Electrosurgical device with automatic shut-off

Abstract

To provide a method and apparatus for creating a puncture in a tissue.SOLUTION: An assembly includes a puncturing device 110 having a distal tip 114 configured to deliver energy to the tissue, creating a puncture. The puncturing device 110 further includes a marker 115 positioned along the puncturing device 110. The assembly further includes a dilator 120 which has a lumen extending from a proximal portion to a distal portion and configured to receive the puncturing device 110. The dilator 120 further comprises a sensor positioned along a length of the dilator 120. When the marker 115 and the sensor 121 are aligned, energy is delivered to the distal tip 114 of the puncturing device 110.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present disclosure relates to surgical perforation devices configured to deliver energy to tissue. More particularly, the present invention relates to devices and methods for forming perforations in the interatrial septum while using markers and sensors to control the delivery of energy. [Background technology]

[0002] Certain medical procedures require the use of medical devices capable of creating punctures or channels through cardiac tissue. Specifically, puncturing the cardiac septum creates a direct pathway to the left atrium, where many cardiology procedures are performed. One such device for accessing the left atrium is a transseptal puncture device, which, in some devices, delivers radiofrequency energy from a generator to tissue to create a puncture. The user positions the puncture device at a target location on the fossa ovalis, located in the cardiac septum, and turns on the generator to begin delivering energy to the target location. The delivery of radiofrequency energy to the tissue results in vaporization of intracellular fluid in cells in contact with the energy delivery device. Ultimately, this results in a void, hole, or channel at the target tissue site.

[0003] Currently, parameters for energy delivery include duration and pulsed or constant delivery of energy. Typically, a user selects parameters, such as constant energy delivery for a 2-second duration, before making a puncture. The user activates the delivery by pressing a button on the generator or via a foot pedal. Once the energy delivery duration is complete, the user checks to determine whether the puncture was successful using various means (i.e., fluoroscopy, pressure readings, ultrasound, or contrast injection, etc.). If the puncture is unsuccessful, the user activates the energy delivery again. Once the duration is complete, the user checks again to verify whether the puncture was successful. While users have the ability to turn off the energy delivery before the duration is complete using a button or foot pedal on the generator, there is still no way to verify whether the puncture was successful during energy delivery. This lack of knowledge regarding the success of the puncture during energy delivery can lead to inadvertent damage to surrounding tissue that was intended to remain undamaged during the procedure. For example, if the duration is set to 2 seconds but the puncture is completed in 1 second, the puncture device will still be delivering energy for an additional time after entering the left atrium.

[0004] Inadvertent perforation of other cardiac tissues can result in general tissue damage within the left atrium, assist device damage (i.e., damage to pacemaker leads located in the atrium), or potentially serious complications such as cardiac tamponade or inadvertent aortic perforation. Cardiac tamponade is a life-threatening complication of transseptal puncture that occurs when a perforation forms in the left atrial wall, left atrial roof, or left atrial appendage. This perforation of the atrial wall leads to the accumulation of fluid in the pericardial space surrounding the heart. This fluid accumulation compresses the heart and reduces the amount of blood that can enter the heart. Inadvertent aortic perforation is a rare life-threatening complication that may require surgical repair when the puncture device enters and perforates the aorta.

[0005] Various minimally invasive procedures involve creating a puncture in biological tissue. One such procedure is performing a transseptal puncture, which allows a surgeon to access the left side of the heart by creating a puncture through the septum from the right side of the heart. Recently, medical devices have been configured to create the puncture by delivering energy, specifically radiofrequency energy, to tissue. The delivery of radiofrequency energy to tissue results in vaporization of intracellular fluid in cells in contact with the energy delivery device, resulting in perforation at the target tissue site. One complication that can occur during a transseptal puncture is inadvertent puncture of the left atrial wall or aorta. These potentially life-threatening complications can result in damage to surrounding tissue or ancillary devices, or perforation of the left atrial wall or aorta.

[0006] In light of these complications associated with inadvertent damage to surrounding tissue, a need exists to provide a novel radiofrequency puncture device in which the delivery of radiofrequency energy is automatically stopped after the puncture device completes the puncture and enters the left atrium. [Brief explanation of the drawings]

[0007] In order that the invention may be more readily understood, embodiments thereof are illustrated by way of example in the accompanying drawings, in which:

[0008] [Figure 1] FIG. 1 is a diagram of an exemplary system that may be used to puncture tissue. [Figure 2A] 10A-10C are diagrams of various marker bands that may be placed on the lancing device. [Figure 2B] 10A-10C are diagrams of various marker bands that may be placed on the lancing device. [Figure 2C] 10A-10C are diagrams of various marker bands that may be placed on the lancing device. [Figure 2D] 10A-10C are diagrams of various marker bands that may be placed on the lancing device. [Figure 2E] 10A-10C are diagrams of various marker bands that may be placed on the lancing device. [Figure 3A]10A-10C are diagrams of various detector placements on a dilator. [Figure 3B] 10A-10C are diagrams of various detector placements on a dilator. [Figure 3C] FIG. 10 shows a detector placed on a puncture device with a marker placed on a dilator. [Figure 4A] FIG. 10 is a diagram of a puncture device moving through a dilator showing alignment of the marker and detector. [Figure 4B] FIG. 10 is a diagram of a puncture device moving through a dilator showing alignment of the marker and detector. [Figure 4C] FIG. 10 is a diagram of a puncture device moving through a dilator showing alignment of the marker and detector. [Figure 5A] 10A and 10B are diagrams of another embodiment in which the dilator delivers energy to the puncture device via a conductive plate. [Figure 5B] 10A and 10B are diagrams of another embodiment in which the dilator delivers energy to the puncture device via a conductive plate. [Figure 5C] 10A and 10B are diagrams of another embodiment in which the dilator delivers energy to the puncture device via a conductive plate. DETAILED DESCRIPTION OF THE INVENTION

[0009] The problem of inadvertent puncture of the left atrium is solved by providing an electrosurgical puncture device with a mechanism that shuts off energy delivery after puncture of the septum is complete.

[0010] In one broad aspect, an embodiment of the invention comprises an assembly for creating a puncture in tissue, the assembly comprising a puncture device comprising an elongate member having a distal tip configured to deliver energy to the tissue to create the puncture. The puncture device further comprises a marker positioned along the elongate member. The puncture device further comprises a dilator having a lumen extending from a proximal end to a distal end configured to receive the puncture device, and further comprises a sensor positioned along the length of the dilator. When the marker and sensor are aligned, energy is delivered to the distal tip of the puncture device.

[0011] With particular reference now to the drawings in detail, it is emphasized that the particulars shown are by way of example and are for purposes of illustrative discussion of particular embodiments of the device only. Before describing at least one embodiment of the device in detail, it should be understood that the device is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The device is capable of other embodiments or of being practiced or carried out in various ways. Also, it should be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting.

[0012] FIG. 1 illustrates an embodiment of a system 100 that can be used to gain access to the left atrium through a transseptal puncture. The system 100 includes a puncture device 110, a dilator 120, a sheath 130, and a generator 140. The puncture device 110 includes an elongate member 111 having a distal region 112 terminating in a distal tip 114. The distal tip 114 includes an energy delivery device 116, such as an electrode, configured to deliver energy to tissue. The puncture device 110 further includes a proximal portion 118 that terminates in a hub 113 that is connected to the generator 140 via a connector cable 150. The generator 140 can deliver energy to the puncture device 110, which travels along the elongate member 111 from the hub 113 to the energy delivery device 116 at the distal tip 114. The puncture device 110 is preferably constructed from an electrically conductive material, such as stainless steel or nitinol. The puncture device 110 may be constructed from a solid, cored wire, or hollow tube and may terminate in an atraumatic distal tip 114. To allow energy to be delivered to tissue by the energy delivery device 116, the puncture device 110 may be coated with any type of insulating material, such as PTFE (polytetrafluoroethylene), while the energy delivery device 116 remains exposed at the distal tip 114. Markers 115 may be located anywhere along the length of the elongate member 111, either at the proximal portion 118 or the distal portion 112. The markers 115 may be color bands, barcode bands, bands with distinct surface roughness, or bands composed of or doped with magnetic or conductive material.

[0013] The dilator 120 comprises an elongate member 123 with a proximal portion 122 and a distal portion 124. The proximal portion 122 of the dilator terminates in a hub 126, while the distal portion 124 tapers to an open distal tip 128. A lumen (not shown) extends within the elongate member 123 between the hub 126 and the distal tip 128. The lumen is large enough to allow the puncture device 110 to be inserted into the hub 126 and move through the lumen. In use, the distal tip 114 of the puncture device 110 extends beyond the distal tip 128 of the dilator 120. The dilator 120 can be constructed of a harder material, such as high-density polyethylene (HDPE), or a softer material, such as polyurethane or polyether block amide. Embedded within the body of the elongate member 123 in the proximal region 122 or the distal region 124 is a detector 121 capable of detecting markers 115 positioned along the length of the elongate member 111 of the puncture device 110. The detector 121 may be a color sensor, a barcode reader, a light intensity sensor, a magnetic sensor, or a capacitive proximity sensor. The detector 121 may be connected to the generator 140 via a connector cable 152 that extends from the detector 121 and exits the hub 126 of the dilator 120.

[0014] In use, when the lancing device 110 is inserted into the dilator 120, alignment of the marker 115 and the detector 121 sends a signal to the generator 140 via the connector cable 152 of the dilator 120, thereby enabling delivery of energy from the generator 140 to the lancing device 110 via the connector cable 150. If the marker 115 and the detector 121 are not aligned, energy delivery will not be possible.

