Devices and systems for entering and circulating fluids within body

Abstract

A first tubular medical device (100) has a lumen (106) through which a guidewire is insertable, and the first tubular medical device may be guided over the guidewire to a target site within a patient. The proximal end of the guidewire may extend into a lumen defined through the second medical device so that the second medical device may be guided on the guidewire alongside the first tubular medical device to a target site. The guidewire may extend into a distal opening (105) in the first tubular medical device and out of a side opening (107) of the first tubular medical device to make it available to guide a second medical device alongside the first tubular medical device.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 448,512, filed February 27, 2023, the entire disclosure of which is incorporated herein by reference for all purposes. Technical Field

[0003] This disclosure generally relates to the field of medical devices, systems, and methods. In particular, this disclosure relates to medical devices, systems, and methods for accessing target sites within the body and / or circulating fluids at target sites within the body. Background Technology

[0004] Various medical procedures performed within a patient's body utilize one or more tubular elements that extend into a natural orifice or a very small incision to access a treatment site / target site within the patient's body (as compared to open surgery which involves a larger incision through which the target site within the patient's body is more directly accessed). Such tubular elements define at least one lumen therethrough through which devices, tools, instruments, etc. can be delivered to the target site. Additionally or alternatively, fluids can be delivered through at least one lumen of the flexible tubular element (such as to provide irrigation at the target site) and / or suction can be applied through at least one lumen (such as to aspirate the target site, such as to remove material therefrom). One example of a flexible tubular element configured to access a target site is a ureteral access sheath. The access sheath can be advanced to the target site with a dilator extending therethrough to facilitate advancement of the access sheath within the body. Once the distal end of the access sheath is positioned at the target site, the dilator is typically removed so that the lumen within the access sheath can be used for other purposes, such as instrument delivery, irrigation, aspiration, etc. A guidewire can extend through the access sheath to facilitate delivery of additional devices to the target site (over the guidewire). Current access sheaths are limited due to having a single lumen. Likewise, other devices that extend through the access sheath (such as endoscopes, ureteroscopes, etc.) are also limited to a single working channel therewithin. There is a continuing need to reduce elevated temperatures at the target site (such as temperatures generated by laser energy delivered to the target site), high fluid pressure at the target site, and to evacuate medical debris generated by the procedure at the target site (e.g., stone fragments generated during lithotripsy performed within a kidney), such as by applying negative pressure suction. There is also a continuing need to provide irrigation (e.g., saline, contrast fluid, etc., such as to facilitate visualization, flush the target site, replenish suctioned fluid, prevent organ (e.g., kidney) failure, etc.). However, it is generally desirable for devices extending into the body, particularly devices extending through delicate lumens formed by, for example, the ureter, to maintain a small profile. While single lumen devices (e.g., single working channel flexible ureteroscopes) lack a second channel, which does not permit continuous fluid flow to and from the target site, devices having more than one lumen can have an undesirably wide profile. Various other challenges must be addressed, such as navigating through curved internal passageways / lumens, separating fluid flow between lumens located within the patient's body, and other additional challenges. There remains a need for low profile devices, systems, and methods for accessing a target site having multiple lumens. The present improvements can be useful in view of these and other considerations. SUMMARY

[0005] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the. This Summary is not intended to necessary identify key or essential features of the claimed subject matter, nor is it intended to be used to determine the scope of the claimed subject matter. One skilled in the art will understand that each of the aspects and features of the present disclosure can be utilized in a variety of circumstances and that the disclosure is not limited to the aspects and features described in this Summary. The inclusion of an element, component, etc. in this Summary does not, and the exclusion of an element, component, etc. from this Summary does not, imply that the element, component, etc. is or is not a key, essential, or critical element, component, or the like.

[0006] According to various principles of the present disclosure, a system for accessing a target site within a patient includes a first tubular medical device having a distal end, a proximal end, and a lumen defined therethrough between the distal end and the proximal end, the lumen configured to accept a guidewire for advancing the first tubular medical device over the guidewire to the target site, and a second medical device advanceable alongside the first tubular medical device over the guidewire along which the first tubular medical device is advanced, the guidewire extending through the lumen defined through the first tubular medical device and a lumen defined through the second medical device.

[0007] In some aspects, the first tubular medical device includes a tubular elongate body extending between a proximal end and a distal end of the first tubular medical device and a wall defining a lumen; the tubular elongate body defines a distal opening at the distal end of the first tubular medical device; the tubular elongate body defines a side opening through the wall thereof; and the guidewire is extendable into the distal opening of the tubular elongate body, through a distal portion of the lumen therein, and out the side opening through the wall of the tubular elongate body so as to be accessible for extension into the lumen defined through the second medical device. The side opening can be selected from any one of a slot, a slit, a skive, a hole, or a bore. In some aspects, the second medical device has a proximal end and a distal end and includes a tubular elongate body extending between the proximal end and the distal end thereof, the tubular elongate body having a wall defining a lumen configured to accept the portion of the guidewire extending out of the side opening of the first tubular medical device. In some aspects, the tubular elongate body of the second medical device defines a distal opening at the distal end of the second medical device, the guidewire being extendable through therein into the lumen defined through the second medical device. In some aspects, the second medical device is configured to allow the proximal end of the guidewire inserted therethrough to exit the system through the proximal end of the second medical device.

[0008] Optionally, the system further comprises a cannula having a distal end and a proximal end. In some aspects, the cannula is configured to be insertable through a lumen defined through the first tubular medical device; the cannula has a wall defining a lumen extending therethrough between the distal end and the proximal end of the cannula; a distal opening is defined in the distal end of the cannula, the distal opening being in communication with the lumen through the cannula; a side opening is defined in the wall of the cannula, the side opening being in communication with the lumen of the cannula; and a distance between the distal opening and the side opening of the tubular elongated body of the first tubular medical device is substantially the same as a distance between the distal opening and the side opening of the cannula.

[0009] Optionally, the first tubular medical device of the system is a sheath. Optionally, the system further comprises a cannula insertable through a lumen defined through the first tubular medical device. Optionally, the system further comprises a stylet insertable through a lumen defined through the cannula. Optionally, the system further comprises a stylet insertable through a lumen defined through the first tubular medical device.

[0010] Optionally, the second medical device is any one of a scope, a flexible scope, a steerable catheter, a guide catheter, a non-steerable catheter, a sheath, or an access sheath.

[0011] Optionally, the first tubular medical device comprises a curved distal section formed of a shape memory material and capable of being straightened for insertion into a target site within a patient.

[0012] Optionally, the second medical device is steerable and capable of steering the first tubular medical device when the second medical device and the first tubular medical device extend over the common guidewire.

[0013] According to various principles of the present disclosure, a kit for accessing a target site within a patient includes a guidewire; a first tubular medical device having a distal end, a proximal end, and a lumen defined therethrough between the distal end and the proximal end, the lumen being configured to accept the guidewire and be advanced over the guidewire to the target site; and a second medical device capable of being advanced over the guidewire alongside the first tubular medical device, the guidewire extending through the lumen defined through the first tubular medical device and a lumen defined through the second medical device.

[0014] Optionally, the first tubular medical device includes a tubular elongate body extending between a proximal end and a distal end of the first tubular medical device and defining a lumen. Optionally, the tubular elongate body defines a distal opening at the distal end of the first tubular medical device. Optionally, the tubular elongate body defines a side opening through a wall defining the lumen. Optionally, the guidewire is extendable into the distal opening of the tubular elongate body, through a distal portion of the lumen therein, and out of the side opening through the wall of the tubular elongate body so as to be accessible for extension into a lumen defined through the second medical device.

[0015] Optionally, the second medical device is any one of a scope, a steerable catheter, a guide catheter, a non-steerable catheter, a sheath, or an access sheath.

[0016] According to various principles of the present disclosure, a method of accessing a target site within a patient includes guiding a first tubular medical device over a guidewire and guiding a second medical device over the same guidewire and alongside the first tubular medical device.

[0017] In some aspects, the method further includes extending a proximal end of the guidewire into a distal end of the first tubular medical device and into a lumen extending therethrough, and out of a side opening through a wall defining the lumen. In some aspects, the method further includes extending a proximal end of the guidewire into a distal end of the second medical device and into a lumen defined through the second medical device to guide the second medical device over the guidewire alongside the first tubular medical device.

[0018] These and other features and advantages of the present disclosure will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, in which: Like reference numerals in the drawings designate similar elements, and their functions are referred to throughout the disclosure. The figures are not intended to be drawn to scale. The figures are provided for purposes of illustration only and are not intended to limit the scope of the disclosure to the precise arrangements and configurations shown. The examples shown herein are meant to be exemplary only and are not meant to be limiting. BRIEF DESCRIPTION OF DRAWINGS

[0019] Non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying drawings, in which: The accompanying drawings are schematic and are not intended to be drawn to scale. The drawings are provided for purposes of illustration only and the dimensions, positions, sequences, and relative sizes reflected in the drawings can vary. For example, devices can be enlarged so that details are discernible, but are intended to be scaled down relative to, for example, mating within a working channel of a delivery catheter or endoscope. For purposes of clarity and simplicity, not every element of every embodiment is labeled in every drawing, nor is every element of every embodiment shown, where no description is needed to allow persons of ordinary skill in the art to understand the present disclosure.

[0020] The detailed description will be better understood in conjunction with the appended drawings, wherein like numerals represent like elements, as follows:

[0021] Figure 1 A perspective view showing an example of an embodiment of a tubular medical device formed in accordance with aspects of the present disclosure is shown.

