Long medical needles

Abstract

To provide an apparatus used for a biological feature of a patient.SOLUTION: An elongated medical needle includes an electrically insulated elongated body having an outer surface extending between an electrically insulated distal section and an electrically insulated proximal section. An insulated electrically conductive wire is aligned proximately along the outer surface between the electrically insulated distal section and the electrically insulated proximal section. An exposed electrically conductive portion is mounted on the electrically insulated distal section. The exposed electrically conductive portion is electrically connected to the insulated electrically conductive wire.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] This document relates to (and is not limited to) the technical field of elongated medical needles (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) alleviate at least one problem associated with existing (known) medical needles. After much research and experimentation with existing (known) medical needles, (at least partial) understanding of the problem and its solution has been (at least partially) identified and (at least partially) described as follows.

[0004] Epicardial access can be performed using a sharp mechanical needle. This needle is used to pierce the pericardial layer (of the heart) to gain access to the pericardial cavity / epicardium of the heart. This procedure can pose a high risk to the patient because the underlying epicardial layer and the myocardium beneath the thin pericardial layer are in close proximity. Performing this operation is similar to piercing a piece of Saran Wrap (registered trademark) covering a steak without damaging the steak itself.

[0005] Transseptal access to the left atrium may be performed by puncturing through the fossa ovalis from the right atrium (of the heart). The puncture device is used together with an accessory device to enter the right atrium through the femoral vein, inferior vena cava, and superior vena cava and is positioned at an ideal location to cross. Using a mechanical needle to puncture the tissue of the atrial septum involves the risk of cardiac tamponade and is otherwise unpredictable with respect to the required input.

[0006] Radiofrequency energy source devices are configured to provide energy (such as radiofrequency energy) to known radiofrequency medical needles for tissue puncture, and do not require mechanical force input compared to mechanical needles. Considering this, known radiofrequency medical needles do not need to be mechanically sharp, reducing the risk of inadvertently puncturing the myocardial layer in epicardial access situations and reducing the risk of cardiac tamponade in transseptal access situations.

[0007] Known radiofrequency medical needles may contain a hollow internal lumen to facilitate the injection and flow of contrast agent, in addition to guidewire insertion. However, in relation to radiofrequency medical needles, the internal lumen must be electrically insulated. If a metal guidewire is inserted into the needle lumen and the inner lumen is not electrically insulated, it could inadvertently deliver an electric shock (and / or burn) to the operator. Generally, the body of known radiofrequency medical needles is made from a core metal component such as stainless steel. It can transmit high-frequency energy to the distal electrode for tissue puncture. By insulating known radiofrequency medical needles from the inside, the inner diameter of the needle is reduced, which can decrease the flow of contrast agent and potentially eliminate compatibility with guidewires.

[0008] Disadvantageously, known medical needles have a long, electrically conductive body (the entire length of the known medical needle), and therefore, known medical needles may require a sufficient amount of electrical insulation (for the safety of the patient and the user or operator). Providing sufficient electrical insulation is a challenge; on the one hand, electrical insulation is necessary for safety, but on the other hand, utilizing a sufficient amount of electrical insulation increases the overall outer diameter of the known medical needle (therefore potentially limiting the applications of the known medical needle).

[0009] An apparatus is provided (according to its primary embodiment) to at least partially mitigate one problem relating to existing technologies. The apparatus is intended for use in conjunction with a patient's biometric features. The apparatus includes, but is not limited to, an elongated medical needle. The elongated medical needle is configured to be operated toward a patient's biometric feature and to be positionable in close proximity to the patient's biometric features. The elongated medical needle includes an electrically insulated elongated body having an outer surface extending between an electrically insulated distal portion and an electrically insulated proximal portion. An insulated conductive wire is aligned in close proximity along the outer surface between the electrically insulated distal portion and the electrically insulated proximal portion. An exposed conductive portion is attached to the electrically insulated distal portion. The exposed conductive portion is electrically connected to the insulated conductive wire.

[0010] To mitigate at least one problem related to existing technologies, an apparatus is provided (according to its primary embodiment). The apparatus is intended for use in conjunction with a patient's biometric features. The apparatus includes, but is not limited to, an elongated medical needle. The elongated medical needle is configured to be operated toward and positioned in close proximity to the patient's biometric features. The elongated medical needle includes an electrically insulated elongated body having an outer surface extending between an electrically insulated distal portion and an electrically insulated proximal portion.

