Deflectable elongated guidewire assembly

Abstract

The present invention provides a method and / or device for applying an ideal amount of tenting force to the pericardial layer 911. [Solution] The elongated guidewire assembly 200 has a distal segment 205 configured to be selectively operated along the elongated introducer assembly 102. The distal segment is configured to selectively transmit a tenting force 700 from the elongated guidewire assembly to the first biological wall 910 after the distal segment has selectively extended away from the distal introducer assembly, with the distal segment at least partially in contact with the first biological wall 910.

Description

Technical Field

[0001] This document relates to the technical field of (A) a synergistic combination of an elongated introducer assembly and a deflectable elongated guidewire assembly (and methods thereof), and / or (B) a deflectable elongated guidewire assembly (and methods thereof) for use with an elongated introducer assembly 100, and / or (C) an elongated introducer assembly (and methods thereof) configured to be used with a deflectable elongated guidewire assembly (not limited to these).

Background Art

[0002] Known medical devices are configured to facilitate medical procedures and assist medical providers in diagnosing and / or treating the medical conditions of diseased patients.

Summary of the Invention

[0003] It will be appreciated that there is a need to (at least partially) mitigate at least one problem associated with existing (known) guidewires. After numerous studies and experiments on existing (known) guidewires, an (at least partial) understanding of the problems and their solutions has been (at least partially) identified and (at least partially) clearly expressed as follows.

[0004] Obtaining epicardial access involves piercing a thin layer of pericardium (also called the pericardial layer) that surrounds the myocardium of the heart (without piercing the myocardium). The pericardial layer (also called the pericardial sac) is an outer layer made of connective tissue that holds the heart and the roots of the great vessels in place within the thoracic cavity. The myocardium is the thick middle layer of the heart and is composed of cardiac muscle. In some cases, a mechanical needle may be used to pierce the pericardial layer, and in such cases, the user may need to control the input force (also called the tenting force) applied to the pericardial layer (via the needle) while attempting to best avoid inadvertently damaging and / or piercing the underlying (heart) myocardium. It is known that this may occur.

[0005] Known epicardial puncture techniques involve directing a relatively rigid (or supported) puncture device directly into the pericardial layer, which is also directed directly into the underlying myocardial layer. This technique (unfortunately) can result in greater sensitivity to forces (tenting forces) applied to the pericardial layer (and the underlying myocardial layer) in response to relatively small changes in the displacement (movement) of the puncture device. As a result, it is very easy to inadvertently apply excessive tenting force to the pericardial layer (through the puncture device), and then inadvertently puncture (damage) the myocardial layer. The application of radiofrequency energy (by radiation from an electrode and / or radiofrequency device) to form a puncture hole through the pericardial layer may be a safer and more effective method overall compared to using a mechanical needle and / or guidewire. The blunt electrode of a radiofrequency needle can be positioned in the pericardial layer, and the blunt electrode can be activated to radiate radiofrequency energy, causing the surrounding tissue to vaporize (to form a puncture hole extending through the pericardial layer).

[0006] After activating a blunt electrode for just a moment (to form a puncture hole), the radiofrequency energy is (rapidly) deactivated, and this arrangement can reduce the risk of inadvertently puncturing the myocardial layer. Known methods are similar to those outlined above, in which a rigid (or supported) radiofrequency puncture device is directed towards the pericardial layer. The user can apply a tenting force to the tissue (thereby forming a tent in the tissue). The tenting force can be applied by a radiofrequency electrode positioned in a deactivated state. When the radiofrequency energy is activated (radiated), the tented tissue evaporates until the applied force (tenting force) decreases to zero as a result of puncture hole formation. However, with respect to this known method, given the high sensitivity of the tenting force to the placement, movement, and / or displacement of the puncture device, it may be easy to over-tent the tissue before activating the radiofrequency energy. Given the proximity of the myocardial and pericardial layers, using this known method and / or known device remains relatively easy to inadvertently puncture the myocardial layer.

[0007] Figures 1A, 1B, and 1C show side views of known radiofrequency aspiration techniques using associated known devices. Figure 1A shows the starting point where a known distal aspiration device 292 (such as an electrode) of a known guidewire assembly 290 (see Figure 2A) is positioned relative to the pericardial layer 911. Figure 1B shows the tenting force 700 applied from the known guidewire assembly 290 to the pericardial layer 911 (tissue). The pericardial layer 911 is forced to take on a tent shape in response to the application of the tenting force 700 to the pericardial layer 911. Radiofrequency energy is activated and radiated from the known distal aspiration device 292, thereby causing the known distal aspiration device 292 (blunt electrode) to radiate radiofrequency energy toward a zone of the tent-shaped pericardial layer 911. Figure 1C shows the pericardial layer 911 sliding along and over the known guidewire assembly 290 and returning to approximately the starting point as shown in Figure 1A. Referring to the embodiments shown in Figures 1A to 1C, a known guidewire assembly 290 equipped with a known distal puncture device 292 (radiofrequency radiation device) tent-like the pericardial layer 911 (tissue or biological wall) by applying a tenting force 700 to the tissue during use. Since the known distal puncture device 292 (radiofrequency radiation device) is not sharp, the known distal puncture device 292 does not mechanically puncture the tissue. When radiofrequency energy is applied by or radiated from the known distal puncture device 292, the tented pericardial layer 911 can be relaxed as the applied tenting force 700 (i.e., applied to the pericardial layer 911) evaporates (as shown in Figure 1A) until it returns to zero.

[0008] Figures 2A and 2B show magnified cross-sectional views (Figure 2A) and schematic diagrams (Figure 2B) of known pericardial punctures using known puncture devices.

[0009] Referring to Figure 2A, the distal tip of the distal puncture device 292 (of the known guidewire assembly 290) is oriented toward the pericardial layer 911 of the heart 940 (along the known introducer assembly 190). The pericardial space 931 is located between the pericardial layer 911 and the myocardial layer 921. This case exhibits greater sensitivity to tenting force 700 when applied to the pericardial layer 911 in response to slight changes in the displacement of the known guidewire assembly 290 and / or the known introducer assembly 190.

[0010] Referring to Figure 2B, the vertical axis 390 represents the amount of tenting force 700. The horizontal axis 392 represents the amount of displacement of the known introducer assembly 190 and / or the known guidewire assembly 290. The first zone 394 indicates a relatively safe range of tenting force 700 that can be applied to the pericardial layer 911 without damaging the myocardial layer 921 when the known distal puncture device 292 is activated. The purpose of puncturing through the pericardial layer 911 is to gain access to the pericardial space 931, thereby allowing the therapeutic device to gain access to the myocardial layer 921 and / or the epicardial layer through a puncture hole extending through the pericardial layer 911. The epicardial layer will be understood to be the thin layer above the myocardial layer. Epicardial access can also be referred to as an alternative to gaining access to the pericardial space. The second zone 396 represents a relatively potentially dangerous range of tenting force 700 that, when applied to the pericardial layer 911 and activated by the distal puncture device 292, could unfortunately damage the myocardial layer 921. It is clear that using this known method and / or known device may present the problem of achieving conditions that may be sufficient to achieve only the avoidance of pericardial puncture and myocardial layer 921 puncture (damage). It will be understood that mere contact or proximity of the electrode to the pericardial layer 911 may, by using radiofrequency energy, vaporize the puncture hole through the pericardial layer 911. Epicardial access may be extremely sensitive because it may be desired to puncture a thin layer of the pericardial layer 911 without damaging the underlying myocardial layer 921. A method and / or device for applying an ideal amount of tenting force 700 to the pericardial layer 911 is desired in order to achieve only the avoidance of puncture (damage) to the pericardial layer 921 and the myocardial layer 921.

[0011] To mitigate at least one problem associated with existing technologies, an apparatus is provided (according to a broad embodiment). The apparatus is intended for use with an elongated guidewire assembly having a first biological wall and a second biological wall of a patient (the second biological wall being positioned in close proximity to the first biological wall), and a distal guidewire exit portal. The distal guidewire exit portal is configured to be selectively operated and positioned in close proximity to the first biological wall. The apparatus includes, but is not limited to, an elongated guidewire assembly having a distal segment terminating at a distal puncture device configured to be selectively operated along the elongated guidewire assembly. The distal segment has a distal length configured to at least partially contact the first outer surface of the first biological wall. This is done in response to a selective extension movement, after the distal guidewire exit portal has been operated to be in close proximity to the first outer surface of the first biological wall, at which point the distal segment and the distal puncture device move away from the distal guidewire exit portal. The distal segment is configured to transmit a tenting force from the elongated guidewire assembly to the first biological wall in response to the application of a tenting force at least partially along the elongated guidewire assembly, after the distal length of the distal segment has at least partially contacted the first outer surface of the first biological wall (without damaging the second biological wall which is positioned in close proximity to the first biological wall).

[0012] An apparatus is provided (according to a broad embodiment) to at least partially mitigate at least one problem associated with existing technologies. The apparatus is intended for use with a patient's first and second biological walls (the second biological wall being positioned in close proximity to the first biological wall). The apparatus includes, but is not limited to, an elongated guidewire assembly having a distal guidewire exit portal configured to be selectively operated and positioned in close proximity to the first biological wall. The elongated guidewire assembly has a distal segment terminating at a distal puncture device configured to be selectively operated along the elongated guidewire assembly. The distal segment has a distal length configured to at least partially contact the first outer surface of the first biological wall. This occurs in response to a selective extension movement, after the distal guidewire exit portal has been operated to be in close proximity to the first outer surface of the first biological wall, at which point the distal segment and the distal puncture device move away from the distal guidewire exit portal. The distal segment is configured to transmit a tenting force from the elongated guidewire assembly to the first biological wall in response to the application of a tenting force at least partially along the elongated guidewire assembly, after the distal length of the distal segment has at least partially contacted the first outer surface of the first biological wall (without damaging the second biological wall which is positioned in close proximity to the first biological wall).

[0013] A method is provided (according to a broad embodiment) to at least partially mitigate at least one problem associated with existing technologies. The method is for use with an elongated guidewire assembly and an elongated induction device assembly with a first biological wall and a second biological wall of a patient (the second biological wall being positioned in close proximity to the first biological wall). The method includes, but is not limited to, selectively manipulating an elongated guidewire assembly having a distal segment that terminates with a distal puncture device along the elongated induction device assembly. The method also includes, but is not limited to, selectively extending the distal segment and the distal puncture device away from the distal induction device exit portal after the distal induction device exit portal has been manipulated to be in close proximity to the first outer surface of the first biological wall. The method also includes, but is not limited to, bringing the distal segment (having distal length) into at least partial contact with the first outer surface of the first biological wall after the distal segment and the distal puncture device have been selectively extended away from the distal induction device exit portal. This method also includes, but is not limited to, applying a tenting force at least partially along the elongated guidewire assembly after the distal length of the distal segment has at least partially contacted the first outer surface of the first biological wall. This method also includes, but is not limited to, transmitting the tenting force from the elongated guidewire assembly to the first biological wall via the distal segment after the tenting force has been applied to the elongated guidewire assembly (without damaging the second biological wall positioned in close proximity to the first biological wall).

