Deflectable elongate guidewire assembly

Abstract

An elongated guidewire assembly has a distal segment configured to be selectively manipulated along an elongated introducer assembly. The distal segment is configured to selectively transmit a bulging force from the elongated guidewire assembly to a first biological wall after the distal segment has at least partially contacted the first biological wall and the distal segment has been selectively extended away from the distal introducer assembly.

Description

Technical Field

[0001] This document relates to (but is not limited to) the following technical fields: (A) synergistic combinations (and methods thereof) of elongated guide assemblies and deflectable elongated guidewire assemblies; and / or (B) deflectable elongated guidewire assemblies (and methods thereof) used with elongated guide assembly 100; and (C) elongated guide assemblies (and methods thereof) configured for use with deflectable elongated guidewire assemblies. Background Technology

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

[0003] It should be understood that there is a need to (at least partially) alleviate at least one problem associated with existing (known) guidewires. Following extensive research and experimentation with existing (known) guidewires, an understanding of this problem and its solutions has been (at least partially) established and is presented (at least partially) as follows:

[0004] Obtaining epicardial access involves puncturing the thin pericardial layer (also known as the pericardial layer) that surrounds the heart's myocardium (without puncturing the myocardium). The pericardial layer (also known as the pericardial sac) is the outer layer composed of connective tissue and holds the roots of the heart and great vessels (in their proper position within the thoracic cavity). The myocardial layer is the thick, middle layer of the heart and is composed of cardiac muscle. It is known that a mechanical needle can be used to puncture the pericardial layer, in which case the user can control the input force (also known as bulging force) to be applied (via the needle) to the pericardial layer while attempting to avoid accidental damage and / or puncture of the underlying myocardial layer as much as possible.

[0005] Known epicardial puncture methods involve aiming a relatively rigid (or supported) puncture device directly at the pericardial layer, which is also directly in the path toward the underlying myocardial layer. This technique can (unfortunately) result in a higher sensitivity of the force (bulging force) 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 can be very easy to unintentionally apply excessive bulging force to the pericardial layer (via the puncture device), and then accidentally puncture (damage) the myocardial layer. Compared to using mechanical needles and / or guidewires, creating a puncture hole through the pericardial layer by applying radiofrequency energy (emitted from electrodes and / or radiofrequency devices) can be a generally safer and more effective method. The blunt electrode of the radiofrequency needle can be positioned at the pericardial layer, and the blunt electrode is activated to emit radiofrequency energy, and the surrounding tissue can be vaporized (to create a puncture hole extending through the pericardial layer).

[0006] After the blunt electrode is activated for only a fraction of a second (to form a puncture hole), the radiofrequency energy is (rapidly) deactivated, and this arrangement reduces the risk of accidental puncture of the myocardium. Known methods are similar, in which a rigid (or supported) radiofrequency puncture device is directed towards the pericardial layer. The user can apply a bulging force to the tissue (thus creating a bulge in the tissue). The bulging force can be applied while the radiofrequency electrode is inactive. When the radiofrequency energy is activated (emitted), the bulging tissue will evaporate until the applied force (bulging force) decreases to zero due to the formation of the puncture hole. However, given the high sensitivity of the bulging force to the placement, movement, and / or displacement of the puncture device, this known method may easily lead to excessive bulging of the tissue before the radiofrequency energy is activated. Considering the proximity of the myocardium and pericardial layers, accidental puncture of the myocardium remains relatively easy using this known method and / or known device.

[0007] Figure 1A , Figure 1B and Figure 1C A side view depicts a known radiofrequency puncture method with associated known devices. Figure 1A A known guidewire assembly 290 is depicted (see...) Figure 2A The known distal puncture device 292 (such as an electrode) is positioned against the pericardial layer 911 at the starting point. Figure 1B The diagram depicts the application of a bulging force 700 from a known guidewire assembly 290 to the pericardial layer 911 (tissue). In response to the application of the bulging force 700 to the pericardial layer 911, the pericardial layer 911 is forced into a bulging shape. Radiofrequency energy is activated and emitted from a known distal puncture device 292, causing the known distal puncture device 292 (blunt electrode) to emit radiofrequency energy toward the region of the bulging pericardial layer 911. Figure 1C The pericardial layer 911 is depicted along the known guidewire assembly 290 and slid back to approximately the starting point, as shown. Figure 1A As depicted. References as follows: Figures 1A to 1C In the depicted embodiment, during use, a known guidewire assembly 290 with a known distal puncture device 292 (radio frequency emitting device) bulges the pericardial layer 911 (tissue or biological wall) by applying a bulging force 700 to the tissue. Because the known distal puncture device 292 (radio frequency emitting device) is blunt, it does not mechanically puncture the tissue. When radio frequency energy is applied by or emitted from the known distal puncture device 292, the bulging pericardial layer 911 is evaporated until the applied (i.e., applied to the pericardial layer 911) bulging force 700 returns to zero (e.g., as shown in the image). Figure 1A (as described) up to this point, and then the pericardial layer 911 can relax.

[0008] Figure 2A and Figure 2BA close-up cross-sectional side view depicting a known pericardial puncture performed using a known puncture device is shown. Figure 2A ) and diagram ( Figure 2B ).

[0009] refer to Figure 2A The distal end of the distal puncture device 292 (of the known guidewire assembly 290) is guided toward the pericardial layer 911 of the heart 940 (along the known guide assembly 190). A pericardial space 931 is located between the pericardial layer 911 and the myocardial layer 921. This configuration results in greater sensitivity of the bulging force 700 in response to minute changes in displacement of the known guidewire assembly 290 and / or the known guide assembly 190 when applied to the pericardial layer 911.

[0010] refer to Figure 2B The vertical axis 390 represents the amount of bulging force 700. The horizontal axis 392 represents the displacement of the known guide assembly 190 and / or the known guidewire assembly 290. The first region 394 indicates the relatively safe range of bulging 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 the pericardial layer 911 is to obtain access to the pericardial space 931 and to allow the treatment device to then obtain access to the myocardial layer 921 and / or the epicardial layer via a puncture hole extending through the pericardial layer 911. It should be understood that the epicardial layer is a thin layer above the myocardial layer. An epicardial access may also be referred to as an alternative to obtaining access to the pericardial space. The second region 396 indicates the range of the relatively potentially dangerous range of bulging force 700 that may unfortunately damage the myocardial layer 921 when applied to the pericardial layer 911 when the distal puncture device 292 is activated. It is clear that using such known methods and / or devices may make it difficult to achieve a condition where the bulging force 700 applied to the pericardial layer 911 is sufficient to achieve pericardial puncture only and avoid puncture (damage) of the myocardial layer 921. It should be understood that mere contact or proximity of the electrode to the pericardial layer 911 can vaporize the puncture site through the pericardial layer 911 using radiofrequency energy. Epicardial access can be extremely sensitive, as it may be desirable to puncture a thin layer of the pericardial layer 911 without damaging the underlying myocardial layer 921. It may be desirable to have a method and / or device for applying an ideal amount of bulging force 700 to the pericardial layer 911 to achieve pericardial puncture only and avoid puncture (damage) of the myocardial layer 921.

[0011] To at least partially alleviate at least one problem associated with the prior art, a device is provided (according to a broad aspect). The device is used with a patient's first and second biological walls (the second biological wall being located near the first biological wall) and an elongated guide assembly having a distal guide outlet. The distal guide outlet is configured to be selectively manipulated and positioned proximal to the first biological wall. The device includes, but is not limited to, an elongated guidewire assembly having a distal segment terminating at a distal puncture device, the distal segment being configured to be selectively manipulated along the elongated guide assembly. The distal segment has a distal length configured to at least partially contact a first outer surface of the first biological wall; this is performed in response to a selective extension movement of the distal segment and the distal puncture device away from the distal guide outlet after the distal guide outlet has been manipulated proximal to the first outer surface of the first biological wall. The distal segment is configured to transfer a bulging force from the elongated guidewire assembly to the first biowall (without damaging the second biowall located near the first biowall) in response to the application of a bulging force 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 biowall.

[0012] To at least partially alleviate at least one problem associated with the prior art, a device is provided (according to a broad aspect). The device is used with a patient's first and second biological walls (the second biological wall being located near the first biological wall). The device includes, but is not limited to, an elongated guide assembly having a distal guide outlet configured to be selectively manipulated and positioned proximally to the first biological wall. An elongated guidewire assembly has a distal segment terminating at a distal puncture device, the distal segment being configured to be selectively manipulated along the elongated guide assembly. The distal segment has a distal length configured to at least partially contact a first outer surface of the first biological wall; this is performed in response to selective extension movement of the distal segment and the distal puncture device away from the distal guide outlet after the distal guide outlet has been manipulated proximally to the first outer surface of the first biological wall. The distal segment is configured to transfer a bulging force from the elongated guidewire assembly to the first biowall (without damaging the second biowall located near the first biowall) in response to the application of a bulging force 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 biowall.

[0013] To at least partially alleviate at least one problem associated with the prior art, a method is provided (according to a broad aspect). The method is for use with an elongated guidewire assembly and an elongated guide device assembly with a patient's first and second biological walls (the second biological wall being located near the first biological wall). The method includes, but is not limited to, selectively manipulating the elongated guidewire assembly having a distal segment terminating at a distal puncture device along the elongated guide 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 guide device outlet after the distal guide device outlet has been manipulated to approach a first outer surface of the first biological wall. The method also includes, but is not limited to, bringing the distal segment (having a distal length) at least partially into contact with the first outer surface of the first biological wall after the distal length of the distal segment has at least partially contacted the first outer surface of the first biological wall. The method also includes, but is not limited to, applying a bulging 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. The method also includes, but is not limited to, transferring the bulging force from the elongated guidewire assembly to the first biowall via the distal segment after a bulging force has been applied to the elongated guidewire assembly (without damaging the second biowall located near the first biowall).