[0011] An insulated conductive wire is aligned in close proximity along the outer surface of an electrically insulated elongated body. The insulated conductive wire extends between an electrically insulated distal portion and an electrically insulated proximal portion. The insulated conductive wire (located in the electrically insulated proximal portion) is configured to be electrically connectable to an energy source device. An exposed conductive portion is attached to the electrically insulated distal portion. The exposed conductive portion is electrically connected to the insulated conductive wire. The exposed conductive portion is configured to receive energy from the insulated conductive wire, which preferably occurs in response to the insulated conductive wire receiving energy from an energy source device. The exposed conductive portion is configured such that (A) the elongated medical needle is manipulated toward a biotissue and positioned in close proximity to the biotissue, and (B) after the insulated conductive wire in use has received energy from an energy source device, it releases energy toward the biotissue (received from the insulated conductive wire).

[0012] A method is provided (according to its primary embodiment) to at least partially mitigate one problem relating to existing technologies. The method is for releasing energy toward a patient's biofeedback. The method includes, but is not limited to, manipulating and positioning a long medical needle toward and in close proximity to a patient's biofeedback. The method also includes, in use, sending energy to an exposed conductive portion along an insulated conductive wire in response to the insulated conductive wire receiving energy from an energy source device. The method also includes, in use, releasing energy toward a biofeedback from the exposed conductive portion (the energy received from the insulated conductive wire), which preferably occurs after (A) the long medical needle has been manipulated toward and positioned in close proximity to the biofeedback, and (B) in use, after the insulated conductive wire has received energy from an energy source device.

[0013] Other embodiments are specified in the claims. Other embodiments and features of the non-limiting embodiments will become apparent to those skilled in the art by examining the following detailed description of the non-limiting embodiments together with the accompanying drawings. This summary is provided to introduce in a simplified form the concepts that will be further described in the following detailed description. This summary is not intended to identify any potentially important or possibly essential features of the disclosed subject matter, nor is it intended to describe each disclosed embodiment or all implementations of the disclosed subject matter. Many other novel advantages, features, and relationships will become apparent as this description progresses. The following drawings and description illustrate the illustrative embodiments in more detail. [Brief explanation of the drawing]

[0014] Non-limiting embodiments can be better understood by referring to the following detailed description of non-limiting embodiments, when interpreted in conjunction with the accompanying drawings. [Figure 1] Figures 1 to 9K show side perspective views (Figures 1, 3, 5, and 7) and top views (Figures 2, 4, 6, 8, and 9A to 9K) of an embodiment of a long medical needle. [Figure 2] Same as above. [Figure 3] Same as above. [Figure 4] Same as above. [Figure 5] Same as above. [Figure 6] Same as above. [Figure 7] Same as above. [Figure 8] Same as above. [Figure 9A] Same as above. [Figure 9B] Same as above. [Figure 9C] Same as above. [Figure 9D] Same as above. [Figure 9E] Same as above. [Figure 9F] Same as above. [Figure 9G] Same as above. [Figure 9H] The same as above. [Figure 9I] The same as above. [Figure 9J] The same as above. [Figure 9K] The same as above. [Figure 10] Figures 10, 11 and 12 show perspective side views of embodiments of the elongate medical needle of FIG. 3. [Figure 11] The same as above. [Figure 12] The same as above. [Figure 13] Figures 13 and 14 show perspective side views of embodiments of the elongate medical needle of FIG. 1. [Figure 14] The same as above. [Figure 15] Figures 15, 16 and 17 show a perspective side view (FIG. 15), a cross-sectional view (FIG. 16), and a schematic view (FIG. 17) of embodiments of the elongate medical needle of FIG. 1. [Figure 16] The same as above. [Figure 17] The same as above. [Figure 18A] Figures 18A and 18B show a side view (FIG. 18A) and a top view (FIG. 18B) of an embodiment of the elongate medical needle 100 of FIG. 1. [Figure 18B] The same as above. [Figure 19A] Figures 19A through 19C show a series of side views of an embodiment of the elongate medical needle 100 of FIG. 1. [Figure 19B] The same as above. [Figure 19C] The same as above. [Figure 20A] Figures 20A and 20B show a side view and a top view, respectively, of an embodiment of the elongate medical needle 100 of FIG. 1 when connected to an energy source device. [Figure 20B] The same as above.