[0022] Figure 1A A perspective view showing an example of an embodiment of a tubular medical device formed in accordance with aspects of the present disclosure is shown. Figure 1 A detailed view of Detail 1A of

[0023] Figure 2 A perspective view showing an example of an embodiment of a tubular medical device formed in accordance with aspects of the present disclosure is shown. Figure 1 An exploded view of the tubular medical device shown in

[0024] Figure 3 A perspective view of the tubular medical device in Figure 1 inserted over a guidewire along which an example insertion of an embodiment of a tubular medical device is shown.

[0025] Figure 4 A perspective view of the tubular medical device in Figure 3 inserted over a guidewire along which an example insertion of an embodiment of a tubular medical device is shown.

[0026] Figure 5 A perspective view of a first example of an embodiment of a second medical device inserted over a guidewire along which an example insertion of an embodiment of a tubular medical device is shown.

[0027] Figure 6 A perspective view of a second example of an embodiment of a second medical device inserted over a guidewire along which an example insertion of an embodiment of a tubular medical device is shown.

[0028] Figure 7 A perspective view of a third example of an embodiment of a second medical device inserted over a guidewire along which an example insertion of an embodiment of a tubular medical device is shown.

[0029] Figure 8 A perspective view showing an example of use of a second medical device and an embodiment of a first medical device as shown in Figure 7

[0030] A perspective view showing an example of use of a second medical device and an embodiment of a first medical device as shown in Figure 8A Figure 8 A detailed view of Detail 8A of

[0031] Figure 9 A perspective view showing a second example of an embodiment of a tubular medical device formed in accordance with various principles of the present disclosure along which a second medical device can be inserted in accordance with various principles of the present invention is shown.

[0032] Figure 10 A perspective view showing a second example of an embodiment of a tubular medical device formed in accordance with various principles of the present disclosure along which a second medical device can be inserted in accordance with various principles of the present invention is shown. Figure 9 A perspective view showing a second example of an embodiment of a tubular medical device formed in accordance with various principles of the present disclosure along which a second medical device can be inserted in accordance with various principles of the present invention is shown. ​

[0033] Figure 11 A perspective view of a third example of an embodiment of an insertable tubular medical device formed in accordance with the various principles of the present disclosure is shown, and along which a second medical device can be inserted in accordance with the various principles of the present disclosure.

[0034] Figure 12 A side view of the medical device shown in Figure 11

[0035] Figure 13 An example of an embodiment of a sleeve that can be used in a tubular medical device as disclosed herein is shown.

[0036] Figure 14 A perspective view of a fourth example of an embodiment of a second medical device inserted over a guidewire along which an example of an embodiment of a tubular medical device is inserted is shown.

[0037] Figure 15 A perspective view of a fourth example of an embodiment of a tubular medical device formed in accordance with the various principles of the present disclosure is shown, and along which a second medical device can be inserted in accordance with the various principles of the present disclosure. DETAILED DESCRIPTION

[0038] The following detailed description should be read with reference to the drawings in which are depicted illustrative embodiments. It should be understood that the disclosure is not limited to the particular embodiments described as these can vary. All devices, systems and methods discussed herein are examples of devices and / or systems and / or methods implemented in accordance with one or more principles of the present disclosure. Each example of an embodiment is provided by way of explanation of the principles of the present disclosure and is not a limitation thereof, and is merely an example. Thus, reference to an element in the drawings must be understood as a reference to an embodiment of the present disclosure, and should not be understood as a literal reference to that particular element in the drawings. Other examples of ways to implement the disclosed principles will occur to those of ordinary skill in the art upon reading the present disclosure. In fact, it will be apparent to those of ordinary skill in the art that various modifications and changes can be made in the present disclosure without departing from the scope or spirit of the subject matter. For example, features shown or described as part of one embodiment can be used with another embodiment to yield still a further embodiment. Thus, it is intended that the present subject matter cover all such modifications and changes as fall within the scope and spirit of the appended claims and their equivalents

[0039] ​It should be understood that the disclosure is set forth herein with various levels of detail in relation to the figures, some of which are more detailed than others. It is contemplated that those skilled in the art will readily recognize how to apply the teachings of the disclosure to alternative embodiments or applications. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. Unless defined otherwise, all technical and scientific terms and any acronyms used herein have the same meanings as commonly understood by one of ordinary skill in the art to which this disclosure belongs. All apparatus and / or methods disclosed herein can be made and executed without undue experimentation in light of the present disclosure.

[0040] As used herein, "proximal" refers to the direction or position closest to a user (medical professional or clinician or technician or operator or physician, etc., such terms are used interchangeably herein without intending to be limiting, and include automated controller systems or otherwise) and "distal" refers to the direction or position furthest from the user, such as when using the device (e.g., introducing the device into a patient, or during implantation, positioning or delivery) and / or closest to the delivery device. "Longitudinal" means extending along a longer or greater dimension of an element. A "longitudinal axis" extends along the longitudinal extent of an element, but is not necessarily straight, and does not necessarily remain in fixed configuration if the element is flexed or bent, while "axial" generally refers to along a longitudinal axis. It will be understood, however, that references to axial or longitudinal movement with respect to the above-described systems or elements thereof need not be strictly limited to axial and / or longitudinal movement along a longitudinal axis or central axis of the referenced element. "Center" means at least approximately bisecting a center point and / or approximately equidistant from a periphery or boundary, and "central axis" means a line that at least approximately bisects a center point of an opening, extending longitudinally along the length of the opening when the opening comprises, for example, a tubular element, channel, cavity or bore. As used herein, "lumen" or "channel" or "bore" or "passage" are not limited to circular cross-sections. As used herein, a "free end" of an element is the terminal end beyond which the element does not extend. It will be understood that terms such as at or on or adjacent to or along an end can be used interchangeably herein without intending to be limiting, and are intended to indicate general relative spatial relationships, rather than precise limiting positions. Finally, reference to being "at" a location or position is intended to include being at and / or near (e.g., along, adjacent to, etc.) such location or position.

[0041] According to various principles of the present disclosure, a system having separate tubular medical devices is provided to perform a minimally invasive (as compared to open surgery) medical procedure in a patient. The separate tubular medical devices can be operated in association with one another, or can be separated from one another for independent operation of each. In some aspects, a first tubular medical device can be inserted into a patient over a guidewire, and a second medical device can be inserted into the patient over the same guidewire. Distal ends of the first and second devices are guided over the guidewire to a target site in the patient. The first tubular medical device has a lumen defined therethrough. The lumen can be defined by a tubular elongate body of the first tubular medical device, and reference can be made herein interchangeably to the lumen of the first tubular medical device or the lumen of the tubular elongate body of the first tubular medical device without intending to be limiting. The second medical device is also generally tubular, or at least has a lumen defined therethrough through which the guidewire extends for guiding the second device to the target site. The second medical device can have a tubular elongate body through which a lumen is defined. Accordingly, reference can be made herein interchangeably to the lumen of the second medical device or the lumen of the tubular elongate body of the second medical device without intending to be limiting. The guidewire can have properties selected based on the procedure to be performed and / or the nature of the anatomical site in which the target site is located and / or the devices used therewith and / or other features or characteristics as can be appreciated by one of ordinary skill in the art.

[0042] More particularly, the first tubular medical device can be a single rail type tubular device, such as a single rail catheter. The guidewire extends into an opening at a distal end of the first tubular medical device and out a side opening defined in a wall of the first tubular medical device proximal of the distal opening. The first tubular medical device can be guided over the guidewire to a target site in the patient. The guidewire along which the first tubular medical device is guided to the target site can be considered a rail for additional devices to be inserted alongside and outside of the first tubular medical device. Accordingly, the second medical device can also be guided over the guidewire to the target site. The second medical device can be guided over the guidewire after the first tubular medical device has been guided to the target site. The guidewire can extend from the distal opening in the first tubular medical device, out the opening in the wall of the first tubular medical device, or can traverse the entire length of the first tubular medical device.

[0043] Providing a first tubular medical device that is configured to be guided over a guidewire and positioning such guidewire to have additional devices guided over such guidewire allows for easy insertion and guidance of two separate devices that can provide two separate lumens to a target site. The devices can be used in conjunction with one another to provide continuous circulation of fluid in a treatment / collection system. For example, the direction of fluid flow in the first tubular medical device can be in the opposite direction of the direction of fluid flow in the second medical device. Alternatively, the direction of fluid flow through the devices can be the same, with the fluid flowing through one of the medical devices supplementing the fluid flowing through the other of the medical devices. In comparison to prior art devices, devices and systems formed in accordance with various principles of the present disclosure allow for simultaneous aspiration and irrigation at a target site. As can be appreciated, the devices can each have a profile that is smaller than a profile of a dual lumen device, and thus each device can be more easily navigated to a target site within a patient (as compared to a dual lumen device). However, the lumen provided by at least one of the devices can be larger than a corresponding channel provided in prior devices (e.g., the irrigation lumen of the present disclosure is larger than an irrigation lumen provided by prior devices and systems). Providing more than one tubular medical device allows a medical professional greater freedom and flexibility and additional options in determining the appropriate tubular medical device for irrigation and the appropriate tubular medical device for aspiration during a procedure without the need to remove, replace, etc. the devices. For example, if desired, by providing a tubular medical device for imaging and a separate and independent tubular medical device for aspiration, the aspiration can be separated from the imaging device (e.g., to protect the imaging device from aspiration debris). Further, each device is navigated to the same target site separately and independently, and can be navigated separately and independently, thereby facilitating delivery of each device to the target site. And, such separate and independent delivery allows for positioning of the distal end of the tubular medical devices in different, spaced apart locations (e.g., axially or laterally relative to one another), delivering irrigation fluid to a location that is separate from the location at which suction is applied to perform aspiration in the area of the target site. For example, delivering fluid to the target site, to a location that is spaced apart from the location at which aspiration is performed, can facilitate viewing of the aspiration location, as not delivering fluid directly to the aspiration location can disperse smaller debris at the target site.

