Expander positioning assembly

Abstract

A vascular dilator positioning assembly and system are described along with methods of using and assembling the same. Such an assembly and system include a grip portion having a wall and an actuator for positioning the dilator tip relative to a sheath.

Description

Technical Field

[0001] This technical field generally relates to vascular dilators, introducer sheaths, and components thereof for insertion into the body to provide intravascular access to various medical devices. This includes, but is not limited to, access to all arterial and vascular structures, abdominal and thoracic cavities, cerebrospinal, urogenital and gynecological, upper gastrointestinal and colorectal surgeries.

[0002] Embodiments generally provide a system and method for positioning a dilator head relative to an introducer sheath to reduce the gap between the introducer sheath and the dilator head.

Background Art

[0003] Vascular access devices, including vascular introducer sheaths and vascular dilators, are currently very common in many intravascular procedures such as transcatheter aortic valve replacement (TAVR), angioplasty, stent placement, etc. They generally facilitate access to the vasculature for the introduction of removable devices such as wires, balloons, pressure transducers, etc., and for the introduction and placement of implantable devices such as mechanical aortic valves and stents.

[0004] Currently, vascular access devices are typically inserted percutaneously into a patient's blood vessels through the skin. The practice of not incising the skin with a scalpel to expose the blood vessel for insertion has led to safer and more frequent use of vascular access devices. In percutaneous insertion techniques, a needle or similar puncture device is inserted into the skin without first incising the skin to expose the blood vessel. The vascular access device is advanced through the skin from the puncture site into the blood vessel. For the patient, percutaneous techniques reduce bleeding and the potential for human error that can occur when incising with a scalpel.

[0005] During a percutaneous procedure, the introducer sheath is typically positioned at the access point to the patient's blood vessel and pushed through the vessel until the sheath seats firmly at the required location within the patient. The proximal end of the introducer sheath protrudes outside the patient's body, providing an access point for subsequent insertion of additional or other intravascular devices. Often, a dilator is placed within the introducer sheath and pushed through the opening of the blood vessel together with the introducer sheath, thereby gradually opening the vascular puncture site and inserting the sheath while minimizing vascular trauma.

[0006] The percutaneous access point is typically much smaller than the diameter of the introducer sheath, and some force is required to stretch the patient's skin at the percutaneous opening to move the vascular access device into the blood vessel. Thus, devices with grooves, notches, or angular edges tend to create snag points where the skin can catch and tear, thereby potentially causing patient site trauma and delayed recovery.

[0007] Thus, a typical introducer sheath has a tapered distal end that provides a smooth transition to the end and tip of the dilator when used to open the vascular structure, allowing the sheath to enter without excessive trauma. Ideally, to avoid trauma, the transition between the dilator tip and the sheath distal end is 0.1 mm or less. However, this is not always achieved. When the dilator is significantly longer than the sheath, the assembly of the sheath and dilator tends to be more forgiving to small manufacturing variations, particularly in the length variations of either the dilator or the sheath, but this is not always achieved in the case of shorter lengths.

[0008] Also, not all sheath and dilator types can tolerate manufacturing variations. In the case of an introducer sheath having multiple layers, inserting a tapered tip into an introducer sheath having layers that slide relative to each other is difficult, if not impossible. To prevent excessive movement of the layers, a stepped gap is often provided between a typical dilator tip and the sheath. To overcome this, a dilator tip having a rounded arrowhead-shaped distal end shape is used to provide a smooth transition between the dilator and the sheath.

[0009] When an arrowhead-shaped dilator tip is used, small manufacturing variations can leave a potential gap between the arrowhead-shaped dilator and the sheath, which can create snag points on the skin or flesh during insertion of the dilator and sheath into the body.

[0010] Therefore, a mechanism for positioning the dilator tip relative to the introducer sheath is needed to minimize snag points caused by gaps or edges in the transition region between the introducer sheath and the dilator. SUMMARY OF THE INVENTION MEANS FOR SOLVING THE PROBLEM

[0011] An embodiment of the present invention is a vascular dilator positioning assembly, comprising a grip portion including a wall having an outer wall surface and an inner wall surface, the wall having a proximal edge defining a proximal opening, a distal edge defining a distal opening, and a lumen formed therethrough; a user-operable actuator disposed near the proximal edge; and a vascular dilator including an elongate tube attached to the actuator at its proximal end and attached to a dilator tip at its distal end, the actuator being configured to move the dilator tip distally from a retracted position to an extended position while the actuator is actuated and to return the dilator tip to the retracted position when the actuator stops actuating.

[0012] As used herein, the terms "proximal" and "distal" are understood as opposite terms with respect to the direction of use of the article to which they refer. The term "distal" is understood to refer to the end of the article that first enters the patient, and the term "proximal" is understood to refer to the end opposite the "distal" end. For example, the "distal end" is most likely closest to the tip of the dilator, and as a result, in use, the distal end is closest to the patient, the proximal end is closest to the user, and the "proximal" end is also closest to the actuator.

[0013] In an embodiment, the actuator has a button disposed near the proximal edge and an actuator core configured to engage the wall, and the actuator is configured to move the distal end of the dilator in the distal direction from the retracted position to the extended position when a force is applied to the button, and to return the distal end of the dilator to the retracted position when the force applied to the button is released.