[0015] The drawings are not necessarily to scale and may be represented by dashed lines, schematics, and partial drawings. In some cases, details that are not necessary for understanding the embodiment (and / or that obscure other details) may be omitted. Corresponding reference numerals indicate corresponding components through several drawings. Elements in some drawings are shown for simplification and clarity and are not drawn to scale. The dimensions of some elements in the drawings may be emphasized relative to others to facilitate understanding of the various disclosed embodiments. In addition, common and well-understood elements that are useful in commercially viable embodiments are often omitted to provide a more unobstructed view of the embodiments of this disclosure.

[0016] List of reference numbers used in drawings Medical needles 100 Long main body 101 Needle lumen 102 Distal portal 103 Electrically insulated distal portion 104 Electrically insulated proximal portion 106 Conductive part 108 Distal foramen 109 Conductive wire 110 Internal conductor portion 112 Insulating part 114 Channel 116 Guide wire assembly 800 900 biological characteristics patient 902 Energy source device 904 First circuit 910 that emits RF energy Second circuit 912 that emits RF energy Electrical cable 906 First conductive portion 914 Second conductive portion 918 Insulated portion 918 of the first circuit Insulated portion 920 of the second circuit [Modes for carrying out the invention]

[0017] The following detailed description is illustrative only and is not intended to limit the embodiments or uses and applications of the embodiments described. As used, the words “exemplary” or “illustrative” mean “serving as an example, case, or illustration.” Any implementation described as “exemplary” or “illustrative” should not necessarily be construed as being preferable or advantageous to other implementations. All implementations described below are illustrative implementations provided to enable a person skilled in the art to make or use embodiments of the disclosure and are not intended to limit the scope of the disclosure. The scope of the disclosure is defined by the claims. For illustrative purposes, the terms “top,” “bottom,” “left,” “back,” “right,” “front,” “vertical,” “horizontal,” and their derivatives relate to examples of orientation in the drawings. It is not intended to be bound by the aforementioned technical field, background art, summary of the invention, or theories expressly or implicitly stated in the following detailed description. It should also be understood that the devices and processes shown in the accompanying drawings and described in the following specification are exemplary embodiments (examples), aspects, and / or concepts as defined in the accompanying claims. Therefore, dimensions and other physical characteristics relating to the disclosed embodiments should not be considered limiting unless expressly provided otherwise by the claims. The phrase “at least one” is understood to be equivalent to “a”. Embodiments (e.g., changes, modifications, options, variations, embodiments, and any equivalents thereof) are described with respect to the drawings. It should be understood that this disclosure is limited to the subject matter provided by the claims and is not limited to the specific embodiments illustrated and described. The meaning of a device configured to be coupled to an item (i.e., connected to an item, interacting with an item, etc.) should be interpreted as a device configured to be coupled to an item directly or indirectly. Therefore, “configured to be” may mean “directly or indirectly” unless specifically stated otherwise.

[0018] Figures 1 to 9K show side perspective views (Figures 1, 3, 5, and 7) and top views (Figures 2, 4, 6, 8, and 9A to 9K) of an embodiment of the elongated medical needle 100.

[0019] Referring to the embodiments (implementation) shown in Figures 1, 3, 5, and 7, the elongated medical needle 100 is configured to be operated toward and positioned in close proximity to the biological features 900 of the patient 902 (as shown in Figures 10 and 11). The elongated medical needle 100 is configured to be inserted into a narrow space defined by the biological tissue (patient). The elongated medical needle 100 includes (preferably) an electrically insulated elongated body 101. The electrically insulated elongated body 101 is sometimes referred to as the needle shaft. The electrically insulated elongated body 101 has an outer surface extending between an electrically insulated distal portion 104 and an electrically insulated proximal portion 106 (the electrically insulated proximal portion 106 is shown in Figure 17). The electrically insulated elongated body 101, the electrically insulated distal portion 104, and the electrically insulated proximal portion 106 are (each) nonconductive (preferably all of them), i.e., the electrically insulated elongated body 101, the electrically insulated distal portion 104, and the electrically insulated proximal portion 106 are preferably completely nonconductive (they are preferably made from nonconductive material only). An alternative embodiment may include an electrically insulated distal portion 104 having a metal outer layer (e.g., a hemispherical shell-coated metal layer formed on the outer surface (of the electrically insulated distal portion 104), on which an electrically insulating material (e.g., polyimide and / or any equivalent thereof) is formed). In an alternative embodiment, the outer surface of the metal layer (such as a dome formed or positioned on the electrically insulated distal portion 104) may be masked during the polyimide coating process to form a pattern of non-insulating portions of the metal layer positioned (formed) on the electrically insulated distal portion 104. The formed pattern may include, for example, a star pattern (a variation as shown in Figure 8), thereby increasing the number of lines from at least two (or more) lines (both configurations extending over the outer tip of the electrically insulated distal portion 104, such as the variations shown in Figures 9A and 9C), and / or include a single circle or concentric circles, etc.

