Patent Application
20230277814
Central venous catheters (“CVCs”) are commonly introduced into patients and advanced through their vasculatures by way of the Seldinger technique. The Seldinger technique utilizes a number of steps and medical devices (e.g., a needle, a scalpel, a guidewire, an introducer sheath, a dilator, a CVC, etc.). While the Seldinger technique is effective, the number of steps are time consuming, handling the number of medical devices is awkward, and both of the foregoing can lead to patient trauma or increased risk of infection. There is a relatively high potential for touch contamination due to the number of medical devices that need to be interchanged during the Seldinger technique. As such, rapidly insertable central catheter (RICC) placement systems have been developed to reduce the number of steps and medical devices involved in placing a catheter, such as a CVC, into a patient.
Whether using a traditional Seldinger techniques or using catheter placement systems, often the clinician is required widen an insertion site after the vasculature has been accessed. This involves sliding a rear side, or dull side, of a scalpel along a guidewire that is stabilizing the insertion site. The sharp side of the scalpel can be facing outwards. As the scalpel is slid over the guidewire into the insertion site, the sharp edge can engage and widen the insertion site in preparation for the CVC to be advanced therethrough.
However, great skill is required to maintain contact between the scalpel tip and the guidewire, as the scalpel is slid therealong. The scalpel must be aligned perfectly with the guidewire and held firmly in place. Gaps between the scalpel and the guidewire can result in “skin bridges” being formed across the insertion site, complicating the procedure. Embodiments described herein are directed to address the foregoing.
Disclosed herein is a catheter placement system, that according to some embodiments, includes a catheter comprising including a dilation section, an access section extending distally away from the dilation section, a catheter section extending proximally away the dilation section, and a notch extending longitudinally along at least a portion of the dilation section. The system further includes a skin nicking device coupled with the catheter, where the skin nicking device includes a handle and a blade extending distally away from the handle, and where a portion of the blade is disposed within the notch. In some embodiments, the blade is removable from the notch.
In some embodiments, the catheter is a rapidly insertable central catheter and, in some embodiments, the access section is mono-luminal and the catheter section is multi-luminal.
In some embodiments, the access section defines a first outer diameter, the catheter section defines a second outer diameter greater than the first outer diameter, and the dilation section defines a tapered outer profile that includes the first outer diameter at a distal end of the dilation section and the second diameter at a proximal end of the dilation section.
In some embodiments, the notch defines a width that is less than a thickness of the blade such that the notch defines an interference fit with the blade. In some embodiments, 7 a dull edge of the blade is disposed within the notch and a sharp edge of the blade is directed radially outward from the catheter. In some embodiments, the sharp edge defines an angle with respect to a longitudinal axis of the catheter such that a distal portion of the sharp edge is closer to the longitudinal axis than a proximal portion of the sharp edge. In some embodiments, the sharp edge is parallel with an outer surface of the dilation section.
In some embodiments, a distal end of the blade is disposed radially inward of the outer surface of the dilation section. In some embodiments, the blade includes a tab extending distally from the distal end of the blade, the notch includes a cavity at a distal end of the notch, and the tap is disposed within the cavity. In some embodiments, during use, a distally oriented force applied to the handle by a clinician is transferred to the catheter via the cavity. In some embodiments, the handle extends proximally along the catheter section. In some embodiments, the notch is configured to align the blade with the longitudinal axis.
In some embodiments, the notch is formed of a slit such that upon removal of the blade from the notch, the notch transitions to a closed state, where the outer surface of the dilation section forms a continuous circumferential surface.
In some embodiments, the catheter includes an access lumen extending along the access, dilation, and catheter sections, and the access section includes a needle access port in fluid communication with the access lumen.
In some embodiments, the system further includes a needle disposed within the access lumen between the needle access port and a distal end of the catheter.
In some embodiments, the system further includes an access guidewire disposed within a lumen of the needle. In some embodiments, the system further includes an advancement guidewire disposed within the access lumen proximal access port.
Also disclosed herein is a method of placing a catheter within a vasculature of a patient that, according to some embodiments, includes (i) forming an insertion site with a needle disposed within an access lumen of an access section of catheter, where the needle is inserted through a needle access port of the access section; (ii) advancing a dilation section disposed proximal the access section into the insertion site, where the dilation section is coupled with a skin nicking device having a blade; (iii) cutting a skin adjacent the insertion site with a sharp edge of the blade during advancement of the dilation section; (iv) dilating the insertion site from a first diameter of the access section to a second diameter of a catheter section disposed proximal the dilation section during advancement of the dilation section; (v) separating the skin nicking device from the dilation section; and (vi) advancing the catheter section through the insertion site into the vasculature.
In some embodiments, the blade includes a handle, and advancing a dilation section includes applying a distally oriented force to the handle.
In some embodiments, the method further includes advancing an access guidewire through a lumen of the needle and into the vasculature, and in some embodiments, the method further includes advancing an advancement guidewire through the access lumen and into the vasculature.
