Hybrid transseptal dilator and method using the same

Abstract

To provide a method and apparatus for an optimized transseptal surgical operation for providing left heart access, which reduces the number of devices that are used, in order to minimize surgical time, complexity and cost.SOLUTION: The apparatus comprises a hybrid dilator 100 that comprises the combined functionality of a transseptal sheath and dilator assembly. The hybrid dilator comprises: a dilator shaft defining a lumen for receiving a crossing device, the dilator shaft being structured to provide support for the crossing device when the crossing device is used to create a puncture in a tissue; and a distal tip 130 having an outer diameter which tapers to an outer diameter of the crossing device for providing a smooth transition between the crossing device and the distal tip when the crossing device is inserted through the lumen and protrudes from the distal tip.SELECTED DRAWING: Figure 1A

Description

Technical Field

[0001] The present disclosure relates to a medical device for use when accessing the cardiovascular system. More particularly, the present disclosure relates to a hybrid transseptal dilator for facilitating a transseptal procedure for accessing the left heart.

[0002] To facilitate understanding of the present invention, embodiments of the present invention are illustrated by way of examples in the accompanying drawings.

Brief Description of the Drawings

[0003]

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DETAILED DESCRIPTION OF THE INVENTION

[0004] When performing a transseptal procedure to access the left atrium of the heart, a physician typically uses a sheath and dilator to support a transverse or puncture device. In some cases, the physician may not be able to transverse the sheath into the left atrium because the transition between the sheath and the dilator may become clogged or obstructed at the tissue boundary, and as a result, the sheath may not be able to transverse the through-hole (or may be difficult to transverse). In other words, the tissue may catch at the sheath / dilator interface. Thus, using multiple devices in a transseptal procedure can make it difficult for the surgeon to complete the procedure due to the instrument transition between the various devices that may be caught at the septal tissue interface. The problem with transseptal puncture performed using a transverse device supported by making a transition where the sheath and dilator set may be obstructed on the tissue when crossing the septum can be addressed by eliminating this transition by using a hybrid dilator (described herein) instead of the sheath and dilator set, the hybrid dilator having appropriate functionality (flexibility, pushability, torqueability, distal taper, etc.) to facilitate a smooth traverse.

[0005] In one broad aspect, embodiments of the present invention include a hybrid dilator for use with a transverse device in a tissue piercing procedure. The hybrid dilator includes a dilator shaft defining a lumen for receiving the transverse device, the dilator shaft being structured to support the transverse device when the transverse device is used to effect a tissue piercing, and a distal tip having an outer diameter that is tapered to the outer diameter of the transverse device to provide a smooth transition between the transverse device and the distal tip when the transverse device is inserted from the lumen and protrudes from the distal tip. In some such embodiments, the dilator shaft includes an inner layer, an outer layer, and a torque layer therebetween.

[0006] In another broad aspect, embodiments of the present invention include a kit for piercing tissue. The kit has a transverse device having a piercing feature and a hybrid dilator, the dilator having a dilator shaft defining a lumen for receiving the transverse device, the dilator shaft being structured to support the transverse device when the transverse device is used to effect a tissue piercing. The hybrid dilator also includes a distal tip having an outer diameter that is substantially tapered to the outer diameter of the transverse device to co-act to provide a smooth outer profile when the hybrid dilator advances through tissue over the transverse device. In some embodiments of this kit, the transverse device is a mechanical needle having a sharp tip, and in some other embodiments, the transverse device is configured to deliver energy to tissue.

[0007] In another broad aspect, embodiments of the present invention include a system for puncturing tissue. The system includes a transverse device having a puncturing feature operable to deliver energy to the tissue, an electrosurgical generator operable to provide energy to the puncturing feature, and a hybrid dilator including a dilator shaft defining a lumen for receiving the transverse device, the dilator shaft being structured to support the transverse device when the transverse device is used to effect a puncture in the tissue. The hybrid dilator also includes a distal tip having an outer diameter that is substantially tapered to the outer diameter of the transverse device so as to cooperate to provide a smooth outer profile as the hybrid dilator advances through the tissue over the transverse device.

[0008] In yet another broad aspect, embodiments of the present invention include a method of using a hybrid dilator and a transverse device to puncture the septum of the heart. The method includes (a) positioning the distal tip of the hybrid dilator at a desired location on the septum, (b) using the hybrid dilator to support a transverse device disposed within the lumen of the hybrid dilator as the transverse device advances beyond the distal tip of the hybrid dilator to effect a puncture in the septum, and (c) expanding the desired location by advancing the hybrid dilator over the transverse device.

[0009] In one broad aspect, a hybrid dilator is provided as a composite device that includes in a single device an interseptal dilator or sheath, or one or more essential features of a combination thereof, in order to provide in an optimal manner the combined functionality of an interseptal sheath and dilator assembly. Some of these features that provide the combined functionality of the sheath and dilator assembly may include shaft stiffness, curvature, and internal and external tapers, and may be incorporated along the distal portion of the hybrid dilator, including a distal tip to facilitate traversing the hybrid dilator. Further, optionally, the hybrid dilator may include features that provide directional information, such as a tactile stimulus or indication to convey the direction of a distal tip curvature state, to facilitate operation of the hybrid dilator and / or to facilitate transseptal surgery. In some instances, these features may be incorporated within the proximal portion of the hybrid dilator, such as within a combined proximal hub.

[0010] In another broad aspect, an optimal method for performing a transseptal medical procedure is provided. The method results in streamlining the workflow of the surgery by providing a hybrid dilator that includes enhanced functionality of conventional transseptal sheaths and dilator assemblies. The hybrid dilator of the present invention can reduce the number of devices required to complete a transseptal surgery, thereby increasing the efficiency of the surgery and reducing the time and complexity of the surgery.

[0011] In some situations, when successfully completing the first transseptal access procedure with a standard sheath and dilator assembly, the sheath may not be large enough to support advancing a catheter with a relatively larger outer diameter (OD) for surgery on the left heart at a later time. As a result, the sheath and dilator assembly may have to be removed, and the catheter may then be advanced across the septum over a guide wire in place into the left heart. In other cases, a physician may desire to use a large delivery sheath for a complex procedure (such as a left atrial appendage closure / occlusion procedure), but knowing that the product may not be able to cross, a standard transseptal kit (including a sheath, dilator, and guide wire) may be introduced to cross and pre - dilate the septum for such procedures. The three - piece kit can be discarded after being removed for subsequent replacement, so the three products (sheath, dilator, guide wire) will only be used for a short period of the surgery. Thus, in some cases, the sheath and dilator assembly may only be useful for performing the initial transseptal puncture, which leads to waste due to the use of multiple devices. Further, performing a transseptal procedure using multiple devices increases the time and complexity of the procedure and contributes to additional costs. Additionally, as clinical interventions in the left heart increase, the need for a safe and reliable transseptal solution is growing.

[0012] In some embodiments, a unique hybrid dilator is provided that reduces the number of physical / geometric transitions and the number of instrument transitions, both of which can potentially cause difficulties or tactile impediments for a physician when completing a transseptal or other tissue crossing. Some examples include smooth lines and tapers to facilitate a smooth transition across tissue.

[0013] Furthermore, the inventor has discovered a method for performing a transseptal medical procedure that rationalizes the surgical workflow by providing a hybrid dilator that replaces conventional transseptal sheaths and dilator assemblies. The hybrid dilator of the present invention can reduce the number of devices required to complete a transseptal operation. This reduces the number of elements that a physician needs to prepare, assemble, and introduce into a patient for a transseptal operation. The method of the present invention provides a dilator that can be used with an invasive guidewire, replacing sheaths, dilators, and guidewire assemblies.

[0014] Specifically referring now to the details of the drawings, it should be emphasized that the details are shown by way of example and are intended only for the purpose of discussing a particular embodiment of the invention. Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and arrangement of components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments and of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein are for the purpose of description and should not be regarded as limiting.

[0015] In some embodiments, a single / integrated device in the form of a hybrid dilator is provided that offers a smooth taper function to facilitate both the crossing and replacement of devices in a transseptal operation, and further provides a physician with a tactile feedback and distal curvature indication that is substantially equivalent to that provided by a sheath / dilator assembly.

[0016] According to one embodiment of the present invention, a hybrid dilator 100 as shown in FIG. 1A is provided. The hybrid dilator 100 provides a combination of features that facilitates transseptal surgery by providing dual functionality of a sheath and a dilator and avoids the drawbacks of conventional sheath and dilator assemblies. The hybrid dilator 100 provides the smoothness of a standard transseptal dilator under the control of a standard transseptal sheath. More specifically, the hybrid dilator 100 functions as a single device that reduces waste by eliminating the need to use a conventional sheath / dilator assembly and the need for assembly. The hybrid dilator 100 includes a sheath-like handle with well-known torque and tactile control. In the specific example shown, the hybrid dilator 100 defines a proximal portion 110 that includes a proximal hub 112 combined by molding as shown in FIGS. 1B and 1D. The distal portion 120 is coupled to the proximal portion 110 that includes a dilator shaft. The dilator shaft further defines a curved distal end 130 that extends from the proximal end and terminates at a distal tip 140 as shown in FIG. 1C.