[0014] Other aspects are identified in the claims. Other aspects and features of the non-limiting embodiments will now become apparent to those skilled in the art after reading the following detailed description of the non-limiting embodiments with accompanying drawings. This summary is provided to introduce concepts in a simplified form that will be further described in the following detailed description. This summary is not intended to identify potential key features or possible essential features of the disclosed subject matter, nor is it intended to describe every disclosed embodiment or every implementation of the disclosed subject matter. The following drawings and description illustrate exemplary embodiments in more detail. Attached Figure Description

[0015] When taken in conjunction with the accompanying drawings, the non-limiting embodiments can be more fully understood by referring to the following detailed description of the non-limiting embodiments, wherein:

[0016] Figure 3A A cross-sectional view depicting an embodiment of the elongated guidewire assembly is shown; and

[0017] Figure 3B Depicting Figure 3A A close-up view shows the tissue arch of the first biological wall in an embodiment of the elongated guidewire assembly; and

[0018] Figure 3C An elongated guidewire assembly with a flexible guide 100 is depicted. Figure 3A A cross-sectional view of the embodiment shows the tissue arching; and

[0019] Figure 3D A schematic diagram of an embodiment of the elongated guidewire assembly is depicted; and

[0020] Figure 3E Depicting the piercing Figure 3B A cross-sectional view of an embodiment of the elongated guidewire assembly following the first biological wall; and

[0021] Figure 3F Depicting the piercing Figure 3C A cross-sectional view of an embodiment of the elongated guidewire assembly following the first biological wall; and

[0022] Figure 4A and Figure 4B Depicting Figure 3A Cross-sectional view of an embodiment of a slender guidewire assembly ( Figure 4A ) and diagram ( Figure 4B );and

[0023] Figure 5A and Figure 5B Depicting Figure 3A A schematic diagram of an implementation scheme for a slender guidewire assembly; and

[0024] Figure 6A and Figure 6B Depicting and Figure 3A A cross-sectional view of an embodiment of an elongated guide wire assembly used in conjunction with an elongated guide wire assembly; and

[0025] Figures 7A to 7F Depicting Figure 3A Cross-sectional view of an embodiment of a slender guidewire assembly ( Figure 7A , Figure 7B and Figure 7E ) and side view ( Figure 7C , Figure 7D and Figure 7F );and

[0026] Figure 8A , Figure 8B and Figure 8C Depicting Figure 3A A cross-sectional view of an embodiment of a slender guidewire assembly; and

[0027] Figure 9 Depicting Figure 3A A side view of an embodiment of the slender guidewire assembly; and

[0028] Figure 10 Depicting Figure 3A A cross-sectional view of an embodiment of a slender guidewire assembly; and

[0029] Figure 11A and Figure 11B Depicting Figure 3A A schematic diagram of an implementation scheme for a slender guidewire assembly; and

[0030] Figure 12A and Figure 12B Depicting Figure 3A Cross-sectional view of an embodiment of a slender guidewire assembly ( Figure 12A ) and diagram ( Figure 12B );and

[0031] Figure 13 Depicting Figure 3A A cross-sectional view of an embodiment of a slender guidewire assembly; and

[0032] Figure 14 Depicting Figure 3A A cross-sectional view of an embodiment of a slender guidewire assembly; and

[0033] Figures 15 to 22 Depicting Figure 3A A cross-sectional view of an implementation scheme for a slender guidewire assembly.

[0034] The accompanying drawings are not necessarily drawn to scale and may be shown using dashed lines, diagrams, and partial views. In some cases, details that are unnecessary for understanding the embodiments (and / or details that make other details difficult to understand) may be omitted. Throughout the various figures, corresponding reference numerals indicate corresponding parts. Elements in the figures are shown for simplicity and clarity and are not necessarily drawn to scale. The dimensions of some elements in the figures may be emphasized relative to other elements to facilitate understanding of the various disclosed embodiments. Additionally, common and well-known elements that are useful in commercially viable embodiments are not typically depicted to provide a less obstructive view of the embodiments of this disclosure.

[0035] List of icon numbers used in the attached figures

[0036] Slender guide assembly 100 Optimal distal portion 206

[0037] Guide cavity 102 Elbow section 209

[0038] Distal guide outlet 104 Axis 300

[0039] Slender guide wire assembly 200, axis 302

[0040] Distal puncture device 202 First area 304

[0041] Distal length 204, Second region 306

[0042] Distal segment 205 First medical image 401

[0043] Second Medical Imaging 402 Second Wire 822

[0044] ST segment elevation 500 patients 900

[0045] Electrodiagram signal 502 First biowall 910

[0046] Elevation force 700, pericardial layer 911

[0047] 802 Tension coil 1st outer surface 912

[0048] Compression coil 804, second biological wall 920

[0049] Distal coil 806, myocardial layer 921

[0050] Marker 808 Second outer surface 922

[0051] Tactile component 810, Bio-space 930

[0052] Hub portion 812 Pericardial space 931

[0053] Proximal visual markers 814, Heart 940

[0054] Sensor 816 Diaphragm 942

[0055] Contrast agent 818, liver 944

[0056] First wire 821 Detailed Implementation

[0057] The following detailed description is merely exemplary and is not intended to limit the described embodiments or their application and use. As used, the terms “exemplary” or “illustrative” mean “used as an example, illustration, or description.” Any implementation described as “exemplary” or “illustrative” is not necessarily to be construed as being more preferred or advantageous than other implementations. All implementations described below are exemplary implementations provided to enable those skilled in the art to make or use the embodiments of this disclosure and are not intended to limit the scope of this disclosure. The scope of this disclosure is defined by the claims. For the purposes of this specification, the terms “upper,” “lower,” “left,” “rear,” “right,” “front,” “vertical,” “horizontal,” and their derivatives should be associated with examples of orientation in the drawings. It is not intended to be limited by any theory expressed or implied by the foregoing technical field, background art, summary of the invention, or the following detailed description. It should also be understood that the apparatus and processes shown in the drawings and described in the following detailed description are exemplary embodiments (examples), aspects, and / or concepts defined in the appended claims. Therefore, unless otherwise stated, dimensions and other physical characteristics relating to the disclosed embodiments should not be considered limiting. It should be understood that the phrase “at least one” is equivalent to “a.” Aspects (examples, changes, modifications, options, variations, embodiments, and any equivalents thereof) are described with reference to the accompanying drawings. It should be understood that this disclosure is limited to the subject matter provided in the claims, and that this disclosure is not limited to the specific aspects depicted and described. It should be understood that the scope of the meaning of "devices configured to couple to an article" (i.e., to be connected to the article, interact with the article, etc.) should be interpreted as devices configured to be directly or indirectly coupled to the article. Therefore, unless otherwise specifically stated, "configured to" can include the meaning of "directly or indirectly."

[0058] For reference Figure 3AIn the depicted embodiment, the distal length 204 of the distal segment 205 (distal portion) of the elongated guidewire assembly 200 moves and extends (protrudes) from the distal guide outlet 104 of the guidewire assembly 100 (via the guide cavity 102 extending along the elongated guidewire assembly 100). In use, the distal length 204 of the distal segment 205 of the elongated guidewire assembly 200 is moved to (at least partially) contact and rest on the first outer surface 912 of the first biological wall 910 (or the pericardial layer 911 of the heart 940 of the patient 900). The distal segment 205 receives a bulging force 700 from the elongated guidewire assembly 200 and transmits the bulging force 700 from the elongated guidewire assembly 200 to the first outer surface 912. The first outer surface 912 slides on the second outer surface 922, causing friction between the distal segment 205 and the first outer surface 912 to cause the first outer surface 912 to arch 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 conditions for tension and arching are met (see...), Figure 3B This results in a puncture (e.g., using RF or mechanical devices, such as flexible wires or their equivalents).

[0059] get Figure 3B The workflow for the illustrated tissue arching and tensioning configuration is as follows: The elongated guide assembly 100 is positioned close to the first biowall 912; the elongated guidewire assembly 200 is advanced through the guide lumen 102; the distal puncture device 202 exits the distal guide outlet 104 and contacts the first biowall 912; during the continued advancement of the elongated guidewire assembly 200, the distal length 204 of the distal segment 205 droops over the first biowall 912 (i.e., the distal segment 205 deflects backward after contacting the first biowall 912 and advances on the surface of the first biowall 912 to achieve...). Figure 3A The configuration of the distal puncture device (or similar configuration) causes the distal puncture device to be positioned parallel to the second biological wall 922, and causes a portion of the tissue of the first biological wall 912 to arch in front of the distal puncture device 202, while tension is generated in the portion of the tissue of the first biological wall 912 adjacent to the distal length 204 of the distal segment 205. Following this procedure, a puncture is made in the first biological wall 912 via the distal puncture device 202, and the elongated guidewire assembly 200 is advanced into the pericardial space 931, as... Figure 3E As depicted. The RF-based distal puncture device 202 is capable of creating a puncture in the first biological wall 912 via RF energy, while the sharp, mechanically based distal puncture device 202 is capable of creating a puncture in the first biological wall by protruding from the distal guidewire assembly 200 and then retracting into the distal guidewire assembly 200 after successful tissue puncture.

[0060] get Figure 3CThe workflow for the illustrated tissue arching and tension configuration is as follows: The flexible, elongated guide assembly 100 is brought into contact with the first biowall 912. The distal length 204 of the distal segment 205 is detached from the first biowall, thereby positioning the flexible, elongated guide assembly 100 parallel to the second biowall 922, and causing a portion of the first biowall to arch in front of the distal guide outlet 104, while tension is generated in the portion of the tissue of the first biowall 912 adjacent to the distal length 204 of the distal segment 205. Following this workflow, the elongated guidewire assembly 200 is advanced through the guide lumen 102. The distal puncture device is disengaged from the distal guide outlet 104 and advanced into the first biowall 912 until the first biowall 912 is punctured via the pointed tip of the distal puncture device 202, as shown. Figure 3F As depicted. Advantageously, the amount of the bulging force 700 transmitted from the distal length 204 of the distal segment 205 of the (elongated guidewire assembly 200) to the first biowall 910 is distributed (dispersed) over a larger portion of the first biowall 910; as described. Figure 2A In stark contrast to the depicted implementation, the bulging force 700 is more concentrated and directed towards a smaller segment of the first biowall 910, and the bulging force 700 is transferred (completely) from the known distal puncture device 292 of the known guidewire assembly 290 to the first biowall 910. (Refer to...) Figure 3A The described embodiment, prior to forming a puncture hole to be extended through the first biological wall 910 using the distal puncture device 202 of the (elongated guidewire assembly 200), may apply a small amount of bulging force 700 to the first outer surface 912 of the (first biological wall 910 or pericardial layer 911); advantageously, this arrangement can at least partially avoid (due to binding) Figure 2A The implementation scheme may deploy a relatively small amount of bulging force 700 compared to the deployment of the second biological wall 920 (or myocardial layer 921), thus imparting undesirable damage. The distal puncture device is also redirected away from the second biological wall 922 (e.g., Figure 3A , Figure 3B and Figure 3C As shown, and with Figure 2A (In contrast to known prior art), and is no longer positioned perpendicular to the second biological wall 922, but parallel to it. In this parallel configuration, undesirable damage to the second biological wall 922 by the distal puncture device 202 is prevented.

[0061] For reference Figure 3A The described implementation plan should be understood to be consistent with... Figure 2A The bulging force associated with the described implementation scheme is 700 (in Figure 2AIn contrast, when the bulging force 700 is fully concentrated and transmitted from the distal puncture device 202 of the elongated guidewire assembly 200 to the first biological wall 910, the amount of bulging force 700 to be transmitted from the distal length 204 of the distal segment 205 of the elongated guidewire assembly 200 to the first biological wall 910 can be relatively low. Figure 2A and / or Figure 1B Compared to the described direct elevation method, (with) Figure 3A The associated bulging force of 700 can be relatively low. Advantageously, (with) Figure 3A The amount of the associated bulge force 700 is relatively insensitive to changes in the displacement of the elongated guide assembly 100.