[0014] Other embodiments are specified in the claims. Other embodiments and features of the non-limiting embodiments may become apparent to those skilled in the art upon consideration of the following detailed description of the non-limiting embodiments with reference to the accompanying drawings. This summary is provided to introduce the concepts in a simplified form, which will be further described below in the detailed description. This summary is not intended to identify any potentially important or possible essential features of the disclosed subject matter, nor is it intended to describe each disclosed embodiment or all realizations of the disclosed subject matter. The figures and the following description illustrate the exemplary embodiments in more detail. [Brief explanation of the drawing]

[0015] Non-limiting embodiments can be better understood by referring to the following detailed description of non-limiting embodiments when interpreted in conjunction with the accompanying drawings. [Figure 1A] A side view of known high-frequency aspiration techniques using relevant known devices is shown. [Figure 1B] A side view of known high-frequency aspiration techniques using relevant known devices is shown. [Figure 1C] A side view of known high-frequency aspiration techniques using relevant known devices is shown. [Figure 2A] This shows an enlarged cross-sectional view of a known pericardial puncture using a known puncture device. [Figure 2B] A schematic diagram of a known pericardial puncture using a known puncture device is shown. [Figure 3A] A cross-sectional view of an embodiment of an elongated guidewire assembly is shown. [Figure 3B] Figure 3A shows an enlarged view illustrating the fold formation of tissue in the first biological wall in an embodiment of an elongated guidewire assembly. [Figure 3C] Figure 3A shows a cross-sectional view of an embodiment of the elongated guidewire assembly that demonstrates tissue fold formation in the flexible introduction device 100. [Figure 3D] A schematic diagram of an embodiment of an elongated guidewire assembly is shown. [Figure 3E]Figure 3B shows a cross-sectional view of an embodiment of an elongated guide wire assembly after piercing of the first biological wall. [Figure 3F] Figure 3C shows a cross-sectional view of an embodiment of an elongated guide wire assembly after piercing of the first biological wall. [Figure 4A] Figure 3A shows a cross-sectional view of an embodiment of the elongated guide wire assembly. [Figure 4B] Figure 3A shows a schematic view of an embodiment of the elongated guide wire assembly. [Figure 5A] Figure 3A shows a schematic view of an embodiment of the elongated guide wire assembly. [Figure 5B] Figure 3A shows a schematic view of an embodiment of the elongated guide wire assembly. [Figure 6A] Figure 3A shows a cross-sectional view of an embodiment of an elongated introducer assembly for use with the elongated guide wire assembly. [Figure 6B] Figure 3A shows a cross-sectional view of an embodiment of an elongated introducer assembly for use with the elongated guide wire assembly. [Figure 7A] Figure 3A shows a cross-sectional view of an embodiment of the elongated guide wire assembly. [Figure 7B] Figure 3A shows a cross-sectional view of an embodiment of the elongated guide wire assembly. [Figure 7C] Figure 3A shows a side view of an embodiment of the elongated guide wire assembly. [Figure 7D] Figure 3A shows a side view of an embodiment of the elongated guide wire assembly. [Figure 7E] Figure 3A shows a cross-sectional view of an embodiment of the elongated guide wire assembly. [Figure 7F] Figure 3A shows a side view of an embodiment of the elongated guide wire assembly. [Figure 7G] Figure 3A shows a cross-sectional view of an embodiment of the elongated guide wire assembly. [Figure 8A] Figure 3A shows a cross-sectional view of an embodiment of the elongated guide wire assembly. [Figure 8B]Figure 3A shows a cross-sectional view of an embodiment of the elongated guidewire assembly. [Figure 8C] Figure 3A shows a cross-sectional view of an embodiment of the elongated guidewire assembly. [Figure 9] Figure 3A shows a side view of one embodiment of the elongated guidewire assembly. [Figure 10] Figure 3A shows a cross-sectional view of one embodiment of the elongated guidewire assembly. [Figure 11A] Figure 3A shows a schematic diagram of an embodiment of the elongated guide wire assembly. [Figure 11B] Figure 3A shows a schematic diagram of an embodiment of the elongated guide wire assembly. [Figure 12A] Figure 3A shows a cross-sectional view of an embodiment of the elongated guidewire assembly. [Figure 12B] Figure 3A shows a schematic diagram of an embodiment of the elongated guide wire assembly. [Figure 13] Figure 3A shows a cross-sectional view of one embodiment of the elongated guidewire assembly. [Figure 14] Figure 3A shows a cross-sectional view of one embodiment of the elongated guidewire assembly. [Figure 15] Figure 3A shows a cross-sectional view of an embodiment of the elongated guidewire assembly. [Figure 16] Figure 3A shows a cross-sectional view of an embodiment of the elongated guidewire assembly. [Figure 17] Figure 3A shows a cross-sectional view of an embodiment of the elongated guidewire assembly. [Figure 18] Figure 3A shows a cross-sectional view of an embodiment of the elongated guidewire assembly. [Figure 19] Figure 3A shows a cross-sectional view of an embodiment of the elongated guidewire assembly. [Figure 20] Figure 3A shows a cross-sectional view of an embodiment of the elongated guidewire assembly. [Figure 21] Figure 3A shows a cross-sectional view of an embodiment of the elongated guidewire assembly. [Figure 22]Figure 3A shows a cross-sectional view of an embodiment of the elongated guidewire assembly.

[0016] The drawings are not necessarily to scale and may be represented by dashed lines, schematics, and partial drawings. In certain cases, details that are unnecessary for understanding the embodiment (and / or details that make other details difficult to perceive) may be omitted. Corresponding reference numerals indicate corresponding components through several drawings. Elements in various drawings are shown for simplicity and clarity and are not drawn to scale. Some dimensions of elements in the drawings may be emphasized relative to other elements to facilitate understanding of the various embodiments disclosed. In addition, common and well-understood elements that are useful in commercially viable embodiments are often omitted to provide an obstructed view of the embodiments of this disclosure.

[0017] [Table 1] [Modes for carrying out the invention]

[0018] Detailed description of non-limiting embodiments The following detailed descriptions are illustrative and not intended to limit the embodiments or uses and applications of the embodiments described. As used, the words “exemplary” or “exemplary” mean “serving as an example, case, or illustration.” Any implementation described as “exemplary” or “exemplary” should not necessarily be construed as being preferable or advantageous to other implementations. All implementations described below are illustrative implementations provided to enable a person skilled in the art to make or use embodiments of the disclosure and are not intended to limit the scope of the disclosure. The scope of the disclosure is defined by the claims. For the purposes of description, “top,” “bottom,” “left,” “rear,” “right,” “front,” “vertical,” “horizontal,” and their derivatives are related to the examples oriented in the drawings. No connection is intended by any expression or implied theory in the preceding technical field, background, abstract, or any expression or implied theory in the following detailed description. It should also be understood that the devices and processes shown in the accompanying drawings and described in the following specification are illustrative embodiments (examples), aspects and / or concepts as defined in the accompanying claims. Accordingly, dimensions and other physical characteristics relating to the disclosed embodiments should not be considered limiting unless otherwise expressly stated in the claims. The phrase “at least one” is understood to be equivalent to “one (a)”. Embodiments (examples, modifications, changes, alternatives, variations, embodiments, and any equivalents thereof) are described with respect to the drawings. It should be understood that this disclosure is limited to the subject matter provided by the claims and is not limited to the specific embodiments shown and described. The scope of the meaning of a device configured to be coupled to an article (i.e., connected to an article, interacting with an article, etc.) will be understood to be interpreted as the device being configured to be coupled to an article either directly or indirectly. Accordingly, “configured to be” may include the meaning of “either directly or indirectly” unless otherwise specifically stated.

[0019] Referring to the embodiment shown in Figure 3A, the distal length 204 of the distal segment 205 (distal portion) of the elongated guidewire assembly 200 extends (projects) from the distal guided device exit portal 104 of the guided device assembly 100 (through the guided device lumen 102 which extends along the elongated guided device assembly 100). During use, the distal length 204 of the distal segment 205 of the elongated guidewire assembly 200 moves to contact (at least partially) the first outer surface 912 of the first biological wall 910 (or the pericardial layer 911 of the patient's heart 940) and lies (approaches) thereon. Tenting force 700 is received by the distal segment 205 from the elongated guidewire assembly 200, and the distal segment 205 transmits the tenting force 700 from the elongated guidewire assembly 200 to the first outer surface 912. The first outer surface 912 slides over the second outer surface 922, and as a result of friction between the distal segment 205 and the first outer surface 912, the first outer surface 912 forms a fold in front of the distal puncture device 202, while simultaneously generating tension in the first outer surface 912 along the length of the distal length 204. Once the tension and fold formation state is achieved (see Figure 3B), puncture can be performed (e.g., using a mechanical device such as an RF or flexible wire or equivalent).

[0020] The workflow for obtaining the tissue fold formation and tension configuration shown in Figure 3B is as follows: An elongated introduction device assembly 100 is positioned close to the first biological wall 912. An elongated guidewire assembly 200 is advanced through the introduction device lumen 102. The distal puncture device 202 exits the distal introduction device exit portal 104 and makes contact with the first biological wall 912. As the elongated guidewire assembly 200 continues to advance, the distal length 204 of the distal segment 205 escapes over the first biological wall 912 (i.e., after contacting the first biological wall 912, the distal segment 205 deflects posteriorly and advances over the surface of the first biological wall 912 to reach the configuration shown in Figure 3A), positioning the distal puncture device parallel to the second biological wall 922 and causing a fold in a portion of the tissue of the first biological wall 912 in front of the distal puncture device 202, while simultaneously creating tension in a portion of the tissue of the first biological wall 912 adjacent to the distal length 204 of the distal segment 205. Following this workflow, a puncture is performed into the first biological wall 912 via the distal puncture device 202, as shown in Figure 3E, advancing the elongated guidewire assembly 200 into the pericardial space 931. The RF-based distal puncture device 202 can puncture the first biological wall 912 via RF energy, while the sharp, mechanically based distal puncture device 202 can puncture the first biological wall and subsequently puncture good tissue by protruding from and then retracting into the distal guidewire assembly 200.

[0021] The workflow for obtaining the tissue fold formation and tension configuration shown in Figure 3C is as follows: A flexible, elongated introducer assembly 100 makes contact with the first biological wall 912. The distal length 204 of the distal segment 205 escapes over the first biological wall, positioning the flexible, elongated introducer assembly 100 parallel to the second biological wall 922, forming a fold in a portion of the first biological wall in front of the distal introducer exit portal 104, while simultaneously generating tension in a portion of the tissue of the first biological wall 912 adjacent to the distal length 204 of the distal segment 205. Following this workflow, the elongated guidewire assembly 200 is advanced through the introducer lumen 102. The distal puncture device moves out of the distal introduction device exit portal 104 and into the first biological wall 912 until puncture of the first biological wall 912 is achieved via the sharp tip of the distal puncture device 202, as shown in Figure 3F. The amount of tenting force 700 transmitted from the distal length 204 of the distal segment 205 (of the elongated guidewire assembly 200) to the first biological wall 910 is conveniently spread (dispersed) over a larger portion of the first biological wall 910. In considerable contrast to the embodiment shown in Figure 2A, the tenting force 700 is directed more concentrated on a smaller section of the first biological wall 910, and the tenting force 700 is transmitted (overall) from the known distal puncture device 292 of the known guidewire assembly 290 to the first biological wall 910. Referring again to the embodiment shown in Figure 3A, a smaller amount of tenting force 700 can be applied to the first outer surface 912 (of the first biological wall 910 or pericardial layer 911) using the distal puncture device 202 (of the elongated guidewire assembly 200) before a puncture hole extending through the first biological wall 910 is formed. Conveniently, this arrangement can at least partially avoid causing unwanted damage to the second biological wall 920 (or myocardial layer 921) as a result of deploying a relatively smaller amount of tenting force 700 (compared to the amount that may be deployed in association with the embodiment in Figure 2A).The distal puncture device is also reoriented away from the second biological wall 922 (as shown in Figures 3A, 3B, and 3C, and in contrast to the known prior art in Figure 2A), and is no longer perpendicular to the second biological wall 922, but rather positioned parallel to it. This parallel configuration prevents the distal puncture device 202 from causing unnecessary damage to the second biological wall 922.