[0044] The first tubular medical device can be a access sheath defining a lumen extending therethrough, and the guidewire can pass through the lumen. Optionally, a stylet or obturator or dilator can be positioned within the lumen of the first tubular medical device to facilitate guiding the first tubular medical device to the target site in a manner known to those of ordinary skill in the art. The first tubular medical device can have a preset curve or other non-straight configuration, which can be held in a different configuration by the stylet or obturator. The second medical device can be any of a variety of devices that can be used with the first tubular medical device, such as but not limited to an active steerable device such as a scope, flexible scope, ureteroscope, steerable catheter, etc., or a passive device such as a catheter, guide catheter, sheath, etc., which can be steered or guided by a steerable device. Optionally, the second medical device is configured to position the guidewire such that the third medical device can be delivered over the guidewire to the target site. As can be appreciated, the first tubular medical device (e.g., an access sheath) and the guidewire along which it is advanced can thus be used not only individually, but also as a side rail for additional, separate devices in accordance with the various principles of the present disclosure. The profile of the first tubular medical device, such as its inner and outer diameters, is optionally reduced relative to existing access sheaths.

[0045] Devices, systems, and methods in accordance with the various principles of the present disclosure can be advantageously used in conjunction with lithotripsy and / or nephrolithotomy procedures. For example, the devices, systems, and methods disclosed herein allow for simultaneous circulation of fluid into and out of a target site, such as within a kidney. Such fluid flow allows for the transport of kidney stones, stone fragments and debris, and elevated temperature and pressure out of the collection system (i.e., suctioned out of the kidney) via the fluid during laser treatment of the stones. Suction through the lumens of the first and / or second devices can be by gravity and / or by electromechanical means, such as vacuum and / or infusion pumps, and / or by electromechanical fluid management systems that can sense pressure and / or temperature. Thus, the first tubular medical device can be a suction catheter, such as configured to suction kidney stones, kidney calculi, or urinary stones, stone fragments, residual stone dust, and / or other undesirable particulates out of the kidney and to reduce the temperature at the target site within the kidney by suctioning out elevated temperature fluid. While one device lumen can be used for suctioning the target site, another device lumen can be used for replenishing the fluid suctioned out, e.g., cooling fluid, flushing fluid, therapeutic fluid, etc., to the target site. The medical professional can select which device lumen to use for suctioning and which device lumen to use for flushing based on any of a variety of factors, such as the nature of the medical device with the lumen, the navigability of the medical device with the lumen, the size of the lumen, the amount of flushing / suctioning applied via the lumen, etc.

[0046] Various embodiments of devices, systems, and methods, such as for accessing a target site within a body and / or circulating fluid at a target site within a body, will now be described with reference to the examples illustrated in the drawings. Reference throughout this specification to “one embodiment,” “an embodiment,” “some embodiments,” “other embodiments,” etc. means that a particular feature, structure, concept, and / or characteristic described in connection with the embodiment is included in at least one embodiment of the disclosure. The appearances of such phrases in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, concepts, and / or characteristics can be combined in any suitable manner in one or more embodiments without necessarily being included in all embodiments. It will be appreciated that one or more of the features, structures, concepts and / or characteristics described with reference to one embodiment can be combined with one or more of the features, structures, concepts and / or characteristics of any of the other embodiments described herein. That is, any combination of the features, structures, concepts and / or characteristics described herein can be mixed and matched to form hybrid embodiments, and such hybrid embodiments are within the scope of the disclosure. Furthermore, the mention of “one embodiment,” “an embodiment,” “some embodiments,” “other embodiments,” etc. does not necessarily refer to the same embodiments, though it can. In addition, the description of the embodiments is not intended to limit the scope of the disclosure to the specific embodiments described herein. Rather, the scope of the disclosure is limited only by the claims.

[0047] It should be understood that common features in the accompanying drawings are identified by common reference numerals, and for the sake of brevity and convenience, and without limitation, descriptions of common features are generally not repeated. For clarity, not all parts having the same reference numerals are numbered. Furthermore, a group of similar elements may be indicated by both numbers and letters, and often one or a group of such elements may be referred to by numbers only (excluding the letters associated with each similar element). It will be understood that in the following description, similar elements or parts in the various illustrative embodiments of the second medical device are generally indicated by the same reference numerals multiplied by a factor of 100, and redundant descriptions are generally omitted for brevity. Furthermore, certain features in one embodiment may be used in different embodiments, and are not necessarily labeled independently when appearing in different embodiments.

[0048] Turning now to the accompanying drawings, an example of an embodiment of the first tubular medical device 100 is shown. Figure 1 The first tubular medical device 100 is shown having a tubular elongated body 102 extending between a distal end 101 and a proximal end 103. The first tubular medical device 100 may be an insertable catheter or other tubular device and is typically elongated and / or flexible. Therefore, the distal end 101 of the first tubular medical device 100 may be configured for insertion into a target site within the patient's body. Therefore, the proximal end 103 of the first tubular medical device 100 may be configured to extend outside the patient's body for access by a medical professional. In some embodiments, a hub 104 is disposed at the proximal end 103 of the first tubular medical device 100. The hub 104 may be configured to be engageable by a medical professional, for example, to guide the first tubular medical device 100 to the target site. Additionally or alternatively, the hub 104 may be configured to provide access to a lumen 106 (…). Figure 1A The passage (shown in the diagram) extends through the tubular elongated body 102 and between the distal end 101 and the proximal end 103 of the first tubular medical device 100.

[0049] 110 needle in the tube Figure 1 The needle 110 is shown positioned within the first tubular medical device 100. Figure 2The distal end 101 of the first tubular medical device 100 is shown in greater detail in exploded view as having an elongated body 102 that extends between a distal end 103 and a proximal end 105. The distal end 103 of the first tubular medical device 100 can be inserted into a lumen 106 of the first tubular medical device 100, such as via a hub 104 located at the proximal end 105 of the first tubular medical device 100. The proximal end 105 of the first tubular medical device 100 is typically retained outside and proximal of the first tubular medical device 100 so as to be accessible by a medical professional. The first tubular medical device 100 can have a cover 108 at its proximal end 105 that is configured to be grasped by a medical professional, such as to guide the first tubular medical device 100. The first tubular medical device 100 can be more rigid than the second tubular medical device 200, such as to facilitate pushing of the second tubular medical device 200 over the first tubular medical device 100, such as in a manner known to those of ordinary skill in the art.

[0050] According to various principles of the present disclosure, the first tubular medical device 100 is configured to be inserted over a guidewire in a manner that permits additional tubular medical devices to be inserted over the same guidewire. An example of an embodiment of the distal end 101 of the first tubular medical device 100 is shown in Figure 1A , showing detail 1A of Figure 1 , the first tubular medical device can be guided over a guidewire, and the second medical device can be guided over the guidewire alongside and outside of the first tubular medical device 100. As referenced in Figure 1A It can be appreciated that the distal end 101 of the first tubular medical device 100 includes a distal opening 105 that provides axial access to a lumen 106 that extends generally longitudinally within the first tubular medical device 100. In addition, a side opening 107 provides lateral access to the lumen 106 that extends laterally through a wall of the tubular elongated body 102 of the first tubular medical device 100. The side opening 107 can have any of a variety of configurations, such as a slot (typically allowing a gentle guidewire exit angle from the lumen 106, such as in an example of an embodiment shown in Figure 1A ), a slit (e.g., a cut in the wall, such as caused by a sharp edge, which can self-close such that a guidewire is pushed therethrough), a beveled cut, a hole (e.g., having a smaller cross-sectional area than a slot), an angled hole, a port, etc., which can be selected or determined based on one or more devices to be used in conjunction with the first tubular medical device 100. As referenced in Figure 1AUnderstandably, the distal end 111 of the needle 110 can be positioned proximal to the side opening 107, thus avoiding interference with the pathway leading to the side opening 107. The first tubular medical device 100 may have a tapered distal section 108 that transitions the outer diameter of the first tubular medical device 100 (from its proximal end 103 to the tapered distal section 108) to a smaller outer diameter at the distal end 101 of the first tubular medical device 100. The tapered distal section 108 may be formed with longitudinal extent, taper, starting diameter, and ending diameter, etc., based on the target insertion site of the first tubular medical device 100. For example, the tapered distal section 108 may be configured to facilitate insertion of the first tubular medical device 100 into a patient (e.g., through the ureteral orifice). Optionally, visualization markers 122 (such as radiopaque markers, strips, or filler material) may be positioned adjacent to the distal end 101 of the first tubular medical device 100 to facilitate visualization, navigation, placement, etc., of the first tubular medical device 100, for example, under fluoroscopic examination. For various purposes, one or more additional side openings 109 (each marked with reference numeral 109, for convenience and not intended to be limiting) may be provided through the wall of the tubular elongated body 102 to allow material (e.g., solid or fluid) passing through it to flow between the lumen 106 within the tubular elongated body 102 and the target site. The additional side openings 109 may have any of a variety of configurations for ease of use. In some aspects, the additional side openings 109 may be used for delivering or removing material, such as during flushing or aspiration. Additionally or alternatively, side openings 107 may be used as flushing or aspiration ports.

