Scalpel blade, scalpel, scalpel assembly, and method thereof

Abstract

The scalpel blade, scalpel, scalpel assembly, and methods thereof may be configured to reduce or eliminate skin bridging resulting from skin incisions, such as when enlarging an insertion site for a catheter. For example, the scalpel blade may include a cutting edge and a trailing edge, and the trailing edge may include a pair of guidewire clips configured to clip onto a guidewire. The cutting edge may terminate at a blade tip at a distal end of the scalpel blade. The pair of guidewire clips may be configured to clip onto a guidewire with sufficient clearance to slidably guide the scalpel blade along the guidewire when cutting the patient's skin and fascia around an insertion site established by a percutaneous puncture. The scalpel and scalpel assembly may include an exemplary scalpel blade. The method may include a method using any of the scalpel blades, scalpels, or scalpel assemblies disclosed herein.

Description

[Technical field]

[0001] The present disclosure relates to scalpel blades, scalpels, scalpel assemblies, and methods thereof. [Background technology]

[0002] Insertion of a central venous catheter ("CVC") into a patient is a multi-step process. For example, a selected insertion site is percutaneously punctured with a needle, thereby establishing a needle pathway from the area of ​​skin to the lumen of the blood vessel, and then a guidewire is inserted through the needle into the lumen of the blood vessel. The needle is then removed, leaving the guidewire in place. At this point, to facilitate insertion of the CVC, a skin incision is typically made using a scalpel to cut both the skin and fascia around the insertion site. Such an incision is made with a conventional scalpel by placing the trailing edge of the scalpel blade over the guidewire and penetrating the skin and fascia with the tip of the scalpel blade to create a larger hole. However, making such an incision cleanly with a scalpel requires considerable skill and practice. In fact, the trailing edge of the scalpel blade must be held firmly against the guidewire without lifting it off the guidewire to ensure that the skin and fascia extending immediately away from the guidewire are incised, rather than the skin and fascia surrounding the guidewire. Otherwise, another percutaneous puncture will occur with a so-called skin bridge between the percutaneous puncture established by the needle, which may become caught between the guidewire and the catheter tip of the CVC, causing unnecessary trauma.In view of the above, there is a need for skin cutting means and methods to facilitate a clean skin incision around the insertion site, at least for the insertion of a CVC into a patient.

[0003] Disclosed herein are scalpel blades, scalpel assemblies, and methods that address at least the aforementioned needs. Summary of the Invention

[0004] Disclosed herein, in some embodiments, is a scalpel blade including a cutting edge and a trailing edge including a pair of guidewire clips configured to clip onto a guidewire, the cutting edge terminating in a blade tip at a distal end of the scalpel blade, the pair of guidewire clips configured to clip onto the guidewire with sufficient clearance to slidably guide the scalpel blade along the guidewire as it incises the patient's skin and fascia around an insertion site established by a percutaneous puncture.

[0005] In some embodiments, a pair of guidewire clips are positioned under or along the sides of the trailing edge of the scalpel blade. In some embodiments, each clip of the pair of guidewire clips includes an opening that opens toward the trailing edge of the scalpel blade and away from the side of the scalpel blade opposite the other clip of the pair of guidewire clips.

[0006] In some embodiments, each clip of the pair of guidewire clips has a transverse cross-section that is approximately a three-quarter sector of a circle. In some embodiments, each clip of the pair of guidewire clips includes an opening that opens along a side of the scalpel blade or on the same side of the scalpel blade but on opposite sides thereof, and each clip of the pair of guidewire clips is mutually exclusive with respect to its opening with the other clip of the pair of guidewire clips.

[0007] In some embodiments, each clip of the pair of guidewire clips is approximately semicircular in transverse cross-section. In some embodiments, each clip of the pair of guidewire clips is sufficiently spaced along the trailing edge of the scalpel blade from the other clip of the pair of guidewire clips such that when the guidewire is loaded into each clip of the pair of guidewire clips, the guidewire can easily straddle the trailing edge of the scalpel blade without significantly bending the guidewire.