[0015] An exemplary method, including an embodiment of the system 100 described above, involves delivering energy to the atrial septum of a patient's heart via an energy delivery device 116, advancing the energy delivery device 116 through the puncture, and automatically disabling the delivery of energy upon completion of the puncture. This may include the steps of (i) accessing the vasculature through the groin to the femoral vein and advancing the assembly (i.e., puncture device 110, dilator 120, and sheath 130) through the inferior vena cava into the right atrium of the heart. At this stage, the distal tip 114 of the puncture device 110 protrudes slightly from the distal tip 128 of the dilator 120 and the sheath 130. The marker 115 of the puncture device 110 is aligned with the detector 121 of the dilator 120, which enables delivery of energy. (ii) The distal tip 114 of the puncture device 110 is manipulated to the target location, for example, the fossa ovalis of the atrial septum. Once in place, the user activates energy delivery with the generator 140, which sends energy to the energy delivery device 116. This energy may be in the radio frequency range, such as radio frequency energy. (iii) Once the puncture is complete, the puncture device 110 is pushed through the puncture into the left atrium. At this point, the marker 115 on the puncture device 110 and the detector 121 on the dilator 120 are no longer aligned and energy delivery is prevented and automatically shuts off. (iv) The dilator 120 and sheath 130 are then pushed through the puncture to achieve access to the left atrium.

[0016] As previously mentioned, the marker 115 located on the lancing device 110 may be any type of detectable band. FIG. 2a shows one embodiment of the lancing device 110 having a marker 115 with a unique color band. In this embodiment, the color band may be applied as a spray coating directly to the elongate member 111 or as a heat-shrink sleeve over the elongate member 111. To allow the marker 115 to be optically detected by a color sensor detector 121 located on the dilator, a coating of a transparent, electrically insulating material 210 (i.e., polytetrafluoroethylene (PTFE) clear coat, etc.) may be applied to the top of the elongate member 111, either over the color band only or along the entire length of the elongate member 111.

[0017] In other embodiments, the marker 115 comprises a unique barcode or radio frequency identification (RFID) code, as shown in FIG. 2b. This may be applied as a heat-shrink sleeve with a unique barcode, or a colorless heat-shrink sleeve may be applied and a laser may be used to ablate distinct lines into the sleeve. For example, if a blue sleeve is applied to the elongate member 111, laser ablation will result in a white line on the sleeve. A clear coat of electrically insulating material 210 may be applied over or along the entire length of the elongate member 111 where the marker 115 will be located. This allows the barcode to be optically detected by a barcode reader on the expander.

[0018] In some embodiments, the marker 115 comprises a band with a different surface roughness than the elongate member 111. During manufacturing, the change in surface roughness can be applied directly to the elongate member 111 during the manufacturing process, as seen in FIG. 2c. Alternatively, the marker 115 can be a band with a different surface roughness and placed on the elongate member 111. The band can be swaged over the elongate member 111 or fitted on top with either a tight or loose fit. As with the previous embodiment, a transparent layer of electrically insulating material 210 can be applied over the elongate member 111, over the marker 115, or along the entire length of the member 111 to allow for detection of light intensity by a sensor within the dilator.

[0019] In other embodiments, the marker 115 on the lancing device 110 is constructed from a magnetic material. The band may be constructed from a magnetic material, such as a band of any magnetic metal, or may be constructed from a non-metallic band doped with a magnetic material, such as metal-doped plastic. For both magnetic metal bands or doped plastic, the marker 115 may be a mechanical fit swaged over the elongate member 111, as shown in FIG. 2d(i), or the band may be fitted over the elongate member 111 with a tight or loose fit around the shaft, as shown in FIG. 2d(ii). The elongate member 111 may have an electrically insulating layer 210 over its entire length that may act to lock the band in place. Alternatively, in embodiments using a doped plastic band as the marker 115, this may be applied as a heat-shrinkable plastic tube doped with a magnetic material that can be applied over the elongate member 111.

[0020] In other embodiments, the marker 115 on the puncture device 110 is constructed from a conductive material. The marker 115 may also be a band constructed entirely from a conductive material or a non-metallic material doped with a conductive material (i.e., a doped plastic band). In these embodiments, the band must be placed over the insulating layer 210 to communicate with the detector in the dilator and not interfere with the delivery of energy along the elongate member 111. For both conductive metallic bands or doped plastic bands, the marker 115 may be a mechanical fit that is swaged onto the insulating layer 210, as shown in FIG. 2e(i), or the band may be fitted over the insulating layer 210 with a tight fit to prevent the band from shifting, as shown in FIG. 2e(ii). In another embodiment, the marker 115 may be constructed from heat-shrinkable plastic tubing doped with a conductive material that can be applied over the insulating material 210.

