Elongated medical needle assembly

Abstract

The elongated medical needle assembly includes an elongated conductive flexible tubing assembly configured to be at least partially manipulated within a patient and toward a biological feature, an electrically exposed outer surface positioned between spaced apart electrically insulating layers and at least partially covering the outer surface of the elongated conductive flexible tubing assembly, and the electrically exposed outer surface configured to selectively emit energy toward the biological feature of the patient.

Description

Technical Field

[0001] This document relates to (but is not limited to) the technical field of elongated medical needle assemblies (and methods therefor).

Background Art

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

Summary of the Invention

[0003] It will be appreciated that there is a need to (at least partially) mitigate at least one problem associated with existing medical needles (also referred to as the prior art). After much research and experimentation with existing medical needles, the problems have been (at least partially) understood, and their solutions have been (at least partially) identified and are (at least partially) shown as follows.

[0004] Based on known systems, what may be required is a device for selectively emitting energy from an elongated medical needle assembly towards a patient's biological characteristics. To at least partially mitigate at least one problem associated with the prior art, a device is provided (in accordance with a main aspect). The device is for use with (along with) a patient's biological characteristics. The device includes an elongated medical needle assembly including an elongated conductive flexible tube assembly configured to be at least partially operated within the patient and towards the biological characteristics, among other things. The electrically exposed outer surface is located between spaced electrical insulation layers and at least partially covers the outer surface of the elongated conductive flexible tube assembly. It will be understood that the hatching markings in all the schematic diagrams (such as in FIG. 1) indicate an insulating coating (such as spaced electrical insulation layers). The electrically exposed outer surface is configured to selectively emit energy towards the patient's biological characteristics.

[0005] Based on known systems, what may be needed is a device for selectively emitting energy towards a patient's biological characteristics without emitting energy from the distal portion of an elongate medical needle assembly.

[0006] To at least partially mitigate at least one problem associated with existing technology, a device is provided for selectively emitting energy towards a patient's biological characteristics without emitting energy from the distal portion of an elongate medical needle assembly (in accordance with the main aspect).

[0007] Based on known systems, what may be needed is a device for selectively emitting energy towards a patient's biological characteristics without emitting energy from the distal portion disposed at the outlet of the elongate lumen defined by the elongate medical needle assembly.

[0008] To at least partially mitigate at least one problem associated with existing technology, a device is provided for selectively emitting energy towards a patient's biological characteristics without emitting energy from the distal portion disposed at the outlet of the elongate lumen defined by the elongate medical needle assembly (in accordance with the main aspect).

[0009] A method is provided (in accordance with a main aspect) to at least partially mitigate at least one problem associated with the existing technology. The method is for use with an elongated medical needle assembly that includes an elongated conductive flexible tube assembly. The method includes manipulating the elongated conductive flexible tube assembly into and towards a patient's biological characteristics, which is not limited to (comprising this). The elongated conductive flexible tube assembly has a distal portion. A first electrical insulation layer at least partially covers an outer surface of the elongated conductive flexible tube assembly. A second electrical insulation layer at least partially covers the distal portion of the elongated conductive flexible tube assembly. An electrically exposed outer surface is located between the first electrical insulation layer and the second electrical insulation layer, proximate to the distal portion. The electrically exposed outer surface is configured to selectively emit energy towards the patient's biological characteristics in response to a selective movement of energy along the elongated conductive flexible tube assembly towards the electrically exposed outer surface. The method also includes selectively emitting energy from the electrically exposed outer surface towards the patient's biological characteristics in response to a selective movement of energy along the elongated conductive flexible tube assembly towards the electrically exposed outer surface.

[0010] Other aspects are specified in the claims. Other aspects and features of the non-limiting embodiments will become apparent to those skilled in the art by considering the following detailed description of the non-limiting embodiments together with the accompanying drawings. This "Summary of the Invention" is provided to introduce concepts in a simplified form and is further explained in the "Detailed Description of the Invention" below. This "Summary of the Invention" is not intended to identify potentially important features or expected essential features of the disclosed subject matter, nor is it intended to explain each or all implementations of the disclosed embodiments of the disclosed subject matter. As the description proceeds, many other novel advantages, features, and relationships will become apparent. The following drawings and description illustrate exemplary embodiments in more specific detail.

[0011] Non-limiting embodiments can be more fully understood by reference to the following detailed description of the non-limiting embodiments when taken in conjunction with the accompanying drawings.

Brief Description of the Drawings

[0012]

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DETAILED DESCRIPTION OF THE INVENTION

[0013] The drawings are not necessarily to scale and may be shown by phantom lines, schematic representations, and partial views. In some cases, details that are unnecessary for an understanding of the embodiments (and / or details that make it difficult to recognize other details) may be omitted. Corresponding reference numerals indicate corresponding components throughout several views of the drawings. Elements in some of the figures are shown for simplicity and clarity and are not drawn to scale. The dimensions of some of the elements in the figures may be emphasized relative to other elements to facilitate an understanding of the various disclosed embodiments. Additionally, commonly understood elements that are useful in commercially realizable embodiments are often not shown so as not to limit the scope of the embodiments of the present disclosure.