[0051] like Figure 3 As shown, the guidewire 120 can extend through the lumen 106 of the first tubular medical device 100. For example, the proximal end 123 of the guidewire 120 can be inserted into the distal opening 105 of the first tubular medical device 100, and then the first tubular medical device 100 is advanced along the guidewire 120 toward the distal end 121 of the guidewire 120 in the advancement direction A. Then, as... Figure 3As shown in FIG. 1, the proximal end 123 of the guidewire 120 extends laterally out of the side opening 107 located in the tubular elongated body 102 of the first tubular medical device 100, so that it is available for insertion of another medical device thereon. The side opening 107 can be positioned proximally of the distal opening 105 of the first tubular medical device 100, distally enough to enable the first tubular medical device 100 to be guided over the guidewire 120 extending from the distal opening 105 of the tubular elongated body 102 to the side opening 107. The distance of the side opening 107 from the distal opening 105 can also be selected / determined based on the interaction of the first tubular medical device 100 with a second medical device to be guided over the guidewire 120 (e.g., to facilitate manipulation of the second medical device with the assistance of the first tubular medical device 100, such as described in further detail below, when both devices are mounted over the common guidewire 120). The proximal end 123 of the guidewire 120 can remain outside the patient's body while the first tubular medical device 100 (optionally supported by the stylet 110) is advanced over the guidewire 120 along the advancement direction A, into the patient's body and to a target site in the patient's body. As referred to above, the distal end 124 of the guidewire 120 can be advanced into the patient's body while the first tubular medical device 100 is advanced over the guidewire 120 along the advancement direction A. Figure 3 and Figure 4 It is appreciated that the guidewire 120 extends along the longitudinal extent of the tubular elongated body 102 as the first tubular medical device 100 is advanced along the advancement direction A.

[0052] As mentioned above, a second medical device can be inserted and guided into a target site in the patient's body over the same guidewire 120 along which the first tubular medical device 100 is inserted and guided. The second medical device can be any of a variety of medical devices, such as a tubular device, configured to be insertable alongside the first tubular medical device 100 and can be used with it in any of a variety of ways for any of a variety of medical procedures, such as in the patient's body.

[0053] An example of an embodiment of a second medical device 200 that can be inserted over the guidewire 120 over which the first tubular medical device 100 is advanced is a steerable medical device, such as a medical scope as shown in FIG. 2. Figure 5 Figure 5 ​An example of the embodiment of the scope shown in FIG. 1 is a ureteroscope, although other forms of scopes (e.g., endoscopes, bronchoscopes, duodenoscopes, colonoscopes, cholangioscopes, arthroscopes, cystoscopes, hysteroscopes, etc.) can alternatively be used. The second medical device 200 has a tubular elongate body 202 that extends between a distal end 201 and a proximal end 203 of the second tubular medical device 200 and is insertable into a patient's body to a target site therein. A handle 204 can be provided at the proximal end 203 of the second medical device 200 to facilitate manipulation of the second medical device 200 to navigate the tubular elongate body 202 to the target site and / or to deliver material to or remove material from the target site via the tubular elongate body 202. A working channel 206 is defined through the tubular elongate body 202 and extends longitudinally therethrough between the distal end 201 of the second medical device 200 and the proximal end 203 of the second medical device 200, such as for access via the handle 204. In some embodiments, the second medical device 200 has a single working channel, although the present disclosure need not be so limited. The working channel 206 of the second medical device 200 extends over the proximal end 123 of the guidewire 120 extending out of the side opening 107 of the first tubular medical device 100. For example, the proximal end 123 of the guidewire can be inserted into a distal opening 205 located at the distal end 201 of the tubular elongate body 202 of the second medical device 200 in communication with the working channel 206 of the second medical device 200. The proximal end 123 of the guidewire 120 can extend out of the proximal end 203 of the second medical device 200 to be held outside of the patient's body (e.g., along the handle 204 of the second medical device 200). The second medical device 200 is advanced over the guidewire 120 in the advancement direction A to the target site.

[0054] Once the respective distal ends 101, 201 of the first tubular medical device 100 and the second medical device 200 are located at or near the target site, the second medical device 200 can be manipulated (e.g., with the help of a handle 204 at its proximal end 203). For example, the second medical device 200 can have a deflectable distal end 201 that can be steered to a particular location within the patient. Additionally or alternatively, the deflectable distal end 201 of the second medical device 200 can also steer the first tubular medical device 100 to a particular location within the patient. For example, the distal ends 101, 201 of the first tubular medical device 100 and the second medical device 200 can be steered to a kidney stone to be treated or to a target calyx (typically the middle or upper pole calyx for ease of access) into which the kidney stone can be repositioned for treatment. With the guidewire 120 still passing through both devices 100, 200, the distal end 201 of the second medical device 200 is advanced toward the proximal end 101 of the first tubular medical device 100, to the side opening 107 of the first tubular medical device 100. The distal end 201 of the second medical device 200 can be deflected (e.g., by using a deflection knob 208 on the handle 204) toward the target site (e.g., the target calyx). The movement of the second medical device 200 can be guided using a scope visualization and / or fluoroscopy in a manner known to those of ordinary skill in the art. Deflection of the distal end 201 of the second medical device 200 can also deflect the guidewire 120 and the distal end 101 of the first tubular medical device 100 toward the target site. To access the target site, the distal end 101 of the first tubular medical device 100 is advanced over the guidewire 120 toward the target site. Once the distal end 101 of the first tubular medical device 100 is in the desired position, the stylet 110 (if provided) and the guidewire 120 can be removed. Removal of the guidewire 120 from the first tubular medical device 100 and the second medical device 200 causes the devices 100, 200 to separate to allow for their individual and independent operation. For example, the second medical device 200 can be manipulated independently of the first tubular medical device 100 to perform other functions, while the first tubular medical device 100 can remain in the position to which it has been delivered to the target site without interference from the manipulation and / or movement of the second medical device 200. Removal of the guidewire 120 from the first tubular medical device 100 and the second medical device 200 also releases the lumen 106 of the first tubular medical device 100 and the working channel 206 of the second medical device 200. Thus, it can be easier to transport material through the devices 100, 200.Additionally, the material can be independently passed through the lumen 106 of the first tubular medical device 100 and the working channel 206 of the second medical device 200, to allow one of the lumen 106 or the working channel 206 to be used as an inlet to the target site, and the other of the lumen 106 or the working channel 206 to be used as an outlet from the target site. For example, fluid (e.g., saline for flushing the target site) can be delivered to the target site by one of the lumen 106 of the first tubular medical device 100 or the working channel 206 of the second medical device 200, and material can be aspirated by the other of the lumen 106 of the first tubular medical device 100 or the working channel 206 of the second medical device 200. In another example, fluid (e.g., saline for flushing the target site) can be delivered to the target site by one of the lumen 106 of the first tubular medical device 100 or the working channel 206 of the second medical device 200, and fluid can be independently delivered to the target site by the other of the lumen 106 of the first tubular medical device 100 or the working channel 206 of the second medical device 200. Optionally, both the lumen 106 of the first tubular medical device 100 and the working channel 206 of the second medical device 200 can be used for aspiration. Generally, a larger lumen at the target site is used for aspiration, to reduce the likelihood of clogging the aspiration lumen.

[0055] Figure 5The example of use of the system shown in the middle with the first tubular medical device 100 and the second medical device 200 is the removal of a stone from a patient's kidney, the first tubular medical device can be in the form of a access catheter and the second medical device can be in the form of a ureteroscope. Thus, the target site can be a calyx. Once the distal end 101 of the first tubular medical device 100 reaches the renal pelvis or otherwise accesses the stone and / or is positioned at the target calyx, the optional stylet 110 and guidewire 120 can be withdrawn from the lumens 106, 206 of the devices 100, 200. A device for treatment (to break up, remove, etc. a kidney stone) can be inserted through the working channel 206 of the tubular elongate body 102 to either reposition the kidney stone to a target calyx or perform laser lithotripsy with an inserted laser fiber. Larger stones can be broken up into smaller or dust size fragments by the laser and suctioned out of the body during or after laser lithotripsy. For example, in a first embodiment, a laser fiber is inserted into the working channel 206 of the second medical device 200 to perform laser lithotripsy. The working channel 206 of the second medical device 200 can also be used as a fluid inlet channel and to flush the target site while the lumen 106 of the first tubular medical device 100 is used to suction / suck out the fluid along with elevated heat, pressure and debris (such as stone debris). In a second embodiment, a laser fiber is inserted into the working channel 206 of the second medical device 200 to perform laser lithotripsy. The working channel 206 of the second medical device 200 can also be used as a fluid outlet channel to suction / suck out the elevated fluid, heat, pressure, debris (such as stone debris) etc. while the first tubular medical device 100 is used as an inlet channel to supplement the fluid to the target site. It will be appreciated that the system as disclosed herein (with separate devices 100, 200 inserted into the target site) allows ready fluid flow in opposite directions, the direction of fluid flow through the first tubular medical device 100 being opposite to the direction of fluid flow through the second medical device 200. However, in some embodiments, the fluid flow through one of the devices 100, 200 can supplement the fluid flow through the other of the devices 100, 200, the fluid flow being independently controllable to achieve the desired fluid flow regulation in a manner that is more easily achieved than with a single device. As can be appreciated, at some point during the procedure it can be desirable to increase the suction in order to draw out heavier materials and / or at a faster rate. This increase in suction can also reduce the volume of fluid, facilitating the performance of the procedure at the target site. The distribution of the increase in flush flow to the target site over more than one lumen helps to dissipate any increase in pressure that might otherwise accompany the increase in flush flow if limited to a single lumen.

