medical equipment

Abstract

A needle assembly configured to move into a cavity of a patient having a biowall. A distal distal segment extends from the needle assembly. The distal distal segment is configured to form a through-hole extending through the biowall of the patient (when or simultaneously with the needle assembly being pushed toward the biowall). The distal distal segment is also configured to (at least partially) prevent the removal of a free-floating tissue core from the biowall when the through-hole is formed by the distal distal segment.

Description

Technical Field

[0001] This document relates to (but is not limited to) the technical field of medical devices including needle assemblies configured to move into a patient having a biological wall, and the needle assembly being configured to form a through-hole extending through the patient's biological wall (and methods thereof). Background Technology

[0002] A medical needle assembly is a medical tool configured to pass through a patient's biological wall and may or may not include a channel extending along the length of the medical needle assembly. Summary of the Invention

[0003] It should be understood that there is a need to mitigate (at least partially) at least one problem associated with existing needle assemblies (also known as the prior art). Following extensive research and experimentation with existing needle assemblies, the understanding of this problem and its solutions has been (at least partially) determined and articulated as follows:

[0004] Radiofrequency needles are commonly used to puncture the atrial septum in transseptal catheterization (TCC) procedures in the heart. They work by evaporating the target tissue when radiofrequency energy is delivered through an active electrode at the distal end. This contrasts with mechanical needles, which use mechanical force delivered by the user to puncture the atrial septum. While radiofrequency needles require less input force to puncture, improve the accuracy of puncture location, and reduce the risk of accidental mechanical puncture (due to their blunter tips compared to mechanical needles), they may remove (or reduce) some of the user's function.

[0005] A typical feature of mechanical needles used for puncturing the atrial septum is that they have a hollow or open lumen. This open lumen allows for direct delivery of contrast agent to the target puncture site, providing the user with visual confirmation under fluoroscopic imaging. Furthermore, the open lumen allows for pressure measurements, enabling the user to confirm their location within the heart. Finally, the open lumen facilitates anchoring the lead placed through the needle and anchoring (fixing) the puncture site in the patient's heart from the right atrium to the left atrium.

[0006] Radiofrequency needles with open lumens offer the aforementioned benefits to users accustomed to mechanical needles while still retaining the advantages of radiofrequency-based atrial septal puncture. However, one issue is the possibility of "core" tissue during puncture. Electroactive open lumens are characterized by closed paths of conductive material that evaporate the tissue encountered. However, within the periphery formed by the closed conductive paths, the tissue is not evaporated but rather separates from the larger tissue wall it resides in, as all the surrounding tissue has been evaporated. This operation is analogous to how a hole punch creates (forms) individual paper discs from a larger sheet of paper. Presenting a free-floating tissue core in the bloodstream is highly undesirable, as it carries a real risk of causing stroke or pulmonary embolism in the patient. Therefore, any open-lumen radiofrequency needle requires a method to prevent this from occurring.

[0007] Radiofrequency transseptal needles and mechanical transseptal needles are both widely used. Both have distinct advantages and disadvantages when considering the puncture method and whether the lumen is open or closed. Ideally, a product combining the advantages of open lumen puncture with radiofrequency puncture would combine the benefits currently offered by both mechanical needles and radiofrequency transseptal needles. Open lumen RF delivery devices for puncturing the fossa ovalis in the heart are well known to those skilled in the art.

[0008] Figure 1 A cross-sectional view depicting an embodiment of a known needle assembly having a known distal end segment is shown.

[0009] refer to Figure 1 In the embodiment depicted, a known needle assembly defines a known lumen extending the length of the known needle assembly. The known needle assembly is configured to move into the lumen of a patient having a biological wall (internal biological wall). A known distal terminal segment extends (distally) from the known needle assembly. The known distal terminal segment is configured to (simultaneously) form a through-hole extending through the patient's biological wall when the known needle assembly is pushed toward the biological wall. The known distal terminal segment is configured to (or simultaneously) form a free-floating tissue core from the biological wall when (or simultaneously) the through-hole is formed by the distal terminal segment in response to moving the known needle assembly toward the biological wall. Figure 1 (As depicted in a known embodiment). The known distal segment is configured to form a free-floating tissue core, which can be assisted by an entrance to a known lumen from the biowall or by the presence of an entrance to the lumen. When the known distal segment is passed through the biowall, the entrance to the known lumen cuts and forms the free-floating tissue core.

[0010] The formation of a free-floating tissue core within a patient's body can be detrimental (or dangerous). For example, a free-floating tissue core can form in a patient's heart and then freely travel through the circulatory system to the brain, potentially causing a stroke.

[0011] Therefore, it may be advantageous to provide a needle assembly having a distal end section configured to prevent free-floating tissue core from being removed from the biowall when (or simultaneously) a through-hole is formed in the distal end section.

[0012] To at least partially mitigate at least one problem associated with the prior art, a device is provided (according to a major aspect). The device includes, but is not limited to, a needle assembly configured to move into a cavity of a patient having a biowall. A distal distal segment extends distally from the needle assembly. The distal distal segment is configured to (simultaneously) form a through-hole extending through the patient's biowall when the needle assembly is pushed toward the biowall. The distal distal segment is also configured to (or simultaneously) prevent free-floating tissue cores (in the presence of the through-hole) when the through-hole is formed by the distal distal segment. Figure 1 (As depicted in the implementation plan) Removed from the biowall.

