Positioning needle

Abstract

A puncture assembly for imaging guided medical procedures to reach a target in deep tissue. The puncture assembly includes: a tubular member having a wall enclosing a lumen and including a distal section extending to a distal end of the tubular member, where the distal section is open on one side toward the distal end of the tubular member and includes the distal end of the tubular member; and a core slidably and rotatably disposed within the lumen of the tubular member and having a distal end section wherein the distal end section is flexible and biased toward a curved shape.

Description

Technical Field

[0001] The present invention relates to a puncture assembly and a method for guiding a tubular member toward target tissue. Background Art

[0002] During minimally invasive image-guided medical procedures, a puncture instrument or needle may be used to manipulate the body to reach one or more specific targets located deep within tissue. Often, the initial insertion may miss the target, resulting in the needle tip being positioned near the target area. To correct this, the needle can be manipulated within the body. Alternatively, the needle can be reinserted or a new one inserted. Both of these methods can cause further tissue damage.

[0003] For example, because medical images provide limited information about the exact location of the target, the target may be missed. Another reason is that because the target composition is often different from the surrounding tissue, the target area may slip or shift away from the needle during needle introduction.

[0004] An alternative method to prevent target slippage is to first insert another needle to stabilize the adjacent target tissue so that the target can be reached. However, this alternative method requires at least two needles and at least two needle insertions.

[0005] CN 103257053 A describes a self-deforming multi-axis puncture device comprising a deformable puncture needle cannula made of shape memory alloy and a curved puncture needle core. However, this solution still carries the risk of missing the target. In general, an improved puncture assembly is needed. Summary of the Invention

[0006] It would be advantageous to provide an improved puncture assembly.

[0007] Therefore, according to a first aspect of the present invention, there is provided a puncture assembly comprising:

[0008] a tubular member having a wall enclosing an inner lumen and including a distal section extending to a distal end of the tubular member, wherein the distal section of the tubular member is open on one side up to and including the distal end of the tubular member and closed on another side up to and including the distal end of the tubular member; and

[0009] A core is slidably and rotatably disposed within the lumen of the tubular member and has a distal section, wherein the distal section is flexible and biased toward a curved shape.

[0010] The puncture assembly can reach one or more targets more efficiently, which can reduce tissue damage. The puncture assembly can simultaneously fix the target area while aiming at it. In the event that the target is missed, the target can be fixed by the tubular member located near the target. Due to the curved shape of the core and the open side of the distal section of the tubular member, the core can extend laterally from the tubular member. Since the open side of the distal section of the tubular member extends all the way to and including the distal end of the tubular member, the tubular member can be partially retracted while the core extends laterally through the open side. In addition, the tubular member can then be rotated relative to the core so that the closed side of the distal section is aligned with the curvature of the deflected core. After this, the tubular member can be reinserted so that it can be guided toward the target through the core.

[0011] If the tubular member successfully reaches the target location during the medical procedure, the procedure can be continued according to the medical protocol. Thus, if the first puncture is successful, the core tube need not be used.

[0012] The distal section of the tubular member, which is open on one side up to and including the distal end of the tubular member, can provide a cutting tool to more easily penetrate surface tissue and extend toward a specific target in deep tissue.

[0013] The distal section of the tubular member may have a length (L1), and the distal section of the core may be biased toward a curve having a radius (R), wherein the length (L1) divided by the radius (R) is at least 0.2, preferably at least 0.4. The distal length of the tubular portion facilitates fixation of adjacent (target) tissue.

[0014] In typical embodiments, the length of the distal section of the tubular member may be between 5 mm and 30 mm, preferably between 15 mm and 30 mm. This makes the puncture assembly particularly useful in common medical applications and interventional procedures, such as biopsy.

[0015] The distal section of the core may have an offset curvature with a radius between 5 mm and 60 mm. This makes the puncture assembly particularly useful in common medical applications such as biopsy.

[0016] The tubular member may have a beveled tip. This has the advantage of providing additional sharpness and helping the tubular member to penetrate and penetrate body tissue. Similarly, the core may also have a beveled tip to provide a cutting means to facilitate piercing the target.

[0017] The core may be hollow. The hollow structure provides a channel for the core, which can be used for various applications, such as injecting or extracting fluids, or providing other components.

