CN114269421A - Rotatable dilator and delivery system - Google Patents

Abstract

The delivery system comprises: a sheath barrel having an outer tube surrounding a hollow interior; and a dilator configured to fit at least partially within the hollow interior of the sheath. The dilator comprises: a distal portion configured to at least partially dilate a blood vessel; a middle portion; a proximal portion; and a lumen extending through the distal portion, the intermediate portion, and the proximal portion.

Description

Rotatable dilator and delivery system

RELATED APPLICATIONS

This application claims priority from U.S. provisional application No. 62/890,533 entitled rotable die or AND DELIVERY SYSTEMS filed on 22.8.2019, the disclosure of which is incorporated by reference in its entirety.

Background

The present disclosure relates generally to the field of delivering medical implant devices and/or treatments.

The heart may be subjected to transcatheter delivery of implant devices and/or therapies to address various cardiac abnormalities. The heart may be subjected to delivery of implant devices and/or therapies to treat various conditions, such as left atrial pressure elevation.

Disclosure of Invention

For the purposes of summarizing the disclosure, certain aspects, advantages, and novel features have been described herein. It is to be understood that not necessarily all such advantages may be achieved in accordance with any particular embodiment. Thus, the disclosed embodiments can be implemented in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.

Some embodiments of the present disclosure relate to a delivery system, comprising: a sheath (sheath) having an outer tube surrounding a hollow interior; and a dilator configured to fit at least partially into the hollow interior of the sheath barrel. The dilator comprises: a distal portion configured to at least partially dilate a blood vessel; a middle portion; a proximal portion; and a lumen extending through the distal portion, the intermediate portion, and the proximal portion.

The dilator may have a cylindrical shape surrounding the lumen. In some embodiments, the distal portion has an at least partially tapered surface. The intermediate portion may be located between the distal portion and the proximal portion.

In some embodiments, the intermediate portion has the largest diameter of the dilator. The diameter at the proximal portion may be less than the maximum diameter of the dilator.

In some embodiments, there is at least one gap between the dilator and the sheath barrel when the dilator is positioned within the hollow interior of the sheath barrel.

The at least one gap may be between the proximal portion and the sheath. In some embodiments, the proximal portion is configured to not contact the sheath. There may be no gap between the intermediate portion and the sheath. In some embodiments, the lumen of the dilator is configured to fit the puncture needle.

The dilator may be configured to twist while at least partially within the hollow interior of the sheath.

In some embodiments, the torsion dilator may be configured to cause the puncture needle within the lumen of the dilator to twist. The dilator may be configured to tilt when at least partially within the hollow interior of the sheath.

Some embodiments of the present disclosure relate to a dilator configured to fit at least partially within a hollow interior of a sheath. The dilator comprises: a distal portion configured to at least partially dilate a blood vessel; a middle portion; a proximal portion; and a lumen extending through the distal portion, the intermediate portion, and the proximal portion.

In some embodiments, the intermediate portion has a cylindrical shape surrounding the lumen. The distal portion may have an at least partially tapered surface.

In some embodiments, the intermediate portion is located between the distal portion and the proximal portion. The intermediate portion may have the largest diameter of the dilator.

In some embodiments, the diameter at the proximal portion is less than the maximum diameter of the dilator. The proximal portion may be configured to form at least one gap between the proximal portion and the sheath.

In some embodiments, the proximal portion is configured to not contact the sheath.

The intermediate portion may be configured to make gapless contact with the sheath. In some embodiments, the lumen is configured to accommodate a puncture needle.

The distal portion may be configured to twist when at least partially positioned within the sheath. In some embodiments, twisting the distal portion is configured to cause twisting of the needle within the lumen at the distal portion. The distal portion may be configured to tilt when at least partially positioned within the sheath.

Some embodiments of the present disclosure relate to methods comprising introducing a sheath and a dilator into a blood vessel. The dilator is at least partially positioned within the sheath, and the dilator includes a lumen. The method further includes inserting the needle through a lumen of the dilator, twisting the dilator to cause the needle to twist to a desired position, and pushing the needle out of a distal end of the dilator.

In some embodiments, there is at least one gap between the dilator and the inner surface of the sheath barrel. At least a portion of the dilator may be in gapless contact with the sheath.

Drawings

Various embodiments are depicted in the drawings for purposes of example, and should not be construed to limit the scope of the invention in any way. In addition, various features of different disclosed embodiments may be combined to form additional embodiments that are part of this disclosure. Throughout the drawings, reference numbers may be reused to indicate correspondence between reference elements. It should be understood, however, that the use of like reference numbers in connection with multiple figures does not necessarily indicate a similarity between their associated corresponding embodiments. Furthermore, it should be understood that the features of the corresponding drawings are not necessarily drawn to scale and that example dimensions thereof are shown for the purpose of illustrating the inventive aspects thereof. In general, some of the illustrated features may be relatively smaller than that shown in some embodiments or configurations.

Fig. 1 is a cross-sectional view of a human heart.

Fig. 2 is a side view of an example delivery system including a sheath and a flared end positioned within a human vessel, according to some embodiments.

Fig. 3 provides a cross-sectional view of a steerable sheath according to some embodiments.

Fig. 4 provides a cross-sectional view of an example dilator, according to some embodiments.

Fig. 5A-5D illustrate a delivery system including a sheath and a dilator, according to some embodiments.

Fig. 6A and 6B illustrate an example needle delivery process for a delivery system including a dilator, sheath, and/or needle, according to some embodiments.

Fig. 7 is a flow diagram of a process for deploying a delivery system including a dilator and a sheath into and/or through a vessel, according to some embodiments.

Detailed Description

The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

Various features of the heart 1 are described with reference to fig. 1 to aid in understanding the present disclosure. The heart 1 comprises four chambers, namely the left atrium 2, the left ventricle 3, the right ventricle 4 and the right atrium 5. A muscular wall called the septum 17 separates the left atrium 2 from the right atrium 5 and separates the left ventricle 3 from the right ventricle 4. Blood flow through the heart 1 is at least partially controlled by four valves, a mitral valve 6, an aortic valve 7, a tricuspid valve 8, and a pulmonary valve 9. The mitral valve 6 separates the left atrium 2 from the left ventricle 3 and controls blood flow therebetween. The aortic valve 7 separates the left ventricle 3 from the aorta 12 and controls blood flow therebetween. The tricuspid valve 8 separates the right atrium 5 from the right ventricle 4 and controls blood flow therebetween. The pulmonary valve 9 separates the right ventricle 4 from the pulmonary artery 11, controlling blood flow therebetween.

In a healthy heart, heart valves may open and close appropriately in response to pressure gradients present in various phases of the cardiac cycle (e.g., diastole and systole) to at least partially control the flow of blood to corresponding regions and/or vessels of the heart. Deoxygenated blood arriving from other parts of the body generally flows into the right side of the heart for delivery to the lungs, and oxygenated blood from the lungs generally flows into the left side of the heart for delivery to other parts of the body. During ventricular diastole, deoxygenated blood reaches the right atrium 5 from the inferior vena cava 18 and the superior vena cava 19 to flow into the right ventricle 4, and oxygenated blood reaches the left atrium 2 from the pulmonary veins to flow into the left ventricle 3. During ventricular systole, deoxygenated blood from the right ventricle 4 may flow into the pulmonary artery 11 for delivery to the lungs (e.g., via the left and right pulmonary arteries), and oxygenated blood may flow from the left ventricle 3 to the aorta 12 for delivery to other parts of the body.