[0020] It will be understood that a variation of the embodiment shown in Figure 4 may have vertically extending lines, thereby generating (forming) a grid pattern (if desired). The pattern may be generated (formed) using wires or by masking a metal layer (e.g., formed as a metal dome). The insulated conductive wire 110 is positioned close along the outer surface and aligned between the electrically insulated distal portion 104 and the electrically insulated proximal portion 106. For example, the insulated conductive wire 110 may be positioned just above the outer surface (and aligned between the electrically insulated distal portion 104 and the electrically insulated proximal portion 106). For example, the insulated conductive wire 110 is preferably positioned below (just below) the outer surface (and aligned between the electrically insulated distal portion 104 and the electrically insulated proximal portion 106). The exposed conductive portion 108 is attached to the electrically insulated distal portion 104. The exposed conductive portion 108 is electrically connected to the insulated conductive wire 110. The conductive portion 108 is exposed and may be arranged in any preferred configuration that facilitates tissue puncture.

[0021] Referring to the embodiments (implementation) shown in Figures 1, 3, 5, and 7, the elongated medical needle 100 (and its components) contains biocompatible material properties suitable for sufficient performance (such as dielectric strength, thermal performance, electrical insulation, corrosion resistance, water resistance, and heat resistance) to comply with industrial standards and regulatory safety standards (or to be suitable for medical applications). To consider the selection of appropriate materials, the following publication is referred to: Plastics in Medical Devices: Properties, Requirements, and Applications, 2nd edition, Author: Vinny R. Sastri, Hardcover ISBN: 9781455732012, Published: November 21, 2013, Publisher: Amsterdam [Pays-Bas]: Elsevier / William Andrew,

[2014] .

[0022] Referring to the embodiments (implementation) shown in Figures 1, 3, 5, and 7, the outer diameter of the insulated conductive wire 110 is advantageously smaller (preferably significantly smaller) than the outer diameter of the electrically insulated elongated body 101. The amount of electrical insulation required for the conductive wire 110 is significantly less than the amount of electrical insulation required for the (fully conductive) elongated body associated with known medical needles. The insulated conductive wire 110 utilizes significantly less electrical insulation, in stark contrast to known medical needles having an (fully) conductive elongated body (therefore, known medical needles utilize substantially more electrical insulation, and this arrangement requires the overall outer diameter of known medical needles to be significantly larger than the outer diameter of the electrically insulated elongated body 101, thus potentially limiting known medical needles with respect to possible medical applications). The elongated bodies of known medical needles are made from conductive material only, which is a significant and unfavorable limiting factor (for known medical needles). In summary and emphasis, the insulated conductive wire 110 utilizes significantly less electrical insulation than known medical needles, which are (fully) conductive, and therefore, the applications of known medical needles are potentially limited by the overall outer diameter of the known medical needles, as they utilize substantially more electrical insulation. Thus, the elongated medical needle 100 can be advantageously deployed for a wider number of medical applications or uses.

[0023] Referring to the embodiments (implementation) shown in Figures 1, 3, 5, and 7, the insulated conductive wire 110 (located at the electrically insulated proximal portion 106) is configured to be electrically connectable to an energy source device 904 (the energy source device 904 is shown in Figure 17). The energy source device 904 is configured to generate energy, such as high-frequency energy, and any equivalent thereof. The exposed conductive portion 108 is configured to receive energy (such as high-frequency energy) from the insulated conductive wire 110. This is preferably done in response to the insulated conductive wire 110 receiving energy from the energy source device 904 (the energy source device 904 is shown in Figure 17). The exposed conductive portion 108 is configured to release the energy received from the insulated conductive wire 110 (from the energy source device) toward the biofeature 900 (as shown in Figures 10 and 11). This is preferably done after (A) the elongated medical needle 100 is manipulated toward the biofeed 900 and positioned in close proximity to the biofeed 900, and (B) the insulated conductive wire 110 in use has received energy from the energy source device 904. The exposed conductive portion 108 is configured to puncture the biofeed 900 in response to the selective release of energy toward the biofeed 900 from the exposed conductive portion 108.