[0013] To at least partially mitigate at least one problem associated with the prior art, a device is provided (according to a major aspect). The device includes, but is not limited to, a needle assembly configured to move into a cavity of a patient having a biowall. A distal distal segment extends distally from the needle assembly. The distal distal segment surrounds an endal cavity inlet leading to an endal cavity extending inwardly along the length of the needle assembly. The distal distal segment is configured to (simultaneously) form a through-hole extending through the patient's biowall when the needle assembly is pushed toward the biowall. The distal distal segment is also configured to (at least partially) prevent the removal of a freely floating tissue core (which in... Figure 1 (as depicted in the implementation scheme), and this may be due to the assistance of an internal lumen entrance from the biowall or the presence of an internal lumen entrance when the through-hole is formed by the distal end segment (or simultaneously).

[0014] To at least partially mitigate at least one problem associated with the prior art, a method is provided (according to a major aspect). The method is used to form a through-hole through the biowall of a patient having a cavity. The method includes, but is not limited to, moving a needle assembly into the cavity of a patient having a biowall, wherein the needle assembly includes a distally extending segment extending from the needle assembly (distally). The method also includes using the distally extending segment to form a through-hole through the patient's biowall while the needle assembly is being pushed toward the biowall. The method includes using the distally extending segment to prevent free-floating tissue cores (in...) from... when the through-hole is formed by the distally extending segment. Figure 1 (As depicted in the implementation plan) Removed from the biowall.

[0015] To at least partially mitigate at least one problem associated with the prior art, a method is provided (according to a major aspect). The method is used to form a through-hole through the biowall of a patient having a cavity. The method includes, but is not limited to, moving a needle assembly into the cavity of a patient having a biowall, wherein the needle assembly includes a distally extending distal segment extending from the needle assembly, the distally extending distal segment surrounding an internal lumen inlet leading to an internal lumen extending inwardly along the length of the needle assembly. The method also includes using the distally extending distal segment to form a through-hole through the patient's biowall while the needle assembly is being pushed toward the biowall. The method also includes using the distally extending distal segment to prevent free-floating tissue cores (in...) while the through-hole is formed by the distally extending distal segment. Figure 1 The implementation scheme depicts removal from the biowall (which may be due to the assistance of the lumen entrance or the presence of the lumen entrance).

[0016] 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. Many other novel advantages, features, and relationships will become apparent as this description proceeds. The following drawings and description illustrate exemplary embodiments in more detail. Attached Figure Description

[0017] 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:

[0018] Figure 1 A cross-sectional view depicting an embodiment of a known needle assembly having a known distal end segment is shown;

[0019] Figure 2 , Figure 3 and Figure 4 A side view depicts an embodiment of a needle assembly having a distal end segment;

[0020] Figure 5 and Figure 6 Depicting Figure 2 Perspective view of the implementation scheme of the needle component ( Figure 5 ) and end view ( Figure 6 );

[0021] Figure 7 , Figure 8 , Figure 9 and Figure 10 Depicting Figure 2 Cross-sectional view of the implementation scheme of the needle assembly ( Figure 7 ) and side view ( Figure 8 , Figure 9 and Figure 10 );

[0022] Figure 11 and Figure 12 Depicting Figure 2 A perspective view of the implementation scheme of the needle component; and

[0023] Figure 13 Depicting Figure 2 A perspective view of the implementation scheme of the needle component.

[0024] 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.

[0025] List of icon numbers used in the attached figures

[0026] Needle assembly 102 Distal end segment 104

[0027] Circumferential leading edge 105, known needle assembly 802

[0028] Lumen inlet 106; known distal segment 804

[0029] Lumen 108 Known lumen 806

[0030] Conductive surface 110, cavity 900

[0031] Dielectric surface 112 Patient 902

[0032] Safety cover 114, biowall 904

[0033] Extension section 116, through hole 905

[0034] The first arc-shaped section 200 has a free-floating tissue core 906.

[0035] Second arched section 202 tissue flap 908 Detailed Implementation

[0036] 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."

[0037] Figure 2 , Figure 3 and Figure 4 A side view depicts an embodiment of a needle assembly 102 having a distal end segment 104.

[0038] refer to Figure 2In the embodiment depicted, needle assembly 102 can be configured to be inserted into a confined space defined by patient 902. Needle assembly 102 can be configured to guide a medical device (known but not depicted, such as catheters and any equivalents thereof) into the confined space defined by patient 902. Needle assembly 102 includes, but is not limited to, an elongated flexible tube (made of medical-grade material) configured to be inserted into the body of patient 902. Needle assembly 102 is (preferably) impermeable to bodily fluids of patient 902. Needle assembly 102 comprises (according to another option) superelastic nitinol. Nitinol alloys exhibit two closely related and unique properties: shape memory effect (SME) and superelasticity (SE; also known as pseudoelasticity or PE). Shape memory is the ability of nitinol to undergo deformation at a temperature and then recover its original undeformed shape when heated above its transition temperature. Superelasticity occurs within a narrow temperature range just above its transition temperature; in this case, heating is not required to recover the undeformed shape, and the material exhibits tremendous elasticity, approximately ten (10) to thirty (30) times that of ordinary metals. The needle assembly 102 may include a shape memory material configured to be manipulated and / or deformed, subsequently returning to its original shape. Shape memory materials (SMMs) are configured to recover their original shape from significant and seemingly plastic deformation in response to a specific stimulus applied to the material. This may be referred to as the shape memory effect (SME). Superelasticity (in alloys) can be observed if a shape memory material deforms when stimulated. The needle assembly 102 may include any biocompatible material with suitable performance characteristics (dielectric strength, thermal properties, insulation and corrosion resistance, water resistance, and heat resistance) for safety performance to meet industrial and regulatory safety standards (or for medical use). When selecting appropriate materials, please refer to the following publication: 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, [Published in 2014].

