Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/34—Trocars; Puncturing needles
  • A61B17/3415—Trocars; Puncturing needles for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/34—Trocars; Puncturing needles
  • A61B17/3478—Endoscopic needles, e.g. for infusion
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
  • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
  • A61B18/14—Probes or electrodes therefor
  • A61B18/1477—Needle-like probes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/06—Body-piercing guide needles or the like
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/09—Guide wires
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
  • A61B2017/00238—Type of minimally invasive operation
  • A61B2017/00243—Type of minimally invasive operation cardiac
  • A61B2017/00247—Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
  • A61B2017/22038—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with a guide wire
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
  • A61B2017/22038—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with a guide wire
  • A61B2017/22042—Details of the tip of the guide wire
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
  • A61B2017/22038—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with a guide wire
  • A61B2017/22047—Means for immobilising the guide wire in the patient
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
  • A61B2018/00345—Vascular system
  • A61B2018/00351—Heart
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
  • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
  • A61B18/14—Probes or electrodes therefor
  • A61B2018/1405—Electrodes having a specific shape
  • A61B2018/1425—Needle
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
  • A61B90/03—Automatic limiting or abutting means, e.g. for safety
  • A61B2090/033—Abutting means, stops, e.g. abutting on tissue or skin
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
  • A61B90/06—Measuring instruments not otherwise provided for
  • A61B2090/062—Measuring instruments not otherwise provided for penetration depth
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
  • A61B90/08—Accessories or related features not otherwise provided for
  • A61B2090/0807—Indication means
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/32—General characteristics of the apparatus with radio-opaque indicia
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
  • A61M2205/582—Means for facilitating use, e.g. by people with impaired vision by tactile feedback

Definitions

• the present disclosure relates to a medical device for using in accessing the cardiovascular system. More particularly the present disclosure relates to a hybrid transseptal dilator for facilitating a transseptal procedure for providing left heart access.
• FIG. 1 A is an illustration of a hybrid dilator, in accordance with an embodiment of the present invention.
• FIG. IB is an illustration of a proximal portion of the hybrid dilator of Fig. 1 A;
• Fig. 1C is a front end view of a distal tip of the hybrid dilator of Fig. 1 A;
• FIG. ID is an illustration of a proximal portion of the hybrid dilator of Fig. 1A;
• Fig. 2A is a cross-sectional view of the distal tip of a hybrid dilator taken along the lines 2A-2A of Fig. 1C;
• Fig. 2B is a cross-sectional view of the distal most end of a hybrid dilator taken along the lines 2B-2B of Fig. 1C;
• FIG. 2C is an illustration of a distal tip, in accordance with an alternative embodiment of the present invention.
• FIGs. 3A-3D illustrate alternate embodiments of a distal tip, in accordance with alternate embodiments of the present invention
• FIG. 4A illustrates a hybrid dilator in accordance with an embodiment of the present invention, and a standard sheath/dilator assembly usable in a standard transseptal procedure;
• FIGs. 4B-4G illustrate a proximal portion of the hybrid dilator in accordance with an embodiment of the present invention
• FIGs. 5A-5C illustrates a proximal portion of a hybrid dilator, in accordance with an alternate embodiment of the present invention
• Fig. 5D illustrates a hybrid dilator, in accordance with an alternate embodiment of the present invention
• FIG. 5E illustrates an alternative embodiment of a proximal hub, in accordance with an embodiment of the present invention
• FIG. 6A is an illustration of a method of using a sheath and dilator, in accordance with a standard transseptal procedure;
• Fig. 6B is a flowchart illustrating steps in a standard transseptal procedure;
• FIG. 7A is an illustration of a method for performing a transseptal puncture procedure using a hybrid dilator, in accordance with an embodiment of the present invention
• FIG. 7B is a flowchart illustrating steps of a method for performing a transseptal puncture procedure using a hybrid dilator, in accordance with an embodiment of the present invention
• Fig. 8 is a cross sectional view of the shaft and distal tip of a hybrid dilator of an alternative embodiment of the present invention.
• Fig. 9 is an enlarged view of the distal tip of Fig. 8.
• a physician When performing a transseptal procedure to gain access to the left atrium of a heart, a physician typically uses a sheath and dilator to support a crossing or puncturing device. In some cases, a physician may not be able to cross through to the left atrium sheath as the transition between sheath and dilator may get stuck or snag at the tissue boundary, and as a result the sheath may not be able to cross through the perforation (or it crosses with difficulty). In other words, the tissue may get hung up at the sheath/dilator interface.
• the use of multiple device in a transseptal procedure may make it difficult for the operator to complete the procedure due to the material transitions between various devices which may get caught at the septal tissue interface.
• the problem of a transseptal puncture being performed using a crossing device which is supported by a sheath and dilator set having a transition which may snag on tissue when crossing the septum can be addressed by using a hybrid dilator (described herein) instead of the sheath and dilator set to thereby eliminate the transition, wherein the hybrid dilator has the appropriate functionality (flexibility, pushability, torqueability, distal taper, etc.) to facilitate a smooth crossing.
• embodiments of the present invention include a hybrid dilator for use with a crossing device in tissue puncturing procedures, the hybrid dilator comprising: a dilator shaft defining a lumen for receiving a crossing device therethrough, 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 having an outer diameter which tapers down 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 beyond the distal tip.
• the dilator shaft comprises an inner layer, an outer layer, and a torque layer therebetween.
• kits for puncturing a tissue comprising: a crossing device having a puncturing feature; and a hybrid dilator, wherein the dilator has a dilator shaft defining a lumen for receiving the crossing device therethrough, 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.
• the hybrid dilator also includes a distal tip which has an outer diameter which substantially tapers down to an outer diameter of the crossing device for cooperatively providing a smooth profile when the hybrid dilator is advanced through a tissue over the crossing device.