[0017] Dilator Shaft / Support and Cylindrical Strength / Positioning The dilator shaft is formed from a smooth distal tubing 121 that is coupled to the molded proximal hub 112. The distal tubing 121 tapers at the distal tip 140 and defines a lumen 122 therein that may be used to planarize the device prior to use. In some embodiments, since the hybrid dilator 100 is provided as a single, integral device, this means that, unlike prior art sheath / dilator assemblies that require each product to be planarized, it is one product that is planarized. The dilator shaft provides mechanical properties that most facilitate the surgical procedure. As further shown in FIG. 2A, at the distal tip 140, the distal tubing 121 transitions through a smooth outer taper T3 that flares proximally to an outer diameter OD that is larger than that of a conventional transseptal kit dilator, so as to expand the septum to a size appropriate for a subsequent delivery device or instrument that may be used. The OD of the distal tubing 121 is substantially constant from the proximal edge of the distal tip 140 to the proximal hub 112 to which the distal tubing is coupled or attached. In some such embodiments, the OD of the hybrid dilator 100 may vary based on the application and clinical utilization. In some embodiments, the size of the hybrid dilator 100 ranges from about 12 French to about 20 French. In a specific example, the hybrid dilator has a size of about 12.5 French (outer diameter of about 0.163 inches (0.414 cm) to about 0.166 inches (0.421 cm)). In another example, the hybrid dilator has a size of about 15 French (outer diameter of about 0.193 inches (0.490 cm) to about 0.205 inches (0.521 cm)).

[0018] Distal end curved state In some embodiments of the present invention, the distal end 130 of the hybrid dilator 100 may be curved as shown in FIG. 1A. Alternatively, the distal end 130 of the hybrid dilator may be straight. In some embodiments where the distal end 130 of the hybrid dilator 100 is curved, the hybrid dilator 100, in combination with a puncture device such as a needle, forms a trajectory that is substantially equivalent to the trajectory achieved with the sheath / dilator / needle assembly of a conventional transseptal kit to provide a predictable and repeatable path for the physician to complete a transseptal puncture. The curved distal end 130 facilitates advancing the hybrid dilator 100 in conjunction with the puncture device to initiate a transseptal puncture.

[0019] In some such embodiments, the hybrid dilator 100 includes a shaft formed from a distal tubular member 121 having sufficient rigidity to enable positioning the hybrid dilator 100 to allow a transverse device, such as a puncture needle or guidewire, to pass therethrough while maintaining the position of the assembly at a desired location, such as the fossa of the septum. As such, the hybrid dilator 100 functions to provide support and column strength to facilitate positioning of the transverse device at the desired location. As disclosed above and shown in FIG. 1A, the distal tubular member 121 is tapered proximally from the distal tip 140 to have a larger outer diameter (OD) that defines an expanding interface to enable expansion of the puncture site 510 (FIG. 6A) to allow an additional device to pass therethrough easily.

[0020] Distal tip More specifically, as shown in FIG. 2A, the distal tip 140 provides a lumen 142 that is suitable for a transverse device such as an insertion puncture device and defines a relatively thin wall to facilitate control of the puncture. In some such examples, the puncture device is a mechanical needle or RF puncture device that can be used with the hybrid dilator 100. The hybrid dilator 100 provides a restricted distal inner diameter (as shown by ID2 and ID3) at the distal tip 140 to control the distance that a puncture device such as a transseptal needle (having a narrow distal portion) projects from the hybrid dilator 100. The narrowest distal portion of the compatible puncture device has an outer diameter less than ID3 and extends within the lumen 142 at this length S2 and beyond the distal edge 148. Typically, a portion of the puncture device having an outer diameter greater than ID3 and less than ID2 fits well into the internal taper T2. Therefore, the dimension of the length S2 is important in determining the distance that the puncture device projects from the hybrid dilator 1. In some such embodiments, this allows the hybrid dilator 100 to meet the same standards as existing transseptal dilators in terms of controlling the distance that the transseptal needle can project when fully inserted. Further, as described above, the distal tip 140 provides an external taper T3 that allows the dilator OD to transition from the narrow OD2 of the most distal end or distal edge 148 of the distal tip 140 to the wider OD1 of this proximal edge 146. In some such embodiments, the hybrid dilator 100 has a smooth line and a smooth external taper T3 to facilitate a smooth transition across the tissue. In some such examples, the hybrid dilator 100 functions to reduce the number of physical or geometric transitions, or instrument transitions, that can cause difficulties and / or provide a tactile interference that can impede the ability of the physician to complete a transseptal or other tissue transverse.

[0021] In a typical example, as shown in FIGS. 1A and 2A, the dilator shaft includes, in some examples, a distal tubing 121 that includes high density polyethylene (HDPE) tubing. In some such embodiments, the HDPE has a hardness ranging from about 55 Shore D to about 70 Shore D, and in a specific example, the HDPE hardness is about 67 Shore D. In a typical embodiment, the distal tubing 121 includes a material that meets the functional requirements of the transseptal sheath / dilator kit. In some such examples, the distal tubing 121 includes a straight shaft that transitions to a curved distal end 130. The distal tip 140 includes a tapered tip having a smooth outer taper T3 with a taper angle TA of about 5.5 degrees + / - 1 degree, and an internal shape that provides an internal diameter (ID) that results in a predictable needle dilation length. In some embodiments, the length of the outer taper T3 ranges from about 0.4 inches (1 cm) to about 1 inch (2.5 cm). In some such examples, the taper length for the outer taper T3 is equal to about 0.646 inches or about 1.6 cm. The distal tubing 121 has an inner diameter ID1 equal to about 0.109 inches (0.277 cm) and an outer diameter OD1 equal to about 0.166 inches (0.422 cm) along the proximal portion (or proximal length 123) of this distal tubing 121 that extends from the proximal hub 112 to the adjacent distal tip 140, as shown in FIG. 1A. In the example shown in FIG. 2A, the inner diameter of the distal tip 140 tapers from ID1 to a relatively smaller inner diameter ID2 along the inner taper T1. In one such embodiment, the taper length of the inner taper T1 is equal to about 0.22 inches (0.56 cm), ID2 extends at a distance S1 of about 0.100 inches (0.254 cm), and ID2 has a value equal to about 0.056 inches (0.142 cm). In some examples, the inner diameter further transitions from ID2 to an even smaller inner diameter ID3 along the inner taper T2. In some embodiments, the distal portion (length S2) of the distal tip has a length ranging from about 0.71 cm to about 0.74 cm, and in some more specific embodiments, has a length ranging from about 0.721 cm to about 0.726 cm.In a specific example, the taper T2 extends at a distance equal to approximately 0.044 inches (0.112 cm), in which case ID3 is equal to approximately 0.034 inches (0.086 cm) and extends at a length S2 of approximately 0.285 inches (0.724 cm). In some alternative embodiments, S1 is equal to zero so that the inner taper T1 and the inner taper T2 are adjacent to each other, thereby providing a smooth transition of the inner diameter. Some alternative embodiments include an expander shaft substantially comprising low density polyethylene or polyetheretherketone, and some such embodiments of the expander shaft have a hardness from about 40 Shore D to about 85 Shore D.

[0022] Some embodiments of the expander shaft composed of a relatively hard material (e.g., HDPE) have an inner diameter ID1 from about 0.072 inches (0.18 cm) to about 0.11 inches (0.28 cm). Other embodiments of the expander shaft composed of a relatively soft material (e.g., polyurethane, polyether block amide) have an inner diameter ID1 from about 0.050 inches (0.13 cm) to about 0.11 inches (0.28 cm). Polyether block amide (PEBA) is a thermoplastic elastomer (TPE) and is known by the trade names VESTAMID® E (Evonik Industries) and Pebax (Arkema).

[0023] In the example shown in FIG. 2A, having several internal transition stages such as the inner taper T1 and the inner taper T2 allows the hybrid expander 100 to expand the tissue puncture site to the desired extent while the wall thickness W of the distal tubing 121 pEnsure that the hybrid expander has an OD along this proximal length (OD1) that can be maintained to provide a shaft rigidity and stiffness comparable to that of a conventional sheath / expander assembly. The internal shape of the distal tip 140, including the binary tapers T1 and T2 and the inner diameter along the distal tip 140, results in the insertion of a piercing device such as a needle and the desired elongation of the needle tip. This internal shape also ensures that the wall thickness W at the distal edge 148 of the distal tip 140 is sufficient to ensure the traversal and followability of the transseptal puncture site. Tip (FIG. 2B) helps ensure that it is thin enough. Furthermore, the binary tapers T1 and T2 ensure that there is a smooth transition between a relatively wide inner diameter ID1 along the proximal portion of the distal tubing 121 and a relatively narrow inner diameter ID3 at the distal edge 148. In some embodiments, the inner diameter ID3 at the distal edge 148 is from about 0.33 inches (0.084 cm) to about 0.037 inches (0.094 cm), and the outer diameter of the distal edge 148 is from about 0.040 inches (0.10 cm) to about 0.055 inches (0.14 cm). In one specific example, the inner diameter ID3 of the distal edge 148 is equal to about 0.034 inches (0.086 cm) (FIG. 2B), and the outer diameter of the distal edge is equal to about 0.042 inches (0.107 cm).

[0024] In some embodiments, the taper angle TA may range from about 5 degrees to about 15 degrees. In some embodiments, the taper length of the outer taper T3 may range from about 1.0 cm to about 1.6 cm. In some embodiments, the length of the outer taper T3 ranges from about 0.4 inches (1 cm) to about 1 inch (2.5 cm). In one example, the taper length of the outer taper T3 may be about 1.0 cm and the taper angle TA may be about 15 degrees. In some embodiments, the wall thickness WTip at the distal edge 148 of the distal tip 140 is from about 4 thousandths of an inch (0.010 cm) to about 5 thousandths of an inch (0.013 cm). The wall thickness W Tip is sufficient to maintain the mechanical integrity of the distal tip 140 while ensuring that it is not so thick as to make it difficult for the distal tip 140 to traverse the puncture site in the tissue.