Various conditions may cause pressure in the left atrium 2 to be higher than normal. Dysfunction of the mitral valve 6 may promote an increase in left atrial pressure. Conditions such as mitral regurgitation and/or stenosis may cause difficulty in pumping blood from the left atrium 2 to the left ventricle 3, causing the pressure in the left atrium 2 to rise. Valve stenosis can result in narrowing or obstruction of the valve. Mitral stenosis may restrict blood flow from the left atrium 2 to the left ventricle 3. Valve regurgitation occurs when the valve is not normally closed. For example, regurgitation may occur due to improper leaflet coaptation. Mitral regurgitation can cause blood to leak from the left ventricle 3 back into the left atrium 2 as the left ventricle 3 contracts. The atrial pressure may be promoted by both restricted blood flow from the left atrium 2 into the left ventricle 3 and leakage of blood flow from the left ventricle 3 back into the left atrium 2. Dysfunction of the left ventricle 3 may also contribute to an increase in left atrial pressure. The increased left atrial pressure may cause the left atrium to enlarge, producing symptoms such as shortness of breath (fatigue), chest pain, fainting, abnormal heart beat, swelling of legs and feet.

Various medical procedures for treating and/or preventing various cardiac conditions include the use of steerable sheath/catheter systems. The steerable sheath can be used to facilitate introduction of various medical devices into the human body. For example, the steerable sheath cartridge may be used in cardiopulmonary bypass procedures such as minimally invasive aortic valve replacement procedures, mitral valve repair or replacement procedures, tricuspid valve procedures, re-surgery, intracardiac myxoma resection (intracardiac myxoma recovery), patent foramen ovale repair, atrial septal defect repair, and ablation maze procedures for atrial fibrillation. The steerable sheath may utilize one or more dilators and/or steerable sheath tips to enable improved insertion and/or navigation through the coronary sinus. In some cases, the dilator may have an at least partially tapered surface, which may enable effective tracing and/or pre-dilation of the vessel.

Fig. 2 is a side view of an example delivery system 200 that includes a sheath 201 and a flared end 202 positioned within a body vessel 205 (e.g., coronary sinus). A cross-sectional view of a blood vessel 205 is shown. The sheath 201 and the dilating tip 202 may be separate devices and/or may constitute a single device. For example, the flared end 202 may extend from the sheath 201. However, the flared end 202 may alternatively be a separate device from the sheath 201. In some embodiments, the dilating end 202 may have a tapered and/or conical shape to gradually dilate at least some portions of the blood vessel 205. For example, portions of the blood vessel 205 may have a smaller diameter than portions of the delivery system 200. Thus, the flared end 202 may first enter the blood vessel 205, and as the delivery system 200 is moved through the blood vessel 205, the surface of the flared end 202 may contact the inner wall of the blood vessel 205 and press and/or expand the blood vessel 205 outward to accommodate the delivery system 200.

The delivery system 200 may be at least partially removed from the body after delivery. For example, with the flared end 202 separated from the sheath 201, the flared end 202 may be removed from the body after delivery. This is because the purpose of the expanded end 202 may be to expand the vessel 205 to allow the sheath 201 to fit within the vessel 205. After the sheath 201 is positioned at the desired location within the vessel 205, the flared end 202 may not serve any purpose and/or may impede other operations, including delivery of needles and/or other devices through the sheath 201.

Some embodiments described herein provide improved sheaths, dilators, and/or other delivery devices and/or improved methods for manipulating and/or otherwise delivering sheaths and/or other instruments into and/or through a human vessel. The terms "dilator," "dilating end," and/or "dilating device" are used herein in their broad and conventional sense and may refer to any device and/or set of devices configured to dilate and/or pre-dilate a blood vessel and/or otherwise facilitate insertion and/or navigation of a sheath into and/or through the body. Similarly, the terms "sheath barrel," "catheter" and/or "steerable sheath barrel" are used herein in their ordinary and customary meaning and may refer or be applicable to generally any type of elongated and/or tubular delivery device, which may include a sheath barrel, catheter, tube, cannula and/or shaft (e.g., inner/outer shaft). The sheath may include a lumen configured to slidably receive an instrument, such as for placement within the atrium and/or coronary sinus.

The dilators described herein may have an at least partially tapered (e.g., conical) surface, at least at or near the distal/distal portion of the dilator. A dilator may be introduced into a blood vessel to stretch the vessel and create a sufficiently sized opening for a sheath (e.g., a steerable sheath) or various other devices. The dilator may be configured to fit at least partially inside the sheath barrel, and/or at least a portion of the dilator may be configured to protrude from the distal end of the sheath barrel. For example, the tapered (distal) end of the dilator may be configured to at least partially protrude from the sheath. The dilator and sheath may be configured to be introduced together to access the inferior vena cava, ostium (otium), coronary sinus, and/or other vessels and/or chambers of the human body. In some cases, the dilator may have a lumen configured to receive various instruments. Thus, the dilator may be retained within the body after delivery to provide a port through which various needles, catheters, guidewires, and/or other devices may be inserted.

Some embodiments described herein provide steerable sheaths and/or dilators that can be used to facilitate delivery of various devices, including, for example, shunt needles. In some embodiments, the dilator may be configured to act as a conduit for delivering shunt needles and similar devices. For example, the dilator may have a lumen configured to receive various instruments. Thus, the dilator may not be removed after delivery of the dilator and/or steerable sheath, but may be configured for post-delivery use.

In some cases, at least a portion of the dilator may be configured to fit tightly into the lumen of the sheath. For example, when the dilator is positioned within the lumen of the sheath, there may be no gap (e.g., no gap contact) and/or minimal gap between at least a portion of the outer surface of the dilator (e.g., the middle portion) and the inner surface of the sheath. The gapless portion of the dilator can have an approximately cylindrical shape to conform to the cylindrical inner surface of the sheath. The surface of the gapless (e.g., middle) portion of the dilator may be generally solid and/or smooth without dimples (dimples), grooves, and/or other features that may form a gap between the dilator and the sheath. However, if the entire dilator is configured to fit tightly and/or without gaps within the lumen of the sheath, it may be difficult to rotate, twist, and/or otherwise adjust the dilator when it is at least partially within the sheath. For example, contact between the outer surface of the dilator and the inner surface of the sheath barrel can cause excessive friction when the dilator is twisted or otherwise adjusted, making it difficult for the surgeon to navigate the dilator and/or sheath barrel.

The steerable sheath and/or dilator described herein can be configured to reduce surface contact between the steerable sheath and dilator. For example, the diameter of at least a portion of the dilator can be sufficiently smaller than the inner diameter of the sheath such that when the dilator is positioned within the lumen of the sheath, there can be at least one gap between at least a portion of the dilator and the sheath on one or more sides of the dilator and/or sheath. Further, at least a portion of the dilator may not contact the sheath when the dilator is positioned within the sheath. In this manner, friction may be reduced and/or minimized when the dilator and/or sheath are twisted or otherwise adjusted, and the surgeon may more easily and/or effectively control the sheath and/or dilator.