[0062] For reference Figure 3A The described implementation scheme should be understood to be such that the direction of the distal puncture device 202 is parallel to the second biological wall 922 (e.g., parallel to...). Figure 2A Compared to the depicted vertical configuration, this parallel configuration advantageously prevents the distal puncture device 202 from causing undesirable damage to the second biological wall 922.

[0063] For reference Figure 3B As described in the embodiment, the tissue arches of the first biological wall 912 are positioned in front of the distal puncture device 202, which is parallel to the second biological wall 922. In this manner, the first biological wall 912 can be punctured by the distal puncture device 202 without accidentally puncturing or damaging the second biological wall 922.

[0064] Additionally, see references such as Figure 3C The described implementation scheme (mechanical puncture) should be understood to involve a tissue arch in the first biological wall 912 positioned in front of the distal guide outlet 104, which is parallel to the second biological wall 922. In this manner, the distal puncture device 202 can puncture the first biological wall, thereby reducing or avoiding accidental puncture or damage to the second biological wall 922.

[0065] For reference Figure 3A In the depicted embodiment, the distal length 204 of the distal segment 205 of the elongated guidewire assembly 200 is configured to extend from the distal guide outlet 104 of the elongated guide assembly 100 (via the guide cavity 102).

[0066] In use, the distal length 204 of the distal segment 205 (also referred to as the distal portion) of the elongated guidewire assembly 200 contacts (rests on, abuts against) the first outer surface 912 (of the first biological wall 910 or pericardial layer 911); advantageously, this arrangement avoids the potential (undesirable) transmission (or over-concentration) of the entire amount of bulging force 700 solely from the distal puncture device 202 toward the first outer surface 912. In this case, the first outer surface 912 can receive a relatively light contact (amount) of bulging force 700 (as opposed to a relatively heavy contact (amount) of bulging force 700). Figure 2A (Compared). Re-reference Figure 2A It should be understood that the concentrated application of bulging force 700 may and unintentionally impart undesirable damage to the second outer surface 922 of the second biological wall 920 (or myocardial layer 921). (See reference again) Figure 3A Advantageously, the amount of the bulging force 700 can be distributed over a larger portion of the first outer surface 912 (as with...). Figure 2A Compared to those known in the art (as shown); in this manner, the present invention (such as...) Figures 3A to 3D (As illustrated) presents or provides safer conditions for puncturing the first outer surface 912 when a bulging force 700 is applied to it (in response to activation of the distal puncture device 202). In this way, this embodiment at least partially avoids (after the first outer surface 912 has been correspondingly punctured) imparting accidental damage to the second outer surface 922. In this way or in such an arrangement, as Figure 3A As depicted, the bulging force 700 applied by the distal length 204 of the distal segment 205 (of the elongated guidewire assembly 200) can extend along a relatively large portion of the distal segment 205 relative to the first outer surface 912 (as shown). Figure 2AThe depicted situation is compared to the distal length 204 of the contact. Advantageously, in response to potential changes in the displacement and / or positioning of the elongated guidewire assembly 200 and / or the elongated guide device assembly 100 relative to the first outer surface 912, the bulge force 700 to be applied via the distal length 204 of the distal segment 205 of the elongated guidewire assembly 200 (towards the first outer surface 912) remains relatively low. This arrangement provides physicians with a relatively high degree of freedom to handle situations where an attempt is made to apply (impart) the bulge force 700 to the first outer surface 912 (via manipulation of the elongated guidewire assembly 200 and / or the elongated guide device assembly 100); in this way, a lower degree of influence of mechanical movement on the distal segment 205 of the elongated guidewire assembly 200 is possible (with respect to applying the bulge force 700 to the first outer surface 912). After the distal segment of the elongated guidewire assembly 200 has extended from the distal guide outlet 104 and the distal length 204 of the distal segment 205 of the elongated guidewire assembly 200 has contacted the first outer surface 912, a bulging force 700 can be applied from the distal length 204 of the distal segment 205 toward the first outer surface 912. While maintaining the bulging force 700 toward the first outer surface 912, a puncture hole to be extended through the first outer surface 912 can be formed using the distal puncture device 202 (activated) (of the elongated guidewire assembly 200) (preferably without causing undesirable damage to the second biological wall 920 or the myocardial layer 921). It should be understood that Figure 20 A distal puncture device 202 is depicted for forming a puncture hole to be extended through the first outer surface 912.

[0067] For reference Figure 3D The described implementation scheme, curve 301, is applicable to, for example... Figure 3A , Figure 3B and Figure 3C The illustrated implementation scheme. Axis 300 represents the amount of bulging force 700. Axis 302 represents the amount of displacement of the elongated guide assembly 100 and / or the elongated guidewire assembly 200. First region 304 indicates the range of a relatively safe amount of bulging 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). Second region 306 indicates the range of potentially dangerous amounts of bulging force 700 that could unfortunately damage the second biological wall 920 (or myocardial layer 921) when the distal puncture device 202 is activated.

[0068] For reference Figure 3A The described implementation provides a procedure (method) including (but not limited to) piercing the first biological wall 910 (or pericardial layer 911). The method includes the following steps: step (1), step (2), step (3), and step (4). Step (1) in... Figure 15 Depicted in (and related to) the middle; step (2) in Figure 16 Depicted in (and related to) the middle; step (3) in Figure 17 and Figure 18 Depicted in (and in connection with) the middle; and step (4) in Figure 19 and Figure 20 The following is described in connection with the above. Step (1) includes percutaneous delivery of the 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 the elongated guide assembly 100.

[0069] Step (2) includes causing the elongated guidewire assembly 200 (via the guide device lumen 102) to protrude from the distal guide device outlet 104 of the elongated guide device assembly 100. 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 to have optimal contact with the first outer surface. Step (4) involves puncturing the first outer surface 912 using the distal puncture device 202 of the elongated guidewire assembly 200 (after the application of a bulging force 700 to the first outer surface 912 from the length of the distal portion of the elongated guidewire assembly 200 (without causing damage to the second biological wall 920 or the myocardial layer 921)). It should be understood that for steps (2) and (3), various devices and / or techniques may be used to help achieve optimal extension (protrusion) of the distal length 204 of the distal segment 205 of the elongated guidewire assembly 200 (from the elongated guide assembly 100), while preferably maintaining the distal length 204 of the distal segment 205 and the distal puncture device 202 in contact arrangement with the first outer surface 912 (before using the distal puncture device 202 to form a puncture hole to be extended through the first outer surface 912).

[0070] For reference Figure 3A The described implementation plan should be understood as follows: Figure 3A The implementation scheme can be used (but is not limited to) to obtain access to the pericardial space 931 of the heart 940, and can be applied to any type of biological space 930 located between the first biological wall 910 and the second biological wall 920.

[0071] For reference Figure 3A In the described implementation scheme, the options for step (1) may include the following: Step (1) Option (A) (see...) Figure 4A and Figure 4B This includes localization assessment using electroanatomical mapping (EAM); step (1) option (B) (see...) Figure 5A and Figure 5BThis includes location assessment using an electrogrammography (EGM) system; step (1) option (C) (see...) Figure 6A and Figure 6B This includes the use of a tip that can be hard or soft (using distal puncture device 202 or other accessory devices can increase hardness).

[0072] For reference Figure 3A In the described implementation scheme, the options for step (2) may include the following: Step (2) Option (A) (see...) Figure 7A and Figure 7B This includes using radiopaque markers (also known as RO markers), tension coils, and / or compression coils (areas of tight and / or loose coil winding) to detect the protruding length of the elongated guidewire assembly 200. At least one radiopaque marker 808C may also be embedded within the elongated guidewire assembly at its distal end (see [link to documentation]). Figure 7G When viewed through a medical imaging system, the user can then align the radiopaque marker on the elongated guidewire assembly 100 between two radiopaque markers (808A and 808B) on the elongated guidewire assembly 200 to ensure optimal length 204 prolapse of the distal segment 205 of the elongated guidewire assembly 200 in order to optimally apply bulging force to the first biowall 912; step (2) option (B) (see Figure 8A , Figure 8B and Figure 8C This includes distal and / or proximal tactile markers for detecting the protruding length of the elongated guidewire assembly 200; step (2) option (C) (see...) Figure 9 This includes proximal visual markers configured to provide a visual indication for detecting the protruding length of the elongated guidewire assembly 200; step (2) option (D) (see...) Figure 10 This includes capacitive sensing for detecting the protruding length of the elongated guidewire assembly 200. Variations of option (A) in step (2) may include the following changes: variation (A) includes using a stretch / spaced coil (tightly and loosely wound areas); variation (B) includes a coil on the distal segment to be protruded (of the elongated guidewire assembly 200); variation (C) includes using spaced solid markers for depth measurement.

[0073] For reference Figure 3A In the described implementation scheme, the options for step (3) may include the following: Step (3) Option (A) (see...) Figure 11A and Figure 11B The steps include (the elongated guidewire assembly 200) a distal puncture device 202 synchronized with cardiac motion; step (3) option (B) (not depicted) includes sensing the bulge force at the distal end; step (3) option (C) (not depicted) includes setting the stiffness of the bulge segment (not exceeding the critical myocardial puncture threshold); step (3) option (D) (see...) Figure 12A and Figure 12B Step (3) option (E) (not depicted) includes EAM for visualizing the contact; Step (3) option (F) (see...) Figure 13 This includes injecting contrast agent; step (3) option (G) (see...) Figure 14 The step (3) includes electrical contacts for forming and disconnecting the circuit to indicate when applying a bulging force is acceptable or unacceptable (if too high, disconnect the circuit, etc.); step (3) option (H) (not depicted) includes positioning the distal puncture device in an area that minimizes cardiac motion perpendicular to the elongated guide assembly 100.

[0074] For reference Figure 3A In the described implementation, the options for step (4) may include the following: option (A) (not depicted) includes activating the radiofrequency energy for only the time it takes for the radiofrequency energy to evaporate the first biological wall 910 (or pericardial layer 911) (to optimize the time for activating the radiofrequency energy to be applied); option (B) includes activating the radiofrequency energy for only less than about 0.5 seconds; option (C) (not depicted) includes deactivating the radiofrequency energy when an impedance change is detected (when the distal portion of the elongated guidewire assembly 200 has been punctured and entered the biological space 930 or pericardial space 931).