[0025] In an alternative embodiment of the present invention, as shown in FIG. 2C, the distal tip 140 may comprise a single internal taper T1 as shown. As shown, the distal tubing 121 is shown with a visible lumen.

[0026] Wall thickness, bending stiffness, and torque As previously discussed with respect to FIG. 2A, the hybrid expander 100 is an HDPE expander having an 8.5 French ID and a 12.5 French OD. The ID and OD are representative of the dimensions along the proximal length 123 of the distal tubing 121. Further, the wall thickness Wp along the proximal length 123 is from about 25.5 thousandths of an inch (0.065 cm) to about 27.5 thousandths of an inch (0.070 cm). The bending stiffness of the example shown is about 3 N / mm and the torque is about 4.5 Ncm.

[0027] In an alternative embodiment, the hybrid expander is an expander having a 12.5 French OD with an 8.5 French ID. The wall thickness Wp along the proximal length 123 of the distal tubing 121 is about 32 thousandths of an inch (0.081 cm). The bending stiffness of a particular example is about 4 N / mm and the torque is about 5 Ncm.

[0028] In yet a further alternative, the hybrid expander 100 is an expander having a 4.5 French ID and a 12.5 French OD. The wall thickness Wp along the proximal length 123 of the distal tubing 121 is about 55 thousandths of an inch (0.140 cm). The bending stiffness of a particular example is about 5.5 N / mm and the torque is about 7 Ncm. In another example, the hybrid expander is a 15 French expander having a wall thickness of less than about 26.5 thousandths of an inch (0.067 cm) to provide appropriate stiffness.

[0029] In some embodiments, the HDPE hybrid expander 100 has a 12.5F OD that is about 0.162 - 0.166 inches (0.411 - 0.422 cm), an ID of 4.5 - 8.5F (about 0.056 - 0.115 inches or 0.142 - 0.292 cm), a wall thickness from about 0.025 inches to about 0.055 inches (about 0.064 - 0.140 cm), a stiffness of about 3.5 - 5.5 N / mm, and a torque transmission of about 4 - about 7 Ncm.

[0030] In an alternative embodiment, the expander shaft is substantially composed of HDPE, has a 12.5 French OD (about 0.162 inches - 0.166 inches or about 0.411 - 0.422 cm), an 8.5 French ID (about 0.108 inches - 0.115 inches or about 0.274 - 0.2921 cm), and a wall thickness from about 0.0235 inches (0.06 cm) to about 0.029 inches (0.074 cm). Such an embodiment may have a flexural stiffness of about 2.5 - 3.5 N / mm and a torque transmission of about 4 - about 4.5 Ncm.

[0031] In another alternative embodiment, the expander shaft is HDPE, has a 12.5 French OD (about 0.162 inches - 0.166 inches or about 0.411 - 0.422 cm), a 7.5 French ID (about 0.095 inches - 0.102 inches or about 0.241 - 0.259 cm), and a wall thickness of about 0.03 - 0.036 inches (about 0.076 - 0.091 cm). The stiffness of such an example is about 3.5 - 4.5 N / mm and the torque transmission is about 4.5 - about 5.5 Ncm. In some specific embodiments, the wall thickness is about 0.032 inches (0.081 cm).

[0032] Another alternative embodiment includes an expander shaft composed of HDPE, the shaft having an OD of 12.5 French (about 0.162 inches to 0.166 inches or about 0.411 to 0.422 cm), an ID of 4.5 French (about 0.056 inches to 0.063 inches or about 0.142 to 0.160 cm), and a wall thickness of about 0.05 to 0.055 inches (0.127 to 0.140 cm). Typically, the bending stiffness of such an embodiment is about 5 to 6 N / mm and the torque is about 6 Ncm to 7 Ncm. In some specific embodiments, the wall thickness is about 55 thousandths of an inch (0.140 cm).

[0033] In some embodiments of the present invention, the torque may range from about 1.0 Ncm to about 7 Ncm over a length of about 50 cm. In some examples, the bending stiffness ranges from about 1.0 N / mm to about 5.5 N / mm over a diameter of 50 mm.

[0034] Surface finish In some embodiments of the present invention, the distal tubing 121 may include different surface finishes to provide varying amounts of friction along the outer surface. In some embodiments, as described above, the distal tubing 121 may be formed substantially from HDPE. Alternatively, the expander may be formed from multiple material layers or composite materials. In some such examples, the multiple layers may extend concentrically and longitudinally along the length of the distal tubing 121 in the form of multiple tubular layers. In one such example, the inner layer or tubing includes an extruded product of an outer layer of PEBAX (polyether block amide) with an HDPE or low density polyethylene (LDPE) core. This can provide a relatively smoother outer surface finish compared to HDPE. Further, the PEBAX tubing can be further provided with a smooth coating on the outer surface by a silicone coating disposed thereon.

[0035] Alternative embodiments of the distal tip In an alternative embodiment of the present invention, as shown in FIGS. 3A-3D, the distal tip 140 includes an improved taper. In one specific example as shown in FIGS. 3A and 3B, the tapered distal tip 140 may include a second feature such as a second surface modification 147 that causes surface changes such as a second ridge 147a or a depression 147b to more meticulously provide a series of tactile portions of a standard sheath / dilator transseptal kit. The first tactile stimulus results from a first / initial feature such as the first surface modification 145, which may be the first ridge 145a represented by the transition stage between the tapered tip 140 and the proximal length 123 of the distal tube member 121. As described above, the second tactile stimulus results from, for example, the second surface modification 147 of the second ridge 147a or the depression 147b.

[0036] Alternatively, as shown in FIG. 3C, the tapered distal tip 140 may include a smooth single external taper T3 by a single surface modification such as the first surface modification 145 in the form of the first ridge 145a during transition, as described above. In a further alternative, there may be two or more external tapers along the outer surface. In a specific example, the distal tip 140 may have two external tapers: an external taper T4 and an external taper T5, as shown in FIG. 3D, in which case the first surface modification 145 and the second surface modification 147 are formed by the transition stage forming the first ridge 145a and the second ridge 145b. These provide a tactile stimulus during use, for example, when the hybrid dilator 100 advances through the septum. This tactile stimulus is very similar to the stimulus generally obtained from the transition in a standard transseptal kit including a standard dilator and sheath assembly. In some such examples, the internal taper may include internal tapers T1 and T2, as shown in FIG. 2A.

[0037] Alternative In an alternative embodiment of the present invention, the distal tip 140 may have an improved outer taper T3. In some such examples, the shape of the outer taper T3 may vary. As outlined previously, the distal tip 140 may have an outer surface improvement along the outer taper T3. The outer taper T3 may comprise a second ridge 147a and the outer taper T3 may comprise a recess 147b. Alternatively, the outer taper T3 may have an improved coarseness.

[0038] In an alternative embodiment, the ID of the distal tip 140 that includes the internal taper(s) is modified to accommodate a transverse / puncture device such as a needle (e.g., an RF needle). Alternatively, the internal shape may be modified to accommodate a transverse / puncture device such as a guide wire (e.g., an RF guide wire). In some embodiments, the distal tubing 121 of the shaft comprises a single material. Alternatively, the distal tubing 121 of the shaft may comprise a composite material by coextrusion or post-extrusion processing / layer formation. In some examples, the distal tubing 121 of the shaft comprises a lubricating coating material along the outer surface. In some such examples, the chemistry and / or processing of the lubricating coating material is varied to provide a suitable coating. In some embodiments, materials according to those known in the art may be used within the distal tubing 121 for coating. In a further alternative of the present invention, the hybrid dilator 100 may comprise a port facing forward along the distal tip 140 to enable a fluid injection method when a needle or guide wire is positioned within the hybrid dilator 100.

[0039] In some embodiments of the present invention, the hybrid dilator 100 is created to optimize the stiffness / torque response of the tubing. Also, the handle / hub 112 improves the operating characteristics (described further hereinbelow). In some embodiments, as shown previously, the distal tip 140 comprises two outer distal tapers. In some embodiments, the internal controlled shape may be provided in a variable configuration.

[0040] Figure 8 is a cross-sectional view of the shaft and distal tip of a hybrid dilator of an alternative embodiment of the present invention, and Figure 9 is an enlarged view of the distal tip of Figure 8, where the dilator shaft has two or more layers, and the tip is typically composed of the same material as one of the shaft layers.

[0041] The hybrid dilator 700 of Figure 8 has a shaft 702 that includes three layers: an inner layer 706, an outer layer 708, and a torque layer 704 which is an intermediate layer, to improve the torqueability of the device. There is a smooth junction between the device tip 720 and the shaft 702. The inner layer 706 is typically composed of HDPE, and the outer layer 708 is typically composed of Pebax or LDPE. A typical embodiment of the shaft 702 provides a mechanical response similar to that of the transseptal sheaths and dilator sets currently commonly used by physicians. The durometer of Pebax may be selected to adjust the flexibility and extrudability of the shaft. The torque layer is typically a braided material, and in alternative embodiments, the torque layer may be a stiff polymer and / or a metal hypo tube. Some further embodiments of the shaft 702 do not include the torque layer 704. The outer layer 708 is typically composed of Pebax or LDPE, but in some alternative embodiments, it is made of HDPE, and all of these are compatible with lubricious coatings. A typical embodiment of the shaft 702 has an outer diameter of at least the size of the current transseptal sheath (approximately 0.144 inches (0.366 cm)) to expand the septum to at least the same size as the current sheath, and has a mechanical response (including flexibility, extrudability, and torqueability) comparable to that of a pair of current transseptal sheaths and dilators. Some embodiments of the shaft 702 have an outer diameter of 12.5F from approximately 0.163 inches (0.414 cm) to approximately 0.166 inches (0.421 cm). Other embodiments of the shaft 702 have an outer diameter of 15F from approximately 0.193 inches (0.490 cm) to approximately 0.205 inches (0.521 cm). Some embodiments of the shaft 702 with the torque layer 704 have a torque transmission of from approximately 4 Ncm to approximately 8 Ncm, and one specific embodiment has a torque transmission of approximately 8.1 Ncm.