[0014] The following detailed description is merely exemplary and is not intended to limit the embodiments described or the uses and applications of the embodiments described. When used, the words "exemplary" or "illustrative" mean "serving as an example, instance, or illustration." No implementation described as "exemplary" or "illustrative" should be construed as necessarily preferred or advantageous over other implementations. All of the implementations described below are exemplary implementations provided to enable those skilled in the art to make or use the embodiments of the present disclosure and are not intended to limit the scope of the present disclosure. The scope of the present disclosure is defined by the claims. In this specification, the terms "above," "below," "left," "rear," "right," "front," "vertical," "horizontal," and derivatives thereof shall relate to the orientation in the example drawings. It is not intended to be bound by any theory, whether explicit or implicit, in the foregoing "Technical Field," "Background Art," "Summary of the Invention," or the following detailed description. It should also be understood that the devices and processes shown in the accompanying drawings and described in the following specification are exemplary embodiments (examples), aspects, and / or concepts defined in the appended claims. Accordingly, dimensions and other physical characteristics relating to the disclosed embodiments should not be considered limiting unless the claims expressly state otherwise. It should be understood that the phrase "at least one" is equivalent to "one (a)." Aspects (examples, variations, modifications, options, variants, embodiments, and any equivalents thereof) are described with respect to the drawings. It should be understood that the present disclosure is limited to the subject matter provided by the claims and that the present disclosure is not limited to the specific aspects shown and described. It will be understood that the meaning of a device being configured to be coupled to an item (i.e., connected to the item so as to interact with the item, for example) is to be construed as the device being configured to be coupled to the item either directly or indirectly. Thus, "configured to" may, in some cases, include the meaning of "either directly or indirectly" unless otherwise specified.

[0015] Figure 1 is a side view of a first embodiment (implementation form) of an elongated medical needle assembly 100. Figure 2 is a side view of a second embodiment (implementation form) of an elongated medical needle assembly 100.

[0016] Figures 3 and 4 are side views of a first embodiment (implementation form) of the elongated medical needle assembly 100 of Figure 1. Figures 5 and 6 are side views of a second embodiment (implementation form) of the elongated medical needle assembly 100 of Figure 2.

[0017] Figures 7 and 8 are a side view (Figure 7) and a side perspective view (Figure 8) of an embodiment of a technical feature part (option) that may be included in any one of (a) the first embodiment of the elongated medical needle assembly 100 of Figure 15, (b) the second embodiment of the elongated medical needle assembly 100 of Figure 17, and / or (c) the third embodiment of the elongated medical needle assembly 100 of Figure 19.

[0018] Figures 9, 10, and 11 are side views of a third embodiment (implementation form) of an elongated medical needle assembly 100. Figures 12A, 12B, 13, and 14 are side views of an embodiment of the technical feature part of Figures 7 and 8.

[0019] Referring to the embodiment (implementation form) shown in Figure 1, the elongated medical needle assembly 100 is configured to be inserted into a narrow space defined by the living body of a patient 902 as shown in Figures 3 to 4. The elongated medical needle assembly 100 includes a relatively thin and flexible wire or flexible tube (elongated flexible shaft) configured to be inserted into a narrow or serpentine space (narrow space) defined by the living body (preferably).

[0020] Referring to the embodiment (implementation form) shown in FIG. 1, the elongated medical needle assembly 100 includes a biocompatible material suitable for specific performance (e.g., dielectric strength, heat insulation, electrical insulation, corrosion resistance, water resistance, heat resistance, etc.) to comply with industrial and / or regulatory safety standards (or to be suitable for medical use). For consideration of appropriate material selection, please refer to the following publication: Plastics in Medical Devices: Properties, Requirements, and Applications; 2nd Edition; Author: Vinny R. Sastri; Hardcover ISBN: 9781455732012; Publication Date: November 21, 2013; Publisher: Amsterdam [Netherlands]: Elsevier / William Andrew,

[2014] .

[0021] Referring to the embodiment (implementation form) shown in FIG. 1, the elongated medical needle assembly 100 includes an elongated conductive flexible tube assembly 102 having a distal portion 104 and defining an elongated lumen 106 that extends longitudinally along the elongated conductive flexible tube assembly 102 toward the distal portion 104. The elongated lumen 106 terminates at a lumen opening 107 (located at the distal portion 104). The electrically exposed outer surface 108 is located adjacent to the distal portion 104 and is spaced from the lumen opening 107. For example, the elongated conductive flexible tube assembly 102 may include a shape-memory material (SMM), and the shape-memory material is configured to return to its original shape (set before operation) after being operated and / or deformed. Since the shape-memory material is well-known, it will not be described in further detail. The shape-memory material is configured to recover its original shape from a significant apparent plastic deformation in response to a specific stimulus applied to the shape-memory material. This is known as the shape memory effect (SME). Once the shape-memory material is deformed in the presence of a stimulus-induced force (applying a force), superelasticity may be observed (in the alloy). The elongated conductive flexible tube assembly 102 may include, for example, (a) a single tube, (b) a single tapered tube, (c) a proximal tube and a distal tube arranged in sequence, (d) a proximal tube and a distal tube with different outer diameters arranged in sequence, etc. It will be understood that the elongated conductive flexible tube assembly 102 is preferably configured to meet dimensional constraints and / or geometric constraints that may allow the insertion of the elongated medical needle assembly 100 (or the elongated conductive flexible tube assembly 102) into other medical devices and / or any equivalents such as, for example, a sheath assembly (known and not shown), a dilator assembly (known and not shown), etc. It will be understood that the elongated conductive flexible tube assembly 102 may include a single tube or a single tapered tube as shown in FIGS. 1, 2, and 9.As shown in FIGS. 15-20, it will be appreciated that the elongate conductive flexible tube assembly 102 may include a two-piece tube assembly (comprising a proximal tube and a distal tube). For clarity, it will be appreciated that the first embodiment and its options are shown in FIGS. 1, 3, 4, 15, 16 and / or 21. For clarity, it will be appreciated that the second embodiment and its options are shown in FIGS. 2, 5, 6, 17, 18 and / or 22. For clarity, it will be appreciated that the third embodiment and its options are shown in FIGS. 9, 10, 11, 19, 20 and 23. It will be appreciated that the catheter assembly 800 (as shown in FIGS. 10 and 11) may include a sheath and a dilator assembly and any equivalents thereof.