[0075] For reference Figure 3AThe depicted embodiment describes a device for use with a first biological wall 910 and a second biological wall 920 (the second biological wall 920 being located near the first biological wall 910) of a patient 900, and an elongated guide assembly 100 having a distal guide outlet 104 is configured to be selectively manipulated and positioned near the first biological wall 910. The device includes, but is not limited to, an elongated guidewire assembly 200 having a distal segment 205 terminating at a distal puncture device 202, the distal segment being configured to be selectively manipulated along the elongated guide assembly 100. This is preferably performed such that the distal puncture device 202 is positioned near the first biological wall 910 after the distal guide outlet 104 has been selectively manipulated and positioned near the first outer surface 912 of 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 biowall 910 after the distal guide outlet 104 has been manipulated to approach the first outer surface 912 of the first biowall 910, in response to selective extension movement of the distal segment 205 and the distal puncture device 202 away from the distal guide outlet 104. The distal segment 205 is configured to, after the distal segment 204 of the distal segment 205 has at least partially contacted the first outer surface 912 of the first biowall 910, transmit a bulging force 700 from the elongated guidewire assembly 200 to the first biowall 910 in response to at least partially applying a bulging force 700 along the elongated guidewire assembly 200 (without damaging the second biowall 920 located near the first biowall 910).

[0076] For reference Figure 3A In the depicted embodiment, the distal segment 205 is configured such that, after the elongated guidewire assembly 200 extends from the elongated guide assembly 100, in response to the distal length 204 at least partially contacting and being deflected away from the first outer surface 912 of the first biowall 910 extending through the longitudinal axis 101 of the elongated guide assembly 100 by the first outer surface 912 of the first biowall 910, further advancement of the distal segment 205 will cause the distal segment 205 to droop over the first outer surface 912 to achieve Figure 3A The configuration.

[0077] For reference Figure 3A In the described implementation, the distal length 204 of the distal segment 205 is also configured to transmit the bulging force 700 when the distal puncture device 202 punctures the first biological wall 910.

[0078] For reference Figure 3AThe depicted embodiment describes a device for use with a first biowall 910 and an elongated guide assembly 100 of a patient 900, the elongated guide assembly being selectively manipulated and positioned proximal to the first biowall 910. The device includes (but is not limited to) an elongated guidewire assembly 200 having a distal segment 205 configured to be selectively manipulated along the elongated guide assembly 100. The distal segment 205 is configured to selectively transmit a bulging force 700 from the elongated guidewire assembly 200 to the first biowall 910 after the distal segment 205 has at least partially contacted the first biowall 910 and has selectively extended away from the distal guide outlet 104 (of the guide assembly 100).

[0079] For reference Figure 3A The depicted embodiment describes a method for use with a first biowall 910 and an elongated guide assembly 100 of a patient 900, the elongated guide assembly being configured to be selectively manipulated and positioned proximal to the first biowall 910. The method includes, but is not limited to, selectively manipulating an elongated guidewire assembly 200 having a distal segment 205 along the elongated guide assembly 100. The method further includes selectively transmitting a bulging force 700 from the elongated guidewire assembly 200 to the first biowall 910 via the distal segment 205 after the distal segment 205 has at least partially contacted the first biowall 910 and has been selectively extended away from the distal guide outlet 104 (of the guide assembly 100).

[0080] For reference Figure 3AThe depicted embodiment describes a method of using an elongated guidewire assembly 200 and an elongated guide device assembly 100 with a first biological wall 910 and a second biological wall 920 (the second biological wall 920 being located near the first biological wall 910) of a patient 900. The method includes, but is not limited to, selectively manipulating the elongated guidewire assembly 200 (which has a distal segment 205 terminating at a distal puncture device 202) along the elongated guide device assembly 100. The method further includes selectively extending the distal segment 205 and the distal puncture device 202 away from the distal guide device outlet 104 after the distal guide outlet 104 has been manipulated close to a first outer surface 912 of the first biological wall 910. The method further includes: after selectively extending the distal segment 205 and the distal puncture device 202 away from the distal guide outlet 104, bringing the distal segment 205, having a distal length 204, into at least partial contact with the first outer surface 912 of the first biowall 910. The method further includes: after the distal length 204 of the distal segment 205 has at least partially contacted the first outer surface 912 of the first biowall 910, applying a bulging force 700 at least partially along the elongated guidewire assembly 200. The method further includes: after the bulging force 700 has been applied to the elongated guidewire assembly 200, transferring the bulging force 700 from the elongated guidewire assembly 200 to the first biowall 910 via the distal segment 205 (without damaging the second biowall 920 located near the first biowall 910).

[0081] For reference Figure 3A The described implementation, components or elongated guidewire assembly 100 and / or elongated guidewire assembly 200 include biocompatible material properties suitable for performance (such as dielectric strength, thermal properties, electrical insulation, corrosion resistance, water resistance and / or heat resistance) to meet industrial and regulatory safety standards (or be compatible for medical use), etc. When selecting suitable materials, the following publication is recommended for consideration: Plastics in Medical Devices: Properties, Requirements, and Applications; Second Edition; Author: Vinny R. Sastri; Hardcover ISBN: 9781455732012; Publication Date: November 21, 2013; Publisher: Amsterdam [Pays-Bas]: Elsevier / William Andrew,

[2014] .

[0082] For reference Figure 3AThe depicted embodiment, the elongated guidewire assembly 200, includes a shape memory material configured to be manipulated and / or deformed, and subsequently return to the initial shape in which the shape memory material was set (before manipulation). Shape memory materials (SMMs) are known and will not be described in further detail. Shape memory materials are configured to recover their initial shape from significant and superficial plastic deformation in response to a specific stimulus applied to the shape memory material. This is called the shape memory effect (SME). Once the shape memory material is deformed in the presence (application) of a stimulating force, superelasticity can be observed (in the alloy).

[0083] For reference Figure 3A In the depicted embodiment, the distal puncture device 202 includes (but is not limited to) a radiofrequency puncture device, such as the BAYLIS (trademark) POWERWIRE (registered trademark) radiofrequency guidewire manufactured by BAYLIS Medical Inc. (headquartered in Canada). According to another embodiment, the distal puncture device 202 includes (but is not limited to) an elongated guidewire having a distal distal segment exhibiting a mechanically cut portion.

[0084] For reference Figure 3A In the depicted embodiment, the elongated guidewire assembly 200 is configured to be inserted into a confined space defined by a living body (patient). The guidewire assembly 200 includes (preferably) a relatively thin and flexible wire (elongated flexible shaft) configured to be inserted into a confined or tortuous space (confined space) defined by a living body. The guidewire assembly 200 is (preferably) positioned in a fluid-impermeable area within the confined space defined by a living body.

[0085] Figure 4A and Figure 4B Depicting Figure 3A Cross-sectional view of an embodiment of the elongated guidewire assembly 200 ( Figure 4A ) and diagram ( Figure 4B ). Figure 4A and Figure 4B An implementation scheme associated with option (A) of step (1) is described.

[0086] refer to Figure 4A In one implementation, the distal puncture device 202 (of the elongated guidewire assembly 200) is configured to selectively emit energy (such as radiofrequency energy) for puncturing the first biological wall 910 (or the pericardial layer 911 of the patient's heart). The distal puncture device 202 is electrically connected to a (known but not depicted) electroanatomical mapping system. Step (1) option (A) includes localization assessment using the electroanatomical mapping system.

[0087] For reference Figure 4BIn the depicted embodiment, medical detection and visualization of a sensing element located at the distal end of the elongated guidewire assembly 100 can be performed (calculated) via a (known and undepicted) electroanatomical mapping system. The electroanatomical mapping system is configured to display (via a display device) a first medical image 401 associated with the distal puncture device 202. The first medical image 401 is reproduced as a live (in situ or real-time) signal on the visual display of the electroanatomical mapping system (EAM). The electroanatomical mapping system is configured (via a known and undepicted display device) to display a visual mapping of the three-dimensional anatomy of the (patient's) heart. The first medical image 401 can be depicted in contrast to a second medical image 402 representing a mapping contour (image) of the patient's heart. The electroanatomical mapping system is configured to track the position of the elongated guidewire assembly 200, provided that the elongated guidewire assembly 200 is electrically connected to the electroanatomical mapping system. The elongated guide assembly 100 can be configured to facilitate connection to an electroanatomical mapping system and is configured to indicate the position of the distal portion of the elongated guide assembly 100, which allows the user to obtain optimal positioning of the elongated guide assembly 100 relative to the heart.

[0088] Figure 5A and Figure 5B Depicting Figure 3A A schematic diagram of an implementation scheme for the slender guide wire assembly 200. Figure 5A and Figure 5B An implementation scheme associated with option (B) of step (1) is described.

[0089] For reference Figure 5A and Figure 5BThe depicted implementation, a (known but not depicted) medical detection system, is configured to measure electrical potential in tissue. The medical detection system may include an electrography system (an electrography system configured to provide tracking of the electrical potential of biological tissue by means of electrodes placed directly in the tissue rather than on the body surface), an electromyography system (an EMG system configured to provide recording of electrical activity in muscle tissue using electrodes attached to the skin or inserted into the muscle, or a representation of electrical activity as a visual display or auditory signal), and any equivalents thereof. The elongated guide assembly 100 includes a sensor (material) positioned at the distal end of the elongated guide assembly 100. The sensor is configured to conduct electrical signals and is configured to be electrically connected to the medical detection system (such as an electrography system). The electrography system may provide the user with feedback regarding the location of the elongated guide assembly 100 relative to the patient's heart (based on information provided by the sensor (from) the elongated guide assembly 100). When the elongated guide assembly 100 is brought closer to the heart, the sensors of the guide assembly 100 can pick up electrical signals and output them to an electrogrammography system. When the tip of the elongated guide assembly 100 contacts the heart, the tip creates local ischemia in the heart tissue, and this ischemic change is manifested by ST segment elevation 50° (e.g., ...). Figure 5B The electrical signals experienced (as depicted). Using this local ischemia, the user can determine when the elongated guide assembly 100 can be ideally positioned. In this way, ST segment elevation 500 caused by local ischemia can be visualized from the electrogram signal 502.

[0090] Figure 6A and Figure 6B Depicting and Figure 3A A cross-sectional view of an embodiment of an elongated guide assembly 100 used in conjunction with an elongated guide wire assembly 200. Figure 6A and Figure 6B An implementation scheme associated with option (C) of step (1) is described.

[0091] For reference Figure 6AIn the depicted embodiment, the elongated guide assembly 100 is configured to be relatively soft (not too stiff). The elongated guide assembly 100 is configured to collapse and / or bend in response to the distal portion of the elongated guide assembly 100 impacting the outer surface of the first biological wall 910 (or the pericardial layer 911 of the patient's heart). This may be more non-invasive during localization. The use of a relatively stiff instance of a distal puncture device 202 or other rigid accessory device can aid in navigation through tissue and initially enable the soft guide assembly 100 to perform its task. For example, the elongated guide assembly 100 may include a tube with a hollow lumen to facilitate delivery of the puncture device. During the initial steps, the elongated guide assembly 100 is delivered through the patient's tissue. The elongated guide assembly 100 may be sufficiently rigid to achieve this traverse. However, once localized to the heart, the elongated guide assembly 100 does not necessarily need to be rigid. Therefore, a rigid version of the distal puncture device 202 may be included, and the distal puncture device 202 may be used when the elongated guide assembly 100 is used to traverse tissue. The rigid version of the distal puncture device 202 may be made of stainless steel and inserted into the lumen of the elongated guide assembly 100. The distal puncture device 202 does not move relative to the elongated guide assembly 100 while held in place and may be removed later after tissue traversal. The rigid version of the distal puncture device 202 may also serve as a catheter for transmitting EGM signals (for step (1) option (B)) or be connected to an EAM system (for step (1) option (A)) to indicate the position of the distal end of the guide to the user when the user initially positions the elongated guide assembly 100 in the desired location relative to the patient's heart.