The devices and/or methods described herein may provide several advantages. In some embodiments, the dilator may have multiple functions. For example, the dilator may be used as a system access tool and/or an instrument (e.g., guidewire and/or needle) delivery device. The use of a dilator as a system access tool may reduce the number of devices that may need to be introduced into the body. Further, the sheath may be configured to have a much smaller profile, as no additional access tools may be required to pass through the sheath. Due at least in part to the multiple functions of the dilator, at least one catheterization step may be eliminated. Further, unlike some conventional sheath and/or dilator designs in which there may be a tight fit between the sheath and dilator, some of the dilators described herein may be able to move freely within the sheath due to reduced surface contact between the dilator and the inner surface of the sheath.

Fig. 3 provides a cross-sectional view of a steerable sheath 300 according to some embodiments. The sheath 300 may be an elongated device having an outer tube 301 and/or a lumen 302, which may include a generally hollow region/interior at least partially or completely surrounded by the outer tube 301 along at least one axis (e.g., transverse cross-section). In some embodiments, the lumen 302 may have a generally tubular (e.g., cylindrical) form. The outer tube 301 may have a cylindrical/tubular or other shape, and/or may be shaped and/or sized to fit through a blood vessel of a human body. In some embodiments, the outer tube 301 may be at least partially flexible to allow the sheath 300 to bend. The outer tube 301 may include an inner surface 301a and/or an outer surface 301 b. The inner surface 301a can be configured to be exposed to the lumen 302 of the sheath 300, and the outer surface 301b can be configured to be exposed to a human blood vessel and/or other region or chamber in which the sheath 300 can be disposed. The outer tube 301 may have any thickness (i.e., the distance between the inner surface 301a and the outer surface 301 b). In some embodiments, the outer tube 301 may have a constant and/or uniform thickness at various points of the outer tube 301. However, the outer tube 301 may have a variable thickness.

The lumen 302 may be a lumen and/or an at least partially empty space through the outer tube 301 of the sheath 300. In some embodiments, the lumen 302 may extend from the distal end 305 of the sheath to the proximal end of the sheath 300. The distal end 305 of the sheath 300 may include an opening into the sheath and/or into the lumen 302 of the sheath 300 (e.g., an exemplary vertical line at the distal end 305 may represent the outer tube 301). The lumen 302 may have a first diameter 306 representing the distance between opposing portions of the inner surface 301 a. The lumen 302 may have a constant diameter along the entire length of the outer tube 301 (e.g., the first diameter 306 may be the diameter of the lumen 302 at any point of the lumen 302), and/or the lumen 302 may have a varying diameter. In some embodiments, the outer tube 301 may include a tapered section 312 at or near the distal end 305 of the sheath barrel 300. The tapered section 312 may represent a portion of the outer tube 301 where the thickness of the outer tube 301 is less than the maximum thickness of the outer tube 301. In some embodiments, the tapered section 312 may represent a gradual decrease and/or increase in the thickness of the outer tube 301. The slope of the tapered section 312 may match the slope of a dilator that may be used in conjunction with the sheath 300. However, in some cases, the dilator may be used separately from the sheath 300 and/or without the sheath 300.

In some embodiments, the sheath 300 may be configured to receive a pull wire 308 or similar device. The pull wire 308 may comprise a wire or similar device and/or may be configured to be at least partially positioned within the outer tube 301 of the sheath barrel 300. The pull wire 308 may be configured to assist the surgeon in manipulating and/or otherwise controlling the sheath 300. For example, the distal end 305 of the sheath barrel 300 may be bent and/or manipulated when the pull wire 308 is pulled and/or tensioned. In some embodiments, the pull wire 308 may be configured to attach to, weld to, contact, and/or extend from the pull ring 310 or similar device. The pull wire 308 and/or the pull ring 310 may be configured to be positioned within the outer tube 301 (e.g., between the inner surface 301a and the outer surface 301 b) and/or within the lumen 302. In some embodiments, the pull wire 308 may be attached to the pull loop 310 by welding and/or other methods. An actuator and/or the like may be used to manipulate the sheath 300.

In some embodiments, the outer tube 301 may have a generally constant thickness (i.e., the distance between the inner surface 301a and the outer surface 301 b) across the entire length of the outer tube 301 (e.g., from the distal end 305 to the proximal end). However, the outer tube 301 may have a varying thickness. For example, at least some portions of the inner surface 301a may be configured to have a corrugated and/or otherwise indented structure such that a thickness of at least some portions of the outer tube 301 may be less than a maximum thickness of the outer tube 301. Thus, the lumen 302 of the sheath 300 may have a varying diameter. For example, the diameter of the lumen 302 may be increased at the sheath 300 site where the outer tube 301 has a reduced thickness. Additionally or alternatively, the diameter of the outer tube 301 may be reduced at the location of the sheath 300 where the outer tube 301 has a reduced thickness. For example, the inner surface 301a of the outer tube 301 may have a generally flat shape, and the outer surface 301b of the outer tube 301 may have a wavy, jagged (jagged), bumpy (bump), indented, and/or otherwise at least partially non-flat shape.

Since fig. 3 provides a cross-sectional view of the sheath 300, the various components of the sheath 300 are shown in a common plane. The various components of the sheath 300 may have a three-dimensional form, as will be appreciated by those skilled in the art. For example, the outer tube 301 may have a cylindrical/tubular form. Similarly, the pulling loop 310 may have an elliptical (e.g., circular) form, and/or may be configured to be located within and/or against a fully elliptical portion of the outer tube 301. For example, the pulling loop 310 may be located within the outer tube 301 and may form a continuous oval around the lumen 302. The lumen 302 may represent a cylindrical or similar space within the sheath 300. In some embodiments, the sheath can generally approximate a blood vessel in size and/or shape.

Fig. 4 provides a cross-sectional view of an example dilator 400 according to some embodiments. Dilator 400 may have any of a variety of shapes and/or sizes. Further, different sections/portions of dilator 400 can have different and/or unique shapes and/or sizes. For example, as shown in fig. 4, the dilator 400 may be made up of at least three longitudinal sections: a distal portion 420, a medial portion 422, and a proximal portion 424. Each of these portions may form a continuous device, and/or may be separate portions that are configured to be interconnected and/or pressed together.

Since fig. 4 provides a cross-sectional view of dilator 400, the various components of dilator 400 are shown in a common plane. However, the various components of the dilator 400 may have a three-dimensional form, as will be appreciated by those skilled in the art. For example, the distal portion 420 can have a conical shape and/or the intermediate portion 422 and/or the proximal portion 424 can have a cylindrical shape around the lumen 402 of the dilator 400. Lumen 402 may represent a cylindrical or similar space within dilator 400.

In some embodiments, the distal portion 420 can have an at least partially tapered surface. For example, between the intermediate portion 422 and the distal end 405 of the dilator 400, the diameter of the dilator 400 may gradually decrease to a minimum diameter at or near the distal end 405. In some embodiments, the minimum diameter of dilator 400 can be approximately equal to the diameter of lumen 402. The tapered surface of the distal portion 420 can allow the dilator 400 to more effectively dilate a blood vessel. For example, the diameter of the vessel can be greater than the smallest diameter of the dilator 400 (e.g., at the distal end 405), but less than the largest diameter of the dilator 400 (e.g., at the intermediate portion 422). Further, the maximum diameter/width of dilator 400 can be proximally equal to the diameter/width of the lumen of the sheath (e.g., first diameter 306 of sheath 300 of fig. 3). Thus, the distal end 405 of the dilator 400 can be configured to fit into a vessel, and the distal portion 420 can be configured to gradually open and/or stretch the vessel as the dilator 400 passes through the vessel until the vessel has a diameter approximately equal to the largest diameter of the dilator 400 (e.g., at the intermediate portion 422).

