WO2024115940A1

WO2024115940A1 - Split tip catheter with stylet

Info

Publication number: WO2024115940A1
Application number: PCT/IB2022/000717
Authority: WO
Inventors: Bryon Ray DENSLEY; Brenda L.f. FEDOR; Diana FIUMEFREDDO; Ian N. THOMAS; Danielle Mariah POMPA
Original assignee: Pristine Access Technologies Ltd.
Priority date: 2022-11-29
Filing date: 2022-11-29
Publication date: 2024-06-06

Abstract

A catheter assembly including a multi-luminal catheter (100) having a split distal tip (130) and stylet (200) coupled with the catheter. The stylet extends along an entirety of a first lumen (121) and at least a distal portion of a second lumen (122) such that the stylet deflects distal extensions of the split distal tip away from a splayed configuration toward an adjacent configuration consistent insertion of catheter with in a patient. The assembly may further include a guidewire disposed within a lumen along with the stylet. Extraction of the stylet from the catheter includes extracting a distal section of the stylet from the second lumen and proximally drawing the distal section into the first lumen. The stylet includes a 180 degree bend that is advanced along the first lumen during assembly. A securement member attached to the stylet limits distal displacement of the stylet along the first lumen.

Description

SPLIT TIP CATHETER WITH STYLET

BACKGROUND

[0001] Multi -lumen catheters are used for the purpose of creating two or more separate fluid pathways, such as in hemodialysis applications. A primary goal of hemodialysis access is to provide a reliable and effective means of dialysis, which means that a sufficient volume of blood over a period of time must be removed from and returned to the patient. Because the contaminated and cleansed blood must be kept separate for an effective dialysis procedure, a dual lumen catheter is generally used. These dual lumen catheters are usually configured so that distal extensions of the two lumens are separated from each other at the distal end such as in a splayed fashion. U.S. Patent No. 8,500,939 is directed to "split-tip” catheters which is incorporated by reference herein. While the splayed distal extensions enhance the dialysis process, the splayed distal extensions add difficulty to the insertion process of the catheter.

[0002] There is a need for improvements to overcome the difficulty of inserting the spit tip catheter. Disclosed herein are systems and methods that address the forgoing.

SUMMARY

[0003] Disclosed herein is a catheter assembly that, according to some embodiments, includes a catheter and a stylet. The catheter includes a catheter tube having at least a first lumen and a second lumen extending along the catheter tube and at least a first extension leg and a second extension leg extending proximally away from a proximal end of the catheter tube. The catheter further includes a split distal tip of the catheter tube, where the split distal tip defines a first distal extension and a second distal extension. The first lumen extends along the first extension leg and the first distal extension, and the second lumen extends along the second extension leg and the second distal extension. The stylet is coupled with the catheter, such that the stylet is (i) inserted into the first lumen via the first extension leg, and (ii) inserted into the second lumen via the second distal extension.

[0004] In some embodiments, the split distal tip is configured such that the first distal extension and the second distal extension are splayed away from each other when the split distal tip is disposed in a free state, and the stylet deflects the first and second distal extensions toward each other when the stylet is coupled with the catheter. [0005] In some embodiments, a length of the stylet extending between the first and second distal extensions is less than a diameter of the catheter tube.

[0006] In some embodiments, the stylet extends along the second lumen to the second extension leg.

[0007] In some embodiments, the assembly further includes a guidewire disposed within at least one of the first lumen or the second lumen.

[0008] In some embodiments, a first luminal wall of the first distal extension includes a first slot extending through the first luminal wall, and a second luminal wall of the second distal extension includes a second slot extending through the second luminal wall. In such embodiments, the stylet is disposed within the first slot and the second slot.

[0009] In some embodiments, a length of the stylet extending between the first lumen and the second lumen is substantially equal to a sum of a thickness of the first luminal wall and a thickness of the second luminal wall.

[0010] In some embodiments, a proximal section of the stylet is disposed within the first lumen, a distal section of the stylet is disposed within the second lumen, and an interposed section of the stylet, disposed between the proximal section and the distal section, extends between the first lumen and the second lumen.

[0011] In some embodiments, a length of the proximal section is greater than a length of the distal section. In some embodiments, the length of the distal section is greater than a length of the interposed section. In some embodiments, the length of the distal section is less than a length of the second distal extension of the split distal tip. In some embodiments, the length of the distal section is less than the diameter of the catheter tube.

[0012] In some embodiments, the proximal section and the distal section include a substantially straight shape in a free state of the stylet, and in some embodiments, the interposed section includes a curved shape in the free state of the stylet. In some embodiments, the curved shape includes a bend of about 180 degrees, and in some embodiments, a diameter of the bend is less than a diameter of the first lumen. In some embodiments, the distal section is disposed substantially parallel with the proximal section in the free state of the stylet. [0013] In some embodiments, a first stiffness of the proximal section is greater than both a second stiffness of the distal section and a third stiffness of the interposed section. In some embodiments, the second stiffness is greater than the third stiffness.