[0018] The core may be longer than the tubular member, which has the advantage of facilitating manipulation of the core from its proximal end.

[0019] The puncture assembly can include an indicator for indicating the axial and / or radial position of the core relative to the tubular member. For example, the radial position can indicate the rotation of the core relative to the tubular member along the longitudinal axis. This has the advantage of facilitating user operation of the puncture assembly. For example, it can facilitate alignment of the open and closed sides of the distal section with the skew of the distal section of the core. The indicator can be located at the proximal portion of the tubular member or the proximal portion of the core. The indicator can be located on a handpiece at the proximal end of the tubular member and / or the core.

[0020] The cross-section of the distal end section of the tubular member may have a semicircular shape, which has the advantage of improving the guidance of the tubular member by the core. For example, the semicircular shape may correspond to 25% to 65% of the circumference of the enclosed portion of the tubular member, preferably 45% to 55% of its circumference. This facilitates guidance of the tubular member on the core.

[0021] The cross-section can remain consistent along the distal section. Alternatively, the cross-sectional shape can vary throughout the length of the distal section, which can improve the cutting characteristics of the distal end of the tubular member and / or provide radial freedom to the distal end of the tubular member as the core extends from the distal section of the tubular member during use. For example, the percentage of the circumference of the tubular member covered by the cross-section of the closed side of the distal section can gradually decrease from at least 55% at the proximal end of the distal section to a maximum of 25% at the distal end of the distal section. This configuration can provide effective sharpness.

[0022] The proximal end of the distal section, ie the transition between the distal section and the closed portion of the tubular member, may have a rounded shape, which has the advantage of facilitating penetration of the distal portion of the tubular member into deeper tissues of the body.

[0023] According to a second aspect of the present invention, and in accordance with the advantages and effects described above, there is provided a method of guiding a tubular member toward a target, the method comprising:

[0024] A tubular member is positioned near a target location, the tubular member having an inner lumen with an enclosing wall and including a distal section extending to a distal end of the tubular member, wherein the distal section is open on one side up to and including the distal end of the tubular member and closed on another side up to and including the distal end of the tubular member. The tubular member can be positioned near the target with the open side of the distal section facing any radial direction relative to the target, in which case the tubular member can be rotated until the open side of the distal section faces the target. Preferably, the tubular member is positioned with the open side of the distal section facing the target.

[0025] a core is disposed in the lumen of the tubular member, the core having a distal section, wherein the distal section is flexible and biased toward a curved shape such that the biased distal section is biased toward an open side of the distal section. The core may be disposed before or after the tubular element is disposed in proximity to the target. The core may be disposed in the lumen with its curved distal section pointing in any radial direction relative to the target, in which case the core may be rotated until the curved distal section points toward the target. Preferably, the core is disposed in proximity to the target together with the tubular element and wherein its distal end is aligned with a proximal portion of the distal section of the tubular element and wherein its curved distal section points toward the target, the core being slid in the lumen of the tubular member until its distal section extends from the distal section of the tubular member in accordance with its curved shape;

[0026] retracting the tubular member;

[0027] rotating the tubular member about the longitudinal axis so that the closed side of the distal section of the tubular member is on one side of the curved distal section of the core; and

[0028] The distal end of the tubular member is slid over the core in a distal direction.

[0029] Those skilled in the art will appreciate that the above features may be combined in any manner deemed useful. Additionally, modifications and variations described with respect to the puncture assembly are equally applicable to the method, and modifications and variations described with respect to the method are equally applicable to the puncture assembly. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] In the following, various aspects of the present invention will be described by way of example with reference to the accompanying drawings. The accompanying drawings are schematic and may not be drawn to scale. Similar items may be marked with the same reference numerals throughout the drawings.

[0031] Figure 1 A perspective view of a puncture assembly according to the present invention is shown.

[0032] Figure 2 Shown Figure 1 A stereoscopic view of the distal portion of the tubular member of the puncture assembly.

[0033] Figure 3 Shown Figure 1 A stereoscopic view of the distal portion of the core of the puncture assembly.

[0034] Figure 4A Shown Figure 1 A longitudinal cross-sectional view of a puncture assembly with the core in a retracted position.

[0035] Figure 4B Shown Figure 1 A longitudinal cross-sectional view of a puncture assembly with the core in an extended position.

