Medical needle assembly and medical stylet

Abstract

The utility model relates to a medical needle assembly and a medical stylet. A medical needle assembly includes a stylet disposed within a needle lumen, the stylet having a non-circular cross-sectional shape. The needle and stylet each define respective electrodes that enable the probing of an electrical property of a body substance adjacent to the distal tip of the needle. An electrically insulating coating having a uniform thickness covers the stylet. The lead leads enable the electrodes to be connected to a measurement module configured to measure an electrical property of a body substance adjacent to the distal end of the needle during insertion of the needle. The electrical property measurements enable identification of the location of the needle tip within the patient based on the measurements. A major diameter of the non-circular cross-sectional shape extends across the needle lumen to create first and second flow paths extending along the lumen on opposite sides of the non-circular cross-sectional shape. The first flow path and the second flow path enable blood to flow along the lumen during use of the lumen.

Description

[0001] priority

[0002] This application claims the benefit of priority to U.S. patent application No. 18 / 135,353, filed on April 17, 2023, which is incorporated by reference in its entirety into this application. Technical Field

[0003] The present application relates to the field of medical devices, and more particularly to a medical needle assembly and a medical stylet. Background Art

[0004] In some cases, accessing the vascular system with a needle may include difficulties such as needle misplacement. Such misplacement may cause harm to the patient and requires additional time to properly place the needle, thereby increasing the cost of the procedure. A common procedure is to draw blood through the needle lumen to obtain blood flash to verify that the needle tip is placed in the blood vessel. Some needles may include a stylet inserted into the lumen of the needle, thereby creating an obstruction to the needle lumen, which prevents obtaining blood flash.

[0005] Disclosed herein are systems, devices, and methods that address the aforementioned issues. Utility Model Content

[0006] According to some embodiments, a medical needle assembly is disclosed herein, comprising a needle configured for vascular access of a patient, wherein the needle defines a needle lumen extending between a proximal end and a distal end of the needle. The assembly also includes a stylet disposed within the needle lumen, wherein the stylet includes a non-circular cross-sectional shape. The needle defines a needle electrode, and the stylet includes a stylet electrode adjacent to the distal end of the stylet. The needle electrode and the stylet electrode are configured to enable probing of electrical properties of body matter adjacent to the distal end of the needle.

[0007] In some embodiments, the stylet is formed of stainless steel, and in such embodiments, the stylet includes an electrically insulating coating extending along the length of the stylet. In some embodiments, the coating defines a uniform thickness.

[0008] In some embodiments, the non-circular cross-sectional shape extends along the entire length of the stylet. In some embodiments, the major diameter of the non-circular cross-sectional shape extends across the needle lumen, and in some embodiments, the needle lumen defines a first flow path extending along a first side of the non-circular cross-sectional shape and a second flow path extending along a second side of the non-circular cross-sectional shape, wherein the second side is opposite the first side. In some embodiments, the non-circular cross-sectional shape comprises an ellipse.

[0009] In some embodiments, the needle includes a needle lead configured to electrically couple the needle electrode to the measurement module, and the stylet includes a stylet lead configured to electrically couple the stylet electrode to the measurement module.

[0010] In some embodiments, the needle includes a hub, the hub including a fluid port in fluid communication with at least one of the first flow path or the second flow path and a stylet port, the stylet port configured to receive a stylet therethrough, wherein the stylet port together with the non-circular shape defines a fluid tight seal. In some embodiments, the stylet is configured for removal from the needle, and the stylet port includes a septum configured to define a fluid tight seal across the stylet port when the stylet is removed from the needle.

[0011] According to some embodiments, a medical stylet is also disclosed herein, comprising a non-circular cross-sectional shape extending along the stylet from the proximal end to the distal end of the stylet and an electrode adjacent to the distal end of the stylet, wherein the electrode is configured to be electronically coupled to a substance of a patient. The stylet also comprises a stylet lead configured to electrically couple the stylet electrode to a measurement module.

[0012] In some embodiments, the stylet is formed of stainless steel, and the stylet includes an electrically insulating coating extending along the length of the stylet, wherein the coating defines a uniform thickness.

[0013] In some embodiments, the stylet is configured for insertion into a lumen of a vascular access needle, and the major diameter of the non-circular shape extends across the lumen. In such embodiments, the lumen defines a first flow path extending along a first side of the non-circular shape and a second flow path extending along a second side of the non-circular shape, wherein the second side is opposite the first side.