[0014] Preferably, the actuator core includes a plug portion having a width extending across the width of the lumen of the grip portion. The plug portion may be configured as a plate or a stopper and may be configured to close the lumen of the grip portion. The plug portion can guide the movement of the distal end of the dilator.

[0015] The distal end of the dilator is preferably substantially conical with a taper towards the point of the distal end. More preferably, the distal end of the dilator is arrowhead-shaped and includes two substantially conical portions, where the first conical portion tapers outward from the proximal end towards the maximum width and the second portion tapers inward towards the rounded tip of the distal end. Alternatively, the distal end of the dilator may have a substantially uniform width along its length and have a flat proximal end face and a rounded tip at the distal end.

[0016] A sheath for use with an embodiment of the present invention preferably includes a semi-rigid layer to prevent significant wrinkling in the longitudinal direction of the sheath, but alternatively may include a semi-rigid element configured to substantially maintain the length of the sheath. Configurations including single-layer sheaths and multi-layer sheaths may be suitable for the present invention.

[0017] In some embodiments, the actuator core is configured to occupy the space within the grip lumen.

[0018] In an embodiment, the vascular dilator positioning assembly includes an elastic biasing element for biasing the dilator tip against the wall. In a further embodiment, the elastic biasing element is a spring having a spring constant between about 0.1 N / mm and 10 N / mm.

[0019] Preferably, the introduction force at maximum deflection is between about 0.1 N and 10 N. More preferably, the spring constant of the elastic biasing element is between 1 N / mm and 3 N / mm, and the introduction force at maximum deflection ranges from 0.5 N to 6.5 N. Most preferably, the spring constant of the elastic biasing element is approximately 0.6 N / mm.

[0020] In an alternative embodiment, the elastic biasing element can be an air pocket, a rubber stopper, an elastic strip, or a repulsive magnet that is compressed by an applied force and biased in the expanding direction, or has a force per distance between about 0.1 N / mm and 10 N / mm, or an introduction force in the maximum deflection range between 0.1 N and 10 N.

[0021] In some embodiments, the inner wall surface includes one or more protrusions. The protrusions are preferably configured such that the actuator core having a plug portion and the one or more protrusions form a space therebetween for maintaining a compressible biasing element therein.

[0022] In a further embodiment, a portion of the actuator core is shaped to occupy a space across the width of the grip lumen, thereby enabling the actuator to slide within the grip lumen, and the elastic biasing element occupies the space substantially defined by the outer surface of the actuator core and the inner surface of the wall.

[0023] An embodiment of the present invention may further include an expander sheath that circumferentially surrounds an elongate tube having a proximal sheath end and a distal sheath end, wherein the actuator is configured to move the expander tip distally from a retracted position to an extended position to widen the gap between the expander sheath and the expander tip when a force is applied to the button, and to partially return the expander tip to an intermediate stationary position when the force is released from the button, thereby closing the gap between the expander sheath and the expander tip.

[0024] The application of force to the button is preferably a thumb or finger press controlled by the user, where the user receives tactile feedback from the elastic biasing element and can control the release of force for the controlled retraction of the expander tip.

[0025] The retracted position is preferably a position where the expander tip is partially within the expander sheath. The extended position is preferably a position where the expander tip is completely out of the expander sheath, exposing its proximal end and forming a gap therebetween. The intermediate stationary position is preferably between the retracted position and the extended position and is defined by the point where the surface of the expander tip abuts the expander sheath.

[0026] In a further embodiment, the expander sheath includes a semi-rigid inner layer and an elastomeric outer layer, and the expander tip is configured to abut the semi-rigid inner layer at an intermediate position, thereby providing a substantially smooth outer surface across the elastomeric outer layer and the expander tip.

[0027] The abutment of the expander tip against the semi-rigid inner layer can be on any surface of the expander tip. Preferably, the expander tip abuts the semi-rigid inner layer on the tapered surface of the proximal conical portion, but alternatively, the semi-rigid inner layer may abut the flat surface at the proximal end of the expander tip or a protrusion around the expander tip.

[0028] In a more preferred embodiment, the elastic biasing element is a spring having a spring constant between about 0.1 N / mm and 10 N / mm.

[0029] Embodiments of the present invention are vascular dilator positioning systems, including a grip portion including a wall having an outer wall surface and an inner wall surface, the wall having a proximal edge defining a proximal opening, a distal edge defining a distal opening, and a lumen formed therethrough, a user-operable actuator disposed near the proximal edge, and a vascular dilator including an elongate tube attached to the actuator at its proximal end and to the dilator tip at its distal end, the actuator being configured to move the dilator tip distally from a retracted position to an extended position while the actuator is actuated and to return the dilator tip to the retracted position when the actuator stops operating, related to a vascular dilator positioning system.

[0030] In an embodiment, the vascular dilator positioning assembly includes an elastic biasing element for biasing the dilator tip against the wall. In a further embodiment, the elastic biasing element is a spring having a spring constant between about 0.1 N / mm and 10 N / mm.

[0031] In an embodiment, the actuator has a button disposed near the proximal edge and an actuator core configured to engage the wall, the actuator being configured to move the dilator tip distally from a retracted position to an extended position when a force is applied to the button and to return the dilator tip to the retracted position when the force on the button is released.

[0032] A further embodiment may include a dilator sheath circumferentially surrounding an elongate tube having a proximal sheath end and a distal sheath end, the actuator being configured to move the dilator tip distally from a retracted position to an extended position when a force is applied to the button to widen a gap between the dilator sheath and the dilator tip and to partially return the dilator tip to an intermediate stationary position when the force is released from the button, thereby closing the gap between the dilator sheath and the dilator tip.

