Guide wire for reducing hoop stress

Abstract

The medical guidewire assembly is movable through the exit portal of the guidewire introducer. The guidewire introducer and the medical guidewire assembly are each at least partially insertable into the patient. The medical guidewire assembly is configured to at least partially reduce hoop stress surrounding a puncture hole extending through the patient's tissue, at least partially in response to movement of the medical guidewire assembly relative to the puncture hole (after the puncture hole is initially formed).

Description

Technical Field

[0001] This document relates to the technical field (and methods therefor) of a medical guidewire assembly configured to at least partially reduce hoop stress (also referred to as circumferential stress) surrounding a puncture hole extending through a patient's tissue, among other things.

Background Art

[0002] Known medical devices, such as medical guidewire assemblies, are configured to facilitate medical procedures and assist medical personnel in diagnosing and / or treating a patient's medical condition.

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 known (existing) medical guidewire assemblies (also referred to as the prior art). After much research and experimentation with known (existing) medical guidewire assemblies, an understanding of the problem and its solution has been (at least partially) identified and (at least partially) clearly expressed as follows.

[0004] There are existing problems that may require technical solutions, such as when known medical devices (such as transseptal dilators) have a piercing stylet (configured for transseptal puncture). This piercing stylet is characterized by having a very sharp distal tip that improves the effectiveness of tissue piercing and / or reduces the applied force required (to move the known medical device) compared to the amount that may be required for a sharp hypodermic tube. For the purpose of piercing a patient's tissue (such as a biological wall like the fossa ovalis of the heart), a relatively low applied force (force input) sufficient to move the known medical device can be facilitated by using a relatively thin flexible material having a sharp bevel positioned at its distal tip (preferably, it may have a relatively small cross-sectional profile, etc.). When a known piercing stylet is advanced across (through) a biological wall (such as the atrial septum), the outer diameter of the piercing stylet can increase, but the actual puncture hole created remains relatively small. As a result, a significant amount of hoop stress can be formed or can exist at the puncture hole (or around it), that is, at the site of tissue dilation when the known medical device passes through the puncture hole. As a result, it may be necessary to increase the amount of applied force (input force) that the known medical device receives for the purpose of moving the known medical device (such as a dilator) across (through) the puncture site. A relatively high amount of applied force (moving force) can result in (A) the accumulation of tension (force) around the puncture site and / or (B) a sudden jump (or its jumping) of the atrial septum (puncture hole) surrounding the medical device at the puncture hole when the medical device is moved through the initially formed puncture hole. Such unpredictable behavior may be undesirable because this arrangement can lead to unintended patient injury and / or surgical delays during the procedure. Therefore, it is desirable to have features associated with a piercing stylet configured to enlarge the initially formed puncture hole (site) (increase its outer perimeter) and better enable the traversal of a known medical device (either through the initially formed puncture hole or through the biological wall), and / or to (at least partially) improve their functionality and / or effectiveness.

[0005] For example, a puncture hole (initially formed) made using a relatively thin penetrating stylet may first form a smaller sized puncture hole through the tissue wall. For example, the puncture hole may be made (formed) with a diameter of 0.0012 inches or less or a diameter of 0.0002 inches. The relatively small size of the first puncture hole can pose greater difficulty for the traversal of a medical device through the initially formed hole passing through the biological wall. Thus, a relatively large initial applied force may be required to obtain the distal tip of a known medical device across the size of this access hole (the initially formed puncture hole).

[0006] Moving a known dilator (known medical device) through a puncture hole (also referred to as a micro-puncture hole) sized to an inner diameter of 0.0012 inches or 0.0002 inches can be done using a known penetrating stylet. However, the hoop stress imposed by the intact tissue on the penetrating stylet can increase the input applied moving force (applied to the known medical device) required to bring the known medical device across (i.e., through the tissue wall) as compared to the ease of potentially utilizing a relatively large stage of the puncture hole (which can be made with different puncture devices).

[0007] It may be desirable to reduce the mechanical input (applied) force required to puncture tissue as compared to a known medical device (having a mechanical needle). However, a smaller puncture hole that is (initially) made as a result of a reduced cross-sectional profile of the sharp distal tip can result in an undesired amount of hoop stress at the device-tissue interface and / or increase the force required to traverse the atrial septum (using a known transseptal dilator, etc.).

[0008] There may be cases where it is desirable to provide a penetrating stylet having a cut-off section along the body of the medical device. The cut-off section may be configured to cut tissue to enlarge a puncture hole initially created in a tissue wall (such as the fossa ovalis) and transect the atrial septum as the penetrating stylet is advanced through the puncture site. The fossa ovalis is a depression in the right atrium of the heart at the level of the atrial septum and is the wall between the right and left atria. The fossa ovalis is the remnant of a thin fibrous sheet that covers the foramen ovale during fetal development. By enlarging the puncture hole created by the puncture device, hoop stress at the device-tissue interface can be (at least partially) reduced. This arrangement can maintain a reduced input (applied) force that may be required to mechanically puncture the biological wall or tissue (such as the fossa ovalis) while allowing for relatively easy transection of the medical device across the atrial septum (through the biological wall).

[0009] Possible uses and / or applications of the solution can increase the size of the puncture site (hole) in the tissue (fossa ovalis) (increasing its periphery), which can at least partially reduce the transection force of the medical device passing through the initially formed puncture site (such as through the atrial septum during a transseptal catheterization procedure).

[0010] An apparatus is provided (in accordance with a first aspect) to at least partially mitigate at least one problem associated with the existing technology.

[0011] The apparatus includes a medical guidewire assembly that is at least partially installable within and at least partially movable along a guidewire introducer (including but not limited to this). The guidewire introducer, within which the medical guidewire assembly is installed, is at least partially insertable into a patient. The medical guidewire assembly is configured to at least partially reduce hoop stress surrounding a puncture hole extending through the patient's tissue in response to at least partial movement of the medical guidewire assembly through the puncture hole (after the puncture hole is initially created).

[0012] To at least partially mitigate at least one problem associated with the existing technology, an apparatus is provided (in accordance with the second aspect). The apparatus includes, without limitation (comprises), a medical guide wire assembly. The medical guide wire assembly is at least partially installable within the guide wire introducer and is movable along (at least partially along) the guide wire introducer. (The medical guide wire assembly is at least partially installed therein), and the guide wire introducer is at least partially insertable into a patient. The medical guide wire assembly is also configured to at least partially form a puncture hole through the patient's tissue in response to at least partial movement of the medical guide wire assembly from the guide wire introducer after the guide wire introducer and the medical guide wire assembly have been at least partially inserted into the patient. The medical guide wire assembly is also configured to at least partially cut a portion of the tissue surrounding the puncture hole in proximity thereto and to at least partially reduce the hoop stress surrounding the puncture hole (at the time when the puncture hole is cut by the medical guide wire assembly and / or (after the puncture hole is first formed), in response to at least partial further removal or movement of the medical guide wire assembly through or with respect to the puncture hole).

[0013] To at least partially mitigate at least one problem associated with the existing technology, an apparatus is provided (in accordance with the third aspect). The apparatus includes, without limitation, a medical guidewire assembly. The medical guidewire assembly is at least partially installable within and at least partially movable along a guidewire introducer. The guidewire introducer is at least partially insertable into a patient. The medical guidewire assembly includes an elongate section. A distal portion extends from the elongate section. The distal portion is at least partially installable within and at least partially movable along an internal longitudinal channel of the guidewire introducer and through an exit portal of the guidewire introducer. The guidewire introducer, within which the medical guidewire assembly is at least partially installed, is at least partially insertable into a closed space defined by a patient. A piercing stylet assembly extends from the distal portion. The piercing stylet assembly is configured to at least partially physically form a puncture hole through a patient's tissue in response to at least partial movement of the distal portion from the exit portal of the guidewire introducer, and the distal portion having the piercing stylet assembly is moved toward and through the patient's tissue (after the guidewire introducer and the medical guidewire assembly are at least partially inserted into a closed space defined by a patient). A cutting assembly is spaced from the distal portion. The cutting assembly is attached to the elongate section. The cutting assembly is configured to be removable from the exit portal of the guidewire introducer. The cutting assembly is also configured to at least partially cut a portion of the tissue surrounding and adjacent to the puncture hole (defined by the tissue).This is done in such a way that the cutting assembly reduces at least partially hoop stress surrounding the puncture hole (preferably this is done after or at the time when the puncture hole has been cut by the cutting assembly and / or through or relative to the exit portal of the guidewire introducer and then in response to at least partial movement of the cutting assembly through the puncture hole after the puncture hole has been at least partially initially formed by the penetrating stylet assembly).