[0024] Referring to the embodiments (implementation) shown in Figures 1, 3, 5, and 7, the medical needle 100 can be used for epicardial and / or transseptal access procedures, etc. When the electrically insulated elongated body 101 is deployed as an epicardial needle, it has an outer diameter of approximately 1.15 mm (approximately 17 gauge) and a length of approximately 15.2 cm (approximately 6 inches). When the electrically insulated elongated body 101 is deployed as an epicardial needle, any outer diameter can be used as long as it does not cause unnecessary trauma to the patient's anatomical structure. Any length can be used as long as it can reach the desired patient's anatomical structure. When the electrically insulated elongated body 101 is deployed as a transseptal needle, it has an outer diameter of approximately 0.76 mm to approximately 0.81 mm (approximately 0.030 inches to approximately 0.032 inches) and a length of approximately 67 to approximately 91 centimeters. When the electrically insulated elongated body 101 is deployed as a transseptal needle, any outer diameter can be used as long as it can still conform to the patient's anatomical structure. Any length can be used as long as it can reach the desired patient anatomical structure from the selected access site.

[0025] Referring to an embodiment (implementation) as shown in Figure 1, the electrically insulated distal portion 104 preferably includes (or completely includes) a nonconductive cap made of a heat-shrinkable material, preferably polytetrafluoroethylene (PTFE) heat-shrinkable material or hybrid polyurethane. Preferably, there is no layer of electrical insulation placed on top of the electrically insulated distal portion 104. The electrically insulated distal portion 104 may be called the needle distal tip. The electrically insulated distal portion 104 may have any configuration and / or material for electrical insulation purposes (i.e., the electrically insulated distal portion 104 is completely nonconductive).

[0026] Referring to an embodiment (implementation) as shown in Figure 1, the insulated conductive wire 110 may have a stainless steel or nitinol core material. The insulated conductive wire 110 may have an outer layer of PTFE heat-shrinkable electrical insulation. Alternatively, the insulated conductive wire 110 may have an outer layer of hybrid polyurethane electrical insulation. The insulated conductive wire 110 may be aligned (extended) proximally into the electrical cable 906 (as shown in Figure 17) along the outside of the elongated body 101. The insulated conductive wire 110 may contain any conductive elements. The electrically insulated elongated body 101 may be made of any biocompatible material, as long as it has sufficient rigidity to traverse the patient's required anatomical structures and / or vascular system.

[0027] Referring to embodiments (implementation) as shown in Figures 1 and 2, the conductive portion 108 forms a rectangular contour (straight contour) positioned on the electrically insulated distal portion 104.

[0028] Referring to embodiments (implementations) as shown in Figures 3 and 4, the conductive portion 108 forms a group of parallel lines extending across the outer tip of the electrically insulated distal portion 104. The parallel lines may act to create incisions in the tissue of the biological wall, allowing for easier penetration by the elongated medical needle 100.

[0029] Referring to embodiments (implementations) as shown in Figures 5 and 6, the conductive portion 108 forms a line (preferably a single line) that extends across the outer tip of the electrically insulated distal portion 104.

[0030] Referring to embodiments (implementation) as shown in Figures 7 and 8, the conductive portion 108 forms an X-shaped configuration that extends across the outer tip of the electrically insulated distal portion 104. Further examples of variations or embodiments of Figures 2, 4, 6, or 8 may include the following configurations: (1) Figure 9B (conductive portion 108 forms a helical configuration extending across the outer tip of the electrically insulated distal portion 104), (2) Figure 9D (conductive portion 108 forms a partial loop extending across the outer tip of the electrically insulated distal portion 104, with a portion of the loop electrically insulated to avoid the formation of a conductive closed loop portion), (3) Figure 9E (may be used / implemented in unipolar, bipolar, or multi-circuit configurations), (4) Figure 9F (partial conductive loops are formed at each end of the electrically insulated distal portion 104, and may be used / implemented in bipolar or multi-circuit configurations), (5) Figure 9G (conductive portion 108 has a wire along the electrically insulated distal portion 104) (6) Figure 9H (conductive portion 108 forms a partial line along a portion of the electrically insulated distal portion 104), (7) Figure 9I (conductive portion 108 forms a spline along a portion of the electrically insulated distal portion 104), (8) Figure 9J (conductive portion 108 forms a spline along the entire length of the electrically insulated portion 104), and (9) Figure 9K (conductive portion 108 of one electrode or circuit forms a partial line along a portion of the electrically insulated distal portion 104, and conductive portion of a second electrode or circuit forms a complete line along the electrically insulated distal portion 104). The embodiment in Figure 9K can be implemented in a bipolar or multiple circuit configuration.