[0022] (a) Refer to the embodiment of the technical feature (option) as shown in FIG. 7, which may be included in any one of the first embodiment of the elongate medical needle assembly 100 in FIG. 15, (b) the second embodiment of the elongate medical needle assembly 100 in FIG. 17, and / or (c) the third embodiment of the elongate medical needle assembly 100 in FIG. 19 where the medical needle assembly includes two shafts, a proximal shaft and a distal shaft. The tapered socket (i.e., the transition tube 506) is configured to enhance and / or reduce the stress concentration that may occur at the shoulder 510. The shoulder 510 may be referred to as a proximal-distal junction, a step, an edge, etc. The shoulder 510 is also shown in FIGS. 15, 17 and 19 (optionally as an option) with the transition tube 506 not attached to the elongate conductive flexible tube assembly 102. The socket (i.e., the transition tube 506) may be shrink-fitted onto the distal shaft 502. Alternatively, the transition tube 506 may preferably be fixed to the distal shaft 502 at the shoulder 510 using an adhesive such as EPO-TEK (trademark) type number 353ND epoxy (manufactured by EPOXY TECHNOLOGY, INC. located in the United States) and / or any equivalents thereof.

[0023] Referring to the embodiment (implementation form) shown in FIG. 7, the elongated medical needle assembly 100 also includes a first electrical insulation layer 201 that at least partially covers the outer surface of the elongated conductive flexible tube assembly 102. The elongated medical needle assembly 100 also includes a second electrical insulation layer 202 that at least partially covers the distal portion 104 of the elongated conductive flexible tube assembly 102. The elongated conductive flexible tube assembly 102 includes a proximal tube 500 and a distal tube 502 (for further details, see FIGS. 12A and 12B).

[0024] Referring to the embodiment (implementation form) shown in FIG. 1, the electrically exposed outer surface 108 is preferably configured to selectively emit energy, similar to a high-frequency puncture device such as the BAYLIS (registered trademark) POWERWIRE (trademark) high-frequency guide wire manufactured by BAYLIS MEDICAL COMPANY (headquartered in Canada).

[0025] Referring to the embodiment (implementation form) shown in FIG. 1, the first electrical insulation layer 201 and the second electrical insulation layer 202 include a coating of polytetrafluoroethylene (PTFE) heat shrink insulator, a parylene dielectric coating, and / or any equivalents thereof. The electrically exposed outer surface 108 (also called the active region) is configured to selectively release energy for puncturing tissue. The electrically exposed outer surface 108 can function as an electrode. The electrically exposed outer surface 108 is configured to selectively release energy (such as high-frequency energy). The electrically exposed outer surface 108 is characterized as an exposed metal region (small region) located between the first electrical insulation layer 201 and the second electrical insulation layer 202. According to a preferred embodiment, the elongated lumen extends over the entire length of the elongated conductive flexible tube assembly 102. According to any embodiment, the elongated lumen extends over the entire length of the elongated conductive flexible tube assembly 102 (i.e., the elongated lumen extends between the proximal tube 500 and the distal tube 502); refer to FIGS. 7 and 12A. Preferably, the lumen extends throughout the needle assembly (as shown in FIG. 24) and through the handle assembly 400. It is preferred that the distal portion 104 does not emit energy (such as high-frequency energy). The electrically exposed outer surface 108 is an exposed metal region that shields the first electrical insulation layer 201 and the second electrical insulation layer 202. If it is desired to avoid tissue coring, the elongated lumen 106 terminating at the distal portion 104 is coated or insulated (with an electrically insulating material) to ensure that there is no risk of inadvertently coring biological tissue (thereby avoiding the formation of free-floating particles that could cause embolism, etc.). The electrically exposed outer surface 108 preferably forms or includes a surface roughness greater than the surface roughness of the elongated conductive flexible tube, the first electrical insulation layer 201, and / or the second electrical insulation layer 202 (because by increasing the friction between the interacting surfaces, the contact between the electrically exposed outer surface 108 and the desired puncture site located on the biological feature to be punctured by the electrically exposed outer surface 108 can be stabilized).The position of the electrically exposed outer surface 108 can provide a non-traumatic unobstructed opening lumen in the distal portion 104 (if desired). The elongated conductive flexible tube assembly 102 may be used in minimally invasive cardiac procedures and enables a surgeon to obtain transseptal access by puncturing, for example, the fossa ovalis of the heart. The elongated conductive flexible tube assembly 102 may be applicable to similar use areas, provided that the constraints and requirements of the procedure are similar to those of minimally invasive transseptal access cardiac surgery.

[0026] Referring to the embodiment (implementation form) shown in FIG. 1, the elongated conductive flexible tube assembly 102 may include a single tapered tube (or hypo-tube), etc. The tapered shape of the elongated conductive flexible tube assembly 102 can ensure that, if desired, the elongated medical needle assembly 100 fits into an accessory device (such as a sheath and / or dilator, etc.).

[0027] Referring to the embodiment (implementation form) shown in FIG. 1, the elongated conductive flexible tube 102 includes SAE (Society of Automotive Engineering) type 304 stainless steel (e.g., suitable for a transseptal access puncture device). Further, type 304 stainless steel is biocompatible, conductive, and has material properties (such as rigidity) suitable for a given application and / or procedure, etc.