[0008] In some embodiments, when the guidewire is loaded into a pair of guidewire clips, the guidewire is coaxial with the guidewire clips. In some embodiments, the guidewire is sufficiently coaxial with a pair of guidewire clips to rotate a scalpel blade about the guidewire to a desired rotational angle to incise the patient's skin and fascia around the insertion site.

[0009] In some embodiments, the scalpel blade further includes a handle attachment slot configured to attach a scalpel handle to the scalpel blade to form a scalpel. Also disclosed herein, in some embodiments, is a scalpel including a scalpel handle and a scalpel blade coupled to the scalpel handle. The scalpel blade includes a cutting edge and a trailing edge including a pair of guidewire clips configured to clip onto a guidewire. The cutting edge terminates in a blade tip at a distal end of the scalpel blade. The pair of guidewire clips are configured to clip onto the guidewire with sufficient clearance to slidably guide the scalpel along the guidewire as it incises the patient's skin and fascia around an insertion site established by a percutaneous puncture.

[0010] In some embodiments, the scalpel handle includes a blade mounting fixture and the scalpel blade further includes a handle mounting slot. The blade mounting fixture is disposed within the handle mounting slot to couple the scalpel blade to the scalpel handle.

[0011] In some embodiments, a pair of guidewire clips are positioned under or along the sides of the trailing edge of the scalpel blade. In some embodiments, each clip of the pair of guidewire clips includes an opening that opens toward the trailing edge of the scalpel blade and away from the side of the scalpel blade opposite the other clip of the pair of guidewire clips.

[0012] In some embodiments, each clip of the pair of guidewire clips has a transverse cross-section that is approximately a three-quarter sector of a circle. In some embodiments, each clip of the pair of guidewire clips includes an opening that opens along a side of the scalpel blade or on the same side of the scalpel blade but on opposite sides thereof, and each clip of the pair of guidewire clips is mutually exclusive with respect to its opening with the other clip of the pair of guidewire clips.

[0013] In some embodiments, each clip of the pair of guidewire clips is approximately semicircular in transverse cross-section. In some embodiments, each clip of the pair of guidewire clips is sufficiently spaced along the trailing edge of the scalpel blade from the other clip of the pair of guidewire clips such that when the guidewire is loaded into each clip of the pair of guidewire clips, the guidewire can easily straddle the trailing edge of the scalpel blade without significantly bending the guidewire.

[0014] In some embodiments, when the guidewire is loaded into a pair of guidewire clips, the guidewire is coaxial with the guidewire clips. In some embodiments, the guidewire is sufficiently coaxial with a pair of guidewire clips to rotate the scalpel around the guidewire to a desired angle of rotation to incise the patient's skin and fascia around the insertion site.

[0015] Also disclosed herein, in some embodiments, is a scalpel assembly including a guidewire, a scalpel handle, and a scalpel blade coupled to the scalpel handle to form a scalpel. The scalpel blade includes a cutting edge and a trailing edge including a pair of guidewire clips that are clipped to the guidewire. The cutting edge terminates in a blade tip at a distal end of the scalpel blade. The pair of guidewire clips are clipped to the guidewire with sufficient clearance to slidably guide the scalpel along the guidewire as it incises the patient's skin and fascia around an insertion site established by a percutaneous puncture.

[0016] In some embodiments, the scalpel handle includes a blade mounting fixture and the scalpel blade further includes a handle mounting slot. The blade mounting fixture is disposed within the handle mounting slot to couple the scalpel blade to the scalpel handle.

[0017] In some embodiments, a pair of guidewire clips are positioned under or along the sides of the trailing edge of the scalpel blade. In some embodiments, each clip of the pair of guidewire clips includes an opening that opens toward the trailing edge of the scalpel blade and away from the side of the scalpel blade opposite the other clip of the pair of guidewire clips.

[0018] In some embodiments, each clip of the pair of guidewire clips has a transverse cross-section that is approximately a three-quarter sector of a circle. In some embodiments, each clip of the pair of guidewire clips includes an opening that opens along a side of the scalpel blade or on the same side of the scalpel blade but on opposite sides thereof, and each clip of the pair of guidewire clips is mutually exclusive with respect to its opening with the other clip of the pair of guidewire clips.