[0014] A method is provided (in accordance with a fourth aspect) to at least partially mitigate at least one problem associated with the existing technology. The method is for at least partially reducing hoop stress surrounding a puncture hole defined by a patient's tissue. The method includes, but is not limited to (including), operations (A), (B), (C), and (D). Operation (A) includes at least partially installing a medical guide wire assembly within a guide wire introducer. (The medical guide wire assembly is at least partially installed internally), and the guide wire introducer is at least partially insertable into a patient. The medical guide wire assembly includes a distal portion extending from an elongated section of the medical guide wire assembly. The medical guide wire assembly also includes a penetrating stylet assembly extending from the distal portion. The medical guide wire assembly also includes a cutting assembly spaced from the distal portion, and the cutting assembly is attached to the elongated section. The cutting assembly is configured to be removable from an exit portal of the guide wire introducer. The guide wire introducer defines an exit portal and an internal longitudinal channel in communication with the exit portal. Operation (B) includes inserting a guide wire introducer having at least partially therein a medical guide wire assembly into a closed space defined by a patient. Operation (C) includes at least partially moving a distal portion of the medical guide wire assembly at least partially along an internal longitudinal channel of the guide wire introducer and through an exit portal of the guide wire introducer. Operation (D) includes at least partially removing the penetrating stylet assembly and the distal portion through an exit portal of the guide wire introducer, and the distal portion is moved, together with the penetrating stylet assembly, toward and through the patient's tissue (when or after the exit portal of the guide wire introducer is positioned in proximity to the patient's tissue). This is done in such a way that the penetrating stylet assembly, in use, at least partially physically forms the puncture hole first such that the puncture hole extends through the patient's tissue.Actuation (E) includes moving the cutting assembly at least partially out from (and through) the exit portal of the guidewire introducer and then through a puncture hole defined by tissue (after the puncture hole has been at least partially initially formed by the penetrating stylet assembly), which is done in such a way that the cutting assembly at least partially cuts a portion of the tissue surrounding and adjacent to the puncture hole defined by the tissue and the cutting assembly at least partially reduces the hoop stress surrounding the puncture hole.

[0015] Other aspects are identified in the claims. Other aspects and features of the non-limiting embodiments may become apparent to those skilled in the art here when considering the following detailed description of the non-limiting embodiments with reference to the accompanying drawings. This summary is provided to introduce concepts in a simplified form that will be further described below in the detailed description. This summary is not intended to identify potential important features or possible essential features of the disclosed subject matter, nor is it intended to describe every embodiment of the disclosed subject matter or all implementations of the disclosed subject matter. Many other novel advantages, features, and relationships will become apparent as this description proceeds. The figures and the following description illustrate exemplary embodiments more specifically.

Brief Description of the Drawings

[0016] The non-limiting embodiments can be more fully understood by reference to the following detailed description of the non-limiting embodiments when interpreted in conjunction with the accompanying drawings.

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[0017] The drawings are not necessarily to scale and may be shown in virtual lines, schematic views, and partial views. In certain instances, details that are not necessary for an understanding of the embodiments (and / or details that make it difficult to perceive other details) may be omitted. Corresponding reference numerals indicate corresponding components throughout several views of the drawings. Elements in the various figures are shown for simplicity and clarity and are not drawn to scale. Some dimensions of the elements in the figures may be emphasized relative to other elements to facilitate an understanding of the various disclosed embodiments. Additionally, in commercially practicable embodiments, generally well-understood elements that are useful are often not shown in order to provide a view that is not overly obstructed by the embodiments of the present disclosure.

[0018] [Table 1] Detailed description of non-limiting embodiments

[0019] The following detailed description is merely illustrative and is not intended to limit the described embodiments or the uses and applications of the described embodiments. As used, the words "exemplary" or "exemplification" mean "serving as an example, instance, or illustration." Any implementation described as "exemplary" or "exemplification" should not necessarily be construed as more preferred or advantageous than other implementations. All of the implementations described below are exemplary implementations provided to enable one of ordinary skill 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 claims is defined by the claims (the claims may be amended during patent examination after the filing of the present application). For the purposes of the description, "upper," "lower," "left," "rear," "right," "front," "vertical," "horizontal," and their derivatives are related to the example oriented in the drawings. No binding is intended by any representation or implied theory in the foregoing technical field, background, summary, 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 by the appended claims. Accordingly, dimensions and other physical characteristics related to the disclosed embodiments should not be considered limiting unless the claims expressly state otherwise. The phrase "at least one" is understood to be equivalent to "one (a)." Aspects (examples, modifications, variations, options, permutations, embodiments, and any equivalents thereof) are described with respect to the drawings. It should be understood that the present invention is limited to the subject matter provided by the claims and is not limited to the specific aspects shown and described. It will be understood that the meaning of the scope of a device configured to be coupled to an article (i.e., connected to the article, interacting with the article, etc.) is construed as being configured such that the device is coupled to the article either directly or indirectly. Accordingly, "configured to" may include the meaning of "either directly or indirectly" unless otherwise specified.

[0020] Figures 1, 2, and 3 show side views of an embodiment of a medical guidewire assembly 100.

[0021] Figures 4, 5, and 6 show cross-sectional views of the embodiment of the medical guidewire assembly 100 of FIG. 3. The cross-sectional views of FIGS. 4, 5, and 6 are taken along cross-section line A-A through the medical guidewire assembly 100 of FIG. 3.

[0022] Referring to the embodiment as shown in FIG. 1, the medical guidewire assembly 100 is configured to be at least partially positioned (disposed) within a patient 800 having tissue 804 (such as a body wall). The medical guidewire assembly 100 is configured to be movable along a movement axis 600 (also referred to as a movement axis) toward the tissue 804 (such as a body wall). The medical guidewire assembly 100 has a longitudinal axis 500 extending therealong. According to a preferred embodiment, the medical guidewire assembly 100 is at least partially installable within and movable along a guidewire introducer 902. The guidewire introducer 902 (within which the medical guidewire assembly 100 is installed) is at least partially insertable into the patient 800.

[0023] Referring to the embodiment as shown in FIG. 1, a medical guidewire assembly 100 (according to a particular embodiment) has a distal portion 104 (tip section) that can be positioned on a patient 800 (configured to be disposed on the patient 800). The distal portion 104 can be positioned proximate to tissue 804. According to a particular embodiment, the medical guidewire assembly 100 includes a penetrating stylet assembly 106 (mounted to the end portion of the distal portion 104). According to a particular embodiment, the medical guidewire assembly 100 includes a cutting assembly 108 spaced from the penetrating stylet assembly 106. The cutting assembly 108 preferably includes spaced cutting sections (108A, 108B) (preferably) positioned on both sides of the medical guidewire assembly 100. The spaced cutting sections (108A, 108B) are spaced from both sides of the medical guidewire assembly 100. The spaced cutting sections (108A, 108B) can include raised cutting wires (a pair of raised cutting wires), and the like, and any equivalents thereof. The cutting assembly 108 preferably includes a guard device 112 positioned on at least the front leading edge portion of the cutting assembly 108. The guard device 112 preferably includes a first guard device 112A and a second guard device 112B (spaced guard devices). The spaced guard devices (112A, 112B) are positioned on each end (each respective end, or each respective terminal portion) of the spaced cutting sections (108A, 108B).

[0024] Referring to the embodiment as shown in FIG. 2, the medical guidewire assembly 100 (i.e., the distal portion 104) is configured to be movable toward the tissue 804. After the medical guidewire assembly 100 (such as the distal portion 104) is caused to move toward the tissue 804, the medical guidewire assembly 100 (preferably the distal portion 104) first forms the puncture hole 802 through the tissue 804 (this is done in response to at least partial movement of the distal portion 104 of the medical guidewire assembly 100 that is (at least partially) toward the tissue 804 and (at least partially) through the tissue 804).