[0042] In embodiments that include a torque layer 704 between the inner material and the outer materials (HDPE and Pebax), the braid typically functions as a fixture between the inner and outer layers. Such embodiments may be manufactured using a reflow process in which the braid layer melts both the inner and outer layers to mechanically bond the two materials together. Some such embodiments have a stainless steel braid and provide a torque transmission of 8 Ncm.

[0043] FIG. 9 shows an embodiment of a tip 720 that is typically composed of HDPE, but where about 20 percent to 50 percent of the distal tip is composed of BaSO4 to facilitate imaging and alternatively may be composed of Pebax or any thermoplastic material. In some embodiments, about 40% of the tip 720 is composed of BaSO4. During inspection, the HDPE exhibits the advantageous property of being rigid enough not to be skived. The tip 720 of FIG. 9 includes a lumen 724, a distal edge 722, and a single external taper T3 for smooth dilation. Inner tapers T1 and T2 guide a device (e.g., a guidewire, a needle) from the shaft to the tip area and limit the protrusion of the needle (of a compatible needle) from the end of the dilator. The example shown includes two distal side holes 726 to limit vacuum and pressure formation when withdrawing the device, and alternative examples include different sizes, locations, numbers of holes, and hole configurations. Other embodiments of the tip 720 include radiopaque features such as bands and coils made of radiopaque materials (e.g., platinum, gold, tungsten, and / or barium sulfate filled polymers).

[0044] Referring further to FIG. 9, the inner diameter of the tip 720 varies from the shaft ID to a smaller diameter that is compatible with commonly used devices such as guidewires and needles of 0.032 inches (0.081 cm) or 0.035 inches (0.089 cm). The length of the outer taper T3 is typically a length of 1.0 cm or more because a shorter length may increase the transverse force or cause the tissue to be transected more steeply. Some examples of the tip 720 have a taper length T3 of up to 3 cm. In some embodiments, the outer taper length of the outer taper T3 ranges from about 0.4 inches (1 cm) to about 1 inch (2.5 cm). The outer diameter of the tip 720 is typically about the same size as 0.055 inches (0.140 cm), or the force to proceed through the tissue may be considered greater than that of a typical transseptal dilator. As an example, if the device is compatible with 0.032 inches (0.081 cm) and has an ID of approximately 0.034 inches (0.086 cm), suppressing the tip OD to a maximum of 0.054 inches (0.137 cm) will allow for easy and smooth advancement within the tissue.

[0045] In a specific embodiment of the hybrid dilator 700 shown in FIGS. 8 and 9, the shaft 702 has an outer diameter of 0.164 inches (0.417 cm) and an inner diameter of 0.072 inches (0.183 cm). The inner diameter of the tip 720 at the distal edge 722 is compatible with a device having an outer diameter of 0.032 inches (0.081 cm) or 0.035 inches (0.089 cm), the maximum OD of the tip is less than 0.055 inches (0.140 cm), the two side holes 726 have a diameter of about 0.012 inches (0.030 cm) to about 0.024 inches (0.061 cm), and the outer taper T3 has a length of 1.6 cm. A typical dilator has a taper length of approximately 1 cm and a diameter smaller than the shown embodiment. To ensure that the hybrid dilator 700 does not have a larger taper angle than a typical dilator (which would increase the transverse force), the hybrid dilator has an outer taper T3 with a length of 1.6 cm that matches this relatively large outer diameter. In some embodiments, the inner diameter of the tip 720 at the distal edge 722 is from about 0.033 inches (0.084 cm) to about 0.037 inches (0.094 cm), and the outer diameter of the tip 720 at the distal edge 722 is from about 0.040 inches (0.10 cm) to about 0.055 inches (0.14 cm).

[0046] A further alternative embodiment of the hybrid dilator 700 includes an outer layer 708 of the shaft 702 made from a thermoplastic material to facilitate manufacturing. Some examples have only one or two or more lumen tapers. Some further embodiments include an electrode configured to puncture at the tip so that one device can perform puncturing, transection, and dilation.

[0047] Some embodiments include a shaft having an inner layer 706 made of HDPE and an outer layer 708 made of Pebax, where during manufacture of the device, the tip 720 and the inner layer 706 are formed by the same extrusion molding of HDPE such that the tip 720 and the inner layer 706 are continuous without any internal joints, thereby eliminating the risk that a sharp needle advancing through the dilator will be caught at the joint between the dilator shaft 702 and the tip 720.

[0048] Proximal hub As further shown in FIG. 4A, the hybrid dilator 100 includes a handle defined at this proximal end by combination with a hybrid or proximal hub 112. The proximal hub 112 includes an expander hub 114 integrally formed with a sheath hub or sheath-like hub 116. FIG. 4A also includes a prior art dilator 650 inserted into a sheath 660 as shown with the expander hub 652 and sheath hub 662 shown proximally, the dilator 650 extending distally from the sheath 660. The sheath 660 and dilator 650 proceed across the septum 505, but the heart tissue is captured on the sheath 660. In contrast, the hybrid dilator 100 proceeds across the septum 505 without hindrance. In some embodiments as shown in FIGS. 4B-4C, and 4F, the expander hub 114 includes a luer hub or luer connector 115, and the sheath hub 116 includes an arm 117 that functions as a pseudo side port that provides a functional feel of a side port to indicate / direct the distal end curved state. The arm 117 mimics a standard sheath side port without providing the flow performance of a standard sheath side port. The proximal hub 112 forms a larger hub / handle than a standard transseptal dilator hub by being characterized by holding additional instruments, giving the physician similar operation and expected tactile feedback, and further causing the arm 117 to indicate the direction of the distal end curved state. In some examples, if flow performance is desired, the arm 117 may be replaced with a functional side port. In one specific example, the proximal hub 112 includes a custom insert molded HDPE hub with the luer connector 115 at the proximal end, and tactile features that indicate the surface of the distal curved state and provide similar operating characteristics (as defined by the side port arm 117). In some such examples, the proximal end 110 has a luer taper to enable connection of a medical syringe or drip. FIG. 4D shows an end view by the distal end of the proximal hub 112 showing a fitting 119 of the proximal hub 112 for connecting the proximal hub 112 to the distal tubing 121. In some such examples, the fitting 119 may include a strain relief.Figures 4E and 4G show a cross-sectional view of the proximal hub 112 showing the internal configuration of the proximal hub 112 which can include features to facilitate entry of other devices during use. In some such examples, the proximal hub 112 includes HDPE.

[0049] The proximal hub 112 includes an outer diameter OD3 of 5.25 mm, an inner angle IA of 40.0 degrees, and a proximal angle PA of 6.0 degrees at this distal end, as shown in FIG. 4E. In the proximal hub 112, as shown in FIG. 4F, the proximal cylinder has an outer diameter OD5 of 6 mm and an outer diameter OD4 of 7.37 mm at the luer connector at this proximal end. The distance D1 between the point 117b opposite the end point 117a is 28.39 mm, and the distance D2 between the opposite point 117b and the central longitudinal axis of the proximal hub 112 is 6.49 mm. The proximal hub 112 has an inner diameter ID5 of 4.25 mm inside the hub proximal end 113a, an inner diameter ID6 of 3 mm at the innermost part of the lumen, an inner diameter ID7 at the narrowest part of the lumen, and an inner diameter ID8 of 4.12 mm at the hub distal end 113b of the hub, as shown in FIG. 4G. Other hub dimensions shown in FIG. 4G include the location H1 of the hub (at the distal end of the proximal internal taper) 12.40 mm from the hub proximal end 113a, the location H2 of the hub (at the proximal end of the distal internal taper) 31.83 mm from the hub proximal end 113a, the location H3 of the hub (at the distal end of the distal internal taper) 33.75 mm from the hub proximal end 113a, and the location H4 of the hub (at the distal end of the narrowest part of the lumen) 35 mm from the hub proximal end 113a.

[0050] Alternative embodiments of the proximal hub In some embodiments, such as those shown in FIGS. 5A - 5D, an alternative embodiment of the hybrid expander 200 comprises an improved proximal portion 210. The hybrid expander 200 includes a proximal hub 212 with a valve, as shown in FIGS. 5A - 5B, where the hub includes a valve 213 at this proximal end, along with a cap 220 for holding the valve in place. The valve 213 is provided as a hemostatic valve. In some examples, as shown in FIG. 5B, the proximal hub 212 with a valve further includes additional features for guiding a device into the valve 213. In some embodiments, the proximal hub 212 has an insertion guide 218 as a molded or external feature that functions in cooperation with the valve to guide and adjust a product inserted into the valve 213. In the specific example shown, the insertion guide 218 is provided proximal to the valve 213.

[0051] According to another embodiment of the present invention, features are provided within the proximal hub 212 with a valve to allow a device to pass through a narrow passage of the shaft tubing. In a particular case, a funnel - shaped guide 222 is provided to guide and adjust a product inserted into the valve 213 into the shaft tubing. The funnel - shaped guide is positioned distal to the valve 213. In some such examples, the funnel - shaped guide 222 is provided as a molded feature. In some embodiments, the funnel - shaped guide 222 is also configured to center the proximal end of a guide wire with respect to the valve. By centering it in this way, the proximal end of the guide wire is guided when inserted into the distal tip of the device for the purpose of device replacement.