[0019] In some embodiments, each clip of the pair of guidewire clips is approximately semicircular in transverse cross-section. In some embodiments, each clip of the pair of guidewire clips is sufficiently spaced along the trailing edge of the scalpel blade from the other clip of the pair of guidewire clips such that when the guidewire is loaded into each clip of the pair of guidewire clips, the guidewire can easily straddle the trailing edge of the scalpel blade without significantly bending the guidewire.

[0020] In some embodiments, when the guidewire is loaded into a pair of guidewire clips, the guidewire is coaxial with the guidewire clips. In some embodiments, the guidewire is sufficiently coaxial with a pair of guidewire clips to rotate the scalpel around the guidewire to a desired angle of rotation to incise the patient's skin and fascia around the insertion site.

[0021] A method for inserting a catheter into a vascular lumen of a patient is also disclosed. The method, in some embodiments, includes a needle path establishment step, a guidewire insertion step, a needle removal step, a skin cutting step, a scalpel blade removal step, and a catheter insertion step. The needle path establishment step includes establishing a needle path from an area of ​​the patient's skin to the vascular lumen with a needle at an insertion site selected for inserting the catheter. The guidewire insertion step includes inserting a guidewire through the needle into the vascular lumen. The needle removal step includes removing the needle from the needle path leaving the guidewire in place in the vascular lumen. The skin cutting step includes cutting the patient's skin and fascia around the insertion site with a scalpel blade guided along the guidewire. The scalpel blade includes a cutting edge and a trailing edge including a pair of guidewire clips that are clipped to the guidewire. The cutting edge terminates at a blade tip at a distal end of the scalpel blade. The pair of guidewire clips are clipped to the guidewire with sufficient clearance to slidably guide the scalpel blade along the guidewire during the skin cutting step. The scalpel blade removing step includes removing the scalpel blade from the guidewire, and the catheter inserting step includes inserting a catheter into the blood vessel lumen over the guidewire.

[0022] In some embodiments, the method further includes a guidewire loading step including loading a guidewire into a pair of guidewire clips of the scalpel blade by rotating the scalpel blade and, for each clip of the pair of guidewire clips, positioning a guidewire within an opening of each clip of the pair of guidewire clips.

[0023] In some embodiments, the opening of each clip of the pair of guidewire clips opens toward the trailing edge of the scalpel blade and away from the side of the scalpel blade opposite the other clip of the pair of guidewire clips.

[0024] In some embodiments, each clip of the pair of guidewire clips has a transverse cross-section that is approximately a three-quarter sector of a circle. In some embodiments, the opening of each clip of the pair of guidewire clips opens along a side of the scalpel blade or on the same side of the scalpel blade but on opposite sides thereof, and each clip of the pair of guidewire clips is mutually exclusive with respect to its opening with the other clip of the pair of guidewire clips.

[0025] In some embodiments, each clip of the pair of guidewire clips is approximately semicircular in transverse cross-section. In some embodiments, the scalpel blade removal step includes removing the guidewire from the pair of guidewire clips of the scalpel blade by rotating the scalpel blade and, for each clip of the pair of guidewire clips, pulling the guidewire out of an opening in each clip of the pair of guidewire clips.

[0026] In some embodiments, the scalpel blade removal step includes withdrawing the scalpel blade over the proximal end of the guidewire. In some embodiments, the method further includes a scalpel forming step, which includes coupling the scalpel blade to the scalpel handle by inserting a blade mounting fixture of the scalpel handle into a handle mounting slot of the scalpel blade to form the scalpel.

[0027] In some embodiments, the method further includes a scalpel blade rotating step, which includes rotating the scalpel blade or scalpel about the guidewire to a desired rotation angle to incise the patient's skin and fascia about the insertion site, the guidewire being sufficiently coaxial with the pair of guidewire clips to rotate the scalpel or scalpel about the guidewire.