[0056] It will be appreciated that the second medical device need not provide a fluid flow in the opposite direction to the first tubular medical device. For example, the second medical device can be a laser fiber inserted into the working channel 206 of the second medical device 200 to perform laser lithotripsy. The working channel 206 of the second medical device 200 can also be used as a fluid outlet channel to suction / suck out the elevated fluid, heat, pressure, debris (such as stone debris) etc. while the first tubular medical device 100 is used as an inlet channel to supplement the fluid to the target site. Figure 5The examples of the embodiments shown are provided by a endoscopic view. For example, in various forms based on the principles of this disclosure and Figure 6 In an example of an embodiment of the system shown, the second medical device 300 may be a steerable medical device guided along the same guidewire 120 along which the first tubular medical device 100 is guided to a target site within the patient's body. For example, Figure 6 An example of an embodiment of the manipulated medical device shown is a deflectable / manipulated guide catheter. Figure 6 The second medical device 300 shown has a tubular elongated body 302 extending between a distal end 301 and a proximal end 303 of the second medical device 300 and insertable into a patient to reach a target site therein. A handle 304 may be located at the proximal end 303 of the second medical device 300 to facilitate manipulation of the second medical device 300 to navigate the tubular elongated body 302 to the target site and / or to deliver or remove material from the target site via the tubular elongated body 302. For example, the handle 304 may include a deflector knob 308 operably coupled to the tubular elongated body 302 to move or bend the tubular elongated body 302 in a certain direction to guide the distal end 301 of the second medical device 300 to the target site. The second medical device 300 has a lumen 306 that extends longitudinally through a tubular elongated body 302 between the distal end 301 and the proximal end 303 of the second medical device 300, for example, for insertion via a handle 304. In some embodiments, the second medical device 300 has a single lumen 306 extending therethrough, although this disclosure does not require such limitation. The lumen 306 of the second medical device 300 extends over the proximal end 123 of a guidewire 120 extending from a side opening 107 of the first tubular medical device 100. For example, the proximal end 123 of the guidewire can be inserted into a distal opening 305 located at the distal end 301 of the tubular elongated body 302 of the second medical device 300, communicating with the lumen 306 of the second medical device 300. The proximal end 123 of the guidewire 120 extends from the proximal end 303 of the second medical device 300 to be held outside the patient's body (e.g., along the handle 302 of the second medical device 300). The second medical device 300 is advanced on the guidewire 120 in the advancement direction A to the target site. The second medical device 300 may be advanced on the guidewire 120 alongside the first tubular medical device 100 to position the first tubular medical device 100 at the target site.

[0057] As in Figure 5In examples of the embodiments shown in the figures, by providing separate devices 100 and 300, separate lumens 106, 306 can allow for greater functionality than is achieved by prior art devices. For example, the direction of fluid flow through the first tubular medical device 100 and the second medical device 200 can be in opposite directions, facilitating simultaneous irrigation and aspiration at a target site in a manner that is not readily achieved with prior art devices. In addition, the lumen 306 of the second medical device 300 can be larger than the lumen 106 of the first tubular medical device 100. Thus, the larger lumen 306 of the second medical device 300 can advantageously be used as Figure 6 The outlet lumen of the system of the embodiments shown in the figures, such as for removing material from a target site.

[0058] Similar to Figure 5 Examples of the embodiments shown in the figures, Figure 6 Examples of the embodiments shown in the figures can be used to remove kidney stones. For example, Figure 6 The system shown in the figures can be used after laser lithotripsy to aspirate stone fragments from a target site. A ureteroscope can be inserted over the guidewire 120 to perform the lithotripsy treatment. After the lithotripsy has been performed, the ureteroscope can be removed, leaving the guidewire 120 in place for use in directing the Figure 6 The second medical device 300 shown in the figures is directed to a target site.

[0059] In contrast to the above examples of the embodiments, the second medical device that can be used with, for example, the first tubular medical device 100 described above need not be steerable. For example, as Figure 7 As shown in the figures, the second medical device 400 can be a passive sheath having a tubular elongate body 402 that extends between a distal end 401 and a proximal end 403 of the second tubular medical device 400 and is insertable into a patient, to a target site therein. A lumen 406 is defined through the tubular elongate body 402, the lumen extending longitudinally between the distal end 401 and the proximal end 403 of the second medical device 400. As in the above examples of the embodiments of the second medical devices 200, 300, Figure 7The example of the embodiment of the second medical device 400 shown in FIG. 4 is guided into a target site in a patient over the same guidewire 120 along which the first tubular medical device 100 was guided. As described above with reference to the second medical devices 200, 300, the proximal end 123 of the guidewire 120 can be inserted into the distal opening 405 at the distal end 401 of the tubular elongate body 402 of the second medical device 400, extend proximally through the lumen 406 of the second medical device 400, and extend out of the proximal end 403 of the second medical device 400. The second medical device 400 can then be advanced over the guidewire 120 alongside the first tubular medical device 100 to the target site. Optionally, a dilator 410 is positioned within the lumen 406 of the tubular elongate body 402 to facilitate advancing the second medical device 400 to the target site. When both devices 100, 400 have been delivered to or near the target site, the dilator 410 can be removed from the lumen 406 of the second medical device 400. Optionally, the guidewire 120 is also removed from the second medical device 400. A scope, such as the scope shown in FIG. 5 Figure 5

[0060] Figure 7 ​​In an example of an embodiment of a pathway system as shown in FIG. 1 1 1, the working channel of a scope inserted through the lumen 406 of the second medical device 400 can be used as a fluid inlet lumen to the target site to provide fluid for irrigation of the target site. The outlet channel of the target site can be defined by the space between the lumen 406 of the second medical device 400 (the inner diameter of the tubular elongated body 402) and the exterior of the scope. More specifically, when the scope is inserted into the lumen 406, the space between the inner diameter of the lumen 406 and the outer diameter of the scope can define the outlet channel of the target site through which material is suctioned. Such a space typically has a cross-sectional area that is larger than the cross-sectional area of the scope. The lumen 106 through the first tubular medical device 100 can be used to supplement irrigation of the target site in order to help maintain a constant pressure or constant fluid volume within the anatomy so that the anatomy is not over-pressurized, or, conversely, is not drawn to a point of collapse. The lumen 106 through the first tubular medical device 100 can be formed with an inner diameter that is large enough to independently provide sufficient fluid to the target site, or used in conjunction with the working channel of the scope used at the target site. In some aspects, it can be preferable to irrigate solely through the lumen 106 through the first tubular medical device 100 in order to avoid the possibility of irrigation fluid delivered through the working channel of the scope being offset by suction applied through the space between the inner diameter of the lumen 406 and the outer diameter of the scope.

[0061] Figure 7 Examples of embodiments of systems as shown in FIG. 1 1 1 can be used for laser lithotripsy, such as Figure 8 Flexible ureteroscope 420 can be inserted through the lumen 406 of the second medical device 400 to perform a lithotripsy procedure at a target site T within the kidney K. Optionally, as shown in the detailed view of FIG. 1 1 1 1, the distal end 421 of the ureteroscope 420 is withdrawn into the second medical device 400 and / or the second medical device 400 is advanced distal to the ureteroscope 420 to provide laser treatment from within the lumen 406 of the second medical device 400 and / or to draw / remove / move larger stones against the distal end 421 of the ureteroscope 400 as the ureteroscope 420 is withdrawn through the second medical device 400. As referenced above, the lumen 406 of the second medical device 400 can be used to provide fluid for irrigation of the target site T. Figure 8A Figure 8A ​A detailed view of the second medical device 400 can be understood with reference to FIG. 4B. The laser fiber 430 (e.g., any suitable energy emitting device capable of fragmenting a kidney stone) can extend through the working channel 406 of the ureteroscope 420, distal of the distal end 421 of the ureteroscope 420, but within the lumen 406 of the second medical device 400. The laser fiber 430 can laser treat a stone S located at the target site or that has been drawn into the lumen 406 of the second medical device 400 into stone dust. Stone dust formed during lithotripsy can be suctioned through the space between the inner diameter of the lumen 406 of the second medical device 400 and the outer diameter of the ureteroscope 420. Optionally, irrigation from the working channel 406 of the ureteroscope 420 can be turned off or reduced so that the irrigation flow does not counteract the suctioning / suction flow between the inner diameter of the second medical device 400 and the outer diameter of the ureteroscope 420. Such suctioning draws the "contained" dust, elevated temperature, and elevated pressure away from the lumen 406 of the second medical device 400 as the stone S is being laser treated. The first tubular medical device 100 can be positioned at a location spaced apart from the stone S, such as shown in FIG. 4A, to avoid having irrigation flow from there disperse stone dust away from the second medical device 400. For example, when the ureteroscope 420 is positioned just proximal of the distal end 401 of the second medical device 400, distal flushing and irrigation can be provided by the working channel 406 of the ureteroscope 420. Additionally or alternatively, the distal end 421 of the ureteroscope 420 can extend distal of the distal end 401 of the second medical device 400 so that the laser fiber 430 can laser treat larger stones S to fit inside the second medical device 400. Figure 8

[0062] The ureteroscope 420 can optionally be withdrawn so that the distal end 421 of the ureteroscope 420 is positioned within the proximal fitting 404 at the proximal end 403 of the second medical device 400. Such positioning of the ureteroscope will allow larger stone fragments to be suctioned out of the lumen 406 of the tubular elongate body 402 of the second medical device 400. To allow larger stones or a large amount of stones to be suctioned out without having to maintain the ureteroscope tip at the proximal fitting 404, the ureteroscope can be removed entirely from the second medical device 400, and then the entire lumen 406 of the second medical device 400 can be used as an outlet lumen (e.g., for suctioning the target site). The first tubular medical device 100 can be used as a fluid inlet lumen (e.g., for irrigating the target site).