• the crossing device is a mechanical needle with a sharp tip, while in some other embodiments, the crossing device is configured for delivering energy to a tissue.
• embodiments of the present invention include a system for puncturing a tissue, the system comprising: a crossing device having a puncturing feature which is operable to deliver energy to a tissue; an electrosurgical generator which is operable to provide energy to the puncturing feature; and a hybrid dilator, wherein the hybrid dilator has a dilator shaft defining a lumen for receiving the crossing device therethrough, 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.
• the hybrid dilator also includes a distal tip having an outer diameter which substantially tapers down to an outer diameter of the crossing device for cooperatively providing a smooth profile when the hybrid dilator is advanced through a tissue over the crossing device.
• embodiments of the present invention comprise a method of using a hybrid dilator and a crossing device for puncturing a septum of a heart, the method comprising the steps of: (a) positioning a distal tip of the hybrid dilator at a desired site of the septum; (b) using the hybrid dilator for supporting a crossing device, located within a lumen of the hybrid dilator, as the crossing device is advanced beyond the distal tip of the hybrid dilator to puncture the septum; and (c) advancing the hybrid dilator over the crossing device thereby dilating the desired site.
• a hybrid dilator is provided as a composite device that comprises one or more requisite features of a transseptal dilator or sheath or a combination thereof in a single device, in order to provide the combined functionality of a transseptal sheath and dilator assembly in an optimized manner.
• Some of these features that provide the combined functionality of a sheath and dilator assembly may include shaft rigidity, curvature and internal and exterior tapers that may be incorporated along a distal portion of the hybrid dilator including along a distal tip to facilitate crossing of the hybrid dilator.
• the hybrid dilator may include features that facilitate handling of the hybrid dilator and/or provide directionality information such as tactile cues or indications to convey the direction of the distal tip curvature for facilitating the transseptal procedure. In some instances these features may be incorporated into a proximal portion of the hybrid dilator such as within a combined proximal hub.
• an optimized method is provided to perform a transseptal medical procedure.
• the method provides for streamlining the procedural workflow by providing a hybrid dilator that includes enhanced functionalities of a conventional transseptal sheath and dilator assembly.
• a reduced number of devices may be required in order to complete the transseptal procedure, which enhances procedural efficiency while reducing procedural time and complexity.
• the sheath may not be large enough to support subsequent advancement of a relatively larger outer diameter (OD) catheter for treatment to the left side of the heart.
• OD outer diameter
• the sheath and dilator assembly may have to be removed and the catheter may then be advanced over a guidewire that is in place across the septum to thereby be advanced into the left side of the heart.
• the physician may want to use a large delivery sheath for complex procedures (such as ⁇ left atrial appendage closure/occlusion procedures) and knows that it may not be possible to cross with that product, so they may introduce a standard transseptal kit (that includes a sheath, dilator and guidewire) in order to cross and pre-dilate the septum.
• the three piece kit may then be removed for exchange, and then discarded, which results in the three products (sheath, dilator, guidewire) only being used for a short procedural time period.
• the sheath and dilator assembly may only be useful to perform an initial transseptal puncture, leading to waste due to multiple devices being used.
• an oversized hybrid dilator is provided that reduces the number of physical/geometric transitions as well as the number of material transitions which can both cause difficulties or tactile obstructions for physicians when completing transseptal or other tissue crossings.
• Some examples include smooth lines and tapers to facilitate a seamless transition across tissue.
• the present inventors have discovered a method to perform a transseptal medical procedure that streamlines the procedural workflow by providing a hybrid dilator that replaces a conventional transseptal sheath and dilator assembly.
• a hybrid dilator of the present invention a reduced number of devices may be required in order to complete a transseptal procedure. This reduces the number of parts that a physician is required to prepare and assemble for the transseptal procedure and introduce into the patient.
• the present method provides a dilator that is usable with a guidewire for access that replaces a sheath, dilator, and guidewire assembly.
• a single piece/unitary device in the form of a hybrid dilator that provides smooth tapers functions to facilitate both the crossing and the exchange of devices in a trans-septal procedure while still providing the physician with tactile feedback and distal curve indication that are substantially equivalent to those provided by a sheath/dilator assembly.
• a hybrid dilator 100 is provided, as shown in Fig. 1A.
• the hybrid dilator 100 comprises a combination of features that provide a dual functionality of a sheath and a dilator for facilitating a transseptal puncture procedure while avoiding disadvantages of conventional sheath and dilator assemblies.
• the hybrid dilator 100 provides the smoothness of a standard transseptal dilator with the control of a standard transseptal sheath. More specifically, the hybrid dilator 100 functions as a single device that removes the need for using a conventional sheath/dilator assembly and eliminates the need for assembly, resulting in less waste.
• the hybrid dilator 100 comprises a sheath-like handle with familiar torque and tactile control.
• the hybrid dilator 100 defines a proximal portion 110 comprising a molded combination proximal hub 112, as shown in Figs. IB and ID.
• a distal portion 120 is coupled to the proximal portion 110 comprising a dilator shaft.
• the dilator shaft extends from the proximal end and defines a curved distal end 130 that terminates in a distal tip 140, as additionally shown in Fig. 1C.
• the dilator shaft is formed from a smooth distal tubing 121 that is coupled to the molded proximal hub 112.
• the distal tubing 121 defines a lumen 122 there- through that narrows at the distal tip 140 and which may be used to flush the device prior to use.
• the hybrid dilator 100 is provided a single unitary device, this means that one product is to be flushed unlike the prior art sheath/dilator assembly where each product requires flushing.