[0033] In some embodiments, the dilator sheath includes a semi-rigid inner layer and an elastomeric outer layer, and the dilator tip abuts the semi-rigid inner layer at an intermediate rest position, thereby providing a substantially smooth outer surface over the elastomeric outer layer and the dilator tip.

[0034] Embodiments of the present invention are methods of using a vascular dilator positioning assembly, comprising obtaining a grip portion including a wall having an outer wall surface and an inner wall surface, a proximal edge defining a proximal opening, a distal edge defining a distal opening, and a lumen formed therethrough, and a user-operable actuator disposed near the proximal edge; attaching a vascular dilator including an elongate tube to the actuator at a proximal end and to a dilator tip at a distal end; circumferentially disposing a dilator sheath having a proximal sheath end and a distal sheath end around the elongate tube; actuating the actuator to move the dilator tip distally from a retracted position to an extended position to widen a gap between the dilator sheath and the dilator tip; and stopping actuation of the actuator to return the dilator tip to the retracted position.

[0035] In an embodiment, the method includes assembling a grip portion, an actuator, and an elastic biasing element for biasing the dilator tip against the wall.

[0036] In an embodiment, the actuator has a button disposed near the proximal edge and an actuator core configured to engage the wall. Actuating the actuator includes applying a force to the button to move the dilator tip distally from a retracted position to an extended position to widen a gap between the dilator sheath and the dilator tip. Stopping actuation of the actuator includes releasing the force on the button to partially return the dilator tip to an intermediate rest position, thereby closing the gap between the dilator sheath and the dilator tip.

[0037] In a further method, the dilator sheath includes a semi-rigid inner layer and an elastomeric outer layer, and the dilator tip abuts against the semi-rigid inner layer in an intermediate rest position, thereby configured to provide a substantially smooth outer surface over the elastomeric outer layer and the dilator tip; the elastic biasing element is a spring having a spring constant between about 0.1 N / mm and 10 N / mm.

[0038] An embodiment of the present invention is a method of assembling a vascular dilator positioning system, the method comprising obtaining a grip portion including a wall having an outer wall surface and an inner wall surface, a proximal edge defining a proximal opening, a distal edge defining a distal opening, and a lumen formed therethrough; obtaining an actuator disposed near the proximal edge; attaching a vascular dilator including an elongate tube to an actuator core at a proximal end and to a dilator tip at a distal end; and circumferentially disposing a dilator sheath having a proximal sheath end and a distal sheath end around the elongate tube.

[0039] In an embodiment, the method includes engaging the grip portion with the actuator and an elastic biasing element for biasing the dilator tip against the wall.

[0040] In a further method, the elastic biasing element is a spring having a spring constant between about 0.1 N / mm and 10 N / mm.

[0041] Next, broad embodiments of the present invention will be described with reference to the accompanying drawings, along with the examples and preferred embodiments disclosed in the detailed description. The present invention can be embodied in many different forms and should not be construed as limited to the embodiments described herein. These embodiments are provided only by way of example so that this disclosure will be thorough and complete and will convey the full scope and breadth of the present invention.

Brief Description of the Drawings

[0042]

Figure 1

Figure 2a

Figure 2b

Figure 2c

Figure 3

Figure 4

Figure 5

Figure 6a

Figure 6b

Figure 7a

Figure 7b

Figure 7c

Figure 8a

Figure 8b

Figure 8c

Figure 9

DETAILED DESCRIPTION OF THE INVENTION

[0043] Some embodiments of the present invention are described in the following examples.

[0044] Prior Art FIG. 1 provides a front view of a prior art expander 100 assembly, shown with a prior art introducer sheath 150 in a see-through state with dashed lines. Detail A provides an enlarged front view of the expander tip 130 and the sheath. The expander 100 is a tubular device for insertion into a vascular opening to reduce trauma while expanding a blood vessel for introduction of the introducer sheath 150.

[0045] In many prior art dilator and introducer sheath assemblies of this type, the designed lengths of both the dilator 100 and the introducer sheath 150 are nominally positioned such that when the dilator hub 110 is attached to the collar 151, the distal end 153 of the sleeve 152 contacts the proximal end of the tapered head 130, and are designed to provide a substantially smooth transition therebetween.

[0046] Detail A shows detailed views of the distal end 153 of the sleeve 152 and the proximal ends of the tapered head 130 of the introducer sheath 150 and the dilator 100, respectively. The designed lengths of the dilator 100 and the introducer sheath 150 nominally place the tapered head 130 against the distal end 153 of the sleeve 152, but manufacturing errors in both the dilator 100 and the introducer sheath 150 can create a gap 140 therebetween. The presence of the gap 140 can prevent a smooth transition between the tapered head 130 and the sleeve 152 and allow skin and tissue 210 to catch on the distal end 153 within the gap 140.

[0047] Figure 2 provides a front cross-sectional view of the prior art dilator and sheath assembly shown in Detail A of Figure 1 to visually illustrate the prior art problems associated with the presence of the gap 140. Figure 2a shows the prior art dilator 100 and introducer sheath 150 assembly during initial insertion into an incision in the tissue 210 of a patient 200. The tapered head 130 smoothly dilates the incision in the tissue 210, but a manufacturing error creates a gap 140 between the tapered head 130 and the distal end 153.