[0022] Referring to the embodiment shown in Figure 3A, it will be understood that the amount of tenting force 700 transmitted from the distal length 204 of the distal segment 205 (of the elongated guidewire assembly 200) to the first biological wall 910 may be relatively small compared to the amount of tenting force 700 associated with the embodiment shown in Figure 2A (in Figure 2A, the tenting force 700 is transmitted entirely concentrated from the distal puncture device 202 of the elongated guidewire assembly 200 to the first biological wall 910). The amount of tenting force 700 (as associated with Figure 3A) may be relatively small compared to the direct tenting method (shown in Figure 2A and / or Figure 1B). Conveniently, the amount of tenting force 700 (as associated with Figure 3A) may be relatively less affected by changes in the displacement of the elongated introducer assembly 100.

[0023] Referring to the embodiment shown in Figure 3A, it will be understood that the orientation of the distal puncture device 202 is parallel to the second biological wall 922 (compared to the vertical configuration shown in Figure 2A). Conveniently, this parallel configuration prevents the distal puncture device 202 from causing unnecessary damage to the second biological wall 922.

[0024] Referring to the embodiment shown in Figure 3B, it will be understood that the tissue of the first biological wall 912 forms a fold in front of the distal puncture device 202, which is positioned parallel to the second biological wall 922. In this way, the first biological wall 912 can be punctured by the distal puncture device 202 without inadvertently puncturing or damaging the second biological wall 922.

[0025] Furthermore, referring to the embodiment shown in Figure 3C (mechanical puncture), it will be understood that the tissue of the first biological wall 912 forms a fold in front of the distal puncture device exit portal 104, which is positioned parallel to the second biological wall 922. In this way, the first biological wall can be punctured by the distal puncture device 202 while reducing or avoiding inadvertent puncture or damage to the second biological wall 922.

[0026] Referring to the embodiment shown in Figure 3A, the distal length 204 of the distal segment 205 (of the elongated guidewire assembly 200) is configured to extend from the distal inlet exit portal 104 (of the elongated inlet assembly 100) through the inlet lumen 102.

[0027] The distal length 204 of the distal segment 205 (also called the distal portion) of the elongated guidewire assembly 200 contacts (lies on, abuts against) the first outer surface 912 (of the first biological wall 910 or pericardial layer 911) during use. Conveniently, this arrangement can avoid the possible (unwanted) transmission (or excessive concentration) of the entire amount of tenting force 700 from the distal puncture device 202 to the first outer surface 912. In this case, the first outer surface 912 can receive a relatively small amount of tenting force 700 (compared to Figure 2A, where the first outer surface 912 can receive a relatively large amount of tenting force 700). Referring again to Figure 2A, it will be understood that a concentrated application of tenting force 700 could, and perhaps unintentionally, cause unwanted damage to the second outer surface 922 of the second biological wall 920 (or myocardial layer 921). Referring again to Figure 3A, conveniently, the amount of tenting force 700 can be distributed over a wider portion of the first outer surface 912 (compared to what is known in the art, as shown in Figure 2A). In this way, the present invention (shown in Figures 3A to 3D) presents or provides a safer condition for puncturing through the first outer surface 912 (in response to the operation of the distal puncture device 202) while the tenting force 700 is applied to the first outer surface 912. In this way, the embodiment avoids causing at least partial damage to the second outer surface 922 (after the first outer surface 912 has been punctured accordingly). In this method or arrangement, as shown in Figure 3A, the tenting force 700 applied by the distal length 204 of the distal segment 205 (of the elongated guidewire assembly 200) can be distributed along the distal length 204 of the distal segment 205 that is in contact with a relatively large portion of the first outer surface 912 (compared to the case shown in Figure 2A). Conveniently, the tenting force 700 applied through (towards the first outer surface 912) the distal length 204 of the distal segment 205 of the elongated guidewire assembly 200 remains relatively low in response to possible changes in the displacement and / or positioning of the elongated guidewire assembly 200 and / or the elongated introducer assembly 100 relative to the first outer surface 912.This arrangement may give the physician a relatively large degree of freedom to address situations when attempting to apply a tenting force 700 to the first outer surface 912 (via the operation of the elongated guidewire assembly 200 and / or the elongated guided device assembly 100). In this way, a lower degree of influence of mechanical motion on the distal segment 205 of the elongated guidewire assembly 200 may be possible (with respect to the application of the tenting force 700 to the first outer surface 912). The length of the distal section of the elongated guidewire assembly 200 extends from the distal guided device exit portal 104, and after the distal length 204 of the distal segment 205 of the elongated guidewire assembly 200 has come into contact with the first outer surface 912, the tenting force 700 can be applied from the distal length 204 of the distal segment 205 toward the first outer surface 912. While the tenting force 700 is maintained against the first outer surface 912, the distal puncture device 202 (of the elongated guidewire assembly 200) can be used (activated) to form a puncture hole extending through the first outer surface 912 (preferably without causing unnecessary damage to the second biological wall 920 or myocardial layer 921). Figure 20 will illustrate the use of the distal puncture device 202 to form a puncture hole extending through the first outer surface 912.

[0028] Referring to the embodiment shown in Figure 3D, Graph 301 is applicable to the embodiments shown in Figures 3A, 3B, and 3C. Axis 300 represents the amount of tenting force 700. Axis 302 represents the amount of displacement of the elongated introducer assembly 100 and / or the elongated guidewire assembly 200. The first zone 304 indicates a range of relatively safe amounts of tenting force 700 that can be applied to the first biological wall 910 (or pericardial layer 911) without damaging the second biological wall 920 (or myocardial layer 921). The second zone 306 indicates a range of relatively potentially dangerous amounts of tenting force 700 that, when applied to the first biological wall 910 (or pericardial layer 911), could unfortunately damage the second biological wall 920 (or myocardial layer 921) when the distal puncture device 202 is activated.

[0029] Referring to the embodiment shown in Figure 3A, a procedure (method) is provided which includes (but is not limited to) puncturing a first biological wall 910 (or pericardial layer 911). This method includes the following steps, namely, step (1), step (2), step (3), and step (4). Step (1) is shown (associated) in Figure 15, step (2) is shown (associated) in Figure 16, step (3) is shown (associated) in Figures 17 and 18, and step (4) is shown (associated) in Figures 19 and 20. Step (1) includes percutaneous delivery of an elongated guidewire assembly 200 to the first biological wall 910 (or the first outer surface 912 of the pericardial layer 911 of the heart 940) via an elongated introducer assembly 100.

[0030] Step (2) includes the protrusion of the elongated guidewire assembly 200 from the distal guidewire exit portal 104 of the elongated guidewire assembly 100 (through the guidewire lumen 102). Step (3) includes positioning the elongated guidewire assembly 200 such that the distal puncture device 202 (of the elongated guidewire assembly 200) extends (or protrudes) toward the first outer surface 912 of the first biological wall 910 (or pericardial layer 911) and is positioned in an optimal contact relationship. Step (4) includes applying a tenting force 700 to the first outer surface 912 from the length of the distal portion of the elongated guidewire assembly 200 (without damaging the second biological wall 920 or myocardial layer 921), and then puncturing through the first outer surface 912 using the distal puncture device 202 of the elongated guidewire assembly 200. With respect to steps (2) and (3), it will be understood that various devices and / or techniques can be used to help obtain the optimal extension (projection) of the distal length 204 of the distal segment 205 of the elongated guidewire assembly 200 (from the elongated introducer assembly 100), while preferably maintaining the distal length 204 of the distal segment 205 and the distal puncture device 202 in contact with the first outer surface 912 (before forming a puncture hole extending through the first outer surface 912 using the distal puncture device 202).

[0031] Referring to the embodiment shown in Figure 3A, it will be understood that the embodiment in Figure 3A may be used (but not limited to) to obtain access to the pericardial space 931 of the heart 940 and may be applicable to any type of biological space 930 located between the first biological wall 910 and the second biological wall 920.

[0032] Referring to the embodiment shown in Figure 3A, the options for step (1) may include the following: Option (A) for step (1) (see Figures 4A and 4B) involves the use of electroanatomic mapping (EAM) to evaluate positioning. Option (B) for step (1) (see Figures 5A and 5B) involves the use of an electrogram system (EGM) to evaluate positioning. Option (C) for step (1) (see Figures 6A and 6B) involves the use of a tip that may be rigid or flexible (the use of distal puncture device 202 or other accessory devices may add rigidity).

[0033] Referring to the embodiment shown in Figure 3A, the options for step (2) may include the following options. Option (A) for step (2) (see Figures 7A and 7B) includes the use of radiopaque markers (also called RO markers), a stretching coil, and / or a compression coil (areas of dense and / or sparse coil windings) to detect the protruding length of the elongated guidewire assembly 200. At least one radiopaque marker 808C may also be embedded in its distal end (see Figure 7G) within the elongated introducer assembly. As viewed by a medical imaging system, the user can then align the radiopaque marker on the elongated introducer assembly 100 between the two radiopaque markers (808A and 808B) on the elongated guidewire assembly 200 to ensure that the optimal length 204 of the distal segment 205 of the elongated guidewire assembly 200 is protruding for optimal application of tenting force to the first biological wall 912. Option (B) of step (2) (see Figures 8A, 8B, and 8C) includes distal and / or proximal tactile markers for detecting the protruding length of the elongated guidewire assembly 200. Option (C) of step (2) (see Figure 9) includes a proximal visual marker configured to provide a visual indication for detecting the protruding length of the elongated guidewire assembly 200. Option (D) of step (2) (see Figure 10) includes a capacitive sensor for detecting the protruding length of the elongated guidewire assembly 200. Variations of option (A) of step (2) may include the following: Variation (A) includes the use of a stretched / separated coil (areas of dense and sparse windings). Variation (B) includes a coil on the protruding distal section (of the elongated guidewire assembly 200). Variation (C) includes the use of a separated solid marker for measuring depth.

[0034] Referring to the embodiment shown in Figure 3A, the options for step (3) may include the following options: Option (A) for step (3) (see Figures 11A and 11B) includes a distal puncture device 202 (of the elongated guidewire assembly 200) synchronized with cardiac motion. Option (B) for step (3) (not shown) includes sensing the tenting force of the distal tip. Option (C) for step (3) (not shown) includes setting the stiffness of the protruding section (so as not to exceed the critical myocardial puncture threshold). Option (D) for step (3) (see Figures 12A and 12B) includes EAM to visualize contact. Option (E) for step (3) (not shown) includes EGM to confirm contact. Option (F) for step (3) (see Figure 13) includes injecting contrast agent. Option (G) of step (3) (see Figure 14) includes electrical contacts for connecting or disconnecting the circuit when the application of tenting force may be acceptable or unacceptable (e.g., if too high, it may damage the circuit). Option (H) of step (3) (not shown) includes a distal puncture device positioned in a region where the cardiac motion perpendicular to the elongated introducer assembly 100 is minimized.

[0035] Referring to the embodiment shown in Figure 3A, the options for step (4) may include the following: Option (A) (not shown) for step (4) includes activating the radiofrequency energy only for the duration required to vaporize the first biological wall 910 (or pericardial layer 911) (in order to optimize the duration for which the applied radiofrequency energy is activated). Option (B) for step (4) includes activating the radiofrequency energy for less than approximately 0.5 seconds. Option (C) (not shown) for step (4) includes stopping the radiofrequency energy when a change in impedance is detected (when the distal portion of the elongated guidewire assembly 200 has punctured and entered the biological space 930 or pericardial space 931).