[0025] Referring to the embodiment as shown in FIG. 3, after first forming the puncture hole 802 through the tissue 804 (as shown in FIG. 2), the medical guidewire assembly 100 (distal portion 104) is caused to move further (at least partially) through the tissue 804. This is done in such a way that the medical guidewire assembly 100 further opens (widens) the puncture hole 802 initially (compared to the size of the puncture hole 802 as shown in the embodiment of FIG. 2).

[0026] (FIG. 4 is a first cross-sectional view taken along the cross-sectional line A-A through the medical guidewire assembly 100 of FIG. 3) Referring to the embodiment as shown in FIG. 4, the initial formation of the puncture hole 802 (of FIG. 2) is shown. The medical guidewire assembly 100 is movable along the movement axis 600. A larger portion (section) of the medical guidewire assembly 100 that is wider (larger) than the initial formation (initial cross-section) of the puncture hole 802 is made to pass through the initial formation of the puncture hole 802. A relatively large amount of hoop stress 700 is formed around the initial formation of the puncture hole 802 (because the larger portion of the medical guidewire assembly 100 is moved through the initial formation of the puncture hole 802).

[0027] (FIG. 5 is a second cross-sectional view taken along cross-sectional line A-A through the medical guide wire assembly 100 of FIG. 3) Referring to the embodiment as shown in FIG. 5, a relatively large amount of hoop stress 700 is (at least partially) reduced by the medical guide wire assembly 100 that acts on (cuts or reforms) the initial formation of the puncture hole 802 because the medical guide wire assembly 100 is moved further at least partially through the initial formation of the puncture hole 802. The medical guide wire assembly 100 is movable along the movement axis 600. In this way, the puncture hole 802 is reshaped (sized), and the amount or magnitude of the hoop stress 700 is reduced as a greater portion of the medical guide wire assembly 100 passes (moves) through the initial formation of the puncture hole 802.

[0028] Referring to the embodiment as shown in FIG. 6, which is a third cross-sectional view taken along cross-sectional line A-A through the medical guide wire assembly 100 of FIG. 3, the medical guide wire assembly 100 is again moved at least partially further through the initial formation of the puncture hole 802. The amount of hoop stress 700 is further reduced (at least partially) by the medical guide wire assembly 100 that further acts on (either further cuts or reforms) the initial formation of the puncture hole 802. The medical guide wire assembly 100 is movable along a movement axis 602 (also referred to as the movement direction). In this way, the puncture hole 802 is further reshaped (further sized), and the amount or magnitude of the hoop stress 700 is further reduced as a greater portion of the medical guide wire assembly 100 passes (moves) further through the initial formation of the puncture hole 802. It will be appreciated that the magnitude (amount) of the hoop stress 700 surrounding the puncture hole 802 in the embodiment as shown in FIGS. 4 and / or 5 is greater than the magnitude of the hoop stress 700 as shown in the embodiment of FIG. 6. The technical effect of the medical guide wire assembly 100 is that there may be a state for relatively easy traversal (transport) of the medical guide wire assembly 100 (and / or the guide wire introducer 902) through the puncture hole 802 (at least partially), such as across the atrial septum of the patient 800's heart, while the medical guide wire assembly 100 allows at least partially for a reduced input force that may be required to initially form the puncture hole 802, such as mechanically puncturing the fossa ovalis of the patient 800's heart, by reducing the amount (magnitude) of the hoop stress 700.

[0029] FIG. 7 shows yet another side view of an embodiment of the medical guide wire assembly 100 of FIG. 1.

[0030] Referring to the embodiment as shown in FIG. 7, after the hoop stress 700 surrounding the puncture hole 802 is (at least partially) reduced, the medical guide wire assembly 100 (distal portion 104) can be retracted (moved or removed) from the puncture hole 802. The medical guide wire assembly 100 is configured to be movable along the movement direction 602 (also referred to as the movement axis) away from the tissue 804 (such as a biological wall).

[0031] Referring to the embodiment as shown in FIG. 1, the medical guide wire assembly 100 may include a shape memory material (and any equivalents thereof), such as a nitinol alloy (and / or any equivalents thereof). Nickel titanium, also known as nitinol, is a metal alloy of nickel and titanium, and the two elements may be present in approximately equal atomic percentages (such as nitinol 55, nitinol 60, etc.). The nitinol alloy exhibits two closely related unique properties, the shape memory effect and superelasticity. The shape memory material is configured to return to its original set shape after being manipulated and / or deformed. The shape memory material (SMM) is configured to recover from an externally plastically deformed state to its original shape in response to a specific stimulus applied to the material. This is known as the shape memory effect (SME). Superelasticity (in the alloy) can be observed when the shape memory material is deformed in the presence of a stimulus. The medical guide wire assembly 100 is preferably biocompatible with the tissue 804. The medical guide wire assembly 100 is configured to be inserted into a closed space defined by the patient 800. The medical guide wire assembly 100 includes a relatively thin flexible wire (elongated flexible shaft) configured to be inserted into a closed or serpentine space (such as a closed space defined by the patient 800). The medical guide wire assembly 100 preferably includes a flexible tube (made of a medical material). The medical guide wire assembly 100 is preferably impermeable to body fluids. The medical guide wire assembly 100 preferably includes SAE (Society of Automotive Engineers) standard 304 stainless steel. SAE standard 304 stainless steel contains both chromium (15% - 20%) and nickel (2% - 10.5%) metals as the main non-ferrous components. The medical guide wire assembly 100 includes superelastic nitinol according to another option.Nitinol alloys exhibit two closely related unique properties, the shape memory effect (SME) and superelasticity (SE; also called pseudoelasticity or PE). Shape memory is the ability of Nitinol to deform at a certain temperature and then recover its original undeformed shape upon heating above its transformation temperature. Superelasticity occurs in a narrow temperature range just above its transformation temperature, where heating is not required to recover the undeformed shape and the material exhibits a very large elasticity about 10 to 30 times that of ordinary metals. The medical guidewire assembly 100 comprises (in accordance with a preferred embodiment) any biocompatible material having properties suitable for sufficient performance (such as dielectric strength, thermal performance, insulation and corrosion resistance, water resistance and / or heat resistance, etc.) to comply with the safety performance required by industrial and regulatory safety standards (and / or suitable for medical use). For considerations in the selection of suitable materials, reference is made to the following publication: Plastics in Medical Devices: Properties, Requirements, and Applications, 2nd Edition, author: Vinny R. Sastri, hardcover ISBN: 9781455732012, published: November 21, 2013, publisher: Amsterdam [Netherlands]: Elsevier / William Andrew,

[2014] .

[0032] Referring to the embodiment as shown in FIG. 1, the medical guidewire assembly 100 is at least partially installable within and movable along a guidewire introducer 902 (and any equivalents thereof). The guidewire introducer 902, within which the medical guidewire assembly 100 is installed, is at least partially insertable into a patient 800. For example, the medical guidewire assembly 100 may have an outer diameter of about 0.032 inches in order to be compatible with the guidewire introducer 902. The guidewire introducer 902 may include, for example, a rigid accessory device (defining) having a hollow lumen, a dilator device, a catheter device, etc., and any equivalents thereof. The guidewire introducer 902 may include any type of medical accessory device, and any equivalents thereof. The guidewire introducer 902 is configured to straighten (at least partially) the medical guidewire assembly 100 such that a piercing stylet assembly 106 (sharp distal tip) can be used to pierce the tissue 804 (such as the fossa ovalis) of the patient 800.

