Catheter Devices

Abstract

A catheter device and a use of the catheter device are provided, the catheter device comprising an inner tubular member and an outer tubular member, each of the inner tubular member and the outer tubular member having a proximal end and a distal end, wherein the distal end of the outer tubular member is a shaped distal end, and the shaped distal end includes at least one bend, such as a right bend of the Jenkins or a left bend of the Aplan. At least a portion of the inner tubular member is coaxially located within the outer tubular member. A control mechanism has a housing having a device for sealing the internal tubular space of the housing, wherein the control mechanism is coupled to the proximal end of the outer tubular member and the proximal end of the inner tubular member. The control mechanism is operable to extend and retract the distal end of the inner tubular member from the shaped distal end of the outer tubular member.

Description

[0001] Citations of Related Applications

[0002] This application claims the benefit of U.S. Provisional Application No. 62 / 857,998, filed on June 6, 2019. The entire disclosure of the above application is incorporated herein by reference. Technical Field

[0003] The present technology relates to catheter devices, including guide extension catheters that provide improved control over the distal configuration of the catheter device. Background Art

[0004] This section provides background information related to the present disclosure which is not necessarily prior art.

[0005] Almost all of the approximately three million percutaneous coronary intervention (PCI) procedures performed worldwide each year use guiding catheters. Percutaneous coronary intervention procedures are designed to clear blockages in the coronary arteries that supply blood to the heart. If the blockage is not treated, the blocked artery (if severe) may cause irreversible myocardial damage, stroke or death. The guiding catheter is designed to enter the coronary artery during PCI so that the operator can deliver a therapeutic device (such as an angioplasty balloon or a coronary stent) to treat the blood vessel blockage and restore blood flow to the heart. The performance of the guiding catheter is crucial to the success of the PCI procedure.

[0006] A stent mounted on a balloon catheter, a guide catheter, and a guidewire are the most basic components of PCI. Although other suitable devices are used, the above three devices are used in nearly every PCI procedure today. Although coronary guidewire and stent design have improved dramatically over the years, the advancement of guide catheter design has been minimal.

[0007] At the same time, the diameter of the guiding catheter has been reduced from 7Fr or 8Fr about twenty years ago to 5Fr or 6Fr today. The smaller diameter helps reduce complications at the vascular access site (near the groin or in the arm).

[0008] However, the undesirable result of reducing the size of the guiding catheter is reduced support. The term support used herein describes the stability of the guiding catheter, for example, at or near the coronary ostium. It is important to keep the guiding catheter in place so that the guidewire and stent can be delivered to the treatment site. Loss of support describes a situation where, for example, the guiding catheter is withdrawn from a position near the coronary ostium when the operator attempts to move the guidewire or stent forward to the lesion in the coronary artery. When this happens, the operator must divert his / her attention from treating the blockage and attempt to restore the guiding catheter to a proper position near the coronary ostium. Typically, the withdrawal of the guiding catheter during the same operation repeatedly annoys the operator and prolongs the operation time. In addition, repeatedly manipulating the catheter at or in the coronary arteries may cause vascular damage, which may cause adverse complications to the patient.

[0009] The concept of a guiding extension catheter to enhance the support of a guiding catheter (in other words, placing an inner catheter concentrically within an outer catheter) has been explored previously. Takahashi et al. ("New Method to Increase a Backup Support of Six French Guiding Coronary Catheter," Catheterization and Cardiovascular Interventions, 63:452-456, 2004) published measurement data on the increased support provided by an inner guiding catheter extended within a conventional 6Fr outer guiding catheter. In Takahashi's study, the distal end of the inner catheter extended past the distal end of the outer catheter into a model of the coronary vessels to assess catheter support. The results showed that the above configuration provided improved support, enabling a 5Fr inner catheter and 6Fr outer catheter system to exceed the size of the support provided by a larger guiding catheter.

[0010] In addition to the guiding catheter extension device, many devices in the art use the two-in-one catheter concept more widely for application. For example, Bao (US7717899B2, US8401673B2) teaches changing the shape of the catheter tip by rotating and translating the inner catheter relative to the outer catheter. In addition, Stace and Gaynor (US20080172036A1, US20150119853A1) describe a two-in-one catheter that can change the shape and top stiffness by manipulating the rotational position and axial position of one of the catheters relative to the other catheter. However, having two separate, non-integrated catheters is necessarily a cumbersome process in use.

[0011] Another two-in-one catheter conceived by Roth et al. (USRE45776E1) adopts a quick-exchange structure using a push rod attached to a short tubular member. Such a device extends beyond the distal end of the guiding catheter into the coronary artery to enhance support. However, the use of the guiding catheter extension device introduces additional devices into the operation, significantly increasing costs and increasing surgical time. In addition, the separate extension device occupies space within the lumen of the guiding catheter, thereby reducing the available space for other devices. Importantly, as reported in the U.S. Food and Drug Administration's Manufacturer and User Facility Equipment Experience (MAUDE) database, extension devices have been reported to cause vascular trauma.

[0012] The use of a separate guiding extension catheter as described above can provide improved guiding catheter support. However, these approaches (whether using a full-length catheter or a shorter rapid exchange device with a push rod element) are essentially temporary solutions. Therefore, there remains a need for improved guiding catheter design to overcome poor support while maintaining the improvement of catheter diameter reduction. Enhanced support thereby eliminates or reduces the common need to use a separate guiding extension catheter.

[0013] Transcatheter aortic valve replacement (TAVR) procedures may similarly benefit from this two-in-one catheter device. For example, in patients post-TAVR, the architecture of the TAVR valve makes coronary artery engagement challenging for PCI procedures. For these patients, physicians currently attempt to place a guide catheter close to the coronary ostium to be treated and then use an available guide extension catheter to engage the coronary artery to deliver the balloon and stent. An integrated guide catheter / guide extension system would provide the same benefits while improving workflow and reducing the number of devices required to perform this complex and difficult procedure.

[0014] Therefore, there remains a need for a more cleverly integrated guide extension catheter that provides the user with a simpler and easier set of controls to accurately and quickly change the catheter distal end configuration. Such a device should more efficiently and cost-effectively address the poor guide catheter support issues frequently experienced with currently available products and technologies in the art. Summary of the invention

[0015] The present technology includes articles, systems, and processes relating to catheter devices, including coronary catheters with integrated guide extension functionality and improved support characteristics.