The distal portion 420 may have any length and/or the tapered surface of the distal portion 420 may have any amount of taper. In some embodiments, the distal portion 420 can have a generally constant slope, and/or the diameter/width of the dilator can gradually increase from the distal end 405 to the intermediate portion 422. The outer surface of the distal portion 420 may be at least partially smooth, and/or may have ridges and/or other indentations to facilitate movement of the dilator 400 through the blood vessel and/or various lumens. For example, the distal portion 420 may include one or more ridges extending generally longitudinally along the surface (i.e., from the distal end 405 toward the intermediate portion 422) to minimize surface contact and/or friction between the distal portion 420 and the vessel or lumen tissue.

The distal portion 420 may be attached to the intermediate portion 422 and/or may form a continuous device with the intermediate portion 422. In some embodiments, dilator 400 may not include intermediate portion 422, and/or intermediate portion 422 may have a similar shape and/or size as distal portion 422 and/or proximal portion 424. For example, the intermediate portion 422 may have a generally tapered surface, similar to the distal portion 420, and/or the diameter and/or width of the intermediate portion 422 may be approximately equal to the proximal portion 424. In some embodiments, the diameter and/or width of dilator 400 may be generally smooth at intermediate portion 422. For example, the diameter and/or width of the dilator may gradually increase from the distal end 405 to the intermediate portion 422, and/or the maximum diameter of the proximal portion 420 may be maintained at the intermediate portion 422. In some embodiments, the diameter and/or width of dilator 400 at intermediate portion 422 can be the maximum diameter of dilator 400.

In some embodiments, the intermediate portion 422 may have an at least partially smooth surface, and/or may include one or more ridges and/or other indentations to minimize friction between the intermediate portion 422 and the tissue wall. For example, the intermediate portion 422 can have an at least partially undulating surface, wherein peaks of the surface have a maximum diameter/width of the intermediate portion 422 and/or the dilator 400, and valleys of the surface have a minimum diameter/width of the intermediate portion 422 and/or a diameter/width approximately equal to a diameter/width of the proximal portion 424. In one application, the intermediate portion 422 may include one or more generally thin ridges that extend laterally and/or longitudinally across the intermediate portion 422. In some embodiments, one or more ridges at intermediate portion 422 (e.g., extending longitudinally along dilator 400) can extend into one or more ridges of distal portion 420.

The intermediate portion 422 may have a generally tapered surface rather than the generally flat surface shown in fig. 4. For example, the intermediate portion 422 may have a taper slope that approximates the slope of the distal portion 420 such that the tapered surface of the distal portion 420 extends into the slope of the intermediate portion 422 in a linear or near linear manner. In one application, the diameter/width of the dilator may taper between the distal portion 420 and the proximal portion 424. For example, a first point 425 where the distal portion 420 and the intermediate portion 422 meet may represent a maximum diameter/width of the dilator 400, and the diameter/width of the dilator may gradually decrease from the first point 425 to a second point 427 where the intermediate portion 422 and the proximal portion 424 meet. In some embodiments, the diameter/width of the dilator 400 can taper along the intermediate portion 422 such that the minimum diameter/width of the intermediate portion 422 (e.g., at the second point 427) can be approximately equal to the diameter/width of the dilator 400 at the proximal portion 424. However, the maximum diameter/width at the intermediate portion 422 may be at any point of the intermediate portion 422. For example, the intermediate portion 422 may form a peak at or near a midpoint or other point of the intermediate portion 422.

In some embodiments, intermediate portion 422 can be configured to at least partially hold dilator 400 in place. For example, at least a portion of the intermediate portion 422 can be configured to press against an inner surface of the sheath to retain the dilator 400 within the sheath. In some embodiments, dilator 400 may include one or more mechanisms to attach to and/or hold against a sheath or other device. For example, dilator 400 may include one or more hooks (e.g., at intermediate portion 422) configured to engage various mechanisms of a sheath or other device. In some embodiments, ridges and/or other indentations of dilator 400 (e.g., at intermediate portion 422) may be configured to fit into and/or otherwise engage threads, grooves, indentations, and/or similar features and/or mechanisms of a sheath or other device. For example, the sheath (e.g., sheath 300 in fig. 3) can include one or more threads extending generally transversely along the inner surface of the sheath, and the dilator 400 can include one or more grooves configured to receive the one or more threads such that the dilator 400 can be twisted along the threaded surface of the sheath.

In some embodiments, dilator 400 can be configured to create minimal friction between dilator 400 and a sheath (e.g., sheath 300 in fig. 3) while establishing and/or maintaining a connection with the sheath. In other words, the dilator 400 may be configured to form a loose connection with the sheath. For example, the dilator 400 and/or sheath can have at least partially threaded surfaces configured to mate with grooved surfaces of the dilator 400 and/or sheath. When the dilator 400 is mated with the sheath, the threads and/or grooves of the dilator 400 and/or sheath can be large enough (i.e., deep enough, high enough) such that the dilator 400 cannot be disconnected from the sheath or at least is unlikely to be disconnected from the sheath. However, there may be a gap between dilator 400 (e.g., at intermediate portion 422) and the sheath such that when dilator 400 (e.g., at least distal portion 420) is twisted within the sheath, there may be minimal contact (e.g., less than fully elliptical contact) between dilator 400 and the sheath.

At least a portion of the proximal portion 424 can have a diameter/width less than the maximum diameter/width of the dilator 400. Thus, at least a portion of the proximal portion 424 may be configured to not contact the inner surface of the outer tube of the sheath. As shown in fig. 4, the proximal portion 424 may have a generally flush diameter/width across the entire length of the proximal portion 424. However, the proximal portion 424 may have a varying diameter/width. For example, the outer surface of the proximal portion 424 may have a wave-like configuration, and/or may include one or more of ridges, grooves, indentations, spikes (pegs), steps, and/or other portions, where the diameter/width of the proximal portion 424 is greater than the minimum diameter/width of the proximal portion 424.

The proximal portion 424 may be located adjacent to the intermediate portion 422. In some embodiments, at least a portion of the proximal portion 424 can be configured to contact an outer tube of the sheath. The proximal portion 424 may include one or more protrusions, undulations, spikes, ridges, and/or other features configured to extend from the smaller diameter/width portion of the dilator 400 to the maximum diameter/width. Accordingly, the proximal portion 424 can be configured to create one or more gaps between the dilator 400 and the sheath.

The proximal portion 424 may have any length. In some embodiments, the proximal portion 424 may be configured to extend outside of the patient's body. The proximal portion 424 can have a tip portion that can provide an opening to the lumen 402 of the dilator 400. The proximal portion 424 may have a generally cylindrical form about the lumen 402, and/or may have any other shape.

As shown in fig. 4, at least a portion of the proximal portion 424 may have a smaller diameter/width than the intermediate portion 422 and/or the distal portion 420. In some embodiments, the second point 427 (i.e., where the intermediate portion 422 meets the proximal portion 424) may represent a step-down of diameter/width from the intermediate portion 422 to the proximal portion 424. However, dilator 400 may have a tapered reduction in diameter/width from intermediate portion 422 to proximal portion 424.