[0052] In a further alternative, as shown in FIG. 5D, the hybrid expander 200 comprises a proximal hub 212 that houses a valve 213, for example a hemostatic valve, and further includes a port 217 of a side port to which a side - port tubing 219 is attached, along with a stopper 228 provided in the same plane and for suction.

[0053] In alternative embodiments of the present invention, the proximal hub 212 may include materials employed from the group consisting of pebax, HDPE, LDPE, and nylon, or combinations thereof, to achieve the desired lubricity and operating characteristics.

[0054] In yet a further alternative, a proximal hub 112 with a luer connector 115 according to ISO 594-1, -2 is shown in FIG. 5E. Further, an arm 117 in the form of a simulated side port is provided to effect the desired operation and align with the distal curvature. Further, the proximal hub 112 includes a strain relief 119b at its distal end, and the distal tubing 121 extends distally from the strain relief 119b.

[0055] Alternative In some embodiments of the present invention, the proximal hub 112 or the proximal hub 212 with a valve may include a molded hub. In some embodiments, the proximal hub 112 or the proximal hub 212 with a valve may include HDPE. Alternatively, other materials may be used. In some embodiments, the shape of the hub may vary as appropriate. In alternative embodiments of the proximal hub 212 with a valve, the valve material and / or shape may vary as known in the art. In some such examples, the slit configuration and / or size may be varied to provide a suitable valve to meet the requirements of a procedure such as a transseptal procedure. In yet a further alternative, the material of the side port tubing, and the ID and OD of the side port tubing may be selected and / or varied as known to those skilled in the art. Similarly, in some examples, the stopcock material may be varied as known in the art as shown in FIG. 5D where a stopcock is provided.

[0056] In yet a further alternative of the present invention, some embodiments of the hybrid dilator of the present invention can simplify a transseptal crossing and, moreover, can enable the co-use of an ablation catheter if the need arises.

[0057] Another aspect of the present invention is a kit for piercing tissue, including a transverse device having a piercing feature and a hybrid dilator 100, where the dilator has a dilator shaft defining a lumen 122 for receiving the transverse device, and the dilator shaft is structured to support the transverse device when the transverse device is used to effect piercing of the tissue. The hybrid dilator also includes a distal tip 140 having an outer diameter that is substantially tapered to the outer diameter of the transverse device to cooperate to provide a smooth outer profile when the hybrid dilator 100 advances through the tissue over the transverse device. In some embodiments of the kit, the transverse device is a mechanical needle having a sharp tip, and in some other embodiments, the transverse device is configured to deliver energy to the tissue.

[0058] Another aspect of the present invention is a system for piercing tissue, including a transverse device having a piercing feature operable to deliver energy to the tissue, an electrosurgical generator operable to provide energy to the piercing feature, and a hybrid dilator 100, where the hybrid dilator has a dilator shaft defining a lumen 122 for receiving the transverse device, and the dilator shaft is structured to support the transverse device when the transverse device is used to effect piercing of the tissue. The hybrid dilator also includes a distal tip 140 having an outer diameter that is substantially tapered to the outer diameter of the transverse device to cooperate to provide a smooth outer profile when the hybrid dilator advances through the tissue over the transverse device.

[0059] Method of performing transseptal surgery using the hybrid dilator of the present invention According to the present invention, the method of the present invention results in streamlining the surgical workflow by providing a hybrid dilator that combines the functionality of conventional transseptal sheath and dilator assemblies. The hybrid dilator of the present invention can reduce the number of devices required to complete transseptal surgery, thereby increasing surgical efficiency and reducing surgical time and complexity.

[0060] In such an example, the method of the present invention avoids the drawbacks associated with conventional transseptal surgery. FIGS. 6A and 6B illustrate an example of a method of performing such a conventional transseptal medical procedure 300. The method includes a step 310 of inserting into the right atrium 501 via the vasculature using a guide wire, and a step 320 of advancing a sheath 20 and a dilator 40 onto the guide wire into the right atrium 501, wherein the sheath 20 and the dilator 40 form a sheath and dilator assembly 50, step 320, a step 330 of replacing the guide wire with a transverse device 60 including a puncture device 62, and a step 340 of advancing the transverse device 60 with the dilator across the septum 505 to effect a transseptal puncture site 510 and expand the transseptal puncture site. In step 340, the sheath 20 may catch at the sheath / dilator interface, and the transition between the sheath and the dilator may affect the physician's ability to transect the tissue in a predictable and repeatable manner. Sometimes, the physician may not be able to transect up to the sheath (since the tissue will catch at the sheath / dilator interface, preventing the sheath from spanning the transseptal puncture site). If, in step 350, the physician is successful, the physician may be able to advance the sheath and dilator assembly 50, and the transverse device 60, through the transseptal puncture site 510, thereby enabling the puncture site 510 to be transected by the transition of the sheath and the dilator. In some such procedures, the physician may wish to use a relatively large delivery sheath (e.g., larger than the transseptal sheath 20) for a complex procedure, such as cryoablation or left atrial appendage closure / occlusion, but knowing that it cannot be transected with the large delivery sheath, the physician will introduce a standard transseptal kit with a sheath and dilator, as discussed in step 350 above, purely to transect and pre-expand the septum. This three-piece kit, when removed for replacement, must be discarded, thus not fully utilizing the three items (sheath, dilator, guide wire) that are present only during the short procedure. Removal of the sheath / dilator assembly and replacement with a larger delivery sheath will be further described below.In step 360 of the method, the crossing device 60 is exchanged for the guide wire 80, which includes steps of removing the crossing device 60 and advancing the guide wire 80 into the left atrium 502. In step 370, the sheath and dilator assembly 50 is removed. In step 380, one or more second devices 70, such as a relatively large delivery sheath, are advanced on the guide wire 80 into the left atrium 502 to complete the desired procedure.

[0061] As outlined above in this specification, embodiments of the present invention provide optimal transseptal surgery. According to the method of the present invention, as shown in FIGS. 7A and 7B, an optimal method 400 is provided for performing transseptal surgery. The method includes step 410 of entering the right atrium via the vasculature using a guidewire, and step 420 of advancing a hybrid dilator 100 having a support shaft / cylinder into the right atrium 501 over the guidewire. By using the hybrid dilator 100, the number of elements that a physician is required to prepare / assemble and introduce into the patient's body is reduced from three to two. Instead of a sheath, dilator, and guidewire, a hybrid dilator 100 and a guidewire may be used. The method further includes, in step 430, replacing the guidewire with a transverse device 60 including a puncture device 62 [in some embodiments of the present invention, the puncture device 62 may include a needle. In some such examples, the needle is a radiofrequency (RF) needle. Alternatively, the needle may include a mechanical needle. In other embodiments of the present invention, the puncture device 62 may include a radiofrequency (RF) guidewire], and in step 440, advancing the transverse device and the hybrid dilator across the septum 505 to provide a transseptal puncture site 510 and expand the puncture site 510 in order to easily advance one or more second devices 70 through the transseptal puncture site. The hybrid dilator 100, which may be referred to as a boosting dilator, is provided as a simplified instrument. This hybrid dilator simplifies the surgical workflow by providing an integrated transseptal instrument as compared to a sheath and a dilator (furthermore, it can be used with a guidewire and a needle as shown). The hybrid dilator 100 is provided as one / single oversized dilator and, by reducing the number of physical / geometric transitions and the number of instrument transitions or tactile interferences during use, enables a physician to more easily complete transseptal or other tissue transection. The hybrid dilator 100 reduces changes in the hybrid dilator 100 due to snagging at the transseptal puncture site by providing smooth lines and tapers to facilitate a smooth transition across the tissue.This allows the hybrid dilator 100 to be advanced more easily across the septum. The method further comprises, at step 450, replacing the crossing device 60 with the guide wire 80 and advancing the guide wire 80 into the left atrium, at step 360, removing the hybrid dilator 100, and at step 470, advancing one or more second devices on the guide wire 80 into the left atrium 502 to complete the desired procedure.

[0062] In procedures where the physician wishes to use a relatively large delivery sheath for a difficult procedure (e.g., cryoablation or LAA occlusion) but knows that the sheath product cannot be crossed, the physician can at this time simply introduce the hybrid dilator 100 on a guide wire as discussed in step 420 using a single device to cross and pre - dilate the septum. The hybrid dilator 100 and the initial guide wire can then be removed for replacement, and thus, only two products (the hybrid dilator 100 and the guide wire instead of a standard sheath, dilator, and guide wire kit) are used. Thus, the improved method further results in removing only the hybrid dilator 100 at steps 460 and 470 to reduce the products consumed in the process and allow replacement with a second device such as a relatively large delivery sheath for a complex procedure.

[0063] Another embodiment of the method uses the hybrid dilator 100 and the transverse device to puncture the cardiac septum 505. This embodiment of the method includes (a) positioning the distal tip 140 of the hybrid dilator at a desired location on the septum; (b) using the hybrid dilator 100 to support a transverse device disposed within the lumen of the hybrid dilator as the transverse device advances beyond the distal tip of the hybrid dilator to puncture the septum; and (c) expanding the desired location by advancing the hybrid dilator over the transverse device. In some such embodiments, the transverse device is a mechanical needle, and step (b) further includes puncturing the septum by applying force to the septum with the mechanical needle. In other embodiments, the transverse device is configured to deliver energy, and step (b) further includes puncturing the septum by supplying electrical energy to the transverse device. Some embodiments further include (d) replacing the transverse device with a guide wire and advancing the guide wire into the left atrium; (e) removing the hybrid dilator; and (f) advancing one or more second devices over the guide wire and into the left atrium.