[0039] refer to Figure 2 , Figure 3 and Figure 4The embodiment described herein depicts the main aspects of the device. The device includes, but is not limited to, a needle assembly 102. The needle assembly 102 is configured to move into a cavity 900 of a patient 902 having a biowall 904 (internal biowall). A distal distal segment 104 extends distally from the needle assembly 102. The distal distal segment 104 (at least partially) surrounds an internal lumen inlet 106. The internal lumen inlet 106 opens into an internal lumen 108. The internal lumen 108 (at least partially) extends inwardly along the length of the needle assembly 102. The distal distal segment 104 is configured to (simultaneously) form a through-hole 905 (wherein the through-hole 905, once formed, extends through the biowall 904 of the patient 902) when the needle assembly 102 is pushed toward the biowall 904. The distal distal segment 104 is also configured to prevent (at least partially) removal of a free-floating tissue core 906 (which in... Figure 1 (As depicted in the implementation scheme), this may be due to the assistance of or presence of the internal cavity entrance 106 from the biowall 904 (when the through-hole 905 is formed by the distal end segment 104 or simultaneously).

[0040] refer to Figure 2 , Figure 3 and Figure 4 In the embodiment depicted, the distal terminal segment 104 (preferably) is also configured to form a tissue flap 908, which remains attached to and extends from the biowall 904 (preferably, when or simultaneously, a through-hole 905 is formed by the distal terminal segment 104), wherein the tissue flap 908 (as Figure 4 (As depicted in the image) Near the positioning of through-hole 905.

[0041] For reference Figure 2 , Figure 3 and Figure 4 The embodiment described herein illustrates the main aspects of the method. The method is used to form a through-hole 905 through a biowall 904 of a patient 902 having a cavity 900. The method includes, but is not limited to, a first operation comprising moving a needle assembly 102 into the cavity 900 of the patient 902; the needle assembly 102 includes a distal distal segment 104 extending distally from the needle assembly 102; the distal distal segment 104 surrounds an internal lumen inlet 106 leading to an internal lumen 108 extending inwardly along the length of the needle assembly 102. The method also includes, but is not limited to, a second operation comprising using the distal distal segment 104 to form a through-hole 905 through the biowall 904 of the patient 902 while the needle assembly 102 is pushed toward the biowall 904. The method also includes, but is not limited to, a third operation comprising using the distal distal segment 104 to prevent removal of a free-floating tissue core 906 from the biowall 904. Figure 1(As depicted in the implementation scheme) (this may be due to the assistance from the inner cavity inlet 106 or the presence of the inner cavity inlet (when the through hole 905 is formed by the distal end section 104 or simultaneously)).

[0042] refer to Figure 2 , Figure 3 and Figure 4 The implementation scheme depicted, for example, allows a user (surgeon) to perform transseptal puncture through the fossa ovalis in the heart of a patient 902.

[0043] refer to Figure 2 , Figure 3 and Figure 4 In the embodiment depicted, the needle assembly 102 (preferably) comprises SAE (Society of Automotive Engineers) 304 stainless steel containing chromium (between about 15% and about 20%) and nickel (between about 2% and about 10.5%). The needle assembly 102 (preferably) is made of a conductive material and provides a rigid profile suitable for surgical procedures. It should be understood that any conductive material can be used for the needle assembly 102.

[0044] refer to Figure 2 , Figure 3 and Figure 4 In the embodiment depicted, a molded plastic handle (known but not depicted) can be positioned at the proximal end of the needle assembly 102. The molded plastic handle allows manipulation of the needle assembly 102 at its proximal end. It should be understood that the handle adds convenience for the user.

[0045] refer to Figure 2 , Figure 3 and Figure 4 In the embodiment depicted, a cable-assisted connection (known but not depicted) is configured to electrically connect the distal end segment 104 (via needle assembly 102) to a radio frequency energy generator (known but not depicted). The cable is configured to facilitate electrical connection with the needle assembly 102 for delivering radio frequency energy (from the radio frequency energy generator) to the needle assembly 102, reaching the biowall 904 (target tissue) at the distal end segment 104.

[0046] refer to Figure 2 , Figure 3 and Figure 4 The embodiment depicted allows the overall length of the needle assembly 102 to be compatible with conventional trans-septate sheaths and expanders (known but not depicted). This facilitates increased usability of the needle assembly 102 with a variety of auxiliary devices, which the user can freely select. For example, the overall length of the needle assembly 102 could be approximately 71 cm, approximately 89 cm, or approximately 98 cm, etc.

[0047] refer to Figure 2 , Figure 3 and Figure 4 In the embodiment depicted, needle assembly 102 (preferably) has a distal section diameter compatible with conventional transposition accessory devices (known and not depicted). The distal section diameter of needle assembly 102 (preferably) does not exceed about 0.032 inches. Alternatively, the distal section diameter of needle assembly 102 does not exceed about 0.035 inches.

[0048] refer to Figure 2 , Figure 3 and Figure 4 In the embodiment described herein, needle assembly 102 may have an overall length compatible with conventional transseptal accessory devices. The overall length of needle assembly 102 may be any length. The length of needle assembly 102 may enable needle assembly 102 to reach the fossa ovalis of the interatrial septum of the patient's heart 902 (anywhere the user can percutaneously access the vascular system).