[0021] In any of the above-described embodiments, the marker 115 can be positioned anywhere along the proximal or distal portion of the puncture device 110, as long as the positioning of the marker 115 aligns with the detector 121 in the dilator in a position that allows for the delivery of energy when the puncture device 110 is in the correct position within the dilator.

[0022] Referring to FIG. 3a, the dilator 120 includes a detector 121 that can detect a marker 115 located on the puncture device 110. This detection can be used to enable and disable the delivery of energy from the generator to the distal tip of the puncture device 110. For example, when the marker 115 and the detector 121 are aligned, energy delivery is enabled. When the marker 115 and the detector 121 are not aligned, energy delivery is disabled. The detector 121 can be located anywhere along the dilator 120. In one embodiment, the detector 121 is located on the elongate member 123 of the dilator 120 at the proximal portion, as seen in FIG. 3a, or at the distal portion (not shown). This embodiment may be ideal because it allows for a tight fit between the detector 121 and the marker 115 without potential blood or fluid interference. Alternatively, the detector 121 is located on the hub 126 of the dilator 120, as shown in FIG. 3b. The detector 121 is embedded in the wall of the dilator 120 and can comprise, for example, a color sensor, a bar code reader, a light intensity sensor, a magnetic sensor, or a spring contact that closes a connection in the presence of a conductive ring.

[0023] In some embodiments, the detector 121 may be a color sensor capable of detecting the unique color bands of the markers 115. For example, the sensor may shine white light onto the elongate member 111 and then record the reflected light. The sensor may include red, green, and blue color filters that can convert the amount of light into an electrical current. Additionally, the sensor may include a converter to convert the electrical current into a voltage that can be sent to a generator. From there, the generator may have a switch implemented as either hardware (e.g., a voltage-based switch) or software (e.g., a computer algorithm), which can then be used to enable or disable the delivery of energy to the lancing device 110.

[0024] In another embodiment, detector 121 may be a barcode reader or scanner that can read barcode information on marker 115 of lancing device 110 and transmit that information to the generator. The scanner can shine a laser onto the barcode on marker 115, which is reflected from the barcode to a photocell. Light areas reflect more light than dark areas. The photocell can then generate a pattern of "on" or "off" pulses (i.e., "on" is light and "off" is dark). The barcode reader or scanner then converts this information into a binary code that can be transmitted back to the generator. This can be used to enable or disable the delivery of energy to lancing device 110.

[0025] In some embodiments, the detector 121 may be a light intensity sensor that detects the amount of light reflected from a surface. In this embodiment, the detector 121 determines the amount of light reflected from the elongate member 111 as well as the amount of light reflected from the marker 115 with a rough surface. For example, the detector 121 may be a photoelectric sensor comprising a light source and a receiving element. The light source may direct a light beam onto the elongate member 111, which is reflected back to the receiving element, which converts it into either an analog (i.e., voltage) or digital (i.e., "on" or "off") output based on the amount of reflected light. This output can then be communicated to a generator to enable or disable energy delivery to the lancing device 110. This may be implemented as a hardware switch or a software algorithm.

[0026] In other embodiments, the marker 115 on the lancing device 110 can comprise a magnetic band, while the detector 121 is disposed within the dilator 120 to detect the magnetic field. This type of sensor detects the magnetic field present in the magnetic band of the device 110. Generally, when a magnetic field is present, the sensor can output a binary signal that can be used to control the delivery of energy to the lancing device 110. For example, when a magnetic field is present (i.e., the marker 115 is aligned with the detector 121), the sensor can output an "on" signal. Conversely, when a magnetic field is not present, the sensor can output an "off" signal. These signals can be communicated back to the generator to control the delivery of energy.

[0027] In some embodiments, the marker 115 may comprise a metal band. The detector 121 in the dilator 120 may be in the form of a capacitive proximity sensor. This type of sensor functions similarly to a magnetic sensor, detecting a metal (magnetic or non-magnetic) band along the lancing device 110. When the marker 121 is not aligned with the detector 121, the detector 121 does not sense the band. This sends a signal to the generator to prevent delivery of energy to the lancing device 110. However, when the marker 115 is positioned so that it can be detected by the capacitive proximity sensor, it triggers a response from the generator, allowing delivery of energy to the lancing device 110. This may be implemented, for example, as a software algorithm that allows energy delivery if the marker 115 is detected; otherwise, it prevents energy delivery.

[0028] For the detector 121 to communicate with the generator, an insulated connector cable 152 must run from the detector 121 to the generator. This signals the generator to enable energy delivery when the marker 115 and detector 121 are aligned, or to disable energy delivery when they are not aligned.