[0033] Referring to the embodiment as shown in FIG. 2, following the first puncture of the tissue 804 (i.e., the first formation of the puncture hole 802 through the tissue 804), the medical guide wire assembly 100 is advanced through the puncture hole 802 (is movable), and the distal portion 104 (distal tip) of the medical guide wire assembly 100 can return to its relaxed shape (more natural shape, non-biased shape) that is naturally curved or curved. The penetrating stylet assembly 106 is oriented away from the leading edge of the distal portion 104. The distal portion 104 may include a curved distal end (when the distal portion 104 is deployed from inside the guide wire introducer 902). The relaxed configuration of the distal portion 104 may adopt a curvature such that the penetrating stylet assembly 106 (sharp distal tip) is oriented away from or surrounded by other sections of the distal portion 104. This arrangement helps to reduce unintended contact between the anatomical structure and the penetrating stylet assembly 106. The distal portion 104 can be of any configuration. The function of the raised cutting section does not (preferably) depend on the geometric shape of the distal portion 104.

[0034] Referring to the embodiment as shown in FIG. 2, the penetrating stylet assembly 106 is configured to mechanically puncture tissue 804 (such as the fossa ovalis of the heart). Sharpness can be a subjective term. When the applied load exceeds the resistance of the tissue 804, all tissue ceases to function (is punctured). The penetrating stylet assembly 106 may be capable of mechanically puncturing the tissue 804 under a desired or predetermined applied force (applied to the penetrating stylet assembly 106). For example, the penetrating stylet assembly 106 may have an expandable and collapsible balloon (known and not shown) equipped on the medical guide wire assembly 100. Inflating the balloon may further expand the puncture hole 802 and enable relatively easy traversal of the guide wire introducer 902 through the puncture hole 802 (in a manner similar to that in which the cutting assembly 108 may be implemented or actuated). For example, the penetrating stylet assembly 106 may include a rotary cutting section (known and deployed with an atherectomy device not shown) configured for removal of arterial plaque. The rotary cutting section may follow a small rotary section attached to the side of the penetrating stylet assembly 106 that further expands the initially formed stage of the puncture hole 802 (i.e., after the puncture hole 802 is first formed) and may be implemented for mechanical transseptal puncture in which the first puncture is made (first formed). For example, the penetrating stylet assembly 106 may be added along both sides of the medical guide wire assembly 100 and may include a high-frequency electrode (known and not shown) and / or a high-frequency cutting section (known and not shown) configured to cut tissue when the penetrating stylet assembly 106 is in place and actuated accordingly (at that point).

[0035] Referring to the embodiment as shown in FIG. 1, a first aspect of the device is shown. The device includes, and is not limited to, a medical guide wire assembly 100 (provided according to the first aspect). The medical guide wire assembly 100 is at least partially installable within and movable along a guide wire introducer 902. The guide wire introducer 902, within which the medical guide wire assembly 100 is installed, is at least partially insertable into a patient 800.

[0036] Referring to the embodiments as shown in FIGS. 1 and 6 (and according to the first aspect), the medical guide wire assembly 100 is configured to at least partially reduce a hoop stress 700 that surrounds a puncture hole 802 (surrounds the inner diameter of the puncture hole 802) extending through the tissue 804 of the patient 800. This occurs after the puncture hole 802 is first formed (by the medical guide wire assembly 100 and / or its aspects or components), and is at least partially in response to the at least partial movement (advancement) of the medical guide wire assembly 100 through the puncture hole 802 and into the patient 800 (further into the patient 800). It will be appreciated that the magnitude of the hoop stress 700 surrounding the puncture hole 802 in the embodiments as shown in FIGS. 4 and / or 5 is greater than the magnitude of the hoop stress 700 as shown in the embodiment of FIG. 6. The technical effect of the medical guide wire assembly 100 is that there can be a state for relatively easy traversal (transport) of the medical guide wire assembly 100 (and / or the guide wire introducer 902) through the puncture hole 802 (at least partially), such as across the atrial septum of the heart of the patient 800, while the medical guide wire assembly 100 at least partially allows for a reduced input force that may be required to initially form the puncture hole 802, such as mechanically puncturing the fossa ovalis of the heart of the patient 800, by reducing the amount (magnitude) of the hoop stress 700.

[0037] Referring to the embodiments as shown in FIGS. 1, 2, and 6, a second aspect of the device is shown.

[0038] Referring to the embodiment as shown in FIG. 1, the apparatus (according to the second aspect) includes, without limitation, a medical guide wire assembly 100. The medical guide wire assembly 100 is at least partially installable within and movable along a guide wire introducer 902. The guide wire introducer 902, within which the medical guide wire assembly 100 is installed, is at least partially insertable into a patient 800.

[0039] Referring to the embodiment as shown in FIG. 2 (and according to the second aspect), the medical guide wire assembly 100 is configured to at least partially form a puncture hole 802 through the tissue 804 of the patient 800. This is done in response to at least partial movement of the medical guide wire assembly 100 from the guide wire introducer 902 (removal includes relative movement between the medical guide wire assembly 100 and the guide wire introducer 902) after the guide wire introducer 902 and the medical guide wire assembly 100 have been at least partially inserted into the patient 800.

[0040] Referring to the embodiment as shown in FIG. 6 (and according to the second aspect), the medical guide wire assembly 100 is further configured to (A) at least partially cut (slice) a portion of the tissue surrounding the puncture hole 802 (the inner diameter of the puncture hole 802 or the tissue positioned adjacent to the puncture hole 802) adjacent to the puncture hole 802, and (B) at least partially reduce the hoop stress 700 surrounding the puncture hole 802, which is preferably done in response to at least partial further movement (advancement) of the medical guide wire assembly 100 through the puncture hole 802 (i) at the time when the puncture hole 802 is cut (sliced) by the medical guide wire assembly 100, and (ii) preferably after the puncture hole 802 is first formed.

[0041] Referring to the embodiment as shown in FIG. 2 (and according to the second aspect), the medical guide wire assembly 100 is movable along the internal longitudinal channel 900 of the guide wire introducer 902 and through the exit portal 904 of the guide wire introducer 902. The guide wire introducer 902 is preferably flexible. The medical guide wire assembly 100 is preferably flexible. The medical guide wire assembly 100 includes a penetrating stylet assembly 106. The penetrating stylet assembly 106 is configured to at least partially form (cut) a puncture hole 802 (puncture site) through the tissue 804 of the patient 800 (such as the fossa ovalis of the heart). This is at least partially in response to at least partial movement (advancement) of the penetrating stylet assembly 106 from (through) the exit portal 904 of the guide wire introducer 902 after the guide wire introducer 902 and the medical guide wire assembly 100 have been at least partially inserted into the closed space defined by the patient 800.

[0042] Referring to the embodiment as shown in FIGS. 3 and 6 (and according to the second aspect), the cutting assembly 108 is configured to at least partially cut (slice) a portion of the tissue surrounding the puncture hole 802 (the inner diameter of the puncture hole 802, or the tissue positioned proximate to the puncture hole 802). This is done in such a way that the cutting assembly 108 at least partially reduces the hoop stress 700 surrounding the puncture hole 802, which occurs when the puncture hole 802 is at least partially further moved (advanced) through the medical guide wire assembly 100 through the puncture hole 802 (preferably after the puncture hole 802 has been initially formed) and is then cut (sliced) by the cutting assembly 108.

[0043] Referring to the embodiments as shown in FIGS. 1, 2, 3, and 6, a third aspect of the medical guide wire assembly 100 is shown.

[0044] Referring to the embodiment as shown in FIG. 1, the apparatus (according to the third aspect) includes, and is not limited to (comprises), a medical guide wire assembly 100. The medical guide wire assembly 100 is preferably flexible. The medical guide wire assembly 100 includes an elongated section 102. The elongated section 102 is preferably flexible. The distal portion 104 extends from the elongated section 102. The distal portion 104 is at least partially installable and movable along the internal longitudinal channel 900 of the guide wire introducer 902 and at least partially through the exit portal 904 of the guide wire introducer 902. The guide wire introducer 902 is preferably flexible. The guide wire introducer 902 with the medical guide wire assembly 100 installed therein is configured to be at least partially inserted (inserted) into the closed space defined by the patient 800.