[0049] refer to Figure 2 , Figure 3 and Figure 4 In the embodiments depicted, the needle assembly 102 may have the diameter of the distal segment of any suitable size, and / or may not exceed the diameter of the vascular system through which blood flow is excessively obstructed.

[0050] refer to Figure 2 , Figure 3 and Figure 4 The embodiments depicted herein, although the circular outline of the needle assembly 102 and / or the distal end segment 104 can provide maximum compatibility with existing accessory devices, the needle assembly 102 can have any suitable shape.

[0051] refer to Figure 2 , Figure 3 and Figure 4 Another option for the embodiment depicted may include the following: instead of the needle assembly 102 being made of a conductive material, and the dielectric surface 112 (dielectric coating) covering at least one or more segments of the distal end segment 104, the materials may be reversed. The needle assembly 102 may be configured such that the needle assembly 102 is made of an electrically insulating material, and a portion of the distal end segment 104 is made of a conductive material. The distal end segment 104 having the conductive material may be connected to a known device configured to generate radio frequency energy via a conduit (wire) of conductive material inside (or outside, or both) of the needle assembly 102.

[0052] refer to Figure 2 , Figure 3 and Figure 4In the embodiment depicted, needle assembly 102 may include a radiofrequency needle having a valve made of a non-conductive material configured at its distal end, which closes the open lumen when radiofrequency energy is applied thereon. This arrangement can prevent tissue core extraction (e.g.) Figure 1 (As depicted in the image), because no tissue evaporates along a closed circumferential path, this evaporation could cause the tissue to break into multiple segments. After the application of radiofrequency energy, the valve can move to a position where it no longer obstructs the lumen 108 of the needle assembly 102.

[0053] refer to Figure 2 , Figure 3 and Figure 4 In the embodiment depicted, needle assembly 102 may include a radiofrequency needle configured with a closed distal end for applying radiofrequency energy to target tissue. An inner lumen 108 is exposed on one side of needle assembly 102 near the distal distal segment 104. The inner lumen 108 facilitates functions such as fluid delivery and aspiration, thread anchoring, and pressure measurement. Tissue core removal (e.g.) can be avoided. Figure 1 (as depicted in the text), because the distal end segment 104 (once activated where radiofrequency energy is applied) is not a circumferential profile that could cause tissue to split into multiple segments.

[0054] refer to Figure 2 , Figure 3 and Figure 4 In the embodiment depicted, the radiofrequency needle (preferably) is configured such that the open lumen at the distal end is composed of a discontinuous conductive material. It is discontinuous because it does not form a completely closed periphery of conductive material at the distal end. Such a configuration would require a mechanism to ensure that the needle is no longer electrically active when it passes through tissue beyond the discontinuous distal end, and therefore cannot be cored.

[0055] refer to Figure 4 The embodiment depicted provides an open-lumen cannulation system with an auxiliary radiofrequency guidewire (known but not shown) instead of a needle assembly 102 (also referred to as a puncture device) with an endoluminal inlet 106 leading to the lumen 108. The open-lumen cannulation system provides a catheter leading to a desired puncture site (e.g., through-hole 905) in the fossa ovalis of the interatrial septum in the patient's heart 902. A guidewire (known but not depicted) can be advanced through the catheter to the desired puncture site. The guidewire may have a core surrounded by an electrically insulating material, except at the distal and proximal ends, for easy connection to a device (known but not depicted) that generates radiofrequency energy. Radiofrequency energy can be applied through the guidewire to the through-hole 905 to vaporize tissue (e.g., without core removal) Figure 1 (As depicted in the text).

[0056] Figure 5 and Figure 6 Depicting Figure 2 Perspective view of the embodiment of the needle assembly 102 ( Figure 5 ) and end view ( Figure 6 ).

[0057] refer to Figure 5 In the embodiment depicted in the perspective view, needle assembly 102 defines (has) an inner cavity 108 (extending along the elongated length of needle assembly 102). Needle assembly 102 preferably comprises (is made of) a conductive material. Needle assembly 102 preferably includes a conductive surface 110. Preferably, needle assembly 102 also includes a dielectric surface 112 (also referred to as a dielectric coating) that covers a portion or part of the distal end segment 104 (e.g., a circumferential portion at the distal end segment 104). Dielectric surface 112 provides electrical insulation to at least one or more selected areas of the distal end segment 104 (such that tissue in contact with dielectric surface 112 does not evaporate); therefore, during puncture associated with the use of needle assembly 102, the tissue in contact with dielectric surface 112 does not become completely separated. Dielectric surface 112 can completely prevent the formation of a free-floating tissue core 906, rather than by using a known needle assembly 802 (such as...). Figure 1 (as depicted in the text) to form a free-floating core 906 (such as...) Figure 1 (As depicted in the implementation scheme). For example, as Figure 1 The choice or alternative of the implementation scheme described herein, the dielectric surface 112 can assist the tissue flap 908 (e.g. Figure 4 The formation of the through hole 905 (as depicted in the diagram) is achieved by the movement of the distal end segment 104 through the biowall 904 (so that a portion of the needle assembly 102 can pass through the biowall 904). Figure 5 The implementation scheme avoids the formation of a free-floating tissue core 906, such as Figure 1 As depicted in the text (that is, no tissue core is taken).