[0092] Figures 7A to 7F Depicting Figure 3A Cross-sectional view of an embodiment of the elongated guidewire assembly 200 ( Figure 7A , Figure 7B and Figure 7E ) and side view ( Figure 7C , Figure 7D and Figure 7F ). Figure 7A and Figure 7B An implementation associated with step (2) option (A) is described. These options enable the user to know (detect) when the length of the distal segment 205 of the elongated guidewire assembly 200 has extended (protruded) from the distal end of the elongated guidewire assembly 100. This 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 bulging force 700 that may be imposed on the first outer surface 912 of the first biological wall 910 (or pericardial layer 911).

[0093] For reference Figure 7AIn the depicted embodiment, the elongated guidewire assembly 200 is (typically) configured to be detectable by a medical imaging system. For example, the elongated guidewire assembly 200 includes a tension coil 802 and a compression coil 804 mounted to the distal segment 205 of the elongated guidewire assembly 200. The tension coil 802 and the compression coil 804 are spaced apart from each other. The tension coil 802 is positioned between the compression coil 804 and the distal puncture device 202. The tension coil 802 and the compression coil 804 are configured to be detectable by a medical imaging system. The tension coil 802 and the compression coil 804 are configured to allow a user to see, via a medical imaging system (such as under fluoroscopy or X-ray), when the distal segment 205 (i.e., the desired or expected length of the distal segment 205 of the elongated guidewire assembly 200) has protruded from the distal portion of the elongated guidewire assembly 100. The tension coil 802 includes a segment of the coil with a relatively loose winding. The compression coil 804 includes a section of the coil that has a relatively tight winding.

[0094] For reference Figure 7B In the depicted embodiment, the elongated guidewire assembly 200 includes a distal coil 806 positioned at the distal segment 205 of the elongated guidewire assembly 200. The distal coil 806 is positioned proximal 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 a user to see, via a medical imaging system (such as under fluoroscopy or X-ray), when the distal segment 205 (i.e., the desired or expected length of the distal segment 205 of the elongated guidewire assembly 200) has protruded from the distal portion of the elongated guidewire assembly 100.

[0095] For reference Figure 7C In the depicted embodiment, the elongated guidewire assembly 200 includes a tension coil 802 positioned between a pair of compression coils 804. The tension coil 802 and the pair of compression coils 804 are mounted to a distal segment 205 of the elongated guidewire assembly 200. One of the compression coils 804 is positioned proximal to the distal puncture device 202. The tension coil 802 and the pair of compression coils 804 are configured to be detectable by a medical imaging system. The tension coil 802 and the pair of compression coils 804 are configured to allow a user to see, via a medical imaging system (such as under fluoroscopy or X-ray), when the distal segment 205 (i.e., the desired or expected length of the distal segment 205 of the elongated guidewire assembly 200) has protruded from the distal portion of the elongated guidewire assembly 100.

[0096] For reference Figure 7DIn the depicted embodiment, the elongated guidewire assembly 200 includes a compression coil 804 mounted to a distal segment 205 of the elongated guidewire assembly 200. The compression coil 804 is configured to protrude from the distal portion of the elongated guidewire assembly 100. The compression coil 804 includes a radiopaque material fixed to the distal segment 205 configured to protrude from the distal end of the elongated guidewire assembly 100. Alternatively, the radiopaque material is fixed to the distal segment 205 configured to protrude from the distal end of the elongated guidewire 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 the radiopaque material are configured to allow the user to see, via a medical imaging system (such as, under fluoroscopy or X-ray), when the distal segment 205 (i.e., the desired or expected length of the distal segment 205 of the elongated guidewire assembly 200) has protruded from the distal portion of the elongated guidewire assembly 100.

[0097] For reference Figure 7E In the depicted embodiment, the elongated guidewire assembly 200 includes a first radiopaque marker 808A mounted to the distal segment 205 of the elongated guidewire assembly 200. A second radiopaque marker 808B is positioned on the elongated guidewire assembly 200 adjacent to the first radiopaque marker 808A. 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 see, via a medical imaging system (such as under fluoroscopy or X-ray), when the distal segment 205 (i.e., the desired or expected length of the distal segment 205 of the elongated guidewire assembly 200) has protruded from the distal portion of the elongated guidewire assembly 100.

[0098] For reference Figure 7FIn the depicted embodiment, the elongated guidewire assembly 200 includes an elbow portion 209 configured to be positioned at the distal guide outlet 104 after the distal segment 205 has extended from the interior of the elongated guidewire assembly 100. A first radiopaque marker 808A is attached to the distal segment 205 of the elongated guidewire assembly 200 in such a way that, after the distal segment 205 has extended from the interior of the elongated guidewire assembly 100, the first radiopaque marker 808A becomes to extend from the interior of the elongated guidewire assembly 100. For example, the first radiopaque marker 808A may be positioned near the distal puncture device 202. A second radiopaque marker 808B is attached to the distal segment 205 in such a way that, after the distal segment 205 has extended from the interior of the elongated guidewire assembly 100, the second radiopaque marker 808B remains within the interior of the elongated guidewire assembly 100. For example, a second radiopaque marker 808B may be positioned near 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 a user to see, via a medical imaging system (such as under fluoroscopy or X-ray), when the distal segment 205 (i.e., the desired or expected length of the distal segment 205 of the elongated guidewire assembly 200) has protruded from the distal portion of the elongated guidewire assembly 100. Spaced-apart radiopaque markers (808A, 808B) may be used for depth measurement. Spaced-apart radiopaque markers (808A, 808B) may be placed at strategic points on the elongated guidewire assembly 200. The spaced-apart radiopaque markers (808A, 808B) provide the user with feedback on how much of the elongated guidewire assembly 200 protrudes from the distal end of the elongated guidewire assembly 100. For example, the spaced-apart radiopaque markers (808A, 808B) may be placed at approximately ten (10) millimeters intervals relative to the distal end of the elongated guidewire assembly 200, thereby providing feedback on how much of the elongated guidewire assembly 200 protrudes when viewed under fluoroscopy or X-ray.

[0099] For reference Figure 7G In the depicted embodiment, the radiopaque marker 808C can also be embedded within the elongated guide assembly at its distal end (see [reference]). Figure 7G When viewed through a medical imaging system, the user can then align the radiopaque marker on the elongated guidewire assembly 100 between two radiopaque markers (808A and 808B) on the elongated guidewire assembly 200 to ensure optimal length 204 prolapse of the distal segment 205 of the elongated guidewire assembly 200 in order to optimally apply bulging force to the first biowall 912.

[0100] For reference Figures 7A to 7G In the depicted embodiment, the coil may comprise a radiopaque material attached to a distal segment of the elongated guidewire assembly 200. The coil may have areas of tight and loose coil winding. When viewed under medical imaging such as fluoroscopy or X-ray, the pattern of the coil winding can visually create an interruption in radiopaqueness. For example, an indicator showing a user the ideal protruding length of the distal portion of the elongated guidewire assembly 200 (from the distal end of the elongated guidewire assembly 100) could be a coil stretched to create two distinct segments of tight winding. A first distal segment with tight coil winding could indicate the ideal length from which the distal segment 205 (of the elongated guidewire assembly 200) would extend from the distal portion of the elongated guidewire assembly 100, while a stretched coil segment could indicate the position where the user might need to pull (retract) the elongated guidewire assembly 200 into the elongated guidewire assembly 100.

[0101] Figure 8A , Figure 8B and Figure 8C Depicting Figure 3A A cross-sectional view of an embodiment of the elongated guidewire assembly 200. Figure 8A , Figure 8B and Figure 8C An implementation scheme associated with option (B) of step (2) is described.

[0102] For reference Figure 8A In the depicted embodiment, 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 interior of the elongated guidewire assembly 100 after the distal segment 205 has extended at least partially from the interior of the elongated guidewire assembly 100. The tactile portion 810 is configured to provide tactile feedback to a user contacting the elongated guidewire assembly 200, thereby informing the user that the elongated guidewire assembly 200 has reached an optimal amount of protrusion of the distal segment 205 from the distal end of the elongated guidewire 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 (over the length of the distal segment 205 of the elongated guidewire assembly 200); this is done in such a way that the tactile portion 810 is exposed (i.e., positioned outside the elongated guidewire assembly 100) after the length of the distal segment 205 of the elongated guidewire assembly 200 has extended away from the interior of the elongated guidewire assembly 100.

[0103] For reference Figure 8B and Figure 8CIn the depicted embodiment, the tactile portion 810 may be placed at the proximal segment of the elongated guidewire assembly 200 (the proximal segment of the guidewire extends externally to the proximal end of the elongated guidewire assembly 100). The tactile portion 810 may be placed at the distal segment 205 of the elongated guidewire assembly 200. According to one option, the tactile portion 810 may be placed at both the proximal and distal segments of the elongated guidewire assembly 200 (if desired). The tactile portion 810 may include any tactile indicator configured to distinguish one segment of the elongated guidewire assembly 200 from another segment of the elongated guidewire assembly 200 based on (the user's) tactile sensation. The tactile portion 810 is configured to provide the user with tactile feedback that the user has reached an optimal amount of protrusion of the elongated guidewire assembly 200 from the distal end of the elongated guidewire assembly 100. The tactile portion 810 may include a sudden change in the outer diameter of at least one segment of the elongated guidewire assembly 200, which may be felt by a user's hand (or when a distal portion of the elongated guidewire assembly 100 may interact with the at least one segment). The tactile portion 810 may include embossing and / or grooves formed in the outer surface of the elongated guidewire assembly 200, or other types of indentations and / or protrusions that feel different from the rest of the elongated guidewire assembly 200.

[0104] Figure 9 Depicting Figure 3A A side view of an embodiment of the slender guidewire assembly 200. Figure 9 An implementation scheme associated with option (C) of step (2) is described.

[0105] For reference Figure 9 In the depicted embodiment, the elongated guidewire assembly 200 includes a proximal visual marker 814 positioned at the proximal end of the elongated guidewire assembly 200. The elongated guidewire assembly 100 includes a hub 812. The proximal visual marker 814 of the elongated guidewire assembly 200 is configured to extend proximally away from the hub 812 in a manner that exposes the proximal visual marker 814 and makes it visually detectable by a user. 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 when the optimal length of the elongated guidewire assembly 200 protrudes from the distal end of the elongated guidewire assembly 100.

