Introducer tool and method thereof

Abstract

An introducer tool comprises a housing, a sheath detachably coupled to the housing, and a needle fixed to the housing. The housing may include a guidewire actuating mechanism configured to extend and retract a guidewire fixed to the guidewire actuating mechanism. The sheath may include a handle and, in a first configuration of an introducer tool designed for intravenous introduction of the sheath, may be detachably coupled to the housing. In the first configuration of the introducer tool, the end of the needle may extend past the end of the sheath. A method for venous access including obtaining and using the introducer tool is also disclosed.

Description

[0001] priority

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 62 / 687,440, filed on June 20, 2018, which is incorporated by reference in its entirety into this application. Background Art

[0003] There is a need for an introducer tool that safely and effectively introduces a sheath for venous access through one or more additional medical devices, including, for example, a port or catheter. Disclosed herein are introducer tools and methods thereof that address at least the aforementioned issues. Summary of the invention

[0004] A kind of introducer tool is disclosed herein, and it comprises housing, the sheath that is detachably connected to housing and the needle that is fixed to housing in some embodiments.Housing comprises guide wire actuating mechanism, and this guide wire actuating mechanism is configured to extend and retract the guide wire that is fixed to guide wire actuating mechanism.Sheath comprises handle.In the first configuration of the introducer tool of the vein introduction of configuration for sheath, sheath is detachably connected to housing.In the first configuration of introducer tool, the end of needle extends through the end of sheath.

[0005] In some embodiments, the introducer tool also includes a needle safety mechanism, which includes a needle safety housing. The needle safety housing is configured to close the end of the needle in the second configuration of the introducer tool after the intravenous introduction of the sheath. The transition of the introducer tool from the first configuration to the second configuration includes withdrawing the needle from the sheath.

[0006] In some embodiments, the sheath is a pullable sheath configured to be pulled to remove the sheath following intravenous introduction of the sheath.

[0007] In some embodiments, the sheath is a peelable sheath configured to be peeled from the handle to the end of the sheath.

[0008] In some embodiments, the sheath has a pair of longitudinal seams or weakened areas that allow the sheath to be peeled away from the handle to the end of the sheath.

[0009] In some embodiments, the sheath comprises a polymer wherein polymer chains of the polymer are longitudinally oriented such that the sheath can be peeled from the handle to the end of the sheath.

[0010] In some embodiments, the end of the needle includes a beveled section and a dilator section. The beveled section of the needle is configured to puncture tissue. The dilator section of the needle is configured to dilate the tissue after the tissue is punctured.

[0011] In some embodiments, the introducer tool further comprises a dilator configured to dilate tissue after the tissue has been punctured by the needle.

[0012] Also disclosed herein is a method for venous access, which in some embodiments includes obtaining a venous introducer tool. The introducer tool includes a housing, a sheath detachably connected to the housing, and a needle fixed to the housing. The housing includes a guide wire actuation mechanism, which is configured to extend and retract the guide wire fixed to the guide wire actuation mechanism. The sheath includes a handle. The sheath is detachably connected to the housing in the initial configuration of the introducer tool. In the initial configuration of the introducer tool, the end of the needle extends through the end of the sheath. The method also includes puncturing the patient's vein with the needle of the introducer tool to obtain venous access by means of perforation; using the guide wire actuation mechanism, the guide wire is extended into the vein through the end of the needle; and by sliding the sheath on the guide wire, the sheath is introduced into the vein.

[0013] In some embodiments, the method further comprises dilating the puncture using a dilator segment of the needle.The needle comprises a bevel segment for puncturing and a dilator segment for dilation.

[0014] In some embodiments, the method further comprises actuating a needle safety mechanism of the introducer tool.Actuating the needle safety mechanism allows for simultaneous withdrawal of the needle from the puncture and enclosing at least the bevel section of the needle in a needle safety housing of the needle safety mechanism.

[0015] In some embodiments, the method further comprises withdrawing the guidewire while leaving the sheath in place.

[0016] In some embodiments, the method further includes inserting one or more medical devices into a vein of the patient through the sheath and removing the sheath from the vein.

[0017] In some embodiments, the one or more medical devices include at least a catheter. Removing the sheath includes withdrawing the sheath from the vein while the catheter is disposed within the sheath, and peeling the sheath from a handle to an end of the sheath.