[0058] refer to Figure 4 and Figure 5 The implementation scheme described in the document includes safety cover 114 (e.g.) Figure 4 The safety cap 114, as depicted in the image, is (preferably) applied to cover the outer surface of the needle assembly 102. The safety cap 114 comprises an electrically insulating material. The safety cap 114 covers the remainder of the needle assembly 102 except for the distal distal segment 104. The safety cap 114 may comprise a heat-shrinkable material, etc. The safety cap 114 (preferably) comprises a heat-shrinkable material having polytetrafluoroethylene (PTFE), which provides relatively greater lubricity compared to parylene, facilitating delivery to and removal from accessory devices (known and not depicted) and / or the patient's vascular system (the vascular system and its arrangement as part of the body). Preferably, only a relatively small portion of the distal distal segment 104 is coated with a dielectric surface 112 (such as...). Figure 5(as depicted in the document), while the remainder of the needle assembly 102 is covered by a safety cover 114 (heat shrinkable). It should be understood that the safety cover 114 may include any electrically insulating material, and / or may include the dielectric coating described in this document.

[0059] refer to Figure 4 and Figure 5 In the embodiment depicted, dielectric surface 112 (dielectric coating) partially covers the circumferential and / or circumferential leading edge 105 of the distal end segment 104. Once the conductive surface 110 is activated or energized (e.g., when radio frequency energy is transmitted to a portion of the biowall 904 via the conductive surface 110), the uncoated portion of the distal end segment 104 (the electroactive segment or conductive surface 110) is used to evaporate tissue at the desired portion of the biowall 904 (e.g., the fossa ovalis of the heart). Figure 4 (As depicted in the text). Tissue core extraction (e.g.) Figure 1 (As depicted in the text) by preventing tissues (part of the biological wall, such as...) Figure 4 The evaporated dielectric surface 112 (dielectric coating) depicted in the diagram mitigates the effect. Cutting can be prevented, at least partially, by evaporating, at least one segment (or segments of) the distal end segment 104 (or the circumferential portion of the distal end segment 104), thus avoiding or preventing tissue separation (i.e., tissue core extraction, as depicted in the diagram). Figure 1 (As depicted in the text) (for cases where the conductive surface 110 is activated, such as when radio frequency energy is applied to the conductive surface 110, etc.).

[0060] refer to Figure 5 The embodiment depicted herein includes, preferably, a radiofrequency end assembly (known to those skilled in the art and not depicted). Radiofrequency embodiments may include an NRG (trademarked) RF transseptal needle manufactured by Baylis Medical (headquartered in Canada) and configured to assist physician access to the left atrium by using radiofrequency (RF) energy in a controlled manner, in opposition to mechanical force.

[0061] refer to Figure 5 In the embodiment depicted, the needle assembly 102 is made of a conductive material. A dielectric coating covers a portion of the conductive material. A distal distal segment 104 (preferably) is configured to puncture a biological wall 904 (also referred to as tissue) using radio frequency energy. An endometrium 108 extends through the distal distal segment 104, defining an endometrium inlet 106 extending from the endometrium 108. The distal distal segment 104 (preferably) has a profile partially coated by a dielectric surface 112. This partial coating (of the dielectric surface 112) is configured to reduce the risk of tissue core extraction (which is... Figure 1(As depicted in the embodiment). A portion of the distal end segment 104 may have a portion of conductive material (conductive surface 110) (electroactive periphery) positioned at the distal end segment 104. A portion of the periphery of the distal end segment 104 is dielectrically coated (having dielectric surface 112) to prevent tissue separation (e.g., once radio frequency energy is applied to the distal end segment 104). Figure 1 (As depicted in the text).

[0062] refer to Figure 5 In the embodiment depicted, needle assembly 102 may include (defining) an internal lumen inlet 106 leading to an internal lumen 108. The internal lumen inlet 106 is located in the distal distal segment 104. A dielectric coating (dielectric surface 112) is applied to at least one or more segments of the distal distal segment 104 (surrounding the internal lumen inlet 106 at the distal distal segment 104) to prevent tissue core extraction (e.g. Figure 1 (As depicted in the implementation scheme). A dielectric coating (dielectric surface 112) may cover at least a portion of the periphery surrounding the inner cavity entrance 106 defined at the distal end segment 104.

[0063] refer to Figure 5 In the embodiment depicted, the exposed conductive surface 110 and the exposed dielectric surface 112 are configured to cover different portions (segments) of the distal end segment 104.

[0064] refer to Figure 5 In the embodiment described herein, the exposed dielectric surface 112 is positioned close to (adjacent to) the exposed conductive surface 110.

[0065] refer to Figure 5 In the embodiment depicted, both the exposed conductive surface 110 and the exposed dielectric surface 112 are configured to at least partially contact the biowall 904 (preferably, when the needle assembly 102 is pushed toward the biowall 904, as...). Figure 4 (As depicted in the implementation plan).

[0066] refer to Figure 5In the embodiment depicted, dielectric surface 112 (preferably) comprises a chemically vapor-deposited poly(p-xylene) polymer configured to provide a moisture and dielectric barrier, such as parylene (trademark). Dielectric surface 112 (dielectric coating) partially covers distal end segment 104. The thickness of the dielectric coating is such that dielectric breakdown does not occur under electrical parameters utilized by, for example, a radio frequency generator, with which distal end segment 104 is configured to interact. For example, the thickness of the dielectric coating may be at least about 30 micrometers, and the final suitable coating thickness may depend on the electrical parameters used for needle assembly 102. It should be understood that any material with sufficient dielectric strength to prevent electrical (such as radio frequency energy) transmission to a circumferential portion of the distal end segment 104 is acceptable. It should be understood that any material with sufficient dielectric strength to prevent electrical (radio frequency energy) transmission to the covered portion of the distal end segment 104 is acceptable. Furthermore, the dielectric coating may be applied to, for example, the interior of lumen inlet 106 and / or lumen 108.