In some embodiments, the difference between the maximum diameter/width of the dilator (e.g., at the intermediate portion 422) and the minimum diameter/width at the proximal portion 424 can be minimal. This is because the difference in diameter/width may only need to be large enough to create a space between the proximal portion 424 and the sheath that can be passed over the dilator 400. For example, the difference between the maximum diameter/width of the dilator and the minimum diameter/width at the proximal portion 424 can be about 0.015-0.040 inches. However, the proximal portion 424 can have any diameter/width(s) ranging from the diameter/width of the lumen 402 to the maximum diameter/width of the dilator 400.

Dilator 400 may be constructed from any one or more of a variety of materials. In some embodiments, dilator 400 may be constructed at least partially of stainless steel braided Pebax and/or similar materials. Dilator 400 may be configured to have an at least partially flexible structure to prevent and/or minimize damage to tissue during dilation. For example, dilator 400 may be constructed of polyether block amide (PEBA) or other materials having a relatively soft and/or elastic structure. In some embodiments, the intermediate portion 422 of the dilator 400 can have a generally soft structure to allow the intermediate portion 422 to at least partially compress and/or squeeze into the lumen of the sheath.

In some embodiments, dilator 400 may be configured to deliver one or more balloons and/or similar devices. For example, a balloon can be attached at or near the distal end 405 of the dilator 400 for placing the distal end 405 of the dilator 400 against a tissue wall during delivery. In some embodiments, dilator 400 may include a plurality of lumens 402. For example, the dilator may have two lumens 402, one of which may be configured to inflate and/or deflate a balloon at or near the distal end 405 of the dilator 400.

Dilator 400 may be configured to cause any amount of vessel dilation. For example, dilator 400 may produce a vascular dilation of about or less than 2 x. Dilator 400 may be configured to open and/or dilate a tissue region surrounding a puncture site. In some embodiments, the lumen 402 of the dilator 400 may be configured to receive various instruments, including a guidewire and/or a needle. The guidewire and needle may each be passed through the dilator 400 simultaneously and/or at different times/stages.

Fig. 5A-5D illustrate a delivery system 500 including a sheath 510 and a dilator 550, according to some embodiments. The above discussion of the sheath barrel 300 of fig. 3 and the dilator 400 of fig. 4 can be applied to the sheath barrel 510 and the dilator 550 of fig. 5A-5D, respectively. As shown in fig. 5A-5D, dilator 550 may be configured to fit at least partially within the lumen of sheath 510. In some embodiments, at least a portion of the distal portion 520 of the dilator 550 can be configured to extend out of the distal end of the sheath 510. The distal portion 520 can be at least partially tapered to produce a gradual expansion of the vessel as the delivery system 500 is moved through the vessel. In some embodiments, the sheath 510 may include a tapered section 512 of the outer tube 501 of the sheath 510. The tapered section 512 may be configured to gradually dilate a blood vessel. As shown in fig. 5A-5D, the distal portion 520 of the dilator 550 can be configured to align with the tapered section 512 of the sheath 510 to create a uniform taper extending from the distal end 505 of the dilator 550 through the tapered section 512 of the sheath 510.

In some embodiments, the intermediate portion 522 of the dilator can be configured to be at least partially and/or fully located within the lumen of the sheath 510. At least a portion of the intermediate portion 522 may be configured to contact the inner surface 501a of the sheath 510. For example, the diameter/width of at least a portion of the intermediate portion 522 may be approximately equal to the diameter/width of the lumen of the sheath 510. The intermediate portion 522 can be configured to remain in contact with the inner surface 501a due to friction and/or one or more attachment mechanisms between the sheath 510 and the dilator 550. In some embodiments, the sheath 510 and dilator 550 can be locked together (e.g., at the intermediate portion 522) by a tight seal lock design.

The dilator 550 can be configured to move independently of the sheath 510, and/or the sheath 510 can be configured to move independently of the dilator 550. In one application, the dilator 550 may be configured to move in the longitudinal direction 521 relative to the sheath 510. For example, the dilator 550 may be moved longitudinally to extend further out of the sheath 510. In another application, the dilator 550 may be configured to twist, and/or rotate relative to the sheath 510. For example, the dilator 550 may be configured to twist about the lumen 502 and/or other center points of the dilator 550. For example, the surgeon can twist the proximal end of the dilator 550 laterally (e.g., outside the body) while the dilator 550 is at least partially within the sheath barrel 510 and/or within the patient's body. In some embodiments, twisting the proximal end of the dilator 550 can cause approximately equal amounts of twisting at the distal portion 520 of the dilator 550 (i.e., there can be a one-to-one correspondence between the proximal and distal portions 520).

The delivery system 500 can be configured to have one or more gaps 513 between the sheath cartridge 510 and the dilator 550. The one or more gaps 513 can represent portions of the lumen of the sheath barrel 510 that may not be filled by the dilator 550. Fig. 5A illustrates an example delivery system 500, wherein the gap 513 can be an elliptical loop and/or a tubular space around the dilator 550 and/or between the dilator 550 and the sheath cartridge 510. In some embodiments, the intermediate portion 522 may be configured to form a seal and/or a complete seal with the sheath barrel 510 such that no blood and/or other fluids and/or gases may be able to flow into the one or more gaps 513. In this manner, where there is a gap 513 between the sheath barrel 510 and the dilator 550, there may be no friction and/or minimal friction at the sheath barrel 510 and/or the dilator 550. The gap 513 may have any size. In some embodiments, gap 513 can be a 0.015-0.050 inch separation between sheath cartridge 510 and at least a portion of dilator 550.

In some embodiments, dilator 550 can have a portion with a diameter/width less than the maximum diameter/width of dilator 550, thereby creating at least some of the one or more gaps 513 between sheath cylinder 510 and dilator 550. For example, there may not be any gap 513 between the intermediate portion 522 of the dilator 550 and the sheath 510, but there may be a gap 513 between the proximal portion 524 of the dilator 550 and the sheath 510. In some embodiments, there may be multiple separate gaps between the sheath 510 and the dilator 550. For example, the gap 513 can be divided into a plurality of separate gaps 513 by one or more partitions, walls, barriers, and/or other segments extending from the dilator 550 (e.g., from the proximal portion 524) to contact and/or nearly contact the inner surface 501a of the sheath barrel 510.

Fig. 5B illustrates an embodiment of a delivery system 500 in which the proximal portion 524 of the dilator 550 has an asymmetric and/or wavy outer surface. In some embodiments, the asymmetric surface of the proximal portion 524 can include one or more peaks 531 configured to extend to and/or adjacent to the inner surface 501a of the sheath barrel 510. Proximal portion 524 can further include one or more valleys 533 configured to form a gap 513 between dilator 550 and sheath 510. In some embodiments, dilator 550 can include a plurality of peaks 531 and/or valleys 533, thereby creating a plurality of gaps 513 between dilator 550 and sheath cylinder 510. Although the intermediate portion 522 of the dilator 550 is shown in fig. 5B as having a generally flat surface, the intermediate portion 522 may have an asymmetric and/or undulating surface similar to the proximal portion 524. In some embodiments, peaks 531 and/or valleys 533 can extend along the full circumference of dilator 550 (e.g., around lumen 502).

Fig. 5C illustrates another embodiment of the delivery system 500, wherein the proximal portion 524 of the dilator 550 includes one or more protrusions 535. In some embodiments, the one or more protrusions 535 can be configured to extend from the dilator 550 to the inner surface 501a of the sheath barrel 510. Other portions of the proximal portion 524 (e.g., the portion of the dilator 550 between the two protrusions 535) can be configured to form a gap 513 between the dilator 550 and the sheath barrel 510. In some embodiments, dilator 550 can include at least one protrusion 535 to create a plurality of gaps 513 between dilator 550 and sheath cylinder 510. Although the intermediate portion 522 of dilator 550 is shown in fig. 5C as having a generally planar surface, the intermediate portion 522 may have a non-symmetrical surface and/or may include one or more protrusions 535 similar to proximal portion 524. In some embodiments, the projections 535 can extend along the entire circumference of the dilator 550.