[0014] According to some embodiments, a method for accessing a patient's vascular system is also disclosed herein, comprising providing a needle assembly, the needle assembly comprising a needle configured for vascular access of the patient, wherein the needle defines a needle lumen extending between the proximal end and the distal end of the needle. The needle assembly also includes a stylet disposed within the needle lumen. The stylet includes a non-circular cross-sectional shape. The needle defines a needle electrode, and the stylet includes a stylet electrode adjacent to the distal end of the stylet, wherein the needle electrode and the stylet electrode are configured to enable detection of electrical properties of body material adjacent to the distal end of the needle. The method also includes: (i) inserting the needle into a first position within the patient's body; (ii) obtaining a first value of an electrical property between the needle electrode and the stylet electrode, wherein the first value is defined by a first body material located at the first position; and (iii) determining the first position based on the first value of the electrical property.

[0015] In some embodiments of the method, the stylet is formed of stainless steel, and the stylet includes an electrically insulating coating extending along a length of the stylet, wherein the coating defines a uniform thickness.

[0016] In some embodiments, the method further includes: (i) inserting the needle to a second location within the patient's body, wherein the second location is different from the first location; (ii) obtaining a second value of an electrical property between the needle electrode and the stylet electrode, wherein the second value is defined by a second body substance located at the second location; and (iii) determining the second location based on the second value of the electrical property.

[0017] In some embodiments of the methods, the non-circular cross-sectional shape defines a flow path extending along the needle lumen.

[0018] In some embodiments of the method, the needle includes a hub having a fluid port in fluid communication with the flow path and a stylet port configured to receive a stylet therethrough, wherein the stylet port together with the non-circular shape defines a fluid tight seal.

[0019] In some embodiments of the method, the fluid port is coupled to the syringe via tubing, and the method further comprises drawing blood through the flow path and into the tubing, and observing the blood within the tubing to confirm placement of the needle within the vasculature.

[0020] These and other features of the concepts provided herein will become more readily apparent to those skilled in the art in view of the accompanying drawings and the following description, which describe in more detail specific embodiments of such concepts. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 A medical needle assembly including a stylet disposed within a needle lumen is shown according to some embodiments.

[0022] Figure 2 According to some embodiments Figure 1 A cross-sectional end view of a medical needle assembly.

[0023] FIG. 3A to FIG. 3C According to some embodiments, Figure 1 The distal portion of a medical needle assembly at various stages of insertion into a patient's body.

[0024] Figure 4 According to some embodiments, the Figure 1 Block diagram of a method for entering a medical needle assembly into a vascular system. DETAILED DESCRIPTION

[0025] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein may have features that can be easily separated from the specific embodiments, and these features may be optionally combined with or replace the features of any of the many other embodiments disclosed herein.

[0026] About the terms used herein, it should also be understood that these terms are for the purpose of describing some specific embodiments, and these terms do not limit the scope of the concepts provided herein.Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a set of features or steps, and do not provide sequence or numerical restrictions.For example, "first", "second" and "third" features or steps do not necessarily appear in this order, and the specific embodiments including such features or steps are not necessarily limited to these three features or steps.For convenience, using labels such as "left", "right", "top", "bottom", "front", "back", etc., these labels are not intended to imply, for example, any specific fixed position, orientation or direction.On the contrary, such labels are used to reflect, for example, relative position, orientation or direction.Singular forms of "a kind of", "one" and "the" include plural references, unless the context clearly stipulates otherwise.

[0027] The phrases "connected to," "coupled to," and "in communication with" refer to any form of interaction between two or more entities, including but not limited to mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interactions. Two components may be coupled to each other even if they are not in direct contact with each other. For example, two components may be coupled to each other through an intermediate component.

[0028] The terms "proximal" and "distal" refer to the opposite ends of a medical device, including the devices disclosed herein. More specifically, the proximal end of a medical device is the end that is closest to a practitioner during use, and the distal end of a medical device is the end or portion that is closest to a patient during use. For example, the distal end or distal portion of a catheter is the end or portion of the catheter that is disposed furthest inside the patient's body. Conversely, the proximal end or proximal portion of a catheter is the end or portion that is disposed outside the patient's body.

[0029] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art. Throughout the specification, references are made to approximate values, such as by using the term "substantially". For each such reference, it is understood that in some embodiments, values, features or characteristics may be specified without approximation. For example, where qualifiers such as "about" and "substantially" are used, these terms include within their scope the situation where the qualified word does not have its qualifier. For example, where the term "substantially straight" is described with respect to a feature, it is understood that in other embodiments, the feature may have a precisely straight configuration.