[0063] In use as shown in FIG. 4B, the first tubular medical device 100 can be used as a fluid inlet lumen (e.g., for irrigating the target site) and the second medical device 400 can be used as a fluid outlet lumen (e.g., for suctioning the target site). The first tubular medical device 100 can be used as a fluid inlet lumen (e.g., for irrigating the target site) and the second medical device 400 can be used as a fluid outlet lumen (e.g., for suctioning the target site). Figure 7 ​In another example of the system shown in FIG. 1, a large diameter device (such as a laser fiber or a retrieval device) can be delivered via the access channel of a scope inserted through the second medical device 400. Such larger diameter devices can primarily block the access working channel of the scope, or can interfere with fluid supply to the target site (e.g., for irrigation of the target site) when the access volume requirements / needs require / incur too high of an access pressure through the access working channel of the scope. In such cases, the first tubular medical device 100 can be used as the primary source of access flow (e.g., for irrigation), or can supplement the access fluid flow of the scope working channel.

[0064] It will be appreciated that various modifications can be made to the first tubular medical device as described herein without departing from the various principles of the present disclosure. For example, a portion (e.g., a distal portion) of the first tubular medical device can be formed into a preset, non-straight shape. For example, at least a portion of the first tubular medical device can be formed from a shape memory material, and bent to anchor the first tubular medical device at a target site. A stylet, obturator, dilator, cannula, guidewire, etc. can be inserted through a lumen defined through such first tubular medical device to maintain a generally straight configuration of the first tubular medical device to facilitate insertion and advancement into a target site within a patient. Upon withdrawal of the stylet, obturator, dilator, cannula, guidewire, etc. from the bent portion of the first tubular medical device, the first tubular medical device can be controlled (deflected, steered, etc.) and positioned. Upon the first tubular medical device resuming to the preset shape, the partial withdrawal of the stylet, obturator, dilator, cannula, guidewire, etc. can cause the first tubular medical device to deflect from the generally straight configuration to another (e.g., curved) shape. Once the distal end of the first tubular medical device reaches the target site, the stylet, obturator, dilator, cannula, guidewire, etc. can be removed to allow the shape memory material to resume to its preset shape to anchor the first tubular medical device relative to the target site. Examples of embodiments of the first tubular medical device having a curved distal section are shown in Figure 9 、 Figure 10 、 Figure 11 and Figure 12 . The curved distal section can be formed from a material that can be heat set into a curve. Examples of suitable materials include any of a variety of biocompatible polymers, such as nylon, rigid polyamide block with soft polyether block copolymers (e.g., Pebax®), etc. The first tubular medical device can be formed from a material that is heat set into a curved shape, or can be formed from a material that is not heat set into a curved shape. In the latter case, the first tubular medical device can be formed into a curved shape by other means, such as by being formed into a curved shape by a mold, or by being formed into a curved shape by a laser cutting process, etc. The first tubular medical device can be formed into a curved shape by other means as well. polyesters, polyethylene, medical grade thermoplastic elastomers, flexible polyvinyl chloride (PVC), urethane, polyurethane, thermoplastic polyurethane (TPU); or shape memory materials such as Nitinol and the like. The shape (e.g., curvature) of the distal section of the first tubular medical device can be based on the properties of the target site in order to hold the first tubular medical device in place relative to the target site and / or to position its distal end in a desired / optimal orientation relative to the target site. For example, the distal section of the first tubular medical device formed in accordance with the various principles of the present disclosure can be curved (e.g., heat set) to a bend of 0° (straight), 30°, 45°, 90°, 135°, 180°, 210°, 270°, 360° (pigtail), and the like, including any angle therebetween.

[0065] In the example of the embodiment of the first tubular medical device 100’ shown in Figure 9 and Figure 10 , the curved distal section 108’ has a bend of approximately 180° in order to reach the inferior pole of the renal pelvis. In the example of the embodiment of the first tubular medical device 100” shown in Figure 11 and Figure 12 , the curved distal section 108’ has a pigtail configuration. The respective distal sections 108’, 108” of the first tubular medical devices 100’, 100” shown can be heat set or otherwise formed to return to a curved or bent configuration after being held in a straight configuration.

[0066] The respective curved distal sections 108’, 108” of the example embodiments of the first tubular medical devices 100’, 100” shown in Figure 9 and Figure 10 and Figure 11 and Figure 12 may be held in a straight configuration by a stylet, obturator, dilator, sheath, guidewire, and the like (extending through a lumen defined therethrough). The example embodiments of the first tubular medical devices 100’, 100” having curved distal sections 108’, 108” are shown supported by a stylet 110 in Figure 9 and Figure 10 and Figure 11 and Figure 12 respectively, as referenced above in Figure 2The. For example, the distal end 111 of the stylet 110 can be positioned proximal of the side opening 107', 107" of the tubular elongate body 102 of the first tubular medical device 100', 100" so as not to interfere with access to the side opening 107', 107" in the respective tubular elongate body 102', 102" of the respective first tubular medical device 100', 100". The stylet 110 can extend proximally from a cap 114 of the stylet 110 at a proximal end 113 of the stylet 110 positioned proximal of the proximal end 103', 103" of the first tubular medical device 100', 100". It should be noted that like reference numerals used in Figure 1 and Figure 2 are used to indicate elements that are substantially similar to the stylet 110 shown in Figures 9-12 , for the sake of brevity and without intending to be limiting, reference is made to the above description of the stylet 110.

[0067] A guidewire, such as the guidewire 120 described above, which can be a super-hard guidewire, can be threaded into the distal hole 105', 105" in the respective tubular elongate body 102', 102" of the respective first tubular medical device 100', 100" and extended out of the respective side opening 107', 107" to straighten the curved distal section 108', 108" for delivery into a patient and to a target site. In some embodiments, such as shown in Figure 9 and Figure 11 , the side opening 107', 107" is positioned alongside the curved distal section 108', 108" of the first tubular medical device 100', 100" (e.g., generally along the same location circumferentially around the first tubular medical device 100', 100"). In some embodiments, such as shown in Figure 10 and Figure 12 , the side opening 107', 107" is positioned circumferentially spaced apart from the curved distal section 108', 108" of the first tubular medical device 100', 100" (e.g., spaced apart by more than about 5°, such as spaced apart by 90°, as shown in Figure 10 and Figure 12 , even spaced apart by 180°, including increments of 1° therebetween). As in Figure 1 and Figure 1AIn the example of the embodiment shown in FIG. 1, one or more additional side holes 109', 109" can be provided along the tubular elongated body 102', 102". If such additional side holes 109', 109" are located on the curved distal section 108', 108" of the first tubular medical device 100', 100", the additional side holes 109', 109" are preferably located on the side of the curved distal section 108', 108" or positioned along the inner radius of the curved distal section. As can be appreciated, when a guidewire is advanced proximally into the lumen 106', 106" in the respective tubular elongated body 102', 102" of the respective first tubular medical device 100', 100", the holes along the outer radius of the curved distal section 108', 108" can allow the guidewire to extend out of the additional side holes 109', 109" along the outer radius of the curved distal section 108', 108" into the distal opening 105', 105", making the task of steering the first tubular medical device 100', 100" over the guidewire more difficult.

[0068] When the guidewire or stylet 110 is withdrawn (proximally and typically slowly, as can be appreciated by one of ordinary skill in the art) from the first tubular medical device 100', 100", the curved distal section 108', 108" is able to recover (typically slowly) to its curved, pre-set (e.g., heat set) shape. The first tubular medical device 100', 100" can be moved axially (along directions A-B) or rotationally (along directions C-D) (such as when the curved distal section 108', 108" has recovered to its curved shape) to position the curved distal section 108', 108" in a particular / desired position relative to the target site.

[0069] In some embodiments, the sleeve 130 (such as Figure 13A sheath 130 (shown in FIG. 1 1 1 ) can be inserted into the lumen of a first tubular medical device, such as any of the first tubular medical devices described herein. Like the stylet 1 10, the sheath 130 has an elongate body 132 extending between a distal end 131 and a proximal end 133 of the sheath 130. The distal end 131 of the sheath 130 is insertable into the lumen defined through the first tubular medical device, such as via a hub located at the proximal end of the first tubular medical device. The proximal end 133 of the sheath 130 is typically left outside and proximal of the first tubular medical device so that it is accessible by a medical professional. The sheath 130 can have a hub 134 at its proximal end 133 that is configured to be grasped by a medical professional in order to guide the sheath 130. Additionally, the hub 134 can be configured to allow access to a lumen 136 extending through the sheath 130 between the distal end 131 and the proximal end 133 of the sheath. In some embodiments, the sheath 130 is more rigid than the stylet 1 10 described above, and thus can replace the stylet 1 10 in reinforcing the tubular elongate body of a first tubular medical device, such as described herein, to facilitate pushability of the first tubular medical device. Optionally, the stylet 1 10, such as described above, can be inserted into the lumen 136 of the sheath 130 to impart additional rigidity to the sheath 130, and thus to the first tubular medical device into which the sheath 130 and stylet 1 10 are inserted. Additionally, a guidewire can be guided through the distal opening 135 of the sheath 130 and proximally into the lumen 136 defined through the sheath 130 to allow the sheath 130 and the first tubular medical device to be guided over the guidewire to a target site within a patient's body. The distal end 131 of the sheath 130 can be advanced within the first tubular medical device to the distal end of the first tubular medical device to straighten a curved distal section of the first tubular medical device, such as described above. Figures 9-12 The sheath 130 can include a side opening 137 spaced proximally from the distal opening 135 in the sheath 130 by substantially the same distance as the side opening in the first tubular medical device is spaced proximally from the distal opening in the first tubular medical device, as shown in FIG. 1 1 1. In this way, when the sheath 130 is inserted and assembled with the first tubular medical device, the position of the side opening 137 of the sheath 130 substantially matches / aligns with the side opening of the first tubular medical device. A guidewire can extend through the distal end of the first tubular medical device and the distal end 131 of the sheath 130, and out of the side opening of the first tubular medical device and the side opening 137 of the sheath 130. It will be understood that the guidewire can be withdrawn to allow the sheath 130 to be withdrawn to allow the curved distal section of the first tubular medical device to resume its preset curved configuration.