[0028] Type 304 stainless steel contains both metals, chromium (about 15% to about 20%) and nickel (about 2% to about 10.5%), as major non-ferrous components. Referring to the embodiment (implementation form) shown in FIG. 1, the electrically exposed outer surface 108 is located at the distalmost end of the elongated conductive flexible tube 102 when the elongated conductive flexible tube 102 is in its original curved shape. The electrically exposed outer surface 108 (exposed metal area) is configured to function as an electrode for applying energy (high-frequency energy) to pierce tissue. The electrically exposed outer surface 108 can be composed of type 304 stainless steel plated with platinum. The use of platinum ensures that the electrically exposed outer surface 108 is radiopaque and can be visualized by fluoroscopy and / or echocardiography. For example, the electrically exposed outer surface 108 may require a width of at least about 0.03 inches. The electrically exposed outer surface 108 can be large enough to pierce tissue by emitting energy, but small enough to ensure that the puncture hole heals postoperatively. The electrically exposed outer surface 108 can be created by heat-shrinking two separate lengths of electrical insulation sections onto the elongated conductive flexible tube 102 before or after bending the elongated conductive flexible tube 102. Alternatively, the electrical insulator may be applied over the entire length of the elongated conductive flexible tube 102, and a portion of the insulator may be cut away (by using a razor or equivalent method) to expose the electrically exposed outer surface 108. Hot air dipping may be used to seal the insulator along the distal portion 104.

[0029] Referring to the embodiment (implementation form) shown in FIG. 1, the first electrical insulation layer 201 and the second electrical insulation layer 202 (electrical insulators) preferably cover the entire length of the elongated conductive flexible tube 102 except for the electrically exposed outer surface 108. The first electrical insulation layer 201 and the second electrical insulation layer 202 are highly lubricious and allow the elongated conductive flexible tube 102 to be easily moved (advanced and / or retracted) from the attached device and / or the patient's vascular system. Any equivalent insulating material that meets all of the mechanical performance requirements, electrical insulation property requirements, and biocompatibility requirements can be used.

[0030] Referring to the embodiment (implementation form) shown in FIG. 24, a molded plastic handle having a curve indicator (known and not shown) can be attached to the elongated medical needle assembly 100. The handle allows the surgeon to more easily navigate and guide the distal portion 104 through the patient's anatomical structure. The curve indicator indicates the direction in which the elongated medical needle assembly 100 is curved, thereby enabling the user to operate the device accordingly. The handle merely serves to improve usability.

[0031] Referring to the embodiment (implementation form) shown in FIG. 24, it may be sufficient in any way that facilitates an electrical connection for sending energy (high-frequency energy) to the electrically exposed outer surface 108. The length of the elongated medical needle assembly 100 may be any length suitable for a given procedure, such as to reach the fossa ovalis from a surgical entry site in the upper thigh.

[0032] Referring to the embodiment (implementation form) shown in FIG. 24, the electrically exposed outer surface 108 is preferably configured to be used with any type of energy generator, such as a BAYLIS MEDICAL MODEL RPA-100A energy generator (or equivalent) configured to transmit (generate) high-frequency energy. A cable (known and not shown) supports the electrical connection between the electrically exposed outer surface 108 and the generator.

[0033] Referring to the embodiment (implementation form) shown in FIG. 2, the first electrical insulation layer 201 covers the entire length of the elongated conductive flexible tube 102 (except for the electrically exposed outer surface 108). The electrically exposed outer surface 108 can be characterized as the exposed metal at the top of the J-shaped curved portion of the elongated conductive flexible tube 102. Preferably, the length (shaft section) of the elongated conductive flexible tube assembly 102 forms two curved portions in its two spaced sections, namely, a first curved portion having a first radius 301 located in the distal portion 104 and a second curved portion (relatively larger curved portion) having a second radius 302 (spaced from the distal portion 104). The electrically exposed outer surface 108 (electrode) is located at the most distal end of the smaller curved portion when in its original curved shape. The electrically exposed outer surface 108 is located in proximity to the distal portion 104 and the elongated lumen 106 (i.e., in proximity to the open lumen surface).

[0034] FIGS. 3 to 4 are side views of an embodiment (implementation form) of the elongated medical needle assembly 100 of FIG. 1. Referring to the embodiment (implementation form) shown in FIG. 3, the elongated conductive flexible tube assembly 102 is configured to be at least partially manipulated within the patient 902 and towards the biological feature 900. The electrically exposed outer surface 108 is located between spaced electrical insulation layers (201, 202) and at least partially covers the outer surface of the elongated conductive flexible tube assembly 102. The electrically exposed outer surface 108 is configured to selectively emit high-frequency energy towards the biological feature 900 of the patient 902.

[0035] Referring to the embodiment (implementation form) shown in FIG. 3, the elongated conductive flexible tube assembly 102 has a distal portion 104 configured to be at least partially manipulated within patient 902 and toward biological feature 900. A first electrical insulation layer 201 at least partially covers the outer surface of the elongated conductive flexible tube assembly 102. A second electrical insulation layer 202 at least partially covers the distal portion 104 of the elongated conductive flexible tube assembly 102. An electrically exposed outer surface 108 is located proximate to the distal portion 104. The electrically exposed outer surface 108 is also located between the first electrical insulation layer 201 and the second electrical insulation layer 202. The electrically exposed outer surface 108 is configured to selectively emit energy toward the biological feature 900 of patient 902 in response to a selective movement of energy along the elongated conductive flexible tube assembly 102 toward the electrically exposed outer surface 108.