[0106] Figure 10 Depicting Figure 3A A cross-sectional view of an embodiment of the elongated guidewire assembly 200. Figure 10 An implementation scheme associated with option (D) in step (2) is described.

[0107] For reference Figure 10In the depicted embodiment, the optimal amount of the distal length 204 is the length (of the distal segment 205 of the elongated guidewire assembly 200) extending from the distal guide outlet 104. The optimal amount of distal length 204 is configured to transfer the desired amount of bulging force 700 (as depicted in Figure 3) to be applied from the optimal amount of distal length 204 (of the elongated guidewire assembly 200) to the first biological wall 910 (or pericardial layer 911), such as... Figure 3A As depicted. The elongated guide assembly 100 includes a sensor 816 (such as a capacitive sensor) positioned at the distal guide outlet 104 of the elongated guide assembly 100. The sensor 816 is configured to provide an indication signal indicating the optimal amount of distal length 204 of the distal segment 205 of the elongated guide wire assembly 200 protruding from the distal end of the elongated guide assembly 100. For example, the capacitive sensor is configured to generate an electric field and determine whether the field has been disturbed. The capacitive sensor positioned at the distal segment of the elongated guide assembly 100 can be optimized to show when the distal puncture device 202 (of the elongated guide wire assembly 200) has extended a critical distance (length) from the distal guide outlet 104 (of the elongated guide wire assembly 100). This arrangement allows a user to determine when the distal segment of the elongated guide wire assembly 200 has extended (protruded) a sufficient distance from the distal portion of the elongated guide assembly 100.

[0108] Figure 11A and Figure 11B Depicting Figure 3A A schematic diagram of an implementation scheme for the slender guide wire assembly 200. Figure 11A and Figure 11B An implementation scheme associated with option (A) of step (3) is described.

[0109] For reference Figure 11A and Figure 11B In the described implementation scheme, the heart 940 is positioned in a systolic state or during systole (e.g., Figure 11A (as described) and relaxation or diastolic state (such as Figure 11B (As depicted). First outer surface 912A (in Figure 11B (Depicted in the image) Positioned during the relaxation state of the heart at 940°. The elongated guidewire assembly 200A (in...) Figure 11BThe distal puncture device 202 (of the elongated guidewire assembly 200) is positioned during the relaxation state of the heart 940. The heart 940 responds to its beating by moving the distal puncture device 202. The distal puncture device 202 is positioned to contact 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 moves synchronously with the beating of the heart 940. This coordinated movement can be visualized on a medical imaging system (such as a fluorescence examination system or an X-ray system). The user can observe the synchronous movement of the distal puncture device 202 and the heart's movement (of the heart 940) on the display of the medical imaging system to determine whether they (i.e., the distal puncture device 202 and the heart 940) are in contact with each other, and thus the user is in a favorable position to puncture the first outer surface 912 (of the pericardial layer of the heart 940).

[0110] For reference Figure 11A and Figure 11B In the described implementation, where the distal segment 205 is positioned close to a biomarker such as the heart, the movement of the distal segment 205 of the elongated guidewire assembly 200 can be detected by observation of the distal segment 205 via a medical imaging system (such as an X-ray machine). Before reaching the heart, the distal segment 205 of the elongated guidewire assembly 200 tends to stabilize, but once or after resting on the first outer surface 912 of the first biowall 910 (or pericardial layer 911), the distal segment 205 may have a tendency to move with the heart's movement (beating). This observed condition (observed via a medical imaging system such as an X-ray machine) can be used to confirm that the distal segment 205 may have reached the first outer surface 912 of the first biowall 910, as a way of confirming that adequate contact has been established between the distal segment 205 and the first outer surface 912 of the first biowall 910.

[0111] Without referring to any accompanying drawings, it should be understood that step (3) option (B) (not depicted) includes sensing the bulging force to be transmitted to the heart. A force contact sensing device (not depicted) is positioned on the distal portion of the elongated guidewire assembly 200 (preferably, at the length to be extended from the distal portion of the elongated guidewire assembly 100). The force contact sensing device is configured to provide a signal indicating whether physical contact has been made between the distal portion of the elongated guidewire assembly 200 and the first outer surface 912 (of the pericardial layer of the heart 940).

[0112] Without referring to any accompanying drawings, it should be understood that step (3) option (C) (not depicted) includes setting the stiffness of the protruding segment of the elongated guidewire assembly 200, preferably exceeding the critical myocardial puncture threshold. The stiffness of the distal segment of the elongated guidewire assembly 200 (to protrude or extend from the distal segment of the elongated guidewire assembly 100) can be adjusted to ensure that there is insufficient bulging force for the distal puncture device 202 to puncture the second outer surface 922 of the second biological wall 920 (such as the myocardial layer 921). Therefore, it is possible that the distal puncture device 202 of the elongated guidewire assembly 200 can be placed at a set protrusion length (e.g., ...) of the distal portion of the elongated guidewire assembly 200. Figure 10 The location depicted allows for the provision of (such as) Figure 10 The optimized length of the depicted distal segment 205 allows for the puncture of the second outer surface 922 of the second biological wall 920 (or myocardial layer 921) with stiffness that enables puncture of only the first biological wall 910 (or pericardial layer 911) to occur. Additionally, with lower stiffness in the length of the distal segment 205 (of the elongated guidewire assembly 200), puncture by the elongated guidewire assembly 200 is less likely; for example, after the elongated guidewire assembly 200 is advanced into the biological space 930 (or pericardial space 931), a burn mark may form on the second biological wall 920 (or myocardial layer 921), which may occur during the emission of radiofrequency energy emitted from the distal puncture device 202.

[0113] Figure 12A and Figure 12B Depicting Figure 3A Cross-sectional view of an embodiment of the elongated guidewire assembly 200 ( Figure 12A ) and diagram ( Figure 12B ).

[0114] refer to Figure 12A and Figure 12B The implementation scheme associated with option (D) in step (3) is described.

[0115] For reference Figure 12A In the depicted embodiment, 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.

[0116] For reference Figure 12B The depicted embodiment illustrates the visualization of the distal puncture device 202 (of the elongated guidewire assembly 200) on the display of the electroanatomical mapping system. First medical image 401 and... Figure 12A The distal puncture device 202 is associated with the second medical image 402. Figure 12AThe electroanatomical mapping system is associated with the heart 940. It enables the user to map the three-dimensional anatomical structure of the heart 940. The electroanatomical mapping system is configured to track the position of the elongated guidewire assembly 200 (provided that the elongated guidewire assembly 200 is positioned in electrical communication with the electroanatomical mapping system). When the distal puncture device 202 is configured to selectively emit energy (radiofrequency energy), the electroanatomical mapping system can provide visual indication of the position of the distal puncture device 202, allowing the user to determine whether there is contact between the distal puncture device 202 and the heart (e.g., ...). Figure 12B (As instructed).

[0117] Without referring to any accompanying drawings, it should be understood that step (3) option (E) includes using an electrogrammography (EGM) system to confirm contact. The electrogrammography system is configured to measure the electrical potential in the tissue. In the case where the distal puncture device 202 is configured to emit energy (radiofrequency energy) using material at the distal segment (of the elongated guidewire assembly 200), the material is suitable for conducting electrical signals and is capable of being connected to the electrogrammography system; the state of the conducted electrical signals can provide feedback (to the user) indicating whether the distal puncture device 202 is in contact with the heart 940. Contact results in local ischemia, which manifests as ST segment elevation on the electrical signal. Using this relationship can help confirm contact between the distal puncture device 202 and the heart.

[0118] Figure 13 Depicting Figure 3A A cross-sectional view of an embodiment of the elongated guidewire assembly 200. Figure 13 An implementation scheme associated with option (F) in step (3) is described.

[0119] For reference Figure 13In the depicted embodiment, contrast agent 818 can be injected along the guide lumen 102 of the elongated guide assembly 100, flowing through the guide lumen and exiting from the distal guide outlet 104. Contrast agent 818 can be detected by a medical imaging system; this is done in such a way that the contrast agent 818 causes the medical imaging system to produce a visual effect to be displayed for determining whether the distal puncture device 202 is in contact with the heart 940. 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. Contrast agent 818 can be injected through the guide lumen 102 with the distal puncture device 202 accordingly positioned. Contrast agent 818 can highlight surfaces and contours on the display of a fluoroscopic examination system or an X-ray imaging system, thereby (at least partially) providing an improved image contour of the cardiac silhouette (of the heart 940). More specifically, the distal guide outlet 104 (of the elongated guide assembly 100) and the distal segment 205 (of the elongated guidewire assembly 200) of the heart 940 are positioned in the region near the contrast agent 818; a medical imaging display can show the darkened segment associated with the contrast agent 818. This arrangement thus makes it easier (for the user) to visualize and determine whether the distal puncture device 202 and the heart 940 may be in contact with each other.

[0120] Figure 14 Depicting Figure 3A A cross-sectional view of an embodiment of the elongated guidewire assembly 200. Figure 14 An implementation scheme associated with option (G) in step (3) is described.

[0121] For reference Figure 14 The depicted embodiment, 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 a distal length 204 being less than an optimal length. The first wire 821 and the second wire 822 are configured to disconnect each other in response to a distal length 204 being greater than an optimal length. The elongated guidewire assembly 200 includes an optimal distal portion 206 positioned and contacting the distal guide outlet 104 (after the optimal amount of distal length 204 extends from the distal guide outlet 104, also...). Figure 10(Depicted in the middle). When the maximum desired bulging force 700 is reached, the first wire 821 and the second wire 822 are electrically disconnected from each other, thereby disconnecting the circuit and stopping the delivery of energy (radio frequency energy) to the distal puncture device 202. In this way, a puncture can be formed through the first biological wall 910 (or the pericardial layer 911) and cannot be performed if: (A) an excessive bulging force 700 is reached (which may accidentally puncture the second biological wall 920 or the second outer surface 922 of the pericardial layer 921), or (B) the distal puncture device 202 bends away from the first outer surface 912 of the first biological wall 910 (or the 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 being less than the optimal length (i.e., after the distal segment 205 of the elongated guidewire assembly 200 protrudes from the distal guide outlet 104 of the elongated guidewire 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 being greater than the optimal length (i.e., after the distal segment 205 of the elongated guide wire assembly 200 protrudes from the distal guide outlet 104 of the elongated guide assembly 100).

[0122] Without referring to any accompanying drawings, it should be understood that step (3) option (H) involves positioning the distal puncture device in an area that minimizes cardiac motion perpendicular to the elongated guidewire assembly 100. This minimization of motion reduces the variation in bulging force transmitted along the elongated guidewire assembly from the distal segment to the first biological wall. This reduction in bulging force variation ensures more consistent and predictable puncture of the pericardial layer.