[0048] Figure 2b shows the state where the insertion of the prior art dilator 100 and the introducer sheath 150 assembly has progressed, and the tapered head 130 has been further inserted into the tissue 210. The tissue 210 has a certain degree of elasticity, whereby pressure is applied to the tapered head 130. If there is a gap 140 at the proximal end of the tapered head 130, the tissue 210 conforms to the shape of the tapered head 130 and enters the gap 140 if there is no smooth transition between the tapered head 130 and the sleeve 152.

[0049] Figure 2c shows the snagging of the skin and tissue 210 on the distal end 153 of the prior art introducer sheath 150 at the incision site. The snagging of the skin and tissue 210 can cause excessive trauma or prevent further insertion of the prior art dilator 100 and introducer sheath 150 assembly. In some cases, insertion may fail due to any of these possibilities, requiring removal and retrial of the dilator 100 and introducer sheath 150 assembly, which itself can increase trauma and contribute to the overall risk profile.

[0050] The invention described herein aims to improve this problem often associated with such prior art devices.

[0051] Embodiments according to the present invention The embodiments will be described in detail below with reference to the figures. The exemplary embodiments are described to illustrate specific aspects and embodiments of the present invention and are not intended to limit their scope, which is defined by the claims. Those skilled in the art will recognize that numerous equivalent variations of the various features provided in the following description may be possible.

[0052] Figure 3 provides a side perspective view of the dilator 300. The dilator 300 is generally composed of a dilator hub 310 at the proximal end 301, a tapered head 330 at the distal end 302, and a dilator body 320 therebetween. The lumen from the proximal end 301 to the distal end 302 of the dilator 300 allows wires and small instruments to pass through.

[0053] The dilator hub 310 provides an attachment point for an introducer sheath (not shown) and allows the operator to handle the dilator 300 when inserting the dilator into the introducer sheath. The dilator hub 310 is a rigid annular structure having a larger diameter portion 311 and a smaller diameter portion 312. The smaller diameter portion 312 is shaped to fit within the introducer sheath collar. The dilator hub 310 further includes fixing means embodied by a plug joint 313 formed on the surface of the smaller diameter portion 312 of the dilator hub 310 body, and a button 340 slidably inserted into the larger diameter portion 311 of the dilator hub 310 and connected thereto by a biasing element (not shown) embodied by a spring, the spring having one end attached to the button 340 and the other end attached to the dilator hub 310.

[0054] The dilator hub 310, the button 340, the dilator body 320, and the tapered head 330 contain a lumen so that wires and small instruments can be passed to the blood vessel. Detail B provides further details of the tapered head 330 that is further used to facilitate insertion of the dilator 300 into the introducer sheath. The tapered head 330 is substantially conical or arrowhead-shaped, tapering outwardly from the diameter of the distal end of the dilator body 320 at the interface 331 between the tapered head 330 and the dilator body 320 to the maximum diameter of the tapered head 330, and tapering inwardly from the maximum diameter of the tapered head 330 to the rounded tip at the distal end of the tapered head 330.

[0055] The space between the interface 331 between the tapered head 330 and the expander body 320 and the maximum diameter of the tapered head 330 provides a catch point for the patient's blood vessel when introduced together with the sheath.

[0056] The expander body 320 is substantially cylindrical, attached to the tapered head 330 at the distal end, entering the expander hub 310 at the proximal end, and attached to the button 340 there. By connecting the button 340 and the biasing element, the expander body 320 can move slidably in the longitudinal direction with respect to the expander hub 310.

[0057] The components of the expander 300 are composed of biocompatible polymers such as polycarbonate, polypropylene, acrylonitrile-butadiene-styrene, polyethylene, polyamide, or polyamide blend. The expander body 320 can further incorporate a metal or synthetic fiber braided reinforcing material to enhance rigidity. These components can incorporate additives or elements that improve opacity under X-ray images, such as metal parts or fillers.

[0058] FIG. 4 provides a side perspective exploded view of the components of an assembly of the expander 300 and the introducer sheath 400 according to a preferred embodiment of the present invention. The expander 300 generally includes an expander hub 310, a button 340, a fixing means 313, a biasing element embodied by a conventional stainless steel coil spring 350 of 0.1 N / mm to 10 N / mm, an expander body 320, and a tapered head 330. The introducer sheath 400 generally includes a rigid annular collar 410, an elongated double-layer sleeve 420, and a fixing joint embodied by a plug receiving portion 440 that receives the fixing means 313 and is suitable for fixing the expander 300 thereto.

[0059] The introducer sheath 400 is generally composed of two main components, namely a rigid annular collar 410 and an elongated double-layer sleeve 420. The collar 410 has a hollow structure configured such that material is supplied into the lumen of the sleeve 420 through the wider opening of the sleeve 420. The collar 410 is formed of a rigid material so that a user can handle the collar 410 and pass an object or material therethrough. The collar 410 includes a fixed joint 440 and terminates in an opening shaped to receive and secure the sleeve 420 therein, thereby connecting the two components.

[0060] After the dilator 300 is inserted into the introducer sheath 400, the dilator hub 310 can be fixedly attached to the collar 410 by engaging the fixing means 313 with the fixed joint 440, positioning the tapered head 330 relative to the distal end 430 of the sleeve 420, and preventing further relative movement.