[0014] In some embodiments, the interposed section is configured to plastically bend between the curved shape the straight shape.

[0015] In some embodiments, the interposed section includes the curved shape when the stylet is inserted along the first lumen, and in some embodiments, the interposed section includes a substantially straight shape when the stylet is extracted along the first lumen.

[0016] In some embodiments, the interposed section is configured to flex away from the curved shape toward the straight shape during extraction of the stylet from at least one of the second lumen or the first lumen. In some embodiments, extraction of the stylet causes the interposed section to flex away from the curved shape toward the straight shape.

[0017] In some embodiments, the assembly further includes a securement member attached to the stylet adjacent the first extension leg, where the securement member is configured to limit distal displacement of the stylet along the first lumen.

[0018] Also disclosed herein is elongate stylet for placement within a catheter. The stylet, according to some embodiments, includes (i) a proximal section extending distally away from a proximal end of the stylet, where the proximal section is configured for placement within the first lumen of the catheter; (ii) a distal section extending proximally away from a distal end of the stylet, where the distal section is configured for placement within the second lumen of the catheter; and (iii) an interposed section extending between the proximal section the distal section, where the interposed section is configured to extend between the first lumen and the second lumen.

[0019] In some embodiments of the stylet, the catheter defines a split distal tip that includes a first distal extension having the first lumen and a second distal extension having the second lumen, where the first and second distal extensions are splayed away from each other in a free state of the catheter. In such embodiments, the stylet is configured to deflect the first and second distal extensions toward one another such that the first distal extension is disposed adjacent the second distal extension. [0020] In some embodiments of the stylet, the proximal section is configured to extend along the first lumen between the first distal extension and a first extension leg of the catheter. In some embodiments of the stylet, the distal section is configured to extend along the second lumen between the second distal extension and a second extension leg of the catheter.

[0021] In some embodiments of the stylet, a length of the proximal section is greater than a length of the distal section. In some embodiments of the stylet, the length of the distal section is greater than a length of the interposed section. In some embodiments of the stylet, the length of the distal section is less than a length of the second distal extension of the split distal tip.

[0022] In some embodiments of the stylet, the catheter includes a catheter tube configured for advancement along a vasculature of a patient, and the length of the distal section is less than a diameter of the catheter tube.

[0023] In some embodiments of the stylet, the proximal section and the distal section include a substantially straight shape in a free state of the stylet. In some embodiments of the stylet, the interposed section includes a curved shape in the free state of the stylet, and in some embodiments of the stylet, the curved shape includes a bend of about 180 degrees. In some embodiments of the stylet, the distal section is disposed substantially parallel with the proximal section in the free state of the stylet.

[0024] In some embodiments of the stylet, the interposed section is configured for insertion through the first lumen in the curved shape. In some embodiments of the stylet, a diameter of the bend is less than a diameter of the first lumen.

[0025] In some embodiments of the stylet, a first stiffness of the proximal section is greater than both a second stiffness of the distal section and a third stiffness of the interposed section. In some embodiments of the stylet, the second stiffness is greater than the third stiffness.

[0026] In some embodiments of the stylet, the interposed section is configured to plastically bend between the curved shape the straight shape.

[0027] In some embodiments of the stylet, the interposed section is configured for extraction of the stylet from the first lumen in the straight shape. In some embodiments of the stylet, the interposed section is configured to flex away from the curved shape toward the straight shape during extraction of the stylet from at least one of the second lumen or the first lumen.

[0028] Also disclosed herein is a method of placing a catheter within a patient that, according to some embodiments, includes (i) advancing the catheter along a vasculature of the patient, where the catheter includes a split distal tip; and (ii) extracting a stylet from a first lumen and a second lumen of the catheter, wherein extracting a stylet includes decoupling a first distal extension of the split distal tip from a second distal extension of the split distal tip, thereby enabling the first and second distal extensions to splay away from each other.

[0029] In some embodiments, extracting a stylet includes proximally extracting the stylet from a first lumen of the catheter and distally extracting the stylet from a second lumen of the catheter. In some embodiments, extracting a stylet includes proximally drawing the distal section of the stylet into the first lumen.

[0030] In some embodiments, extracting a stylet includes transitioning an interposed section of the stylet from a curved shape toward a straight shape, where the interposed section is located between the proximal section and a distal section.

[0031] In some embodiments, the method further includes coupling the stylet with the catheter, where coupling the stylet includes distally advancing the stylet along the first lumen, and where the interposed section is disposed in the curved shape.