[0016] Provided is a method for the construction and use of a catheter device, wherein the catheter device includes an outer tubular member and an inner tubular member and a control mechanism. The outer tubular member has a proximal end and a shaped distal end. At least a portion of the inner tubular member is coaxially positioned within the outer tubular member, wherein the inner tubular member includes a proximal end and a distal end. The control mechanism has a housing having a device that seals its inner luminal space. The control mechanism is coupled to the proximal end of the outer tubular member and the proximal end of the inner tubular member. The control mechanism is configured to extend and retract the distal end of the inner tubular member from the shaped distal end of the outer tubular member. The lumen of the inner tubular member is unobstructed, and can accommodate various appliances, treatment operations, and conveying devices (such as balloons and stents) through the inner tubular member when the inner tubular member is deployed at a desired position in a patient's body.

[0017] Further areas of applicability will become apparent from the description provided herein.The description and specific examples in this summary are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] The drawings described herein are for illustrative purposes only of selected embodiments and not all possible implementations, and are not intended to limit the scope of the present disclosure.

[0019] Figure 1A An embodiment of a catheter device according to the present technology is shown positioned within a patient with the inner tubular member in a retracted state.

[0020] Figure 1B Shown according to Figure 1A An embodiment of a catheter device wherein the inner tubular member is in an extended state.

[0021] Figure 1C Shown according to Figure 1B An embodiment of a catheter device wherein the inner tubular member is retracted.

[0022] Figure 2A An embodiment of a catheter device according to the present technology is shown in retracted and extended states.

[0023] Figure 2B An embodiment of a catheter device according to the present technology is shown in which the control mechanism includes a sliding handle in an extended position.

[0024] Figure 3A An embodiment of a catheter device in accordance with the present technology is shown, depicting internal components of the catheter device including a push lead in the form of a coil.

[0025] Figure 3BAn embodiment of a catheter device in accordance with the present technology is shown, depicting internal components of the catheter device including an actuator.

[0026] Figure 3C An embodiment of a catheter device in accordance with the present technology is shown, depicting internal components of the catheter device including a plurality of actuators.

[0027] Figure 3D Shown according to Figure 3C A cross-sectional view of an embodiment of a catheter device depicting internal components of the catheter device including six actuators.

[0028] Figure 4A An embodiment of a control mechanism for controlling extension of an inner tubular member according to the present technology is shown, the control mechanism comprising a rotary control mechanism having a guide wire actuator, and the inner tubular member is in a retracted state.

[0029] Figure 4B Shown for Figure 4A An embodiment of a control mechanism of an inner tubular member wherein the lead actuator is in an extended state.

[0030] Figure 4C An alternative embodiment of a control mechanism for controlling extension of an inner tubular member in accordance with the present technology is shown, the control mechanism comprising a rotary control mechanism having a coil-like actuator in a retracted state.

[0031] Figure 4D Shows Figure 4C An inner tubular member wherein the coil-like actuator is in an extended state.

[0032] Figure 5A A telescoping assembly according to the present technology is shown having two concentric tubes, one of which is able to slide over the other (outer tubular members omitted for clarity), wherein the telescoping tubes are extended.

[0033] Figure 5B Shows Figure 5A A telescopic assembly wherein the telescopic tube is retracted.

[0034] Fig. 6A is a cross-sectional view of an inner tubular member in accordance with the present technology, wherein the inner tubular member is in a retracted state.

[0035] Figure 6B Shown in extended state Fig. 6A The inner tubular member of the

[0036] Fig. 7AComponents of an inner tubular member assembly in accordance with the present technology are shown with a partially compressible inner tubular member in an extended state.

[0037] Figure 7B Shown in a retracted state Fig. 7A A partially compressible inner tubular member.

[0038] Figure 7C An alternative embodiment of an inner tubular member assembly in accordance with the present technology is shown that includes a telescoping mechanism shown with concentric tubes where one tube slides into the other.

[0039] Fig.7D An alternative embodiment of an inner tubular member assembly in accordance with the present technology is shown including a telescoping mechanism shown with separate concentric tubes and with a single push lead.

[0040] Fig. 7E An alternative embodiment of an inner tubular member assembly in accordance with the present technology is shown including a telescoping mechanism slide shown with separate concentric tubes and with a coil-like actuation mechanism.

[0041] Fig. 8A An alternative embodiment of an actuation mechanism in accordance with the present technology is shown in a coil-like configuration.

[0042] Figure 8B An alternative embodiment of an actuation mechanism according to the present technology is shown having a multiple pulley arrangement.

[0043] Figure 8C Shows Figure 8B Detailed view of the multiple pulley arrangement.

[0044] Fig. 9A An embodiment of a control mechanism having a rotary actuation mechanism according to the present technology is shown.

[0045] Fig. 9B An embodiment of a control mechanism having a sliding actuation mechanism according to the present technology is shown.

[0046] Fig. 10A An alternative embodiment of a push rod mechanism integrated into a luer fitting in accordance with the present technology is shown.

[0047] Fig. 10B Shown according to Fig. 10A A push rod mechanism is shown outside the lumen of the inner tubular member.

[0048] Fig. 10C Shown according to Fig. 10AA push rod mechanism, wherein the push rod assembly is in a retracted state (the outer tubular member is omitted for clarity).

[0049] Fig. 10D Shown according to Fig. 10A A push rod mechanism, wherein the push rod assembly is in an extended state (the outer tubular member is omitted for clarity).

[0050] Fig.11A An embodiment of an inner tubular member in accordance with the present technology is shown wherein a partially compressible inner tubular member is in an extended state.

[0051] Fig. 11B An embodiment of an inner tubular member in accordance with the present technology is shown wherein a partially compressible inner tubular member is in a retracted (shortened) state.

[0052] Fig. 11C An embodiment of an inner tubular member in accordance with the present technology is shown depicting the position of the control mechanism housing (profile) when the inner tubular member is in an extended state.

[0053] Fig.11D An embodiment of an inner tubular member in accordance with the present technology is shown depicting the position of the control mechanism housing (outline) when the inner tubular member is in a retracted state. DETAILED DESCRIPTION

[0054] The following description of the present technology is merely exemplary in nature of the subject matter, manufacture and use of one or more inventions and is not intended to limit the scope, application or use of any particular invention claimed in this application or in such other applications that may be filed to claim priority to this application or patents authorized thereby. With respect to the disclosed methods, the order of the steps presented is exemplary in nature, and therefore, in various embodiments, the order of the steps may be different, including where certain steps may be performed simultaneously. "One" and "an" as used herein indicate that there is "at least one" item; where possible, there may be multiple such items. Unless otherwise expressly stated, all numerical quantities in this specification should be understood to be modified by the word "approximately", and when describing the widest scope of the present technology, all geometric and spatial descriptors will be understood to be modified by the word "substantially". When applied to numerical values, "approximately" means that the calculation or measurement allows some slight imprecision in the value (somewhat close to the precision of the value; appropriately or reasonably close to the value; almost). If for some reason the imprecision provided by "about" and / or "substantially" is not understood in the art with its ordinary meaning, then "about" and / or "substantially" as used herein at least represents the variation that may result from ordinary methods of measuring or using these parameters.

