16 may be a small radius or other angled approach, as shown in FIG. 8A. Facilitates navigation and access to secondary vascular pathways / branching 54 with distal-most Once end 22 is positioned within or near secondary pathway 54, guidewire 52 may be positioned as shown in FIG. 8B. 5, the guide 54 can extend through the catheter body 12 and into the secondary passageway 54. The axial force directed along the catheter body 12 while extending the wire 52 is indicated by the arrows in FIG. 8B. As shown, portions of the intermediate and / or distal segments 16 may be connected to the primary pathway 50 and the secondary pathway 52. Shifting the shape and / or position of the device 10 so that it abuts the vasculature wall surrounding the passageway 54 This contact allows the guidewire 52 to pass from the distal end 22 into the secondary pathway 54. movement of the distal segment 16 so as not to cause it to retract from the secondary pathway 54 and lose its position. Provides fixed backup support at the location of the distal segment 16. Alternatively, a preformed The fixation of the device 10 by the segment is achieved by introducing the guide wire 52 into the second passage 54. resists any recoil force imparted by

[0049] 9A-9B illustrate an exemplary method of use of the example device 10 shown in FIG. In the illustrated example of FIG. 9A, as well as the resistance provided to the retraction of the device from the secondary path 54, The geometry of the intermediate segment 19 and distal segment 16 of the device 10 may be small radius or Navigate and access secondary vascular pathways / branchings 54 with other oblique approaches. When the distal-most end 22 is positioned within or near the secondary passageway 54, the guidewire The ear 52 extends through the catheter body 12 into a secondary passageway 54, as shown in FIG. 9B. The guide wire 52 is guided along the catheter body 12 while extending. The axial force is applied to the intermediate and / or distal segments 16 as shown by the arrows in FIG. 9B. The device 10 is configured so that the primary and secondary pathways 50, 54 contact the vasculature walls surrounding the pathways. This contact can shift the position of the distal segment 16. Provides fixed backup support for maintenance and anchoring.

[0050] The medical device 10 may have one or more coatings disposed on its interior and / or exterior surfaces; The distal segment 16 may include a liner and / or other layered components. It may include a radiopaque coating to improve visibility of the device 10 under medical imaging procedures. An example of such a radiopaque coating is shown in Figure 10. , a layer of gold, platinum, tungsten, iridium, etc., about 1 to 100 microns thick The device 10 may include one or more coatings on its interior and / or exterior surfaces. The device 10 may include a polymer liner or coating. The liner may include a portion of the inner lumen 18, and the liner may be a pre-formed distal segment 1 6 and / or the ability of distal segment 16 to retain its preformed configuration. To avoid this, the distal segment 16 may terminate in a preformed shape. , otherwise it will not extend.

[0051] It is understood that the present disclosure is not limited to what has been particularly shown and described hereinabove. Further, unless stated to the contrary above, the accompanying drawings Please note that not all of the above are to scale. The disclosure is not obscured by details that will be readily apparent to those skilled in the art having the benefit of the description herein. In order to avoid overloading the drawings, only specific details pertinent to understanding the embodiments of the present disclosure are shown. Further, the specific implementations described herein are represented where appropriate by the following symbols: Although the configurations or figures may show features that are not explicitly shown in other figures or embodiments, , the features and elements of the examples disclosed herein are not necessarily mutually exclusive and may be used interchangeably in any manner in accordance with the present disclosure. may be included in various different combinations or configurations without departing from the scope and spirit of the It is understood that the scope and spirit of this disclosure is limited only by the following claims. Many modifications and variations are possible in light of the above teaching without departing from the spirit or scope of the invention.

Claims

1. A medical device comprising: a proximal segment, a distal segment, and a coupling member for coupling the proximal segment and the distal segment; a catheter body defining a lumen therethrough, the distal segment being in an unloaded state. A preformed segment having a first geometric configuration and a second geometric configuration in a loaded state. a catheter body including a catheter; In the first geometric configuration, the preformed segments are at least 1 m a 180 degree arc having a radius of m, the center of the arc being in the vicinity of the catheter body; the medical device being laterally offset from the longitudinal axis of the distal segment.

2. The preformed segment has a 180 degree arc with a radius of at least 2 mm. The medical device of claim 1 .

3. The preformed segment is configured to retain the first geometric configuration under a load of 6 gF to 14 gF. The medical device of claim 1 , wherein the medical device transitions from a first geometric configuration to the second geometric configuration.

4. The preformed segment is configured to retain the first geometric configuration under a load of 9 gF to 11 gF. The medical device of claim 1 , wherein the medical device transitions from a first geometric configuration to the second geometric configuration.

5. 10. The medical device of claim 1, wherein at least a portion of the distal segment is radiopaque. Device.

6. The medical device of claim 1 , wherein the distal segment includes an atraumatic distal tip.

7. A medical device comprising: a proximal segment, a distal segment, and a coupling member for coupling the proximal segment and the distal segment; a catheter body defining a lumen therethrough, the distal segment being in an unloaded state. A preformed segment having a first geometric configuration and a second geometric configuration in a loaded state. a catheter body including a catheter; In the first geometric configuration, the preformed segments are at least 2 m a 180 degree arc having a radius of m, the center of the arc being in the vicinity of the catheter body; The medical device is collinear with the longitudinal axis of the proximal segment.

8. the catheter body includes an intermediate segment extending proximally of the distal segment; 8. The medical device of claim 7, wherein the intermediate segment defines a radius of curvature of between 20 mm and 30 mm. Place.

9. The medical device of claim 8, wherein the intermediate segment has a length of between 5 mm and 15 mm.

10. The medical device of claim 8 , wherein the intermediate segment has an arc length of between 30 degrees and 60 degrees.