[0070] It will be appreciated that the second medical device can be a substantially similar device to the first tubular medical device. For example, in the example of the embodiment of the system shown in Figure 14 , the first tubular medical device 100 and the second medical device 500 have respective tubular elongate bodies 102, 502 having respective lumens 106, 506 defined therethrough, the tubular elongate bodies 102, 502 and lumens 106, 506 extending between distal and proximal ends 101, 501, 103, 503 of the first tubular medical device 100 and the second medical device 500, respectively. The distal end 101, 501 of the tubular elongate body 102, 502 can include a curved distal section, such as described above with reference to the first tubular medical device 100', 100" shown in Figures 9-12 . Such optional curved distal sections of the first tubular medical device 100 and the second medical device 500 are not shown as curved in Figure 14 , as the guidewire 120 or optional stylet or sheath extending therethrough can straighten the distal section of the first tubular medical device 100 and the second medical device 500. If the distal section of the first tubular medical device 100 and the second medical device 500 is curved, withdrawal of the guidewire 120 (and optional stylet and / or sheath, if provided) will allow the distal section to return to the preset curved configuration. As can be appreciated, because the second medical device 500 includes the side opening 507 through which the guidewire 120 exits and extends proximally, additional medical devices can be guided over the guidewire 120 and alongside the first tubular medical device 100 and the second medical device 500. Various other features of the first tubular medical device 100 and the second medical device 500 can be as described above with reference to the first tubular medical device 100 shown in Figure 1 and Figure 1A . The first tubular medical device 100 and the second medical device 500 can be used for aspiration and irrigation of a target site into which the devices 100, 500 have been inserted. In some cases, the direction of fluid flow through the first tubular medical device 100 is opposite to the direction of fluid flow through the second tubular medical device 500. For example, the first tubular medical device 100 can be used as an inlet lumen to the target site to flush and / or pulse fluid to the target site to agitate stone fragments / debris for aspiration with the second tubular medical device 500. However, other fluid flow as described above can be implemented.

[0071] According to various principles of the present disclosure, instead of the guidewire 120 extending through the wall of the first medical device through the side opening 107 as shown in Figure 3 , the guidewire 120 can extend through the sidewall of the dilator 110' through the side opening 117', extending through the first tubular medical device 100"' as shown in Figure 15As shown in the diagram, the guidewire 120 can be inserted through the distal opening 115' of the dilator 110' and extend proximally to extend out from the side opening 117' of the dilator 110'. As will be understood, the illustrated example of the embodiment of the dilator 110' allows the guidewire 120 to extend alongside the first tubular medical device 100"' to provide a side rail on which the second medical device can be guided, for example, alongside and outside the first tubular medical device 100"', as referenced above. Figures 1-13 The first tubular medical device 100, 100', 100" is described in various examples of embodiments shown. In some aspects, the first tubular medical device 100"' does not have a side opening (as in the example above in the embodiments) and only has a distal opening 105"' from which the dilator 110' extends distally. The dilator 110' and the first tubular medical device 100"' can be releasably connected between the hub 104 of the first tubular medical device 100"' and the hub 114' of the dilator 110' by means of a sliding fit, threads, etc., such as in a manner known to those skilled in the art, and thus in Figure 15 It is not shown in detail in the text.

[0072] Based on the various principles of this disclosure, at least a portion (e.g., the distal portion) of the first tubular medical device 100”’ can be formed as a predetermined, non-straight shape, such as the one described above. Figures 9-12 The examples shown are illustrated in the embodiments. For the sake of brevity, refer to... Figures 9-12 The above description of the embodiments is applicable to, for example, Figure 15 The first tubular medical device 100”' is shown. The preset bend of the first tubular medical device 100”' can be straightened by inserting a dilator 110’ through the lumen 106”' of the first tubular medical device 100”', for example, from the proximal end to the distal end of the first tubular medical device 100”'. During the removal / retraction of the dilator 110’ from the first tubular medical device 100”', even as the segment is returning to its preset configuration, non-straight (e.g., bent) segments can be manipulated and / or positioned.

[0073] It will be appreciated that the various devices and systems described herein can be used in any of a variety of medical procedures, such as but not limited to lithotripsy as described above. In some aspects, a laser is used to break up a kidney stone into very small sizes, such as less than 1 mm or dust size (e.g., less than 250 μ). Both the first tubular medical device and the second medical device formed in accordance with the various principles of the present disclosure can be positioned with their respective distal ends in close proximity to the stone (e.g., at the lower pole calyx) using scope visualization and / or fluoroscopic visualization. During laser treatment, the first tubular medical device can be used to aspirate stone dust, elevated temperatures, and / or elevated pressures, while the second medical device (ureteroscope) can be used to flush and scour the fragments toward the first tubular medical device. For example, if the working channel is partially occupied by the laser fiber, using the working channel of the ureteroscope for flushing instead of for aspiration can reduce the likelihood of stone fragments blocking / plugging the working channel. Aspiration of stone dust can be performed after laser treatment or between laser treatment of more than one stone. The laser fiber can be removed from the working channel of the ureteroscope, and then the working channel can be used for aspiration, which has the advantage of direct scope visualization, a forward-facing working / aspiration channel, and pull wire steerability to steer the scope closer to the stone fragments. The first tubular medical device can be advantageously used to flush and / or gently scour the stone dust toward the ureteroscope. If the medical professional prefers to perform aspiration only after or between laser treatment, the first tubular medical device can be initially positioned farther away from the fragments to avoid the fragments flowing around with the flush.

[0074] The first tubular medical device having a preset, non-straight (e.g., curved) distal portion can be advantageously used to access stones located in the upper and lower poles of the kidney. Repositioning lower pole stones (e.g., with a retrieval device) to the upper or middle pole of the kidney can allow easier access and / or placement of tools, and can relieve hand fatigue (which can otherwise occur while holding the deflection knob of the ureteroscope handle), and can thereby reduce the amount of time needed to perform the procedure.

[0075] In the case of using a reusable scope, the medical professional can wish to reduce the potential risk of damaging the scope by suctioning debris through its working channel. In such a case, the first tubular medical device can be a catheter, and a second medical device inserted alongside the first tubular medical device such as in the manner described above can be a steerable device, such as a steerable guide catheter without an imager (no direct scope view). Alternatively, the first tubular medical device and the second medical device have a preset curve, such as described above, have limited steerability, and do not have an imager (no direct view). Suctioning of stone dust with the first tubular medical device and the second medical device can be performed after substantially all of the kidney stone is laser treated into dust using the scope (with a laser fiber extending through the working channel of the scope). The scope and the laser fiber are then exchanged for the first tubular medical device and the second medical device installed in the manner such as described above. The first tubular medical device and the second medical device can be guided to the appropriate location over a common guide wire such as described above. Fluoroscopy can be used to visualize the position of the devices and the irrigation / suction of stone fragments.

[0076] A first tubular medical device as described herein can be sold as a kit with one or more additional medical devices, such as one or more of the second medical devices described herein. The kit optionally includes a guide wire such as described above. At least the first tubular medical device and one of the additional medical devices of the kit includes a lumen through which the guide wire can be inserted and is configured to allow the associated medical device to be guided over the guide wire to a target site within a patient.

[0077] It will be understood that various features of one example of the embodiments of medical devices described herein can be present in other examples of the embodiments described herein, whether explicitly stated or described or not. Not all components with the same reference label are numbered. It will be further understood that various features described herein can be used singularly or in any combination thereof. Accordingly, the present invention is not limited to combinations of features described for the embodiments specifically described herein. Further, it will be understood that various operations of the devices or systems described above can be performed by other devices or systems described above.

[0078] While embodiments of the present disclosure can be described with particular reference to medical devices and systems and procedures for treating the urinary tract, it will be understood that such medical devices and methods can be used to treat tissues of the gastrointestinal system, abdominal cavity, digestive system, urinary tract, reproductive tract, respiratory system, cardiovascular system, circulatory system, etc. Moreover, the medical devices, instruments, tools, etc. of the present disclosure are not limited and can include various medical devices, instruments, tools, etc. for accessing body lumens, including, for example, ureteroscopes, duodenoscopes, catheters, bronchoscopes, colonoscopes, arthroscopes, cholangioscopes, cystoscopes, hysteroscopes, etc. Such devices, instruments, tools, etc. can be disposable and intended for single use only, or can be sterilizable and reusable, the present disclosure not being limited in this regard.

[0079] While embodiments of the present disclosure can be described with particular reference to medical devices and systems (e.g., endoscopic devices, auxiliary tools, and / or guide wires inserted in the vicinity of or through the urinary tract, etc.), it will be understood that such medical devices and systems can be used in a variety of medical procedures for navigating one or more devices through a catheter-like, lumen-like, vessel-like, or body cavity anatomical structure. The disclosed medical devices and systems can be inserted via different access points and methods, such as percutaneously, endoscopically, laparoscopically, or combinations thereof, the present disclosure not being limited in this regard.

