Mechanism for coupling dilator and sheath

Abstract

A system 200 for facilitating access to a patient's heart includes a sheath 202 having a sheath body defining a lumen adapted to receive a dilator 204. A sheath hub 206 is coupled to a proximal portion of the sheath. The sheath hub includes an opening. The system includes a dilator 204 having a dilator shaft 205 defining a lumen adapted to receive and support a puncture device. The dilator shaft includes a proximal portion for user manipulation and a tapered distal portion for placement within or near the heart. A dilator hub 212 is coupled to the proximal portion of the dilator shaft. The dilator hub includes a flange 214 configured to be received in the opening. The opening and flange include symmetrical shapes along a vertical axis and asymmetrical shapes along a horizontal axis.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 566,460, filed March 18, 2024, entitled “MECHANISM COUPLING A DILATOR AND SHEATH”, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This invention generally relates to methods and apparatus for delivering treatment to patients. More specifically, this invention relates to a system and method for delivering a therapeutic device to the heart. Background Technology

[0004] Devices exist for creating punctures, channels, or perforations within tissues located within a patient's body. One such device is the Brockenbrough™ needle, commonly used for puncturing the atrial septum of the heart. This device is a rigid, elongated needle, its structure allowing it to be inserted into the patient via the femoral vein and directed towards the heart. The device relies on mechanical force to drive its pointed tip through the septum. Alternatively, radiofrequency perforation devices have been developed, whereby septal perforation is achieved by applying focused radiofrequency energy to the septal tissue via electrodes at the distal end of a relatively thin conductive probe.

[0005] These types of perforation devices are typically used in conjunction with dilators to help support and guide the perforation device. These dilators are often used in conjunction with treatment sheaths suitable for delivering treatment to the patient. Summary of the Invention

[0006] Example 1 is an dilator for facilitating access to a patient's heart and for engagement with a sheath including a sheath hub. The dilator includes a dilator shaft defining a lumen adapted to receive and support a puncture device. The dilator shaft includes a proximal portion for user manipulation and a distal portion for placement within or near the heart. The dilator hub is engaged with the proximal portion of the dilator shaft. The dilator hub includes a flange having a symmetrical shape along a vertical axis and an asymmetrical shape along a horizontal axis. The flange is configured to engage with the sheath hub to prevent relative rotation between the dilator and the sheath.

[0007] Example 2 is the expander described in Example 1, wherein the expander hub is directly connected to the expander shaft.

[0008] Example 3 is the dilator described in Example 1 or 2, wherein the sheath is a treatment sheath and the puncture device is a radiofrequency puncture device.

[0009] Example 4 is an expander as described in any one of Examples 1-3, further comprising an axial locking feature configured to generate resistance to an axial disengagement force, such that the expander hub is axially secured within the sheath hub.

[0010] Example 5 is an expander as described in any one of Examples 1-4, wherein the axial locking feature includes a protrusion adapted to engage with a shoulder.

[0011] Example 6 is the expander described in Example 5, wherein the protrusion is annular.

[0012] Example 7 is an expander as described in any one of Examples 5 or 6, wherein the protrusion includes a distal inclined surface, a proximal inclined surface, and an external flat surface located between the distal inclined surface and the proximal inclined surface.

[0013] Example 8 is an expander as described in any one of Examples 1-7, wherein the hub includes a cylindrical portion and the axial locking feature is located at the distal end of the cylindrical portion.

[0014] Example 9 is an expander as described in any one of Examples 1-8, wherein the flange includes a thickness inclined toward the distal portion.

[0015] Example 10 is an expander as described in any one of Examples 1-9, wherein the flange includes a surface having a plurality of supports.

[0016] Example 11 is the expander described in Example 10, wherein the plurality of supports include a bottom support, a middle support, and an upper support.

[0017] Example 12 is the expander described in Example 11, wherein the upper support includes a first horizontal support and a second vertical support, the second vertical support being aligned with the vertical axis.

[0018] Example 13 is an expander as described in any one of Examples 1-10, wherein the flange includes a horizontal bottom wall, a left wall substantially orthogonal to the horizontal bottom wall, a right wall substantially orthogonal to the horizontal bottom wall, and a curved upper wall.

[0019] Example 14 is an expander as described in any one of Examples 1-10, wherein the flange includes a first wall perpendicular to a pair of spaced-apart second walls.

[0020] Example 15 is the expander described in Example 12, wherein a third convex wall is opposite to the first wall and connects the pair of spaced-apart second walls.