[0064] In some embodiments that use a hybrid dilator and a transverse device to puncture the cardiac septum, the transverse device is configured to deliver energy and is further configured to be used as a guide wire, and the method further includes (d) removing the hybrid dilator and (e) typically advancing one or more second devices over the transverse device and into the left atrium. Further details of a transverse device suitable for delivering energy and being used as a guide wire are shown in International Application No. PCT / IB2013 / 060287, entitled "METHODS AND DEVICE FOR PUNCTURING TISSUE", which is hereby incorporated by reference in its entirety.

[0065] Thus, according to embodiments of the present invention, a method for streamlining the surgical workflow is provided by providing a hybrid dilator that combines the functionality of conventional transseptal sheaths and dilator assemblies. By means of the hybrid dilator of the present invention, the number of devices required to complete a transseptal operation can be reduced, thereby enhancing the surgical efficiency and reducing the surgical time and complexity.

[0066] The problem when a transseptal puncture is performed using a transverse device supported by a sheath and dilator set that has a transition stage where tissue may interfere when crossing the septum can be addressed by eliminating the transition stage by using a hybrid dilator (described herein) instead of the sheath and dilator set. In this case, the hybrid dilator has appropriate functionality (flexibility, extrudability, torqueability, distal taper, etc.) to facilitate a smooth crossing.

[0067] The above-described embodiment(s) of the present invention are intended to be merely illustrative. Accordingly, the scope of the present invention is intended to be limited solely by the appended claims.

[0068] It should be understood that certain features of the present invention that are described in the context of separate embodiments for clarity may be provided in combination in a single embodiment. Conversely, various features of the present invention that are described in the context of a single embodiment may be provided separately or in any suitable partial combination for brevity.

[0069] Although the present invention has been described in conjunction with this specific embodiment, it will be apparent to those skilled in the art that many alternatives, improvements, and modifications are possible. Therefore, it is intended to embrace all such alternatives, improvements, and modifications that fall within the broad scope of the appended claims. All publications, patents, and patent applications mentioned in this specification are hereby incorporated by reference in their entirety to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. Further, the citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention.

[0070] Some aspects of the present disclosure are (1) A hybrid dilator for use with a transverse device in a tissue piercing procedure, comprising a dilator shaft defining a lumen for receiving the transverse device, the dilator shaft being structured to support the transverse device when the transverse device is used to effect a puncture in tissue; and a distal tip having an outer diameter that tapers to the outer diameter of the transverse device to provide a smooth transition between the transverse device and the distal tip when the transverse device is inserted from the lumen and protrudes from the distal tip. (2) The hybrid dilator of (1) above, wherein the dilator shaft has an outer diameter from about 12 French to about 20 French. (3) The hybrid dilator of (1) above, wherein the dilator shaft has an outer diameter from about 0.414 cm to about 0.421 cm. (4) The hybrid dilator of (1) above, wherein the dilator shaft has an outer diameter from about 0.490 cm to about 0.521 cm. (5) The hybrid dilator of (1) above, wherein the dilator shaft substantially comprises high density polyethylene. (6) The high-density polyethylene has a hardness of from about 55 Shore D to about 70 Shore D, and the hybrid dilator according to (5) above. (7) The high-density polyethylene has a hardness of about 67 Shore D, and the hybrid dilator according to (5) above. (8) The dilator shaft defines an inner diameter of from about 0.18 cm to about 0.28 cm, and the hybrid dilator according to (5) above. (9) The dilator shaft substantially comprises a material selected from the group consisting of polyurethane and polyether block amide, and the hybrid dilator according to (1) above. (10) The dilator shaft defines an inner diameter of from about 0.13 cm to about 0.28 cm, and the hybrid dilator according to (9) above. (11) The dilator shaft substantially comprises a material selected from the group consisting of low-density polyethylene and polyether ether ketone, and the hybrid dilator according to (1) above. (12) The dilator shaft has a hardness of from about 40 Shore D to about 85 Shore D, and the hybrid dilator according to (11) above. (13) The dilator shaft comprises an outer layer made of polyether block amide and an inner layer made of a material selected from the group consisting of low-density polyethylene and high-density polyethylene, and the hybrid dilator according to (1) above. (14) The distal portion of the distal tip defines a distal inner diameter for controlling the distance that a transverse device having a narrow distal portion protrudes from the hybrid dilator by being restricted. The hybrid dilator according to (1) above. (15) The distal inner diameter is from about 0.084 cm to about 0.094 cm, and the hybrid dilator according to (14) above. (16) The distal inner diameter is about 0.086 cm, and the hybrid dilator according to (14) above. (17) The distal portion of the distal tip has a length of from about 0.71 cm to about 0.74 cm, and the hybrid dilator according to any one of (14) to (16) above. (18) The distal portion of the distal tip has a length ranging from about 0.721 cm to about 0.726 cm, for the hybrid expander described in (17) above. (19) The distal portion of the distal tip has a length of about 0.724 cm, for the hybrid expander described in (18) above. (20) The distal edge of the distal tip has an outer diameter ranging from about 0.10 cm to about 0.14 cm, for the hybrid expander according to any one of (14) to (16) above. (21) The distal tip includes an external taper having a taper angle ranging from about 4.5 degrees to about 6.5 degrees, for the hybrid expander described in (1) above. (22) The distal tip includes an external taper having a taper angle ranging from about 5 degrees to about 15 degrees, for the hybrid expander described in (1) above. (23) The external taper has a taper length ranging from about 1.0 cm to about 1.6 cm, for the hybrid expander described in (21) or (22) above. (24) The external taper has a taper length ranging from about 1 cm to about 2.5 cm, for the hybrid expander described in (21) or (22) above. (25) The distal tip includes an external taper having a taper length of about 1.0 cm and a taper angle of about 15 degrees, for the hybrid expander described in (1) above. (26) The distal edge of the distal tip defines an inner diameter ranging from about 0.084 cm to about 0.094 cm, for the hybrid expander described in (1) above. (27) The distal edge has an outer diameter ranging from about 0.10 cm to about 0.14 cm, for the hybrid expander described in (26) above. (28) The distal edge of the distal tip has a wall thickness ranging from about 0.010 cm to about 0.013 cm, for the hybrid expander described in (1) above. (29) The proximal end of the distal tip has an inner diameter of about 0.277 cm and an outer diameter of about 0.422 cm, and the distal edge of the distal tip has an inner diameter of about 0.086 cm and an outer diameter of about 0.107 cm, for the hybrid expander described in (1) above. (30) The distal tip includes indentations configured to provide a series of tactile portions, the hybrid expander according to (1) above, (31) The distal tip includes two or more external tapers, the hybrid expander according to (1) above, (32) The expander shaft has an outer diameter from about 0.411 cm to about 0.422 cm and an inner diameter from about 0.142 cm to about 0.292 cm, the hybrid expander according to (5) above, (33) The expander shaft has a wall thickness from about 0.064 cm to about 0.140 cm, the hybrid expander according to (32) above, (34) The expander shaft has a stiffness from about 3.5 N / mm to about 5.5 N / mm, the hybrid expander according to (33) above, (35) The expander shaft has a torque transmission of from about 4 N / cm to about 7 N / cm, the hybrid expander according to (33) above.