In some embodiments, a portion of the blade is disposed within a notch extending along a least a portion of the dilation section, where the notch includes a cavity at a distal end thereof, and the blade includes a tab extending distally away from a distal end of the blade. In such embodiments, the tab is disposed within the cavity such that the distally oriented force applied to the handle is transferred to the catheter via the tab disposed within the cavity.
A more particular description of the present disclosure will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. Example embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein.
Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and the 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 group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.
In the following description, the terms “or” and “and/or” as used herein are to be interpreted as inclusive or meaning any one or any combination. As an example, “A, B or C” or “A, B and/or C” mean “any of the following, A, B, C, A and B, A and C, B and C, A, B and C.” An exception to this definition will occur only when a combination of elements, components, functions, steps or acts are in some way inherently mutually exclusive.
With respect to “proximal,” a “proximal portion” or a “proximal end portion” of, for example, a catheter disclosed herein includes a portion of the catheter intended to be near a clinician when the catheter is used on a patient. Likewise, a “proximal length” of, for example, the catheter includes a length of the catheter intended to be near the clinician when the catheter is used on the patient. A “proximal end” of, for example, the catheter includes an end of the catheter intended to be near the clinician when the catheter is used on the patient. The proximal portion, the proximal end portion, or the proximal length of the catheter can include the proximal end of the catheter; however, the proximal portion, the proximal end portion, or the proximal length of the catheter need not include the proximal end of the catheter. That is, unless context suggests otherwise, the proximal portion, the proximal end portion, or the proximal length of the catheter is not a terminal portion or terminal length of the catheter.
With respect to “distal,” a “distal portion” or a “distal end portion” of, for example, a catheter disclosed herein includes a portion of the catheter intended to be near or in a patient when the catheter is used on the patient. Likewise, a “distal length” of, for example, the catheter includes a length of the catheter intended to be near or in the patient when the catheter is used on the patient. A “distal end” of, for example, the catheter includes an end of the catheter intended to be near or in the patient when the catheter is used on the patient. The distal portion, the distal end portion, or the distal length of the catheter can include the distal end of the catheter; however, the distal portion, the distal end portion, or the distal length of the catheter need not include the distal end of the catheter. That is, unless context suggests otherwise, the distal portion, the distal end portion, or the distal length of the catheter is not a terminal portion or terminal length of the catheter.
Any methods disclosed herein include one or more steps or actions for performing the described method. The method steps and/or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order and/or use of specific steps and/or actions may be modified. Moreover, sub-routines or only a portion of a method described herein may be a separate method within the scope of this disclosure. Stated otherwise, some methods may include only a portion of the steps described in a more detailed method. Additionally, all embodiments disclosed herein are combinable and/or interchangeable unless stated otherwise or such combination or interchange would be contrary to the stated operability of either embodiment.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art.
To assist in the description of embodiments described herein, as shown in
The catheter 120 includes an access section 122 extending proximally away from a distal end 120A of the catheter 120, a catheter section 126 extending distally away from a catheter hub 128, and a dilation section 124 disposed between the access section 122 and the catheter section 126. The access section 122 can define a single lumen and a first outer diameter 122A. The catheter section 126 can define more than one lumen and a second outer diameter 126A, where the second outer diameter 126A is greater than the first outer diameter 122A. In the illustrated embodiment, the catheter section 126 defines three lumens. However, it will be appreciated that the catheter section 126 may define more or less than three lumens. The dilation section 124 can define a tapered outer profile having the first outer diameter 122A at a distal end of the dilation section 124 and the second outer diameter 126A at a proximal end of the dilation section 124.
The hub 128 is disposed at a proximal end of the catheter section 126 and is coupled with one or more extension legs 130 extending proximally therefrom. Each extension leg 130 can be in fluid communication with a lumen of the catheter 120. For example, a first extension leg 130A can be in fluid communication with a distal (or access) lumen 132A (see
In an embodiment, the medial lumen opening 134B can be disposed adjacent the dilation section 124 and the proximal lumen opening 134C can be disposed proximal of the medial lumen opening 134B or vice versa. In an embodiment, the medial lumen opening 134B and the proximal lumen opening 134C can be disposed equidistant from the distal lumen opening 134A. In an embodiment, one or both of the medial lumen opening 134B and the proximal lumen opening 134C can be disposed along the dilation section 124.
In an embodiment, the needle 110 can extend through a portion of the distal lumen 132A until a distal tip 112 of the needle 110 extends distally from the distal lumen opening 134A. The needle 110 can access the portion of the distal lumen 132A by way of a needle aperture 116 extending through a wall of the catheter 120 and communicating with the distal lumen 132A. As shown, the needle aperture (or needle access port) 116 can extend through a wall of the access section 122. Alternatively, the needle aperture 116 can extend through a wall of the dilation section 124 or the catheter section 126.