• the dilator shaft provides mechanical properties to best facilitate procedural activities. At the distal tip 140, as illustrated further in Fig.
• the distal tubing 121 transitions through a smooth external taper T3 that widens in the proximal direction to a greater outer diameter OD than a conventional transseptal kit dilator so as to dilate the septum to an appropriate size for the subsequent delivery device or equipment that may be used.
• the OD of the distal tubing 121 is substantially constant from the proximal edge of distal tip 140 till the proximal hub 112 where the distal tubing is coupled or attached thereto.
• the OD of the hybrid dilator 100 may vary based on the application and clinical use.
• the size of hybrid dilator 100 is from about 12 French to about 20 French.
• 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)).
• 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 puncturing device such as a needle, forms a trajectory that is substantially equivalent to the trajectory achieved by the combination of a sheath/dilator/needle assembly of a conventional transseptal kit to provide physicians with a predictable and repeatable path for completing a transseptal puncture. The curved distal end 130 facilitates advancement of the hybrid dilator 100 in conjunction with the puncturing device to initiate a transseptal puncture.
• the hybrid dilator 100 comprises a shaft formed from distal tubing 121 that is sufficiently rigid to enable positioning of a crossing device such as a puncturing needle or a guidewire to be advanced through it while maintaining the position of the assembly at a desired site, such as a fossa of a septum.
• the hybrid dilator 100 functions to provide support and columnar strength to facilitate placement of the crossing device at the desired location.
• distal tubing 121 tapers proximally from the distal tip 140 to a greater OD defining a dilating interface to allow dilation of the puncture site 510 (Fig. 6A) to facilitate additional devices to be advanced there-through.
• the distal tip 140 provides a lumen 142 that is appropriate for a crossing device such as a puncturing device to be inserted there-through and defines a relatively thin wall to facilitate controlled puncture.
• the puncturing device is a mechanical needle or an RF puncturing device that is usable with the hybrid dilator 100.
• the hybrid dilator 100 provides a restricted distal internal diameter (as shown by ID2 and ID3) at the distal tip 140 to control the distance by which the puncture device such a transseptal needle (with a narrow distal portion) protrudes from the hybrid dilator 100.
• the narrowest distal portion of a compatible puncturing device has an outer diameter less than ID3 whereby it extends into and through length S2 of lumen 142, and beyond distal edge 148, while, typically, a part of the puncturing device having an outer diameter greater than ID3 and less than ID2 will be seated in internal taper T2. Consequently, the dimension of length S2 is significant in determining the distance the puncturing device protrudes from the hybrid dilator 1. In some such embodiments, this allows the hybrid dilator 100 to meet the same standard as existing transseptal dilators in that it controls the distance by which a transseptal needle can protrude when fully inserted therein.
• the distal tip 140 provides an external taper T3 that allows the dilator OD to transition from a narrow OD2 at a distal most end or distal edge 148 of the distal tip 140, to a wider ODl at its proximal edge 146.
• the hybrid dilator 100 has smooth lines and a smooth external taper T3 to facilitate a seamless transition across tissue.
• the hybrid dilator 100 functions to reduce the number of physical or geometric transitions or material transitions which can cause difficulties and/or create tactile obstructions hindering a physician's ability to complete a transseptal or other tissue crossing.
• the dilator shaft includes a distal tubing 121 which, in some examples, comprises a high density polyethylene (HDPE) Tubing.
• the HDPE has a hardness from about 55 shore D to about 70 shore D, and in a specific example, the HDPE hardness is about 67 shore D.
• the distal tubing 121 comprises material that meets the functional requirements of a transseptal sheath/dilator kit.
• the distal tubing 121 comprises a straight shaft that transitions into curved distal end 130.
• the distal tip 140 comprises a tapered tip with a smooth external taper T3, having a taper angle TA of about 5.5° +/- 1° degrees, and internal geometry which provides a controlled internal diameter (ID) to provide a predicable needle extension length.
• ID controlled internal diameter
• the length of the external taper T3 ranges from about 0.4 inches (1 cm) to about 1 inch (2.5 cm).
• the taper length for external taper T3 is equal to about 0.646" or about 1.6cm.
• the distal tubing 121 has an inner diameter IDl that is equal to about 0.109" (0.277 cm) and an outer diameter OD1 that is equal to about 0.166" (0.422 cm) along its proximal portion (or proximal length 123), which extends from the proximal hub 112 to adjacent the distal tip 140, , as shown in Fig. 1 A.
• IDl inner diameter
• OD1 outer diameter
• proximal portion or proximal length 123
• the taper length for internal taper Tl is equal to about 0.22" (cm 0.56) and ID2 extends for a distance SI for about 0.100" (0.254 cm) and ID2 has a value equal to about 0.056" (0.142 cm).
• the inner diameter then further transitions from ID2 along an internal taper T2 to an even smaller inner diameter ID3.
• the distal portion of the distal tip (length S2) has a length from about 0.71 cm to about 0.74 cm, and in some more specific embodiments, a length from about 0.721 cm to about 0.726 cm.
• taper T2 extends for a distance equal to about 0.044" (0.112 cm), where the ID3 is equal to about 0.034" (0.086 cm) and extends for a length S2 of about 0.285" (0.724 cm).
• S I is equal to zero, whereby internal taper Tl and internal taper T2 are adjacent to each other to thereby provide a smooth transition of internal diameter.
• Some alternative embodiments include the dilator shaft substantially comprising a low density polyethylene or a polyether ether ketone, with some such embodiments of the dilator shaft having a hardness from about 40 shore D to about 85 shore D.
• dilator shaft comprised of a relatively harder material (e.g. HDPE) have an inner diameter IDl of about 0.072 inches (0.18 cm) to about 0.11 inches (0.28 cm).