11. The preformed segment is configured to retain the first geometric configuration under a load of 6 gF to 14 gF. The medical device of claim 7 , wherein the medical device transitions from a first geometric configuration to the second geometric configuration.

12. A medical device comprising: a proximal segment, a distal segment, and a coupling member for coupling the proximal segment and the distal segment; a catheter body defining a lumen therethrough, the distal segment being in an unloaded state. A preformed segment having a first geometric configuration and a second geometric configuration in a loaded state. a catheter body including a catheter; In the first geometric configuration, the preformed segments are at least 2 m a 180 degree circular arc having a radius of m, The center of the arc is laterally spaced from the longitudinal axis of the proximal segment of the catheter body. Offset, the catheter body includes an intermediate segment extending proximally of the distal segment; The medical device, wherein the intermediate segment defines a radius of curvature of between 20 mm and 30 mm.

13. The medical device of claim 12, wherein the intermediate segment has a length of 10 mm to 20 mm. Place.

14. The medical device of claim 12, wherein the intermediate segment has an arc length between 45 degrees and 90 degrees. 。

15. The preformed segment is configured to retain the first geometric configuration under a load of 6 gF to 14 gF. The medical device of claim 12 , wherein the medical device transitions from a first geometric configuration to the second geometric configuration.

16. A medical device comprising: a proximal segment, a distal segment, and a coupling member for coupling the proximal segment and the distal segment; a catheter body defining a lumen therethrough, the distal segment being in an unloaded state. a nonlinear preformed structure having a first geometric configuration and a second geometric configuration under load; a catheter body including a segment; The distal segment includes a tube having a cut pattern therein, But, a plurality of cuts, each having a width of 0.03 mm to 0.05 mm; a longitudinal uncut width between each of said plurality of cuts of 0.02 mm to 0.03 mm; and, The preformed segment is configured to retain the first geometric configuration under a load of 6 gF to 14 gF. the medical device transitions from a first geometric configuration to the second geometric configuration.

17. The cut pattern has a gap of 0.08 mm to 0.12 mm between each of the plurality of cuts. The medical device of claim 16 , defining a post height.

18. The cut pattern has a gap of 0.05 mm to 0.08 mm for each of the plurality of cuts. The medical device of claim 17 , defining a pitch of

19. In the first geometric configuration, the preformed segments are at least 1 m a 180 degree arc having a radius of m, the center of the arc being in the vicinity of the catheter body; 17. The medical device of claim 16, wherein the distal end of the distal segment is laterally offset from the longitudinal axis of the distal segment. Device.

20. The preformed segment has a 180 degree arc with a radius of at least 2 mm.

20. The medical device of claim 19, comprising:

21. In the first geometric configuration, the preformed segments are at least 2 m a 180 degree arc having a radius of m, the center of the arc being in the vicinity of the catheter body; 17. The medical device of claim 16, wherein the distal end of the distal segment is collinear with the longitudinal axis of the distal segment.

22. In the first geometric configuration, the preformed segments are at least 2 m a 180 degree arc having a radius of m, the center of the arc being in the vicinity of the catheter body; 17. The medical device of claim 16, wherein the distal end of the distal segment is laterally offset from the longitudinal axis of the distal segment. Device.

23. The preformed segment is configured to retain the first geometric configuration under a load of 9 gF to 11 gF.

17. The medical device of claim 16, wherein the medical device transitions from a first geometric configuration to the second geometric configuration.

24. 17. The medical device of claim 16, wherein at least a portion of the distal segment is radiopaque. medical equipment.

25. The medical device of claim 16 , wherein the distal segment includes an atraumatic distal tip.

26. A medical device comprising: a proximal segment, a distal segment, and a coupling member for coupling the proximal segment and the distal segment; a catheter body defining a lumen therethrough, the distal segment being in an unloaded state. a nonlinear preformed structure having a first geometric configuration and a second geometric configuration under load; a catheter body including a segment; The distal segment includes a tube having a cut pattern therein, But, a plurality of cuts, each having a width of 0.03 mm to 0.05 mm; a longitudinal uncut width between each of said plurality of cuts of 0.01 mm to 0.03 mm; and, The preformed segment is configured to maintain the first geometric configuration under a load of 5 gF to 7 gF. to the second geometric configuration.

27. The cut pattern has a gap of 0.06 mm to 0.15 mm between each of the plurality of cuts.

27. The medical device of claim 26, defining a post height.

28. The cut pattern has a gap of 0.05 mm to 0.07 mm for each of the plurality of cuts.

28. The medical device of claim 27, defining a pitch of

29. The catheter body includes a first tube segment proximal to the distal segment. , the first tube segment has a cut pattern therein, the cut pattern comprising: A plurality of cuts forming an interrupted spiral cut, each cut having a length of 0.03 mm to a plurality of cuts having a width of 0.05 mm; a longitudinal uncut width between each of said plurality of cuts of 0.03 mm to 0.04 mm; and, a post height between each of said plurality of cuts of between 0.08 mm and 0.12 mm.

27. The medical device of claim 26.

30. The cut pattern of the first tube segment is 30. The medical device of claim 29, defining a pitch of between 0.06 mm and 0.09 mm.

31. The catheter body has a second tube segment proximal to the first tube segment. the second tube segment having a cut pattern therein, The turn, A plurality of cuts forming an interrupted spiral cut, each cut having a length of 0.03 mm to a plurality of cuts having a width of 0.05 mm; a longitudinal uncut width between each of said plurality of cuts of 0.06 mm to 0.07 mm; and, a post height between each of said plurality of cuts of between 0.08 mm and 0.12 mm.

27. The medical device of claim 26.

32. The cut pattern of the second tube segment is 32. The medical device of claim 31, defining a pitch of between 0.09 mm and 0.11 mm.

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