[0018] Also disclosed herein is a method for venous access, which in some embodiments includes obtaining an introducer tool. The introducer tool includes a housing, a peelable sheath detachably connected to the housing, and a needle fixed to the housing. The housing includes a guide wire actuating mechanism, which is configured to extend and retract the guide wire fixed to the guide wire actuating mechanism. The sheath is detachably connected to the housing in the initial configuration of the introducer tool. The sheath includes a handle, and the sheath is configured to be peeled off from the handle of the sheath to the end. The end of the needle includes a bevel section and a dilator section. The method also includes puncturing the vein of the patient using the bevel section of the needle of the introducer tool to obtain venous access by perforation. The end of the needle extends through the end of the sheath of the introducer tool for puncturing the vein. The method also includes dilating the puncture using the dilator segment of the needle; extending the guidewire through the end of the needle into the vein using the guidewire actuation mechanism; introducing the sheath into the vein by sliding the sheath over the guidewire; actuating the needle safety mechanism of the introducer tool; simultaneously withdrawing the needle from the puncture and enclosing at least the bevel segment of the needle in the needle safety housing of the needle safety mechanism; withdrawing the guidewire while leaving the sheath in place; inserting a catheter into the vein through the sheath; and removing the sheath from the vein. Removing the sheath includes withdrawing the sheath from the vein while the catheter is disposed within the sheath, and stripping the sheath from the handle to the end of the sheath.

[0019] In some embodiments, the sheath has a pair of longitudinal seams or weakened areas that allow the sheath to be peeled away from the handle to the end of the sheath.

[0020] In some embodiments, the sheath comprises a polymer wherein polymer chains of the polymer are oriented longitudinally along the sheath such that the sheath can be peeled away from the handle to the end of the sheath.

[0021] These and other features of the concepts provided herein will become more apparent to those skilled in the art in view of the accompanying drawings and the following description, which disclose in more detail certain embodiments of these concepts. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 An introducer tool is shown in a first configuration according to some embodiments.

[0023] Figure 2 The introducer tool is shown in a second configuration according to some embodiments.

[0024] Figure 3 The introducer tool is shown in a third configuration according to some embodiments.

[0025] Figure 4 The introducer tool is shown in a fourth configuration according to some embodiments.

[0026] Figure 5 Shown is the end of a needle of an introducer tool according to some embodiments. DETAILED DESCRIPTION

[0027] 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 can have features that can be easily separated from the specific embodiments and optionally combined with or substituted for any of the features of any of the many other embodiments disclosed herein.

[0028] About the term 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 concept 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 series or numerical restrictions.For example, "first", "second", "third" features or steps do not need to appear in order, and the specific embodiments including these features or steps do not need to be limited to these three features or steps.Marks such as "left", "right", "front", "back", "top", "bottom", "positive", "negative", "clockwise", "counterclockwise", "up", "down" or other similar terms such as "upper", "lower", "rear", "front", "vertical", "horizontal", "near side", "distal side" etc. are used for convenience, and are not intended to imply, for example, any specific fixed position, orientation or direction.On the contrary, such marks are used to reflect, for example, relative position, orientation or direction.Unless the context clearly provides otherwise, the singular "one", "a kind of" and "the" include plural references.

[0029] For example, the "proximal side", "proximal portion" or "proximal end portion" of a catheter disclosed herein includes the portion of the catheter that is intended to be close to the clinician when the catheter is used on a patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter that is intended to be close to the clinician when the catheter is used on a patient. For example, the "proximal end" of a catheter includes an end of the catheter that is intended to be close to the clinician when the catheter is used on a patient. The proximal portion, proximal portion or proximal length of a catheter may include the proximal end of the catheter; however, the proximal portion, proximal portion or proximal length of a catheter does not need to include the proximal end of the catheter. That is, unless the context otherwise indicates, the proximal portion, proximal portion or proximal length of a catheter is not the terminal portion or terminal length of a catheter.

[0030] For example, the "distal side", "distal portion" or "distal end portion" of a catheter disclosed herein includes the portion of the catheter that is intended to be near the patient or in the patient when the catheter is used on the patient. Similarly, for example, the "distal length" of a catheter includes the length of the catheter that is intended to be near the patient or in the patient when the catheter is used on the patient. For example, the "distal end" of a catheter includes an end of the catheter that is intended to be near the patient or in the patient when the catheter is used on the patient. The distal portion, distal portion or distal length of a catheter can include the distal end of the catheter; however, the distal portion, distal portion or distal length of a catheter does not need to include the distal end of the catheter. That is, unless the context otherwise indicates, the distal portion, distal portion or distal length of a catheter is not the terminal portion or terminal length of a catheter.