[0021] Example 16 is an dilator for facilitating access to a patient's heart and for engagement with a sheath including a sheath hub. The dilator includes a dilator shaft defining a lumen adapted to receive and support a puncture device. The dilator shaft includes a proximal portion for user manipulation and a tapered distal portion for placement within or near the heart. The dilator hub is engaged with the proximal portion of the dilator shaft. The dilator hub includes a flange having a symmetrical shape along a vertical axis and an asymmetrical shape along a horizontal axis. The flange is configured to engage with the sheath hub to prevent relative rotation between the dilator and the sheath.

[0022] Example 17 is the expander described in Example 16, further including an axial locking feature configured to generate resistance to axial disengagement forces, such that the expander hub is axially secured within the sheath hub.

[0023] Example 18 is the expander described in Example 17, wherein the axial locking feature includes an annular protrusion adapted to engage with a shoulder.

[0024] Example 19 is the expander described in Example 18, wherein the protrusion includes a distal inclined surface, a proximal inclined surface, and an external flat surface located between the distal inclined surface and the proximal inclined surface.

[0025] Example 20 is the expander described in Example 16, wherein the hub includes a cylindrical portion and the axial locking feature is located at the distal end of the cylindrical portion.

[0026] Example 21 is the expander described in Example 16, wherein the flange includes a thickness inclined toward the distal portion.

[0027] Example 22 is the expander described in Example 16, wherein the flange includes a surface having a plurality of supports.

[0028] Example 23 is the expander described in Example 16, wherein the flange includes a horizontal bottom wall, a left wall substantially orthogonal to the horizontal bottom wall, a right wall substantially orthogonal to the horizontal bottom wall, and a curved upper wall.

[0029] Example 24 is the expander described in Example 16, wherein the flange includes a first wall perpendicular to a pair of spaced-apart second walls and a third convex wall opposite to the first wall.

[0030] Example 25 is a sheath for facilitating access to a patient's heart and for coupling with an dilator including a dilator hub. The sheath includes a sheath shaft defining a lumen adapted to receive and support the dilator. The sheath shaft includes a proximal portion for user manipulation and a distal opening through which the dilator can extend. The sheath hub is coupled to the proximal portion of the sheath shaft. The sheath hub includes an opening having a symmetrical shape along a vertical axis and an asymmetrical shape along a horizontal axis. The opening is configured for coupling to a flange of the dilator to prevent relative rotation between the sheath and the dilator.

[0031] Example 26 is the sheath described in Example 25, wherein the opening includes a horizontal bottom wall, a left wall substantially orthogonal to the horizontal bottom wall, a right wall substantially orthogonal to the horizontal bottom wall, and a curved upper wall.

[0032] Example 27 is the sheath described in Example 25, wherein the opening includes a first wall perpendicular to a pair of spaced-apart second walls and a third convex wall opposite to the first wall.

[0033] Example 28 is the sheath described in Example 25, wherein the sheath hub includes a passage for receiving at least a portion of the expander hub.

[0034] Example 29 is the sheath described in Example 25, wherein the sheath hub includes a recess for receiving a valve.

[0035] Example 30 is the sheath described in Example 29, wherein the sheath hub includes at least one connector and a valve plate configured to receive a snap-fit ​​runway, wherein the valve plate includes a plurality of guide rails to guide the hub cover and protrusions.

[0036] Example 31 is the sheath described in Example 30, wherein the protrusion prevents incorrect orientation of the hub cap.

[0037] Example 32 is the sheath described in Example 31, wherein the hub cover includes a plurality of slots to receive the plurality of guide rails and at least one opening to receive the connector.

[0038] Example 33 is a system for facilitating access to a patient's heart. The system includes a sheath having a sheath body defining a lumen suitable for receiving a dilator. The sheath body includes a proximal portion and a distal portion. A sheath hub is coupled to the proximal portion of the sheath. The sheath hub includes an opening. The system includes a dilator having a dilator shaft defining a lumen suitable for receiving and supporting a puncture device. The dilator shaft includes a proximal portion for user manipulation and a tapered distal portion for placement within or near the heart. The dilator hub is coupled to the proximal portion of the dilator shaft. The dilator hub includes a flange configured to be received within the opening. The opening and flange include symmetrical shapes along a vertical axis and asymmetrical shapes along a horizontal axis.

[0039] Example 34 is the system described in Example 33, wherein the opening and the flange include a horizontal bottom wall, a left wall substantially orthogonal to the horizontal bottom wall, a right wall substantially orthogonal to the horizontal bottom wall, and a curved upper wall.

[0040] Example 35 is the system described in Example 33, wherein the opening and the flange include a first wall perpendicular to a pair of spaced-apart second walls, and a third convex wall opposite to the first wall.