• a relatively softer material e.g. polyurethanes, polyether block amide
• PEBA polyether block amide
• TPE thermoplastic elastomer
• a hybrid dilator having several internal transitions, such as internal taper Tl and internal taper T2, ensures that the hybrid dilator has an OD along its proximal length (OD1) that enables the hybrid dilator 100 to dilate a tissue puncture site to a desired extent, while at the same time allowing the wall thickness W p of the distal tubing 121 to be maintained to provide shaft rigidity and stiffness that is comparable to a conventional sheath/dilator assembly.
• the internal geometry of distal tip 140 including dual tapers Tl and T2 and the inner diameter along the distal tip 140, provides for insertion of a puncturing device such as needle there-through and for the desired extension of a needle tip.
• the internal geometry also helps ensure that the wall thickness Wxi (Fig. 2B) at the distal edge 148 of the distal tip 140 is sufficiently thin to ensure crossing and trackability through the transseptal puncture site. Still furthermore, the dual tapers Tl and T2 ensure that a smooth transition is provided between the relatively wider inner diameter ID1 along the proximal portion of distal tubing 121, and the relatively narrower inner diameter ID3 at the distal edge 148.
• the inner diameter ID3 at distal edge 148 is about 0.033 inches (0.084 cm) to about 0.037 inches (0.094 cm) and the outer diameter at distal edge 148 is about 0.040 inches (0.10 cm) to about 0.055 inches (0.14 cm). In one specific example, the inner diameter ID3 at the distal edge 148 is equal to about 0.034" (0.086 cm) (Fig. 2B) and the outer diameter OD2 at the distal edge is equal to about 0.042" (0.107 cm).
• the taper angle TA may range from about 5° to about 15°.
• the taper length of external taper T3 may range from about 1.0 cm to about 1.6 cm. In some embodiments, length of the external taper T3 ranges from about 0.4 inches (1 cm) to about 1 inch (2.5 cm). In one example, the taper length of external taper T3 may be about 1.0 cm with a taper angle TA of about 15°.
• the wall thickness WTip at the distal edge 148 of the distal tip 140 is between about 4 thousandths of an inch (0.010 cm) to about 5 thousandths of an inch (0.013 cm). The wall thickness W-ri P is sufficient for maintaining mechanical integrity of the distal tip 140 while ensuring that it is not too thick to make it difficult for the distal tip 140 to cross a puncture site within the tissue.
• a distal tip 140 may be provided with a single internal taper Tl as shown. As shown, the distal tubing 121 is shown with inner lumen visible.
• the hybrid dilator 100 is an HDPE Dilator with a 12.5 French OD with an 8.5 French ID.
• the ID and OD are representative of the dimensions along the proximal length 123 of the distal tubing 121. Additionally, the wall thickness Wp along the proximal length 123 is about 25.5 thousandths of an inch (0.065 cm) to about 27.5 thousandths of an inch (0.070 cm). Bending stiffness for the illustrated example is about 3 N/mm and the torque is about 4.5 N cm.
• the hybrid dilator is a 12.5 French OD dilator 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). Bending stiffness for the particular example is about 4 N/mm and the torque is about 5 N cm.
• the hybrid dilator 100 is a 12.5 French OD dilator with a 4.5 French ID.
• the wall thickness Wp along the proximal length 123 of the distal tubing 121 is about 55 thousandths of an inch (0.140 cm). Bending stiffness for the particular example is about 5.5 N/mm and the torque is about 7 N cm.
• the hybrid dilator is a 15 French dilator where the wall thickness is less than about 26.5 thousandths of an inch (0.067 cm) to provide adequate stiffness.
• a HDPE hybrid dilator 100 has: a 12.5F OD which is about 0.162-0.166" (0.411- 0.422 cm); a 4.5-8.5F ID (about 0.056-0.115 inches or about 0.142-0.292 cm); a wall thickness from about 0.025" to about 0.055" (about 0.064-0.140 cm), a stiffness of about 3.5 to 5.5 N/mm, and a torque transmission from about 4 to about 7 N cm.
• the dilator shaft is comprised substantially of HDPE and includes: a 12.5 French OD (about 0.162"-0.166" or about 0.411 - 0.422 cm); an 8.5 French ID (about 0.108"-0.115" or about 0.274- 0.2921 cm); a wall thickness from about 23.5 thousandths of an inch (0.06 cm) to about 29 thousandths of an inch (0.074 cm).
• Such embodiments may have a bending stiffness from about 2.5 to 3.5 N/mm and a torque transmission from about 4 to 4.5 N cm.
• the dilator shaft is HDPE and has: a 12.5 French OD (about 0.162"- 0.166" or about 0.411-0.422 cm); a 7.5 French ID (about 0.095"-0.102" or about 0.241-0.259 cm); and a wall thickness which is about 0.03-0.036" (about 0.076-0.091 cm). Bending stiffness for such examples is about 3.5 to 4.5 N/mm and the torque transmission is about 4.5 to 5.5 N cm. In some specific embodiments, the wall thickness is about 32 thousandths of an inch (0.081 cm).
• Another alternative embodiment includes the dilator shaft being comprised of HDPE and the shaft having: a 12.5 French OD (about 0.162"-0.166" or about 0.411-0.422 cm); a 4.5 French ID (about 0.056"-0.063" or about 0.142-0.160 cm); and a wall thickness of about 0.05-0.055" (0.127-0.140 cm).
• bending stiffness for such embodiments is from about 5 to 6 N/mm and the torque is about 6 N cm to 7 N cm.
• the wall thickness is about 55 thousandths of an inch (0.140 cm).
• Torque may range from about 1.0 N cm to about 7 N cm 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 span of 50 mm.