[0045] Referring to the embodiment as shown in FIG. 1, the apparatus (according to the third aspect) also includes a piercing stylet assembly 106 extending from the distal portion 104. The piercing stylet assembly 106 is configured to physically at least partially form (cut) a puncture hole 802 (puncture site) through the tissue 804 of the patient 800 (such as the fossa ovalis of the heart). This is done in response to at least partial movement (advancement) of the distal portion 104 from (through) the exit portal 904 of the guide wire introducer 902, and the distal portion 104 and the piercing stylet assembly 106 move toward and through the tissue 804 of the patient 800 when (or after) the guide wire introducer 902 and the medical guide wire assembly 100 are at least partially inserted into the closed space defined by the patient 800. It will be understood that removal may include any relative movement between the medical guide wire assembly 100 and the guide wire introducer 902.

[0046] Referring to the embodiment as shown in FIG. 2, the device (according to the third aspect) also includes a cutting assembly 108 spaced from the distal portion 104. The cutting assembly 108 is attached to the elongated section 102. The cutting assembly 108 is configured to be removable from the exit portal 904 of the guidewire introducer 902 (advancing through the exit portal 904 of the guidewire introducer 902) when the medical guidewire assembly 100 is moved along the inside of the guidewire introducer 902.

[0047] Referring to the embodiments as shown in FIGS. 3 and 6 (according to the third aspect), the cutting assembly 108 is further configured to at least partially cut (slice) a portion of the tissue surrounding and adjacent to the puncture hole 802 defined by the tissue 804 (the inner diameter of the puncture hole 802, or the tissue positioned adjacent to the puncture hole 802 defined by the tissue 804). This is done in such a way that the cutting assembly 108 at least partially reduces the hoop stress 700 surrounding the puncture hole 802, which preferably occurs when the puncture hole 802 is cut (sliced) by the cutting assembly 108, or thereafter, and / or in response to at least partial movement (advancement) of the cutting assembly 108 through the exit portal 904 of the guidewire introducer 902 and then through the puncture hole 802, i.e., after the puncture hole 802 is first formed. The technical effect of the medical guidewire assembly 100 is that the medical guidewire assembly 100 (at least partially) reduces the hoop stress 700, a state that at least partially allows the reduced input force that may be required for the medical guidewire assembly 100 to first form the puncture hole 802 (such as the initial puncture of the fossa ovalis of the patient 800), while enabling relatively easy traversal of the medical guidewire assembly 100 (and / or the guidewire introducer 902) through the puncture hole 802 (such as across the atrial septum of the patient 800's heart).

[0048] Referring to the embodiments as shown in FIGS. 3 and 6 (according to the third aspect), the cutting assembly 108 is further configured to at least partially reduce the hoop stress 700, which occurs in response to the medical guide wire assembly 100 at least partially moving (being movable) through the puncture hole 802 while the medical guide wire assembly 100 expands (extends) the puncture hole 802.

[0049] Referring to the embodiments as shown in FIGS. 3 and 6 (according to the third aspect), the cutting assembly 108 is further configured to completely transect the tissue 804 (such as the atrial septum of the patient 800's heart) when the cutting assembly 108 is advanced through the puncture hole 802 (also referred to as the puncture site).

[0050] Referring to the embodiments as shown in FIGS. 3 and 6 (according to the third aspect), the cutting assembly 108 is mounted (configured to be mounted) on the outer surface 110 of the body portion of the elongated section 102.

[0051] Referring to the embodiments as shown in FIGS. 3 and 6 (according to the third aspect), the medical guide wire assembly 100 is configured to expand (extend) the puncture hole 802. This occurs in response to the continuous movement (advancement) of the distal portion 104 of the medical guide wire assembly 100 through the patient 800's tissue 804 (after a portion of the tissue positioned adjacent to the puncture hole 802 has been at least partially cut by the cutting assembly 108).

[0052] Referring to the embodiments as shown in FIGS. 3 and 6 (according to the third aspect), the cutting assembly 108 includes spaced cutting sections (108A, 108B) positioned on the outer surface (such as the elongated section 102) of the medical guide wire assembly 100.

[0053] Referring to embodiments as shown in FIGS. 1, 3, and 6, a method is shown. The method is for at least partially reducing hoop stress 700 surrounding puncture hole 802 defined by tissue 804 (such as the fossa ovalis of the heart) of patient 800.

[0054] Referring to embodiments as shown in FIG. 1, the method includes, but is not limited to (including), operation (A). Operation (A) includes at least partially installing medical guidewire assembly 100 within guidewire introducer 902. Medical guidewire assembly 100 includes a distal portion 104 extending from an elongated section 102 of medical guidewire assembly 100. Medical guidewire assembly 100 also includes a penetrating stylet assembly 106 extending from distal portion 104. Medical guidewire assembly 100 also includes a cutting assembly 108 spaced from distal portion 104. Cutting assembly 108 is attached to elongated section 102. Cutting assembly 108 is configured to be removable from exit portal 904 of guidewire introducer 902. Guidewire introducer 902 defines exit portal 904 and also defines an internal longitudinal channel 900 in fluid communication with exit portal 904.

[0055] Referring to embodiments as shown in FIG. 1, the method further includes operation (B). Operation (B) includes inserting guidewire introducer 902 having at least partially medical guidewire assembly 100 (together) into a closed space defined by patient 800.

[0056] Referring to embodiments as shown in FIG. 1, the method further includes operation (C). Operation (C) includes at least partially moving distal portion 104 of medical guidewire assembly 100 along internal longitudinal channel 900 of guidewire introducer 902 such that distal portion 104 moves through exit portal 904 of guidewire introducer 902.

[0057] Referring to the embodiment as shown in FIG. 2, the method further includes operation (D). Operation (D) includes removing the penetrating stylet assembly 106 and the distal portion 104 at least partially from (through) the exit portal 904 of the guidewire introducer 902 such that the distal portion 104 and the penetrating stylet assembly 106 move toward and through the tissue 804 (i.e., when or after the exit portal 904 of the guidewire introducer 902 is positioned proximate to the tissue 804 of the patient 800). This is done in such a way that the penetrating stylet assembly 106 initially physically forms (cuts) at least a portion of the puncture hole 802 such that the puncture hole 802 extends through the tissue 804 of the patient 800.

[0058] Referring to the embodiments as shown in FIGS. 3 and 6, the method further includes operation (E). Operation (E) includes removing the cutting assembly 108 at least partially through the exit portal 904 of the guidewire introducer 902 and then through the puncture hole 802 defined by the tissue 804 of the patient 800 (after the puncture hole 802 has been initially formed at least in part by the penetrating stylet assembly 106). This is done in such a way that (A) the cutting assembly 108 at least partially cuts (slices) a portion of the tissue surrounding and proximate to the puncture hole 802 defined by the tissue 804 during use (the inner diameter of the puncture hole 802 or the tissue positioned proximate to the puncture hole 802), and (B) the cutting assembly 108 at least partially reduces the hoop stress 700 surrounding the puncture hole 802.

[0059] Referring to the embodiment as shown in FIG. 6, the medical guide wire assembly 100 is configured to at least partially reduce the hoop stress 700 surrounding the puncture hole 802 extending through the tissue 804, which preferably occurs after the puncture hole 802 is first formed, as shown in the embodiments of FIGS. 2 and / or 4, at least partially in response to the movement (advancement) of the medical guide wire assembly 100 through or relative to the puncture hole 802. Specifically, the hoop stress 700 at least partially surrounds the inner diameter of the puncture hole 802. By reducing the hoop stress 700, it enables a relatively easy traversal of the medical guide wire assembly 100 and / or the guide wire introducer 902 through the puncture hole 802 while at least partially reducing and / or maintaining the reduced input force required to initially form the puncture hole 802. Preferably, the medical guide wire assembly 100 is also configured to at least partially form the puncture hole 802 extending through the tissue 804 of the patient 800 (before the hoop stress 700 is at least partially reduced in response to at least partial movement of the medical guide wire assembly 100 by the medical guide wire assembly 100 and from the guide wire introducer 902). It will be understood that the removal of the medical guide wire assembly 100 may include any relative movement between the medical guide wire assembly 100 and the guide wire introducer 902.

[0060] FIG. 8 shows a front perspective view of an embodiment of the medical guide wire assembly 100 of FIG. 1.