[0041] While several embodiments have been disclosed, other embodiments of the invention will become apparent to those skilled in the art from the following detailed description, in which exemplary embodiments of the invention are shown and described. Therefore, the drawings and detailed description should be considered illustrative in nature, rather than restrictive. Attached Figure Description

[0042] Figure 1A-1C This is a schematic diagram of performing a medical procedure within a patient's heart using a transatrial septal approach system according to an embodiment of the present invention.

[0043] Figure 2 This is a perspective view of the expander in the insert sheath hub according to an embodiment of the present invention.

[0044] Figure 3 This is an embodiment of the present invention. Figure 2 Perspective view of the expander hub.

[0045] Figure 4 This is an embodiment of the present invention. Figure 2 A perspective view of the sheath hub.

[0046] Figure 5 This is an embodiment of the present invention. Figure 2 Exploded view of the sheath hub.

[0047] Figure 6A This is an embodiment of the present invention. Figure 2A side view of the sheath hub, showing the cover in the correct orientation; Figure 6B yes Figure 2 A side view of the sheath hub shows the cover in an incorrect orientation.

[0048] Figure 7 This is an embodiment of the present invention. Figure 2 A cross-sectional view of the sheath hub.

[0049] Figure 8 This is an embodiment of the present invention. Figure 2 A cross-sectional view of the sheath hub that mates with the expander hub.

[0050] While the invention can be modified and alternatively implemented in various ways, specific embodiments are shown by way of example in the accompanying drawings and are described in detail below. However, the purpose is not to limit the invention to the described embodiments. Rather, the invention is intended to cover all modifications, equivalents, and alternatives that fall within the scope of the invention as defined in the appended claims. Detailed Implementation

[0051] Figure 1A-1C This is a schematic diagram of performing a medical procedure 10 within a patient's heart 20 using an interatrial septal approach system 50 according to an embodiment of the present disclosure. As is known, the human heart 20 has four chambers: the right atrium 55, the left atrium 60, the right ventricle 65, and the left ventricle 70. The right atrium 55 and the left atrium 60 are separated by an atrial septum 75, and the right ventricle 65 and the left ventricle 70 are separated by a ventricular septum 80. As further known, deoxygenated blood from the patient returns to the right atrium 55 via the inferior vena cava (IVC) 85 or the superior vena cava (SVC) 90.

[0052] Various medical procedures have been developed to diagnose or treat physiological disorders originating from the left atrium 60 and related structures. Exemplary such procedures include, but are not limited to, the deployment of diagnostic or mapping catheters within the left atrium 60 to generate electroanatomical mappings or diagnostic images. Other exemplary procedures include endocardial catheter-based ablation (e.g., radiofrequency ablation, pulsed field ablation, cryoablation, laser ablation, high-frequency ultrasound ablation, etc.) at targeted sites within the chamber or adjacent vessels (e.g., pulmonary veins and their orifices) to terminate arrhythmias such as atrial fibrillation and atrial flutter. Other exemplary procedures may include the deployment of left atrial appendage (LAA) occlusion devices. Of course, the above examples of procedures within the left atrium 60 are merely illustrative and are by no means limiting of this disclosure.

[0053] Figure 1A-1C The medical procedure 10 shown is an exemplary embodiment for providing access to the left atrium 60 using a transatrial septal approach system 50, so as to subsequently deploy the aforementioned diagnostic and / or therapeutic devices within the left atrium 60. Figure 1A-1C As shown, the target tissue site can be defined by tissue on the atrial septum 75. In the illustrated embodiment, the target site can be accessed via IVC 85 (e.g., through the femoral vein) according to conventional catheter insertion techniques. In other embodiments, access to the target site on the atrial septum 75 can be achieved using an upper approach, wherein the approach is advanced to the right atrium 55 via SVC 90 through the septal approach system 50.