• the distal tubing 121 may comprise different surface finishes to provide various amounts of friction along the exterior surface.
• the distal tubing 121 may be formed substantially of HDPE.
• the dilator may be formed from multiple material layers or a composite material.
• the multiple layers may extend concentrically and longitudinally along the length of the distal tubing 121 in the form of multiple tubular layers.
• the inner layer or tubing comprises an HDPE or a low density polyethylene (LDPE) core with an outer layer of PEBAX (polyether block amide) extrusion. This may provide a relatively smoother exterior finish compared to HDPE.
• PEBAX tubing allows for silicone coating to be disposed thereon to additionally provide a smooth coating on the exterior.
• the distal tip 140 comprises a modified taper.
• the tapered distal tip 140 may comprise a secondary feature such as a secondary surface modification 147 that creates a surface variation, such as a secondary bump 147a or a divot 147b to more closely create the tactile queues of a standard sheath/dilator transseptal kit.
• the first tactile cue comes from a first/primary feature such as a first surface modification 145, which may be a first bump 145a that is represented by the transition between the tapered tip 140 and the proximal length 123 of the distal tubing 121.
• a first surface modification 145 which may be a first bump 145a that is represented by the transition between the tapered tip 140 and the proximal length 123 of the distal tubing 121.
• the second tactile cue comes from the secondary surface modification 147, for example the secondary bump 147a or divot 147b.
• the tapered distal tip 140 may comprise a smooth single external taper T3 with a single surface modification such as a first surface modificationl45 in the form of a first bump 145a at the transition, as described previously.
• a single surface modification such as a first surface modificationl45 in the form of a first bump 145a at the transition, as described previously.
• the distal tip 140 may have two external tapers: external taper T4 and external taper T5 as shown in Fig. 3D, where the first surface modification 145 and secondary surface modification 147 are formed by transitions that form first bump 145a and second bump 145b.
• the tactile cues mimic the cues that are generally obtained from transitions in a standard transseptal kit that includes a standard dilator and sheath assembly.
• the internal taper may be as shown in Fig. 2A comprising internal tapers Tl and T2.
• the distal tip 140 may have a modified external taper T3.
• the geometry of the external taper T3 may be varied.
• the distal tip 140 may have surface modifications along the external taper T3.
• the external taper T3 may be provided with a secondary bump 147a, the external taper T3 may be provided with divot 147b.
• the external taper T3 may be provided with a modified roughness.
• the ID of the distal tip 140 is modified in order to accommodate a crossing/puncturing device such as a needle (for example an RF needle).
• a crossing/puncturing device such as a needle (for example an RF needle).
• internal geometry may be modified in order to accommodate a crossing/puncturing device such as a guide wire (for example an RF guidewire).
• the shaft distal tubing 121 comprises a single material.
• the shaft distal tubing 121 may comprise a composite material via co-extrusion or post extrusion processing/layering.
• the shaft distal tubing 121 comprises a lubricious coating material along the exterior.
• the chemistry and/or processing of the lubricious coating material is varied to provide a suitable coating.
• material may be used within the distal tubing 121, and for coating, in accordance with what is known in the art.
• the hybrid dilator 100 may be provided with forward facing ports along, the distal tip 140, to allow for fluid injection when a needle or a guidewire is positioned inside the hybrid dilator 100.
• the hybrid dilator 100 has been created to optimize the tubing stiffness/torque response.
• the handle/hub 112 provides enhanced handing features (discussed further herein below).
• the distal tip 140 is provided with two external distal tapers.
• the internal controlled geometry may be provided in varying configurations.
• Fig. 8 is a cross sectional view of the shaft and distal tip of a hybrid dilator of an alternative embodiment of the present invention
• Fig. 9 is an enlarged view of the distal tip of Fig 8, wherein the dilator shaft has more than one layer and the tip is typically comprised of the same material as one of the shaft layers.
• Hybrid dilator 700 of Fig. 8 has a shaft 702 which includes three layers, inner layer 706, outer layer 708, and a middle layer, torque layer 704, to improve the torqueability of the device.
• shaft 702 which includes three layers, inner layer 706, outer layer 708, and a middle layer, torque layer 704, to improve the torqueability of the device.
• Inner layer 706 is typically comprised of HDPE and outer layer 708 typically of Pebax or LDPE.
• Typical embodiments of shaft 702 provide a mechanical response that is similar to transseptal sheath and dilator sets that physicians commonly currently use.
• the durometer of the Pebax may be selected to adjust the flexibility and pushability of the shaft.
• the torque layer is typically a braided material, while in alternative embodiments the torque layer may be a stiff polymer and/or a metallic hypotube. Some further embodiments of shaft 702 do not include torque layer 704. While outer layer 708 is typically comprised of Pebax or LDPE, in some alternative embodiments it is made of HDPE, all of which are compatible with lubricious coatings. Typical embodiments of shaft 702 have an outer diameter at least the size of current transseptal sheaths (approximately 0.144" (0.366 cm)) to dilate the septum to at least the same size as current sheaths, and have a mechanical response (including flexibility, pushability, and torqueability) comparable to current transseptal sheath and dilator pairings.
• shaft 702 have a 12.5 F outer diameter of about 0.163 inches (0.414 cm) to about 0.166 inches (0.421 cm). Other embodiments of shaft 702 have a 15 F outer diameter of about 0.193 inches (0.490 cm) to about 0.205 inches (0.521 cm). Some embodiments of shaft 702 which have the torque layer 704 have a torque transmission from about 4 N cm to about 8 N cm, with one specific embodiment having a torque transmission of about 8.1 N cm.
• the braid normally functions as an anchor between the inner and outer layers.
• Such embodiments may be manufactured using a reflow process which melts both the inner and outer layers into the braided layer whereby the braided layer mechanically joins the two materials together.