Fig. 5D illustrates another embodiment of the delivery system 500 in which the proximal portion 524 of the dilator 550 has an asymmetric and/or threaded outer surface. In some embodiments, the asymmetrical surface of the proximal portion 524 can include one or more threads 537 configured to extend to and/or adjacent to the inner surface 501a of the sheath barrel 510. The proximal portion 524 may further include a portion between the thread(s) 537 that is configured to form one or more gaps 513 between the dilator 550 and the sheath barrel 510. In some embodiments, the dilator 550 can include multiple threads 537 and/or a single thread that passes around the outer surface of the dilator 550 multiple times in a helical or similar pattern, thereby creating multiple gaps 513 between the dilator 550 and the sheath barrel 510. Although the intermediate portion 522 of dilator 550 is shown in fig. 5B as having a generally flat surface, the intermediate portion 522 may have an asymmetrical and/or threaded surface similar to the proximal portion 524.

Dilator 550 may include a lumen 502 configured to receive various instruments. For example, the shunt needle can be configured to pass through the lumen 502 and out the distal end 505 of the dilator 550, and/or can be delivered to a tissue wall (e.g., a coronary sinus wall). In some embodiments, the needle or other instrument may have a curved, bent, helical, and/or other configuration while within the lumen 502 and/or after exiting the lumen 502. For example, the needle may be constructed of nitinol and/or other shape memory alloys, and may be shaped to have a curved tip. As the needle passes through the lumen 502 (which may have a generally linear form), the needle may at least straighten to fit within the lumen 502. As the needle exits the cavity 502, the needle may assume a curvilinear and/or other predetermined configuration. For example, the needle may curve to extend approximately perpendicularly and/or tangentially (i.e., at an approximately 90 ° angle) from the distal end 505 of the dilator 550. In this manner, the needle can be configured to contact and/or penetrate a tissue wall (e.g., coronary sinus) that can be generally parallel to the dilator 550.

The dilator 550 and/or the sheath 510 can be configured to move through a vessel in a first direction guided by the distal portion 520 of the dilator 550 and/or in a second direction guided by the proximal portion 524 of the dilator 550. In some embodiments, dilator 550 may have lumen 502, and lumen 502 may pass through distal portion 520, intermediate portion 522, and/or proximal portion 524. The lumen 502 can be accessible via one or more openings at the distal end 505 and/or proximal end of the dilator 550 and can be configured to allow a guidewire and/or other device to pass through the dilator 550 and/or the sheath 510. In some embodiments, lumen 502 can be positioned at or near a central point of dilator 550. For example, any transverse (i.e., into the page of fig. 5A-5D) cross-section of dilator 550 may include lumen 502 at and/or around the center point of dilator 550. However, the lumen 502 can be located at any location of the dilator 550.

The dilator 550 and/or the sheath 510 may be configured to dilate and/or pre-dilate a blood vessel. In some embodiments, the maximum diameter of the dilator 550 and/or the sheath 510 can be greater than the diameter of the blood vessel. As the dilator 550 and/or sheath 510 are moved through the blood vessel, the dilator 550 and/or sheath 510 may be configured to stretch and/or otherwise dilate the blood vessel to create a larger diameter at the blood vessel. Thus, the dilator 550 and/or the sheath 510 can contact and/or rub against the inner wall of the blood vessel as the dilator 550 and/or the sheath 510 move through the blood vessel.

As shown in fig. 5A-5D, dilator 550 may have a reduced diameter/width at proximal portion 524. In some embodiments, at least a portion of the proximal portion 524 can have a maximum diameter of the dilator 550 (e.g., the diameter at the intermediate portion 522), and/or the dilator 550 can have one or more indentations at an outer surface of the dilator 550 (e.g., at the proximal portion 524). The setback can be configured to reduce surface contact between the dilator 550 and the sheath 510 when the dilator 550 is twisted, rotated, extended, retracted, tilted, and/or otherwise moved relative to the sheath 510. The setback can provide a reduction in the radius and/or diameter of the dilator 550. In some embodiments, one or more of the indentations may have an elliptical shape or other shape. The indentation may represent material removed from the dilator 550. In this manner, the amount of surface area of the dilator 550 having the largest radius may be reduced due to the setback. In some embodiments, the indentations can reduce the surface area of the dilator 550 having the dilator's largest radius.

The indentation may have any shape. For example, the indentation may have a circular, rectangular or triangular shape. In some embodiments, the one or more indentations may include one or more thin, shallow grooves, which may have a linear, curvilinear, wavy, and/or other shape.

In some embodiments, the outer surface of the dilator 550 and/or the sheath 510 can have an at least partially tapered structure. For example, the distance from the outer surface of dilator 550 and/or sheath 510 to the center point (e.g., lumen 502) of dilator 550 and/or sheath 510 can gradually increase from the distal and/or proximal end of dilator 550 to intermediate portion 522.

The dilator 550 may be configured to twist, rotate, and/or twist in any direction and/or at any angle while at least partially within the sheath 510. For example, the dilator 550 may be configured to rotate up to and/or over 360 ° in either direction to a desired position. Thus, the surgeon may be able to twist the dilator 550 as desired so that the needle and/or other instrument passing through the lumen 502 may be configured to exit the distal end 505 of the dilator 550 in a desired orientation. For example, the dilator 550 may be twisted into a position: a needle inserted through the lumen 502 can exit the dilator 550 and contact and/or pierce a tissue wall. In some embodiments, the dilator 550 and/or the sheath 510 can be at least partially coated with and/or constructed of a generally lubricious material to facilitate movement of the dilator 550 and/or the sheath 510 relative to one another. For example, the dilator 550 and/or the sheath 510 can be at least partially constructed of High Density Polyethylene (HDPE) and/or other materials. In some embodiments, the dilator 550 and/or the sheath 510 can be at least partially coated (e.g., at the outer surface of the dilator 550 and/or the inner surface 501a of the sheath 510) with a hydrophilic coating.

In some embodiments, a needle and/or other instrument configured to fit within the lumen 502 of the dilator 550 can be locked with the dilator 550 and/or otherwise attached to the dilator 550. For example, the dilator 550 and/or the needle may each have one or more clasps (clasps), hooks, grooves, ridges, and/or similar locking mechanisms configured to hold the dilator 550 and the needle together. In this manner, when the dilator 550 is twisted, the needle may be twisted together with the dilator 550. In some embodiments, the twist dilator 550 can cause the needle to twist without the use of a locking mechanism. For example, the size and/or shape of the lumen 502 of the dilator 550 can be configured to create a tight and/or "snug" fit with the needle such that movement of the dilator 550 can cause the needle to move by friction between the dilator 550 and the needle.

In some embodiments, dilator 550 and sheath 510 can be configured to be locked together during and/or after delivery. The dilator 550 and the sheath 510 can further be configured to be unlocked after delivery, and the dilator 550 can be advanced forward (i.e., out of the sheath 510), and/or the sheath 510 can be pulled backward while the dilator 550 is held in place. In some embodiments, the dilator 550 can be advanced out of the sheath 510 using a guidewire. The guidewire may be configured to be removed and/or a shunt needle and/or other instrument may be advanced through the sheath barrel 510 and/or dilator 550. The sheath 510 and/or dilator 550 can include one or more stops at the proximal end of the sheath 510 and/or dilator 550.