[0036] Referring to the embodiment shown in Figure 3A, a device for use with a patient 900's first biological wall 910 and second biological wall 920 (the second biological wall 920 being positioned in close proximity to the first biological wall 910) is shown, and an elongated guidewire assembly 100 having a distal guidewire exit portal 104 is configured to be selectively operated and positioned in close proximity to the first biological wall 910. The device includes, but is not limited to, an elongated guidewire assembly 200 having a distal segment 205 terminating with a distal puncture device 202 configured to be selectively operated along the elongated guidewire assembly 100. This is preferably done in such a manner that the distal guidewire exit portal 104 is selectively operated and positioned in close proximity to the first outer surface 912 of the first biological wall 910, and then the distal puncture device 202 is positioned in close proximity to the first biological wall 910. The distal segment 205 has a distal length 204 configured to at least partially contact the first outer surface 912 of the first biological wall 910 in response to a selective extension movement of the distal segment 205 and distal puncture device 202 away from the distal input device exit portal 104 after the distal input device exit portal 104 has been operated in close proximity to the first outer surface 912 of the first biological wall 910. The distal segment 205 is configured to transmit a tenting force 700 from the elongated guidewire assembly 200 to the first biological wall 910 in response to the application of a tenting force 700 at least partially along the elongated guidewire assembly 200 after the distal length 204 of the distal segment 205 has at least partially contacted the first outer surface 912 of the first biological wall 910 (without damaging the second biological wall 920 which is positioned in close proximity to the first biological wall 910).

[0037] Referring to the embodiment shown in Figure 3A, the distal segment 205 is configured such that, after the elongated guidewire assembly 200 is extended from the elongated injector assembly 100, the distal length 204 is deflected away from the longitudinal axis 101 extending through the elongated injector assembly 100 by the first outer surface 912 of the first biological wall 910 in response to the distal length 204 coming into at least partial contact with the first outer surface 912 of the first biological wall 910.

[0038] Referring to the embodiment shown in Figure 3A, the distal length 204 of the distal segment 205 is also configured to transmit a tenting force 700 while puncturing through the first biological wall 910 using the distal puncture device 202.

[0039] Referring to the embodiment shown in Figure 3A, a device is shown for use with a first biological wall 910 of a patient 900 and an elongated introducer assembly 100 configured to be selectively operated and positioned in close proximity to the first biological wall 910. The device includes (but is not limited to) an elongated guidewire assembly 200 having a distal segment 205 configured to be selectively operated along the elongated introducer assembly 100. The distal segment 205 is configured to selectively transmit a tenting force 700 from the elongated guidewire assembly 200 to the first biological wall 910 after the distal segment 205 has at least partially contacted the first biological wall 910 and has been selectively extended away from the distal introducer exit portal 104 (of the introducer assembly 100).

[0040] Referring to the embodiment shown in Figure 3A, a method is provided for use with a first biological wall 910 of a patient 900 and an elongated introducer assembly 100 configured to be selectively operated and positioned in close proximity to the first biological wall 910. This method includes, but is not limited to, operating an elongated guidewire assembly 200 having a distal segment 205 along the elongated introducer assembly 100. This method also includes selectively transmitting a tenting force 700 from the elongated guidewire assembly 200 to the first biological wall 910 via the distal segment 205, after the distal segment 205 has been selectively extended away from the distal introducer exit portal 104 (of the distal introducer assembly 100) and the distal segment 205 has been selectively extended away from the distal introducer exit portal 104 (of the distal introducer assembly 100).

[0041] Referring to the embodiment shown in Figure 3A, a method is shown for using an elongated guidewire assembly 200 and an elongated guidewire assembly 100 together with a first biological wall 910 and a second biological wall 920 of a patient 900 (the second biological wall 920 is positioned in close proximity to the first biological wall 910). This method includes, but is not limited to, selectively manipulating the elongated guidewire assembly 200 (the elongated guidewire assembly 200 having a distal segment 205 terminating at a distal puncture device 202) along the elongated guidewire assembly 100. This method also includes selectively extending the distal segment 205 and the distal puncture device 202 away from the distal guidewire exit portal 104 after the distal guidewire exit portal 104 has been manipulated in close proximity to the first outer surface 912 of the first biological wall 910. This method also includes selectively extending the distal segment 205 and the distal puncture device 202 away from the distal introduction device exit portal 104, and then bringing the distal segment 205, having a distal length 204, into at least partial contact with the first outer surface 912 of the first biological wall 910. This method also includes applying a tenting force 700 at least partially along the elongated guidewire assembly 200 after the distal length 204 of the distal segment 205 has at least partially contacted the first outer surface 912 of the first biological wall 910. This method also includes transmitting the tenting force 700 from the elongated guidewire assembly 200 to the first biological wall 910 via the distal segment 205 after the tenting force 700 has been applied to the elongated guidewire assembly 200 (without damaging the second biological wall 920 which is positioned in close proximity to the first biological wall 910).

[0042] Referring to the embodiment shown in Figure 3A, the components or the elongated introducer assembly 100 and / or the elongated guidewire assembly 200 include biocompatible material properties suitable for performance (such as dielectric strength, thermal performance, electrical insulation, corrosion resistance, water resistance, and / or heat resistance) for compliance with industrial and regulatory safety standards (or suitability for medical use). For considerations in selecting suitable materials, refer to the following publication: Plastics in Medical Devices: Properties, Requirements, and Applications, 2nd edition, by Vinny R. Sastri, hardcover ISBN: 9781455732012, published November 21, 2013, publisher: Amsterdam [Pays-Bas]: Elsevier / William Andrew,

[2014] .

[0043] Referring to the embodiment shown in Figure 3A, the elongated guidewire assembly 200 includes a shape memory material, which is configured to return to its original shape (as set before the operation) after being manipulated and / or deformed. Since shape memory material (SMM) is known, further details are omitted. The shape memory material is configured to recover its original shape from large and significant plastic deformation in response to the application of a specific stimulus. This is known as the shape memory effect (SME). Superelasticity (in alloys) can be observed when the shape memory material is deformed in the presence (application) of a stimulating force.

[0044] Referring to the embodiment shown in Figure 3A, the distal puncture device 202 includes (but is not limited to) a high-frequency puncture device, such as a BAYLIS® POWERWIRE® high-frequency guidewire manufactured by BAYLIS MEDICAL COMPANY (headquartered in Canada). According to another embodiment, the distal puncture device 202 includes (but is not limited to) an elongated guidewire having a distal tip section indicating a mechanically cut portion.

[0045] Referring to the embodiment shown in Figure 3A, the elongated guidewire assembly 200 is configured to be inserted into a closed space defined by a living organism (patient). The guidewire assembly 200 includes a relatively thin flexible wire (elongated flexible shaft) configured to be inserted into a closed or tortuous space (closed space) defined by a living organism (preferably). The guidewire assembly 200 is (preferably) impermeable to bodily fluids located within the closed space defined by the living organism.

[0046] Figures 4A and 4B show a cross-sectional view (Figure 4A) and a schematic view (Figure 4B) of an embodiment of the elongated guidewire assembly 200 of Figure 3A. Figures 4A and 4B show an embodiment associated with option (A) of step (1).

[0047] Referring to an embodiment in Figure 4A, the distal puncture device 202 (of the elongated guidewire assembly 200) is configured to selectively emit energy (such as radiofrequency energy) for puncturing through a first biological wall 910 (or the pericardial layer 911 of the patient's heart). The distal puncture device 202 is electrically connected to an electroanatomical mapping system (known and not shown). Step (1) Option (A) involves the use of an electroanatomical mapping system to evaluate positioning.

[0048] Referring to the embodiment shown in Figure 4B, medical detection and visualization of a sensing element positioned at the distal tip of the elongated guidewire assembly 100 may be performed (calculated) by an electroanatomical mapping system (known and not shown). The electroanatomical mapping system is configured to display a first medical image 401 associated with the distal puncture device 202 (via a display device). The first medical image 401 is rendered as a live (instant or real-time) signal on the visual display of the electroanatomical mapping system (EAM). The electroanatomical mapping system is configured to display a visual map showing the three-dimensional anatomical structure of (the patient's) heart (via a display device known and not shown). The first medical image 401 may be shown relative to a second medical image 402 representing the mapped outline (image) of the patient's heart. The electroanatomical mapping system is configured to track the location of the elongated guidewire assembly 200 when the elongated guidewire assembly 200 is electrically connected to the electroanatomical mapping system. The elongated introducer assembly 100 may be configured to facilitate connection with an electroanatomical mapping system and to indicate the position of the distal portion of the elongated introducer assembly 100, which may allow the user to obtain optimal positioning of the elongated introducer assembly 100 relative to the heart.

[0049] Figures 5A and 5B show schematic diagrams of embodiments of the elongated guidewire assembly 200 of Figure 3A. Figures 5A and 5B show embodiments associated with option (B) of step (1).

[0050] Referring to embodiments shown in Figures 5A and 5B, a medical detection system (known, but not shown) is configured to measure the potential of tissue. The medical detection system may include an electromagnetism system (configured to provide tracking of the potential of biological tissue, performed by electrodes placed directly within the tissue instead of on the surface of the body), an electromyography system (EMG system is configured to provide recording of the electrical activity of muscle tissue, or its representation as a visual or audible signal, using electrodes attached to the skin or inserted into the muscle), and any equivalent thereof. The elongated introducer assembly 100 includes a sensor (material) positioned at the tip of the elongated introducer assembly 100. The sensor is configured to conduct electrical signals and is configured to be electrically connected to the medical detection system (e.g., the electromagnetism system). The electromagnetism system may provide the user with feedback on the location of the elongated introducer assembly 100 relative to the patient's heart (based on information provided by (from) the sensor of the elongated introducer assembly 100). As the elongated injector assembly 100 approaches the heart, the sensors on the injector assembly 100 can receive an electrical signal and output that signal to the electromorphic system. When the tip of the elongated injector assembly 100 makes contact with the heart, the tip causes local ischemia in the tissue (of the heart), which alters the electrical signal, as seen by the occurrence of an ST segment elevation 500 (as shown in Figure 5B). This allows the user to know when the elongated injector assembly 100 is ideally positioned. In this way, the ST segment elevation 500, which has caused local ischemia, can be visualized from the electromorphic signal 502.

[0051] Figures 6A and 6B show cross-sectional views of an embodiment of an elongated introducer assembly 100 for use with the elongated guidewire assembly 200 of Figure 3A. Figures 6A and 6B show an embodiment associated with option (C) of step (1).

[0052] Referring to the embodiment shown in Figure 6A, the elongated introducer assembly 100 is configured to be relatively flexible (not very rigid). The elongated introducer assembly 100 is configured to collapse and / or bend in response to the distal portion of the elongated introducer assembly 100 striking the outer surface of the first biological wall 910 (or the pericardial layer 911 of the patient's heart). In this case, it may be less traumatic during positioning. The use of a relatively rigid example of the distal puncture device 202 or other rigid accessory devices may assist navigation through the tissue and may also allow the flexible introducer assembly 100 to perform the task initially. For example, the elongated introducer assembly 100 may include a tube with a hollow lumen to facilitate delivery of the puncture device. During the initial step, the elongated introducer assembly 100 is delivered through the patient's tissue. The elongated introducer assembly 100 may be rigid enough to allow this traverse. However, once positioned in the heart, the elongated introducer assembly 100 does not necessarily need to be rigid. As a result, a stiffer example of the distal puncture device 202 may be included, which can be used when traversing tissue by the elongated introducer assembly 100. The stiffer example of the distal puncture device 202 may be made of stainless steel and inserted into the lumen of the elongated introducer assembly 100. The distal puncture device 202 does not move relative to the elongated introducer assembly 100 while in place, and can be later removed following tissue traversal. The stiffer example of the distal puncture device 202 can also function as a conduit for transmitting EGM signals (in the case of option (B) of step (1)) or be connected to an EAM system to indicate the position of the distal tip of the introducer to the user while they first position the elongated introducer assembly 100 to the desired location relative to the patient's heart (in the case of option (A) of step (1)).