[0067] refer to Figure 5 In the embodiment depicted, the dielectric surface 112 (preferably) has a parylene thickness of about 30 micrometers. The dielectric surface 112 may include other suitable coatings or materials, such as any alternative formulations of silica, alumina, parylene, silicon-based coating formulations, fluoropolymer coatings, etc., and any equivalents thereof.

[0068] refer to Figure 5 In one embodiment depicted, dielectric surface 112 is applied to the outer portion of the distal end segment 104, which is sufficient to prevent tissue core extraction (e.g.) Figure 1 (As depicted in the text).

[0069] refer to Figure 5 In the embodiment depicted, according to another option, the dielectric surface 112 may be applied to the inner surface of the lumen inlet 106 and / or the lumen 108. When the needle assembly 102 passes through tissue (i.e., as...), Figure 4 When the biowall 904 is depicted, the interior of the needle assembly 102 approaches the biowall 904 (tissue). Although the inner surfaces of the lumen inlet 106 and / or the lumen 108 may not necessarily be in direct contact with the biowall 904, the proximity of the inner surfaces may be close enough that an electric arc may occur and unintentionally cut the tissue (which may be undesirable), and thus may lead to tissue core extraction (e.g., ...). Figure 1(As depicted in the image). To mitigate such situations, the length of the inner surface of the inner cavity inlet 106 and / or the inner cavity 108 (e.g., about five (5) millimeters (mm)) can be coated with a dielectric surface 112 that can prevent unwanted (electrical) arcing (e.g.,) that may occur from the interior of the distal end segment 104 when the distal end segment 104 of the needle assembly 102 passes through the biowall 904. Figure 4 (As depicted in the text).

[0070] refer to Figure 6 The embodiment depicted in the (end view) illustrates the circumferential profile of the distal end segment 104. The distal end segment 104 (preferably) includes a first arcuate portion 200 and a second arcuate portion 202 positioned adjacent to the first arcuate portion 200. The distal end segment 104 (preferably) includes a circumferentially peripheral leading edge 105. The circumferentially peripheral leading edge 105 (preferably) includes the first arcuate portion 200 and the second arcuate portion 202.

[0071] refer to Figure 6 In the embodiment depicted, a portion of the distal end segment 104 (dielectric surface 112) is coated with a dielectric material configured to provide electrical insulation. For example, once radio frequency energy is applied to the distal end segment 104, the uncoated portion of the distal end segment 104 (the active portion without dielectric material coating) is activated (energized) and can cut tissue (biowall 904), while the segment coated with dielectric material cannot (does not) cut tissue. Therefore, no tissue separation occurs (e.g., Figure 1 (The implementation details).

[0072] refer to Figure 6 In the embodiment depicted, the distal end segment 104 includes a first arcuate portion 200 and a second arcuate portion 202 positioned adjacent to the first arcuate portion 200. An exposed conductive surface 110 is also configured to cover the first arcuate portion 200. An exposed dielectric surface 112 is also configured to cover (cover) the second arcuate portion 202 of the distal end segment 104.

[0073] refer to Figure 6 In the embodiment depicted, the exposed conductive surface 110 is also configured to electrically cut through the biological wall 904 (preferably, once the exposed conductive surface 110 of the distal end segment 104 in use is moved to at least partially contact the biological wall 904, and when the exposed conductive surface 110 is activated to cut through the biological wall 904 or simultaneously).

[0074] refer to Figure 6In the embodiment depicted, the exposed dielectric surface 112 is also configured to electrically isolate a portion of the distal end segment 104 surrounding the inner cavity entrance 106 from the biowall 904; preferably, this is when the exposed conductive surface 110 comes into contact with the biowall 904 during use (or simultaneously), and when the exposed conductive surface 110 is activated to form a through-hole 905 extending through the biowall 904 (and when the needle assembly 102 is pushed toward the biowall 904, as... Figure 4 (As described in the implementation plan), this process is completed.

[0075] refer to Figure 6 In the embodiment depicted, the exposed dielectric surface 112 is configured to electrically isolate a portion of the distal end segment 104 surrounding the internal cavity entrance 106 from the biowall 904 (while the exposed conductive surface 110 is activated, and the exposed dielectric surface 112 prevents the formation of...). Figure 1 The implementation scheme depicts a free-floating tissue core 906.

[0076] refer to Figure 6 In the embodiment depicted, the distal end segment 104 presents (has) a circumferential leading edge 105 surrounding the lumen inlet 106. The circumferential leading edge 105 is configured to prevent the free-floating tissue core 906 from being removed from the biowall 904 (when or simultaneously with the through-hole 905 formed by the distal end segment 104).

[0077] refer to Figure 6 In the embodiment depicted, the exposed conductive surface 110 is configured to cover (cover) a first arcuate portion 200 of the circumferential leading edge 105. The exposed dielectric surface 112 is configured to cover (cover) a second arcuate portion 202 of the circumferential leading edge 105. The second arcuate portion 202 is positioned close to the first arcuate portion 200. The exposed dielectric surface 112 is positioned close to the exposed conductive surface 110. Both the exposed conductive surface 110 and the exposed dielectric surface 112 are configured to at least partially contact the biowall 904 (in use, when the needle assembly 102 moves toward or simultaneously with the biowall 904).