[0061] FIGS. 9 and 10 show cross-sectional views of the embodiment of the medical guide wire assembly 100 of FIG. 8. The cross-sectional view of FIG. 9 is taken along the cross-section line A-A of FIG. 8. The cross-sectional view of FIG. 10 is taken along the cross-section line A-A of FIG. 8.

[0062] Referring to the embodiment as shown in FIG. 8, the medical guidewire assembly 100 includes a cutting assembly 108 spaced from the penetrating stylet assembly 106. The cutting assembly 108 preferably includes spaced cutting sections (108A, 108B) (preferably) positioned on both sides of the medical guidewire assembly 100. The spaced cutting sections (108A, 108B) are spaced from both sides of the medical guidewire assembly 100.

[0063] Referring to the embodiment as shown in FIG. 8, the cutting assembly 108 includes spaced cutting segments (108A, 108B). The spaced cutting segments (108A, 108B) may include raised cutting wires positioned along (and spaced from) the outer surface of the medical guidewire assembly 100. The spaced cutting segments (108A, 108B) may be positioned parallel to and raised from the outer surface of the main body of the medical guidewire assembly 100 and include relatively thin wires. The spaced cutting segments (108A, 108B) are configured to cut tissue and enlarge the size of the initially formed stage of the puncture hole 802 (compared to the size of the puncture hole 802 formed in FIG. 2) when the medical guidewire assembly 100 is advanced into the puncture hole 802. The cutting assembly 108 may include any type of cutting structure that enlarges the size of the initially formed stage of the puncture hole 802. The cutting assembly 108 may include, for example, high-frequency electrodes, blades, lasers, etc., and any equivalents thereof. The cutting assembly 108 may include any device configured to further cut and enlarge the initially formed stage of the puncture hole 802. The cutting assembly 108 may include a balloon device (known and not shown) configured to create (form) the puncture hole 802 in the tissue 804 and widen (expand) the puncture hole 802. The balloon can pass through the puncture hole 802 and then be inflated to achieve this effect. The cutting assembly 108 may include an atherectomy device (known and not shown) having a rotating bar positioned on the medical guidewire assembly 100. The rotating bar has an elliptical shape and acts to widen an occluded blood vessel. The cutting assembly 108 is positioned along or near the penetrating stylet assembly 106. The cutting assembly 108 has a size (outer dimension or outer diameter) larger than the size (outer dimension or outer diameter) of the penetrating stylet assembly 106.

[0064] Referring to the embodiments as shown in FIGS. 9 and 10, the medical guidewire assembly 100 further includes a guard device 112 positioned proximate to the cutting assembly 108. Preferably, the guard device 112 is positioned at the leading edge of the cutting assembly 108. The guard device 112 forms a bulge that extends axially (outwardly) from the medical guidewire assembly 100. The guard device 112 is configured to further expand the puncture hole 802 when the medical guidewire assembly 100 is advanced (passed) through the puncture hole 802. The guard device 112 preferably includes spaced guards (112A, 112B) positioned at the end portions of the spaced cutting sections (108A, 108B). The spaced cutting sections (108A, 108B) may include raised cutting wires. The spaced guards (112A, 112B) are configured to physically suspend the spaced cutting sections (108A, 108B). The spaced guards (112A, 112B) are also configured to prevent skiving of the inner longitudinal channel 900 of the guidewire introducer 902 when the medical guidewire assembly 100 passes through the guidewire introducer 902. The spaced guards (112A, 112B) are (preferably) of an inclined shape to allow for smooth passage of the medical guidewire assembly 100 through the initially formed stage of the puncture hole 802. When the cutting assembly 108 cuts tissue via mechanical means during use, the guard device 112 can assist in the smooth traversal of the piercing stylet assembly 106 through the tissue 804. The guard device 112 may include a tissue expansion section. The guard device 112 may be configured to allow for propulsion and non-traumatic forces to the tissue 804 (if so desired). The guard device 112 may include a raised section configured to further expand the puncture hole 802 rather than cutting the sidewall forming the puncture hole 802. The guard device 112 may be configured to expand the puncture hole 802 such that the guidewire introducer 902 can traverse the puncture hole 802 and achieve the result of relatively easy traversal of the guidewire introducer 902.The guard device 112 is configured to prevent contact of the cutting assembly 108 with the guide wire introducer 902 and reduce any damage that may occur to the guide wire introducer 902. The guard device 112 (also referred to as the puncture site expansion section) does not necessarily have to be on the main body of the medical guide wire assembly 100, and the guard device 112 can be disposed at any suitable position provided that the guard device 112 can function to expand the size at the stage when the puncture hole 802 is first formed.