[0032] In some embodiments, coupling the stylet with the catheter further includes advancing the distal section of the stylet proximally along the second lumen to couple the first distal extension to the second distal extension.

[0033] These and other features of the concepts provided herein will become more apparent to those of skill in the art in view of the accompanying drawings and following description, which describe particular embodiments of such concepts in greater detail.

DRAWINGS

[0034] FIG. 1 A illustrates a catheter having a split distal tip, in accordance with some embodiments. [0035] FIG. IB is a detailed illustration of a distal portion of the catheter of FIG. 1A, in accordance with some embodiments.

[0036] FIG. 2 illustrates a stylet configured for use with the catheter of FIG. 1A, in accordance with some embodiments.

[0037] FIG. 3 A illustrates a catheter assembly including the catheter of FIG. 1A and the stylet of FIG. 2, in accordance with some embodiments.

[0038] FIG. 3B is a detailed illustration of a distal portion of the catheter assembly of FIG. 3 A, in accordance with some embodiments.

[0039] FIGS. 4A-4G illustrate the distal portion of the FIG. 3B in various states of use of the catheter assembly, in accordance with some embodiments.

[0040] FIG. 5 is a flow chart of an exemplary method of utilizing the catheter assembly to place the catheter within a vasculature of a patient, in accordance with some embodiments.

[0041] FIG. 6A illustrates another embodiment of a catheter assembly, in accordance with some embodiments.

[0042] FIG. 6B is a detailed illustration of a distal portion of the catheter assembly of FIG. 6A, in accordance with some embodiments.

DESCRIPTION

[0043] Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein.

[0044] Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.

[0045] The phrases “connected to,” “coupled with,” and “in communication with” refer to any form of interaction between two or more entities, including but not limited to mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components may be coupled with each other even though they are not in direct contact with each other. For example, two components may be coupled with each other through an intermediate component.

[0046] The terms “proximal” and “distal” refer to opposite ends of a medical device, including the devices disclosed herein. As used herein, the proximal portion of a medical device is the portion nearest a practitioner during use, while the distal portion is the portion at the opposite end. For example, the distal end of an ultrasound probe is defined as the end closest to the patient during utilization of the ultrasound probe, such as an ultrasound probe head, for example. The proximal end is the end opposite the distal end, such as cable connection to the ultrasound probe, for example.

[0047] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art. References to approximations are made throughout this specification, such as by use of the term “substantially.” For each such reference, it is to be understood that, in some embodiments, the value, feature, or characteristic may be specified without approximation. For example, where qualifiers such as “about” and “substantially” are used, these terms include within their scope the qualified words in the absence of their qualifiers. For example, where the term “substantially straight” is recited with respect to a feature, it is understood that in further embodiments, the feature can have a precisely straight configuration.

[0048] Any methods disclosed herein comprise one or more steps or actions for performing the described method. The method steps and/or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order and/or use of specific steps and/or actions may be modified.

[0049] FIG. 1A illustrates a catheter 100. The catheter 100 may be configured for use during a dialysis procedure. The catheter 100 includes a catheter tube 120 having a split distal tip 130. The catheter 100 further includes a number (e.g., 2, 3, or more) of extension legs, such as the first extension leg 111 and the first extension leg 112, for example. The catheter 100 includes a number (2, 3, or more) of lumens, such as the first lumen 121, and the second lumen 122, for example, extending along the catheter tube 120. The split distal tip 130 includes a first distal extension 131 and second distal extension 132. The first lumen 121 extends along the first extension leg 111 and first distal extension 131 and the second lumen 122 extends along the second extension leg 112 and second distal extension 132.

[0050] FIG. IB illustrates a detailed view of a distal portion of the catheter tube 120 including the split distal tip 130. The catheter tube 120 defines a diameter 123 configured for insertion within a vasculature of a patient. The first lumen 121 and the second lumen 122 are disposed side by side along the catheter tube 120. The first lumen 121 defines a first lumen diameter 121 A.

[0051] The first distal extension 131 includes a first extension length 131 A and a first luminal wall 13 IB having a first luminal wall thickness 131C. Similarly, the second distal extension 132 includes a second distal extension length 132A and a second luminal wall 132B having a second luminal wall thickness 132C.

[0052] In some embodiments, the first distal extension 131 and the second distal extension 132 may include a first slot 13 ID and a second slot 132D, respectively. The first slot 13 ID and a second 132D extend through the first luminal wall 13 IB and the second luminal wall 132B, respectively. Each of the first slot 13 ID and a second 132D also extend proximally away from a distal end of the first distal extension 131 and the second distal extension 132, respectively. The first slot 13 ID and a second slot 132D may be configured to enhance blood flow into and/or out of the first lumen 121 and the second lumen 122, respectively.