[0078] Figure 7 , Figure 8 , Figure 9 and Figure 10 Depicting Figure 2 Cross-sectional view of an embodiment of the needle assembly 102 ( Figure 7 ) and side view ( Figure 8 , Figure 9 and Figure 10 ). Figure 7 The view depicted in the middle is along Figure 6 It is intercepted by the cross-sectional line AA.

[0079] refer to Figure 7 In the embodiment depicted in the (cross-sectional view), a dielectric surface 112 (also referred to as a dielectric coating or electrical insulation) is applied to the inner surface facing the cavity 108 and / or the cavity inlet 106. This arrangement alleviates the impact on tissues (such as...) Figure 4 The biowall 904 depicted in the image may experience an undesirable (electric) arc as it passes near the distal terminal segment 104 (which could lead to...). Figure 1 (The tissue core is depicted in the image).

[0080] refer to Figure 8 , Figure 9 and Figure 10 The embodiments depicted illustrate various embodiments of the lateral profile of the distal terminal segment 104. In some embodiments, the distal terminal segment 104 has a tapered profile, which is configured to facilitate passage through the biowall 904 (e.g., Figure 4 (As depicted in the text). Initially, a cross section smaller than the total diameter of the distal terminal segment 104 passes through the biowall 904 (tissue wall), and then, as the conical segment moves through the biowall 904 (crossing point), the crossing point gradually expands to reach a relatively fuller diameter of the distal terminal segment 104.

[0081] refer to Figure 8 In the implementation scheme depicted, the distal end segment 104 presents an inclined front surface.

[0082] refer to Figure 9 In the embodiment depicted, the distal end segment 104 provides a blunt portion with a tapered profile. The blunt distal end mitigates scratching (abrasion) of the plastic material as the needle assembly 102 is advanced through the accessory device (known to those skilled in the art and not depicted). The tapered profile is configured to enhance penetration through the biowall 904 (e.g., Figure 4 As depicted in the image), such as the diaphragm passing through, because it is initially formed via a puncture (using needle assembly 102) through a hole (through hole 905, as shown in the image). Figure 4 The dimensions of the distal distal segment 104 (as depicted in the diagram) are relatively small compared to the overall diameter of the distal distal segment 104. The tapered profile is configured to allow the puncture orifice (through-hole 905) to gradually widen to a relatively large diameter, thus producing a smooth rather than abrupt sensation when passing through a biological wall 904 (such as the atrial septum of the heart). It should be understood that any profile (external shape) of the distal distal segment 104 can be utilized. The distal distal segment 104 preferably provides or defines an internal lumen inlet 106 leading to an internal lumen 108 located within the needle assembly 102.

[0083] refer to Figure 10 In the embodiment depicted, the distal end segment 104 presents an extension that extends in front of the inclined front surface.

[0084] Figure 11and Figure 12 Depicting Figure 2 A perspective view of an embodiment of the needle component 102.

[0085] refer to Figure 11 and Figure 12 In the embodiment depicted, an extension 116 of the distal end segment 104 extends (forward) from the distal end segment 104. The extension 116 is made of (including) a conductive surface 110, and the remainder of the contour of the distal end segment 104 (or the circumferential leading edge 105) is coated with a dielectric material (that is, the dielectric surface 112 includes the remainder of the contour of the distal end segment 104 or the circumferential leading edge 105). For example, it may be advantageous to prevent radio frequency energy from being applied to the tissue in these regions (at the biowall 904).

[0086] Figure 13 Depicting Figure 2 A perspective view of an embodiment of the needle component 102.

[0087] refer to Figure 13 In the embodiment depicted, the distal terminal segment 104 is depicted penetrating the biowall 904. Radiofrequency energy is applied (via conductive surface 110) to the tissue at the uncoated portion of the distal terminal segment 104, while the remaining portion of the segment of the needle assembly 102 adjacent to the tissue is covered in a dielectric coating (on which a dielectric surface 112 is formed). The tissue evaporates only at the conductive surface 110 (i.e., the uncoated portion of the distal terminal segment 104). Figure 13 In some implementations, the needle assembly 102 does not provide or includes an internal inlet 106 and / or an internal cavity 108 (e.g., they are...). Figure 2 (The project described in the implementation plan).

[0088] refer to Figure 13 The embodiment described herein illustrates the main aspects of the device. The device includes, but is not limited to, a needle assembly 102. The needle assembly 102 is configured to move into a cavity 900 of a patient 902 having a biowall 904 (internal biowall). A distal distal segment 104 extends distally from the needle assembly 102. The distal distal segment 104 is configured to move toward the biowall 904 when the needle assembly 102 is pushed (e.g., ...). Figure 4 The implementation scheme depicts forming a through-hole 905 extending through the biowall 904 of the patient 902. When the through-hole 905 is formed by the distal distal segment 104 (or simultaneously), the distal distal segment 104 is also configured to prevent free-floating tissue core 906 (in Figure 1 (As depicted in the implementation plan) Removed from biowall 904.

[0089] refer to Figure 13In the embodiment depicted, the exposed conductive surface 110 and the exposed dielectric surface 112 are configured to cover different portions of the distal end segment 104.

[0090] refer to Figure 13 In the embodiment described herein, the exposed dielectric surface 112 is positioned close to (adjacent to) the exposed conductive surface 110.

[0091] refer to Figure 13 In the embodiment depicted, both the exposed conductive surface 110 and the exposed dielectric surface 112 are configured to at least partially contact the biowall 904 when the needle assembly 102 is pushed toward the biowall 904 (or simultaneously). Figure 4 (As depicted in the implementation plan).