In an embodiment, the access guidewire 140 may inserted through the needle lumen 118 such that the access guidewire 140 is disposed within the access section 122. In some embodiments, access guidewire 140 may be configured to (i) stabilize the insertion site 90 once the needle 110 has been removed from the access section 122 and (ii) facilitate distal advancement of the access section 122. Similarly, in an embodiment, the advancement guidewire 142 may be inserted through a first extension leg 130A and into the distal lumen (or access lumen) 132A, where the advancement guidewire 142 is configured to facilitate distal advancement of the catheter section 126 along the vasculature.
Further details of catheter placement systems can be found, for example, in U.S. Pat. No. 10,376,675 and U.S. Published Applications 2019/0255294, 2021/0069471, 2021/0085927, 2021/0113809, 2021/0113810, 2021/0121661, 2021/0121667, 2021/0228843, 2021/0322729, 2021/0330941, 2021/0330942, 2021/0361915, 2021/0402153, 2021/0402149, 2022/0001138, each of which is incorporated by reference in its entirety into this application.
The system 100 further includes a skin nicking device (“device”) 150 coupled with the catheter 120. In some embodiments, the device 150 may be coupled with the dilation section 124 of the catheter 120. The device 150 includes a blade 154 coupled with a handle 152. The blade 154 extends distally away from the handle 152. In some embodiments, a proximal end of the blade 154 is supported by the handle 152. The handle 152 can include one or more gripping surfaces configured to enable a clinician to grasp the handle, e.g. between a thumb and forefinger, and to manipulate the skin nicking device 150. Optionally, the handle 152 can include one or more gripping features, such as ridges, ribs, or a second material such as silicone rubber or the like, and having a high friction coefficient.
As shown in
In an embodiment, as shown in
In an embodiment, the notch 156 can further include a recess (or cavity) 160 disposed at a distal end of the notch 156, where the recess 160 defines a lip 162. The blade 154 can further include a tab 164 extending distally from a distal end of the blade 154. The tab 164 can extend longitudinally, laterally, or at an angle therebetween. The tab 164 can engage the recess 160 and the lip 162 when the blade 154 engages the notch 156. As such, the tab 164 when disposed within the recess 160 can retain the distal end of the blade 154 within the notch 156 so that the distal end of the blade 154 is disposed radially inward of the outer surface of the dilation section 124. Furthermore, the lip 162 and tab 164 structures may co-operate to prevent skin or tissues from passing between the blade 154 and the catheter 120 during insertion, forming a skin bridge, as described in more detail herein.
Initially, the needle 110 disposed within the access section 122 of the catheter 120 can puncture a skin surface 80 and access the vasculature of a patient. The blood flash indicator system (not shown) can draw a fluid proximally through a needle lumen 118 to confirm that the needle tip 112 is correctly placed within the vasculature by observation of a fluid color (e.g., red according to blood) and/or pulsatile flow. To note, the diameter 122A of the access section 122 is less than the diameter 126A of the catheter section 126. The diameter 122A of the access section 122 is such that should the needle 110 fail to correctly access the vasculature, the needle 110 and access section 122 can be withdrawn from the insertion site 90 and the insertion site 90 can be repaired without requiring vascular surgery.
In the instance where the correct vascular access has been confirmed, the access guidewire 140 can be advanced through the needle lumen 118 and into the vasculature. The needle 110 can then be removed proximally from the distal lumen 132A by way of the needle aperture 116 (see
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Referring to
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The method 200 may further include advancing the dilation section into the insertion site (block 220), where the dilation section is coupled with the skin nicking device. The method 200 may further include cutting a skin adjacent the insertion site (block 230), where the skin is cut with the sharp edge of the blade, and where cutting a skin may take place during advancement of the dilation section into the insertion site. As the blade includes the handle, advancing a dilation section may include applying a distally oriented force to the handle. As a portion of the blade is disposed within a notch, where the notch includes the cavity at the distal end thereof, and as the blade includes the tab extending distally away from a distal end of the blade, where the tab is disposed within the cavity, the distally oriented force applied to the handle may be transferred to the catheter via the tab disposed within the cavity.
The method 200 may further include dilating the insertion site from the first diameter of the access section to the second diameter of a catheter section (block 240). The method 200 may further include separating the skin nicking device from the catheter or more specifically the dilation section (block 250). The method 200 may further include advancing the catheter section through the insertion site into the vasculature (block 260).
The method 200 may further include advancing the access guidewire through the lumen of the needle and into the vasculature (block 270), and the method 200 may further include advancing the advancement guidewire through the access lumen and into the vasculature (block 280).
While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. Additional adaptations and/or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations and/or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein.
This application claims the benefit of priority to U.S. Provisional Application No. 63/316,271, filed Mar. 3, 2022, which is incorporated by reference in its entirety into this application.
| Number | Date | Country | |
|---|---|---|---|
| 63316271 | Mar 2022 | US |