[0031] Figures 10, 11, and 12 show side perspective views of an embodiment of the elongated medical needle 100 of Figure 3. Referring to the embodiments (implementations) shown in Figures 10, 11, and 12, a method for releasing energy toward a biofeed 900 of a patient 902 is provided. The method includes manipulating and positioning a long medical needle 100 toward and in close proximity to the biofeed 900 of the patient 902 (as shown in Figure 10). The method also includes, in use, transferring energy to an exposed conductive portion 108 along the insulated conductive wire 110 (as shown in Figure 11) in response to the insulated conductive wire 110 receiving energy from an energy source device 904 (as shown in Figure 17). The method also includes, in use, releasing the energy received from the insulated conductive wire 110 toward the biofeed 900 from the exposed conductive portion 108 after the long medical needle 100 has been manipulated toward and positioned in close proximity to the biofeed 900 (as shown in Figure 11), and after the insulated conductive wire 110 has received energy from the energy source device 904 during use. Once the biofeed 900 is punctured, the energy source device 904 is deactivated, and the elongated medical needle 100 may be advanced forward (if so desired), for example, to traverse the biofeed 900 (tissue wall). The biofeed 900 may include, for example, the pericardial layer or atrial septum of the heart. Figures 10 and 11 are particularly related to Figure 3 or Figure 7, and it will be understood that this method is applicable to all embodiments of the elongated medical needle 100.

[0032] Figures 13 and 14 show side perspective views of an embodiment of the elongated medical needle 100 of Figure 1. Referring to embodiments (implementations) as shown in Figures 13 and 14, the electrically insulated elongated body 101 defines the elongated needle lumen 102 (according to any embodiment). The elongated needle lumen 102 extends between an electrically insulated distal portion 104 and an electrically insulated proximal portion 106 (the electrically insulated proximal portion 106 is shown in Figure 17). Advantageously, the interior of the elongated needle lumen 102 is electrically insulated by the electrically insulated elongated body 101, and therefore the patient is protected from electrical hazards from any type of device that may be inserted into the elongated needle lumen 102. The elongated needle lumen 102 may receive a conductive element or device (such as an elongated guidewire assembly 800). The elongated needle lumen 102 is configured to at least partially slidably receive the elongated guidewire assembly 800 and to guide the movement of the guidewire assembly 800 between the electrically insulated proximal portion 106 and the electrically insulated distal portion 104.

[0033] Referring to embodiments (implementations) as shown in Figures 13 and 14, the elongated needle lumen 102 may provide an inclined surface leading to a distal portal 103 formed through the outer surface of the side wall of the elongated needle lumen 102. Advantageously, this arrangement facilitates fluid flow through the elongated needle lumen 102 and the insertion of a guidewire (if necessary). The distal portal 103 is sometimes referred to as the needle distal port.

[0034] Figures 15, 16, and 17 show a side perspective view (Figure 15), a cross-sectional view (Figure 16), and a schematic diagram (Figure 17) of an embodiment of the elongated medical needle 100 of Figure 1. The cross-sectional view in Figure 16 is a cross-sectional view along the cross-sectional line AA of Figure 15.

[0035] Referring to the embodiments (implementations) shown in Figure 15 and / or Figure 16, it will be understood that Figure 15 is related to Figures 3 and 7. The channel 116 (at least one channel, which is more clearly shown in Figure 16) may be formed (or cut) into the electrically insulated distal portion 104 (and / or electrically insulated elongated body 101) for the purpose of receiving (at least partially) a conductive wire 110. Thus, the outer surface of the electrically insulated distal portion 104 (and / or electrically insulated elongated body 101) may be perfectly smooth. The channel 116 is formed on the outer surface of the electrically insulated elongated body 101, as shown in Figure 16. The insulated conductive wire 110 includes an inner conductor portion 112 (shown in Figure 16) surrounded by the insulating portion 114. The insulating portion 114 is received within the channel 116.