[0123] Without referring to any accompanying drawings, it should be understood that step (4) option (A) includes activating the radiofrequency energy to evaporate the pericardium, thereby optimizing the duration of radiofrequency energy application. The duration of radiofrequency application can be optimized to ensure that the radiofrequency energy is effective only for the time it takes for the radiofrequency energy to penetrate the pericardial layer.

[0124] Without referring to any accompanying drawings, it should be understood that step (4) option (B) involves activating radiofrequency energy from the distal puncture device 202 for less than about 0.5 seconds. This radiofrequency activation time of less than about 0.5 seconds minimizes damage to the myocardial layer and ensures successful puncture of the pericardial layer.

[0125] Without referring to any accompanying drawings, it should be understood that step (4) option (C) includes shutting off the transmission of energy (such as radiofrequency energy) from the distal puncture device 202 in response to the detection of an impedance change associated with puncture of the first outer surface 912 of the first biological wall 910 (or pericardial layer 911). Real-time impedance measurements can be performed from the distal puncture device 202 (if the distal puncture device 202 is configured to transmit radiofrequency energy). The impedance value can vary from the outside of the heart 940 to the inside of the pericardial space 931. When such an impedance change is detected, the delivery of radiofrequency energy can be shut off to ensure that no further tissue puncture occurs.

[0126] Without referring to any accompanying drawings, it should be understood that the side-mounted distal puncture device is configured to emit energy (radio frequency energy) and is mounted on the side of the distal guide outlet 104 of the elongated guide assembly 100.

[0127] Without referring to any accompanying drawings, it should be understood that the elongated guidewire assembly 200 may include a side-mounted distal puncture device configured to emit energy (radio frequency energy) and mounted on the side of the distal portion of the elongated guidewire assembly 200.

[0128] Without referring to any accompanying drawings, it should be understood that the elongated guidewire assembly 200 includes elongated electrodes configured to transmit energy (radio frequency energy).

[0129] Figures 15 to 22 Depicting Figure 3A A cross-sectional view of an embodiment of the elongated guidewire assembly 200.

[0130] For reference Figure 15 In the depicted embodiment, the heart 940 of the patient 900 is positioned near the diaphragm 942, which is positioned near the liver 944. An elongated guide assembly 100 is (at least partially) disposed in the patient 900; this is done such that the distal portion of the elongated guide assembly 100 is positioned near the heart 940 of the patient 900. In this manner, 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 guide assembly 100.

[0131] For reference Figure 16In the depicted embodiment, the elongated guidewire assembly 200 is inserted into the elongated guidewire assembly 100 and advanced (extended) from the elongated guidewire assembly (via the guidewire lumen 102). This is done such that the length of the distal segment 205 of the elongated guidewire assembly 200 can be advanced (extended) from the distal guidewire outlet 104 of the elongated guidewire assembly 100 to position (locate) the distal segment 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.

[0132] For reference Figure 17 In the depicted embodiment, the length of the distal segment 205 of the elongated guidewire assembly 200 (via the guidewire lumen 102) is advanced (extended) from the distal guide outlet 104 of the elongated guidewire assembly 100. This is done in such a way that, in use, the distal length 204 of the distal segment 205 of the elongated guidewire assembly 200 contacts the first outer surface 912 of the first biological wall 910 (or pericardial layer 911) of the heart 940 (resting on the first outer surface). The distal puncture device 202 (of the elongated guidewire assembly 200) also contacts the first outer surface 912 (after the distal segment of the elongated guidewire assembly 200 extends from the elongated guidewire assembly 100).

[0133] For reference Figure 18 The depicted embodiment shows a close-up cross-sectional view of the length of the distal segment of the elongated guidewire assembly 200 (via the guidewire lumen 102) extending from the distal guide outlet 104 of the elongated guidewire assembly 100. In use, the distal length 204 of the distal segment 205 of the elongated guidewire assembly 200 contacts the first outer surface 912 of the first biological wall 910 (or pericardial layer 911) (resting on the first outer surface); advantageously, this arrangement avoids the potential (undesirable) transmission (concentration) of the entire amount of bulging force only from the distal puncture device 202 (of the elongated guidewire assembly 200) toward the first outer surface 912; it should be understood that concentrated application of bulging force may and unintentionally impart undesirable damage to the second biological wall 920 or the second outer surface 922 of the myocardial layer 921. Advantageously, the amount of bulging force can be distributed across the first outer surface 912, thereby creating relatively safer conditions for piercing the first outer surface 912 and thus at least partially preventing damage to the second outer surface 922. In this manner or in such an arrangement, as... Figure 18As depicted, the bulging force applied from the distal segment 205 (extending from the distal puncture device 202 of the elongated guidewire assembly 200) can be dispersed along the distal length 204 of the elongated guidewire assembly 200 that contacts the first outer surface 912. In response to potential changes in the displacement and / or positioning of the elongated guide assembly 100 relative to the first outer surface 912, the bulging force applied at the distal length 204 (towards the first outer surface 912) of the distal segment 205 of the elongated guidewire assembly 200 remains relatively low. This arrangement provides physicians with a relatively high degree of freedom in handling situations where an attempt is made to apply (impart) a bulging force to the first outer surface 912 (via manipulation of the elongated guidewire assembly 200 and / or the elongated guide assembly 100), thereby exhibiting a lower impact on the distal segment of the elongated guidewire assembly 200 (with respect to applying a bulging force to the first outer surface 912). After the distal segment 205 of the elongated guidewire assembly 200 has extended from the distal guide outlet 104 and the distal length 204 of the distal segment 205 of the elongated guidewire assembly 200 has contacted the first outer surface 912, a bulging force can be applied toward the first outer surface 912 toward the distal length 204 of the distal segment 205 of the elongated guidewire assembly 200, and then the distal puncture device 202 (of the elongated guidewire assembly 200) can be used to form a puncture hole through the first outer surface 912 (preferably without causing undesirable damage to the second biological wall 920 or the myocardial layer 921).

[0134] For reference Figure 19 The depicted embodiment utilizes a distal puncture device 202 (of the elongated guidewire assembly 200) to puncture 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 the first biological wall 910.

[0135] For reference Figure 20 In the depicted embodiment, after the first biological wall 910 (or pericardial layer 911) has been punctured by the distal puncture device 202 (of the elongated guidewire assembly 200), the elongated guidewire assembly 200 is advanced into the biological space 930 (or pericardial space 931). The direction of travel of the distal segment of the elongated guidewire assembly 200 is aligned substantially parallel to the heart 940 (i.e., the direction of travel is aligned along the second outer surface 922 of the second biological wall 920 or myocardial layer 921), rather than perpendicular to the heart 940; this arrangement (at least in part) further reduces the possibility of accidental puncture of the second biological wall 920 (or myocardial layer 921).

[0136] For reference Figure 21 The described implementation scheme, upon successful penetration of the first biological wall 910 (or pericardial layer 911) (as shown in the image) Figure 20Following the depiction, the distal segment of the guidewire assembly 200 is advanced into the bio-space 930 (or pericardial space 931). The distal segment of the elongated guidewire assembly 200 is advanced along the surface region of the second bio-wall 920 (or the myocardial layer 921 of the heart 940) and wraps around the cardiac silhouette (of the heart 940). It should be understood that a portion of the distal segment of the elongated guidewire assembly 200 remains within the bio-space 930 (or pericardial space 931), while another portion of the distal segment of the elongated guidewire assembly 200 is advanced along the surface region of the second bio-wall 920 (or myocardial layer 921). In this way, the distal segment of the elongated guidewire assembly 200 secures the pathway (to the second bio-wall 920 (or the myocardial layer 921 of the heart 940)). The elongated guide assembly 100 is then advanced toward the entry site, and the elongated guide assembly 100 is used to dilate the puncture hole (extending through the first biological wall 910 or pericardial layer 911) created by the distal puncture device 202 of the actuated guidewire assembly 200. Dilation of the puncture hole is performed (via the elongated guide assembly 100) to allow delivery of a known therapeutic device (not depicted) after the elongated guide assembly 100 has been removed from the patient 900, and the known delivery device is manipulated along the guidewire assembly and positioned close to the heart 940.

[0137] For reference Figure 22 In the depicted embodiment, the access is secured to the second biological wall 920 (i.e., through a puncture hole formed through the first biological wall 910); preferably, the access site is dilated. The elongated guide assembly 100 is removed (retracted), and the elongated guidewire assembly 200 maintains the access (to the second biological wall 920), allowing known therapeutic devices (as needed) to be delivered (deployed) using the elongated guidewire assembly 200. The elongated guide assembly 100 (e.g., Figure 21 (As depicted) completely removed from patient 900 (e.g.) Figure 22The elongated guidewire assembly 200 (as depicted) can be set aside, leaving the elongated guidewire assembly 200 positioned within the patient 900. The elongated guidewire assembly 200 is at least partially retained within the patient 900 and (at least partially) wrapped around the heart 940. The distal segment of the elongated guidewire assembly 200 remains positioned close to the second biowall 920 (or myocardial layer 921) of the heart 940. A known treatment device (not depicted) can be manipulated along the elongated guidewire assembly 200 toward the distal segment of the elongated guidewire assembly 200 through a puncture hole and through the first biowall 910 (of the pericardial layer 911) into the biospace 930 (or pericardial space 931); this is done in such a way that the known treatment device can be positioned in the biospace 930 and close to the second biowall 920 (or myocardial layer 921) of the heart 940, thereby enabling treatment to be delivered to the second biowall 920 of the heart 940 using the known treatment device. During the deployment of a known treatment device, it is preferable that the distal puncture device 202 (of the elongated guidewire assembly 200) remains inactive (unused) during the deployment of the known treatment device.