[0053] The first distal extension 131 and second distal extension 132 are splayed away from each other in a free state of the catheter 100, i.e., in the absence of a force applied to the first distal extension 131 and/or second distal extension 132. The first distal extension 131 and second distal extension 132 are configured to deflect toward each other as a result of a force exerted on the first distal extension 131 and second distal extension 132 so that the first distal extension 131 and second distal extension 132 are disposed adjacent one another, i.e. so that the first distal extension 131 and second distal extension 132 are not splayed away from each other. The first slot 13 ID and second slot 132D may be positioned on their respective distal extensions so that the first slot 13 ID and second slot 132D are disposed immediately adjacent one another when the first distal extension 131 and second distal extension 132 are disposed adjacent one another.

[0054] FIG. 2 illustrates a stylet 200, according to some embodiments. The stylet 200 is generally configured for placement within the first and second lumens 121, 122 of the catheter 100 prior to placement of the catheter 100 within the patient. The stylet 200 is further generally configured for extraction from the first and second lumens 121, 122 after placement of the catheter 100 within the patient. The stylet 200 generally includes a proximal section 210 extending distally away from a proximal end 201 and a distal section 230 adjacent a distal end 202. An interposed section 220 extends between the proximal section 210 the distal section 230. The proximal section 210 is configured to extend along the first lumen 121 between the first distal extension 130 and a first extension leg 111 of the catheter 100. Similarly, the distal section 230 is configured for insertion into the second lumen 122.

[0055] The proximal section 210 defines a proximal section length 211 and the distal section 230 defines a distal section length 231. The proximal section length 211 is greater than the distal section length 231. The interposed section 220 defines an interposed section length 221 that, in some embodiments, may be less than the distal section length 231. In some embodiments the distal section length 231 is less than the second extension length 132A.

[0056] FIG. 2 illustrates the stylet 200 in a free state, i.e., absent any external forces applied thereto. The proximal section 210 and the distal section 230 generally include a substantially straight shape. The interposed section 220 includes a curved shape 225. In some embodiments, the curved shape 225 includes a bend of about 180 degrees. As such, in some embodiments, the distal section 230 may be substantially parallel with the proximal section 210. In other embodiments, the curved shape 225 may be bent further than 180 degrees. For example, in some embodiments, the curved shape 225 may include a bend greater than about 180 degrees so that the distal end 202 is disposed near the proximal section 210. In some embodiments, the curved shape 225 may include a closed loop. In some embodiments, a bend diameter 225A of the curved shape 225 may be less than the first lumen diameter 121A. A such, stylet 200 may be inserted into the first lumen 121, when the interposed section 220 includes the curved shape 225.

[0057] The stylet 200 may include different stiffness characteristics along various sections of the stylet 200. In the illustrated embodiment, the proximal section 210 includes a first stiffness 212, the distal section 230 include a second stiffness 232 and the interposed section 220 includes a third stiffness 222. In some embodiments, the first stiffness 212 may be configured to enable a pushability of the catheter 100 when the proximal section 210 is disposed within the first lumen 121. In other words, the first stiffness 212 of the proximal section 210 may prevent buckling of the catheter tube 120 during advancement of the catheter tube 120 along the vasculature. In some embodiments, a first stiffness 212 may be greater than the second stiffness 232 and the third stiffness 222, and in some embodiments, the second stiffness 232 may be greater than the third stiffness 222.

[0058] The third stiffness 222 is generally configured to enable bending of the interposed section 220 between the curved shape 225 and a straight shape during use. In some embodiments, the interposed section 220 may include a resiliency so that when the interposed section 220 is deflected away from the curved shape 225 via an external force, the curved shape 225 returns upon removal of the external force. In other embodiments, the interposed section 220 may be configured to plastically bend between the curved shape 225 and a straight shape. In other words, when the interposed section 220 is deflected away from the curved shape 225 toward a straight shape via the external force, the interposed section 220 remains in the straight shape upon removal of the external force.

[0059] In some embodiments, the interposed section 220 is configured for extraction from the first lumen 121 in a straight or straightened shape. In some embodiments, the interposed section 220 is configured to flex away from the curved shape 225 toward the straight shape during extraction of the stylet 200 from at least one of the second lumen 122 or the first lumen 121. More specifically, the interposed section 220 is configured to straighten away from the curved shape 225 as a result of the stylet 200 being extracted from the catheter 100.