• Some such embodiments have a stainless steel braid and provide 8 N cm of torque transmission.
• Fig. 9 illustrates an embodiment of tip 720 typically comprised of HDPE with from about 20 percent to 50 percent of the distal tip being comprised of BaS04 to facilitate imaging, but alternatively may be comprised of Pebax or any thermoplastic. In some embodiments, tip 720 is comprised of about 40% BaS04. In testing, HDPE has displayed the advantageous characteristic of being stiff enough to be skive resistant.
• Tip 720 of Fig. 9 includes internal lumen 724, distal edge 722, and a single external taper T3 for smooth dilation. Internal taper Tl and internal taper T2 guide devices (e.g. guidewires, needles) from the shaft into the tip area, and limits needle protrusion (of compatible needles) out of the end of the dilator.
• the illustrated example includes two distal side holes 726 for limiting vacuum and pressure formation when withdrawing devices, while alternative examples include different size, location, number of holes, and configuration of holes.
• Other embodiments of tip 720 include radiopaque features such as bands and coils made from radiopaque materials (e.g. platinum, gold, tungsten, and/or barium sulfate-filled polymer).
• the inner diameter of tip 720 varies from the shaft ID to a smaller diameter compatible with commonly used 0.032" (0.081 cm) or 0.035" (0.089 cm) devices (e.g. guidewires and needles).
• the length of the external taper T3 is typically more than 1.0 cm long since a shorter length increases the crossing force or may make crossing tissue more abrupt, with some examples of tip 720 having a taper length T3 up to 3 cm in length.
• the external taper length of the external taper T3 ranges from about 0.4 inches (1 cm) to about 1 inch (2.5 cm).
• the outer diameter of tip 720 is typically no greater than 0.055" (0.140 cm) or else the force in advancing through tissue would be larger than typical transseptal dilators. As an example, if the device is 0.032" (0.081 cm) compatible and has an ID of approximately 0.034" (0.086 cm), restraining the tip OD to a maximum of 0.054" (0.137 cm) facilitates smooth advancement through tissue.
• 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 tip 720 at distal edge 722 is compatible with device having outer diameters of 0.032 inches (0.081 cm) or 0.035 inches (0.089 cm), the maximum tip OD is less than 0.055 inches (0.140 cm), the two side holes 726 have diameters of about 0.012 inches (0.030 cm) to about 0.024 inches (0.061 cm), and external taper T3 has a length of 1.6 cm.
• Typical dilators have a taper length of approximately 1 cm and a smaller diameter than the illustrated embodiment.
• hybrid dilator 700 has an external taper T3 with a length of 1.6 cm which corresponds with its relatively larger outer diameter.
• the inner diameter of tip 720 at distal edge 722 is about 0.033 inches (0.084 cm) to about 0.037 inches (0.094 cm) and the outer diameter of tip 720 at distal edge 722 is about 0.040 inches (0.10 cm) to about 0.055 inches (0.14 cm).
• hybrid dilator 700 include outer layer 708 of shaft 702 being made of thermoplastic to facilitate manufacturing. Some examples have only one internal lumen taper or more than two. Some further embodiments include an electrode configured for puncturing at the tip so that the one device can puncture, cross, and dilate.
• Some embodiments include the shaft having an inner layer 706 made of HDPE and an outer layer 708 made of Pebax, wherein, during manufacture of the device, tip 720 and inner layer 706 are formed in the same extrusion of HDPE whereby tip 720 and inner layer 706 are continuous without any internal joint, which eliminates the risk of a sharp needle being advanced through the dilator catching at a joint between the dilator shaft 702 and tip 720.
• the hybrid dilator 100 comprises a handle defined by a hybrid or combination proximal hub 112 at a proximal end thereof, as additionally shown in Fig. 4 A.
• the proximal hub 112 comprises dilator hub 114 that is formed integrally with a sheath hub or a sheath-like hub 116.
• Fig. 4A also includes a prior art dilator 650 inserted into sheath 660 such as to show a dilator hub 652 and a sheath hub 662 proximally, and dilator 650 extending out of sheath 660 distally.
• the dilator hub 114 comprises a Lure hub or Luer connector 115 and the sheath hub 116 comprises an arm 117 that functions as pseudo side-port that provides the functional feel of a side-port to provide an indication/ direction of the distal end curvature.
• the arm 117 mimics the side-port of a standard sheath without providing the fluid capability of a standard sheath side-port.
• the proximal hub 112 forms a hub/handle that is larger than a standard transseptal dilator hub so as to provide the physician with similar handling and expected tactile feedback, by featuring additional material to hold onto and additionally provides the arm 117 to indicate the direction of the distal end curvature.
• the arm 117 may be replaced by functional side-port if the fluid capability is desired.
• the proximal hub 112 comprises a custom insert molded HDPE Hub at the proximal end with a luer connector 115 and tactile features (defined by a side-port arm 117) to indicate the plane of distal curvature and provide similar handling characteristics.
• the proximal end 110 has a luer taper to allow for connection of medical syringes or fluid drips.
• Fig. 4D illustrates an end view taken from a distal end of the proximal hub 112 showing a coupling 119 of the proximal hub 112 for connecting the proximal hub 112 to the distal tubing 121.
• the coupling 119 may comprise a strain relief.
• Figs. 4E and 4G show cross-sectional views of the proximal hub 112 illustrating the internal configuration of the proximal hub 112, which may include features for facilitating entry of other devices therein during use.
• the proximal hub 112 comprises HDPE.
• Proximal hub 112 as illustrated in Fig. 4E, includes an outer diameter OD3 of 5.25 mm at its distal end, an internal angle IA of 40.0 degrees, and a proximal angle PA of 6.0 degrees.