[0036] Referring to the embodiment (implementation) shown in Figure 17, it will be understood that a hub (known and not shown) may be provided and configured to provide a user grip for the user (at the proximal end of the medical needle 100). The hub may provide a port that fits into a syringe to facilitate fluid injection. The electrical cable 906 facilitates connection of the conductive portion 108 to an energy source device 904 (such as a high-frequency generator). The electrical cable 906 may include any cable that facilitates connection to the energy source device 904 (such as a high-frequency generator). For example, the energy source device 904 may include a source device associated with a BAYLIS® POWERWIRE® high-frequency guidewire manufactured by BAYLIS MEDICAL COMPANY (headquartered in Canada).

[0037] Figures 18A and 18B show a side view (Figure 18A) and a top view (Figure 18B) of an embodiment of the elongated medical needle 100 of Figure 1. Figures 19A to 19C show a series of side views of an embodiment of the elongated medical needle 100 of Figure 1. Figures 20A and 20B show a side view and a top view, respectively, of an embodiment of the elongated medical needle 100 of Figure 1 when connected to an energy source device.

[0038] Referring to the embodiments shown in Figures 18A and 18B, the elongated medical needle 100 may have two circuits (910 and 912) that emit RF energy. The first circuit 910 is configured to deliver RF energy in a first conductive portion 914, while the second circuit 912 is differentially selected to deliver RF energy in a second conductive portion 918 to achieve further cutting for difficult or thicker biological walls 900. One of the circuits may be bypassed via a distal hole 109 to avoid contact with the conductive portion of the other circuit. Alternatively, the conductive portion 914 of the first circuit 910 may simply be terminated before contacting the conductive portion 918 of the second circuit 912. The conductive portion of each circuit may be fixed to an electrically insulated distal portion 104 by adhesive. Alternatively, the conductive portion may not be fixed to the electrically insulated distal portion 104, and the insulated portion of the conductive wire 110 may be fixed to the elongated body 101 by adhesive or by direct molding onto the elongated body 101.

[0039] Referring to the embodiments shown in Figures 19A to 19C, a long medical needle 100 is shown having two circuits 910 and 912 that traverse through a tissue wall 900. In Figure 19A, the circuits are not activated, and the long medical needle 100 is shown applying a tenting force to the biological wall 900. In Figure 19B, the first circuit 910 is activated, and the conductive portion 914 is shown cutting through the biological wall 900. In Figure 19C, the conductive portion 918 of the second circuit 912 is activated to facilitate further cutting of the biological wall 900.

[0040] Referring to the embodiment shown in Figure 20A, an arbitrary bipolar configuration on the elongated medical needle 100 is shown. The flow of electrons is from the first electrode of the generator (energy source device) 904 to the second electrode (indicated by arrows in Figure 20A), eliminating the need for dispersed ground electrodes required in a unipolar electrode configuration. The conductive portion forms the first electrode (electrode 1) and the second electrode (electrode 2) on the elongated medical needle 100.

[0041] The following is provided as a further description of the embodiments, and any one or more of any technical features (described in the Detailed Description, Summary, and Claims) may be combined with any one or more other technical features (described in the Detailed Description, Summary, and Claims). Each claim in the Claims is understood to be an open-ended claim unless otherwise specified. Unless otherwise specified, the terms used in these specifications should be interpreted as including certain tolerances that a person skilled in the art would recognize as providing equivalent functionality. For example, the term "perpendicular" is not necessarily limited to 90.0 degrees and may include variations thereof that a person skilled in the art would recognize as providing equivalent functionality for the purposes described for the relevant member or element. Terms such as "about" and "substantially" in the context of configuration generally refer to the position, arrangement, or configuration of the relevant element, or an arrangement, arrangement, or configuration sufficiently close to them, in order to maintain the functionality of the elements in this disclosure that does not materially alter the disclosure. Similarly, unless otherwise explicitly stated in the context, numerical values ​​should be interpreted as including certain tolerances that a person skilled in the art would recognize as being of negligible importance, as they do not significantly alter the applicability of this disclosure. The description and / or drawings will be understood to identify and describe (expressly or essentially) embodiments of the apparatus. The apparatus may include any preferred combination and / or permutations of technical features as identified in the detailed description, as required and / or desired to conform to a particular technical purpose and / or technical function. Where possible and appropriate, it will be understood that any one or more of the technical features of the apparatus can be combined (in any combination and / or permutation) with any one or more other of the technical features of the apparatus. A person skilled in the art will understand that the technical features of each embodiment may be expanded (if possible) in other embodiments, even if not explicitly stated as above. A person skilled in the art will understand that other options for the configuration of the components of the apparatus are possible to suit manufacturing requirements and still remain within the scope described in at least one or more claims.The description provided provides embodiments, including best-in-class forms, and enables those skilled in the art to fabricate and use the embodiments. The patentable scope may be defined by the claims. The description and / or drawings provided may be helpful in understanding the claims. It is assumed that all important aspects of the disclosed subject matter are provided herein. Herein, the word “includes” is equivalent to the word “comprising,” and both words are used to mean an open-ended list of assemblies, components, parts, etc. The term “comprising,” which is synonymous with the terms “including,” “containing,” or “characterized by,” is comprehensive or open-ended and does not exclude additional undescribed elements or method steps. “Includes” is an “open” phrase and allows for the scope of application of the art that uses additional undescribed elements. When used in the claims, the word “comprising” is a temporary verb (transitional word) that separates the claims preamble from the technical features of this disclosure. The above outlines non-limiting embodiments (examples). The explanation will be given with respect to specific non-limiting embodiments (examples). It should be understood that non-limiting embodiments are merely illustrative examples.