[0054] In the illustrated embodiment, the transatrial septal approach system 50 includes an inlet sheath 100, an expander 105 having an expander body 107 and a tapered distal end portion 108, and a perforation device (e.g., a radio frequency (RF) perforation device) 110 having a distal end portion 112 terminating at a distal electrode 115. As shown, in Figure 1A-1C In the assembled and usable configuration shown, the RF puncture device 110 can be housed within the dilator 105, which itself can be housed within the sheath 100. In one embodiment, deployed into the right atrium 55 via the interventricular septal approach system 50 through the IVC 105, the user introduces a guidewire (not shown) into the femoral vein (typically the right femoral vein) and advances it toward the heart 20. The sheath 100 can then be introduced over the guidewire into the femoral vein and advanced toward the heart 20. In one embodiment, the distal ends of the guidewire and sheath 100 are then positioned in the SVC 90. These steps can be performed with the assistance of an imaging system, such as fluoroscopy or ultrasound imaging. The dilator 105 can then be introduced into the sheath 100 and over the guidewire, and advanced through the sheath 100 into the SVC 90. Alternatively, the dilator 105 can be fully inserted into the sheath 100 before entering the body, and both can be advanced toward the heart 20 simultaneously. Once the guidewire, sheath 100, and dilator 105 are positioned in the SVC 90, the guidewire is removed from the body, and the sheath 100 and dilator 105 retract so that their distal ends are positioned in the right atrium 55. The described RF perforation device 110 can then be introduced into the dilator 105 and advanced toward the heart 20. In various embodiments, the guidewire and RF perforation device are the same component and therefore do not require replacement.

[0055] Subsequently, the user can position the distal end of the dilator 105 against the atrial septum 75, which can be done under imaging guidance. The RF perforation device 110 is then positioned such that the electrode 115 is aligned with or slightly protrudes from the distal end of the dilator 105. The dilator 105 and the RF perforation device 110 can be dragged along the atrial septum 75 and positioned, for example, against the foramen ovale of the atrial septum 75 under imaging guidance. Various additional steps can be performed, such as measuring one or more properties of the target site, such as electrocardiography or ECG (electrocardiogram) tracking and / or pressure measurement, or delivering materials to the target site, such as contrast agent. These steps can help position the distal electrode 115 at the desired target site. Furthermore, tactile feedback provided by the medical RF perforation device 110 can be used to facilitate the positioning of the distal electrode 115 at the desired target site.

[0056] When the distal electrode 115 and the dilator 105 are positioned at the target site, energy is delivered from an energy source (e.g., an RF generator) through the RF perforation device 110 to the distal electrode 115 and the target site. In some embodiments, the energy is delivered at a power of at least about 5 W and a voltage of at least about 75 V (peak to peak) and is used to vaporize cells near the distal electrode 115, thereby creating a gap or perforation through the tissue at the target site. The user then applies force to the RF perforation device 110 to advance the distal electrode 115 at least partially through the perforation. In these embodiments, energy delivery stops when the distal electrode 115 has penetrated the target tissue, that is, when the distal electrode has reached the left atrium 60. In some embodiments, the energy delivery step occurs within a time period of about 1 second to about 5 seconds.

[0057] As the terminal electrode 115 of the RF perforation device 110 has passed through the atrial septum 75, the dilator 105 can be advanced forward, and the distal conical end portion 108 operates to gradually enlarge the perforation, thereby allowing the distal end of the sheath 100 to advance into the left atrium 60.

[0058] In some embodiments, the distal end portion 112 of the RF perforation device 110 may be pre-shaped to present a non-invasive shape, such as a J-shape (e.g., Figure 1B-1CThe RF perforation device 110 can be a tail-shaped or other shape selected to guide the distal electrode 115 away from the intracardiac surface of the left atrium 60. Examples of such RF perforation devices can be found, for example, in U.S. Patent Applications Nos. 16 / 445,790 and 16 / 346,404 assigned to Baylis Medical Company, Inc. The aforementioned pre-formed shape can advantageously minimize the risk of accidental contact between the distal electrode 115 and the tissue within the left atrium 60, and can also anchor the distal end portion 112 within the left atrium 60 during subsequent procedural steps. For example, in an embodiment, the RF perforation device 110 can be structurally configured to serve as a delivery track for the deployment of a relatively large-aperture therapeutic delivery sheath and associated dilator. In such embodiments, after the distal end portion 112 of the RF perforation device 110 is deployed into the left atrium 60, the dilator 105 and sheath 100 are withdrawn. During such extraction, the anchoring function of the pre-formed distal end portion 112 prevents accidental retraction of the distal end portion 112 and correspondingly prevents loss of access to the perforation site on the atrial septum 75.

[0059] Various medical procedures have been developed to diagnose or treat physiological disorders originating from the left atrium 60 and related structures. Exemplary such procedures include, but are not limited to, the deployment of diagnostic or mapping catheters within the left atrium 60 to generate electroanatomical mappings or diagnostic images. Other exemplary procedures include endocardial catheter-based ablation (e.g., radiofrequency ablation, pulsed field ablation, cryoablation, laser ablation, high-frequency ultrasound ablation, etc.) at targeted sites within the chamber or adjacent vessels (e.g., pulmonary veins and their openings) to terminate arrhythmias such as atrial fibrillation and atrial flutter. Other exemplary procedures may include the deployment of left atrial appendage (LAA) occlusion devices. Of course, the above examples of procedures within the left atrium 60 are merely illustrative and are by no means limiting of this disclosure.