[0036] Figure 5A and Figure 5B Shown respectively Figure 1 Geometric parameters of the tubular member and the core.

[0037] Figure 6A Shown Figure 2 The radial cross section of the tubular member.

[0038] Figure 6B A radial cross-section of a tubular member of a puncture assembly according to another configuration is shown.

[0039] 7A to 7D Side views of different configurations of the distal section of the tubular member are shown.

[0040] Figure 8 Examples of indicators at the distal portion and core of the tubular member are shown.

[0041] Figure 9 A puncture assembly is shown having a visual indicator at a proximal portion.

[0042] Figures 10A to 10H Various aspects of a method of guiding a tubular member toward a target are presented. DETAILED DESCRIPTION

[0043] Certain exemplary embodiments will be described in more detail with reference to the accompanying drawings. The disclosure in the specification, such as detailed construction and elements, is provided to assist in a comprehensive understanding of the exemplary embodiments. Therefore, it is apparent that the exemplary embodiments can be implemented without these specifically defined contents. In addition, well-known operations or structures are not described in detail because they would obscure the description due to unnecessary detail. Certain embodiments of the present disclosure may be used during medical procedures such as biopsy, drainage, surgery, injection, and ablation. However, the present invention is applicable to any procedure involving reaching one or more targets.

[0044] Figure 1 A perspective view of a puncture assembly 10 according to the present invention is shown. The puncture assembly 10 comprises a tubular member 20 and a core 30.

[0045] Figure 2 Shown Figure 1 2 is a perspective view of the distal portion of a tubular member 20. The tubular member 20 has a tubular body including a wall 21 enclosing an inner lumen 22. A distal section 25 extending to a distal end 23 is open on one side up to and including the distal end 23 of the tubular member 20. In the illustrated embodiment, the tubular member 10 has a beveled tip 24. The tubular member 20 can be used alone or in conjunction with a core during a medical procedure.

[0046] In certain embodiments, tubular member 20 can be substantially rigid or slightly flexible, or can have varying degrees of flexibility along its length, e.g., its distal section 25 being less rigid than its proximal portion. For example, tubular member 20 is not biased into a curved shape to effectively penetrate both superficial and deep tissue. Furthermore, tubular member 20 can have a substantially straight shape, e.g., to facilitate directing distal section 25 toward a target. For example, the wall thickness of the tubular member can be approximately 0.3 mm. In certain embodiments, such as biopsy devices, tubular member 20 can have an outer diameter of up to 3 mm. For example, in these specific embodiments, such as biopsy devices, the lumen of the tubular member can have an inner diameter of up to 2.4 mm. In alternative embodiments, the puncture assembly can be, for example, a surgical device or catheter, in which the tubular member can have an outer diameter of, for example, between 5 mm and 15 mm, preferably between 8 mm and 12 mm. For example, in these embodiments, the wall thickness can range from 0.2 mm to 2 mm.

[0047] Figure 3 Shown Figure 1 3D view of the distal portion of the core 30. In an exemplary embodiment, the core 30 has a slightly flexible elongated body with a flexible distal section 32 that is biased toward a unidirectional curved shape (i.e., the curved portion extends in a plane). Preferably, the remainder of the body of the core 30 remains unbiased. The elongated body of the core 30 can be solid or hollow. Figure 3 Shown, hollow structure can provide inner chamber for core.Such inner chamber can be used for various purposes, such as conveying fluid or providing another parts by inner chamber.In certain embodiments, the distal section 32 of core 30 can be biased towards multiple directions at its length, and this helps to arrive target under more complicated situation.In the illustrated embodiment, core 30 has the distal end 33 with beveled tip 34.

[0048] The distal section 32 of the core may be flexible so as to be able to assume a (nearly) straight shape and be disposed within the lumen 22 of the tubular member 20, as shown. Figure 4A As shown in FIG. 1 , the distal section 32 of the core 30 can be disposed within the lumen 22 of the tubular member 20, proximal to the distal section 25 of the tubular member 20. In certain embodiments, the distal section 32 can have a distal end 33 (wherein the distal end 33 can terminate at the distal tip of the core 30), which can be more rigid than the distal section 32, thereby enhancing the puncture properties of the core 30. For example, this can make it easier to use the core 30 to penetrate tissue to reach multiple targets located near the distal section 25 of the tubular member 20.