[0060] FIG. 3A illustrates a catheter assembly 300 including the stylet 200 coupled with the catheter 100. FIG. IB illustrates a detailed view of a distal portion of the catheter tube 120 including the split distal tip 130. Referring to FIGS. 3A-3B, the stylet 200 is inserted the first extension leg 111 and advanced along the first lumen 121 of the catheter tube 120 such that the proximal section 210 extends between the proximal end 311 of the first extension leg 111 and the distal end 331 of the first distal extension 131. The distal section 230 is inserted into the second lumen 122 via the distal end 332 of the second distal extension 132. The interposed section 220 extends between the first lumen 121 and the second lumen 122. The stylet 200, when coupled with catheter 100, deflects the first and second distal extensions 131, 132 toward each other so that the first and second distal extensions 131, 132 are constrained adjacent each other. With the first and second distal extensions 131, 132 are constrained adjacent each other (i.e., no longer splayed away from each other), the catheter tube 120 is configured for insertion into and advancement along the vasculature of the patient.

[0061] In the illustrated embodiment, the distal section 230 of the stylet 200 extends proximally only partially along the second distal extension 132. The bend diameter 225A of the curved shape 225 is defined such that (i) the proximal section 210 is disposed adjacent the first luminal wall 13 IB and the distal section 230 is disposed adjacent the second luminal wall 132B. As such, the curved shape 225 is configured to constrain the first luminal wall 13 IB adjacent second luminal wall 132B. In the illustrated embodiment, the interposed section 220 is disposed within the first slot 13 ID and the second slot 132D.

[0062] With further reference to the FIG. 3 A, an optional securement member 340 may be coupled with the stylet 200 along the proximal section 210. The proximal section 210 extends proximally away from the proximal end 311 of the first extension leg 111 and the securement member 340 is located on the proximal section 210 adj acent the proximal end 311. The securement member 340 is generally configured to provide a displacement stop for the stylet 200. In other words, the securement member 340 is configured to limit distal displacement of the stylet 200 along the first lumen 121.

[0063] In some embodiments, the securement member 340 may be permanently attached to the stylet 200 at a fixed location. In other embodiments, the securement member 340 may be positionably attached to the stylet 200 such that a clinician may adjust the location of the securement member 340 along the stylet 200. The securement member 340 may take the form of any suitable device, such as a clamp, a collar, or a volume of adhesive, for example.

[0064] In some embodiments, the during insertion and advancement of the catheter 100 within the patient vasculature, the catheter 100 may threaded over a guidewire 350. The guidewire 350 may threaded through either the first lumen 121 or the second lumen 122. As such, in some embodiments, the catheter assembly 300 may include the guidewire 350.

[0065] FIGS. 4A-4G illustrate detailed views of the distal portion of the catheter assembly 300 is various states of assembly and use. Shown generally in FIGS. 4A-4G are the catheter tube 120, the first distal extension 131 and the second distal extension 132. The various portions of the stylet 200, i.e., the proximal section 210, the distal section 230 and the interposed section 220 including the curved shape 225, are also shown in various states of insertion and extraction. FIGS. 4A-4D illustrate states of assembly of the catheter assembly 300 prior to in preparation for inserting the catheter assembly 300 into the patient. FIGS. 4E- 4G illustrate states of disassembly of the catheter assembly 300 (i.e., separation of the stylet 200 from the catheter 100) after inserting the catheter assembly 300 into the patient, i.e., while the catheter 100 is disposed within the patient.

[0066] FIG. 4 A illustrates the split distal tip 130 in the free state, including the first and second distal extensions 131, 132 splayed away from each other. The stylet 200 is shown partially inserted into the first lumen 121, and the interposed section 220 includes the curved shape 225.

[0067] FIG. 4B illustrates the split distal tip 130 in the free state, including the first and second distal extensions 131, 132 splayed away from each other. The stylet 200 is shown fully inserted into and advanced along the first lumen 121 such that the proximal section 210 extends distally beyond the distal end 431, and the interposed section 220 and the distal section 230 are disposed beyond the distal end 431 of the first distal extension 131.

[0068] FIG. 4C illustrates the split distal tip 130 in deflected state. Inward facing forces 401, 402 exerted on the first and second distal extensions 131, 132 have deflected the first and second distal extensions 131, 132 toward each other so that the first and second distal extensions 131, 132 are disposed adjacent one another. The stylet 200 is still shown fully inserted into and advanced along the first lumen 121 such that the proximal section 210 extends distally beyond the distal end 431, and the interposed section 220 and the distal section 230 are disposed beyond the distal end 431 of the first distal extension 131.