[0055] Unless otherwise expressly stated, all documents cited in this detailed description (including patents, patent applications, and scientific literature) are incorporated herein by reference. In the event of any conflict or ambiguity between the documents included by reference and this detailed description, the detailed description shall prevail.

[0056] Although the open-ended term "comprising" (as a synonym for non-limiting terms such as includes, contains, or having) is used herein to describe and claim embodiments of the present technology, however, alternatively, more restrictive terms (such as "consisting of" or "consisting essentially of") may be used to describe embodiments. Thus, for any given embodiment that lists materials, components, or process steps, the present technology also specifically includes embodiments that consist of or consist essentially of such materials, components, or process steps, thereby excluding additional materials, components, or processes (not consisting of additional materials, components, or processes) and excluding additional materials, components, or processes that affect significant properties of the embodiment (not consisting essentially of additional materials, components, or processes), even if such additional materials, components, or processes are not explicitly listed in this application. For example, a recitation of a composition or process that lists elements A, B, and C specifically contemplates embodiments that consist of A, B, and C and do not include element D, which may be listed in the art, as well as embodiments that consist essentially of A, B, and C and do not include element D, which may be listed in the art, even if element D is not explicitly described as not included herein.

[0057] As mentioned herein, unless otherwise specified, all composition percentages are by weight of the total composition. Unless otherwise specified, the disclosed range includes endpoints, and includes all different values ​​and further divided ranges within the entire range. Therefore, for example, the range of "from A to B" or "from about A to about B" includes A and B. The values ​​and value ranges of the disclosed specific parameters (e.g., amount, weight percentage, etc.) do not exclude other values ​​and value ranges useful herein. It is conceivable that two or more specific example values ​​of a given parameter can define the endpoints of the value range that the parameter can claim for. For example, if parameter X is exemplified herein as having value A and is also exemplified as having value Z, it is conceivable that parameter X can have a value range from about A to about Z. Similarly, it is conceivable that two or more ranges of the values ​​of the disclosed parameters (whether these ranges are nested, overlapping or different) are included in all possible combinations of the value ranges claimed using the endpoints of the disclosed ranges. For example, if parameter X is illustrated herein as having a value in the range of 1-10 or 2-9 or 3-8, it is also contemplated that parameter X can have other ranges of values ​​including 1-9, 1-8, 1-3, 1-2, 2-10, 2-8, 2-3, 3-10, 3-9, etc.

[0058] When an element or layer is referred to as being "on," "engaged to," "connected to," or "coupled to" another element or layer, the element or layer may be directly on, directly engaged to, connected to, or coupled to another element or layer, or there may be intermediate elements or layers. In contrast, when an element is referred to as being "directly on," "directly engaged to," "directly connected to," or "directly coupled to" another element or layer, there are no intermediate elements or layers. Other words used to describe the relationship between elements should also be interpreted in a similar manner (e.g., "between" versus "directly between," "adjacent" versus "directly adjacent," etc.). As used herein, the term "and / or" includes any and all combinations of one or more of the relevant listed items.

[0059] Although the terms first, second, third, etc. can be used in this article to describe each element, component, region, layer and / or section, these elements, components, regions, layers and / or sections should not be limited to these terms. These terms can only be used to distinguish an element, component, region, layer or section from another region, layer or section. Terms such as "first", "second" and other numerical terms when used in this article do not imply order or sequence unless the context clearly indicates. Therefore, the first element, component, region, layer or section discussed below can be referred to as the second element, component, region, layer or section without departing from the teaching of exemplary embodiments.

[0060] For ease of description, spatially relative terms such as "inside", "outside", "below", "below", "lower", "above", "upper" used in this article can be used to describe the relationship between one element or feature and another element or feature as shown in the accompanying drawings. Spatially relative terms can be intended to include different orientations of the device in use or operation other than the orientation described in the figure. For example, if the device in the figure is turned over, the elements described as "below" or "below" other elements or features are then oriented to be "above" other elements or features. Therefore, the exemplary term "below" can include both above and below. The device can be positioned in other ways (rotated 90 degrees or in other orientations) and the spatially relative descriptive symbols used in this article are interpreted accordingly.

[0061] The present technology relates to a catheter device and its use, which includes an inner tubular member and an outer tubular member and a control mechanism. The outer tubular member includes a proximal end and a shaped distal end, and the inner tubular member includes a proximal end and a distal end. At least a portion of the inner tubular member is coaxially located within the outer tubular member. The control mechanism includes a housing having a device for sealing the inner tubular space of the housing. The control mechanism is connected to the proximal end of the outer tubular member and the proximal end of the inner tubular member. Through the operation of the control mechanism, the distal end of the inner tubular member can be extended and retracted from the shaped distal end of the outer tubular member.

[0062] The catheter device improves the prior art of coronary artery guiding catheters by providing a guiding catheter with a small profile diameter (6Fr or less), which is designed to provide enhanced support to prevent the guiding catheter from withdrawing or losing support. In addition, based on a new mechanism contained in or near the proximal end of the catheter, the catheter device is configured to provide the above-mentioned benefits in a single, convenient and easy-to-use catheter system. The catheter device provides the benefits of improving workflow, provides ease of use and eliminates the need for expensive auxiliary devices at the same time. The additional devices required in current operations make the working space messy and occupy the valuable space inside the guiding catheter. The space inside the present catheter device can be used alternatively for other purposes, such as leaving room for double guidewire technology.

[0063] Certain embodiments of the catheter device include an outer tubular member having a shaped distal end, a straight inner tubular member, and a control mechanism and a housing for the control mechanism. The inner tubular member and the outer tubular member are coaxially arranged, and their respective proximal ends are connected to the control mechanism at or near the proximal end of the device. The control mechanism housing has an integrated Luer interface fitting or has a device that uses an auxiliary sealing device (such as a Touhy Borst fitting) to seal the internal tubular cavity space.