[0049] Figure 4A Shown in Figure 1 , which shows the core 30 in a retracted position inside the lumen 22 of the tubular member 20. Thus, the flexibility of the distal section 32 of the core 30 facilitates its radial and axial manipulation within the lumen 22 of the tubular member 10. Figure 4B The distal end section 32 of the core 30 is shown in a position extending from the lumen 22 of the tubular member 20. For example, the core 30 can be used when a target is located near the distal end section 25 of the tubular member 20 or when multiple targets need to be targeted sequentially. The distal end 33 of the core 30 can be at an angle θ to the longitudinal axis of the core, where θ can be between 15 and 90 degrees, preferably between 25 and 60 degrees. The flexibility of the core 30 and its distal end section 32 can be adjusted according to the axial stiffness and shape of the tubular member 10. That is, the stiffness of the wall 21 of the tubular member 20 is generally greater than the stiffness of the distal end section 32 of the core 30. In some embodiments, the core 30 can be biased as a whole into a curved shape, and its flexibility enables it to be radially and axially manipulated within the lumen 22 of the tubular member 20.

[0050] The outer diameter of the core 30 can be smaller than the inner diameter of the tubular member 20 (or the diameter of the lumen 22) to facilitate sliding and rotating the core 30 relative to the tubular member 20. In certain embodiments, when the puncture assembly is used for, for example, a biopsy, the core 30 can have an outer diameter of at most 2.7 mm, preferably at most 2.4 mm, and at least 1 mm. In alternative embodiments, when the puncture assembly is, for example, a catheter or a surgical device, the core 30 can have an outer diameter of between 3 mm and 10 mm, preferably between 6 mm and 10 mm. It should be understood that the inner and outer diameters of the tubular member 20 and the outer diameter of the core 30 can depend on their material properties and shape, and therefore the difference between the diameters can be adjusted accordingly.

[0051] Figure 5A and Figure 5B Shown respectively Figure 1 The length L1 of the distal section 25 of the tubular member 10 can control the amount of tissue fixation. The curvature R of the offset shape of the distal section 32 of the core 30 and the length L2 of the distal section 32 of the core can control the lateral distance that can be reached from the tubular element 20 by the tip 34 of the core 30.

[0052] When the core 30 is used during a medical procedure, the accessible space of its distal section 32 is defined by its curvature R and length L2. There is an interaction between L1, L2, and R that helps the puncture assembly 10 effectively reach the target. For these reasons, in certain embodiments, the ratio L1 / R between the length L1 of the distal section 25 of the tubular member 20 and the curvature R of the distal section 32 of the core 30 may be at least 0.2, preferably at least 0.4, and more preferably at least 0.8. In addition, this ratio may preferably be at most 1.2. In addition, the length L2 of the distal section 32 of the core 30 may be at least L1 / 2, preferably at least equal to L1. In certain embodiments, the entire core 30 is offset, and in principle, there is no upper limit to the length L2 of the distal section 32 of the core 30.

[0053] Figure 6A Shown Figure 2 The cross section of the distal end section 25 of the tubular member 20. In some embodiments, the distal end section 25 of the tubular member may have a semicircular cross section, such as Figures 6A to 6B As shown. Preferably, the semicircular cross-section may range from 25% to 65% of the circumference of the wall 21 of the tubular member 20, more preferably between 45% and 55%. This range firstly causes the distal end section 32 of the core 30 to be radially deflected in a direction perpendicular to the longitudinal axis of the tubular member 20, thereby facilitating the core 30 reaching the target; and secondly, this range guides the movement of the tubular member 20 over the core 32, facilitating the distal end section 25 of the tubular member 20 reaching the target.

[0054] The shape of the distal section 25 of the tubular member 20 may remain constant or vary over its length L1, for example, tapering toward the distal end, such as 7A to 7D In certain embodiments shown, these figures show side views of different configurations of the distal end section 25 of the tubular member 20. For example, in Figure 7B and Figure 7D In the embodiment shown in FIG. 1 , the percentage of the circumference of the wall 21 of the tubular member 10 that is covered by the semicircle decreases from at least 55% at the proximal end 28 of the distal section 25 to at most 25% at the distal end 23 of the distal section 25 .