[0029] In other embodiments, the lancing device 110 includes the detector 121, while the dilator 120 includes the marker 115. An example of this embodiment is shown in FIG. 3c. Similar to the previous embodiment, the marker 115 can include, for example, a color band, a barcode band, a band with distinct surface roughness, or a band composed of or doped with a magnetic or conductive material. These bands may be embedded in the dilator 121. The detector 121 may be any sensor capable of detecting the marker 115, such as a color sensor, a barcode reader, a light intensity sensor, a magnetic sensor, or a capacitive proximity sensor. For some markers 115, the dilator material may need to be composed of a transparent material so that the light detector 121 can detect when the marker 115 is aligned. For example, color bands and color sensors, barcode markers and barcode readers, and markers with surface roughness and light intensity sensors detect transparent materials using light transmission and reception and therefore require transparent materials. The marker 115 and detector 121 may be located anywhere along the length of the dilator 120 or the puncture device 110 (i.e., proximal or distal) if they are indicators of the proper location for the automatic shutoff to function. In these embodiments, the connector cable 152 is insulated and runs along the length of the elongate member 111 and exits the hub 113 of the puncture device 110. The connector cable 152 may be included with the cable used to deliver energy to the puncture device 110, so that the user only needs to plug one cable into the generator rather than two cables (i.e., one from the puncture device 110 and the other from the dilator 120) of the previous embodiments.

[0030] 4a-4c show the puncture device 110 with the marker 115 and the dilator 120 with the detector 121 as the puncture device 110 moves along the length of the dilator 120. FIG. 4a shows the puncture device 116 in a position where the energy delivery device 110 is still housed within the dilator 120 prior to puncture. At this stage, the marker 115 and the detector 121 are not aligned, and therefore energy cannot be delivered to the energy delivery device 116. Once the marker 115 and the detector 121 are aligned, energy delivery is enabled, which occurs when the energy delivery device 116 slightly protrudes from the distal tip 128 of the dilator 121 (FIG. 4b). When energy delivery is enabled, this may be signaled to the user via a sound or prompt on the generator. The user then activates energy delivery to create a puncture in the tissue. Once the puncture is complete, the puncture device 110 moves through the puncture such that the energy delivery device 116 passes the distal tip 128 of the dilator 121, causing the marker 115 and detector 121 to no longer be aligned (FIG. 4c). As a result, energy delivery to the puncture device 110 cannot occur and is automatically shut off.

[0031] Referring now to FIG. 5a, in another embodiment, the dilator 120 is a device that delivers energy from the generator to the energy delivery device 116 at the distal tip 114 of the puncture device 110. The dilator 120 may be constructed of an electrically insulating material with conductive plates 510 embedded in the sidewall of the dilator along members 123 so that the plates 510 can contact the puncture device 110. The dilator 120 can be constructed of a harder material, such as high-density polyethylene (HDPE), or a softer material, such as polyurethane or polyether block amide. The conductive plates 510 can deliver energy from the generator via an insulated connecting cable 154 that exits the hub 126 of the dilator and connects to the generator. The puncture device 110 includes a conductive band 520, which can be constructed of a non-conductive material doped with a conductive material, or a band constructed entirely of a conductive material. The band 520 may be fitted by a mechanical fit, swaged over the elongate member 111, or the band 520 may be fitted over the elongate member 111. The elongate member 111 of the puncture device 110 may be constructed from a conductive material, such as a conductive hypotube or shaft, as shown in FIG. 5b, in which case the insulating coating 210 covers the entire elongate member 111 while leaving the conductive band 520 exposed so that the conductive band 520 can contact the conductive plate 510 of the dilator 120. The insulator layer 210 may be one of many biocompatible dielectric materials, including, but not limited to, polytetrafluoroethylene (PTFE, Teflon®), parylene, polyimide, polyethylene terephthalate (PET), polyether block amide (PEBAX®), and polyether ether ketone (PEEK™), or any combination thereof. Alternatively, the elongate member may be manufactured with a larger outer diameter in one cross-section. This portion is exposed (ie, not covered with insulating material) so that it can be contacted by the conductive plate 510 .In some embodiments, the elongate member 111 may be comprised of a non-conductive material portion 530 proximal to the conductive band 520 and a conductive material portion 540 distal to the conductive band 520 with an insulating coating 210 thereon (FIG. 5c). In other embodiments, the conductive band 520 may be part of the distal portion 540 of the elongate member 111. For example, the outer diameter of the elongate member 111 may be large enough so that it contacts the conductive plate 510. The conductive band 520 is in electrical communication with the energy delivery device 116 of the lancing device 110. Energy delivery is possible only when the conductive plate 510 of the dilator 120 is in contact with the conductive band 520 of the lancing device. When the energy delivery device 116 slightly protrudes from the distal tip 128 of the dilator 120, the conductive band 520 and the plate 510 contact each other. This allows energy to flow from the generator to the conductive plates 510 of the dilator 120, and upon contact with the conductive bands 520, to the energy delivery device 116 of the puncture device 110. Once the tissue puncture is complete, the puncture device 110 is advanced through the puncture and there is no longer contact between the conductive plates 510 and the conductive bands 520, preventing energy delivery.