[0060] In some embodiments, after the sheath 100 has been successfully deployed into the desired cardiac chamber (e.g., the left atrium), the catheter, treatment device, and sheath can be deployed through the sheath. In other embodiments, the treatment device (e.g., mapping catheter, treatment sheath, medical device, etc.) is part of the sheath 100, forming a treatment sheath.

[0061] Figure 2 This is a perspective view of a system 200 for easy access to a patient's heart. According to an embodiment of the invention, the system includes an expander 204 having an expander hub 212 configured for insertion into a sheath 202 having a sheath hub 206. As shown, the expander 204 is partially inserted into the lumen of the sheath 202. The expander 205 includes a handle 208, an expander hub 212, a proximal connector 210, and an expander shaft 205.

[0062] The sheath 202 includes a sheath hub 206 and a sheath shaft (not shown) that defines a lumen adapted to receive and support the expander shaft 205. The sheath shaft includes a proximal portion for user manipulation and a distal opening through which the expander can extend, such as... Figure 1A-1C As described above. The sheath hub 206 is coupled to the proximal portion of the sheath shaft. The sheath hub 206 can be directly or indirectly coupled to the sheath shaft. The sheath hub 206 includes a passage 220 for receiving a portion of the expander hub. The sheath hub 206 includes an opening 221 surrounding and leading to the passage 220. The opening 221 has a symmetrical shape along a vertical axis and an asymmetrical shape along a horizontal axis. The opening 221 is configured for coupling to a flange 214 of the expander 204 to prevent relative rotation between the sheath 202 and the expander 204.

[0063] The dilator 204 includes a dilator shaft 205 that defines a lumen adapted to receive and support a puncture device. A puncture device can be inserted into the dilator 204 using a proximal connector 210. The proximal connector 210 is also configured to connect to a fluid delivery device, such as a syringe or other container for delivering fluid (e.g., contrast agent) through the dilator shaft 205. The puncture device may include a mechanical puncture device, such as a guidewire with a needle-like tip or an RF puncture device. The dilator shaft 205 includes a proximal portion for manipulation by a user, for example, using a handle 208, and a tapered distal portion for placement within or near the heart. A dilator hub 212 is coupled to the proximal portion of the dilator shaft 205. The dilator hub 212 may be directly or indirectly coupled to the dilator shaft 205. The dilator hub 212 includes a flange 214 having a shape substantially consistent with the opening 221. The flange 214 includes a symmetrical shape along a vertical axis and an asymmetrical shape along a horizontal axis. When flange 214 is received in opening 221, relative rotation between expander 204 and sheath 202 is prevented or avoided. This creates a rotational lock between the two components. This allows the user to rotate expander 204 and sheath 202 simultaneously.

[0064] Figure 3 This is an embodiment of the present invention. Figure 2A perspective view of the expander hub 212. The flange 214 of the expander hub 212 includes a symmetrical shape along a vertical axis 240 and an asymmetrical shape along a horizontal axis 242. The vertical axis 240 and the horizontal axis 242 pass through the longitudinal axis of the expander 204. The flange 214 includes an edge 216 having a thickness that slopes toward the distal portion. In other words, the edge 216 tapers gradually toward the distal portion of the expander 204. This allows the flange 214 to easily self-align into the opening. In some embodiments, the edge 216 does not taper gradually but is substantially parallel to the longitudinal axis of the expander hub 212.

[0065] Flange 214 includes a surface 218 that includes a plurality of supports 218a, 218b, 218c, and 218d. The plurality of supports includes a bottom support 218a, a middle support 218b, and upper supports 218c, 218d. The upper supports include a first horizontal support 218c and a second vertical support 218d, the second vertical support 218d being aligned with the vertical axis 240. In some embodiments, surface 218 may be a distal surface of flange 214. In other embodiments, the supports may be positioned on a proximal surface of flange 214.

[0066] Flange 214 includes a horizontal bottom wall 215a, a left wall 215b substantially orthogonal to the horizontal bottom wall 215a, a right wall 215b substantially orthogonal to the horizontal bottom wall 215a, and a curved upper wall 215d. In other words, flange 214 includes a first wall 215a perpendicular to a pair of spaced-apart second walls 215b, 215c, and a third convex or dome-shaped wall 215d opposite the first wall 215a, connecting the pair of spaced-apart second walls 215b, 215c. The shape of flange 214 does not necessarily have to perfectly match the shape of opening 221. For example, in some embodiments, the curved upper wall 215d is replaced by a straight, flat, or other shaped wall, as long as the wall can fit into opening 221. Each wall 215a, 215b, 215c, 215d forms part of edge 216.