[0065] The following is proposed as a further description of an embodiment in which any one or more arbitrary technical features (described in the detailed description, summary, and claims) can be combined with any one or more other arbitrary technical features (described in the detailed description, summary, and claims). It is understood that each claim in the claims paragraphs is a non-limiting claim unless otherwise specified. Unless otherwise specified, the relational terms used in these specifications should be construed to include certain tolerances that those skilled in the art will recognize as providing equivalent functionality. 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 will recognize as providing equivalent functionality for the purposes described for the associated member or element. Terms such as "about" and "substantially" in the context of a configuration generally relate to an arrangement, deployment, or configuration that is exactly or sufficiently close to maintain the operability of the elements within the present invention without substantially changing the present invention. Similarly, unless otherwise clear from the context, numerical values should be construed to include certain tolerances recognized as negligible by those skilled in the art so as not to substantially change the operability of the present invention. It will be understood that the description and / or drawings identify and describe embodiments of the apparatus (either explicitly or inherently). The apparatus may include any suitable combination and / or permutation of the technical features identified in the detailed description as necessary and / or desired to be suitable for a particular technical purpose and / or technical function. It will be understood that, where possible and suitable, any one or more technical features of the apparatus may be combined with any one or more other technical features of the apparatus (in any combination and / or permutation). It will be understood that those skilled in the art will know that, even if not explicitly stated as above, in other embodiments, the technical features of each embodiment may be developed. It will be understood that those skilled in the art will know that other options are possible for the configuration of the components of the apparatus, adapting to manufacturing requirements and remaining within the scope described in at least one or more of the claims. This specification provides embodiments including the best mode and enables those skilled in the art to make and use the embodiments.The scope of patentability can be defined by the claims. The written description and / or drawings can be useful in understanding the scope of the claims. It is believed that all important aspects of the disclosed subject matter are provided herein. In this specification, the word "includes" is understood to be equivalent to the term "comprising" in that both words are used to indicate a preamble, elements, components, and other non-limiting lists. The term "comprising", which is synonymous with the terms "including", "containing", or "characterized by", is inclusive or non-limiting and does not exclude additional, unrecited elements or method steps. Comprising (comprised of) is a "non-limiting" phrase that enables the scope of application of technologies that adopt additional, unrecited elements. When used in a claim, the word "comprising" is a temporary verb (transition term) that separates the preamble of the claim from the technical features of the invention. The foregoing outlines non-limiting embodiments. The description is made with respect to specific non-limiting embodiments. It is understood that the non-limiting embodiments are merely illustrative as examples. The technical idea included in the present disclosure is described below. (Appendix 1) An apparatus comprising a medical guide wire assembly that is at least partially installable within and at least partially movable along a guide wire introducer, the guide wire introducer having the medical guide wire assembly at least partially installed therein and being at least partially insertable into a patient's body wall. The medical guide wire assembly is configured to pierce a hole in the body wall and, after the guide wire introducer and the medical guide wire assembly have been at least partially inserted into the patient and after the puncture hole has been initially formed by the medical guide wire assembly, increase the outer periphery of the puncture hole while extending through the patient's body wall in response to at least partial movement of the medical guide wire assembly through the puncture hole. (Appendix 2) The medical guide wire assembly is configured to at least partially initially form the puncture hole extending through the patient's body wall before the outer periphery of the puncture hole is at least partially increased by the medical guide wire assembly by at least partial movement of the medical guide wire assembly relative to the guide wire introducer. The apparatus according to Appendix 1. (Appendix 3) An apparatus comprising a medical guide wire assembly that is at least partially installable within and at least partially movable along a guide wire introducer, the guide wire introducer having the medical guide wire assembly at least partially installed therein and being at least partially insertable into a patient's body wall. The medical guide wire assembly is configured to at least partially form a puncture hole through tissue in response to at least partial movement of the medical guide wire assembly from the guide wire introducer after the guide wire introducer and the medical guide wire assembly have been at least partially inserted into the patient. The medical guide wire assembly is configured to at least partially cut a portion of the body wall surrounding the puncture hole adjacent to the puncture hole, and to at least partially increase the outer periphery of the puncture hole in response to at least partial further movement of the medical guide wire assembly relative to the puncture hole. Device. (Appendix 4) The medical guide wire assembly is at least partially movable along the internal longitudinal channel of the guide wire introducer and through the exit portal of the guide wire introducer. The medical guide wire assembly is A penetrating stylet assembly, wherein after the guide wire introducer and the medical guide wire assembly are at least partially inserted into the closed space defined by the patient, at least partial movement of the penetrating stylet assembly from the exit portal of the guide wire introducer is provided. Responsive, configured to at least partially form a puncture hole through the body wall of the patient. A device according to claim 5, further comprising a penetrating stylet assembly. The device according to Appendix 3. (Appendix 5) The medical guide wire assembly is A cutting assembly, the cutting assembly being configured to at least partially cut a portion of the body wall surrounding the puncture hole adjacent to the puncture hole in such a way as to at least partially increase the outer periphery of the puncture hole in response to at least partial movement of the medical guide wire assembly relative to the puncture hole. The device according to Appendix 4, further comprising a cutting assembly. The device according to Appendix 4. (Appendix 6) A device, A medical guide wire assembly that can be at least partially installed within a guide wire introducer and is at least partially movable along the guide wire introducer, the medical guide wire assembly being at least partially installed therein. The guide wire introducer is provided with a medical guide wire assembly that can be at least partially inserted into the body wall of a patient. The medical guide wire assembly is An elongated section, A distal portion extending from the elongated section, the distal portion being at least partially insertable into the internal longitudinal channel of the guidewire introducer, movable along the internal longitudinal channel of the guidewire introducer and through the exit portal of the guidewire introducer, and the guidewire introducer in which the medical guidewire assembly is installed being at least partially insertable into the closed space defined by the body wall of the patient, the distal portion; A penetrating stylet assembly extending from the distal portion, the penetrating stylet assembly being configured to at least partially form a puncture hole through the body wall of the patient in response to at least partial movement of the distal portion from the exit portal of the guidewire introducer, and the distal portion and the penetrating stylet assembly moving toward and through the body wall of the patient after the guidewire introducer and the medical guidewire assembly are at least partially inserted into the closed space defined by the body wall of the patient, the penetrating stylet assembly; A cutting assembly spaced from the distal portion and attached to the elongated section, the cutting assembly being configured to be removable from the exit portal of the guidewire introducer, and the cutting assembly being configured to at least partially cut a portion of the body wall surrounding the puncture hole defined by the body wall in such a way as to at least partially increase the outer periphery of the puncture hole in response to at least partial movement of the cutting assembly relative to the exit portal of the guidewire introducer and then through the puncture hole in the body wall, the cutting assembly; A device comprising: (Appendix 7) The cutting assembly is configured to at least partially reduce hoop stress in response to the medical guidewire assembly enlarging the puncture hole while the medical guidewire assembly is at least partially moved through the puncture hole; The device according to Appendix 6. (Appendix 8) When the cutting assembly is advanced through the puncture hole, the cutting assembly completely transects the tissue; The device according to Appendix 6. (Appendix 9) The cutting assembly is mounted on the outer surface of the body portion of the elongated section. The device according to appended claim 6. (Appended claim 10) After the tissue positioned adjacent to the puncture hole is at least partially cut by the cutting assembly, the distal portion of the medical guide wire assembly passing through the living wall of the patient is continuously removed, and in response thereto, the puncture hole is configured to expand. The device according to appended claim 6. (Appended claim 11) The cutting assembly includes spaced cutting sections (A, B) positioned on both sides of the medical guide wire assembly. The device according to appended claim 6. (Appended claim 12) The spaced cutting sections (A, B) include raised cutting wires. The device according to appended claim 11. (Appended claim 13) The cutting assembly includes a guard device positioned on at least the front leading edge portion of the cutting assembly. The device according to appended claim 11. (Appended claim 14) The guard device a first guard device A, and a second guard device B spaced from the first guard device A. The device according to appended claim 13, including. (Appended claim 15) The first guard device A and the second guard device B are respectively positioned at each end of the cutting assembly. The device according to appended claim 14. (Appended claim 16) The medical guide wire assembly includes a shape memory material. The device according to appended claim 6. (Appended claim 17) The medical guide wire assembly has an outer diameter of about 0.032 inches. The device according to appended claim 6. (Appended claim 18) The medical guide wire assembly has a maximum outer diameter of 0.032 inches. The device according to appended claim 6. (Appended claim 19) The piercing stylet assembly is configured to mechanically pierce the living wall under a desired or predetermined applied force applied to the piercing stylet assembly. The device according to appended claim 6. (Appended claim 20) The piercing stylet assembly is configured to include a conductive high-frequency electrode for piercing the living wall. The device according to appended claim 6. (Appended claim 21) The cutting assembly includes spaced cutting sections (A, B), and the spaced cutting sections (A, B) are positioned along the outer surface of the medical guide wire assembly and include raised cutting wires spaced from the outer surface of the medical guide wire assembly. The spaced-apart cutting segments (A, B) are positioned parallel to and raised from the outer surface of the medical guide wire assembly, A guard device is positioned adjacent to the cutting assembly, The guard device is positioned at a leading edge of the cutting assembly, the guard device forming a bulge that extends axially from the medical guide wire assembly, The guard device is configured to further expand the puncture hole when the medical guide wire assembly is advanced through the puncture hole, The guard device includes spaced-apart guards (A, B) positioned at end segments of the spaced-apart cutting segments (A, B), the spaced-apart guards (A, B) being configured to physically suspend the spaced-apart cutting segments (A, B), the spaced-apart guards (A, B) also being configured to prevent skiving of the inner longitudinal channel of the guide wire introducer when the medical guide wire assembly passes through the guide wire introducer, The spaced-apart guards (A, B) are of an inclined shape to allow smooth passage of the medical guide wire assembly through the puncture hole after the puncture hole is first formed, The device according to appendix 6. (Appendix 22) The cutting assembly includes spaced-apart cutting segments (A, B), The spaced-apart cutting segments (A, B) are positioned along and spaced from the outer surface of the medical guide wire assembly and include high-frequency electrodes, The spaced-apart cutting segments (A, B) are positioned parallel to and raised from the outer surface of the medical guide wire assembly, A guard device is positioned adjacent to the cutting assembly, The guard device is positioned at a leading edge of the cutting assembly, The guard device forms a bulge that extends axially from the medical guide wire assembly, The guard device is configured to further expand the puncture hole when the medical guide wire assembly is advanced through the puncture hole, The guard device includes spaced-apart guards (A, B) positioned at end segments of the spaced-apart cutting segments (A, B), The spaced guards (A, B) are configured to physically suspend the spaced cutting sections (A, B), and the spaced guards (A, B) are also configured to prevent skiving of the internal longitudinal channel of the guidewire introducer when the medical guidewire assembly passes through the guidewire introducer. The spaced guards (A, B) are of an inclined shape to enable smooth passage of the medical guidewire assembly through the puncture hole after the puncture hole is first formed. The device according to appended claim 6. (Appended claim 23) The medical guidewire assembly is configured to at least partially cut a portion of the body wall surrounding the puncture hole adjacent to the puncture hole, and to at least partially reduce hoop stress surrounding the puncture hole in response to at least partial further movement of the medical guidewire assembly relative to the puncture hole. The device according to appended claim 1 or 2. (Appended claim 24) A method of at least partially reducing hoop stress surrounding a puncture hole defined by a patient's tissue, comprising installing a medical guidewire assembly at least partially within a guidewire introducer, the guidewire introducer being at least partially insertable into a patient, the medical guidewire assembly including a distal portion extending from an elongate section of the medical guidewire assembly, the medical guidewire assembly also including a penetrating stylet assembly extending from the distal portion, the medical guidewire assembly also including a cutting assembly spaced from the distal portion, the cutting assembly being attached to the elongate section, the cutting assembly being configured to be removable from an exit portal of the guidewire introducer, the guidewire introducer defining the exit portal and an internal longitudinal channel in communication with the exit portal; inserting at least partially into a closed space defined by the patient the guidewire introducer having the medical guidewire assembly. Moving at least partially the distal portion of the medical guidewire assembly along at least a portion of the internal longitudinal channel of the guidewire introducer and through the exit portal of the guidewire introducer. Removing at least partially the piercing stylet assembly and the distal portion through the exit portal of the guidewire introducer, wherein the piercing stylet assembly, in use, first physically forms at least partially a puncture hole such that the puncture hole extends through the tissue of the patient, and then, after the exit portal of the guidewire introducer is positioned in proximity to the tissue of the patient, moving and removing the distal portion and the piercing stylet assembly, in use, towards and through the tissue of the patient. Removing at least partially the cutting assembly through the exit portal of the guidewire introducer, and then, after the puncture hole is at least partially initially formed by the piercing stylet assembly, the cutting assembly, in use, at least partially cuts a portion of the tissue surrounding the puncture hole defined by the tissue such that the cutting assembly at least partially reduces the hoop stress surrounding the puncture hole, and removing at least partially the cutting assembly through the puncture hole defined by the tissue of the patient. A method comprising the above steps.