[0036] Referring to the embodiments (implementation forms) shown in FIGS. 3-6, a method of using the elongated medical needle assembly 100 is shown. The method may be applicable to all embodiments of the elongated conductive flexible tube assembly 102. The method includes manipulating the elongated conductive flexible tube assembly 102 (as shown in FIG. 3 or FIG. 5) into patient 902 and toward the biological feature 900 of patient 902. The method also includes selectively emitting energy from the electrically exposed outer surface 108 toward the biological feature 900 of patient 902 in response to a selective movement of energy along the elongated conductive flexible tube assembly 102 toward the electrically exposed outer surface 108 (as shown in FIG. 3 or FIG. 5). In this way, the electrically exposed outer surface 108 can thus form a puncture hole through the biological feature 900 of patient 902 (as shown in FIGS. 4 and 6).

[0037] Referring to the embodiments (implementations) shown in FIGS. 4 and 6, the electrically exposed outer surface 108 (electrode) is located at the distal portion 104 of the elongated conductive flexible tube 102, thereby enabling the user to advance the elongated conductive flexible tube 102 when the biological feature 900 (such as the septum) is first punctured. The electrically exposed outer surface 108 is coated with an electrically insulating material to prevent the risk of causing tissue coiling and / or embolism.

[0038] Referring to the embodiments (implementations) shown in FIGS. 5 and 6, the elongated conductive flexible tube 102 includes a J-shaped bend extending from the distal portion 104. The J-shaped bend is preferably configured to advance through the septum when the tissue is first punctured.

[0039] (Applicable to the embodiments shown in FIGS. 3 and 4) (i.e., for showing the workflow) Referring to the embodiments (implementations) shown in FIGS. 5 and 6, the method (workflow) includes (a) advancing the elongated conductive flexible tube assembly 102 towards the biological feature 900 of the patient 902 (i.e., into the patient's vasculature), (b) using the electrically exposed outer surface 108 to tent the biological feature 900 (such as the septum or the heart), (c) activating the emission of energy (high frequency) such that the electrically exposed outer surface 108 emits energy towards the tented biological feature 900 during use (so that the biological feature 900 can be punctured), and (d) immediately after the puncture is made (formed), operating the elongated conductive flexible tube assembly 102 to penetrate the biological feature 900 with the electrically exposed outer surface 108 leading (the electrode first) (the curvature of the distal tip is small enough to pass through the puncture hole).

[0040] FIG. 7 and FIG. 8 are side views (FIG. 7) and side perspective views (FIG. 8) of one embodiment of a technical feature portion (optional) that may be included in any one of (a) a first embodiment of the elongated medical needle assembly 100 of FIG. 15, (b) a second embodiment of the elongated medical needle assembly 100 of FIG. 17, and / or (c) a third embodiment of the elongated medical needle assembly 100 of FIG. 19.

[0041] Referring to the embodiment (implementation form) shown in FIG. 8, the elongated conductive flexible tube assembly 102 may include two spaced tubes (or hypodermic tubes) such as a large-diameter proximal shaft section and a small-diameter distal shaft section, and the electrically exposed outer surface 108 is disposed therebetween. In order to reduce the risk of bending / fracture at the proximal-distal junction 510, a tapered socket may be included at the junction. The socket may be adhered or shrink-fitted to the junction prior to the application of the electrical insulator. The tapered length of the socket may be sufficient to minimize the risk of breakage at the proximal-distal junction and along the boundary of the socket. Referring to the embodiment (implementation form) shown in FIG. 8, the socket may be composed of SAE (Society of Automotive Engineering) type 304 stainless steel (or equivalent). Further, type 304 stainless steel is biocompatible, conductive, and has material properties (such as rigidity) suitable for a given application and / or treatment.

[0042] FIGS. 10 and 11 (the fourth of four) are side views of an embodiment (implementation form) of the elongated medical needle assembly 100 of FIG. 9. FIGS. 10 and 11 (the fourth of four) are side views of an embodiment (implementation form) of the elongated medical needle assembly 100 of FIG. 9.

[0043] (Alternative to the embodiments shown in FIGS. 1 and 2) Referring to the embodiment (implementation form) shown in FIG. 9, the shape of the elongated conductive flexible tube assembly 102 (shown in FIG. 9) is not the same as that of the embodiments shown in FIGS. 1 and 2. The length (shaft section) of the elongated conductive flexible tube assembly 102 forms a single curved portion having a second radius 302 (i.e., a single radius).

[0044] Referring to the embodiment (implementation form) shown in FIG. 9, the electrically exposed outer surface 108 (electrode) is located at the most distal section of the single curved portion (when the elongated conductive flexible tube assembly 102 is in its original curved shape as shown in FIG. 9). The electrically exposed outer surface 108 is spaced from the inlet (portal lumen 107 or open lumen surface) of the elongated lumen 106 in the distal portion 104. The electrically exposed outer surface 108 may have a surface roughness greater than that of the proximal shaft of the elongated conductive flexible tube assembly 102 (if necessary) for purposes such as improving contact with the biological feature 900 (such as the septum of the heart) when tenting the biological feature 900 at the distal portion 104.