• the distance Dl between arm endpoint 117a and opposing point 117b is 28.39 mm, and the distance D2 between opposing point 117b and the central longitudinal axis of proximal hub 112 is 6.49 mm.
• 4g has an inner diameter ID5 of 4.25 mm internal to the hub proximal end 113a, an inner diameter ID6 of 3 mm at the innermost portion of the lumen, an inner diameter ID7 at the narrowest portion of the lumen, and an inner diameter ID8 of 4.12 mm at the hub distal end 113b of the hub.
• hub location HI at the distal end of the proximal internal taper
• hub location H2 at the proximal end of the distal internal taper
• hub location H3 at the distal end of the distal internal taper
• hub location H4 at the distal end of narrowest portion of the lumen is 35 mm from hub proximal end 113a.
• an alternate embodiment of a hybrid dilator 200 is provided with a modified proximal portion 210.
• the hybrid dilator 200 comprises a valved proximal hub 212, as shown in Figs. 5A-5B, where the hub comprises a valve 213 at its proximal end with a cap 220 for retaining the valve in position.
• the valve 213 is provided as a hemostasis valve.
• the valved proximal hub 212 may additionally comprise an extra feature to direct devices into the valve 213.
• the proximal hub 212 has an insertion guide 218 as a molded or an external feature that function cooperatively with the valve to direct and align product being inserted into the valve 213.
• the insertion guide 218 is provided proximal of the valve 213.
• a feature is provided within the valved proximal hub 212 to funnel device into the shaft tubing.
• a funnel guide 222 is provided to direct and align product inserted into valve 213 into the shaft tubing.
• the funnel guide is positioned distal of the valve 213.
• the funnel guide 222 is provided as a molded feature.
• funnel guide 222 is configured such that it also centers the proximal end of the guidewire with respect to the valve. This centering directs the proximal end of the guidewire when it is inserted through the device's distal tip for the purpose of device exchange.
• a hybrid dilator 200 is provided with a proximal hub 212 that houses a valve 213, for example a hemostasis valve, and additionally comprises a side-port port 217 that has a side- port tubing 219 attached thereto, with a stopcock 228 to provide for flushing and aspiration.
• a valve 213 for example a hemostasis valve
• a side-port port 217 that has a side- port tubing 219 attached thereto, with a stopcock 228 to provide for flushing and aspiration.
• the proximal hub 212 may comprise material that is taken from the group consisting of pebax, HDPE, LDPE, and Nylon or a combination thereof to achieve desired lubricity and handling characteristics.
• a proximal hub 112 is shown in Fig. 5E, that comprises a Luer connector 115 according to ISO 594-1,-2. Additionally, an arm 117 is provided in the form of a mock side-port to provide expected handling and align with the distal curve. Additionally, the proximal hub 112 is provided with a strain relief 119b at its distal end and the distal tubing 121 extends in a distal direction out of strain relief 119b.
• the proximal hub 112 or valved proximal hub 212 may comprise a molded hub.
• the proximal hub 112 or valved proximal hub 212 may comprise HDPE. Alternatively, other materials may be used.
• the geometry of the hub may be varied as may be suitable.
• the valved proximal hub 212 the valve material and/or geometry may be varied as may be 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 the procedure, such as a transseptal procedure.
• the material of the side-port tubing, and the ID and OD of side-port tubing may be selected and/or varied as may be known to a person skilled in the art.
• the stopcock material may be varied as may be known in the art.
• some embodiments of a hybrid dilator of the present invention may provide the simplicity of transseptal crossing, and yet may still allow an ablation catheter to be used with it in case the need arises.
• kits for puncturing a tissue comprising: a crossing device having a puncturing feature; and a hybrid dilator 100, wherein the dilator has a dilator shaft defining a lumen 122 for receiving the crossing device therethrough, 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.
• the hybrid dilator also includes a distal tip 140 having an outer diameter which substantially tapers down to an outer diameter of the crossing device for cooperatively providing a smooth profile when the hybrid dilator 100 is advanced through a tissue over the crossing device.
• the crossing device is a mechanical needle with a sharp tip, while in some other embodiments, the crossing device is configured for delivering energy to a tissue.
• Another aspect of the invention is a system for puncturing a tissue comprising: a crossing device having a puncturing feature which is operable to deliver energy to a tissue; an electrosurgical generator which is operable to provide energy to the puncturing feature; and a hybrid dilator 100, wherein the hybrid dilator has a dilator shaft defining a lumen 122 for receiving the crossing device therethrough, 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.
• the hybrid dilator also includes a distal tip 140 having an outer diameter which substantially tapers down to an outer diameter of the crossing device for cooperatively providing a smooth profile when the hybrid dilator is advanced through a tissue over the crossing device.
• a method of the present invention provides for streamlining the procedural workflow by providing a hybrid dilator that combines the functionalities of a conventional transseptal sheath and dilator assembly.
• a hybrid dilator of the present invention a reduced number of devices may be required in order to complete the transseptal procedure, which enhances procedural efficiency while reducing procedural time and complexity.
• a method of the present invention avoids the disadvantages associated with a conventional transseptal procedure.
• Figs. 6A and 6B illustrate an example of method of performing such a conventional transseptal medical procedure 300.
• the method comprises the steps of: at step 310, gaining access into the right atrium 501 via vasculature using a guidewire; at step 320, advancing a sheath 20 and dilator 40 over the guidewire into the right atrium 501, the sheath 20 and dilator 40 forming a sheath and dilator assembly 50; at step 330, exchanging the guidewire for a crossing device 60 which comprises a puncturing device 62; at step 340, advancing the crossing device 60 along with the dilator across a septum 505 to create a transseptal puncture site 510 and dilate the transseptal puncture site.