[0064] The control mechanism can be completely or partially contained in the control mechanism housing near the proximal end of the catheter system or at the proximal end of the catheter system. The control mechanism is provided with a device that extends the inner tubular member from the inside of the outer tubular member so that the inner tubular member extends beyond the distal end of the outer tubular member. The control mechanism is also suitable for retracting the inner tubular member so that the inner tubular member is completely contained in the outer tubular member. The range of extension and retraction is controlled by a stopper in the control mechanism, and the stopper limits the maximum extension of the inner tubular member and the entire range of travel of the inner tubular member relative to the distal end of the outer tubular member. The control mechanism and all its parts are configured to be located outside the inner tubular member so as not to occupy any space in the lumen of the catheter system, therefore, maximizing the available space in the inner lumen for conveying other devices (such as guide wires, stent delivery catheters, etc.).

[0065] The devices for extending and controlling the movement of the inner tubular member include, but are not limited to, manual devices, mechanical devices, electrical devices, electromagnetic devices, and other devices that extend the inner tubular member from the outer tubular member and retract the inner tubular member into the outer tubular member. Examples include manually operated control mechanisms having an integral Luer interface (which is incorporated into the outer control ring) and having a mechanical system using a rotating knob, a gear set, a pulley, and / or a push rod, etc. to convert the rotational motion of the outer control ring into a device for longitudinal movement of the inner tubular member. The above-mentioned control mechanism is connected to the inner tubular member, so that the movement of the outer control ring is converted into the extension of the inner tubular member from the outer tubular member and the retraction of the inner tubular member into the outer tubular member.

[0066] The shaped distal end of the outer tubular member can be one of many existing shapes used in guiding catheters. Examples can be a Judkins right bend or an Aplant left bend or any of the widely available standard Judkins or Amplatzer bends. These and other curved shapes of the distal end have been developed to more easily access specific coronary arteries and to provide support for the catheter to keep it in place during the procedure.

[0067] The outer tubular member is immovably fixed to the control mechanism and / or the hub, and the lumen space is sealed to prevent blood loss or air ingress / egress. The hub is an interface fitting designed to attach the accessory to the catheter in a sealed manner to prevent air leakage. The inner tubular member is coupled to the control mechanism, which, through operator manipulation, can extend the tip of the inner tubular member beyond the distal tip of the outer tubular member.

[0068] This catheter device provides additional support and stability to a larger guide catheter or a combination of a standard guide catheter and a guide extension catheter. The above-mentioned mechanical system of rotating knobs, gear sets, pulleys and / or push rods, etc., describes the device that actuates the inner tubular member to move it. Importantly, the actuating device that can extend and retract the inner tubular member does not occupy any space in the inner lumen of the inner tubular member. Therefore, the lumen space is reserved for other uses, such as inserting additional devices into the artery.

[0069] In summary, the catheter device provides the following benefits: allowing smaller vascular access sites to reduce complications and a control mechanism that allows the inner tubular member to extend into the vascular system when needed, all in a single, easy-to-use catheter system. The catheter device minimizes the device length in a novel manner, and thus retains the length that a device inserted through the catheter device can advance in the vascular system. Another benefit is that this design reduces the clutter at the proximal end, where the operator must manipulate devices such as guide wires or stent delivery catheters. The present technology can be used for a variety of uses that require traversal of the vascular system (such as interventional cardiology, interventional neurology, and peripheral vascular intervention), thereby providing guiding catheter support and providing a small device profile.

[0070] Exemplary embodiments of the present technology are provided with reference to several drawings attached hereto.

[0071] Figure 1A , Figure 1B and Figure 1C FIG. 1 shows an embodiment of a catheter device 101 positioned in a coronary vessel 103. The catheter device 101 has an inner tubular member 105 that can extend into the coronary vessel 103 to enhance the guiding catheter support, such as Figure 1B In the lower portion of each picture, the position of the slide 107 in the control mechanism 109 is shown, which corresponds to the position of the inner tubular member 105 relative to the outer tubular member 111. The position of the slide 107 and the corresponding position of the inner tubular member 105 are shown in a fully retracted state ( Figure 1A ), fully extended state ( Figure 1B ) and the intermediate state ( Figure 1C ). When the procedure is completed, the extended inner tubular member 105 can be retracted and the guiding catheter system can be withdrawn from the human body, such as Figure 1C As shown in the process.

[0072] Figure 2A and Figure 2B Another embodiment of a catheter device 200 is shown. Figure 2A , the sliding control mechanism 201 is shown with the inner tubular member 209 in a fully retracted position with the slider 211 in its most proximal position 203. The outer tubular member 213 is shown with a shaped distal end 215. Figure 2B , the sliding control mechanism 201 is shown in its most distal position 205 , which corresponds to the inner tubular member 209 being in its extreme extended position 207 .

[0073] like Figure 2A and Figure 2BAs shown, the available range of movement of the inner tubular member 209 is limited by the design of the control mechanism 201, and the open slot 217 in the control mechanism 201 precisely defines the longitudinal range of movement of the inner tubular member 209. The slot 217 is a feature that defines the range of travel and allows the operator to avoid taking his / her eyes off other tasks in order to manipulate the position of the inner tubular member 209. In addition, in other embodiments, rails, slots, or other devices may be incorporated to ensure that only the inner tubular member 209 is moved in a manner that is consistent with the inner tubular member 209. Figure 2A and 2B The use of rails or slots 217 can prevent rotational movement of the control mechanism 201 and inner tubular member 209 that would interfere with an operator manipulating the catheter device 200, thereby potentially requiring an undesirable distraction of the operator's attention.

[0074] The markings, indicated at 227, can provide a unit of measurement or scale for the user to see how much the inner tubular member 209 extends from the outer tubular member 213. These markings 227 can be integrated into the housing and / or applied to the control mechanism 201. The markings 227 can include a variety of indicia, including numbers, scales, symbols, colors, etc. In some embodiments, the markings 227 in the position of the slider 211 relative to the markings 227 directly correspond to the length of the inner tubular member 209 extending from the shaped distal end 215 of the outer tubular member 213.