The sheath 510 can be tilted in any direction as desired to orient the dilator 550 and/or the needle passing through the dilator 550 at a desired puncture location. The sheath 510 can be flexed as desired to point the dilator 550 to the puncture location. For example, the proximal end of the dilator 550 and/or the sheath 510 can be accessible to the surgeon and can be tilted and/or flexed to cause the distal portion 520 of the dilator 550 to tilt.

The delivery systems described herein may be used to position sheaths and/or dilators to various regions of a human heart. For example, the dilator and/or sheath may be configured to access the coronary sinus from the right atrium. However, it will be understood that this description may refer to or generally apply to the positioning of a sheath and/or dilator from a first body chamber or lumen into a second body chamber or lumen, where the sheath and/or dilator may be bent when positioned from the first body chamber or lumen into the second body chamber or lumen. A body chamber or cavity may refer to any of a variety of fluid passages, blood vessels, and/or organ chambers (e.g., heart chambers). Additionally, references herein to "catheter," "tube," "shaft," "sheath cartridge," "steerable sheath cartridge," and/or "steerable catheter" may generally refer or be applicable to any type of elongate tubular delivery device that includes a lumen configured to slidably receive an instrument, such as an instrument for positioning within an atrium or coronary sinus, including, for example, a delivery catheter and/or cannula. It will be appreciated that other types of medical implant devices and/or procedures may be delivered to the coronary sinus using the delivery systems described herein, including, for example, ablation procedures, drug delivery, and/or coronary sinus lead placement.

Fig. 6A and 6B illustrate an example needle 609 delivery procedure for a delivery system 600, the delivery system 600 including a dilator 650, a sheath 610, and/or a needle 609. Needle 609 (e.g., a puncture needle and/or similar device) can be configured to pass through lumen 602 of dilator 650 and/or sheath 610 when dilator 650 and/or sheath 610 are positioned within vessel 605. The terms "needle" and/or "penetration device" are used herein in their broad and conventional meaning and may refer to any needle, wire, suture, pin, and/or other wire or device configured to pass through a lumen of a dilator, sheath, and/or other delivery device and/or penetrate a vessel wall.

In some embodiments, the needle 609 may have a predetermined shape. For example, the needle 609 may be at least partially constructed of nitinol and/or similar materials having shape memory characteristics. Needle 609 can be configured to pass through the lumen of dilator 650 and/or exit the distal end of dilator 650 such that needle 609 can be exposed to blood vessel 605. In some embodiments, needle 609 may have a curved and/or coil-like form such that when needle 609 exits dilator 650 and/or sheath 610, the needle may naturally curve and/or bend towards the wall of blood vessel 605. In some cases, when delivery system 600 reaches a desired location within vessel 605, needle 609 may be moved away from dilator 650 and/or sheath 610 in a direction and/or may curve/bend in a direction away from target puncture location 611. In such a case, at least some components of delivery system 600 may be configured to twist while within blood vessel 605 so that needle 609 may be directed to target puncture location 611 (see fig. 6B).

In some embodiments, dilator 650 and/or needle 609 can be configured to twist relative to sheath 610 and/or the blood vessel. That is, sheath 610 may be configured to not twist when dilator 650 and/or needle 609 are twisted. In some embodiments, the presence of one or more gaps 613 between dilator 650 and sheath 610 can reduce surface contact and/or friction between dilator 650 and sheath 610 to improve the ease and/or effectiveness of twisting dilator 650 relative to sheath 610.

Twisting dilator 650 (e.g., by a surgeon) may cause needle 609 to twist (e.g., approximately a 1: 1 ratio). For example, contact and/or friction between dilator 650 and needle 609 may result in reciprocal movement, including twisting, between dilator 650 and needle 609. In some embodiments, needle 609 can be attached and/or locked to dilator 650 to facilitate reciprocal movement between dilator 650 and needle 609. By allowing for twisting (including simpler and/or more efficient twisting) of dilator 650 and/or needle 609 within vessel 605 and/or sheath 610, delivery system 600 may provide a simpler and/or more efficient delivery procedure for the surgeon. For example, the surgeon may not be required to accurately position the delivery sheath and/or needle at an initial stage of the delivery process, as some displacement and/or improper positioning of the needle 609 may be corrected after the delivery system 600 is positioned at a desired location within the vessel 605. Although dilator 650 is shown within sheath 610, dilator 650 may be configured to be used without sheath 610 in some cases.

Fig. 7 is a flow diagram of a process 700 for deploying a delivery system including a dilator and a sheath into and/or through a blood vessel. In block 702, the process 700 includes providing a dilator positioned at least partially within the sheath.

In block 704, the process 700 includes introducing the sheath and dilator into a vessel (e.g., blood vessel) and/or lumen of the body. The sheath and dilator may be locked together via one or more locking mechanisms. In some embodiments, the dilator may be retained within the sheath-based at least in part on friction between at least a portion of the dilator and the sheath. The sheath can have a lumen, and/or can include an outer tube at least partially enclosing a hollow interior configured to fit at least a portion of a dilator. The dilator can be integrally fitted within the sheath, and/or at least a portion (e.g., a distal portion) of the dilator can be configured to extend outside the sheath.

At least a portion of the dilator may be configured to fit closely within the sheath without a gap between the portion of the dilator and the sheath. The portion may include a cylindrical and/or helical section of the dilator configured to establish full or near full elliptical contact between the dilator and the sheath. The dilator may be held in place by friction based at least in part on a tight fit between the portion of the dilator and the sheath. In some embodiments, one or more locking and/or engagement mechanisms (e.g., grooves, ridges, spikes, hooks, rails (guide tracks), etc.) can be configured to interconnect the sheath and dilator.

In some embodiments, at least a portion of the dilator may be configured to not contact the sheath. For example, the diameter/width of the portion may be less than the maximum diameter/width of the dilator and/or the diameter/width of the hollow interior of the sheath. Thus, the portion may not contact the sheath when the portion is within the sheath.

In block 706, the process 700 includes inserting a puncture needle through a lumen of a dilator. The needle may be inserted through the lumen of the dilator before the dilator is inserted into the body or after the dilator is positioned within the body. In some embodiments, one or more locking mechanisms can be configured to hold the needle and dilator together such that the needle can move with the dilator when the dilator is twisted, tilted, or otherwise moved.

In block 708, the process includes twisting the dilator to align the needle with the desired puncture location. In some embodiments, the needle may have an at least partially curvilinear form. Thus, aligning the needle with the puncture location may include positioning the needle such that the needle may contact the puncture location when the needle is off the dilator and curved (e.g., tangential to the dilator).

In block 710, the process 700 includes advancing a needle out of a dilator and to a puncture location. The needle may be configured to contact and/or penetrate tissue at the puncture location.

Depending on the embodiment, certain acts, events or functions of any process or algorithm described herein may be performed in a different order, may all be added, merged or omitted. Thus, in some implementations, not all described acts or events are required for the practice of the processes.