[0071] (36) The expander shaft has an outer diameter from about 0.411 cm to about 0.422 cm and an inner diameter from about 0.274 cm to about 0.292 cm, the hybrid expander according to (5) above, (37) The expander shaft has a wall thickness from about 0.06 cm to about 0.074 cm, the hybrid expander according to (36) above, (38) The expander shaft has a flexural stiffness from about 2.5 N / mm to about 3.5 N / mm, the hybrid expander according to (37) above, (39) The expander shaft has a torque transmission of from about 4 Ncm to about 4.5 Ncm, the hybrid expander according to (37) above, (40) The expander shaft has an outer diameter from about 0.411 cm to about 0.422 cm and an inner diameter from about 0.241 cm to about 0.259 cm, the hybrid expander according to (5) above, (41) The expander shaft has a wall thickness from about 0.076 cm to about 0.091 cm, the hybrid expander according to (40) above, (42) The expander shaft has a bending stiffness of from about 3.5 N / mm to about 4.5 N / mm for the hybrid expander described in (41) above, (43) The expander shaft has a torque transmission of from about 4.5 Ncm to about 5.5 Ncm for the hybrid expander described in (41) above, (44) The expander shaft has a wall thickness of about 0.081 cm for the hybrid expander according to any one of (40) to (43) above, (45) The expander shaft has an outer diameter of from about 0.411 cm to about 0.422 cm and an inner diameter of from about 0.142 cm to about 0.160 cm for the hybrid expander described in (5) above, (46) The expander shaft has a wall thickness of from about 0.127 cm to about 0.140 cm for the hybrid expander described in (45) above, (47) The expander shaft has a bending stiffness of from about 5 N / mm to about 6 N / mm for the hybrid expander described in (46) above, (48) The expander shaft has a torque transmission of from about 6 Ncm to about 7 Ncm for the hybrid expander described in (46) above, (49) The expander shaft has a wall thickness of about 0.140 cm for the hybrid expander according to any one of (45) to (48) above, (50) The expander shaft includes an inner layer, an outer layer, and a torque layer therebetween for the hybrid expander described in (1) above, (51) The inner layer is made of high-density polyethylene for the hybrid expander described in (50) above, (52) The outer layer is made of a material selected from the group consisting of polyether block amide, low-density polyethylene, and high-density polyethylene for the hybrid expander described in (50) above, (53) The torque layer is made of a braided material for the hybrid expander according to any one of (50) to (52) above, (54) The braided material includes stainless steel for the hybrid expander described in (53) above, (55) The torque layer is the hybrid expander according to any one of (50) to (52) above, which is composed of a rigid polymer. (56) The torque layer is the hybrid expander according to any one of (50) to (52) above, which is composed of a metal hypo tube. (57) The expander shaft is the hybrid expander according to (50) above, which has an outer diameter ranging from about 0.414 cm to about 0.421 cm. (58) The expander shaft is the hybrid expander according to (50) above, which has an outer diameter ranging from about 0.490 cm to about 0.521 cm. (59) The distal tip portion is the hybrid expander according to (50) above, which includes an external taper having an external taper length ranging from about 1 cm to about 2.5 cm. (60) The distal tip portion is the hybrid expander according to (50) above, which includes a single external taper having a taper length of about 1.6 cm. (61) The distal tip portion is the hybrid expander according to (50) above, which is composed of high-density polyethylene, and about 20% to 50% of the distal tip portion is composed of BaSO4 to facilitate imaging. (62) About 40% of the distal tip portion is the hybrid expander according to (61) above, which is composed of BaSO4. (63) The distal edge portion of the distal tip portion is the hybrid expander according to (57) or (58) above, which has an inner diameter ranging from about 0.084 cm to about 0.094 cm. (64) The distal edge portion of the distal tip portion is the hybrid expander according to (63) above, which has an outer diameter ranging from 0.10 cm to about 0.14 cm. (65) The hybrid expander according to (64) above further includes side holes having a diameter ranging from about 0.030 cm to about 0.061 cm to limit vacuum and pressure formation when pulling the device out of the lumen. (66) The inner layer contains high-density polyethylene, the outer layer contains polyether block amide, the distal tip contains high-density polyethylene, and the distal tip and the inner layer are continuous with substantially no internal joints. The hybrid dilator according to (63) above, (67) The dilator shaft has a torque transmission degree from about 4 N / cm to about 8 N / cm. The hybrid dilator according to any one of (50) to (52) above, (68) The dilator shaft has a torque transmission degree of about 8.1 Ncm. The hybrid dilator according to any one of (50) to (52) above, (69) A method of using a hybrid dilator and a transverse device to puncture the septum of the heart, (a) Positioning the distal tip of the hybrid dilator at a desired location on the septum; (b) Using the hybrid dilator to support a transverse device disposed within the lumen of the hybrid dilator as the transverse device advances beyond the distal tip of the hybrid dilator to puncture the septum; (c) Expanding the desired location by advancing the hybrid dilator over the transverse device. A method including the above steps, (70) The transverse device is a mechanical needle, and step (b) further includes puncturing the septum by applying a force with the mechanical needle to the septum. The method according to (69) above, (71) The transverse device is configured to deliver energy, and step (b) further includes puncturing the septum by supplying electrical energy to the transverse device. The method according to (69) above, (72) Further including step (d) of replacing the transverse device with a guide wire and advancing the guide wire into the left atrium. The method according to (70) or (71) above, (73) Further including step (e) of removing the hybrid dilator. The method according to (72) above, (74) The method according to (73), further comprising the step (f) of advancing one or more second devices into the left atrium on the guide wire. (75) The transverse device is configured to be used as a guide wire, and the method further comprises the step (d) of removing the hybrid expander, the method according to (71). (76) The method according to (75), further comprising the step (e) of advancing one or more second devices into the left atrium on the transverse device. (77) A kit for puncturing tissue, A transverse device having a puncturing feature, A hybrid expander, comprising an expander shaft defining a lumen for receiving the transverse device, the expander shaft being structured to support the transverse device when the transverse device is used to effect puncture of tissue, and a distal tip having an outer diameter that is substantially tapered to the outer diameter of the transverse device so as to cooperate to provide a smooth outer profile when the hybrid expander advances through tissue on the transverse device. (78) The kit according to (77), wherein the transverse device is a mechanical needle. (79) The kit according to (77), wherein the transverse device is configured to deliver energy to tissue. (80) A kit for puncturing tissue, A transverse device having a puncturing feature, The kit comprising the hybrid expander according to any one of (1)-(16), (21), (22), (25)-(43), (45)-(48), (50)-(52), and (57)-(62). (81) The kit according to (80), wherein the transverse device is a mechanical needle. (82) The kit according to (80), wherein the transverse device is configured to deliver energy to tissue. (83) A system for puncturing tissue, A transverse device having a piercing feature operable to deliver energy to tissue, An electrosurgical generator operable to provide energy to the piercing feature, A hybrid dilator comprising a dilator shaft defining a lumen for receiving the transverse device, the dilator shaft being structured to support the transverse device when the transverse device is used to effect a puncture in tissue, and a distal tip having an outer diameter that is substantially tapered to the outer diameter of the transverse device so as to cooperate to provide a smooth outer profile when the hybrid dilator advances through tissue over the transverse device, (84)A system for piercing tissue, A transverse device having a piercing feature operable to deliver energy to tissue, An electrosurgical generator operable to provide energy to the piercing feature, The system comprising the hybrid dilator according to any one of (1)-(16), (21), (22), (25)-(43), (45)-(48), (50)-(52), and (57)-(62), (85)The hybrid dilator according to (1) or (50), wherein the distal tip defines an inner diameter that is tapered along a first inner taper, (86)The hybrid dilator according to (85), wherein the distal tip defines a second inner taper, (87)The hybrid dilator according to (86), wherein the first inner taper and the second inner taper are spaced apart, and (88)The hybrid dilator according to (86), wherein the first inner taper and the second inner taper are adjacent to each other.

Claims

**Claim 1** A hybrid dilator for use with a transverse device in a tissue piercing procedure, comprising: a dilator shaft defining a lumen for receiving the transverse device, the dilator shaft being structured to support the transverse device when the transverse device is used to effect a tissue puncture; and a distal tip having an outer diameter that tapers to the outer diameter of the transverse device to provide a smooth transition between the transverse device and the distal tip when the transverse device is inserted from the lumen and protrudes from the distal tip. **Claim 2** The hybrid dilator of claim 1, wherein the dilator shaft has an outer diameter from about 12 French to about 20 French. **Claim 3** The hybrid dilator of claim 1, wherein the dilator shaft has an outer diameter from about 0.414 cm to about 0.421 cm. **Claim 4** The hybrid dilator of claim 1, wherein the dilator shaft has an outer diameter from about 0.490 cm to about 0.521 cm. **Claim 5** The hybrid dilator of claim 1, wherein the dilator shaft substantially comprises high density polyethylene. **Claim 6** The hybrid dilator of claim 5, wherein the high density polyethylene has a hardness from about 55 Shore D to about 70 Shore D. **Claim 7** The hybrid dilator of claim 5, wherein the high density polyethylene has a hardness of about 67 Shore D. **Claim 8** The hybrid dilator of claim 5, wherein the dilator shaft defines an inner diameter from about 0.18 cm to about 0.28 cm. **Claim 9** The hybrid dilator of claim 1, wherein the dilator shaft substantially comprises a material selected from the group consisting of polyurethane and polyether block amide. **Claim 10** The hybrid dilator of claim 9, wherein the dilator shaft defines an inner diameter from about 0.13 cm to about 0.28 cm. **Claim 11** The hybrid dilator of claim 1, wherein the dilator shaft substantially comprises a material selected from the group consisting of low density polyethylene and polyether ether ketone. **Claim 12** The hybrid dilator of claim 11, wherein the dilator shaft has a hardness from about 40 Shore D to about 85 Shore D. **Claim 13** The hybrid expander according to claim 1, wherein the expander shaft includes an outer layer composed of polyether block amide and an inner layer composed of a material selected from the group consisting of low density polyethylene and high density polyethylene.

14. The hybrid expander according to claim 1, wherein the distal portion of the distal tip defines a distal inner diameter so as to control the distance by which a transverse device having a narrow distal portion by being restricted protrudes from the hybrid expander.

15. The hybrid expander according to claim 14, wherein the distal inner diameter is from about 0.084 cm to about 0.094 cm.

16. The hybrid expander according to claim 14, wherein the distal inner diameter is about 0.086 cm.

17. The hybrid expander according to any one of claims 14 to 16, wherein the distal portion of the distal tip has a length from about 0.71 cm to about 0.74 cm.

18. The hybrid expander according to claim 17, wherein the distal portion of the distal tip has a length from about 0.721 cm to about 0.726 cm.

19. The hybrid expander according to claim 18, wherein the distal portion of the distal tip has a length of about 0.724 cm.

20. The hybrid expander according to any one of claims 14 to 16, wherein the distal edge of the distal tip has an outer diameter from about 0.10 cm to about 0.14 cm.

21. The hybrid expander according to claim 1, wherein the distal tip includes an external taper having a taper angle from about 4.5 degrees to about 6.5 degrees.

22. The hybrid expander according to claim 1, wherein the distal tip includes an external taper having a taper angle from about 5 degrees to about 15 degrees.

23. The hybrid expander according to claim 21 or 22, wherein the external taper has a taper length from about 1.0 cm to about 1.6 cm.

24. The hybrid expander according to claim 21 or 22, wherein the external taper has a taper length from about 1 cm to about 2.5 cm.

25. The hybrid expander according to claim 1, wherein the distal tip includes an external taper having a taper length of about 1.0 cm and a taper angle of about 15 degrees.

26. The hybrid expander according to claim 1, wherein the distal edge of the distal tip defines an inner diameter from about 0.084 cm to about 0.094 cm.