[0075] In addition, with respect to the outer tubular member 213, as Figure 2A and 2BAs shown in , the outer tubular member 213 is configured as a catheter shaft having a shaped distal end 215 designed to facilitate access to a target vessel (such as a coronary artery ostium). Examples of the shaped distal end 215 may include a right-guided configuration of the Jenkins or a left-guided configuration of the Aplan, etc. The outer tubular member 213 is sealed to prevent air from entering / exiting. The outer tubular member 213 is also immovably fixed to the control mechanism 201 and / or the hub 219. The outer tubular member 213 can be a composite shaft tube (not shown) that includes a PTFE (trade name Teflon (TEFLON)) liner and includes a braided layer and a coating, wherein the PTFE liner is used as the innermost layer of the outer tubular member 213, and the coating seals the braided layer into a structure that is combined together. The stainless steel braided layer can be woven onto the above-mentioned PTFE liner. The braided material can be made of any grade of stainless steel (such as 302, 304 or 316LV). Other metals, such as nitinol, are also considered. In addition, the braid may use other materials including polymeric materials, such as polyamide (trade name NYLON) or liquid crystal monofilament polymer (LCP). Non-ferrous and non-metallic braid materials can be used to make the device MRI compatible. The "PIC" number of the braid can be changed to optimize the flexibility and torsional properties of the outer tubular member 213. The PIC number can be changed at the formed distal end 215 (where greater flexibility may be required) and at the proximal end 221 (where greater stiffness may be required). "PIC" refers to the number of times the braid crosses per inch for the weaving pattern. A higher PIC number improves the flexibility of the catheter shaft, and a lower PIC number increases the stiffness of the catheter shaft. The PIC number can be changed within a specified length to provide variable flexibility.

[0076] The coating can be applied to the braided layer and the PTFE liner. The coating can be extruded onto the braided liner or a separate section of tubular material can be used to apply the coating to the liner, and the coating is fused to the shrink tube cover using a thermal process. Other known external tubular member construction methods can also be foreseen. The coating can include any number of suitable biocompatible polymers familiar to those skilled in the art. These polymers include polyether block amides or PEBA (also known by its trade name PEBAX) available from ARKEMA, which can have a Shore D hardness of 27 and a flexural modulus of 12MPA to a Shore D hardness of 69 or higher and a flexural modulus of 513MPA or higher. The available grades of PEBAX range from soft to hard from PEBAX 2533 to PEBAX 7433. Other suitable materials such as thermoplastic polyurethanes can also be used, such as Pellathane from Lubrizol. One exemplary configuration includes making the proximal shaft from Pebax 7233 for providing axial stiffness, and making the softer distal segment from Pebax 3533 for reducing stiffness, and attaching the proximal shaft to the distal segment. Any combination of polymer segments can be used to optimize the flexibility and stiffness of the catheter shaft at the distal segment, the proximal segment, and anywhere in between.

[0077] The distal tip 223 of the outer tubular member 213 can be made of a soft polymer (such as Pebax 2533 or 3533) to prevent damage. The tip 223 can be fused together as described above. The distal tip 223 of the outer tubular member 213 can be loaded with a radiopaque material (such as barium sulfate) loaded into the PEBAX at a mass or volume percentage of 20% or more to make the tip 223 highly visible under fluoroscopy. Other loading percentages (whether by weight or volume) can make the tip 223 more or less visible under fluoroscopy.

[0078] The shaped distal end 215 of the outer tubular member 213 can be preformed into any number of desired shapes. The shapes can include the right side Jenkins guide catheter 3, 4, 5, or the shape can be AL-1, AL-2 or AL-3. The shaped distal end 215 can be preformed into other guide catheter tip shapes defined by terms understood by the device operator. The shaped distal end 215 can be made by inserting a forming mandrel into the outer tubular member 213 and then baking it at an elevated temperature for a specified period of time before assembly with the inner tubular member 209. Various temperatures and oven baking times can be used to preform the shaped distal end 215 of the outer tubular member 213. This can be done before assembly with the inner tubular member 209 and is well known to those skilled in the art.

[0079] In an alternative embodiment, the outer tubular member 213 can be deflectable. Therefore, an additional controller can be incorporated into the control mechanism 201 to actuate the pull lead assembly / distal anchoring ring assembly incorporated into the outer tubular member 213. The pull lead of the pull lead assembly can be covered by a PTFE liner to facilitate smooth actuation. The pull lead assembly and the TEFLON sheath can be inserted through a dedicated lumen in the wall of the outer tubular member 213. Single pull lead and double pull lead configurations are expected to enable unidirectional and bidirectional steering. Any number of lumens can be integrated into the wall of the outer tubular member 213. For example, four lumens are incorporated into the wall to enable four-axis steering. It is also conceivable that the inner tubular member 209 can be similarly configured to be able to deflect. Similarly, one or more lumens integrated into the wall of the inner tubular member 209 can accommodate a pull lead mechanism to facilitate deflection of the inner tubular member 209.

[0080] The inner tubular member 209 or the outer tubular member 213 can be deflectable. It is also conceivable that both the inner tubular member 209 and the outer tubular member 213 can be deflectable. This arrangement of the inner tubular member 209 and the outer tubular member 213 that are deflectable and are integrated with the control mechanism 201 (e.g., a slot configuration) ensures that the deflection of the inner tubular member 209 and the outer tubular member 213 remains unchanged relative to the other. For example, the outer tubular member 213 can be designed to deflect in the front-to-back direction, and the inner tubular member 209 can be configured to accurately deflect 90 degrees from the outer tubular member 213, so that the inner tubular member moves in the up-down direction. Therefore, the distalmost tip 223 of the catheter device can be accurately and reproducibly positioned in the human body.

[0081] In addition, with respect to the inner tubular member 209, the following aspects can be considered. The inner tubular member 209 may include an assembly designed to move the inner tubular member 209 relative to the outer tubular member 213. Thus, the distal end 225 of the inner tubular member 209 can extend through the shaped distal end 215 of the outer tubular member 213. When used in the body, the distal tip 223 of the outer tubular member is positioned near or at the coronary artery ostium, and then the distal end 225 of the inner tubular member 209 advances into the coronary artery to enhance the catheter support. It can also be imagined that the catheter device 200 can be used in other areas of the body. The inner tubular member 209 is designed to extend 10cm to 40cm from the distal end of the outer tubular member according to the position of the control mechanism 201. However, the extendable range can be made into any other length to better adapt to specific applications. The control mechanism 201 can be non-movably coupled to the inner tubular member 209 to enable an operator to precisely control the length that the inner tubular member 209 extends from the outer tubular member 213 .

[0082] exist Figure 3A , Figure 3B and Figure 3C Other embodiments of catheter devices 300A, 300B, and 300C are shown in the Figures, which depict views through the outer tubular member 301, which are drawn to reveal different embodiments of the inner tubular member 303 and other internal components. The inner tubular member 303 may include a tubular portion 313, a lead 305 (which may also be a cable), and the lead is connected to both the tubular portion 313 and the control mechanism 307. Figure 3A The control mechanism 307 in FIG. 1 is shown with a larger control mechanism housing 315. Figure 3A , the lead 305 is shown as a coiled lead, thereby providing a compact device to actuate the inner tubular member 303 to extend and retract the inner tubular member relative to the outer tubular member 301. Figure 3B An alternative embodiment of the lead 309 is shown, which may also be a cable. Figure 3C Six leads 311 (which may also be cables) are shown arranged radially around the inner tubular member. Figure 3D A cross-sectional view of leads 311 (which may also be cables) radially arranged around the inner tubular member 303 is shown. Any number of leads 311 or cables, etc. may be used as part of the control mechanism 307 to actuate the movement of the inner tubular member 303. Actuation devices described later are coupled to the leads 311 (which may also be cables, etc.) to facilitate the extension or retraction of the inner tubular member 303 from the outer tubular member 301 into the outer tubular member.