Conditional language, as used herein, such as "may, could", "may, may", "for example", etc., is intended in its conventional sense and is generally intended to convey that certain embodiments include but not others that do not include certain features, elements and/or steps, unless expressly stated otherwise or otherwise understood in the context of such usage. Thus, such conditional language is not generally intended to imply that one or more embodiments require the features, elements, and/or steps in any way or that one or more embodiments necessarily include logic for deciding, with or without author input or suggestion, whether such features, elements, and/or steps are included or are to be performed in any particular embodiment. The terms "comprising," "including," "having," and the like, are synonymous and are used in their conventional sense and are used inclusively in an open-ended fashion, and do not exclude other elements, features, acts, operations, and the like. Furthermore, the term "or" is used in its inclusive sense (and not exclusive sense) such that, when used in connection with a listed element, for example, the term "or" means one, some, or all of the listed elements. Unless otherwise expressly stated, a connective language such as the phrase "X, Y and at least one of Z" should be understood to convey that an item, term, element, etc., can be X, Y or Z, in general in connection with the context in which it is used. Thus, such connectivity language is not intended to generally imply that certain embodiments require at least one of X, at least one of Y, and at least one of Z to all be present.

It should be appreciated that in the foregoing description of embodiments, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim requires more features than are expressly recited in the claim. Furthermore, any component, feature, or step illustrated and/or described in a particular embodiment herein can be applied to or used with any other embodiment(s). Further, no element, feature, step, or group of elements, features, or steps is essential or essential to every embodiment. Therefore, it is intended that the scope of the invention herein disclosed and claimed should not be limited by the particular embodiments described above, but should be determined only by a fair reading of the claims that follow.

It should be understood that certain ordinal terms (e.g., "first" or "second") may be provided for ease of reference, and do not necessarily imply a physical feature or order. Thus, as used herein, ordinal terms (e.g., "first," "second," "third," etc.) used to modify an element such as a structure, component, operation, etc., do not necessarily indicate a priority or order of the element relative to any other element, but generally may distinguish the element from another element having a similar or identical name (except where the ordinal term is used). In addition, as used herein, the indefinite articles "a" and "an" may indicate "one or more" rather than "an". Further, an operation performed "based on" a condition or event may also be performed based on one or more other conditions or events not expressly recited.

Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which example embodiments belong. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

Although certain preferred embodiments and examples are disclosed below, the inventive subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses, as well as modifications and equivalents thereof. Thus, the scope of claims that may be generated thereby is not limited by any of the specific embodiments described below. For example, in any method or process disclosed herein, the acts or operations of that method or process may be performed in any suitable order and are not necessarily limited to any particular disclosed order. Various operations may be described as multiple discrete operations in turn, in a manner that is helpful in understanding certain embodiments; however, the order of description should not be construed as to imply that these operations are order dependent. In addition, the structures, systems, and/or devices described herein may be implemented as an integrated component or as separate components. Certain aspects and advantages of the various embodiments are described for purposes of comparing the embodiments. Not all of these aspects or advantages are necessarily achieved by any particular embodiment. Thus, for example, various embodiments may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as may be taught or suggested herein.

Spatially relative terms "outer," "inner," "upper," "lower," "below," "over," "vertical," "horizontal," and the like may be used herein for ease of description to describe the relationship of one element or component to another element or component as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, where a device is turned over as shown in the figures, a device that is "below" or "underside" another device may be "above" the other device. Thus, the exemplary term "below" can include both a lower position and an upper position. The device may also be oriented in other directions, and the spatially relative terms may be interpreted differently depending on the orientation.

Unless expressly stated otherwise, comparative and/or quantitative terms, such as "less," "more," "greater," and the like, are intended to encompass equivalent concepts. For example, "less" may mean not only "less" in the strictest mathematical sense but also "less than or equal to".

Claims (30)

1. A delivery system, comprising:

a sheath barrel having an outer tube surrounding a hollow interior; and

a dilator configured to fit at least partially within the hollow interior of the sheath barrel, the dilator comprising:

a distal portion configured to at least partially dilate a blood vessel;

a middle portion;

a proximal portion; and

a lumen extending through the distal portion, a medial portion, and the proximal portion.

2. The delivery system of claim 1, wherein the dilator has a cylindrical shape around the lumen.

3. The delivery system of claim 1 or claim 2, wherein the distal portion has an at least partially tapered surface.

4. The delivery system of any one of claims 1-3, wherein the intermediate portion is located between the distal portion and the proximal portion.

5. The delivery system of claim 4, wherein the intermediate portion has a maximum diameter of the dilator.

6. The delivery system of any of claims 1-5, wherein the diameter at the proximal portion is less than the maximum diameter of the dilator.

7. The delivery system of any one of claims 1-6, wherein when the dilator is positioned within the hollow interior of the sheath, there is at least one gap between the dilator and the sheath.

8. The delivery system of claim 7, wherein the at least one gap is between the proximal portion and the sheath.

9. The delivery system of claim 8, wherein the proximal portion is configured to not contact the sheath.

10. The delivery system of any one of claims 7-9, wherein there is no gap between the intermediate portion and the sheath.

11. The delivery system of any of claims 1-10, wherein the lumen of the dilator is configured to fit a puncture needle.

12. The delivery system of any one of claims 1-11, wherein the dilator is configured to twist while at least partially within the hollow interior of the sheath.

13. The delivery system of claim 12, wherein twisting the dilator is configured to cause a twisting of a puncture needle within the lumen of the dilator.

14. The delivery system of any one of claims 1-13, wherein the dilator is configured to tilt when at least partially positioned within the hollow interior of the sheath.

15. A dilator configured to fit at least partially within the hollow interior of the sheath barrel, the dilator comprising:

a distal portion configured to at least partially dilate a blood vessel;

a middle portion;

a proximal portion; and

a lumen extending through the distal portion, the intermediate portion, and the proximal portion.

16. The dilator of claim 15, wherein said intermediate portion has a cylindrical shape around said lumen.

17. The dilator of claim 15 or claim 16, wherein the distal portion has an at least partially tapered surface.

18. The dilator of any one of claims 15 to 17, wherein the intermediate portion is located between the distal portion and the proximal portion.

19. The dilator of claim 18, wherein said intermediate portion has a maximum diameter of said dilator.

20. The dilator of claims 15-19, wherein a diameter at said proximal portion is less than a maximum diameter of said dilator.

21. The dilator of claims 15-20, wherein the proximal portion is configured to form at least one gap between the proximal portion and the sheath.

22. The dilator of claim 21, wherein the proximal portion is configured to not contact the sheath.

23. The dilator of claims 15-22, wherein the intermediate portion is configured to make gapless contact with the sheath.

24. The dilator of claims 15-23, wherein the lumen is configured to fit a puncture needle.

25. The dilator of claims 15-24, wherein the distal portion is configured to twist when at least partially within the sheath.

26. The dilator of claim 25, wherein twisting the distal portion is configured to cause twisting of a puncture needle within the lumen at the distal portion.

27. The dilator of claims 15-26, wherein the distal portion is configured to tilt when at least partially within the sheath.

28. The method comprises the following steps:

introducing a sheath barrel and a dilator into a blood vessel, wherein the dilator is at least partially located within the sheath barrel and the dilator comprises a lumen;

inserting a needle through the lumen of the dilator;

twisting the dilator to cause the needle to twist to a desired position; and

advancing the needle out of the distal end of the dilator.

29. The method of claim 28, wherein there is at least one gap between the dilator and an inner surface of the sheath.

30. The method of claim 29, wherein at least a portion of the dilator makes gapless contact with the sheath.

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