Claims

1. In a device used for measuring a patient's biological characteristics, A long medical needle configured to be operated toward the said biological characteristics of the patient and positioned in close proximity to the said biological characteristics of the patient, comprising a long non-conductive body having an outer surface extending between a non-conductive distal portion and a non-conductive proximal portion, A conductive wire, which is aligned in close proximity along the outer surface of the elongated body and has an outer layer of electrical insulation, extending between the distal and proximal portions, and configured at the proximal portion to be electrically connectable to an energy source device, An apparatus comprising: an exposed conductive portion attached to the distal portion, comprising a metal outer layer forming a pattern of non-insulating portions, electrically connected to the conductive wire at the distal portion of the elongated medical needle via the metal outer layer, and configured to receive energy from the conductive wire in response to the conductive wire receiving energy from the energy source device, and to release the energy toward the biological feature after the elongated medical needle has been manipulated toward the biological feature and positioned in close proximity to the biological feature, and after the conductive wire has received the energy from the energy source device.

2. The elongated body defines an elongated needle lumen extending between the distal and proximal portions, The inside of the elongated needle lumen is electrically insulated by the elongated body. The apparatus according to claim 1, wherein the elongated needle lumen is configured to at least partially slidably receive an elongated guidewire assembly and to guide the movement of the elongated guidewire assembly between the proximal and distal portions.

3. The apparatus according to claim 2, wherein the elongated needle lumen provides an inclined surface that leads to a distal portal formed through the outer surface of the side wall of the elongated needle lumen.

4. The apparatus according to claim 1, wherein the conductive portion is also configured to puncture the biological feature in response to the selective release of energy from the conductive portion toward the biological feature during use.

5. The apparatus according to claim 1, wherein the outer diameter of the conductive wire is smaller than the outer diameter of the elongated body.

6. The apparatus according to claim 1, wherein the distal portion includes a non-conductive cap.

7. The apparatus according to claim 1, wherein the conductive portion forms a linear contour positioned above the distal portion.

8. The apparatus according to claim 1, wherein the conductive portion forms a group of parallel lines extending across the outer tip of the distal portion.

9. The apparatus according to claim 1, wherein the conductive portion forms a line extending across the outer tip of the distal portion.

10. The apparatus according to claim 1, wherein the conductive portion forms an X-shaped configuration extending across the outer tip of the distal portion.

11. The elongated body defines the elongated needle lumen. The elongated needle lumen extends between the distal and proximal portions, The apparatus according to claim 1, wherein the inside of the elongated needle lumen is electrically insulated by the elongated body.

12. The apparatus according to claim 11, wherein the elongated needle lumen provides an inclined surface that leads to a distal portal formed through the outer surface of the side wall of the elongated needle lumen.

13. In order to receive the conductive wire at least partially, a channel is formed in the elongated body and the distal portion, The apparatus according to claim 1, wherein the conductive wire includes an internal conductor portion surrounded by an insulating portion, the insulating portion being received within the channel.

14. The distal portion has a metal outer layer formed on the outer surface of the distal portion. The apparatus according to claim 1, wherein the electrical insulating material is formed on the metal outer layer.

15. The apparatus according to claim 1, wherein the elongated medical needle has a first circuit and a second circuit for emitting high-frequency energy (RF), the first circuit being configured to deliver RF energy in a first conductive portion, and the second circuit being differentially selected to deliver RF energy in a second conductive portion.

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