[0083] Figure 4A , Figure 4B , Figure 4C and Figure 4D Alternative embodiments of catheter devices 400A, 400B, 400C, 400D are shown, with FIG. 3A to FIG. 3D Each catheter device has a low profile or small diameter control mechanism 403 compared to the embodiment of the present invention. The perspective view of the outer tubular member 409 more clearly shows the inner tubular member assembly 401. The inner tubular member assembly 401 is connected to the control mechanism 403 via a straight-line lead or cable 405 or a coiled-line lead or cable 407. Actuation devices are shown in other figures.

[0084] Figure 4A A rotary control mechanism 403 (the movement of which is indicated by the curved arrows) having one or more leads 405 (which may also be cables) is shown with the inner tubular member 401 in a retracted state. Figure 4B Shows Figure 4A The inner tubular member 401 in which the lead 405 is in an extended state. Figure 4C An alternative embodiment is shown in which the rotary control mechanism 403 in the retracted state has one or more coiled leads 407 . Figure 4D Shows Figure 4C The inner tubular member in the embodiment of the present invention, wherein the coiled lead wire 407 is in an extended state. The coiled lead wire 407 can be used to reduce the space required within the control mechanism 403, so that the housing of the control mechanism 403 can be shortened.

[0085] Figure 5A and Figure 5B An embodiment of a catheter device 500 incorporating an inner tubular member 511 is shown having a telescoping feature 505 and a proximal stop 507 and a distal stop 509 that define the range of motion of the inner tubular member 511. The telescoping feature 505 includes a plurality of concentric tubular segments 501 that are designed to slide on each other. The telescoping feature 505 allows the device to be reduced in length. The telescoping feature 505 of the inner tubular member 511 includes at least one fixed tubular segment 501 that seals to a Luer interface or hub 513 and includes at least one slidable tubular segment 501. It is contemplated that one or more slidable telescoping segments 501 may be incorporated into the inner tubular member 511 assembly. The stop ring 503 is non-movably coupled to one of the plurality of tubular segments 501 of the inner tubular member 511 and defines the range of motion of the inner tubular member 511. The retaining ring 503 may be secured to the inner tubular member 511 by swaging, crimping, heat bonding, adhesive bonding, and / or any other means of fastening the components together. Figure 5AThe slidable inner tubular member 511 is shown in a distal-most position, which is associated with a maximum extension of the inner tubular member 511 beyond the outer tubular member (not shown). Figure 5B The slidable inner tubular member 511 is shown in the fully retracted position.

[0086] In FIG. 6 , the telescoping feature 505 of the inner tubular member 511 of the embodiment of FIG. 5 is shown inside the outer tubular member 603. The control mechanism housing is omitted for clarity. The stop ring 503 shows the position of the inner tubular member 601 relative to the outer tubular member 603 in their respective positions. Fig. 6A , the slidable inner tubular section of the inner tubular member 601 is shown in a retracted state and in Figure 6B The slidable inner tubular section of the middle inner tubular member 601 is shown in an extended state.

[0087] like Fig. 7A , Figure 7B , Figure 7C , Fig.7D and Fig. 7E As shown, an embodiment of the inner tubular member 701 may include a polymer tube 703 and a coil-on-tube subassembly 705. Fig. 7A As shown, the inner tubular member 701 is in an extended state. Figure 7B The compressible coil-on-tube subassembly 705 is shown in a compressed state when the inner tubular member is in a retracted state. Figure 7C The lead 711 is shown as replacing Fig. 7A An alternative embodiment of the coil-on-tube subassembly 705 in FIG. Fig.7D and Fig. 7E As shown, the inner tubular portion is composed of at least two separate inner tubular segments (e.g. FIG. 6A to FIG. 6B The telescopic structure made of (as shown in FIG. 1 ) includes at least one slidable inner tubular section 707 and at least one non-slidable inner tubular section 709, which can be advanced or retracted one over the other. The actuation mechanism can compress the length of the inner tubular member 701 when the inner tubular member is retracted into the control mechanism. It is contemplated that the length of the control mechanism housing when the inner tubular member 701 is fully retracted can be reduced by using multiple slidable tubes arranged using a telescopic arrangement.

[0088] Fig. 8A , Figure 8B and Figure 8C An embodiment is shown using operation of multiple pulleys 801 and at least one lead 803 to facilitate extension or retraction of the inner tubular member, and at least one lead may be incorporated into a control mechanism (not shown) to facilitate extension or retraction of the inner tubular member relative to the outer tubular member.

[0089] Fig. 9A An embodiment of a control mechanism 901 having a rotating control ring 903 is shown. The rotating ring 903 has a series of undulations 911 on its surface to improve grip. Markings 905 on the outer control mechanism housing 909 and the rotating ring 903 may provide a visual indication of the extent of extension of the inner tubular member. Alternatively, these markings may include numerical units for the same function instead of symbols. Fig. 9B The use of the aforementioned sliding mechanism 907 (eg, Figures 1A to 1C , FIG. 2A to FIG. 2B ) of the control mechanism 901, which also incorporates an undulating portion 911 to facilitate improved grip.

[0090] Fig. 10A , Fig. 10B , Fig. 10C and Fig. 10D An alternative embodiment of a control mechanism 1001 is shown, which includes a push rod 1005 that travels in a specific manner outside the inner tubular member lumen 1007, Fig. 10B The inner tubular member lumen is depicted and the Fig. 10A FIG. 1 is an end view of the control mechanism 1001 taken along the cutting line AA in FIG. In other words, the push rod 1005 enters the luer interface or hub 1003 located outside the lumen 1007. This allows the lumen space 1007 to be utilized by other devices. The push rod 1005 is coupled to the inner tubular member 1013 via an anchoring ring 1015 or other device to immovably secure the push rod 1005 to the inner tubular member 1013. The push rod 1005 actuates the movement of the inner tubular member 1013. Fig. 10C The push rod 1005 is shown in a position maximally extended toward the operator and the inner tubular member 1013 is fully retracted. When the push rod 1005 is maximally advanced into the luer interface 1003, the inner tubular member 1013 is fully extended through the outer tubular member (not shown).