[0067] The expander hub 212 includes a cylindrical portion 217 located between a flange 214 and an annular protrusion 222. In some embodiments, the cylindrical portion 217 is configured as a cylinder with a constant diameter. In other embodiments, the cylindrical portion 217 does not have a constant diameter, or is configured to have a shape other than a cylinder, such as a partial cylinder, an extruded ellipse, or a rectangular prism. In some embodiments, the annular protrusion 222 surrounds the entire cylindrical portion 217. In some embodiments, the annular protrusion 222 surrounds only a portion of the cylindrical portion 217. The annular protrusion 222 is located at the distal end of the cylindrical portion 217 of the expander hub 212. Figure 8As shown, the annular protrusion 222 includes a distal inclined surface 222a, a proximal inclined surface 222b, and an outer flat surface 222c located between the distal inclined surface 222a and the proximal inclined surface 222b. The annular protrusion 222 forms part of an axial locking feature to restrict axial movement of the expander 204 relative to the sheath 202, as described below.

[0068] Figure 4 This is an embodiment of the present invention. Figure 2 A perspective view of the sheath hub 206. The sheath hub 206 includes an opening 221 having a symmetrical shape along a vertical axis 244 and an asymmetrical shape along a horizontal axis 246. The vertical axis 244 and the horizontal axis 246 pass through the longitudinal axis of the sheath 202. The opening 221 is configured to engage with a flange 214 of the expander 204 to prevent relative rotation between the sheath 202 and the expander 204. The opening 221 includes a horizontal bottom wall 221a, a left wall 221b substantially orthogonal to the horizontal bottom wall 221a, a right wall 221c substantially orthogonal to the horizontal bottom wall, and a curved or dome-shaped upper wall 221d. In other words, the opening 221 includes a first wall 221a perpendicular to a pair of spaced-apart second walls 221b, 221c, and a third convex wall 221d opposite to the first wall 221a. An opening 221 surrounds a passage 220, which is configured to receive an annular protrusion 222 and a cylindrical portion 217 of an expander hub 212.

[0069] Figure 5 This is an embodiment of the present invention. Figure 2 An exploded view of the sheath hub 206. The sheath hub 206 includes a body 230, a valve 232, a valve plate 234, a snap-fit ​​track 236, a hub cover 238, and a protrusion 239. The body 230 includes a recess 231 for receiving the valve 232. The valve 232 is configured to allow the introduction of a medical device into the sheath 202 while maintaining a seal. The valve plate 234 covers the valve 232 to secure the valve 232 in the recess 231. The valve plate 234 is configured to receive and guide the snap-fit ​​track 236. The valve plate 234 includes a plurality of guide rails 235 to guide the hub cover 238. Figure 6B As shown, the protrusion 239 prevents the hub cap 238 from being incorrectly oriented during assembly.

[0070] Figure 6A This is an embodiment of the present invention. Figure 2 A side view of the sheath hub 206 shows the hub cover 238 in the correct orientation, and Figure 6BThis is a side view showing the hub cap 238 in an incorrect orientation. The hub cap 238 includes a plurality of slots 241 configured to receive a plurality of guide rails 235. During assembly, a valve 232 is located in a recess 231, a valve plate 234 is positioned on the valve 232, a snap-fit ​​track 236 is positioned within the valve plate 234, and the hub cap 238 is secured to the body 230 to hold the components together. Figure 6A As shown, if the hub cap 238 is correctly oriented, the plurality of slots 241 slide on the plurality of guide rails 235 until the opening 243 of the hub cap 238 receives the connector 245 located on the body 230. In some embodiments, the opening 243 and the connector 245 may be configured for a snap-fit ​​connection. Figure 6B As shown, if the hub cap 238 is incorrectly oriented, the protrusion 239 prevents the hub cap 238 from moving further, thereby preventing the connector 245 from being received in the opening 243. This prevents the hub cap 238 from being fastened to the body 230.

[0071] Figure 7 This is a cross-sectional view of the sheath hub 206 that mates with the expander hub 212 according to an embodiment of the present invention. Figure 7 As shown, the cylindrical portion 217 of the expander hub 212 is inserted into the passage 220 of the sheath hub 206. The snap-fit ​​track 236 is configured to expand when the annular protrusion 222 moves through the snap-fit ​​track 236, and then contract on the cylindrical portion 217 to form an axial locking feature.