27. The hybrid expander according to claim 26, wherein the distal edge has an outer diameter ranging from about 0.10 cm to about 0.14 cm. **Claim 28** The hybrid expander according to claim 1, wherein the distal edge of the distal tip has a wall thickness ranging from about 0.010 cm to about 0.013 cm. **Claim 29** The hybrid expander according to claim 1, wherein the proximal end of the distal tip has an inner diameter of about 0.277 cm and an outer diameter of about 0.422 cm, and the distal edge of the distal tip has an inner diameter of about 0.086 cm and an outer diameter of about 0.107 cm. **Claim 30** The hybrid expander according to claim 1, wherein the distal tip includes a recess configured to provide a series of tactile portions. **Claim 31** The hybrid expander according to claim 1, wherein the distal tip includes two or more external tapers. **Claim 32** The hybrid expander according to claim 5, wherein the expander shaft has an outer diameter ranging from about 0.411 cm to about 0.422 cm and an inner diameter ranging from about 0.142 cm to about 0.292 cm. **Claim 33** The hybrid expander according to claim 32, wherein the expander shaft has a wall thickness ranging from about 0.064 cm to about 0.140 cm. **Claim 34** The hybrid expander according to claim 33, wherein the expander shaft has a stiffness ranging from about 3.5 N / mm to about 5.5 N / mm. **Claim 35** The hybrid expander according to claim 33, wherein the expander shaft has a torque transmission degree ranging from about 4 N / cm to about 7 N / cm. **Claim 36** The hybrid expander according to claim 5, wherein the expander shaft has an outer diameter ranging from about 0.411 cm to about 0.422 cm and an inner diameter ranging from about 0.274 cm to about 0.292 cm. **Claim 37** The hybrid expander according to claim 36, wherein the expander shaft has a wall thickness ranging from about 0.06 cm to about 0.074 cm. **Claim 38** The hybrid expander according to claim 37, wherein the expander shaft has a flexural stiffness ranging from about 2.5 N / mm to about 3.5 N / mm. **Claim 39** The hybrid expander according to claim 37, wherein the expander shaft has a torque transmission degree ranging from about 4 Ncm to about 4.5 Ncm. **Claim 40** The hybrid expander according to claim 5, wherein the expander shaft has an outer diameter ranging from about 0.411 cm to about 0.422 cm and an inner diameter ranging from about 0.241 cm to about 0.259 cm. **Claim 41** The expander shaft is the hybrid expander according to claim 40, having a wall thickness ranging from about 0.076 cm to about 0.091 cm.

42. The expander shaft is the hybrid expander according to claim 41, having a bending stiffness ranging from about 3.5 N / mm to about 4.5 N / mm.

43. The expander shaft is the hybrid expander according to claim 41, having a torque transmission degree ranging from about 4.5 Ncm to about 5.5 Ncm.

44. The expander shaft is the hybrid expander according to any one of claims 40 to 43, having a wall thickness of about 0.081 cm.

45. The expander shaft is the hybrid expander according to claim 5, having an outer diameter ranging from about 0.411 cm to about 0.422 cm and an inner diameter ranging from about 0.142 cm to about 0.160 cm.

46. The expander shaft is the hybrid expander according to claim 45, having a wall thickness ranging from about 0.127 cm to about 0.140 cm.

47. The expander shaft is the hybrid expander according to claim 46, having a bending stiffness ranging from about 5 N / mm to about 6 N / mm.

48. The expander shaft is the hybrid expander according to claim 46, having a torque transmission degree ranging from about 6 Ncm to about 7 Ncm.

49. The expander shaft is the hybrid expander according to any one of claims 45 to 48, having a wall thickness of about 0.140 cm.

50. The expander shaft is the hybrid expander according to claim 1, including an inner layer, an outer layer, and a torque layer therebetween.

51. The inner layer is composed of high-density polyethylene in the hybrid expander according to claim 50.

52. The outer layer is composed of a material selected from the group consisting of polyether block amide, low-density polyethylene, and high-density polyethylene in the hybrid expander according to claim 50.

53. The torque layer is composed of a braided material in the hybrid expander according to any one of claims 50 to 52.

54. The braided material includes stainless steel in the hybrid expander according to claim 53.

55. The torque layer is composed of a rigid polymer in the hybrid expander according to any one of claims 50 to 52.

56. The torque layer is composed of a metal hypodermic tube, and the hybrid expander according to any one of claims 50 to 52.

57. The expander shaft has an outer diameter of from about 0.414 cm to about 0.421 cm, and the hybrid expander according to claim 50.

58. The expander shaft has an outer diameter of from about 0.490 cm to about 0.521 cm, and the hybrid expander according to claim 50.

59. The distal tip includes an external taper having an external taper length of from about 1 cm to about 2.5 cm, and the hybrid expander according to claim 50.

60. The distal tip includes a single external taper having a taper length of about 1.6 cm, and the hybrid expander according to claim 50.

61. The distal tip is composed of high density polyethylene, and from about 20 percent to 50 percent of the distal tip is composed of BaSO4 to facilitate imaging, and the hybrid expander according to claim 50.

62. About 40% of the distal tip is composed of BaSO4, and the hybrid expander according to claim 61.

63. The distal edge of the distal tip has an inner diameter of from about 0.084 cm to about 0.094 cm, and the hybrid expander according to claim 57 or 58.

64. The distal edge of the distal tip has an outer diameter of from 0.10 cm to about 0.14 cm, and the hybrid expander according to claim 63.

65. The hybrid expander according to claim 64 further includes side holes having a diameter of from about 0.030 cm to about 0.061 cm to limit vacuum and pressure formation when the device is withdrawn from the lumen.

66. The inner layer includes high density polyethylene, the outer layer includes polyether block amide, the distal tip includes high density polyethylene, and the distal tip and the inner layer are continuous with substantially no internal joints, and the hybrid expander according to claim 63.

67. The expander shaft has a torque transmission degree of from about 4 N / cm to about 8 N / cm, and the hybrid expander according to any one of claims 50 to 52.

68. The expander shaft has a torque transmission degree of about 8.1 Ncm, and the hybrid expander according to any one of claims 50 to 52.

69. A method of using a hybrid dilator and a transverse device for puncturing the cardiac septum, comprising: (a) positioning a distal tip of the hybrid dilator at a desired location on the septum; (b) using the hybrid dilator to support a transverse device disposed within a lumen of the hybrid dilator as the transverse device advances beyond the distal tip of the hybrid dilator to puncture the septum; (c) expanding the desired location by advancing the hybrid dilator over the transverse device. **Claim 70** The method of claim 69, wherein the transverse device is a mechanical needle, and step (b) further comprises puncturing the septum by applying a force to the septum with the mechanical needle. **Claim 71** The method of claim 69, wherein the transverse device is configured to deliver energy, and step (b) further comprises puncturing the septum by supplying electrical energy to the transverse device. **Claim 72** The method of claim 70 or 71, further comprising (d) replacing the transverse device with a guide wire and advancing the guide wire into the left atrium. **Claim 73** The method of claim 72, further comprising (e) removing the hybrid dilator. **Claim 74** The method of claim 73, further comprising (f) advancing one or more second devices over the guide wire into the left atrium. **Claim 75** The method of claim 71, wherein the transverse device is configured to be used as a guide wire, and the method further comprises (d) removing the hybrid dilator. **Claim 76** The method of claim 75, further comprising (e) advancing one or more second devices over the transverse device into the left atrium. **Claim 77** A kit for puncturing tissue, comprising: a transverse device having a puncturing feature; A hybrid dilator comprising a dilator shaft defining a lumen for receiving the transverse device, the dilator shaft being structured to support the transverse device when the transverse device is used to effect a puncture in tissue, and a distal tip having an outer diameter that is substantially tapered to the outer diameter of the transverse device so as to cooperate to provide a smooth outer profile when the hybrid dilator advances through tissue over the transverse device.

78. The kit according to claim 77, wherein the transverse device is a mechanical needle.

79. The kit according to claim 77, wherein the transverse device is configured to deliver energy to tissue.

80. A kit for puncturing tissue, comprising a transverse device having a puncturing feature and a hybrid dilator according to any one of claims 1-16, 21, 22, 25-43, 45-48, 50-52, and 57-62.

81. The kit according to claim 80, wherein the transverse device is a mechanical needle.

82. The kit according to claim 80, wherein the transverse device is configured to deliver energy to tissue.

83. A system for puncturing tissue, comprising: A transverse device having a puncturing feature operable to deliver energy to tissue; An electrosurgical generator operable to provide energy to the puncturing feature; A hybrid dilator comprising a dilator shaft defining a lumen for receiving the transverse device, the dilator shaft being structured to support the transverse device when the transverse device is used to effect a puncture in tissue, and a distal tip having an outer diameter that is substantially tapered to the outer diameter of the transverse device so as to cooperate to provide a smooth outer profile when the hybrid dilator advances through tissue over the transverse device.

84. A system for puncturing tissue, comprising: A transverse device having a puncturing feature operable to deliver energy to tissue; An electrosurgical generator operable to provide energy to the puncturing feature; A hybrid dilator according to any one of claims 1-16, 21, 22, 25-43, 45-48, 50-52, and 57-62. **Claim 85** The hybrid expander according to claim 1 or 50, wherein the distal tip defines an inner diameter that is tapered along a first internal taper. **Claim 86** The hybrid expander according to claim 85, wherein the distal tip defines a second internal taper. **Claim 87** The hybrid expander according to claim 86, wherein the first internal taper and the second internal taper are spaced apart. **Claim 88** The hybrid expander according to claim 86, wherein the first internal taper and the second internal taper are adjacent to each other.

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