[0091] Another embodiment may include multiple inner tubular segments that are concentrically arranged to slide over each other so that when actuated by a push rod 1005 or other actuation device, the inner tubular member becomes shorter or longer; for example, FIG. 5A to FIG. 5B , FIG. 6A to FIG. 6B The push rod 1005 can be located outside the inner lumen 1007 to reserve lumen space for delivering guidewires and catheters. The push rod 1005 can be coupled to the inner tubular member by different means, such as an anchoring ring 1015 that is immovably fixed to the inner tubular member. Other configurations for coupling the push rod 1005 to the inner tubular member are also possible.

[0092] exist Fig.11A and Fig. 11B In yet another embodiment shown in , the inner tubular member 1100 can have both an extended state and a retracted state. This is achieved by using a compressible bellows, wherein the inner tubular member 1100 can include a partially compressible member formed by a bellows structure. Fig.11A The partially compressible member is shown in a fully extended state 1101 . Fig. 11B A partially compressible member is shown in a compressed state 1103. The compressible corrugated section 1105 of the inner tubular member 1100 can be located in the control mechanism and combined or fused with an incompressible member that can extend through the control mechanism. Thus, a shorter control mechanism is possible. An advantage of the compressible or foldable inner tubular member 1100 is that the overall length of the catheter device is reduced. The foldable section can range from a few millimeters to more than 40 centimeters. More preferably, the foldable section is intended to be folded to 5 centimeters to 20 centimeters.

[0093] exist Fig. 11C and Fig.11D In the illustrated alternative embodiment, the incompressible inner tubular member 1107 can be slid from the proximal end to the distal end within the outer tubular member (not shown) such that a portion of the inner tubular member extends from the outer tubular member. This simple arrangement provides the benefit of lower manufacturing costs.

[0094] The catheter device described herein can be used in different ways. Among many available guiding catheter shapes, the device operator can select the guiding catheter shape that he / she thinks will provide sufficient coaxial support for successful interventional treatment. The guiding catheter can be used to engage the coronary artery in a standard manner, just like any other type of guiding catheter currently available to the operator. For example, in order to engage the right coronary artery, the operator will adopt the guiding catheter of standard 6Fr JR4 shape and advance the guiding catheter to the ascending aorta with 0.035 inch guide wire. Then, the operator makes the guiding catheter touch the aortic valve gently, then pulls back the guiding catheter on the proximal part with the right hand, and then applies clockwise torque with the left hand (and right hand) to make the catheter enter the right coronary artery to engage the coronary artery ostium. Similarly, for the left coronary artery, the operator will adopt a standard shape guiding catheter, such as 6Fr JL4 or EBU4, and insert the standard shape guiding catheter on 0.035 inch guide wire. The guiding catheter and guide wire can be advanced in the ascending aorta, and then the guide wire is removed. A guiding catheter is advanced into the left coronary artery to engage the coronary ostium.

[0095] After making the patient fully anticoagulated, for subsequent interventional treatment, a 0.014 inch guidewire is carefully advanced into the coronary artery to pass through the stenotic lesion. After the guidewire passes through the lesion, the operator can advance the balloon and stent catheter to treat the lesion. However, there may not be enough support for the delivery of the balloon / stent catheter system. In this case, common practices such as described below can be adopted: using a double guidewire system, utilizing a balloon to further alleviate the lesion, using a guiding catheter extension, changing to a more supportive guidewire, changing to a larger guiding catheter or a guiding catheter of different shapes that can provide greater support. These optional solutions are not ideal, and all solutions require additional equipment, while interrupting the smooth workflow of interventional treatment. A better solution is needed, which does not need to use any additional equipment, which is important from the workflow, patient safety and cost perspectives. An ideal solution has been built into the guiding catheter.

[0096] The method outlined below describes how the present technology can provide improved treatment methods using a catheter device with a novel guiding catheter system. The inner tubular member enters the body in an initial configuration, so the distal end of the inner tubular member does not protrude from the outer tubular member. As described above, the catheter device of this initial configuration is used to engage the coronary artery. The lesion in question can be passed through a 0.014-inch guidewire in a standard manner as described above. When it is difficult to advance the balloon / stent delivery system, or in anticipation that the balloon / stent delivery system may be difficult to advance, the inner tubular member of the present technology can be extended into the vascular system to enhance the guiding catheter support.

[0097] The catheter device can be inserted into the femoral artery near the groin, a vascular access site, using techniques known to those skilled in the art. Alternatively, the device can be inserted into the radial artery at the patient's wrist. In the femoral or radial artery technique, the catheter device is advanced through the vasculature until it reaches the coronary ostia. Markings on the catheter shaft can indicate the location of the catheter tip within the body, and thus can reduce the radiation used in positioning the catheter.

[0098] In order to use the catheter device, the operator will first use his / her right hand to advance the balloon catheter into the coronary artery about 10mm to 15mm, and use his / her left hand to keep the 0.014 inch guide wire in place. Then, the advancing balloon catheter can be used as a guide rail to safely extend the inner tubular member of the catheter device. In the case where the balloon catheter advances to the blood vessel to be treated, the left hand is then used to extend the inner guiding catheter from the catheter device by manipulating the control mechanism. The control mechanism acts on the inner tubular member, so that the inner tubular member can be advanced into the artery and retracted into the outer tubular member, and the actuating device does not utilize the space in the lumen of the inner tubular member, so that the lumen space can be used for other purposes. This technology provides an additional safety measure to prevent vascular dissection.

[0099] One method to extend the inner tubular member is to use the operator's (his / her) left hand to turn the small knob clockwise (for embodiments with a rotating ring control mechanism) while holding the guidewire and balloon catheter with the right hand. Another method is to use the sliding mechanism to extend the inner tubular member with the left hand while holding the balloon and guidewire with the right hand.

[0100] When the inner tubular member has been advanced into the coronary artery to provide sufficient support, the interventional procedure can be completed in a common manner. To retract the extended inner tubular member when the interventional procedure is completed, according to an embodiment, the operator uses the left hand to turn the knob counterclockwise or retract the sliding mechanism backward. Then, the other equipment used to perform the procedure is retracted, and the access site is sutured to complete the procedure.