[0055] In some embodiments, the transition portion 26 between the distal end section 25 and the closed portion 29 of the tubular member 20 may be rounded, such as Figure 7C and Figure 7D as shown, or have an angular shape, as Figure 7A and Figure 7B A rounded shape may be preferred because it facilitates penetration of the tubular member into deeper tissues of the body.

[0056] The tubular member 20 and the core 30 may include indicators to indicate to the user the axial and / or radial position relative to each other. This facilitates the user in operating the puncture assembly, and in particular enables the user to more accurately determine the axial and / or radial position of the distal end section 32 of the core 30 relative to the tubular member 20. In certain embodiments, such as Figure 8 As shown, an indicator 41 having a contrasting property, such as color, perceived by an imaging device may be indirectly visualized by being adjacent to the distal end portion 25 of the tubular member 20 and or core 30 .

[0057] In some embodiments, the indicator can be directly visualized by being located at the proximal portion of the tubular member and / or core. The radial indicator at the proximal portion can be a printed or engraved marking, or a graduated / tapered circular marking. For example, Figure 9 The proximal portion of the puncture assembly is shown, and the tubular member 20 and the core 30 include hubs 42 and 43 on their surfaces, respectively, and their circumferences are engraved with scales to indicate rotation around the longitudinal axis. In other embodiments, the indicator at the proximal portion of the puncture assembly can be a printed or engraved longitudinal indicator and can extend on the surface of the core, which can be engraved with scales to provide the user with information about the axial position of the distal section of the core relative to the tubular member. In other embodiments, the tubular member 20 and the core 30 can be operated by an actuator located at the proximal portion of the puncture assembly. The actuator can be controlled by a computer that is configured to plan the axial and radial trajectories of the tubular member 20 and the core 30 based on the location of one or more targets in the body.

[0058] The tubular member 20 of the present invention can be inserted to provide access to deep or superficial tissue beneath the skin. The open side of the distal section 25 of the tubular member 20 has the advantage of providing different functions, for example: first, it has puncture properties, allowing it to penetrate deep tissue in the body that may have different mechanical properties (i.e., stiffness, viscosity, etc.). Second, after insertion, it provides mechanical stability to the tissue surrounding its distal end 23, facilitating access to a target 60 located proximal thereto. Third, it provides distal and lateral access to the core 30, which facilitates access to a target located radially from the distal section 25 of the tubular member 20.

[0059] The advantage of the distal section 32 of the core 30 being biased into a curved shape is that it reaches a target located near the distal section 25 of the tubular member 20. Its flexibility enables it to adapt to the axial shape of the lumen 22 of the tubular member 20, and when the tubular member 20 is guided toward the target, it can directly hold the target 60 and ensure its position.

[0060] The distal end section 25 of the tubular member 20 can be guided to the target location 60 by following the path formed by the core 30. The tubular member 20 can be rotated so that the open side of its distal end section 25 faces in the direction opposite to the curved shape, which has the first advantage of facilitating the arrival of the tubular member 20 at its distal-most end 23 at the target location 60, thereby minimizing the amount of extension necessary to reach the target location 60. The second advantage is that as the distal end section 25 of the tubular member 20 is extended toward the target location 60, it straightens the distal end section 32 of the core 30, which prepares the various components of the puncture assembly for removal from the body together, thereby simplifying the user's operating procedure.

[0061] A second aspect of the present disclosure relates to a method of guiding a tubular member toward a target, such as Figures 10A to 10H This method can be used when a target is located near a tubular member or when multiple targets need to be tracked. For example, this method can be used in a minimally invasive medical procedure where the skin is initially punctured and the tubular member is inserted into the body. The method may include:

[0062] - inserting a tubular member 20 into the vicinity of a target 60, the tubular member 20 having a wall 21 enclosing an inner cavity 22 and including a distal section 25 extending up to a distal end 23 of the tubular member 20, wherein one side of the distal section 25 is open up to and including the distal end 23 of the tubular member 20. The tubular member 10 may be inserted such that the open sides of its distal section 25 face in opposite directions (see FIG. Figure 10A ), towards the goal (see Figure 10B ) or other directions. Preferably, the tubular member 20 is inserted in a radial orientation so that its open distal section 25 faces the target 60. Alternatively, the tubular member 20 can be rotated about the longitudinal axis so that the open side of the distal section 25 faces the target 60. The open side of the distal section 25 of the tubular member 20 has the advantage of providing different functions, for example: first, it provides puncture properties to penetrate deep tissue in the body that may have different mechanical properties (i.e., stiffness, viscosity, etc.). Second, after insertion, it provides mechanical stability to the tissue around its distal end 23, which helps to reach the target located near it with the help of the core 30. Third, it provides distal and lateral channels to facilitate access to the target located radially from its distal section 25.