[0031] Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art.

[0032] Again, there is a need for an introducer tool that safely and effectively introduces a sheath for venous access through one or more additional medical devices including, for example, a port or catheter.Disclosed herein are introducer tools and methods thereof that address at least the aforementioned problems.

[0033] Introducer Tool

[0034] Figure 1-4 The introducer tool 100 is shown in a variety of different configurations according to some embodiments. Figure 1 The introducer tool 100 is shown in a first or initial configuration, with the housing 110 coupled to the sheath 120 , the guidewire G fully retracted within the needle 130 , and the end of the needle 130 extending from the sheath 120 . Figure 2 The introducer tool 100 is shown in a second configuration, wherein the housing 110 is coupled to the sheath 120 , the end of the guidewire G extends over the end of the needle 130 , and the end of the needle 130 extends from the sheath 120 . Figure 3 The introducer tool 100 is shown in a third configuration, with the sheath 120 advanced over the guidewire G, the needle 130 and guidewire G partially retracted within the sheath 120 , and the housing 110 disengaged from the sheath 120 . Figure 4 The introducer tool 100 is shown in a fourth configuration, with the housing 110 completely disengaged from the sheath 120 and the end of the needle 130 enclosed in the needle safety housing 124 . Figure 5 The end of the needle 130 of an introducer according to some embodiments is shown.

[0035] It should be understood that Figure 1-5The introducer tool 100 is shown in a simplified manner. Some features of the introducer will become more apparent to those skilled in the art from one or more references selected from US 9,872,971, US 8,932,258, US 8,998,852, US 9,950,139, US 2015 / 0119806, US 2016 / 0256667, and US 2018 / 0028780, each of which is incorporated herein by reference in its entirety.

[0036] like Figure 1-4 As shown, the introducer tool 100 may include a housing 110 , a sheath 120 detachably coupled to the housing 110 , and a needle 130 fixed to the housing 110 .

[0037] The housing 110 may include a guidewire actuation mechanism 112 configured to extend and retract a guidewire G fixed to the guidewire actuation mechanism 112. As shown, the guidewire actuation mechanism 112 may include a slidable button, etc. The guidewire actuation mechanism 112 may be similar to the guidewire advancement assembly of the catheter placement device of at least US 2018 / 0028780 in the aforementioned reference.

[0038] In at least a first configuration of the introducer tool 100, which is configured for intravenous introduction of the sheath 120, the sheath 120 can be removably coupled to the housing 110. The sheath 120 can include a handle 122. The sheath 120 can be a peelable sheath configured to be peeled off from the handle 122 to the end of the sheath 120. The sheath 120 can have a pair of longitudinal seams or weakened areas so that the sheath 120 can be peeled off from the handle 122 to the end of the sheath 120. The sheath 120 can include a polymer (e.g., expanded polytetrafluoroethylene (“ePTFE”) in which polymer chains are longitudinally oriented such that the sheath 120 can be peeled off from the handle 122 to the end of the sheath 120. The sheath 120 can include a longitudinal seam or weakened area, longitudinally oriented polymer chains, or both. That is, the sheath 120 need not be a peelable sheath. Alternatively, the sheath 120 can be a pullable sheath configured for pulling the sheath as a method for removing the sheath 120.

[0039] In the first configuration of the introducer tool 100, the end of the needle 130 may extend past the end of the sheath 120. Figure 5As shown, the end of needle 130 may include a bevel section 132 and a dilator section 134. Bevel section 132 of needle 130 is configured to puncture tissue. Dilator section 134 of needle 130 is configured to dilate tissue after the tissue is punctured. In order to allow the introduction of a sheath (e.g., sheath 120) having a diameter large enough to accommodate an 8-Fr catheter, needle 130 may be manufactured to expand from a diameter less than 8Fr proximal to the bevel section to a diameter greater than 8Fr proximal to the dilator section 134. However, needle 130 does not have to include dilator section 134. In such an embodiment, a separate dilator may be used to accommodate up to at least an 8-Fr catheter.

[0040] The introducer tool 100 may include a needle safety mechanism including a needle safety housing 124. The needle safety housing 124 may be configured to close the end of the needle 130 in another configuration (e.g., a fourth configuration) of the introducer tool 100 after intravenous introduction of the sheath 120. The needle safety housing 124 of the needle safety mechanism may be similar to the safety housing of the catheter placement device of at least US2018 / 0028780 in the aforementioned reference.