[0028] These and other features of the concepts provided herein will become more apparent to those of ordinary skill in the art in view of the accompanying drawings and following description, which describe in more detail certain embodiments of such concepts. [Brief description of the drawings]

[0029] [Figure 1] 13A-13C illustrate a scalpel blade when clipped to a guidewire with a first pair of guidewire clips, according to some embodiments. [Diagram 2] 1A illustrates a distal end of a scalpel blade when clipped to a guidewire with a first pair of guidewire clips, according to some embodiments. [Diagram 3] FIG. 13 is a perspective view from a proximal end of a scalpel blade when clipped to a guidewire with a first pair of guidewire clips, according to some embodiments. [Figure 4] FIG. 13 is a perspective view from a distal end of a scalpel blade when clipped to a guidewire with a first pair of guidewire clips, according to some embodiments. [Diagram 5] FIG. 13 is a detailed side view of a scalpel blade when clipped to a guidewire with a first pair of guidewire clips, according to some embodiments. [Figure 6] FIG. 13 illustrates a scalpel blade having a second pair of guidewire clips, according to some embodiments. [Figure 7A] FIG. 13 is a simplified distal end view of a scalpel blade and a distal guidewire clip of a first pair of guidewire clips, according to some embodiments. [Figure 7B]FIG. 13 is a simplified proximal end view of a scalpel blade and a proximal guidewire clip of a first pair of guidewire clips, according to some embodiments. [Figure 8A] FIG. 13 is a simplified distal end view of a scalpel blade and a distal guidewire clip of a first pair of guidewire clips, according to some other embodiments. [Figure 8B] FIG. 13 is a simplified proximal end view of a scalpel blade and a proximal guidewire clip of a first pair of guidewire clips, according to some other embodiments. [Figure 9A] FIG. 13 is a simplified distal end view of a scalpel blade and a distal guidewire clip of a second pair of guidewire clips, according to some embodiments. [Figure 9B] FIG. 13 is a simplified proximal end view of a scalpel blade and a proximal guidewire clip of a second pair of guidewire clips, according to some embodiments. [Figure 10] FIG. 1 illustrates a scalpel including a scalpel blade coupled to a scalpel handle with the scalpel blade clipped to a guidewire with a first pair of guidewire clips, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0030] Before some specific embodiments are disclosed 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 embodiment and can be combined or substituted in any way with any of the other several embodiments disclosed herein.

[0031] With regard to the terms used herein, it should also be understood that the terms are intended to describe certain particular embodiments, and that 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 within a group of features or steps, and do not provide sequentiality or numerical limitations. For example, the "first," "second," and "third" features or steps need not appear in that order, nor need a particular embodiment that includes such features or steps be limited to those three features or steps. In addition, any of the features or steps described above can further include one or more features or steps, unless otherwise indicated. Designations such as "left," "right," "top," "bottom," "front," "rear," and similar terms are used for convenience and are not intended to imply, for example, a particular fixed position, orientation, direction, etc. Rather, such designations are used to reflect, for example, a relative position, orientation, direction, etc. The singular forms "a," "an," and "the" include plural references unless the context clearly indicates a singular number.

[0032] With respect to "proximal," a "proximal portion" or "proximal section," e.g., of a scalpel, includes the portion or section of the scalpel that is intended to be near the clinician when the scalpel is used on a patient. Similarly, a "proximal length," e.g., of a scalpel, includes the length of the scalpel that is intended to be near the clinician when the scalpel is used on a patient. A "proximal end," e.g., of a scalpel, includes the end of the scalpel that is intended to be near the clinician when the scalpel is used on a patient. The proximal portion, section, or length of the scalpel may include the proximal end of the scalpel. However, the proximal portion, section, or length of the scalpel does not necessarily include the proximal end of the scalpel. That is, unless the context suggests otherwise, the proximal portion, section, or length of the scalpel is not the terminal portion or length of the scalpel.

[0033] With respect to "distal," a "distal portion" or "distal section," e.g., of a scalpel, includes the portion or section of the scalpel that is intended to be near or on a patient when the scalpel is used on a patient. Similarly, a "distal length," e.g., of a scalpel, includes the length of the scalpel that is intended to be near or on a patient when the scalpel is used on a patient. A "distal end," e.g., of a scalpel, includes the end of the scalpel that is intended to be near or on a patient when the scalpel is used on a patient. A distal portion, section, or length of a scalpel may include the distal end of the scalpel. However, a distal portion, section, or length of a scalpel does not necessarily include the distal end of the scalpel. That is, unless the context suggests otherwise, a distal portion, section, or length of a scalpel is not a terminal portion or length of the scalpel.