[0063] - A core 30 is disposed in the lumen 22 of the tubular member 20, the core 30 having a distal section 32, wherein the distal section 32 is flexible and biased toward a curved shape. Depending on the surgical procedure, the core 30 can be disposed in the lumen 22 before or after the tubular member 20 is inserted into the body. In the first case, the distal section 32 of the core 30 can be aligned with or adjacent to the proximal end of the distal section 25 of the tubular member 20 before insertion. In any case, the core 30 can be disposed in a radial position so that its biased distal section 32 points in a direction opposite to the target (see FIG. Figure 10C ), towards the goal (see Figure 10D ) or other directions. Preferably, the core 30 is positioned before insertion into the tubular member so that its biased distal section 32 points toward the open side of the distal section 25. In this case, the core 30 can be positioned inside the closed portion of the tubular member 20 and all the way to the distal end 23 without extending into the distal section 32. Alternatively, after the step of inserting the tubular member 20, the core 20 can be rotated about the longitudinal axis, and with the core 30 positioned in the closed portion 29 of the tubular member 20, the core 30 does not substantially extend into the distal section 25 of the tubular member 20, so that its curved distal section 32 is biased toward the open side of the distal section 25. After insertion into the tubular member 20, the target 60 can be located near the distal section 25 thereof. The distal section 32 of the core 30 biased into a curved shape has the advantage of reaching a target located near the distal section of the tubular member. - Sliding the core 30 in the lumen 22 of the tubular member 20 in the distal direction until its distal section 21 extends from the distal section 25 of the tubular member 20 according to its curved shape (see Figure 10E ) until the target 60 is reached. Once the target is reached, the distal end 32 of the core 30 can selectively penetrate the target 60 and / or deliver fluid to the target 60, depending on the procedure. The distal end 32 of the core 30 can mechanically stabilize the surrounding tissue, including the target 60, simply by its presence. Depending on the procedure, for example, when targeting multiple targets, the core 30 can be retracted so that its distal end section 32 is (almost) straight in the lumen 22 of the tubular member 20. Subsequently, the core 30 can be rotated about its longitudinal axis and then extended again until the next target is reached. The steps of retracting, rotating, and extending the core 30 can be repeated in sequence until all the targeted targets have been reached.

[0064] - Retract the tubular member 20. Once the core 30 reaches the target location, the distal section 25 of the tubular member 20 can be guided toward the target 60 by first retracting the tubular member 20; the amount of retraction can be such that the distal section 25 is aligned with the core 30 (see Figure 10F ).

[0065] - rotating the tubular member 20 about the longitudinal axis, for example, by about 180 degrees, so that the curved distal section 32 of the core 30 points toward the closed side of the distal section 25 (in a semicircular shape), i.e., the open side of the distal section 25 faces in the opposite direction to the curved shape (see FIG. Figure 10G The rotation of the tubular member 20 ensures that its distal section 25 can reach the target 60 while partially influencing the curved distal section 32 of the core 30 to make its shape straighter.

[0066] - Slide the distal section 25 of the tubular member 20 on the core 30 in the distal direction. Under the guidance of the core 30, the tubular member 20 can slide in the distal direction to effectively reach the target position 60 (see Figure 10H ). Thereafter, if desired, the core 30 may be completely removed, leaving the tubular member 20 in place with its distal tip at the target location.

[0067] The step of retracting the tubular member 20 and all subsequent steps are optional. In an alternative embodiment, the step of retracting the tubular member 20 includes removing the tubular member 20, and then both steps of the method can be omitted. After this, the core 30 can be used as a guide to push any other components toward the target. Alternatively, however, a fluid or other material can be delivered to the target 60 through the optional lumen of the core 30.