[0072] Figure 8 This is a cross-sectional view taken along line 8'-8' of a sheath hub 206 that mates with an expander hub 212 according to an embodiment of the present invention. An annular protrusion 222 is adapted to engage with a corresponding shoulder 219 within the sheath hub 206. The interaction between the protrusion 222 and the shoulder 219 generates resistance to axial disengagement forces, thereby axially securing the expander hub 212 within the sheath hub 206. The shoulder 219 is formed by a snap-fit ​​runway 236. When the expander hub 212 is inserted into the sheath hub 206, the snap-fit ​​runway 236 deforms, and the annular protrusion 222 enters the locking chamber 237, as... Figure 8As shown. The annular protrusion 222 is held within the locking chamber 237 and cannot move proximally through the shoulder 219, thereby axially locking the expander hub 212 to the sheath hub 206. In one aspect, the locking chamber 237 is configured to allow slight axial movement of the annular protrusion 222 by providing a gap between the shoulder 219 and the annular protrusion 222. In another aspect, the locking chamber 237 is configured to firmly hold the annular protrusion 222, wherein the annular protrusion 222 contacts the shoulder 219. The expander hub 212 and the sheath hub 206 are configured such that when the annular protrusion 222 is located within the locking chamber 237, the flange 214 is located within the opening 221, thereby resisting or preventing relative rotation as described above.

[0073] To remove the expander hub 212 from the sheath hub 206, a release force is generated by the interaction of the inclined surface of edge 216 with the surface defining opening 221. The inclined surface of edge 216 and the surface defining opening 221 may have slightly different angles or the same angle (but not horizontally oriented), such that an axial release force is generated when torque is applied to the expander hub 212. The release force (with an axial component) causes axial movement of the expander hub 212, which disengages the expander hub 212 from the sheath hub 206. When the release force becomes sufficient to overcome the axial locking force formed by the interaction of the annular protrusion 222 and the shoulder 219, relative movement occurs in both the axial and rotational directions, thereby allowing the expander hub 212 to be removed from the sheath hub 206. The amount of torque and rotation angle required for disengagement can be adjusted by changing the angles of these surfaces.

[0074] Various modifications and additions may be made to the exemplary embodiments discussed without departing from the scope of the invention. For example, while the above embodiments relate to specific features, the scope of the invention also includes embodiments with different combinations of features and embodiments that do not include all described features. Therefore, the scope of the invention is intended to include all such alternatives, modifications, and variations falling within the scope of the claims, as well as all equivalents thereof.

Claims

1. An expander for easy access to a patient's heart and for engagement with a sheath including a sheath hub, the expander comprising: A dilator shaft defining a lumen adapted to receive and support a puncture device, the dilator shaft including a proximal portion for manipulation by a user and a distal portion for placement within or near the heart; as well as An expander hub, which is connected to the proximal portion of the expander shaft, includes a flange having a symmetrical shape along a vertical axis and an asymmetrical shape along a horizontal axis, the flange being configured to engage with the sheath hub to prevent relative rotation between the expander and the sheath.

2. The expander according to claim 1, wherein, The expander hub is directly connected to the expander shaft.

3. The expander according to claim 1 or 2, wherein, The sheath is a treatment sheath, and the puncture device is a radiofrequency puncture device.

4. The expander according to any one of claims 1-3, further comprising an axial locking feature configured to generate resistance to an axial disengagement force, such that the expander hub is axially fixed within the sheath hub.

5. The expander according to any one of claims 1-4, wherein, The axial locking feature includes a protrusion adapted to engage with the shoulder.

6. The expander according to claim 5, wherein, The protrusion is ring-shaped.

7. The expander according to any one of claims 5 or 6, wherein, The protrusion includes a distal inclined surface, a proximal inclined surface, and an external flat surface located between the distal inclined surface and the proximal inclined surface.

8. The expander according to any one of claims 1-7, wherein, The hub includes a cylindrical portion, and the axial locking feature is located at the distal end of the cylindrical portion.

9. The expander according to any one of claims 1-8, wherein, The flange includes a thickness that slopes toward the distal portion.

10. The expander according to any one of claims 1-9, wherein, The flange includes a surface with multiple supports.

11. The expander according to claim 10, wherein, The plurality of support components include a bottom support component, a middle support component, and an upper support component.

12. The expander according to claim 11, wherein, The upper support includes a first horizontal support and a second vertical support, with the second vertical support aligned with the vertical axis.

13. The expander according to any one of claims 1-10, wherein, The flange includes a horizontal bottom wall, a left wall substantially orthogonal to the horizontal bottom wall, a right wall substantially orthogonal to the horizontal bottom wall, and a curved upper wall.