[0045] (To illustrate the workflow) Referring to the embodiments (implementation forms) shown in FIGS. 10 and 11, the method (workflow) includes: (a) advancing the elongated conductive flexible tube assembly 102 towards the biological feature 900 of the patient 902 (i.e., into the patient's vasculature); (b) using the electrically exposed outer surface 108 to tent the biological feature 900 (such as the septum or heart); (c) activating the release of energy (high frequency) so that the electrically exposed outer surface 108 releases energy towards the tented biological feature 900 (so that the biological feature 900 can be punctured); and (d) manipulating the elongated conductive flexible tube assembly 102 to ensure that the distal tip first penetrates the biological feature 900 (the distal curved portion 302 is too large to directly pass through the puncture hole formed within the biological feature 900).

[0046] FIG. 12A, FIG. 12B, FIG. 13 and FIG. 14 are side views of embodiments of the technical feature portions of FIGS. 7 and 8. Referring to the embodiment (implementation form) shown in FIG. 12A, the elongated conductive flexible tube assembly 102 includes a proximal tube 500 and a distal tube 502. The outer diameter of the proximal tube 500 is larger than the outer diameter of the distal tube 502. The proximal tube 500 defines a proximal lumen 501 that extends along the longitudinal axis of the proximal tube 500. The distal tube 502 defines a distal lumen 503 that extends along the longitudinal axis of the distal tube 502. A portion of the distal tube 502 is (at least partially) received within the proximal lumen 501 of the proximal tube 500. For example, the distal tube 502 preferably includes a transition section 504 that extends longitudinally and coaxially with the distal lumen 503. The transition section 504 defines a transition lumen 505 that extends longitudinally along the transition section 504. The transition lumen 505 is defined to provide a smooth transition (a tapered transition) between the proximal lumen 501 and the distal lumen 503. A shoulder 510 is formed on the end section of the distal tube 502 and the outer portion of the transition section 504. The shoulder 510 is positioned or disposed between the proximal tube 500 and the distal tube 502, and the distal tube 502 is in contact with the proximal tube 500 at the shoulder 510. The shoulder 510 is configured to contact (abut) the end portion of the proximal tube 500 when the end portion of the distal tube 502 (such as the transition section 504) is (at least partially) received within the proximal lumen 501 of the proximal tube 500 (as shown in FIG. 12B). According to one option, the shoulder 510 is disposed between the proximal tube 500 and the distal tube 502. This is the shoulder between the portions of the distal tube 502 that are (at least partially) received within the proximal lumen 501. The elongated conductive flexible tube assembly 102 also includes a transition tube 506. According to a preferred option (not limited to this), the transition tube 506 includes (defines) a transition lumen 507 configured to at least partially receive the distal tube 502. It will be understood that according to another embodiment, the transition lumen 505 may not provide a smooth transition (and may be a stepped transition if necessary).According to another embodiment, it will be appreciated that the transition section 504 and the transition lumen 505 are not present. According to another embodiment, the distal tube 502 has a smaller diameter than the proximal tube 500, and thus it will be appreciated that the distal tube 502 fits within the proximal tube 500 as a means of joining the tubes together. The distal tube 502 may be (at least partially) fitted within the proximal lumen 501 of the proximal tube 500 using an adhesive such as EPO-TEK (trademark) type number 353ND epoxy (manufactured by EPOXY TECHNOLOGY, INC. located in the United States) and / or any equivalent thereof. It will be appreciated that a portion of the distal tube 502 is disposed inside the proximal tube 500 (for adhesive purposes).

[0047] Referring to the embodiment (implementation form) shown in FIG. 12B, the transition section 504 (a part of the distal tube 502) is not used in the embodiment shown in FIG. 12A. According to the embodiment shown in FIG. 12A, the transition section 504 is configured to be (at least partially) received within the proximal lumen 501 of the proximal tube 500.

[0048] Referring to the embodiment (implementation form) shown in FIG. 13, the transition tube 506 is attached such that the transition lumen 507 at least partially receives the distal tube 502. When the transition tube 506 is attached and moved towards the end section of the proximal tube 500, the transition tube 506 is configured to contact or abut against the end section of the proximal tube 500. The transition tube 506 is configured to provide a smooth transition between the outer surfaces of the proximal tube 500 and the distal tube 502 (when attached as shown).

[0049] Referring to the embodiment shown in FIG. 14, the elongated conductive flexible tube assembly 102 also includes an electrical insulation layer 508 formed at least partially on the transition tube 506, the distal tube 502, and the proximal tube 500. The electrical insulation layer 508 includes a coating of polytetrafluoroethylene (PTFE) heat shrink insulator, a parylene insulation coating, and / or any equivalents thereof.

[0050] FIGS. 15 and 16 are side views of a first embodiment of the elongated medical needle assembly 100 of FIG. 1 in combination with the technical features of FIG. 12A. The elongated conductive flexible tube assembly 102 of FIGS. 15 and 16 is adapted to include a proximal tube and a distal tube (arranged in sequence), while the elongated conductive flexible tube assembly 102 of FIG. 1 shows a single tube (or a single tapered tube).

[0051] Referring to the embodiment shown in FIG. 15, the transition tube 506 is not in use (deployed or installed). The electrically exposed outer surface 108 is preferably located on the distal tube 502 (as shown in FIGS. 15 and / or 17) and spaced from the proximal tube 500.

[0052] Referring to the embodiment shown in FIG. 16, the transition tube 506 is attached to the distal tube 502. FIGS. 17 and 18 are side views of a second embodiment of the elongated medical needle assembly 100 of FIG. 2 in combination with the technical features of FIG. 12A. The elongated conductive flexible tube assembly 102 of FIGS. 17 and 18 includes a proximal tube and a distal tube, while the elongated conductive flexible tube assembly 102 of FIG. 2 includes a single tube (or a single tapered tube).