[0032] Further Examples 1) an assembly for providing a puncture in tissue, comprising: a puncture device comprising an elongate member having a distal tip configured to deliver energy to tissue to effect puncture; the lancing device further comprising a marker positioned along the elongate member; a dilator comprising a lumen extending from a proximal portion to a distal portion and configured to receive a puncture device; the dilator further comprises a detector positioned along the length of the dilator; Once the marker and detector are aligned, energy is delivered to the distal tip of the lancing device. assembly. 2) The assembly of Example 1, wherein the marker is a color band and the detector is a color sensor. 3) The assembly of Example 2, wherein the color band comprises a spray coating. 4) The assembly of Example 2, wherein the color band comprises a different colored sleeve positioned over the elongate member. 5) The assembly of any one of Examples 3 or 4, wherein the elongate member comprises a coating of insulating material. 6) The assembly of Example 5, wherein the coating of insulating material comprises a portion of a transparent coating positioned over the color band. 7) The assembly of Example 5, wherein the coating of insulating material comprises a transparent coating extending over the entire length of the elongated member. 8) The assembly of example 1, wherein the marker is a band with a barcode and the detector is a barcode reader. 9) The assembly of Example 8, wherein the band comprises a sleeve positioned over the elongate member. 10) The assembly of Example 9, wherein the sleeve comprises a unique barcode. 11) The assembly of Example 9, where the sleeve is colorless and the etching of the lines is ablated onto the sleeve. 12) The assembly of any one of Examples 9 to 11, wherein the elongate member comprises a coating of insulating material. 13) The assembly of Example 12, wherein the coating of insulating material comprises a portion of a transparent coating positioned over the band. 14) The assembly of Example 12, wherein the coating of insulating material comprises a transparent coating extending along the entire length of the elongated member. 15) The assembly of Example 1, wherein the markers are distinct bands of surface roughness and the detector is a light intensity sensor. 16) The assembly of Example 15, wherein the separate surface roughness is applied directly to the surface of the elongate member. 17) The assembly of example 15, wherein the band is a separate piece positioned over the elongate member. 18) The assembly of Example 17, wherein the band is swaged over the elongate member. 19) The assembly of Example 17, wherein the band is fitted over the elongate member. 20) The assembly of any one of Examples 16 to 19, wherein the elongate member comprises a coating of insulating material. 21) The assembly of example 20, wherein the coating of insulating material comprises a portion of a transparent coating positioned over the band. 22) The assembly of Example 20, wherein the coating of insulating material comprises a transparent coating extending along the entire length of the elongated member. 23) The assembly of Example 1, wherein the marker is a magnetic band and the detector is a magnetic sensor. 24) The assembly of example 23, wherein the marker is positioned on the elongate member. 25) The assembly of Example 23, wherein the marker is swaged over the elongate member. 26) The assembly of Example 23, wherein the marker comprises a metal band. 27) The assembly of Example 23, wherein the marker consists of a doped plastic band. 28) The assembly of any one of Examples 24 to 27, wherein the elongate member comprises a coating of insulating material. 29) The assembly of Example 27, wherein the doped plastic band comprises a heat-shrinkable plastic tube doped with a magnetic material. 30) The assembly of Example 1, wherein the marker is a metal band and the detector is a capacitive proximity sensor. 31) The assembly of example 30, wherein the marker is positioned on the elongate member. 32) The assembly of example 31, wherein the metal band is made of a magnetic material. 33) The assembly of Example 31, wherein the metal band is composed of a non-magnetic material. 34) The assembly of any one of Examples 1 to 33, wherein the detector is embedded in the wall of the expander. 35) An assembly for providing a puncture to tissue, comprising: a puncture device comprising an elongate member having a distal tip configured to deliver energy to tissue to effect puncture; the lancing device further comprising a detector positioned along the elongate member; a dilator comprising a lumen extending from a proximal portion to a distal portion and configured to receive a puncture device; the dilator further comprises markers positioned along the length of the dilator; Once the marker and detector are aligned, energy is delivered to the distal tip of the lancing device. assembly. 36) The assembly of example 35, wherein the marker is a color band and the detector is a color sensor. 37) The assembly of example 35, wherein the marker is a band with a barcode and the detector is a barcode reader. 38) The assembly of example 35, wherein the markers are distinct bands of surface roughness and the detector is a light intensity sensor. 39) The assembly of any one of Examples 35 to 37, wherein the dilator comprises a portion of transparent material in which the marker is located. 40) The assembly of example 35, wherein the marker is a magnetic band and the detector is a magnetic sensor. 41) The assembly of example 35, wherein the marker is a metal band and the detector is a capacitive proximity sensor. 42) An assembly for providing a puncture to tissue, comprising: a puncture device comprising an elongate member having a distal tip configured to deliver energy to tissue to effect puncture; the lancing device further comprising a conductive band; a dilator comprising a lumen extending from a proximal portion to a distal portion and configured to receive a puncture device; The dilator further comprises a conductive plate embedded in a sidewall of the lumen; When the conductive bands of the lancing device are brought into proximity with the conductive plates of the dilator, energy is delivered to the distal tip of the lancing device. assembly. 43) The assembly of example 42, wherein the dilator is constructed from an electrically insulating material. 44) The assembly of Example 43, wherein the dilator is composed of one or a combination of high density polyethylene, polyurethane, or polyether block amide. 45) The assembly of Example 42, wherein the dilator further comprises an insulated connecting cable extending from the proximal end of the dilator to the conductive plate. 46) The assembly of Example 42, wherein the conductive band is comprised of a non-conductive material doped with a conductive material. 47) The assembly of Example 42, wherein the conductive band is entirely composed of a conductive material. 48) The assembly of any one of Examples 46 or 47, wherein the conductive band can be swaged over the elongate member. 49) The assembly of any one of examples 46 or 47, wherein the conductive band is fitted over the elongate member. 50) The assembly of Example 42, wherein the elongate member is constructed of a conductive material with an insulating coating extending the entire length of the elongate member, and the conductive band is positioned such that it is exposed from the insulating coating. 51) The assembly of example 50, wherein the conductive band is part of an elongate member having an increased diameter so that it contacts the conductive plate of the dilator. 52) A method of effecting a puncture in the cardiac septum using a puncture device having markers positioned along the length of the puncture device and a dilator having detectors positioned along the length of the puncture device, wherein alignment of the markers and detectors enables energy delivery; introducing an assembly of the puncture device and the dilator into the right atrium of the heart, the puncture device being received within the dilator such that the marker and the detector are not aligned; locating a target location on the septum with the distal tip of the assembly; aligning the marker and the detector to allow energy delivery to the distal tip of the lancing device; advancing the puncture device so that the distal tip enters the left atrium, such that the marker and detector are no longer aligned and energy delivery is not possible; A method comprising:

[0033] It will be appreciated that certain features of the invention that are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention that are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination.

[0034] While the present invention has been described in conjunction with specific embodiments thereof, many alternatives, modifications, and variations will become apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications, and variations that fall within the broad scope of the appended claims. All publications, patents, and patent applications mentioned in this specification are incorporated herein by reference in their entirety, as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application should not be construed as an admission that such reference is available as prior art to the present invention.

Claims

1. 1. An assembly for providing a puncture in tissue, comprising: a puncture device comprising an elongate member having a distal tip configured to deliver energy to tissue to effect puncture; the lancing device further comprising markers positioned along the elongate member; a dilator comprising a lumen extending from a proximal end to a distal end and configured to receive the puncture device; the dilator further comprising a detector positioned along the length of the dilator; Once the marker and the detector are aligned, energy is delivered to the distal tip of the lancing device. assembly.

2. The assembly of claim 1 , wherein the marker is a color band and the detector is a color sensor.

3. The assembly of claim 2 , wherein the color band comprises a spray coating.

4. The assembly of claim 2 , wherein the color band comprises a sleeve of a different color positioned over the elongate member.

5. 5. The assembly of claim 3 or 4, wherein the elongate member is provided with a coating of insulating material.

6. The assembly of claim 5 , wherein the coating of insulating material comprises a portion of a transparent coating positioned over the color band.

7. The assembly of claim 5 , wherein the coating of insulating material comprises a transparent coating extending the entire length of the elongate member.

8. The assembly of claim 1 , wherein the marker is a band with a bar code and the detector is a bar code reader.

9. The assembly of claim 8 , wherein the band comprises a sleeve positioned over the elongate member.

10. The assembly of claim 9 , wherein the sleeve comprises a unique bar code.

11. The assembly of claim 9 , wherein the sleeve is colorless and the etching of lines is ablated onto the sleeve.

12. 12. The assembly of claim 9, wherein the elongate member is provided with a coating of insulating material.

13. The assembly of claim 12 , wherein the coating of insulating material comprises a portion of a transparent coating positioned over the band.

14. The assembly of claim 12 , wherein the coating of insulating material comprises a transparent coating extending the entire length of the elongate member.

15. The assembly of claim 1 , wherein the markers are distinct bands of surface roughness and the detector is a light intensity sensor.

16. The assembly of claim 15 , wherein the distinct surface roughness is applied directly to the surface of the elongate member.

17. The assembly of claim 15 , wherein the band is a separate piece positioned over the elongate member.

18. The assembly of claim 17 , wherein the band is swaged over the elongate member.

19. The assembly of claim 17 , wherein the band is fitted over the elongate member.

20. 20. The assembly of any one of claims 16 to 19, wherein the elongate member is provided with a coating of insulating material.