[0092] refer to Figure 13 The embodiment described herein illustrates a key aspect of a method. The method is used to form a through-hole 905 through a biowall 904 of a patient 902 having a cavity 900. The method includes, but is not limited to, a first operation comprising moving a needle assembly 102 into the cavity 900 of the patient 902 having the biowall 904. The needle assembly 102 includes a distal distal segment 104 extending distally from the needle assembly 102. The method includes, but is not limited to, a first operation comprising (simultaneously) moving the needle assembly 102 toward the biowall 904. Figure 4 As depicted in the implementation scheme, a distal distal segment 104 is used to form a through-hole 905 through the biowall 904 of the patient 902. The method includes, but is not limited to, a first operation comprising using the distal distal segment 104 to prevent a freely floating tissue core 906 from being formed when (or simultaneously) the through-hole 905 is formed by the distal distal segment 104. Figure 1 (As depicted in the implementation plan) Removed from biowall 904.

[0093] 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 medical device comprising: A needle assembly configured to move into a cavity of a patient with a biological wall; and A distal distal segment, the distal distal segment extending from the needle assembly; and The distal end section is configured to form a through-hole extending through the patient's biological wall when the needle assembly is pushed toward the biological wall; and The distal end segment is also configured to at least partially prevent the removal of a free-floating tissue core from the biowall when the through-hole is formed by the distal end segment. The distal end segment surrounds an inner cavity entrance leading to the inner cavity of the needle assembly, the inner cavity extending inward along the length of the needle assembly, and The inner surface of the distal end section is coated with a dielectric coating.

2. The medical device according to claim 1, further comprising: Exposed conductive surfaces and exposed dielectric surfaces are configured to cover different portions of the distal end segment.

3. The medical device according to claim 2, wherein: The exposed dielectric surface can be positioned close to the exposed conductive surface.

4. The medical device according to claim 2, wherein: Both the exposed conductive surface and the exposed dielectric surface are configured to at least partially contact the biological wall when the needle assembly is pushed toward the biological wall.

5. A medical device comprising: A needle assembly configured to move into a cavity of a patient with a biological wall; and A distal distal segment extends from the needle assembly and surrounds an inner cavity inlet leading to an inner cavity extending inward along the length of the needle assembly; and The distal end section is configured to form a through-hole extending through the patient's biological wall when the needle assembly is pushed toward the biological wall; and The distal end segment is also configured to at least partially prevent the removal of a free-floating tissue core from the biowall, due to assistance from or the presence of the lumen inlet when the distal end segment forms the through-hole. The inner surface of the distal end section is coated with a dielectric coating.

6. The medical device according to claim 5, wherein: The distal end segment is also configured to form a tissue flap, wherein the tissue flap remains attached to and extends from the biowall when the through-hole is formed by the distal end segment, wherein the tissue flap is positioned close to the through-hole.

7. The medical device according to claim 5, further comprising: Exposed conductive surfaces and exposed dielectric surfaces are configured to cover different portions of the distal end segment.

8. The medical device according to claim 7, wherein: The exposed dielectric surface can be positioned close to the exposed conductive surface.

9. The medical device according to claim 7, wherein: Both the exposed conductive surface and the exposed dielectric surface are configured to at least partially contact the biological wall when the needle assembly is pushed toward the biological wall.

10. The medical device according to claim 7, wherein: The distal end segment includes a first arcuate portion and a second arcuate portion positioned close to the first arcuate portion; and The exposed conductive surface is also configured to cover the first arcuate portion; and The exposed dielectric surface is also configured to cover the second arcuate portion of the distal end segment.

11. The medical device according to claim 7, wherein: The exposed conductive surface is also configured to electrically cut through the biological wall once the exposed conductive surface of the distal end segment in use is moved to at least partially contact the biological wall and activated to cut through the biological wall.

12. The medical device according to claim 7, wherein: When the exposed conductive surface comes into contact with the biowall during use, and when the exposed conductive surface is activated to form a through-hole extending through the biowall while the needle assembly is pushed toward the biowall, the exposed dielectric surface is also configured to electrically isolate a portion of the distal end segment surrounding the lumen entrance from the biowall.

13. The medical device according to claim 7, wherein: When the exposed conductive surface is activated, the exposed dielectric surface is configured to electrically isolate a portion of the distal end segment surrounding the lumen entrance from the biowall, and the exposed dielectric surface prevents the formation of the free-floating tissue core.

14. The medical device according to claim 5, wherein: The distal end segment presents a circumferential leading edge surrounding the inlet of the cavity; and The circumferential leading edge is configured to at least partially prevent the removal of a free-floating tissue core from the biowall when the through-hole is formed by the distal end segment.

15. The medical device according to claim 14, further comprising: An exposed conductive surface, the exposed conductive surface being configured to cover a first arcuate portion of the circumferential peripheral leading edge.

16. The medical device according to claim 15, further comprising: An exposed dielectric surface, the exposed dielectric surface being configured to cover a second arcuate portion of the circumferential peripheral leading edge, wherein the second arcuate portion is positioned close to the first arcuate portion.

17. The medical device according to claim 16, wherein: The exposed dielectric surface can be positioned close to the exposed conductive surface.

18. The medical device according to claim 17, wherein: Both the exposed conductive surface and the exposed dielectric surface are configured to at least partially contact the biowall when the needle assembly moves toward the biowall during use.

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