Claims

1. An apparatus comprising a medical guide wire assembly that is at least partially installable within and at least partially movable along a guide wire introducer, wherein the guide wire introducer, at least partially installed therein, is at least partially insertable into a patient's body wall; the medical guide wire assembly being configured to at least partially form a puncture hole through tissue in response to at least partial movement of the medical guide wire assembly from the guide wire introducer after the guide wire introducer and the medical guide wire assembly have been at least partially inserted into the patient; the medical guide wire assembly being configured to at least partially cut a portion of the body wall surrounding the puncture hole and to at least partially increase the outer perimeter of the puncture hole in response to at least partial further movement of the medical guide wire assembly relative to the puncture hole; the medical guide wire assembly comprising a cutting assembly configured to at least partially cut a portion of the body wall surrounding the puncture hole in a manner that at least partially increases the outer perimeter of the puncture hole in response to at least partial movement of the medical guide wire assembly relative to the puncture hole, the cutting assembly including a guard device positioned on at least a forward leading edge portion of the cutting assembly, the guard device forming a bulge extending axially from the medical guide wire assembly; the apparatus.

2. the medical guide wire assembly being at least partially movable along an internal longitudinal channel of the guide wire introducer and through an exit portal of the guide wire introducer; the medical guide wire assembly comprising A penetrating stylet assembly configured to at least partially form a puncture hole through the living wall of the patient in response to at least partial movement of the penetrating stylet assembly from the exit portal of the guidewire introducer after the guidewire introducer and the medical guidewire assembly are at least partially inserted into a closed space defined by the patient. The penetrating stylet assembly includes The device according to claim 1.

3. The medical guidewire assembly An elongated section, A distal portion extending from the elongated section, the distal portion being at least partially installable within an internal longitudinal channel of the guidewire introducer and movable along the internal longitudinal channel of the guidewire introducer and through an exit portal of the guidewire introducer, and the guidewire introducer having the medical guidewire assembly installed therein being at least partially insertable into a closed space defined by the living wall of the patient. A distal portion, A penetrating stylet assembly extending from the distal portion, the penetrating stylet assembly being configured to at least partially form a puncture hole through the living wall of the patient in response to at least partial movement of the distal portion from the exit portal of the guidewire introducer, and the distal portion and the penetrating stylet assembly moving toward and through the living wall of the patient after the guidewire introducer and the medical guidewire assembly are at least partially inserted into the closed space defined by the living wall of the patient. A penetrating stylet assembly, further comprising The cutting assembly is spaced from the distal portion and is mounted on the elongated section, and the cutting assembly is configured to be removable from the exit portal of the guide wire introducer, and the cutting assembly is at least partially responsive to movement of at least a portion of the cutting assembly relative to the exit portal of the guide wire introducer and then through the puncture hole in the body wall to at least partially increase the outer periphery of the puncture hole, and is configured to at least partially cut a portion of the body wall that proximally surrounds the puncture hole defined by the body wall. The device according to claim 1.

4. The cutting assembly is configured to at least partially reduce hoop stress in response to the medical guide wire assembly expanding the puncture hole while the medical guide wire assembly is at least partially moved through the puncture hole. The device according to claim 3.

5. When the cutting assembly is advanced through the puncture hole, the cutting assembly completely transects the tissue. The device according to claim 3.

6. The cutting assembly is mounted on the outer surface of the body portion of the elongated section. The device according to claim 3.

7. The medical guide wire assembly is configured to expand the puncture hole in response to continued removal of the distal portion of the medical guide wire assembly through the patient's body wall after tissue positioned adjacent to the puncture hole has been at least partially cut by the cutting assembly. The device according to claim 3.

8. The cutting assembly includes spaced cutting sections (A, B) positioned on both sides of the medical guide wire assembly. The device according to claim 3.

9. The spaced cutting sections (A, B) include raised cutting wires. The device according to claim 8.

10. The guard device a first guard device A, and a second guard device B spaced from the first guard device A. The device according to claim 1.

11. The first guard device A and the second guard device B are respectively positioned at each respective end of the cutting assembly. The device according to claim 10.

12. The medical guide wire assembly includes a shape memory material, The device according to claim 3.

13. The medical guide wire assembly has an outer diameter of about 0.032 inches, The device according to claim 3.

14. The medical guide wire assembly has a maximum outer diameter of 0.032 inches, The device according to claim 3.

15. The piercing stylet assembly is configured to mechanically pierce the body wall under a desired or predetermined applied force applied to the piercing stylet assembly, The device according to claim 3.

16. The piercing stylet assembly is configured to include a conductive high-frequency electrode for piercing the body wall, The device according to claim 3.

17. The cutting assembly includes spaced cutting sections (A, B), The spaced cutting sections (A, B) are positioned along the outer surface of the medical guide wire assembly and include raised cutting wires spaced from the outer surface of the medical guide wire assembly, The spaced cutting sections (A, B) are positioned parallel to the outer surface of the medical guide wire assembly and project from the outer surface of the medical guide wire assembly, The guard device is positioned proximate to the cutting assembly, The guard device is positioned at the leading edge of the cutting assembly, The guard device is configured to further expand the puncture hole when the medical guide wire assembly is advanced through the puncture hole, The guard device includes spaced guards (A, B) positioned at the end sections of the spaced cutting sections (A, B), The spaced guards (A, B) are configured to physically suspend the spaced cutting sections (A, B), The spaced guards (A, B) are also configured to prevent skiving of the inner longitudinal channel of the guide wire introducer when the medical guide wire assembly passes through the guide wire introducer, The spaced guards (A, B) are in an inclined shape to allow smooth passage of the medical guide wire assembly through the puncture hole after the puncture hole is first formed, The device according to claim 3.

18. The cutting assembly includes spaced cutting sections (A, B), The spaced-apart cutting segments (A, B) include high-frequency electrodes positioned along and spaced from the outer surface of the medical guide wire assembly, The spaced-apart cutting segments (A, B) are positioned parallel to and protrude from the outer surface of the medical guide wire assembly, The guard device is positioned adjacent to the cutting assembly, The guard device is positioned at the leading edge of the cutting assembly, The guard device is configured to further expand the puncture hole when the medical guide wire assembly is advanced through the puncture hole, The guard device includes spaced-apart guards (A, B) positioned at the end segments of the spaced-apart cutting segments (A, B), The spaced-apart guards (A, B) are configured to physically suspend the spaced-apart cutting segments (A, B), The spaced-apart guards (A, B) are also configured to prevent skiving of the inner longitudinal channel of the guide wire introducer when the medical guide wire assembly passes through the guide wire introducer, The spaced-apart guards (A, B) are in an inclined shape to allow smooth passage of the medical guide wire assembly through the puncture hole after the puncture hole is initially formed, The device according to claim 3.

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