[0053] Figures 7A to 7F show cross-sectional views (Figures 7A, 7B, and 7E) and side views (Figures 7C, 7D, and 7F) of embodiments of the elongated guidewire assembly 200 of Figure 3A. Figures 7A and 7B show embodiments associated with option (A) of step (2). These options allow the user to know (detect) that the length of the distal segment 205 of the elongated guidewire assembly 200 extends (protrudes) from the distal end of the elongated introducer assembly 100. The length (of the distal segment 205 of the elongated guidewire assembly 200) is preferably an optimal length in order to reduce or minimize the amount of tenting force 700 that may be applied to the first outer surface 912 of the first biological wall 910 (or pericardial layer 911).

[0054] Referring to the embodiment shown in Figure 7A, the elongated guidewire assembly 200 is configured to be detectable by a medical imaging system (generally speaking). For example, the elongated guidewire assembly 200 includes a stretching coil 802 and a compression coil 804 mounted on the distal segment 205 of the elongated guidewire assembly 200. The stretching coil 802 and the compression coil 804 are spaced apart from each other. The stretching coil 802 is positioned between the compression coil 804 and the distal puncture device 202. The stretching coil 802 and the compression coil 804 are configured to be detectable by a medical imaging system. The stretching coil 802 and the compression coil 804 are configured to allow the user to visually observe (e.g., under fluoroscopy or X-ray) the distal segment 205 (i.e., the required or desired length of the distal segment 205 of the elongated guidewire assembly 200) when it protrudes from the distal portion of the elongated introducer assembly 100. The stretched coil 802 includes a section of coil having relatively sparse windings. The compressed coil 804 includes a section of coil having relatively dense windings.

[0055] Referring to the embodiment shown in Figure 7B, the elongated guidewire assembly 200 includes a distal coil 806 positioned on the distal segment 205 of the elongated guidewire assembly 200. The distal coil 806 is positioned in close proximity to the distal puncture device 202. The distal coil 806 is configured to be detectable by a medical imaging system. The distal coil 806 is configured to allow the user to visually observe (e.g., under fluoroscopy or X-ray) the distal segment 205 (i.e., the required or desired length of the distal segment 205 of the elongated guidewire assembly 200) when it protrudes from the distal portion of the elongated introducer assembly 100.

[0056] Referring to the embodiment shown in Figure 7C, the elongated guidewire assembly 200 includes a stretch coil 802 positioned between a pair of compression coils 804. The stretch coil 802 and the pair of compression coils 804 are mounted on the distal segment 205 of the elongated guidewire assembly 200. One of the coils of the pair of compression coils 804 is positioned in close proximity to the distal puncture device 202. The stretch coil 802 and the pair of compression coils 804 are configured to be detectable by a medical imaging system. The stretch coil 802 and the pair of compression coils 804 are configured to allow the user to visually observe (e.g., under fluoroscopy or X-ray) the distal segment 205 (i.e., the required or desired length of the distal segment 205 of the elongated guidewire assembly 200) when it protrudes from the distal portion of the elongated introducer assembly 100.

[0057] Referring to the embodiment shown in Figure 7D, the elongated guidewire assembly 200 includes a compression coil 804 mounted on the distal segment 205 of the elongated guidewire assembly 200. The compression coil 804 is configured to protrude from the distal portion of the elongated introducer assembly 100. The compression coil 804 includes radiopaque material fixed to the distal segment 205 configured to protrude from the distal end of the elongated introducer assembly 100. Alternatively, the radiopaque material is fixed to the distal segment 205 configured to protrude from the distal end of the elongated introducer assembly 100. The compression coil 804 and the radiopaque material are configured to be detectable by a medical imaging system. The compression coil 804 and radiopaque material are configured to allow the user to visually observe (e.g., under fluoroscopy or X-ray) the distal segment 205 (i.e., the required or desired length of the distal segment 205 of the elongated guidewire assembly 200) when it protrudes from the distal portion of the elongated introducer assembly 100.

[0058] Referring to the embodiment shown in Figure 7E, the elongated guidewire assembly 200 includes a first radiopaque marker 808A mounted on the distal segment 205 of the elongated guidewire assembly 200. A second radiopaque marker 808B is positioned adjacent to the first radiopaque marker 808A on the elongated guidewire assembly 200. The first radiopaque marker 808A and the second radiopaque marker 808B are configured to be detectable by a medical imaging system. The first radiopaque marker 808A and the second radiopaque marker 808B are configured to allow a user to visually observe (e.g., under fluoroscopy or X-ray) the distal segment 205 (i.e., the required or desired length of the distal segment 205 of the elongated guidewire assembly 200) when it protrudes from the distal portion of the elongated introducer assembly 100.

[0059] Referring to the embodiment shown in Figure 7F, the elongated guidewire assembly 200 includes an elbow portion 209 configured such that the distal segment 205 is positioned in the distal introducer exit portal 104 after it has extended from inside the elongated introducer assembly 100. A first radiopaque marker 808A is attached to the distal segment 205 of the elongated guidewire assembly 200. This is done in such a way that the first radiopaque marker 808A extends from inside the elongated introducer assembly 100 after the distal segment 205 has extended from inside the elongated introducer assembly 100. For example, the first radiopaque marker 808A may be positioned in close proximity to the distal puncture device 202. A second radiopaque marker 808B is attached to the distal segment 205. This is done in such a manner that the second radiopaque marker 808B remains inside the elongated guidewire assembly 100 after the distal segment 205 has extended out of the elongated guidewire assembly 100. For example, the second radiopaque marker 808B may be positioned close to the elbow portion 209. The first radiopaque marker 808A and the second radiopaque marker 808B are configured to be detectable by a medical imaging system. The first radiopaque marker 808A and the second radiopaque marker 808B are configured to allow the user to visually observe (e.g., under fluoroscopy or X-ray) the distal segment 205 (i.e., the required or desired length of the distal segment 205 of the elongated guidewire assembly 200) when it protrudes from the distal portion of the elongated guidewire assembly 100. Separated radiopaque markers (808A, 808B) can be used for depth measurement. Separated radiopaque markers (808A, 808B) can be placed in strategic sections on the elongated guidewire assembly 200. Separated radiopaque markers (808A, 808B) can provide the user with feedback on how far the elongated guidewire assembly 200 protrudes from the distal tip of the elongated introducer assembly 100.For example, spaced-out radiopaque markers (808A, 808B) are placed at approximately 10-millimeter intervals relative to the distal end of the elongated guidewire assembly 200, thereby providing feedback on how much the elongated guidewire assembly 200 protrudes when viewed under fluoroscopy or X-ray.

[0060] Referring to the embodiment shown in Figure 7G, a radiopaque marker 808C may also be embedded at its distal end on the elongated introducer assembly (see Figure 7G). When viewed by a medical imaging system, the user can then align the radiopaque marker on the elongated introducer assembly 100 between the two radiopaque markers (808A and 808B) on the elongated guidewire assembly 200 to ensure that the optimal length 204 of the distal segment 205 of the elongated guidewire assembly 200 is exposed for optimal application of tenting force to the first biological wall 912.

[0061] Referring to the embodiments shown in Figures 7A to 7G, the coil may include a radiopaque material fixed to the distal section of the elongated guidewire assembly 200. The coil may have areas of dense and sparse coil winding. The pattern of the coil winding may visually produce radiopaque breaks when viewed under medical imaging such as fluoroscopy or X-ray. For example, an indicator to the user regarding the ideal projection length of the distal portion of the elongated guidewire assembly 200 (from the distal tip of the elongated introducer assembly 100) may be a stretched coil that produces two different sections of dense winding. The first distal section with dense coil winding may indicate the ideal length of the distal segment 205 (of the elongated guidewire assembly 200) extending from the distal portion of the elongated introducer assembly 100, while the stretched coil section may indicate a location where the user may need to retract (retract) the elongated guidewire assembly 200 into the elongated introducer assembly 100.

[0062] Figures 8A, 8B, and 8C show cross-sectional views of an embodiment of the elongated guidewire assembly 200 of Figure 3A. Figures 8A, 8B, and 8C show embodiments associated with option (B) of step (2).

[0063] Referring to the embodiment shown in Figure 8A, the elongated guidewire assembly 200 includes a tactile portion 810 positioned on the distal segment 205 of the elongated guidewire assembly 200. This is done such that the tactile portion 810 extends from the elongated introducer assembly 100 after the distal segment 205 has extended at least partially from the elongated introducer assembly 100. The tactile portion 810 is configured to provide tactile feedback to a user in contact with the elongated guidewire assembly 200 indicating that the elongated guidewire assembly 200 has reached the optimal amount of protrusion of the distal segment 205 from the distal tip of the elongated introducer assembly 100. The tactile portion 810 is positioned on the distal segment 205 of the elongated guidewire assembly 200. The tactile portion 810 is positioned (on the length of the distal segment 205 of the elongated guidewire assembly 200). This is done in such a way that the length of the distal segment 205 of the elongated guidewire assembly 200 extends away from the interior of the elongated introducer assembly 100, after which the tactile portion 810 is exposed (i.e., positioned outside the elongated introducer assembly 100).

[0064] Referring to embodiments shown in Figures 8B and 8C, the tactile portion 810 may be installed on the proximal guidewire section of the elongated guidewire assembly 200 (the proximal guidewire section extends outward from the proximal end of the elongated introducer assembly 100). The tactile portion 810 may be installed on the distal segment 205 of the elongated guidewire assembly 200. Depending on the choice, the tactile portion 810 may be installed on the proximal and distal sections of the elongated guidewire assembly 200 (optionally). The tactile portion 810 may include any tactile indicator configured to distinguish one section of the elongated guidewire assembly 200 from another section of the elongated guidewire assembly 200 based on (user) tactile sensation. The tactile portion 810 is configured to give the user tactile feedback that it has reached the optimal amount of protrusion of the elongated guidewire assembly 200 from the distal tip of the elongated introducer assembly 100. The tactile portion 810 may include a sudden change in the outer diameter of at least one section of the elongated guidewire assembly 200 that can be sensed by the user's hand (or with which the distal portion of the elongated introducer assembly 100 may interact). The tactile portion 810 may include knurling and / or grooves formed on the outer surface of the elongated guidewire assembly 200, or other types of recesses and / or raised sections that feel different from the rest of the elongated guidewire assembly 200.

[0065] Figure 9 shows a side view of one embodiment of the elongated guidewire assembly 200 of Figure 3A. Figure 9 shows an embodiment associated with option (C) of step (2).

[0066] Referring to the embodiment shown in Figure 9, the elongated guidewire assembly 200 includes a proximal visual marker 814 positioned at the proximal end of the elongated guidewire assembly 200. The elongated introducer assembly 100 includes a hub 812. The proximal visual marker 814 of the elongated guidewire assembly 200 is configured to extend away from the hub 812 of the elongated introducer assembly 100 in such a manner that the proximal visual marker 814 is exposed and can be visually detected by the user (in response to the movement of the elongated guidewire assembly 200 away from the hub 812 proximally). The proximal visual marker 814 is visually distinct from the rest of the elongated guidewire assembly 200. The proximal visual marker 814 is configured to visually indicate that the optimal length of the elongated guidewire assembly 200 protrudes from the distal end of the elongated introducer assembly 100.

[0067] Figure 10 shows a cross-sectional view of one embodiment of the elongated guidewire assembly 200 of Figure 3A. Figure 10 shows an embodiment associated with option (D) of step (2).