• the sheath 20 may get hung up at the sheath/dilator interface and the transition between the sheath/dilator can affect a physician' s ability to cross tissue in a predictable, repeatable fashion. Sometimes the physician may not able to cross through to the sheath (get the sheath across the septal puncture site because the tissue will get hung up at the sheath/dilator interface). If at step 350, the physician is successful, the physician may be able to advance the sheath and dilator assembly 50 and the crossing device 60 through the transseptal puncture site 510 to enable the sheath and dilator transition to cross the puncture site 510.
• the physician may wish to use a relatively large delivery sheath (for example which is larger than the transseptal sheath 20) for complex procedures for example for cryoablation procedures or a left atrial appendage closure/occlusion procedure and knows they cannot cross with the large delivery sheath, so the physician will introduce a standard transseptal kit with the sheath and dilator as discussed at step 350 above to purely to cross and pre-dilate the septum. Once this three piece kit is removed for exchange, it must be disposed, thereby underutilizing the three items (sheath, dilator, guidewire) for only a short procedural presence. The removal of the sheath/dilator assembly and exchange with the larger delivery sheath is described further below.
• the crossing device 60 is exchanged with a guidewire 80, which comprises the steps of removing the crossing device 60 and advancing the guidewire 80 into the left atrium 502; at step 370, removing the sheath and dilator assembly 50; and at step 380, advancing one or more secondary devices 70 such as a relatively large delivery sheath over the guidewire 80 into the left atrium 502 to complete the desired procedure.
• an optimized method 400 is provided for carrying out a transseptal procedure.
• the method comprises the steps of: at step 410, gaining access into the right atrium via vasculature using a guidewire; and at step 420, advancing a hybrid dilator 100 having a supporting shaft/column over the guidewire into the right atrium 501; By using the hybrid dilator 100 it reduces number of parts that the physician is required to prep/assemble and introduce into the patient from three to two.
• a hybrid dilator 100 and guidewire may be used.
• the method additionally provides: at step 430, exchanging the guidewire for a crossing device 60 which comprises a puncturing device 62
• the puncturing device 62 may comprise a needle.
• the needle is a radiofrequency (RF) needle.
• the needle may comprise a mechanical needle.
• the puncturing device 62 may comprise a radiofrequency (RF) guidewire]; and at step 440 advancing the crossing device and the hybrid dilator across the septum 505 to create a transseptal puncture site 510 and dilate the puncture site 510 to facilitate advancement of one or more secondary devices 70 through the transseptal puncture site.
• the hybrid dilator 100 which may also be referred to as the step-up dilator, is provided as a simplified tool. It simplifies the procedural workflow by providing a one piece transseptal tool compared to a sheath and dilator (it is additionally usable with a guidewire and needle as shown).
• the hybrid dilator 100 is provided as a one/single oversized dilator and in use it reduces the number of physical geometric transitions as well as the number of material transitions or tactile obstructions which may allow the physicians to complete a transseptal or other tissue crossings with greater ease.
• the hybrid dilator 100 reduces the changes of the hybrid dilator 100 from getting caught at the transseptal puncture site, by provided smooth lines and tapers to facilitate a seamless transition across tissue. This allows the hybrid dilator 100 to be advanced across the septum with greater ease.
• the method additionally provides for; at step 450, exchanging the crossing device 60 with a guidewire 80 and advancing the guidewire 80 into the left atrium; at step 360, removing the hybrid dilator 100; and at step 470, advancing the one or more secondary devices over the guidewire 80 into the left atrium 502 to complete the desired procedure.
• the physician can now introduce just the hybrid dilator 100 over a guidewire as discussed in step 420 using a single device to cross and pre-dilate the septum.
• hybrid dilator 100 and the initial guidewire may then be removed for exchange, thus using only two products (hybrid dilator 100 and guidewire, instead of a standard sheath, dilator and guidewire kit).
• the improved method additionally provides at steps 460 and 470 removing just the hybrid dilator 100 to allow exchange with the secondary device such as a relatively large delivery sheath for complex procedures, wasting fewer products in the process.
• Another embodiment of the method of uses a hybrid dilator 100 and a crossing device for puncturing a septum 505 of a heart.
• This embodiment of the method comprises the steps of: a) positioning a distal tip 140 of the hybrid dilator at a desired site of the septum; b) using the hybrid dilator 100 for supporting a crossing device, located within a lumen of the hybrid dilator, as the crossing device is advanced beyond the distal tip of the hybrid dilator to puncture the septum; and c) advancing the hybrid dilator over the crossing device thereby dilating the desired site.
• the crossing device is a mechanical needle and step (b) further includes applying force with the mechanical needle to the septum to thereby puncture the septum.
• the crossing device is configured for delivering energy, and step (b) further includes supplying electrical energy to the crossing device to thereby puncture the septum.
• Some embodiments further comprise a step (d) of exchanging the crossing device with a guidewire and advancing the guidewire into a left atrium, a step (e) of removing the hybrid dilator, and a step (f) of advancing one or more secondary devices over the guidewire into the left atrium.
• the crossing device is further configured for use as a guide-wire, and the method further comprises a step (d) of removing the hybrid dilator, and typically, a step (e) of advancing one or more secondary devices over the crossing device into a left atrium.
• a step (d) of removing the hybrid dilator and typically, a step (e) of advancing one or more secondary devices over the crossing device into a left atrium.
• a method for streamlining the procedural workflow by providing a hybrid dilator that combines the functionalities of a conventional transseptal sheath and dilator assembly.
• a hybrid dilator of the present invention a reduced number of devices may be required in order to complete the transseptal procedure, which enhances procedural efficiency while reducing procedural time and complexity.

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