[0061] FIG. 5 shows a front cross-sectional view of the assembled arrangement of the dilator 300 and the introducer sheath 400. The assembly of the dilator 300 and the introducer sheath 400 is such that the dilator body 320 is surrounded by the length of the sleeve 420 that nominally abuts the proximal end of the tapered head 330. The dilator hub 310 has a larger diameter portion 311 at its proximal end and a smaller diameter portion 312 at its distal end. The smaller diameter portion 312 is shaped to be slidably inserted into the collar 410, and the larger diameter portion is shaped to abut the proximal end of the collar 410.

[0062] The button 340 is formed as an integral annular component shaped to generally include a pusher 341 at its proximal end shaped to receive a syringe connection, an actuator core 343 connected thereto, a hook ridge 342 at the interface between the pusher 341 and the actuator core 343, a plunger body 344 at the distal end of the actuator core 343, and a plunger stopper 345 at the distal end of the button 340.

[0063] The pusher 341 is shaped for tactile engagement by a user to slidably push the button 340 within the larger diameter portion 311 and has a central lumen therethrough for receiving wires or instruments. The actuator core 343 is substantially cylindrical with a central lumen therethrough. The diameter of the actuator core 343 provides a space between the actuator core 343 and the larger diameter portion 311 for receiving the spring 350. The hook ridge 342 is a portion of the actuator core 343 of larger diameter and is configured to slidably fit within the larger diameter portion 311 and to contain the spring 350 within the space between the actuator core 343 and the larger diameter portion 311.

[0064] The plunger body 344 is substantially cylindrical with a central lumen therethrough. Its diameter is smaller than that of the actuator core 343 and is shaped to fit within and extend through the smaller diameter portion 312. The plunger stopper 345 is shaped to abut against the surface 312a within the smaller diameter portion 312 to maintain the button 340 within the dilator hub 310.

[0065] The spring 350 is a coiled spring steel having a coil proximal end 351 and a coil distal end 352. The spring 350 is sized to fit between the actuator core 343 and the larger diameter portion 311 and is sized to slidably fit within the larger diameter portion 311. The coil proximal end 351 abuts against and applies force to the hook ridge 342. The coil distal end 352 is attached to the interface between the larger diameter portion 311 and the smaller diameter portion 312 such that expansion is toward the coil proximal end 351.

[0066] Figures 6a and 6b provide detailed side perspective views of the proximal components of the dilator 300 and introducer sheath 400 according to the preferred embodiment of the invention shown in Figures 4 and 5.

[0067] As shown in FIG. 6a, the expander hub 310 is a rigid, substantially tubular component having a larger diameter portion 311 at its proximal end and a smaller diameter portion 312 at its distal end, and contains a biasing element embodied by a spring 350 (not shown) within and along the inner circumference of its larger diameter portion 311. The button 340 is slidably inserted within the expander hub 310 and abuts against the spring 350 so as to resist further intrusion into the expander hub 310. The expander body 320 is connected to the button 340 such that actuation of the button 340 biased by the spring 350 causes the expander body 320 to move longitudinally and the tapered head 330 attached thereto to move toward the distal end 302. Formed integrally with the smaller diameter portion 312 of the expander hub 310 is fixing means embodied as a plug-in joint 313, which enables the expander hub 310 to be fixed to the introducer sheath 400.

[0068] The fixing of the expander 300 to the introducer sheath 400 is shown in detail in FIG. 6b, where the plug-in joint of the fixing means 313 is inserted into and fixed to a corresponding fixing joint 440.

[0069] The sleeve 420 is double-layered, with the outer elastomeric layer providing outward resistance to the semi-rigid inner layer. The sleeve 420 is attached at its proximal end to a rigid collar 410. The fixing joint 440 is attached to the proximal end of the collar 410 and provides a corresponding joint for the fixing means 313. Secure engagement of the fixing means 313 to the fixing joint 440 provides an anchor point that allows movement of the expander body 320 and the tapered head 330 relative to the sleeve 420 when the button 340 is in its actuated and non-actuated states.

[0070] FIGS. 7a-7c provide front cross-sectional views of the expander 300 and the introducer sheath 400, where the expander hub 310 is attached to the collar 410 via engagement of the fixing means 313 to the fixing joint 440, and detail the interaction of the tapered head 330 and the sleeve 420 at various actuation points of the button 340.

[0071] When the expander 300 is inserted into the introducer sheath 400, the fixing means 313 engages with and is fixed to the fixing joint 440. The button 340 and the expander body 320 are connected for combined longitudinal movement relative to the introducer sheath 400. The button 340 is further connected to a spring 350, and when the button 340 is actuated, it enables the combined longitudinal movement of the button 340 and the expander body 320 towards the distal end 302 of the introducer sheath 400, and provides a return force towards the proximal end 301 when not actuated.

[0072] FIG. 7a provides a front cross-sectional view of the expander 300 and the introducer sheath 400 after the expander 300 has been initially inserted into the introducer sheath 400 and the two are fixed, but before the button 340 is actuated. Accordingly, the spring 350 is in a substantially uncompressed state, and the plunger stopper 345 is in contact with the surface 312a. The length of the expander body 320 is such that at this point, as detailed in detail D, the tapered head 330 does not completely exit from the distal end of the sleeve 420.