[0069] FIG. 4D illustrates the split distal tip 130 in the deflected state of FIG. 4C. The stylet 200 is shown proximally displaced in relation to the position shown in FIG. 4C. As such, the distal section 230 is proximally inserted into the second lumen 122 and the interposed section 220 extends between the first lumen 121 and the second lumen 122, i.e., across the first luminal wall 13 IB and the second luminal wall 132B. As such, the stylet 200 is fully coupled with the catheter 100 so that the first and second distal extensions 131, 132 are constrained adjacent to one another. In the fully coupled state, the catheter assembly 300 is configured for (i.e., ready for) insertion into the patient.

[0070] FIG. 4E illustrates the split distal tip 130 in deflected state of FIG. 4C after the catheter assembly 300 has been placed within the patient (not shown). The stylet 200 is shown proximally extracted in relation to the position shown in FIG. 4D. As such, the proximal section 210 is proximally displaced with the first lumen 121 in relation to the position shown in FIG. 4D. The distal section 230 is shown distally displaced within the second lumen 122 in relation to the position shown in FIG. 4D. The distal section 230 is partially extracted from the second lumen 122. The interposed section 220 is shown entering the first lumen 121 and interposed section 220 is shown deflected away from the curved shape 225 toward a straight shape.

[0071] FIG. 4F illustrates the split distal tip 130 in deflected state of FIG. 4E. The stylet 200 is shown proximally extracted further in relation to the position shown in FIG. 4E. As such, the proximal section 210 is proximally displaced further within the first lumen 121 in relation to the position shown in FIG. 4D. The interposed section 220 is shown further drawn into the first lumen 121 in relation to the position shown in FIG. 4E and interposed section 220 is shown further deflected away from curved shape 225 toward the straight shape. The distal section 230 is shown fully extracted from the second lumen 122 and partially drawn into the first lumen 121.

[0072] FIG. 4G illustrates the split distal tip 130 in the splayed state of FIG. 4A. The stylet 200 is shown proximally extracted further in relation to the position shown in FIG. 4F. The interposed section 220 and the distal section 230 are shown fully drawn into the first lumen 121. The interposed section 220 is shown deflected further away from curved shape 225 toward the straight shape in relation to the shape of FIG. 4F.

[0073] FIG. 5 illustrates a flow chart of a method 500 of placing a catheter within a patient, where the method 500 may include all or any subset of the following steps, actions or processes. The method 500 may include coupling the stylet with the catheter (block 510). In some embodiments, coupling the stylet includes distally advancing the stylet along the first lumen. In some embodiments, the interposed section is inserted into the first lumen with interposed section disposed in the curved shape. In some embodiments, coupling the stylet with the catheter further includes advancing the distal section of the stylet proximally along the second lumen to couple the first distal extension to the second distal extension.

[0074] The method 500 may include advancing the catheter along a vasculature of the patient (block 520), where the catheter includes the split distal tip.

[0075] The method 500 may further include extracting the stylet from the catheter (block 530). Extracting the stylet from the catheter further includes extracting the stylet from the first lumen and the second lumen of the catheter. As a result of extracting the stylet the first distal extension of the split distal tip is decoupled from the second distal extension of the split distal tip so that the first and second distal extensions may splay away from each other.

[0076] In some embodiments, extracting the stylet includes proximally extracting the stylet from the first lumen of the catheter and distally extracting the stylet from the second lumen of the catheter. In some embodiments, extracting the stylet includes extracting the distal section of the stylet from the second lumen and drawing the distal section of the stylet into the first lumen.

[0077] The method 500 may further include transitioning a curved shape of the stylet toward a straight shape (block 540) or more specifically, transitioning an interposed section of the stylet away from a curved shape toward a straight shape, where the interposed section is located between the proximal section and a distal section and where the interposed section includes the curved shape in a free state of the stylet.

[0078] FIGS. 6A-6B illustrate another embodiment of a catheter assembly that can, in certain respects, resemble components of the catheter assembly described in connection with FIGS. 1 A-3B. It will be appreciated that all the illustrated embodiments may have analogous features. Accordingly, like features may be designated with the same reference numerals. Relevant disclosure set forth above regarding similarly identified features thus may not be repeated hereafter. Moreover, specific features of the catheter assembly 300 and related components shown in FIGS. 1 A-3B may not be shown or identified by a reference numeral in the drawings or specifically discussed in the written description that follows. However, such features may clearly be the same, or substantially the same, as features depicted in other embodiments and/or described with respect to such embodiments. Accordingly, the relevant descriptions of such features apply equally to the features of the catheter assembly 600 of FIGS. 6A-6B. Any suitable combination of the features, and variations of the same, described with respect to the catheter assembly 300 and components illustrated in FIGS. 1A-3B can be employed with the catheter assembly 600 and components of FIGS. 6A-6B, and vice versa.