[0068] Referring to the embodiment shown in Figure 10, the optimal amount of distal length 204 (of the distal segment 205 of the elongated guidewire assembly 200) is the length extending from the distal injector exit portal 104. The optimal amount of distal length 204 is configured to transmit a desired amount of tenting force 700 (shown in Figure 3) which is applied from the optimal amount of distal length 204 (of the distal segment 205 of the elongated guidewire assembly 200) to the first biological wall 910 (or pericardial layer 911), as shown in Figure 3A. The elongated injector assembly 100 includes a sensor 816 (such as a capacitance sensor) positioned at the distal injector exit portal 104 of the elongated injector assembly 100. The sensor 816 is configured to provide an indication signal, which indicates that the optimal amount of distal length 204 of the distal segment 205 of the elongated guidewire assembly 200 is protruding from the distal tip of the elongated injector assembly 100. For example, a capacitance sensor is configured to generate an electric field and determine whether the electric field is disturbed. A capacitance sensor positioned in the distal section of the elongated guidewire assembly 100 may be optimized to indicate that the distal puncture device 202 (of the elongated guidewire assembly 200) extends a critical distance (length) from the distal guidewire exit portal 104 (of the elongated guidewire assembly 100). This arrangement allows the user to determine that the distal section of the elongated guidewire assembly 200 extends (protrudes) a sufficient distance from the distal portion of the elongated guidewire assembly 100.

[0069] Figures 11A and 11B show schematic diagrams of embodiments of the elongated guidewire assembly 200 of Figure 3A. Figures 11A and 11B show embodiments associated with option (A) of step (3).

[0070] Referring to the embodiments shown in Figures 11A and 11B, the heart 940 is positioned in a systolic or contractile state (shown in Figure 11A) and a relaxed or diastolic state (shown in Figure 11B). The first outer surface 912A (shown in Figure 11B) is positioned during the relaxed state of the heart 940. The elongated guidewire assembly 200A (shown in Figure 11B) is positioned during the relaxed state of the heart 940. The heart 940 moves the distal puncture device 202 (of the elongated guidewire assembly 200) in response to the heart's beating. The distal puncture device 202 (of the elongated guidewire assembly 200) is positioned in contact with the first outer surface 912 (of the pericardial layer 911 of the heart). Once in contact with the heart 940, the distal puncture device 202 may move synchronously with the heart's beating. This collaborative movement can be visualized on a medical imaging system (such as a fluoroscopy system or an X-ray system). The user can see the synchronized movement of the distal puncture device 202 and the cardiac movement (of the heart 940) on the display of the medical imaging system and identify whether they (i.e., the distal puncture device 202 and the heart 940) are in contact with each other, and thus the user can be in a good position to continue puncturing the first outer surface 912 (of the pericardial layer of the heart 940).

[0071] Referring to the embodiments shown in Figures 11A and 11B, the motion behavior of the distal segment 205 of the elongated guidewire assembly 200 can be detected when the distal segment 205 is positioned close to a biological feature such as the heart, by utilizing observation of the distal segment 205 via a medical imaging system (such as an X-ray machine). The distal segment 205 of the elongated guidewire assembly 200 tends to be stable before reaching the heart, but once the distal segment 205 lies on the first outer surface 912 of the first biological wall 910 (or pericardial layer 911), or thereafter, the distal segment 205 may tend to move with the movement (beat) of the heart. As a way to confirm that adequate contact has been established between the distal segment 205 and the first outer surface 912 of the first biological wall 910, this observation state (observed via a medical imaging system such as an X-ray machine) can be used to confirm that the distal segment 205 can reach the first outer surface 912 of the first biological wall 910.

[0072] Without referring to any drawings, it will be understood that the optional step (B) of step (3), which is not shown, involves sensing the tenting force transmitted to the heart. A force contact sensing device (not shown) is positioned (on) the distal portion of the elongated guidewire assembly 200 (preferably in a length extending from the distal portion of the elongated introducer assembly 100). The force contact sensing device is configured to provide a signal indicating whether physical contact has occurred between the distal portion of the elongated guidewire assembly 200 and the first outer surface 912 (of the pericardial layer of the heart 940).

[0073] Without referring to any drawings, it will be understood that the option (C) of step (3), which is not illustrated, involves setting the stiffness of the protruding section of the elongated guidewire assembly 200 to preferably exceed the critical myocardial puncture threshold. The stiffness of the distal section of the elongated guidewire assembly 200 (protruding or extending from the distal section of the elongated introducer assembly 100) may be adjusted to ensure that there is insufficient tenting force for the distal puncture device 202 to puncture through the second outer surface 922 of the second biological wall 920 (such as the myocardial layer 921). Therefore, with a set projection length (shown in Figure 10) of the distal portion of the elongated guidewire assembly 200 that can provide the stiffness (of the optimized length of the distal segment 205 shown in Figure 10) to puncture through the second outer surface 922 of the second biological wall 920 (or myocardial layer 921), there may be no position where the distal puncture device 202 (of the elongated guidewire assembly 200) can be positioned, thus resulting in puncture of only the first biological wall 910 (or pericardial layer 911). Furthermore, lower stiffness of the length of the distal segment 205 (of the elongated guidewire assembly 200) may reduce the likelihood of puncture. For example, burn marks may be formed on the second biological wall 920 (or myocardial layer 921) after the elongated guidewire assembly 200 has advanced into the biological space 930 (or pericardial space 931) due to the radiation of high-frequency energy emitted from the distal puncture device 202.

[0074] Figures 12A and 12B show a cross-sectional view (Figure 12A) and a schematic view (Figure 12B) of an embodiment of the elongated guidewire assembly 200 shown in Figure 3A.

[0075] Referring to Figures 12A and 12B, embodiments associated with option (D) of step (3) are shown.

[0076] Referring to the embodiment shown in Figure 12A, the distal puncture device 202 is positioned to contact the heart 940 and can be visualized on the system display of the medical imaging system.

[0077] Referring to the embodiment shown in Figure 12B, a visualization of the distal puncture device 202 (of the elongated guidewire assembly 200) on the display of the electroanatomical mapping system is shown. A first medical image 401 is associated with the distal puncture device 202 in Figure 12A. A second medical image 402 is associated with the heart 940 in Figure 12A. The electroanatomical mapping system allows the user to map the three-dimensional anatomical structure of the heart 940. The electroanatomical mapping system is configured to track the location of the elongated guidewire assembly 200 (if the elongated guidewire assembly 200 is installed in electrical communication with the electroanatomical mapping system). If the distal puncture device 202 is configured to selectively emit energy (high-frequency energy), the electroanatomical mapping system may provide visual indication of the location of the distal puncture device 202, which allows the user to determine whether contact exists between the distal puncture device 202 and the heart (as shown in Figure 12B).

[0078] Without referring to any drawings, it will be understood that option (E) of step (3) involves using an electromagnetism (EGM) system to confirm contact. The electromagnetism system is configured to measure the potential of tissue. If the distal puncture device 202 is configured to radiate energy (high-frequency energy) with a material in its distal section (of the elongated guidewire assembly 200) that is suitable for conducting electrical signals and can be connected to an electromagnetism system, then the state of electrical signal conduction may provide feedback (to the user) indicating whether the distal puncture device 202 is in contact with (or not in contact with) the heart 940. Contact will result in local ischemia, which will manifest as an elevation of the ST segment of the electrical signal. Using this relationship may help confirm contact between the distal puncture device 202 and the heart.

[0079] Figure 13 shows a cross-sectional view of one embodiment of the elongated guidewire assembly 200 of Figure 3A. Figure 13 shows an embodiment associated with option (F) of step (3).

[0080] Referring to the embodiment shown in Figure 13, the contrast agent 818 can be injected along the inlet lumen 102 of the elongated inlet assembly 100, flow through the interior, and exit through the distal inlet exit portal 104. The contrast agent 818 is detectable by the medical imaging system. This is done in such a manner that the contrast agent 818 produces a visual effect that is displayed to the medical imaging system for determining whether the distal puncture device 202 is in contact with the heart 940. The contrast agent 818 is configured to produce a greater visual effect for the user to determine whether the distal puncture device 202 is in contact with the heart 940. The contrast agent 818 may be injected through the inlet lumen 102, and the distal puncture device 202 may be positioned accordingly. The contrast agent 818 can enhance surfaces and contours on the display of the fluoroscopy system or X-ray imaging system, thereby providing an improved image outline of the cardiac silhouette (of the heart 940) (at least partially). More specifically, the cardiac region 940, where the distal introducer exit portal 104 (of the elongated introducer assembly 100) and the distal segment 205 (of the elongated guidewire assembly 200) are positioned near the contrast agent 818. A medical imaging display may show a dark section associated with the contrast agent 818. This arrangement makes visualization (for the user) and determination of whether the distal puncture device 202 and the heart 940 can come into contact with each other easier.

[0081] Figure 14 shows a cross-sectional view of one embodiment of the elongated guidewire assembly 200 of Figure 3A. Figure 14 shows an embodiment associated with option (G) of step (3).

[0082] Referring to the embodiment shown in Figure 14, the elongated guidewire assembly 200 includes a first wire 821 and a second wire 822. The first wire 821 and the second wire 822 are configured to contact each other in response to the distal length 204 becoming less than an optimal length. The first wire 821 and the second wire 822 are configured to disconnect from each other in response to the distal length 204 becoming greater than an optimal length. The elongated guidewire assembly 200 includes an optimal distal portion 206 positioned in contact with and adjacent to the distal introducer exit portal 104 (after the optimal amount of distal length 204, also shown in Figure 10, extends from the distal introducer exit portal 104). When the maximum desired amount of tenting force 700 is reached, the first wire 821 and the second wire 822 are electrically disconnected from each other, thereby interrupting the electrical circuit and stopping the delivery of energy (radio frequency energy) to the distal puncture device 202. In this way, the puncture may be formed through the first biological wall 910 (or pericardial layer 911) but may not be performed if (A) an excessive amount of tenting force 700 is reached (which may inadvertently puncture the second biological wall 920 or the second outer surface 922 of the myocardial layer 921), or (B) the distal puncture device 202 bends away from the first outer surface 912 of the first biological wall 910 (or pericardial layer 911). The first wire 821 and the second wire 822 are configured to contact each other in response to the distal length 204 becoming shorter than the optimal length (i.e., after the distal segment 205 of the elongated guidewire assembly 200 has emerged from the distal introducer exit portal 104 of the elongated introducer assembly 100). The first wire 821 and the second wire 822 are configured to disconnect from each other in response to the distal length 204 becoming greater than the optimal length (i.e., after the distal segment 205 of the elongated guidewire assembly 200 protrudes from the distal introducer exit portal 104 of the elongated introducer assembly 100).

[0083] Without referring to any drawings, it will be understood that option (H) in step (3) involves positioning the distal puncture device in a region where the cardiac motion perpendicular to the elongated introducer assembly 100 is minimized. Minimizing this motion reduces the variation in tenting force transmitted along the elongated guidewire assembly from the distal segment to the first biological wall. This reduction in tenting force ensures a more consistent and predictable puncture through the pericardial layer.

[0084] Without referring to any drawings, it will be understood that option (A) in step (4) involves activating radiofrequency energy for the duration it takes to vaporize the pericardium, thereby optimizing the duration for which radiofrequency energy is applied. The duration of the radiofrequency application can be optimized to ensure that the radiofrequency energy is activated only for the duration it takes to puncture through the pericardial layer.

[0085] Without referring to any drawings, it will be understood that option (B) of step (4) involves activating radiofrequency energy from the distal puncture device 202 for less than approximately 0.5 seconds. A radiofrequency activation time of less than approximately 0.5 seconds can minimize damage to the myocardial layer and ensure successful puncture of the pericardial layer.