[0030] Any method disclosed herein includes one or more steps or actions for performing the described method. These method steps and / or actions can be interchangeable with each other. In other words, unless the correct operation of the embodiment requires a specific order of steps or actions, the order and / or use of specific steps and / or actions can be modified. In addition, a subroutine or only a portion of the method described herein can be a separate method within the scope of the disclosed text. In other words, some methods can include only a portion of the steps described in the more detailed method. In addition, all embodiments disclosed herein are combinable and / or interchangeable, unless otherwise stated, or such combination or interchange will be contrary to the operability of any embodiment.

[0031] Figure 1 A medical needle assembly is shown that is configured to enable a clinician to access a patient's vasculature. According to some embodiments, the medical needle assembly (assembly) 100 generally includes a needle 110 configured for insertion into a patient's body between the patient's skin surface and the vasculature and a stylet 150 disposed within a needle lumen 111 of the needle 110. The needle lumen 111 extends between a proximal end 110A and a distal end 110B of the needle 110.

[0032] The needle 110 defines an inclined needle tip 115 at the distal end 110B, and the inclined needle tip 115 defines an inclined surface 115A. The stylet 150 extends between the proximal end 150A and the distal end 150B of the stylet 150. In some embodiments, the stylet 150 can define an inclined stylet tip 155, and the inclined stylet tip 155 can also define an inclined surface 155A. In some embodiments, the inclined surface 115A of the needle 110 can be aligned with the inclined surface 155A of the stylet 150. In other embodiments, the inclined surface 155A can be recessed relative to the inclined surface 115A or can extend beyond the inclined surface 115A.

[0033] According to some embodiments, the needle 110 may include a hub 120 coupled to the needle 110 at the proximal end 110A. The hub 120 may include a fluid port 122 in fluid communication with the needle lumen 111. A tubing 123 is coupled to the fluid port 122 such that the tubing 123 is in fluid communication with the needle lumen 111. The tubing 123 includes a connector 124 configured to couple with a syringe 60. In use, a clinician may utilize the syringe 60 to draw fluid (e.g., blood) along the needle lumen 111 and draw the blood into the tubing 123 to obtain blood return.

[0034] Needle 110 defines a needle electrode 118, which is configured to electrically couple with a body substance of the patient when needle 110 is inserted into the patient. For example, needle 110 can be formed of stainless steel to define electrode 118. Stylet 150 also includes a stylet electrode 158. Stylet electrode 158 is disposed adjacent to distal end 150B of stylet 150. In some embodiments, an angled surface 155A of stylet 150 can define stylet electrode 158. Stylet electrode 158 is configured to electrically couple with a body substance adjacent to distal end 150B.

[0035] Needle 110 includes a needle lead 131 (e.g., a wire) coupled to needle electrode 118 and configured to couple to measurement module 50. Stylet 150 also includes a stylet lead 132 coupled to stylet electrode 158 and configured to couple to measurement module 50. Thus, during use, measurement module 50 can measure a value of an electrical property of body material extending between needle electrode 118 and stylet electrode 158, as described further below.

[0036] Figure 2 2 is a cross-sectional view of assembly 100 taken along section line 2-2, showing stylet 150 disposed within needle lumen 111. Stylet 150 includes a non-circular cross-sectional shape 260 to provide space for fluid to flow along needle lumen 111. In some embodiments, non-circular cross-sectional shape 260 may include an elliptical shape. In some embodiments, non-circular cross-sectional shape 260 may extend along the entire length of stylet 150 consistent with manufacturing stylet 150 via an extrusion process.

[0037] The non-circular cross-sectional shape 260 includes a major diameter 261, and in some embodiments, the major diameter 261 can extend across the needle lumen 111. In such embodiments, the major diameter 261 can define a first flow path 211A extending along a first side 262A of the stylet 150 (e.g., along the first side 262A of the non-circular cross-sectional shape 260). Similarly, the major diameter 261 can define a second flow path 211B extending along a second side 262B of the stylet 150, wherein the second side 262B is disposed opposite the first side 262A. Either or both of the first flow path 211A and the second flow path 211B can be configured for passing blood along them.