[0079] FIG. 6 A illustrates the catheter assembly 600 including the catheter 100 and a stylet 620. The stylet 620 is inserted entirely through each of the first lumen 121 and the second lumen 122. More specifically, the stylet 620 is inserted proximately along the first lumen 121 and distally along the second lumen 122. The stylet 620 extends between the first and second distal extensions 131, 132 forming a loop 625 between the first lumen 121 and the second lumen 122 at the split distal tip 130. First and second end portions 621, 622 of the stylet 620 extend proximally away from the extension legs 111, 112.

[0080] FIG. 6B illustrates a distal portion of the catheter tube 120 including the distal tip 130, where the stylet 620 is fully coupled with the catheter 100. Tension has been applied to the stylet 620 at the first and second end portions 621, 622 so that tension in the loop 625 pulls the first and second distal extensions 131, 132 adjacent to one another.

[0081] In use, prior to and in preparation for insertion of the catheter tube 120 with in a vasculature, the stylet 620 is threaded through each of the first lumen 121 and the second lumen 122 to form the loop 625. Tension is then applied to the stylet to transition the first and second distal extensions 131, 132 away from the splayed configuration to the adjacent configuration. After placement of the catheter tube 120 with in a vasculature, tension is released from the first and second end portions 621, 622 and the stylet 620 is drawn out of the first lumen 121 and the second lumen 122 by pulling on either one of the first end portion 621 or the second end portion 622.

[0082] While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. Additional adaptations and/or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations and/or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

CLAIMS What is claimed is:

1. A catheter assembly, comprising: a catheter comprising: a catheter tube having at least a first lumen and a second lumen extending a long the catheter tube; at least a first extension leg and a second extension leg extending proximally away from a proximal end of the catheter tube; and a split distal tip of the catheter tube defining a first distal extension and a second distal extension, wherein: the first lumen extends along the first extension leg and the first distal extension, and the second lumen extends along the second extension leg and the second distal extension; and a stylet coupled with the catheter, wherein the stylet is: inserted into the first lumen via the first extension leg, and further inserted into the second lumen via the second distal extension.

2. The assembly according to claim 1, wherein: the split distal tip is configured such that the first distal extension and the second distal extension are splayed away from each other when the split distal tip is disposed in a free state, and the stylet deflects the first and second distal extensions toward each other when the stylet is coupled with the catheter.

3. The assembly according to claim 1 or claim 2, wherein a length of the stylet extending between the first and second distal extensions is less than a diameter of the catheter tube.

4. The assembly according to any of the preceding claims, wherein the stylet extends along the second lumen to the second extension leg.

5. The assembly according to any of the preceding claims, further comprising a guidewire disposed within at least one of the first lumen or the second lumen.

6. The assembly according to any of the preceding claims, wherein: a first luminal wall of the first distal extension includes a first slot extending through the first luminal wall, a second luminal wall of the second distal extension includes a second slot extending through the second luminal wall, and the stylet is disposed within the first slot and the second slot.

7. The assembly according to claim 6, wherein a length of the stylet extending between the first lumen and the second lumen is substantially equal to a sum of a thickness of the first luminal wall and a thickness of the second luminal wall.

8. The assembly according to any of claims 1-3 or claims 5-7, wherein: a proximal section of the stylet is disposed within the first lumen, a distal section of the stylet is disposed within the second lumen, an interposed section of the stylet disposed between the proximal section and the distal section extends between the first lumen and the second lumen.

9. The assembly according to claim 8, wherein a length of the proximal section is greater than a length of the distal section.

10. The assembly according to claim 8 or claim 9, wherein the length of the distal section is greater than a length of the interposed section.

11. The assembly according to any of claims 8-10, wherein the length of the distal section is less than a length of the second distal extension.

12. The assembly according to any of claims 8-11, wherein a length of the distal section is less than the diameter of the catheter tube.

13. The assembly according to any of claims 8-12, wherein the proximal section and the distal section include a substantially straight shape in a free state of the stylet.

14. The assembly according to any of claims 8-13, wherein the interposed section includes a curved shape in the free state of the stylet.

15. The assembly according to claim 14, wherein the curved shape includes a bend of about 180 degrees.

16. The assembly according to claim 15, wherein a diameter of the bend is less than a diameter of the first lumen.

17. The assembly according to claim 15 or claim 16, wherein the distal section is disposed substantially parallel the proximal section in the free state of the stylet.

18. The assembly according to any of claims 8-17, wherein a first stiffness of the proximal section is greater than (i) a second stiffness of the distal section and (ii) a third stiffness of the interposed section.

19. The assembly according to claim 18, wherein the second stiffness is greater than the third stiffness.

20. The assembly according to any of claims 14-19, wherein the interposed section is configured to plastically bend between the curved shape and a straight shape.

21. The assembly according to any of claims 14-20, wherein the interposed section includes the curved shape when the stylet is inserted along the first lumen.