[0073] When the button 340 is pressed, the spring 350 contracts and the tapered head 330 is pushed out beyond the distal end of the sleeve 420. FIG. 7b provides a front cross-sectional view of the expander 300 and the introducer sheath 400 when the expander 300 has been initially inserted into the introducer sheath 400, the two are fixed, and the button 340 is actuated to the maximum extent. Accordingly, the spring 350 is in a maximally compressed state, and the expander body 320 is at its maximum stroke. At this point, the tapered head 330 has completely exited from the distal end of the sleeve 420, leaving a gap therebetween, as detailed in detail E.

[0074] When the button 340 is released, the spring 350 expands, the tapered head 330 returns and abuts against the distal end of the sleeve 420, and a smooth transition is formed therebetween. FIG. 7c provides a front cross-sectional view of the dilator 300 and the introducer sheath 400 after the dilator 300 is first inserted into the introducer sheath 400 and fixed thereto, and after the button 340 is released from the maximum actuation point to the intermediate point. The spring 350 is released from the maximum compression point to the intermediate point. At this point, the tapered head 330 retreats relative to the sleeve 420, and further retreat is prevented by the stiffness of the sleeve 420 and the small force exerted by the spring 350. As shown in detail F in detail, the gap between the tapered head 330 and the sleeve 420 is closed, and a substantially smooth transition remains between the tapered head 330 and the sleeve 420.

[0075] FIG. 8 provides a front cross-sectional view of the assembly of the dilator 300 and the sheath 400 shown in detail F of FIG. 7c, providing a visual illustration of the present invention in use, where after the button 340 is actuated and deactuated and the tapered head 330 is positioned relative to the sleeve 420, the assembly of the dilator 300 and the introducer sheath 400 is inserted into an incision in the tissue 210 of the patient 200. FIG. 8a shows the dilator 300 and the introducer sheath 400, where the tapered head 330 abuts against the distal end of the sleeve 420 due to the expansion force of the spring 350 during the initial insertion into the incision in the tissue 210 of the patient 200. The tapered head 330 smoothly expands the incision in the tissue 210 to reduce trauma.

[0076] FIG. 8b shows the initial interaction between the incision in the tissue 210 and the tapered head 330 during further insertion. The tissue 210 has an elasticity such that it applies an inward pressure to the tapered head 330. At the proximal end of the tapered head 330, if there is no gap, the tissue 210 conforms to the shape of the tapered head 330, but the substantially smooth transition therebetween prevents it from significantly entering the path of the sleeve 420.

[0077] FIG. 8c shows the absence of snagging of the skin and tissue 210 of patient 200 at the incision point relative to the distal end of the sleeve 420. The substantially smooth transition from the tapered head 330 to the sleeve 420 allows the tapered head 330 and the sleeve 420 to enter the incision in the tissue 210 without snagging or causing excessive trauma, thereby reducing the risk of insertion failure and thus reducing the overall risk profile of patient 200.

[0078] FIG. 9 provides a flowchart demonstrating how a new combination of the integers shown in FIGS. 3 - 8c can be operated in a normal use scenario. In step 901, an introducer sheath suitable for combination with a dilator according to an embodiment of the present invention is obtained, and in step 902, the dilator itself is obtained.

[0079] Step 903 requires inserting the dilator tip into the proximal end of the introducer sheath such that when fully inserted, the dilator tip partially exits from the distal end of the introducer sheath. Next, step 904 requires fixing the dilator to the introducer sheath in this position by engaging the fixing means of the dilator with the fixing fitting of the introducer sheath.

[0080] In step 905, the user actuates or presses a button on the dilator to compress the spring connected thereto, fully extending the dilator tip relative to the introducer sheath. This exposes the dilator tip completely and creates a gap between the dilator tip and the distal end of the introducer sheath.

[0081] In step 906, the user de - actuates or releases the button on the dilator, releasing the spring pressure and retracting the dilator tip towards the proximal end of the introducer sheath. This pulls the dilator tip towards the distal end of the introducer sheath, closing the gap between the dilator tip and the introducer sheath and forming a substantially smooth transition therebetween.

[0082] In step 907, as shown in FIGS. 8a - 8c, an assembly of an expander and an introducer sheath according to an embodiment of the present invention is inserted into a patient.

[0083] Throughout this specification, the word "comprise", or variations such as "comprises" or "comprising", is understood to mean that the recited element, integer, or step, or group of elements, integers, or steps is included, but does not mean the exclusion of other elements, integers, or steps, or group of elements, integers, or steps.

[0084] The terms "fastener" or "fasten", "connect" or "seal", when used alone or in combination with other terms such as "means", may be used interchangeably where their interpretation can be considered by those skilled in the art to be functionally interchangeable with another term. Further, the use of one of the foregoing terms does not exclude the interpretation where another term is included.

[0085] The various devices and components of the devices as described herein may be provided in various sizes and / or dimensions as desired. The appropriate size and / or dimension may vary depending on the specifications of the components to be connected or the field of use, and these may be selected by those skilled in the art.

[0086] It will be understood that the features, elements, and / or characteristics described with respect to one embodiment of the present disclosure may, if desired, be used with other embodiments of the present invention.

[0087] The preferred embodiments of the present disclosure are disclosed for illustrative purposes, and those skilled in the art will understand that various modifications, additions, and substitutions are possible without departing from the scope and spirit of the present disclosure and the appended claims.