[0068] The examples and embodiments described herein are intended to illustrate, not to limit, the present invention. Those skilled in the art will be able to devise alternative embodiments without departing from the spirit and scope of the present disclosure as defined by the appended claims and their equivalents. Reference signs in parentheses in the claims should not be construed as limiting the scope of the claims. Items described as independent entities in the claims, or items described in the description, may be implemented as a single item of hardware that combines the features of the items.

[0069] Certain aspects are defined in the following technical solutions.

[0070] 1. A puncture assembly (10), comprising:

[0071] a tubular member (20) having a wall (21) enclosing an inner lumen (22) and including a distal section (25) extending to a distal end (23) of the tubular member (20), wherein the distal section (25) of the tubular member (20) is open on one side up to and including the distal end (23) of the tubular member (20) and closed on another side up to and including the distal end (23) of the tubular member (20); and

[0072] A core (30) is slidably and rotatably disposed within the lumen (22) of the tubular member (20) and has a distal section (32), wherein the distal section (32) is flexible and biased toward a curved shape.

[0073] 2. A puncture assembly according to technical solution 1, wherein the distal segment (25) of the tubular member (20) has a length (L1), and the distal segment (32) of the core (30) is biased toward a curve of a radius (R), wherein the length (L1) divided by the radius (R) is at least 0.2, preferably at least 0.4.

[0074] 3. The puncture assembly according to technical solution 1, wherein the distal section (25) of the tubular member (20) has a length (L1) of approximately 5 mm to 30 mm, preferably 15 mm to 30 mm.

[0075] 4. The puncture assembly according to any of the above technical solutions, wherein the distal section (32) of the core (30) has a biased curvature, wherein the radius (R) is between 5 mm and 60 mm.

[0076] 5. The puncture assembly according to any of the above technical solutions, wherein the tubular member (20) has a beveled tip.

[0077] 6. The puncture assembly according to any of the above technical solutions, wherein the core (30) has a beveled tip.

[0078] 7. The puncture assembly according to any of the above technical solutions, wherein the core (30) is hollow.

[0079] 8. The puncture assembly according to any of the above technical solutions, wherein the wall (21) of the tubular member is rigid.

[0080] 9. The puncture assembly according to any of the above technical solutions further includes an indicator for indicating the axial position and / or radial position relative to each other.

[0081] 10. The puncture assembly according to technical solution 9, wherein the indicator is located at the proximal portion (24) of the tubular member (20) or the proximal portion (31) of the core (30).

[0082] 11. The puncture assembly according to any of the above technical solutions, wherein the cross-section of the closed side of the distal section (25) of the tubular member (20) has a semicircular shape.

[0083] 12. The puncture assembly according to technical solution 11, wherein the semicircular cross section corresponds to 25% to 65%, preferably 45% to 55% of the circumference of the tubular member (20).

[0084] 13. The puncture assembly according to technical solution 11 or 12, wherein the semicircular cross section changes over the length of the distal section (25).

[0085] 14. A puncture assembly according to technical solution 12, wherein the percentage of the circumference of the tubular member (20) covered by the semicircular cross-section gradually decreases from at least 55% at the proximal end of the distal segment (25) to a maximum of 25% at the distal end of the distal segment (25).

[0086] 15. The puncture assembly according to any of the above technical solutions, wherein, at the proximal end of the distal section (25), the transition portion (26) between the distal section (25) and the closed portion of the tubular member (20) is rounded.

[0087] 16. A method of guiding a tubular member toward a target, the method comprising:

[0088] a) arranging a tubular member (20) near a target location, the tubular member (20) having a wall (21) enclosing an inner cavity (22) and comprising a distal section (25) extending to a distal end (23) of the tubular member (20), wherein the distal section (25) is open on one side up to and including the distal end of the tubular member (20) and closed on the other side up to and including the distal end of the tubular member (20);

[0089] b) disposing a core (30) within the lumen (22) of the tubular member (20), the core (30) including a distal section (32), wherein the distal section (32) is flexible and biased toward a curved shape such that the biased distal section (32) is biased toward an open side of the distal section (25); and

[0090] c) Sliding the core (30) in the lumen (22) of the tubular member (20) until its distal section (32) extends from the distal section (25) of the tubular member (20) according to its curved shape.

[0091] 17. The method according to technical solution 16 further includes:

[0092] d) retracting the tubular member (20);

[0093] e) rotating the tubular member (20) about the longitudinal axis so that the closed side of the distal section (25) of the tubular member (20) is located on one side of the curved distal section (32) of the core (30); and

[0094] f) Sliding the tubular member (20) over the core in the distal direction.