[0080] It will be understood by those having ordinary skill in the art that the discussion is merely an illustration of illustrative examples of embodiments and is not intended to limit the broader aspects of the present disclosure. All devices and methods discussed herein are examples of devices and / or methods implemented in accordance with one or more principles of the present disclosure. These examples are not the only way to implement these principles, but merely an example, and are not intended to limit the broader aspects of the present disclosure. Thus, reference to an element or structure or feature in the drawings must be understood as a reference to an example of an embodiment of the present disclosure and should not be understood as a limitation on the particular element, structure, or feature to the specific embodiment depicted in the drawing. Other examples of ways to implement the disclosed principles will occur to those of ordinary skill in the art upon reading the present disclosure. It will be readily apparent to those of ordinary skill in the art that variations of the disclosed devices, systems, and / or methods and / or sequences of steps of the methods described herein can be made without departing from the spirit, scope, and concept of the present disclosure. Various features described in relation to one embodiment can generally be applied to another embodiment, whether or not explicitly indicated. The various features described below can be used singularly or in any combination thereof. Accordingly, the present disclosure is not limited to the embodiments specifically described herein, and all alternatives and modifications that will occur to those skilled in the art are considered to be within the spirit, scope, and concept of the present disclosure as defined by the appended claims.

[0081] In addition to the foregoing, a person of ordinary skill in the art will further appreciate that various other benefits can be derived from the various aspects, features, components, and structures of the devices, systems, and methods described herein, such as from the above-described device, system, and method.

[0082] The foregoing discussion is presented solely to illustrate and describe the present disclosure and is not intended to limit the disclosure to the forms disclosed herein. It will be understood by those skilled in the art that various additions, modifications, and substitutions can be made to the embodiments disclosed herein without departing from the concepts, spirit, and scope of the disclosure. In particular, those skilled in the art will recognize that the principles of the present disclosure can be embodied in other forms, structures, arrangements, proportions, and with other elements, materials, and components, without departing from the concepts, spirit or scope of the disclosure. For example, the various features of the disclosure discussed above can be combined in one or more aspects, embodiments or configurations. However, it will be understood that certain features of the aspects, embodiments or configurations of the disclosure can be combined in alternative aspects, embodiments or configurations. While the disclosure is presented in terms of embodiments, it should be appreciated that individual features of the disclosure need not all be present in order to achieve desirable characteristics and / or benefits of the disclosure. Those skilled in the art will further appreciate that the disclosure can be used with any number of architectures, systems, devices, and / or components suitable for storing, transmitting, and / or receiving data without departing from the spirit or ambit of the present disclosure. For example, elements shown as integrally formed can be constructed of multiple parts, or elements shown as multiple parts can be integrally formed, the operation of elements can be reversed or otherwise varied, the size and dimensions of the elements can be varied, and the like. Similarly, while operations or actions are described in a particular order, this should not be understood as requiring such particular order, nor that all operations or actions be performed, to achieve a desired result. Further, other implementations are within the scope of the following claims. In some cases, the actions recited in the claims can be performed in a different order and still achieve desirable results. Accordingly, the presently disclosed embodiments are to be considered in all respects as illustrative and not restrictive, the scope of the claimed subject matter being indicated by the appended claims, and not limited to the foregoing description or the particular embodiments or arrangements described herein. In view of the foregoing, various features of the embodiments can be used separately or in any combination, and the scope of the subject matter is indicated by the appended claims, and not limited to the foregoing description or the particular embodiments or arrangements described herein.

[0083] In the foregoing description and in the accompanying claims, the following understandings will be understood. The phrases “at least one”, “one or more”, and “and / or” as used herein are open-ended expressions that are both conjunctive and disjunctive in operation. The terms “a”, “an”, “the”, “first”, “second”, and the like do not denote a limitation of quantity, but rather denote the presence of that entity. For example, the term “a” or “an” entity, as used herein, means one or more than one of the entity. Thus, the terms “a”, “an”, “one or more”, and “at least one” are used interchangeably herein. The term “or” as used herein is generally intended to mean either or both of the listed options, unless otherwise indicated by context. As used herein, the conjunction “and” includes each of the structures, components, features, etc. so conjoined, individually, and in any combination and quantity, unless otherwise indicated by context. All directional references (e.g., proximal, distal, upper, lower, up, down, left, right, lateral, longitudinal, front, back, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, counterclockwise, and / or the like) are only used for identification purposes to aid the reader’s understanding of the present disclosure, and / or to help distinguish one associated element from another, and do not limit the associated elements, particularly with respect to the position, orientation, or use of the associated elements, in the present disclosure. Unless otherwise indicated, a connection reference (e.g., attached, coupled, connected, joined, and linked) is to be construed broadly and can include intermediate members and relative movement between elements. Accordingly, a connection reference does not necessarily infer that two elements are directly connected and in a fixed relationship with one another. Identifying references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to imply importance or priority, but are used to distinguish one feature from another.

[0084] The appended claims are hereby incorporated into the detailed description, wherein each claim by itself is hereby incorporated into the disclosure of the present disclosure. In the claims, the terms “comprises”, “comprising”, “includes”, and “including” do not exclude the presence of other elements, components, features, groups, integers, steps, operations, etc. Additionally, although various features can have been included in different claims, these features can be combinable, and the inclusion of different claims does not indicate that a combination of features is not feasible and / or advantageous. Also, singular references do not exclude a plurality. Reference signs in the claims are provided merely as an example, and do not constitute a limitation of the scope of the claims.

Claims

1. A system for accessing a target site within a patient, the system comprising: a first tubular medical device having a distal end, a proximal end, and a lumen defined therethrough between the distal end and the proximal end, the lumen configured to accept a guidewire to advance the first tubular medical device over the guidewire to the target site; and a second medical device advanceable over the guidewire along which the first tubular medical device is advanced, the guidewire extending through the lumen defined through the first tubular medical device and a lumen defined through the second medical device.

2. The system of claim 1, wherein: the first tubular medical device comprises a tubular elongate body extending between the proximal end and the distal end of the first tubular medical device and a wall defining the lumen; the tubular elongate body defines a distal opening at the distal end of the first tubular medical device; the tubular elongate body defines a side opening through the wall thereof; and a guidewire is extendable into the distal opening of the tubular elongate body, through a distal portion of the lumen therein, and out the side opening through the wall of the tubular elongate body to be accessible to extend into the lumen defined through the second medical device. the side opening is selected from the group consisting of a slot, a slit, a beveled cut, a hole, or a bore. the second medical device has a proximal end and a distal end and comprises a tubular elongate body extending between the proximal end and the distal end thereof, the tubular elongate body having a wall defining a lumen configured to accept the portion of the guidewire extending out of the side opening of the first tubular medical device.

3. The system of claim 2, wherein, the tubular elongate body of the second medical device defines a distal opening at the distal end of the second medical device through which the guidewire is extendable into the lumen defined through the second medical device.

4. The system of any one of claims 2-3, wherein, the second medical device is configured to allow the proximal end of the guidewire inserted therethrough to exit the system through the proximal end of the second medical device.

5. The system of claim 4, wherein, 7. The system of any of claims 2-6, further comprising a sleeve having a distal end and a proximal end, wherein:

6. The system of claim 5, wherein, the sleeve is configured to be insertable through the lumen defined through the first tubular medical device; the sleeve has a wall defining a lumen extending therethrough between the distal end and the proximal end of the sleeve; a distal opening is defined in the distal end of the sleeve in communication with the lumen through the sleeve; a side opening is defined in the sleeve wall in communication with the lumen of the sleeve; and the distance between the distal opening and the side opening of the tubular elongate body of the first tubular medical device is substantially the same as the distance between the distal opening and the side opening of the sleeve. the first tubular medical device is a sheath.

9. The system of any of claims 1-8, further comprising a sleeve insertable through the lumen defined through the first tubular medical device.

8. The system of any one of claims 1-7, wherein, ​ ​ 10. The system of any of claims 1-9, further comprising a stylet insertable through the lumen defined through the first tubular medical device.

11. The system of any one of claims 1-10, wherein, the second medical device comprises a device selected from the group consisting of: a scope, a flexible scope, a steerable catheter, a guide catheter, a non-steerable catheter, a sheath, or an access sheath.

12. The system of any one of claims 1, wherein, the first tubular medical device comprises a curved distal section formed of a shape memory material and is straightenable for insertion into a target site within a patient.

13. The system of any one of claims 1, wherein, the second medical device is steerable and is capable of steering the first tubular medical device when the second medical device and the first tubular medical device are extended over a common guidewire.

14. A kit for accessing a target site within a patient, the kit comprising: a guidewire; a first tubular medical device having a distal end, a proximal end, and a lumen defined through the first tubular medical device between the distal end and the proximal end, the lumen configured to accept the guidewire and be advanced over the guidewire to the target site; and a second medical device advanceable over the guidewire alongside the first tubular medical device, the guidewire extending through the lumen defined through the first tubular medical device and a lumen defined through the second medical device.

15. The kit of claim 15, wherein: the first tubular medical device comprises a tubular elongate body extending between a proximal end and a distal end of the first tubular medical device and defining the lumen; the tubular elongate body defines a distal opening at the distal end of the first tubular medical device; the tubular elongate body defines a side opening through a wall defining the lumen; and the guidewire is extendable into the distal opening of the tubular elongate body, through a distal portion of the lumen therein, and out of the side opening through the wall of the tubular elongate body to be accessible to be extended into the lumen defined through the second medical device. ​

Images