[0088] When an element or layer is referred to as being "on" or "inside" another element or layer, it should be understood that the element or layer can be directly on or inside the other element or layer, or intervening elements or layers may be present. In contrast, when an element is referred to as being "directly on" or "directly inside" another element or layer, there are no intervening elements or layers.

[0089] As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0090] In this specification, terms such as first, second, third, etc. may be used to describe various elements, components, regions, layers, and / or sections, but it is understood that these elements, components, regions, layers, and / or sections should not be limited by these terms. These terms are only used to distinguish one element, component, region, layer, or section from another. Thus, a first element, component, region, layer, or section can be referred to as a second element, component, region, layer, or section without departing from the teachings of the present disclosure.

[0091] In this specification, spatially relative terms such as "below", "above", "top", "bottom", "left", "right", etc. may be used to more easily describe the relationship between one element or feature and another as shown in the figures. It is understood that the spatially relative terms are intended to encompass different orientations of the structure in use or operation in addition to the orientation depicted in the drawings. For example, if the device in the drawing is turned over, an element described as "below" in comparison to another element or function will be oriented "above" in comparison to the other element or function. Thus, the exemplary term "below" can encompass both upward and downward orientations. The device may be oriented in other ways (rotated 90 degrees or other orientations), and the spatially relative descriptors used herein should be interpreted accordingly.

[0092] The terms used in this specification are for the sole purpose of describing particular embodiments and are not intended to limit the present disclosure. As used in this specification, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless the context clearly dictates otherwise. Further, as used in this specification, the terms "including", "comprises", and / or "comprising" identify the presence of the described features, integers, steps, operations, elements, and / or components, but do not preclude the presence and addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0093] The embodiments described herein are described with reference to, for example, figures and / or cross-sectional views that are schematic illustrations of the preferred embodiments (and intermediate structures) described herein. As a result, for example, variations from the shapes of the figures are to be expected as a result of manufacturing techniques and / or tolerances. Accordingly, the embodiments described herein should not be construed as being limited to the particular shapes of the components shown herein and include, for example, shape deviations resulting from manufacturing.

[0094] Unless otherwise defined, all terms (including technical and scientific terms) used in this specification have the same meaning as commonly understood by one of ordinary skill in the art to which this description belongs. Terms such as those defined in commonly used dictionaries are to be interpreted as having a meaning that coincides with the meaning in the context of the relevant art and are not to be interpreted in an idealized or overly formal sense unless expressly defined herein.

[0095] As used herein, expressions such as "one embodiment", "embodiment", "exemplary embodiment", etc. mean that the specific functions, structures, or characteristics described in connection with that embodiment are included in at least one of the described embodiments. The appearance of such phrases in various places in this specification does not necessarily refer to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with any embodiment, those skilled in the art can bring about and / or use such feature, structure, or characteristic in connection with other embodiments.

[0096] Embodiments are intended to cover any and all ways of using or manufacturing using any or all of the elements disclosed above.

[0097] Although the present invention has been described above with respect to specific embodiments, it should be understood that the present invention is not limited to these disclosed embodiments. Many modifications and other embodiments of the present invention will come to the mind of those skilled in the art upon reading the teachings of this disclosure. These are intended to be covered by, and are covered by, both this disclosure and the appended claims.

[0098] All publications mentioned in this specification are hereby incorporated by reference. Any consideration of the documents, acts, materials, devices, articles, etc. included in this specification is for the purpose of explaining the background of the present invention only. It should not be construed as admitting that any of these matters form part of the prior art or were common general knowledge in the field related to the present invention as they existed in Australia or other countries prior to the priority date of each claim of this application.

[0099] It is intended that the scope of the present invention be determined by appropriately interpreting and constructing the appended claims and their legal equivalents as would be interpreted by those skilled in the art relying on the disclosure of this specification and the accompanying drawings.

Claims

1. A vascular dilator positioning assembly, comprising a grip portion including a wall having an outer wall surface and an inner wall surface, the wall having a proximal edge defining a proximal opening, a distal edge defining a distal opening, and a lumen formed therethrough; a user-operable actuator disposed near the proximal edge; a vascular dilator including an elongate tube attached to the actuator at its proximal end and to the dilator tip at its distal end; wherein the actuator is configured to move the dilator tip distally from a retracted position to an extended position while the actuator is actuated, and to return the dilator tip to the retracted position when actuation of the actuator stops. A vascular dilator positioning assembly.

2. The vascular dilator positioning assembly of claim 1, further comprising an elastic biasing element for biasing the dilator tip against the wall.

3. The vascular dilator positioning assembly of claim 2, wherein the elastic biasing element is a spring having a spring constant between about 0.1 N / mm and 10 N / mm.

4. The actuator has a button disposed near the proximal edge and an actuator core configured to engage the wall, and the actuator is configured to move the dilator tip distally from the retracted position to the extended position when a force is applied to the button, and to return the dilator tip to the retracted position when the force on the button is released.

5. The vascular dilator positioning assembly of claim 4, wherein the actuator core is configured to occupy a space within the grip lumen.

6. A portion of the actuator core is shaped to occupy a space across the width of the grip lumen, thereby enabling the actuator to slide within the grip lumen. The elastic biasing element occupies a space substantially defined by the outer surface of the actuator core and the inner surface of the wall. The vascular dilator positioning assembly of claim 2 or 4.