[0038] In some embodiments, the stylet 150 includes a stainless steel core 252 covered by an electrically insulating coating 254. In some embodiments, the coating 254 can be configured to ensure that only the inclined surface 155A of the stylet 150 is used as the stylet electrode 158. The coating 254 can also prevent electrical contact between the stainless steel core 252 and the needle 110. In some embodiments, the coating 254 can extend along the entire length of the stylet 150. In other embodiments, the coating 254 can extend only along a portion (or length) of the stylet 150 that is arranged within the needle lumen 111. The coating 254 can define a uniform thickness consistent with applying the coating 254 via an extrusion process. In other embodiments, instead of or in addition to the coating 254, the needle 110 may include a coating (not shown) arranged on the inner surface of the needle 110.

[0039] Although stylet 150 is described as a component of assembly 100, stylet 150 may also constitute a stand-alone device. In other words, stylet 150 may be provided separately from needle 110. Thus, a clinician may, for example, couple stylet 150 with needle 110, such as at the time of use.

[0040] FIG. 3A to FIG. 3C The distal portion of assembly 100 is shown at various stages of insertion into patient 40 . FIG. 3A to FIG. 3C A cross-sectional view of a patient 40 is shown, including, for example, layers of body tissue (or material), such as a skin layer 41, a subcutaneous tissue layer 42, and a blood vessel 43. Each of the layers 41 to 43 defines a different property, including, for example, an electrical property, such as resistivity or conductivity. Such electrical properties (or levels of electrical properties) may be determined, for example, via electrical measurements (such as impedance, capacitance, or inductance measurements). As an example, the skin layer 41 may define a first resistivity, the subcutaneous tissue layer 42 may define a second resistivity, and the blood vessel 43 (or more specifically, the blood within the blood vessel 43) may define a third resistivity, wherein the first resistivity, the second resistivity, and the third resistivity are different from each other.

[0041] Figure 3A A first example of this example is shown, in which distal end 110B of needle 110 is disposed within skin layer 41 such that needle electrode 118 and stylet electrode 158 are electrically coupled to skin layer 41 (or body matter of skin layer 41). Thus, a first resistivity of skin layer 41 defines a first impedance between needle electrode 118 and stylet electrode 158. In such a first example, measurement module 50 ( Figure 1 ) can measure a first impedance defined by a first resistivity, thereby determining or identifying that the position of the distal end 110B is within the skin layer 41.

[0042] Figure 3B A second example of this example is shown, in which the distal end 110B of the needle 110 is disposed within the subcutaneous layer 42 such that the needle electrode 118 and the stylet electrode 158 are electrically coupled to the subcutaneous layer 42 (or body matter of the subcutaneous layer 42). Thus, the second resistivity of the subcutaneous layer 42 defines a second impedance between the needle electrode 118 and the stylet electrode 158. In such a second example, the measurement module 50 ( Figure 1 ) can measure a second impedance defined by a second resistivity to determine or identify that the position of the distal end 110B is within the subcutaneous layer 42.

[0043] Figure 3C A third example of this example is shown, in which distal end 110B of needle 110 is disposed within blood vessel 43 such that needle electrode 118 and stylet electrode 158 are electrically coupled to blood vessel 43 (or blood within blood vessel 43). Thus, a third resistivity of blood vessel 43 defines a third impedance between needle electrode 118 and stylet electrode 158. In such a third example, measurement module 50 ( Figure 1 ) can measure a third impedance defined by a third resistivity, thereby determining or identifying that the position of the distal end 110B is within the blood vessel 43.

[0044] Figure 4 A block diagram of an exemplary method 400 for accessing a patient's vascular system is shown, and according to some embodiments, the method may include all or any subset of the following steps, actions or processes. Method 400 may include providing a needle assembly (frame 410), wherein the needle assembly includes a needle configured for vascular access of a patient, and wherein the needle defines a needle lumen extending between the proximal end and the distal end of the needle. The needle assembly also includes a stylet disposed within the needle lumen, wherein the stylet includes a non-circular cross-sectional shape. The needle defines a needle electrode, and the stylet includes a stylet electrode adjacent to the distal end of the stylet, wherein the needle electrode and the stylet electrode are configured to enable probing of electrical properties of body matter adjacent to the distal end of the needle. In some embodiments of method 400, the non-circular cross-sectional shape defines a flow path extending along the needle lumen.

[0045] The method 400 may also include inserting the needle into a first location in the patient's body (block 420). The method 400 may also include obtaining a first value of an electrical property between the needle electrode and the stylet electrode (i.e., measuring a first electrical property of a first layer of body material) (block 430). The method 400 may also include determining (or identifying) a first location based on the first value of the electrical property (block 440).