[0053] Referring to the embodiment shown in FIG. 17, the transition tube 506 is not in use (deployed or installed). Referring to the embodiment shown in FIG. 18, the transition tube 506 is attached to the distal tube 502.

[0054] FIGS. 19 and 20 are side views of a third embodiment of the elongated medical needle assembly 100 of FIG. 9 in combination with the technical feature portion of FIG. 12A. The elongated conductive flexible tube assembly 102 of FIGS. 19 and 20 includes a proximal tube and a distal tube, but the elongated conductive flexible tube assembly 102 of FIG. 9 shows a single tube (or a single tapered tube).

[0055] Referring to the embodiment shown in FIG. 19, the transition tube 506 is not in use (deployed or installed). The electrically exposed outer surface 108 is preferably located on the proximal tube 500 (as shown in FIG. 19) and spaced from the distal tube 502.

[0056] Referring to the embodiment shown in FIG. 20, the transition tube 506 is attached to the distal tube 502. FIGS. 21, 22, and 23 are side views (FIG. 21) of a first embodiment of the elongated medical needle assembly 100 of FIG. 1, side views (FIG. 22) of a second embodiment of the elongated medical needle assembly 100 of FIG. 2, and side views (FIG. 23) of a third embodiment of the elongated medical needle assembly 100 of FIG. 9, shown side by side for comparison purposes.

[0057] Referring to the embodiments shown in FIG. 21 (first embodiment), FIG. 22 (second embodiment), and FIG. 23 (third embodiment), the geometric shapes of the first radius 301 and the second radius 302 are emphasized.

[0058] FIG. 24 is a side view of an embodiment of the elongated medical needle assembly 100 of any of FIGS. 1, 2, or 9. Referring to the embodiment (implementation form) shown in FIG. 24, an elongate conductive flexible tube assembly 102 is configured to be attached to a handle assembly 400. A cable assembly 402 is configured to extend from the handle assembly 400. A connector assembly 404 is attached to an end portion of the cable assembly 402. The connector assembly 404 is configured to be electrically connected to an energy generator (such as a high-frequency generator, known and not shown) configured to generate energy (such as high-frequency energy). This is done so that the energy (generated by the energy generator) can move along the cable assembly 402, along the conductive portion of the (elongate conductive flexible tube assembly 102), and then to the electrically exposed outer surface 108 (also referred to as an electrode). The lumen opening 107 of the elongate lumen 106 is configured to selectively receive (and / or guide) a medical element from the proximal end to the distal end of the elongate conductive flexible tube assembly 102. The medical element can include, for example, a contrast agent, a guide wire assembly, etc., and any equivalents thereof. The contrast agent can be injected into the elongate lumen 106 at the proximal end (i.e., from the handle assembly 400). The contrast agent is a medical element configured to be used (detected) by a medical imaging system (known and not shown). The guide wire assembly can be advanced into the elongate lumen 106 at the proximal end (i.e., from the handle assembly 400).

[0059] The following is provided as a further description of embodiments, and any one or more of any of the (any technical features described in "Embodiments for Carrying Out the Invention", "Summary of the Invention", and "Claims") may be combined with any one or more of any of the other (any technical features described in "Embodiments for Carrying Out the Invention", "Summary of the Invention", and "Claims"). Each claim in the "Claims" is understood to be an open-ended claim unless otherwise specified. Unless otherwise specified, the related terms used in these specifications should be construed to include a specific tolerance range that those skilled in the art would recognize as providing equivalent functions. By way of example, the term "vertical" is not necessarily limited to 90.0 degrees and may include its variations that those skilled in the art would recognize as providing equivalent functions for the purposes described for the related member or element. In the context of a configuration, terms such as "about" and "substantially" generally relate to any arrangement, location, or configuration that either exactly corresponds to or is sufficiently close to the location, arrangement, or configuration of the related element, maintaining the feasibility of the element in the present disclosure and not substantially changing the present disclosure. Similarly, unless otherwise clear from the context, numerical values should be construed to include a certain tolerance that those skilled in the art would recognize as being negligible for not substantially changing the feasibility of the present disclosure. It will be understood that the specifications and / or drawings (explicitly or inherently) identify and describe embodiments of the apparatus. The apparatus may include any suitable combination and / or rearrangement of the technical features specified in the detailed description as may be required and / or desired to adapt to a particular technical purpose and / or technical function. It will be understood that, where possible and suitable, any one or more of the technical features of the apparatus may be combined with any one or more of the other technical features of the apparatus (in any combination and / or rearrangement). Those skilled in the art will recognize and understand that the technical features of each embodiment may be developed in other embodiments (if possible) even if not explicitly stated as described above.One of ordinary skill in the art will recognize that other alternatives are possible for configuring the components of the device to comply with manufacturing requirements while still remaining within the scope recited in at least one of the claims. This specification provides embodiments including the best mode and enables one of ordinary skill in the art to make and use the embodiments. The scope of patentability can be defined by the claims. The written specification and / or drawings provided may be helpful in understanding the claims. It is believed that all important aspects of the disclosed subject matter are provided herein. As used herein, the term "includes" is synonymous with the term "comprising," and both terms are understood to be equivalent in that they are used to list assemblies, components, parts, etc. in an open-ended manner. The term "comprising," which is synonymous with terms such as "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional elements or method steps not recited. Comprising (comprised of) is an "open" clause that allows for the scope of technology to use additional, unrecited elements. When used in the claims, "comprising" is a transitional verb that separates the preamble of the claim from the technical features of the disclosure. The foregoing has outlined non-limiting embodiments (examples). The description herein has been made with respect to specific non-limiting embodiments (examples). It is understood that the non-limiting embodiments are merely illustrative.