[0138] The following provides a further description of the embodiments, wherein any one or more of any technical feature (described in the detailed description, summary, and claims) may be combined with any other one or more of any technical features (described in the detailed description, summary, and claims). It should be understood that each claim in the claims section is an open-ended claim unless otherwise stated. Unless otherwise stated, relational terms used in these descriptions should be interpreted to include specific tolerances that provide equivalent functionality as would be recognized by a person skilled in the art. For example, the term vertical is not necessarily limited to 90.0 degrees and may include variations thereof that would be understood by a person skilled in the art to provide equivalent functionality for the purpose described for the relevant component or element. In the context of configuration, terms such as “about” and “substantially” generally refer to a position, location, or configuration of the relevant element that is precisely or sufficiently close to maintain the operability of the element within this disclosure without substantially modifying the disclosure. Similarly, unless specifically and explicitly stated from their context, numerical values ​​should be interpreted to include certain tolerances of negligible importance as would be recognized by a person skilled in the art, since they do not substantially alter the operability of the disclosure. It should be understood that the description and / or drawings identify and describe embodiments of the device (expressly or inherently). The device may include any suitable combination and / or arrangement of technical features identified in the detailed description, as may be required and / or desired to suit a particular technical purpose and / or technical function. It should be understood that, where possible and suitable, any one or more technical features of the device may be combined with any other one or more technical features of the device (in any combination and / or arrangement). It should be understood that those skilled in the art will recognize that, even if not expressly stated above, the technical features of each embodiment may (where possible) be deployed in other embodiments. It should be understood that those skilled in the art will recognize that other options for the configuration of the components of the device may be possible to adapt to manufacturing requirements and still remain within the scope described in at least one or more claims. This written description provides embodiments including the best mode and also enables those skilled in the art to manufacture and use the embodiments. The scope of this disclosure may be defined by the claims. The written description and / or drawings help to understand the scope of the claims. It is believed that all key aspects of the disclosed subject matter have been provided in this document. It should be understood that, for the purposes of this document, the word “comprising” is equivalent to the word “including,” where both words are used to indicate an open list of components, parts, components, etc. The term “comprising” is synonymous with the terms “including,” “containing,” or “characterized in,” and is inclusive or open-ended, and does not exclude additional, unlisted elements or method steps. “Comprising” is an “open-ended” phrase and allows coverage of techniques employing additional, unlisted elements.When used in claims, the word "comprising" is a transitional verb (transitional term) that separates the preamble of the claim from the technical features of this disclosure. The foregoing outlines non-limiting embodiments (examples). Specific non-limiting embodiments are described (examples). It should be understood that the non-limiting embodiments are merely illustrative examples.

Claims

1. A device for use with a first biological wall and an elongated guide assembly of a patient, the elongated guide assembly being configured to be selectively manipulated and positioned near the first biological wall, the device comprising: A slender guidewire assembly having a distal segment terminating at a distal puncture device and configured to be selectively manipulated along the slender guidewire assembly; and The distal segment has a distal length and is configured to selectively transfer bulging force from the elongated guidewire assembly to the first biowall after the distal segment has at least partially contacted the first biowall and the distal segment has selectively extended away from the longitudinal axis of the elongated guidewire assembly. Wherein, after contacting the first biological wall and deflecting backward, the distal length of the distal segment is further configured to advance on the first outer surface of the first biological wall, such that the distal puncture device is positioned parallel to the second biological wall and selectively transmits the bulging force to the tissue portion of the first biological wall adjacent to the distal length of the distal segment, such that the first outer surface slides on the second outer surface of the second biological wall and arches in front of the distal puncture device, thereby allowing the distal puncture device to puncture the arched first biological wall.

2. A device for use with a first biowall of a patient and a second biowall located near the first biowall, and an elongated guide assembly having a distal guide outlet configured to be selectively manipulated and positioned proximate to the first biowall, the device comprising: A slender guidewire assembly having a distal segment terminating in a distal puncture device, the distal segment being configured to be selectively manipulated along the slender guidewire assembly; and The distal segment has a distal length configured to at least partially contact the first outer surface of the first biological wall after the distal guide outlet has been manipulated to approach 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 guide outlet. The distal segment is configured such that, after the elongated guidewire assembly extends from the elongated guide assembly, in response to the distal length at least partially contacting the first outer surface of the first biowall, it is deflected away from the longitudinal axis extending through the elongated guide assembly by the first outer surface of the first biowall. The distal segment is configured such that, after the distal length of the distal segment has at least partially contacted the first outer surface of the first biowall and has been deflected away from the first outer surface of the first biowall from the longitudinal axis extending through the elongated guide assembly, it selectively transmits the bulging force from the elongated guidewire assembly to the first biowall in response to the application of the bulging force at least partially along the elongated guidewire assembly, without damaging the second biowall located near the first biowall.

3. The device according to claim 2, wherein: After contacting and deflecting backward, the distal length of the distal segment is further configured to advance on a first outer surface of the first biological wall, such that the distal puncture device is positioned parallel to the second biological wall and selectively transmits the bulging force to a tissue portion of the first biological wall adjacent to the distal length of the distal segment, such that the first outer surface slides on a second outer surface of the second biological wall and arches in front of the distal puncture device, thereby allowing the distal puncture device to puncture the arched first biological wall.

4. The device according to claim 2, wherein: The elongated guidewire assembly is configured to be detectable by a medical imaging system.

5. The device of claim 2, wherein the elongated guide assembly is configured to be detectable by a medical imaging system.

6. The device according to claim 2, wherein: The elongated guidewire assembly includes: A stretching coil and a compression coil are mounted to the distal segment of the elongated guidewire assembly; The tension coil and the compression coil are spaced apart from each other; and The tension coil is positioned between the compression coil and the distal puncture device; and The stretching coil and the compression coil are configured to be detectable by a medical imaging system.

7. The device according to claim 2, wherein: The elongated guidewire assembly includes: A distal coil, the distal coil being positioned at the distal segment of the elongated guidewire assembly; and The distal coil is positioned close to the distal puncture device; and The distal coil is configured to be detectable by a medical imaging system.

8. The device according to claim 2, wherein: The elongated guidewire assembly includes: A stretching coil positioned between a pair of compression coils; and The stretching coil and the pair of compression coils are mounted to the distal section of the elongated guidewire assembly; and One of the pair of compression coils is positioned close to the distal puncture device; and The stretching coil and the pair of compression coils are configured to be detectable by a medical imaging system.

9. The device according to claim 2, wherein: The elongated guidewire assembly includes: A compression coil, the compression coil being mounted to the distal segment of the elongated guidewire assembly; and The compression coil is configured to protrude from the distal portion of the elongated guide assembly; and A radiopaque material is attached to the distal segment configured to protrude from the distal portion of the elongated guide assembly; and The compression coil and the radiopaque material are configured to be detectable by a medical imaging system.

10. The device according to claim 2, wherein: The elongated guidewire assembly includes: A first radiopaque marker A is mounted at the distal segment of the elongated guidewire assembly; and A second opaque marker B is positioned close to the first opaque marker; and The first radiopaque marker A and the second radiopaque marker B are configured to be detectable by a medical imaging system.

11. The device of claim 2, wherein the elongated guidewire assembly comprises: A first radiopaque marker A is mounted on the distal segment of the elongated guidewire assembly. and A second opaque marker B is positioned on the elongated guidewire assembly close to the first opaque marker A; And the elongated guide assembly includes: A radiopaque marker C is positioned at the distal segment of the elongated guidewire assembly and aligned between the first radiopaque marker A and the second radiopaque marker B of the elongated guidewire assembly to ensure optimal protrusion and bulge force of the distal segment to be optimally applied to the first biowall; and 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.

12. The device according to claim 2, wherein: The elongated guidewire assembly includes: Elbow portion, configured to be positioned at the distal guide outlet after the distal segment has extended from the interior of the elongated guide assembly; and A first opaque marker A is mounted to the distal segment of the elongated guidewire assembly in such a manner that, after the distal segment has at least partially extended from the interior of the elongated guidewire assembly, the first opaque marker A extends from the interior of the elongated guidewire assembly; and A second opaque marker B is mounted to the distal segment such that, after the distal segment has extended out of the interior of the elongated guide assembly, the second opaque marker B remains within the interior of the elongated guide assembly; and The first radiopaque marker A and the second radiopaque marker B are configured to be detectable by a medical imaging system.

13. The device according to claim 2, wherein: The elongated guidewire assembly includes: The tactile portion is configured to provide tactile feedback indicating that the elongated guidewire assembly has reached an optimal amount of protrusion of the distal segment from the distal end of the elongated guidewire assembly.

14. The device according to claim 2, wherein: The elongated guidewire assembly includes: A tactile portion is positioned on the distal segment of the elongated guidewire assembly such that, after the distal segment has at least partially extended from the interior of the elongated guidewire assembly, the tactile portion extends from the interior of the elongated guidewire assembly; and The tactile portion is configured to provide tactile feedback indicating that the elongated guidewire assembly has reached an optimal amount of protrusion of the distal segment from the distal end of the elongated guidewire assembly.

15. The device according to claim 2, wherein: The elongated guidewire assembly includes a proximal visual marker positioned at the proximal end of the elongated guidewire assembly; and The elongated guide assembly includes a hub; and The proximal visual marker is configured to be located away from the hub extension of the elongated guide assembly in a manner that exposes the proximal visual marker and makes it visually detectable.

16. The device according to claim 2, wherein: The elongated guide assembly includes a sensor positioned at the distal guide outlet of the elongated guide assembly; and The sensor is configured to provide an indication signal indicating the distal length of the distal segment of the elongated guidewire assembly protruding from the distal guide outlet of the elongated guidewire assembly.

17. The device according to claim 2, wherein: The contrast agent can be injected along the guide cavity of the elongated guide assembly, flow through the guide cavity, and exit from the distal guide outlet; and The contrast agent can be detected by a medical imaging system in such a way that the contrast agent causes the medical imaging system to produce a visual effect to be displayed for determining whether the distal puncture device is in contact with the patient's heart.

18. The device according to claim 2, wherein: The elongated guidewire assembly includes: First wire and second wire; and The first and second wires are configured to contact each other in response to the distal length being less than an optimal length after the distal section of the elongated guidewire assembly protrudes from the distal guide outlet of the elongated guidewire assembly; and 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 section of the elongated guide wire assembly protrudes from the distal guide outlet of the elongated guide assembly.

19. The device according to claim 2, wherein: The elongated guide assembly includes sensors; and The sensor is configured to be electrically connected to a medical detection system, which is configured to provide feedback on where the elongated guide assembly is located within the patient, based on information provided by the sensor of the elongated guide assembly.

20. A device for use with a patient's first biological wall, the device comprising: An elongated guide assembly configured to be selectively manipulated and positioned close to the first biowall; and An elongated guidewire assembly having a distal segment configured to be selectively manipulated along the elongated guidewire assembly; The distal segment is configured to deflect away from the longitudinal axis extending through the elongated guide assembly upon contact with the first biowall; and The distal segment is configured to selectively transfer bulging force from the elongated guidewire assembly to the first biological wall after the distal segment has at least partially contacted the first biological wall and the distal segment has selectively extended away from the elongated guidewire assembly.

21. A device for use with a first biowall of a patient and a second biowall located near the first biowall, the device comprising: An elongated guide assembly having a distal guide outlet configured to be selectively manipulated and positioned close to the first biowall. and A slender guidewire assembly having a distal segment terminating in a distal puncture device, the distal segment being configured to be selectively manipulated along the slender guidewire assembly; and The distal segment has a distal length configured to at least partially contact the first outer surface of the first biological wall after the distal guide outlet has been manipulated to approach 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 guide outlet. and The distal segment is configured such that, after the distal length of the distal segment has at least partially contacted the first outer surface of the first biowall and has been deflected away from the first outer surface of the first biowall from the longitudinal axis extending through the elongated guide assembly, it selectively transmits the bulging force from the elongated guide wire assembly to the first biowall in response to the application of the bulging force at least partially along the elongated guide wire assembly, without damaging the second biowall located near the first biowall.

Images