21. 21. The assembly of claim 20, wherein the coating of insulating material comprises a portion of a transparent coating positioned over the band.

22. 21. The assembly of claim 20, wherein the coating of insulating material comprises a transparent coating extending the entire length of the elongate member.

23. The assembly of claim 1 , wherein the marker is a magnetic band and the detector is a magnetic sensor.

24. The assembly of claim 23 , wherein the marker is located on the elongate member.

25. 24. The assembly of claim 23, wherein the marker is swaged onto the elongate member.

26. 24. The assembly of claim 23, wherein the marker comprises a metal band.

27. 24. The assembly of claim 23, wherein the marker comprises a doped plastic band.

28. 28. The assembly of any one of claims 24 to 27, wherein the elongate member is provided with a coating of insulating material.

29. 28. The assembly of claim 27, wherein the doped plastic band comprises a heat-shrinkable plastic tube doped with a magnetic material.

30. The assembly of claim 1 , wherein the marker is a metal band and the detector is a capacitive proximity sensor.

31. The assembly of claim 30, wherein the marker is located on the elongate member.

32. 32. The assembly of claim 31, wherein the metal band is constructed from a magnetic material.

33. 32. The assembly of claim 31, wherein the metal band is constructed from a non-magnetic material.

34. 34. The assembly of any one of claims 1 to 33, wherein the detector is embedded in the wall of the dilator.

35. 1. An assembly for providing a puncture in tissue, comprising: a puncture device comprising an elongate member having a distal tip configured to deliver energy to tissue to effect puncture; the lancing device further comprising a detector positioned along the elongate member; a dilator comprising a lumen extending from a proximal end to a distal end and configured to receive the puncture device; the dilator further comprising markers positioned along the length of the dilator; Once the marker and the detector are aligned, energy is delivered to the distal tip of the lancing device. assembly.

36. 36. The assembly of claim 35, wherein the marker is a color band and the detector is a color sensor.

37. 36. The assembly of claim 35, wherein the marker is a band with a barcode and the detector is a barcode reader.

38. 36. The assembly of claim 35, wherein the markers are distinct bands of surface roughness and the detector is a light intensity sensor.

39. 38. The assembly of any one of claims 35 to 37, wherein the dilator comprises a portion of transparent material in which the marker is located.

40. 36. The assembly of claim 35, wherein the marker is a magnetic band and the detector is a magnetic sensor.

41. 36. The assembly of claim 35, wherein the marker is a metal band and the detector is a capacitive proximity sensor.

42. 1. An assembly for providing a puncture in tissue, comprising: a puncture device comprising an elongate member having a distal tip configured to deliver energy to tissue to effect puncture; the lancing device further comprising a conductive band; a dilator comprising a lumen extending from a proximal end to a distal end and configured to receive the puncture device; the dilator further comprises a conductive plate embedded in a sidewall of the lumen; When the conductive band of the lancing device is adjacent to the conductive plate of the dilator, energy is delivered to the distal tip of the lancing device. assembly.

43. 43. The assembly of claim 42, wherein the dilator is constructed from an electrically insulating material.

44. 44. The assembly of claim 43, wherein the dilator is constructed from one or a combination of high density polyethylene, polyurethane, or polyether block amide.

45. 43. The assembly of claim 42, wherein the dilator further comprises an insulated connecting cable extending from a proximal end of the dilator to the conductive plate.

46. 43. The assembly of claim 42, wherein the conductive bands are comprised of a non-conductive material doped with a conductive material.

47. 43. The assembly of claim 42, wherein the conductive band is constructed entirely from a conductive material.

48. 48. The assembly of claim 46 or 47, wherein the conductive band can be swaged over the elongate member.

49. 48. The assembly of claim 46 or 47, wherein the conductive band is fitted over the elongate member.

50. 43. The assembly of claim 42, wherein the elongate member is constructed from a conductive material with an insulating coating extending the entire length of the elongate member, and the conductive band is positioned such that it is exposed from the insulating coating.

51. 51. The assembly of claim 50, wherein the conductive band is a portion of the elongate member that has an increased diameter so that it contacts the conductive plate of the dilator.

52. 1. A method of effecting a puncture in the cardiac septum using a puncture device having markers positioned along a length of the puncture device and a dilator having a detector positioned along a length of the puncture device, wherein alignment of the markers and the detector allows for energy delivery; introducing an assembly of the puncture device and the dilator into the right atrium of the heart, the puncture device being received within the dilator such that the marker and the detector are not aligned; locating a target location on the septum with the distal tip of the assembly; aligning the marker and the detector to allow energy delivery to the distal tip of the lancing device; advancing the puncture device so that the distal tip enters the left atrium, such that the marker and the detector are no longer aligned and energy delivery is not possible; A method comprising:

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