[0046] In some embodiments of method 400, the stylet is formed of stainless steel, and the stylet includes an electrically insulating coating extending along a length of the stylet, wherein the coating defines a uniform thickness.

[0047] The method 400 may also include inserting the needle to a second location in the patient (block 450), wherein the second location is different from the first location. The method 400 may also include obtaining a second value of an electrical property between the needle electrode and the stylet electrode (block 460), wherein the second value is defined by a second body substance located at the second location. The method 400 may also include determining a second location based on the second value of the electrical property (block 470).

[0048] In some embodiments of method 400, the needle includes a hub having a fluid port in fluid communication with the flow path and a stylet port configured to receive a stylet therethrough, wherein the stylet port together with the non-circular shape defines a fluid tight seal.

[0049] In some embodiments of method 400, the fluid port is connected to the syringe via tubing, and method 400 may also include drawing blood through a flow path between the stylet and the needle (block 480) and into the tubing, and observing the blood within the tubing to confirm that the needle is placed within the vascular system.

[0050] Although some specific embodiments have been disclosed herein, and although these specific embodiments have been disclosed in considerable detail, these specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications may be envisioned by those of ordinary skill in the art, and in broader aspects, these adaptations and / or modifications are also encompassed. Therefore, changes may be made to the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. A medical needle assembly, characterized in that: include: a needle configured for vascular access of a patient, the needle defining a needle lumen extending between a proximal end and a distal end of the needle; a stylet disposed within the needle lumen, the stylet comprising a non-circular cross-sectional shape, in: The needle defines a needle electrode, The stylet includes a stylet electrode adjacent a distal end of the stylet, and The needle electrode and the stylet electrode are configured to enable probing of electrical properties of body material adjacent the distal end of the needle.

2. The medical needle assembly according to claim 1, characterized in that The stylet is formed from stainless steel.

3. The medical needle assembly according to claim 1 or 2, characterized in that: The stylet includes an electrically insulating coating extending along the length of the stylet.

4. The medical needle assembly according to claim 3, characterized in that The coating defines a uniform thickness.

5. The medical needle assembly according to claim 1, characterized in that The non-circular cross-sectional shape extends along the entire length of the stylet.

6. The medical needle assembly according to claim 1, characterized in that The major diameter of the non-circular cross-sectional shape extends across the needle lumen.

7. The medical needle assembly according to claim 1, characterized in that The needle lumen defines: a first flow path extending along a first side of the non-circular cross-sectional shape, and A second flow path extends along a second side of the non-circular cross-sectional shape, the second side being opposite the first side.

8. The medical needle assembly according to claim 1, characterized in that The non-circular cross-sectional shape includes an elliptical shape.

9. The medical needle assembly according to claim 1, characterized in that: The needle includes a needle lead configured to electrically couple the needle electrode to a measurement module, and The stylet includes a stylet lead configured to electrically couple the stylet electrode to the measurement module.

10. The medical needle assembly according to claim 7, characterized in that The needle includes a hub, the hub comprising: a fluid port in fluid communication with at least one of the first flow path or the second flow path, and A stylet port is configured to receive the stylet therethrough, the stylet port together with the non-circular cross-sectional shape defining a fluid tight seal.

11. The medical needle assembly according to claim 10, characterized in that: The stylet is configured for removal from the needle, and The stylet port includes a septum configured to define a fluid tight seal across the stylet port when the stylet is removed from the needle.

12. A medical stylet, characterized in that: include: a non-circular cross-sectional shape extending along the stylet from the proximal end to the distal end of the stylet, an electrode adjacent the distal end of the stylet, the electrode being configured to electronically couple with a substance in a patient, and A stylet lead is configured to electrically couple the stylet electrode to a measurement module.

13. The medical stylet according to claim 12, characterized in that: The stylet is formed of stainless steel. The stylet includes an electrically insulating coating extending along a length of the stylet, and The coating defines a uniform thickness.

14. The medical stylet according to claim 12 or 13, characterized in that: The stylet is configured for insertion into a lumen of a vascular access needle, the major diameter of the non-circular cross-sectional shape extending across the lumen, and The inner cavity defines: a first flow path extending along a first side of the non-circular cross-sectional shape, and A second flow path extends along a second side of the non-circular cross-sectional shape, the second side being opposite the first side.

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