[0101] Exemplary embodiments are provided so that the present disclosure is thorough and the scope is fully conveyed to those skilled in the art. Many specific details such as examples of specific components, devices and methods have been set forth to provide a thorough understanding of the embodiments of the present disclosure. It is apparent to those skilled in the art that specific details do not need to be adopted, and exemplary embodiments can be implemented in many different forms and should not be interpreted as limiting the scope of the present disclosure. In some exemplary embodiments, well-known processes, well-known device structures and well-known technologies are not described in detail. In the case where the results are substantially the same, equivalent changes, modifications and variations of some embodiments, materials, compositions and methods can be made within the scope of the present technology.

Claims

1. A catheter device, comprising: a control mechanism having a housing extending from a proximal end to a distal end, the housing having a means for sealing an internal luminal space of the housing, the means for sealing the internal luminal space of the housing being configured to be disposed at a luer or hub at the proximal end of the housing; a fixed tubular section extending from a proximal end of the fixed tubular section to a distal end of the fixed tubular section, the proximal end of the fixed tubular section sealingly coupled to the luer or hub portion of the housing; an outer tubular member extending from a proximal end of the outer tubular member to a distal end of the outer tubular member, the proximal end of the outer tubular member being coupled to the housing; an inner tubular member extending from a proximal end of the inner tubular member to a distal end of the inner tubular member, the inner tubular member being slidably received within an interior of the outer tubular member and slidably received on an exterior of the fixed tubular section, the inner tubular member being configured to slide relative to each of the fixed tubular section and the outer tubular member to selectively extend the distal end of the inner tubular member in a distal direction outside and away from the distal end of the outer tubular member and to retract the distal end of the inner tubular member in a proximal direction toward or into the distal end of the outer tubular member, Wherein, the control mechanism is connected to the proximal end of the outer tubular member and the proximal end of the inner tubular member, and the control mechanism is configured to extend the distal end of the inner tubular member from the distal end of the outer tubular member and retract to the distal end of the outer tubular member.

2. The catheter device according to claim 1, wherein The control mechanism also includes a slider that is non-movably coupled to the inner tubular member and slidably coupled to the housing, wherein the slider is configured to slide relative to the housing to slide the inner tubular member relative to the fixed tubular section and the outer tubular member.

3. The catheter device according to claim 2, wherein: The housing defines a proximal stop and a distal stop, wherein the slide is configured to slide between a retracted position in which the slide abuts the proximal stop and the distal end of the inner tubular member is located within the outer tubular member, and an extended position in which the slide abuts the distal stop and the distal end of the inner tubular member is disposed outside the outer tubular member.

4. The catheter device according to claim 1, wherein: When the inner tubular member slides in the distal direction, a portion of the inner tubular member disposed distally beyond the distal end of the outer tubular member increases in length.

5. The catheter device according to claim 1, wherein: As the inner tubular member slides in the distal direction, the length of a portion of the inner tubular member received on the exterior of the fixed tubular section decreases.

6. The catheter device of claim 1, wherein: The catheter device includes an internal tubular cavity space formed by the interior of the fixed tubular section and the interior of a portion of the internal tubular member arranged to extend distally beyond the distal end of the fixed tubular section, and wherein the length of the internal tubular cavity space of the catheter device increases when the internal tubular member slides along the distal direction.

7. The catheter device of claim 1, wherein: The inner tubular member is arranged directly radially outside the fixed tubular section, wherein the inner tubular member is received on the outside of the fixed tubular section, and wherein the outer tubular member is arranged directly radially outside the inner tubular member, wherein the inner tubular member is received within the outer tubular member.

8. The catheter device of claim 1, wherein: The catheter device includes an internal tubular cavity space formed by the interior of the fixed tubular section and the interior of a portion of the internal tubular member arranged to extend distally beyond the distal end of the fixed tubular section, wherein the internal tubular cavity space of the catheter device is configured to receive a guide wire passing therethrough, and wherein, when the guide wire advances through the internal tubular cavity space of the catheter device along the distal direction, the guide wire enters the internal tubular cavity space of the catheter device at the proximal end of the fixed tubular section, passes through the internal tubular cavity space of the catheter device, and extends out of the internal tubular cavity space of the catheter device when advancing distally beyond the distal end of the internal tubular member.

9. The catheter device of claim 8, wherein: The internal lumen space of the catheter device is also configured to receive one of a stent delivery catheter or a balloon catheter therein, and wherein the one of the stent delivery catheter or the balloon catheter is disposed over the guidewire within the internal lumen space of the catheter device.

10. The catheter device of claim 1, wherein: The control mechanism is configured to deflect the outer tubular member in a first direction and to deflect the inner tubular member in a second direction, the first direction being different from the second direction.

11. The catheter device of claim 1, wherein: The distal end of the outer tubular member is shaped to include at least one bend.

12. The catheter device of claim 1, wherein: The distal end of the outer tubular member is shaped to include one of a right bend of Judkins and a left bend of Aplant.

13. The catheter device according to claim 1 further includes a guide wire extending through an internal tubular space of the catheter device, wherein the internal tubular space of the catheter device is formed by the interior of the fixed tubular segment and the interior of a portion of the internal tubular member arranged to extend distally beyond the distal end of the fixed tubular segment.

14. The catheter device of claim 13, wherein: As the guidewire advances through the internal tubular space of the catheter device in the distal direction, the guidewire enters the internal tubular space of the catheter device at the proximal end of the fixed tubular section, passes through the internal tubular space of the catheter device, and extends out of the internal tubular space of the catheter device when advancing distally beyond the distal end of the inner tubular member.

15. The catheter device of claim 13, further comprising one of a stent delivery catheter or a balloon catheter extending through the interior lumen space of the catheter device, and wherein, One of the stent delivery catheter or the balloon catheter is disposed over the guidewire within the interior lumen space of the catheter device.

16. The catheter device of claim 1, wherein: The luer or hub is configured as a fitting designed to attach an accessory to the catheter device in a sealed manner that prevents air leakage.

17. The catheter device of claim 1, wherein: The flexibility of the outer tubular member changes between the shaped distal and proximal ends of the outer tubular member.

18. The catheter device according to claim 1 further includes at least one of a guide wire, a stent delivery catheter or a balloon catheter extending through an internal tubular space of the catheter device, wherein the internal tubular space of the catheter device is formed by the interior of the fixed tubular segment and the interior of a portion of the internal tubular member arranged to extend beyond the distal end of the fixed tubular segment at the distal end.

19. The catheter device of claim 18, wherein: At least one of the guidewire, the stent delivery catheter, or the balloon catheter extends through the interior lumen space of the catheter device from the proximal end of the fixed tubular section to the distal end of the inner tubular member.

20. The catheter device of claim 18, wherein: At least a portion of at least one of the guidewire, the stent delivery catheter, or the balloon catheter extends distally beyond the distal end of the outer tubular member.

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