[0095] 18. The method according to technical solution 16 or 17, wherein step a) of arranging the tubular element (20) near the target (60) further comprises:

[0096] - Rotating the tubular element (20) about the longitudinal axis so that its open distal section (25) faces the target (60).

[0097] 19. The method according to any one of technical solutions 16 to 18, wherein the step b) of arranging the core (30) in the inner cavity (22) of the tubular member (20) further comprises:

[0098] - rotating the core (30) about the longitudinal axis so that its curved distal section (32) points towards the open side of the distal section (25).

Claims

1. A puncture assembly (10), comprising: a tubular member (20) having a wall (21) enclosing an inner lumen (22) and including a distal section (25) extending to a distal end (23) of the tubular member (20), wherein the distal section (25) of the tubular member (20) is open on one side up to and including the distal end (23) of the tubular member (20) and closed on another side up to and including the distal end (23) of the tubular member (20); and A core (30) is slidably and rotatably disposed in the inner cavity (22) of the tubular member (20) and has a distal section (32), wherein the distal section (32) is flexible and biased toward a curved shape, wherein the core (30) is configured to extend laterally from the tubular member (20).

2. The puncture assembly according to claim 1, characterized in that: The distal section (25) of the tubular member (20) has a length (L1) and the distal section (32) of the core (30) is biased toward a curve having a radius (R), wherein the length (L1) divided by the radius (R) is at least 0.2, preferably at least 0.

4.

3. The puncture assembly according to claim 1, characterized in that: The distal section (25) of the tubular member (20) has a length (L1) between about 5 mm and 30 mm, preferably between 15 mm and 30 mm.

4. The puncture assembly according to any of the preceding claims, characterized in that The distal section (32) of the core (30) has an offset curvature with a radius (R) between 5 mm and 60 mm.

5. The puncture assembly according to any of the preceding claims, characterized in that The tubular member (20) has a beveled tip and / or the core (30) has a beveled tip.

6. The puncture assembly according to any one of the preceding claims, characterized in that The core (30) is hollow.

7. The puncture assembly according to any of the preceding claims, characterized in that The wall (21) of the tubular member is rigid.

8. The puncture assembly according to any of the preceding claims, further comprising an indicator for indicating the axial position and / or radial position relative to each other.

9. The puncture assembly according to claim 8, characterized in that: The indicator is located at the proximal end portion (24) of the tubular member (20) or at the proximal end portion (31) of the core (30).

10. The puncture assembly according to any of the preceding claims, characterized in that The cross-section of the closed side of the distal end section (25) of the tubular member (20) has a semicircular shape.

11. The puncture assembly according to claim 10, characterized in that: The semicircular cross section corresponds to 25% to 65%, preferably 45% to 55%, of the circumference of the tubular member (20).

12. The puncture assembly according to claim 10 or 11, characterized in that: The semicircular cross-section varies over the length of the distal section (25).

13. The puncture assembly according to any one of claims 10 to 12, characterized in that: The percentage of the circumference of the tubular member (20) covered by the semicircular cross section decreases distally from at least 55% at the proximal end of the distal section (25) to at most 25% at the distal end of the distal section (25).

14. The puncture assembly according to any of the preceding claims, characterized in that At the proximal end of the distal section (25), a transition (26) between the distal section (25) and the closed portion of the tubular member (20) is rounded.

15. A method of guiding a tubular member toward a target, the method comprising: A tubular member (20) is provided near a target, the tubular member (20) having a wall (21) enclosing an inner lumen (22) and including a distal section (25) extending to a distal end (23) of the tubular member (20), wherein the distal section (25) is open on one side up to and including the distal end of the tubular member (20) and closed on the other side up to and including the distal end of the tubular member (20); providing a core (30) in the lumen (22) of the tubular member (20), the core (30) having a distal section (32), wherein the distal section (32) is flexible and biased toward a curved shape such that the biased distal section (32) is biased toward the open side of the distal section (25); and The core (30) is slid in the lumen (22) of the tubular member (20) until its distal section (32) extends from the distal section (25) of the tubular member (20) according to its curved shape, wherein the core extends laterally from the tubular member.

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