[0086] Without referring to any drawings, it will be understood that option (C) of step (4) involves turning off the emission of energy (such as radiofrequency energy) from the distal puncture device 202 in response to the detection of an impedance change associated with puncturing the first outer surface 912 of the first biological wall 910 (or pericardial layer 911). Real-time impedance measurement may be performed by the distal puncture device 202 (if the distal puncture device 202 is configured to emit radiofrequency energy). The impedance value may change from the outside of the heart 940 to the inside of the pericardial space 931. When this impedance change is detected, the delivery of radiofrequency energy may be cut off to ensure that no further tissue puncture occurs.

[0087] Without referring to any drawings, it will be understood that the laterally mounted distal puncture device is configured to emit energy (radio frequency energy) and is mounted on the lateral portion of the distal puncture exit portal 104 of the elongated puncture device assembly 100.

[0088] Without referring to any drawings, it will be understood that the elongated guidewire assembly 200 may include a laterally mounted distal puncture device configured to radiate energy (high-frequency energy) and attached to the lateral portion of the distal end of the elongated guidewire assembly 200.

[0089] Without referring to any drawings, it will be understood that the elongated guidewire assembly 200 includes an elongated electrode configured to radiate energy (high-frequency energy).

[0090] Figures 15 to 22 show cross-sectional views of an embodiment of the elongated guide wire assembly 200 shown in Figure 3A.

[0091] Referring to the embodiment shown in Figure 15, the heart 940 of patient 900 is positioned in close proximity to the diaphragm 942, and the diaphragm is positioned in close proximity to the liver 944. The elongated introducer assembly 100 is installed (at least partially) within patient 900. This is done in such a manner that the distal portion of the elongated introducer assembly 100 is positioned in close proximity to the heart 940 of patient 900. In this way, percutaneous delivery of the elongated guidewire assembly 200 to the first outer surface 912 of the first biological wall 910 (or the pericardial layer 911 of the heart 940) can be achieved via the elongated introducer assembly 100.

[0092] Referring to the embodiment shown in Figure 16, the elongated guidewire assembly 200 is inserted into and along the elongated induction assembly 100 (through the induction lumen 102) and advances (extends). This is done in such a manner that the length of the distal segment 205 of the elongated guidewire assembly 200 can advance (extend) from the distal induction exit portal 104 of the elongated induction assembly 100 in order to position the distal section of the elongated guidewire assembly 200 against or on the first outer surface 912 of the first biological wall 910 (or pericardial layer 911) of the heart 940.

[0093] Referring to the embodiment shown in Figure 17, the length of the distal segment 205 of the elongated guidewire assembly 200 advances (extends) from the distal introducer exit portal 104 of the elongated introducer assembly 100 (through the introducer lumen 102). This is done in such a manner that, during use, the distal length 204 of the distal segment 205 of the elongated guidewire assembly 200 contacts (lies over) the first outer surface 912 of the first biological wall 910 (or pericardial layer 911) of the heart 940. The distal puncture device 202 (of the elongated guidewire assembly 200) also contacts the first outer surface 912 (after the distal section of the elongated guidewire assembly 200 has extended from the elongated introducer assembly 100).

[0094] Referring to the embodiment shown in Figure 18, an enlarged cross-sectional view is shown of the length of the distal section of the elongated guidewire assembly 200 extending from the distal guidewire exit portal 104 of the elongated guidewire assembly 100 (through the guidewire lumen 102). The distal length 204 of the distal segment 205 of the elongated guidewire assembly 200 contacts (lies on) the first outer surface 912 of the first biological wall 910 (or pericardial layer 911) when in use. Conveniently, this arrangement simply avoids the possible (unwanted) transmission (or concentration) of the entire amount of tenting force from the distal puncture device 202 (of the elongated guidewire assembly 200) toward the first outer surface 912. It will be understood that concentrated application of tenting force could, perhaps, also unintentionally, cause unwanted damage to the second biological wall 920 or the second outer surface 922 of the myocardial layer 921. Conveniently, the amount of tenting force is distributed across the first outer surface 912, thereby creating a relatively safe condition for puncturing through the first outer surface 912, and thereby at least partially avoiding damage to the second outer surface 922. In this method or arrangement, as shown in Figure 18, the tenting force applied from (by) the distal segment 205 (extending from the distal puncture device 202 of the elongated guidewire assembly 200) can be distributed along the distal length 204 of the elongated guidewire assembly 200 that is in contact with the first outer surface 912. The tenting force applied through the distal length 204 of the distal segment 205 of the elongated guidewire assembly 200 (towards the first outer surface 912) remains relatively low in response to potential changes in the displacement and / or positioning of the elongated introducer assembly 100 relative to the first outer surface 912. This arrangement gives the physician a relatively large degree of freedom to deal with situations when attempting to apply a tenting force to the first outer surface 912 (via the operation of the elongated guidewire assembly 200 and / or the elongated introducer assembly 100), thereby reducing the influence of mechanical motion on the distal segment of the elongated guidewire assembly 200 (with respect to the application of a tenting force to the first outer surface 912).The distal segment 205 of the elongated guidewire assembly 200 extends from the distal introduction device exit portal 104, and after the distal length 204 of the distal segment 205 of the elongated guidewire assembly 200 contacts the first outer surface 912, a tenting force may be applied to the distal length 204 of the distal segment 205 of the elongated guidewire assembly 200 toward the first outer surface 912, and then the distal puncture device 202 (of the elongated guidewire assembly 200) may be used (activated) to form a puncture hole through the first outer surface 912 (preferably without causing unnecessary damage to the second biological wall 920 or myocardial layer 921).

[0095] Referring to the embodiment shown in Figure 19, a distal puncture device 202 (of an elongated guidewire assembly 200) is used to puncture through the first biological wall 910 (or pericardial layer 911). Preferably, the distal puncture device 202 is configured to emit energy (radio frequency energy) to puncture through the first biological wall 910.

[0096] Referring to the embodiment shown in Figure 20, after the first biological wall 910 (or pericardial layer 911) is punctured by the distal puncture device 202 (of the elongated guidewire assembly 200), the elongated guidewire assembly 200 advances into the biological space 930 (or pericardial space 931). The direction of advancement of the distal section of the elongated guidewire assembly 200 is aligned substantially parallel to the heart 940, rather than perpendicular to the heart 940 (i.e., the direction of advancement is aligned along the second outer surface 922 of the second biological wall 920 or myocardial layer 921). This arrangement further reduces (at least partially) the possibility of inadvertent puncture of the second biological wall 920 (or myocardial layer 921).

[0097] Referring to the embodiment shown in Figure 21, following the successful puncture of the first biological wall 910 (or pericardial layer 911) (as shown in Figure 20), the distal segment of the guidewire assembly 200 advances into and along the biological space 930 (or pericardial space 931). The distal segment of the elongated guidewire assembly 200 is advanced along the surface region of the second biological wall 920 (or myocardial layer 921 of the heart 940) and wrapped around the cardiac silhouette (of the heart 940). It will be understood that a portion of the distal segment of the elongated guidewire assembly 200 remains in the biological space 930 (or pericardial space 931), while another portion of the distal segment of the elongated guidewire assembly 200 advances along the surface region of the second biological wall 920 (or myocardial layer 921). In this way, the distal segment of the elongated guidewire assembly 200 confirms access (to the second biological wall 920 (or the myocardial layer 921 of the heart 940)). The elongated introducer assembly 100 then advances toward the access site and is used to dilate the puncture hole (extending through the first biological wall 910 or pericardial layer 911) created by the operation (utilization) of the distal puncture device 202 of the elongated guidewire assembly 200. The elongated introducer assembly 100 is removed from the patient 900, and a known delivery device is manipulated forward along the guidewire assembly and positioned in close proximity to the heart 940, after which the puncture hole is dilated (by the elongated introducer assembly 100) to allow delivery of a known therapeutic device (not shown).

[0098] Referring to the embodiment shown in Figure 22, access to the second biological wall 920 (i.e., access through a puncture hole formed through the first biological wall 910) is ensured. Preferably, the access site is enlarged. With the elongated guidewire assembly 200 maintaining access (to the second biological wall 920), the elongated introducer assembly 100 can be removed (pulled out), and thus the elongated guidewire assembly 200 can be used (if necessary) to deliver (deploy) a known therapeutic device. The elongated introducer assembly 100 (shown in Figure 21) can be completely removed from the patient 900 (shown in Figure 22) and discarded, leaving the elongated guidewire assembly 200 positioned within the patient 900. The elongated guidewire assembly 200 remains at least partially within the patient 900 and is (at least partially) wrapped around the heart 940. The distal segment of the elongated guidewire assembly 200 remains positioned close to the second biological wall 920 (or myocardial layer 921) of the heart 940. A known therapeutic device (not shown) can be manipulated along the elongated guidewire assembly 200 toward the distal segment of the elongated guidewire assembly 200, through the puncture site, past the first biological wall 910 (of the pericardial layer 911), and into the biological space 930 (or pericardial space 931). This is done in such a manner that the known therapeutic device is positioned in the biological space 930 and close to the second biological wall 920 (or myocardial layer 921) of the heart 940, so that the known therapeutic device can be used to deliver the procedure to the second biological wall 920 of the heart 940. During the deployment of the known therapeutic device, it is preferable that the distal puncture device 202 (of the elongated guidewire assembly 200) remains stopped (unused) while the known therapeutic device is being deployed.

[0099] The following are proposed as further descriptions of embodiments in which any one or more arbitrary technical features (described in the Detailed Description, Abstract, and Claims) can be combined with any one or more other arbitrary technical features (described in the Detailed Description, Abstract, and Claims). Each claim in the paragraph of Claims is understood to be a non-limiting claim unless otherwise specified. Unless otherwise specified, the terms used in these specifications should be interpreted as including certain tolerances that a person skilled in the art would recognize as providing equivalent functionality. For example, the term "perpendicular" is not necessarily limited to 90.0 degrees, but may include variations thereof that a person skilled in the art would recognize as providing equivalent functionality for the purposes described for the relevant member or element. Terms such as "about" and "substantially" in the context of configuration generally refer to an arrangement, configuration, or arrangement of the relevant element that is exactly or sufficiently close to the arrangement, configuration, or arrangement of the element in question, in order to maintain the operability of the element in the Disclosure that does not substantially alter the Disclosure. Similarly, unless otherwise made clear from its context, numerical values ​​should be interpreted as including certain tolerances that a person skilled in the art would recognize as negligible in importance because they do not substantially alter the operability of the Disclosure. It will be understood that the description and / or drawings identify and describe (either explicitly or essentially) embodiments of the apparatus. The apparatus may include any preferred combination and / or rearrangement of the technical features identified in the detailed description, as required and / or desired to suit a particular technical purpose and / or technical function. It will be understood that, where possible and preferred, any one or more technical features of the apparatus may be combined with any one or more other technical features of the apparatus (in any combination and / or rearrangement). It will be understood that a person skilled in the art will know that, even if not explicitly stated above, the technical features of each embodiment may be expanded upon in other embodiments. A person skilled in the art will understand that other options are possible for the configuration of the components of the apparatus, adapting to manufacturing requirements and remaining within the scope described in at least one or more of the claims.This specification provides embodiments including the best mode and enables those skilled in the art to fabricate and use the embodiments. The patentable scope may be defined by the claims. Written descriptions and / or drawings may be helpful in understanding the claims. It is assumed that all essential aspects of the disclosed subject matter are provided in this document. In this document, the word “includes” is understood to be equivalent to the word “comprising,” in that both words are used to indicate presuppositions, components, parts, or other non-limiting lists. The term “comprising,” which is synonymous with the terms “including,” “containing,” or “characterized by,” is comprehensive or non-limiting and does not exclude additional, unlisted elements or method steps. “Comprising” (comprised of) is a “non-limiting” phrase and allows for the scope of application of art that employs additional, unlisted elements. When used in a claim, the word “comprising” is a temporary verb (transitional term) that separates the preamble of the claim from the technical features of the present disclosure. The foregoing outlines non-limiting embodiments. The description is made with respect to specific non-limiting embodiments. It is understood that non-limiting embodiments are merely illustrative examples.