22. The assembly according to any of claims 14-21, wherein the interposed section includes a substantially straight shape when the stylet is extracted along the first lumen.

23. The assembly according to claim 22, wherein the interposed section is configured to flex away from the curved shape toward the straight shape during extraction of the stylet from at least one of the second lumen or the first lumen.

24. The assembly according to claim 23, wherein extraction of the stylet causes the interposed section to flex away from the curved shape toward the straight shape.

25. The assembly according to any of the preceding claims, further comprising: a securement member attached to the stylet adjacent the first extension leg, the securement member configured to limit distal displacement of the stylet along the first lumen.

26. An elongate stylet for placement within a catheter, comprising: a proximal section extending distally away from a proximal end of the stylet, the proximal section configured for placement within the first lumen of the catheter; a distal section extending proximally away from a distal end of the stylet, the distal section configured for placement within the second lumen of the catheter; and an interposed section extending between the proximal section the distal section, the interposed section configured to extend between the first lumen and the second lumen.

27. The stylet according to claim 26, wherein: the catheter defines a split distal tip, including: a first distal extension having the first lumen; a second distal extension having the second lumen, the first and second distal extensions splayed away from each other in a free state of the catheter, and the stylet is configured to deflect the first and second distal extensions toward one another such that the first distal extension is disposed adjacent the second distal extension.

28. The stylet according to claim 27, wherein the proximal section is configured to extend along the first lumen between the first distal extension and a first extension leg of the catheter.

29. The stylet according to claim 27 or claim 28, wherein the distal section is configured to extend along the second lumen between the second distal extension and a second extension leg of the catheter.

30. The stylet according to any of claims 26-29, wherein a length of the proximal section is greater than a length of the distal section.

31. The stylet according to claim 30, wherein the length of the distal section is greater than a length of the interposed section.

32. The stylet according to claim 30 or claim 31, wherein the length of the distal section is less than a length of the second distal extension of the split distal tip.

33. The stylet according to any of claims 30-32, wherein: the catheter includes a catheter tube configured for advancement along a vasculature of a patient, and the length of the distal section is less than a diameter of the catheter tube.

34. The stylet according to any of claims 26-32, wherein the proximal section and the distal section include a substantially straight shape in a free state of the stylet.

35. The stylet according to any of claims 26-33, wherein the interposed section includes a curved shape in the free state of the stylet.

36. The stylet according to claim 35, wherein the curved shape includes a bend of about 180 degrees.

37. The stylet according to claim 35 or claim 36, wherein the interposed section is configured for insertion through the first lumen in the curved shape.

38. The stylet according to any of claims 35-37, wherein a diameter of the bend is less than a diameter of the first lumen.

39. The stylet according to any of claims 36-38, wherein the distal section is disposed substantially parallel with the proximal section in the free state of the stylet.

40. The stylet according to any of claims 26-39, wherein a first stiffness of the proximal section is greater than (i) a second stiffness of the distal section and (ii) a third stiffness of the interposed section.

41. The stylet according to claim 40, wherein the second stiffness is greater than the third stiffness.

42. The stylet according to any of claims 35-41, wherein the interposed section is configured to plastically deform between the curved shape a straight shape.

43. The stylet according to claim 42, wherein the interposed section is configured for extraction of the stylet from the first lumen in the straight shape.

44. The stylet according to claim 43, wherein the interposed section is configured to flex away from the curved shape toward the straight shape during extraction of the stylet from at least one of the second lumen or the first lumen.

45. A method of placing a catheter within a patient, comprising: advancing the catheter along a vasculature of the patient, the catheter including a split distal tip; and extracting a stylet from a first lumen and a second lumen of the catheter, wherein extracting a stylet includes decoupling a first distal extension of the split distal tip from a second distal extension of the split distal tip, thereby enabling the first and second distal extensions to splay away from each other.

46. The method according to claim 45, wherein extracting a stylet includes: proximally extracting the stylet from a first lumen of the catheter; and distally extracting the stylet from a second lumen of the catheter.

47. The method according to claim 46, wherein extracting a stylet includes: proximally drawing the distal section of the stylet into the first lumen.

48. The method according to any of claims 45-47, wherein extracting a stylet includes transitioning an interposed section of the stylet from a curved shape toward a straight shape, the interposed section located between the proximal section and a distal section.

49. The method according to any of claims 45-48, further comprising coupling the stylet with the catheter, wherein coupling the stylet includes distally advancing the stylet along the first lumen, and wherein the interposed section is disposed in the curved shape.

50. The method according to claim 49, wherein coupling the stylet with the catheter further includes advancing the distal section of the stylet proximally along the second lumen to couple the first distal extension to the second distal extension.