14. The expander according to any one of claims 1-10, wherein, The flange includes a first wall perpendicular to a pair of spaced-apart second walls.

15. The expander according to claim 12, wherein, The third convex wall is opposite to the first wall and connects the pair of spaced-apart second walls.

16. An expander for facilitating access to a patient's heart and for engagement with a sheath including a sheath hub, the expander comprising: A dilator shaft defining a lumen adapted to receive and support a puncture device, the dilator shaft including a proximal portion for manipulation by a user and a tapered distal portion for placement within or near the heart; as well as An expander hub, which is connected to the proximal portion of the expander shaft, includes a flange having a symmetrical shape along a vertical axis and an asymmetrical shape along a horizontal axis, the flange being configured to engage with the sheath hub to prevent relative rotation between the expander and the sheath.

17. The expander of claim 16, further comprising an axial locking feature configured to generate resistance to an axial disengagement force, such that the expander hub is axially fixed within the sheath hub.

18. The expander according to claim 17, wherein, The axial locking feature includes an annular protrusion adapted to engage with the shoulder.

19. The expander according to claim 18, wherein, The protrusion includes a distal inclined surface, a proximal inclined surface, and an external flat surface located between the distal inclined surface and the proximal inclined surface.

20. The expander according to claim 16, wherein, The hub includes a cylindrical portion, and the axial locking feature is located at the distal end of the cylindrical portion.

21. The expander according to claim 16, wherein, The flange includes a thickness that slopes toward the distal portion.

22. The expander according to claim 16, wherein, The flange includes a surface with multiple supports.

23. The expander according to claim 16, wherein, The flange includes a horizontal bottom wall, a left wall substantially orthogonal to the horizontal bottom wall, a right wall substantially orthogonal to the horizontal bottom wall, and a curved upper wall.

24. The expander according to claim 16, wherein, The flange includes a first wall perpendicular to a pair of spaced-apart second walls and a third convex wall opposite to the first wall.

25. A sheath for facilitating access to a patient's heart and for coupling with an expander including an expander hub, the sheath comprising: A sheath shaft defining a lumen adapted to receive and support a dilator, the sheath shaft including a proximal portion for user manipulation and a distal opening through which the dilator can extend; as well as A sheath hub, which is coupled to the proximal portion of the sheath shaft, the sheath hub including an opening having a symmetrical shape along a vertical axis and an asymmetrical shape along a horizontal axis, the opening being configured for coupling to a flange of the expander to prevent relative rotation between the sheath and the expander.

26. The sheath according to claim 25, wherein, The opening includes a horizontal bottom wall, a left wall substantially orthogonal to the horizontal bottom wall, a right wall substantially orthogonal to the horizontal bottom wall, and a curved upper wall.

27. The sheath according to claim 25, wherein, The opening includes a first wall perpendicular to a pair of spaced-apart second walls and a third convex wall opposite to the first wall.

28. The sheath according to claim 25, wherein, The sheath hub includes a passageway for receiving at least a portion of the expander hub.

29. The sheath according to claim 25, wherein, The sheath hub includes a recess for receiving the valve.

30. The sheath according to claim 29, wherein, The sheath hub includes at least one connector and a valve plate configured to receive a snap-fit ​​track, wherein the valve plate includes a plurality of guide rails to guide the hub cover and protrusions.

31. The sheath according to claim 30, wherein, The protrusion prevents the hub cover from being incorrectly oriented.

32. The sheath according to claim 31, wherein, The hub cover includes a plurality of slots to receive the plurality of guide rails, and at least one opening to receive the connector.

33. A system for facilitating access to a patient's heart, the system comprising: A sheath having a sheath body defining a lumen suitable for receiving a dilator, the sheath body including a proximal portion and a distal portion; A sheath hub, which is connected to the proximal portion of the sheath, the sheath hub including an opening; An expander having an expander shaft defining a lumen adapted to receive and support a puncture device, the expander shaft including a proximal portion for manipulation by a user and a conical distal portion for placement within or near the heart; as well as An expander hub, which is connected to the proximal portion of the expander shaft, includes a flange configured to be received in the opening. The opening and the flange include symmetrical shapes along the vertical axis and asymmetrical shapes along the horizontal axis.

34. The system according to claim 33, wherein, The opening and the flange include a horizontal bottom wall, a left wall substantially orthogonal to the horizontal bottom wall, a right wall substantially orthogonal to the horizontal bottom wall, and a curved upper wall.

35. The system according to claim 33, wherein, The opening and the flange include a first wall perpendicular to a pair of spaced-apart second walls, and a third convex wall opposite to the first wall.

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