[0041] From the first configuration of the introducer tool 100 (see Figure 1 ) to a second configuration of the introducer tool 100 (see Figure 2 ) includes extension of the guidewire G. From the second configuration of the introducer tool 100 (see Figure 2 ) to the third configuration of the introducer tool 100 (see Figure 3 ) includes advancement of the sheath 120 over the needle 130 and the guidewire G. From the third configuration of the introducer tool 100 (see Figure 3 ) to the fourth configuration of the introducer tool 100 (see Figure 4 ) includes withdrawing the needle 130 from the sheath 120.

[0042] method

[0043] Also disclosed herein is a method for venous access, which in some embodiments includes obtaining an introducer tool 100; puncturing a patient's vein using a needle 130 of the introducer tool 100 to obtain venous access by means of puncture; extending a guidewire G through the end of the needle 130 into the vein using a guidewire actuator 112; and introducing the sheath 120 into the vein by sliding the sheath 120 over the guidewire G.

[0044] After puncturing a patient's vein, dilator segment 134 of needle 130 may be used to dilate the puncture or its tissue.

[0045] After sliding the sheath 120 over the guidewire G, the needle safety mechanism of the introducer tool 100 may be actuated. Actuating the needle safety mechanism allows the needle 130 to be simultaneously withdrawn from the puncture and at least the bevel section 132 of the needle 130 is enclosed in the needle safety housing 124 of the needle safety mechanism.

[0046] Upon or after withdrawing the needle 130 from the puncture, the guidewire G may be withdrawn, leaving the sheath 120 in place.

[0047] With the sheath 120 in place, one or more medical devices can be inserted into the patient's vein through the sheath 120. The one or more medical devices can include at least a port or a catheter. After the one or more medical devices are inserted into the patient's vein, the sheath 120 can be removed. Removing the sheath 120 includes withdrawing the sheath 120 from the vein while the port is disposed outside the end of the sheath 120 or the catheter is disposed within the sheath 120. Removing the sheath includes withdrawing the sheath 120 or peeling the sheath 120 from the handle 122 to the end of the sheath 120.

[0048] Although some specific embodiments have been disclosed herein, and although specific embodiments have been disclosed in detail, the specific embodiments are not intended to limit the scope of the concepts provided herein. A person of ordinary skill in the art may conceive of additional adaptations and / or modifications, and in a broader aspect, these adaptations and / or modifications are also included. Therefore, without departing from the scope of the concepts provided herein, it is possible to deviate from the specific embodiments disclosed herein.

Claims

1. An introducer tool, comprising: a housing including a guidewire actuation mechanism configured to extend and retract a guidewire to which the guidewire is secured; a sheath including a handle, the outer diameter of a portion of the sheath received into the housing being smaller than the inner diameter of the distal opening of the housing, wherein in a first configuration of the introducer tool configured for intravenous introduction of the sheath, the sheath is removably coupled to the housing; and a needle fixed to the housing; Wherein in the first configuration of the introducer tool, the end of the needle extends past the end of the sheath.

2. The introducer tool according to claim 1 further comprises a needle safety mechanism, the needle safety mechanism comprising a needle safety housing, the needle safety housing being configured to close the end of the needle in a second configuration of the introducer tool after intravenous introduction of the sheath, wherein the transition of the introducer tool from the first configuration to the second configuration comprises withdrawing the needle from the sheath.

3. The introducer tool according to any one of claims 1 or 2, wherein the sheath is a pullable sheath configured to be pulled to remove the sheath after intravenous introduction of the sheath.

4. The introducer tool according to any one of claims 1 or 2, wherein the sheath is a peelable sheath configured to be peeled from the handle to an end of the sheath.

5. The introducer tool of claim 4, wherein the sheath has a pair of longitudinal seams or weakened areas to enable the sheath to be peeled away from the handle to the end of the sheath.

6. The introducer tool of claim 4, wherein the sheath comprises a polymer whose polymer chains are longitudinally oriented such that the sheath can be peeled from the handle to the end of the sheath.

7. The introducer tool of claim 1, wherein the end of the needle comprises a bevel section and a dilator section, wherein the bevel section of the needle is configured to puncture tissue, and wherein the dilator section of the needle is configured to dilate the tissue after the tissue is punctured.

8. The introducer tool of claim 1, further comprising a dilator configured to dilate the tissue after it has been punctured by the needle.

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