Description of Reference Numerals

[0060] Elongated medical needle assembly 100 Elongated conductive flexible tube assembly 102 Distal portion 104 Elongated lumen 106 Lumen opening 107 Electrically exposed outer surface 108 First electrical insulation layer 201 Second electrical insulation layer 202 First radius 301 Second radius 302 Handle assembly 400 Cable assembly 402 Connector assembly 404 Proximal tube 500 Proximal lumen 501 Distal tube 502 Distal lumen 503 Transition section 504 Transition lumen 505 Transition tube 506 (tapered socket) Transition lumen 507 (tapered socket) Electrical insulation layer 508 Shoulder 510 Catheter assembly 800 Biological feature 900 Patient 902

Claims

1. An apparatus for use in relation to a patient's biological characteristics, the apparatus comprising: An elongated medical needle assembly, An elongated conductive flexible tube assembly having a distal portion and defining an elongated lumen extending longitudinally along the length of the elongated conductive flexible tube assembly towards the distal portion and terminating at a distal lumen opening, the elongated conductive flexible tube assembly being configured to be at least partially manipulated within the patient and towards the biological characteristics; A first electrical insulation layer at least partially covering an outer surface of the elongated conductive flexible tube assembly; A second electrical insulation layer at least partially covering the distal portion of the outer surface of the elongated conductive flexible tube assembly up to the distal lumen opening; The elongated medical needle assembly including the above; Comprising the above; The first electrical insulation layer is disposed longitudinally spaced from the second electrical insulation layer, with an electrically exposed outer surface proximal to the distal lumen opening exposed therebetween.

2. The apparatus according to claim 1, wherein the electrically exposed outer surface is proximal to the distal portion.

3. The apparatus according to claim 2, wherein the electrically exposed outer surface is configured to selectively release the energy towards the biological characteristics of the patient in response to a selective movement of energy along the elongated conductive flexible tube assembly towards the electrically exposed outer surface.

4. The apparatus according to any one of claims 1 to 3, wherein the electrically exposed outer surface includes a surface roughness greater than a surface roughness of the second electrical insulation layer.

5. The apparatus according to any one of claims 1 to 3, wherein the electrically exposed outer surface includes a surface roughness greater than a surface roughness of the first electrical insulation layer.

6. The elongated conductive flexible tube assembly includes a large-diameter section and a small-diameter section, the small-diameter section extending longitudinally from the large-diameter section and coaxial with the large-diameter section, the small-diameter section forming the distal portion of the elongated conductive flexible tube assembly, the device according to any one of claims 1 to 3.

7. The electrically exposed outer surface is disposed on the small-diameter section, the device according to claim 6.

8. The electrically exposed outer surface is disposed on the large-diameter section, the device according to claim 6.

9. The elongated conductive flexible tube assembly includes a proximal tube, a distal tube partially disposed within the proximal tube and extending longitudinally from the proximal tube and coaxial with the proximal tube, and the electrically exposed outer surface is located on the proximal tube and spaced from the distal tube, the device according to any one of claims 1 to 3.

10. The elongated conductive flexible tube assembly includes a proximal tube, a distal tube partially disposed within the proximal tube and extending longitudinally from the proximal tube and coaxial with the proximal tube, and the electrically exposed outer surface is located on the distal tube and spaced from the proximal tube, the device according to any one of claims 1 to 3.

11. The elongated conductive flexible tube assembly is configured to form a single curved portion having a single radius, The electrically-exposed outer surface is located at the most distal section of the single curved portion. The apparatus according to any one of claims 1 to 3. **Claim 12** The elongated conductive flexible tube assembly has a first curved portion with a first radius located on the electrically-exposed outer surface, and a second curved portion with a second radius larger than the first radius, spaced proximally from the first curved portion. It is configured to form the above. The apparatus according to any one of claims 1 to 3. **Claim 13** The elongated conductive flexible tube assembly includes a proximal tube and a distal tube partially disposed within the proximal tube and extending longitudinally and coaxially with the proximal tube, the distal tube forming the distal portion of the elongated conductive flexible tube assembly. The outer diameter of the proximal tube is larger than the outer diameter of the distal tube. The proximal tube defines a proximal lumen extending along the longitudinal axis of the proximal tube. The distal tube defines a distal lumen extending along the longitudinal axis of the distal tube. The electrically-exposed outer surface is disposed on the proximal tube. The apparatus according to any one of claims 1 to 3. **Claim 14** The elongated conductive flexible tube assembly includes a proximal tube and a distal tube partially disposed within the proximal tube and extending longitudinally and coaxially with the proximal tube, the distal tube forming the distal portion of the elongated conductive flexible tube assembly. The outer diameter of the proximal tube is larger than the outer diameter of the distal tube. The apparatus according to any one of claims 1 to 3. The proximal tube and the distal tube are adhered to each other. The device according to any one of claims 1 to 3.

15. The elongated conductive flexible tube assembly includes a proximal tube, a distal tube that is partially disposed within the proximal tube and extends longitudinally and coaxially with the proximal tube, the distal tube forming the distal portion of the elongated conductive flexible tube assembly, and the outer diameter of the proximal tube is larger than the outer diameter of the distal tube, the proximal tube defines a proximal lumen extending along the longitudinal axis of the proximal tube, the distal tube defines a distal lumen extending along the longitudinal axis of the distal tube. The device according to any one of claims 1 to 3.

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