Claims

1. A device for use with a first biological wall of a patient, and an elongated introduction assembly configured to be selectively operated and positioned in close proximity to the first biological wall, wherein the device is The system comprises an elongated guidewire assembly having a distal segment configured to be selectively operated along the elongated introducer assembly, The apparatus wherein the distal segment is configured to at least partially contact the first biological wall, selectively extend the distal segment away from the longitudinal axis of the elongated introducer assembly, and then selectively transmit tenting forces from the elongated guidewire assembly to the first biological wall.

2. A device for use with an elongated induction assembly having a first biological wall of a patient, a second biological wall positioned adjacent to the first biological wall, and a distal induction outlet portal configured to be selectively operated and positioned adjacent to the first biological wall, wherein the device is The system comprises an elongated guidewire assembly having a distal segment that terminates with a distal puncture device configured to be selectively operated along the elongated introduction assembly, The distal segment has a distal length and is configured to at least partially contact the first outer surface of the first biological wall in response to a selective extension movement of the distal segment and the distal puncture device away from the distal insertion device exit portal after the distal insertion device exit portal has been operated in close proximity to the first outer surface of the first biological wall. The apparatus wherein the distal segment is configured such that the distal length of the distal segment contacts at least partially the first outer surface of the first biological wall without damaging the second biological wall which is positioned in close proximity to the first biological wall, and then selectively transmits the tenting force from the elongated guidewire assembly to the first biological wall in response to the application of a tenting force at least partially along the elongated guidewire assembly.

3. The apparatus according to claim 2, wherein the distal segment is configured to be deflected away from the longitudinal axis extending through the elongated introducer assembly by the first outer surface of the first biological wall in response to the distal length at least partially contacting the first outer surface of the first biological wall after the elongated guidewire assembly has been extended from the elongated introducer assembly.

4. The apparatus according to claim 2, wherein the distal length of the distal segment is also configured to selectively transmit the tenting force while puncturing through the first biological wall using the distal puncture device.

5. The apparatus according to claim 2, wherein the elongated guidewire assembly is configured to be detectable by a medical imaging system.

6. The apparatus according to claim 2, wherein the elongated introduction assembly is configured to be detectable by a medical imaging system.

7. The aforementioned elongated guide wire assembly, The elongated guidewire assembly includes a stretching coil and a compression coil attached to the distal segment, The stretching coil and the compression coil are separated from each other. The stretching coil is positioned between the compression coil and the distal puncture device. The apparatus according to claim 2, wherein the stretching coil and the compression coil are configured to be detectable by a medical imaging system.

8. The aforementioned elongated guide wire assembly, The assembly includes a distal coil positioned in the distal segment of the elongated guidewire assembly, The distal coil is positioned in close proximity to the distal puncture device. The apparatus according to claim 2, wherein the distal coil is configured to be detectable by a medical imaging system.

9. The aforementioned elongated guide wire assembly, Includes a stretching coil positioned between a pair of compression coils, The stretching coil and the pair of compression coils are mounted on the distal segment of the elongated guidewire assembly. One of the pair of compression coils is positioned in close proximity to the distal puncture device. The apparatus according to claim 2, wherein the stretching coil and the pair of compression coils are configured to be detectable by a medical imaging system.

10. The aforementioned elongated guide wire assembly, A compression coil attached to the distal segment of the elongated guidewire assembly, A compression coil is configured to protrude from the distal portion of the elongated introduction assembly, A radiopaque material fixed to the distal segment is configured to protrude from the distal portion of the elongated introducer assembly, The apparatus according to claim 2, wherein the compression coil and the radiopaque material are configured to be detectable by a medical imaging system.

11. The aforementioned elongated guide wire assembly, A first radiopaque marker A is attached to the distal segment of the elongated guidewire assembly, The present invention includes a second radiopaque marker B positioned in close proximity to the first radiopaque marker, The apparatus according to claim 2, wherein the first radiopaque marker A and the second radiopaque marker B are configured to be detectable by a medical imaging system.

12. The aforementioned elongated guide wire assembly, A first radiopaque marker A is attached to the distal segment of the elongated guidewire assembly, The elongated guidewire assembly includes a second radiopaque marker B positioned in close proximity to the first radiopaque marker A on the elongated guidewire assembly, and the elongated introducer assembly is The radiopaque marker C is positioned in the distal section of the elongated introducer assembly and is aligned between the first radiopaque marker A and the second radiopaque marker B of the elongated guidewire assembly to ensure optimal projection of the distal segment against the first biological wall and optimal application of tenting force, The apparatus according to claim 2, wherein the first radiopaque marker A, the second radiopaque marker B, and the radiopaque marker C are configured to be detectable by a medical imaging system.

13. The aforementioned elongated guide wire assembly, The distal segment is configured to extend from the inside of the elongated inlet assembly and then be positioned at the distal inlet exit portal, and the elbow portion is configured to A first radiopaque marker A, which is attached to the distal segment of the elongated guidewire assembly such that the first radiopaque marker A extends out of the interior of the elongated guidewire assembly after the distal segment extends at least partially out of the interior of the elongated guidewire assembly, A second radiopaque marker B, which is attached to the distal segment such that the second radiopaque marker B remains inside the elongated introducer assembly after the distal segment has extended out of the elongated introducer assembly, The apparatus according to claim 2, wherein the first radiopaque marker A and the second radiopaque marker B are configured to be detectable by a medical imaging system.

14. The aforementioned elongated guide wire assembly, The apparatus according to claim 2, comprising a tactile portion configured to provide tactile feedback, wherein the tactile feedback indicates that the elongated guidewire assembly has reached the optimal protrusion of the distal segment from the distal tip of the elongated introducer assembly.

15. The aforementioned elongated guide wire assembly, A tactile portion, positioned on the distal segment of the elongated guidewire assembly, such that the tactile portion extends from the interior of the elongated guidewire assembly after the distal segment extends at least partially from the interior of the elongated guidewire assembly, The apparatus according to claim 2, wherein the tactile portion is configured to provide tactile feedback, the tactile feedback indicating that the elongated guidewire assembly has reached the optimal protrusion amount of the distal segment from the distal tip of the elongated introducer assembly.

16. The elongated guidewire assembly includes a proximal visual marker positioned at the proximal end of the elongated guidewire assembly, The elongated introduction assembly includes a hub, The apparatus according to claim 2, wherein the proximal visual marker is configured to extend away from the hub of the elongated introducer assembly in such a manner that the proximal visual marker is exposed and visually detectable.

17. The elongated inlet assembly includes a sensor positioned at the distal inlet outlet portal of the elongated inlet assembly, The apparatus according to claim 2, wherein the sensor is configured to provide an instruction signal, the instruction signal indicating that the distal length of the distal segment of the elongated guidewire assembly protrudes from the distal inlet exit portal of the elongated inlet assembly.

18. The contrast agent, which can be injected along the lumen of the elongated inlet assembly, flows through the interior and out through the distal inlet outlet portal. The apparatus according to claim 2, wherein the contrast agent is detectable by the medical imaging system in such a manner that it causes the medical imaging system to create a visual effect that is displayed for determining whether the distal puncture device is in contact with the patient's heart.

19. The aforementioned elongated guide wire assembly, Including a first wire and a second wire, The first wire and the second wire are configured to come into contact with each other in response to the distal length being less than the optimal length after the distal segment of the elongated guidewire assembly protrudes from the distal inlet exit portal of the elongated inlet assembly. The apparatus according to claim 2, wherein the first wire and the second wire are configured to disconnect from each other in response to the distal length being greater than the optimal length after the distal segment of the elongated guide wire assembly protrudes from the distal inlet exit portal of the elongated inlet assembly.

20. The elongated introduction assembly includes a sensor, The apparatus according to claim 2, wherein the sensor is configured to be electrically connected to a medical detection system configured to provide feedback on the location in which the elongated introducer assembly is positioned within the patient, based on information provided by the sensor of the elongated introducer assembly.

21. A device for use with the patient's first biological wall, wherein the device is An elongated introducer assembly configured to be selectively manipulated and positioned in close proximity to the first biological wall, A long, slender guidewire assembly having a distal segment configured to be selectively operated along the long, slender introducer assembly, The apparatus wherein the distal segment is configured to at least partially contact the first biological wall, selectively extend the distal segment away from the elongated introducer assembly, and then selectively transmit tenting forces from the elongated guidewire assembly to the first biological wall.

22. A device for use with a first biological wall of a patient and a second biological wall positioned adjacent to the first biological wall, wherein the device is An elongated inlet assembly having a distal inlet outlet portal configured to be selectively operated and positioned in close proximity to the first biological wall, The system comprises an elongated guidewire assembly having a distal segment terminating at a distal puncture device configured to be selectively operated along the elongated introduction assembly, The distal segment has a distal length and is configured to at least partially contact the first outer surface of the first biological wall in response to a selective extension movement of the distal segment and the distal puncture device away from the distal insertion device exit portal after the distal insertion device exit portal has been operated in close proximity to the first outer surface of the first biological wall. The apparatus wherein the distal segment is configured such that the distal length of the distal segment contacts at least partially the first outer surface of the first biological wall without damaging the second biological wall which is positioned in close proximity to the first biological wall, and then selectively transmits the tenting force from the elongated guidewire assembly to the first biological wall in response to the application of a tenting force at least partially along the elongated guidewire assembly.

23. A method for use with a first biological wall of a patient, and an elongated introducer assembly configured to be selectively operated and positioned in close proximity to the first biological wall, wherein the method is Selectively manipulating an elongated guidewire assembly having a distal segment along the elongated introducer assembly, A method comprising: selectively extending the distal segment away from the elongated introducer assembly such that the distal segment is at least partially in contact with the first biological wall and at least a portion of the distal segment is parallel to the first biological wall; and selectively transmitting a tenting force from the elongated guidewire assembly to the first biological wall via the distal segment.

24. A method for using an elongated guidewire assembly and an elongated introduction device assembly together with a first biological wall of a patient and a second biological wall positioned in close proximity to the first biological wall, wherein the method is Selectively manipulating the elongated guidewire assembly having a distal segment terminating at a distal puncture device along the elongated introduction assembly, After the distal insertion device exit portal is operated in close proximity to the first outer surface of the first biological wall, the distal segment and the distal puncture device are selectively extended away from the distal insertion device exit portal, After selectively extending the distal segment and the distal puncture device away from the distal insertion device exit portal, the distal segment having a distal length is brought into at least partial contact with the first outer surface of the first biological wall, After the distal length of the distal segment is at least partially in contact with the first outer surface of the first biological wall, and at least a portion of the distal segment is parallel to the first biological wall, a tenting force is at least partially applied along the elongated guidewire assembly. A method comprising: applying the tenting force to the elongated guidewire assembly, and then transmitting the tenting force from the elongated guidewire assembly to the first biological wall via the distal segment, without damaging the second biological wall which is positioned in close proximity to the first biological wall.

25. The method according to claim 23, wherein the elongated introducer assembly is used, and the sensor is configured to be electrically connected to a medical detection system configured to provide feedback on where the elongated introducer assembly is positioned within the patient, based on information provided by the sensor of the elongated introducer assembly.

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