7. An expander sheath that circumferentially surrounds the elongate tube having a proximal sheath end and a distal sheath end, wherein the actuator is configured to move the expander tip distally from a retracted position to an extended position to widen a gap between the expander sheath and the expander tip when a force is applied to the button, and to partially return the expander tip to an intermediate stationary position when the force is released from the button, thereby closing the gap between the expander sheath and the expander tip. The vascular expander positioning assembly according to claim 4.

8. The vascular expander positioning assembly according to claim 7, wherein the expander sheath includes a semi-rigid inner layer and an elastomeric outer layer, and the expander tip is configured to abut against the semi-rigid inner layer at the intermediate position, thereby providing a substantially smooth outer surface over the elastomeric outer layer and the expander tip.

9. A vascular expander positioning system, A grip portion including a wall having an outer wall surface and an inner wall surface, the wall having a proximal edge defining a proximal opening, a distal edge defining a distal opening, and a lumen formed therethrough; A user-operable actuator disposed near the proximal edge; A vascular expander including an elongate tube attached to the actuator at a proximal end and attached to an expander tip at a distal end; The actuator is configured to move the expander tip distally from a retracted position to an extended position while the actuator is operating, and to return the expander tip to the retracted position when the actuator stops operating. Vascular expander positioning system.

10. The vascular expander positioning system according to claim 9, further comprising an elastic biasing element for biasing the expander tip against the wall.

11. The vascular expander positioning system according to claim 10, wherein the elastic biasing element is a spring having a spring constant between about 0.1 N / mm and 10 N / mm.

12. The actuator has a button disposed near the proximal edge and an actuator core configured to engage the wall. The actuator is configured to move the distal end of the dilator from the retracted position to the extended position in the distal direction when a force is applied to the button, and to return the distal end of the dilator to the retracted position when the force applied to the button is released. The vascular dilator positioning system according to claim 11.

13. Including a dilator sheath that circumferentially surrounds the elongate tube having a proximal sheath end and a distal sheath end, the actuator being configured to move the distal end of the dilator from the retracted position to the extended position in the distal direction when a force is applied to the button to widen the gap between the dilator sheath and the distal end of the dilator, and to partially return the distal end of the dilator to an intermediate stationary position when the force is released from the button, thereby closing the gap between the dilator sheath and the distal end of the dilator. The vascular dilator positioning system according to claim 9.

14. The dilator sheath includes a semi-rigid inner layer and an elastomeric outer layer, and the distal end of the dilator is configured to abut the semi-rigid inner layer at the intermediate stationary position, thereby providing a substantially smooth outer surface over the elastomeric outer layer and the distal end of the dilator. The vascular dilator positioning system according to claim 13.

15. Preferably, it is a method of using a vascular dilator positioning assembly according to claim 1, comprising: Obtaining a grip portion including a wall having an outer wall surface and an inner wall surface, a proximal edge defining a proximal opening, a distal edge defining a distal opening, and a lumen formed therethrough, and a user-operable actuator disposed near the proximal edge; Attaching a vascular dilator including an elongate tube to the actuator at the proximal end and to the distal end of the dilator at the distal end; Circumferentially disposing a dilator sheath having a proximal sheath end and a distal sheath end around the elongate tube; Actuating the actuator to move the distal end of the dilator from the retracted position to the extended position in the distal direction to widen the gap between the dilator sheath and the distal end of the dilator, and stopping the actuation of the actuator to return the distal end of the dilator to the retracted position; A method comprising.

16. The step of assembling the grip portion, the actuator, and an elastic biasing element for biasing the distal end of the dilator against the wall. The method of using the vascular dilator positioning assembly according to claim 15, further comprising this step.

17. The actuator has a button disposed near the proximal edge and an actuator core configured to engage with the wall. The step of actuating the actuator includes applying a force to the button to move the distal end of the dilator in the distal direction from the retracted position to the extended position to widen the gap between the dilator sheath and the distal end of the dilator. The step of stopping the actuation of the actuator includes releasing the force on the button to partially return the distal end of the dilator to the intermediate rest position, thereby closing the gap between the dilator sheath and the distal end of the dilator. The method of using the vascular dilator positioning assembly according to claim 15.

18. The dilator sheath includes a semi-rigid inner layer and an elastomeric outer layer. The distal end of the dilator abuts against the semi-rigid inner layer in the intermediate rest position, thereby providing a substantially smooth outer surface over the elastomeric outer layer and the distal end of the dilator. The elastic biasing element is a spring having a spring constant between about 0.1 N / mm and 10 N / mm. The method of using the vascular dilator positioning assembly according to claim 15.

19. A method of assembling a vascular dilator positioning system, preferably according to claim 9, comprising: obtaining a grip portion including a wall having an outer wall surface and an inner wall surface, a proximal edge defining a proximal opening, a distal edge defining a distal opening, and a lumen formed therethrough; obtaining an actuator disposed near the proximal edge; attaching a vascular dilator including an elongate tube to the actuator core at the proximal end and to the distal end of the dilator at the distal end; circumferentially disposing a dilator sheath having a proximal sheath end and a distal sheath end around the elongate tube; and including this step.

20. The step of engaging the grip portion with the actuator and an elastic biasing element for biasing the distal end of the dilator against the wall. The method of assembling the vascular dilator positioning system according to claim 19, further comprising this step.

21. A method of assembling a vascular dilator positioning system according to claim 20, wherein the elastic biasing element is a spring having a spring constant between about 0.1 N / mm and 10 N / mm.

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