[0034] Unless defined otherwise, all technical or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

[0035] As mentioned above, the insertion of a CVC into a patient is a multi-step process. For example, a selected insertion site is percutaneously punctured with a needle, thereby establishing a needle pathway from the area of ​​skin to the lumen of the blood vessel, and then a guidewire is inserted through the needle into the lumen of the blood vessel. The needle is then removed, leaving the guidewire in place. At this point, to facilitate the insertion of the CVC, a skin incision is typically made using a scalpel to cut both the skin and fascia around the insertion site. Such an incision is made with a conventional scalpel by placing the trailing edge of the scalpel blade against the guidewire and piercing the skin and fascia with the tip of the scalpel blade to create a larger hole. However, making such an incision cleanly with a scalpel requires considerable skill and practice. In fact, the trailing edge of the scalpel blade must be held firmly against the guidewire without lifting it off the guidewire to ensure that the skin and fascia extending immediately away from the guidewire are incised, rather than the skin and fascia surrounding the guidewire. Otherwise, another percutaneous puncture will occur with a so-called skin bridge between the percutaneous puncture established by the needle, which may become caught between the guidewire and the catheter tip of the CVC, causing unnecessary trauma.In view of the above, there is a need for skin cutting means and methods to facilitate a clean skin incision around the insertion site, at least for the insertion of a CVC into a patient.

[0036] Disclosed herein are scalpel blades, scalpels, scalpel assemblies, and methods thereof for reducing or eliminating skin bridging resulting from skin incisions, such as when enlarging an insertion site for a catheter. For example, the scalpel blade can include a cutting edge and a trailing edge, and the trailing edge can include a pair of guidewire clips configured to clip onto a guidewire. The cutting edge can terminate at a blade tip at a distal end of the scalpel blade. The pair of guidewire clips can be configured to clip onto a guidewire with sufficient clearance to slidably guide the scalpel blade along the guidewire when incising the patient's skin and fascia around an insertion site established by a percutaneous puncture. The scalpel and scalpel assembly can include an exemplary scalpel blade. The method can include using any of the scalpel blades, scalpels, or scalpel assemblies disclosed herein.

[0037] Scalpel blade 1-6, 7A, 7B, 8A, 8B, 9A, and 9B show various views of a scalpel blade 100, according to some embodiments.

[0038] As shown, scalpel blade 100 includes a sharp cutting edge or cutting tip 102 and a blade ridge or trailing edge 104. Optionally, scalpel blade 100 further includes a handle attachment slot 106. Such scalpel blades may be formed from surgical steel.

[0039] The cutting edge 102 terminates in a blade tip 108 at the distal end of the scalpel blade 100 . Trailing edge 104 includes a pair of guidewire clips 110 configured to clip onto a guidewire 112. However, it should be understood that trailing edge 104 is not limited to a pair of guidewire clips 110. Indeed, trailing edge 104 may include a single guidewire clip or a set of three or more guidewire clips, optionally having alternating openings such as those of a pair of guidewire clips 110 described below.

[0040] The pair of guidewire clips 110 may be positioned below the trailing edge 104 of the scalpel blade 100 (see FIGS. 7A and 7B) or along the side of the trailing edge 104 of the scalpel blade 100 (see FIGS. 8A and 8B, or 9A or 9B). The pair of guidewire clips 110 are configured to clip onto the guidewire 112 with sufficient clearance to slidably guide the scalpel blade 100 over or along the guidewire 112 as it incises the patient's skin and fascia around an insertion site established by a percutaneous puncture. In effect, the pair of guidewire clips 110 help the clinician hold the scalpel blade 100 flush against such guidewire during incision, thereby reducing or even eliminating the occurrence of skin bridging when dilating an insertion site for a CVC or some other medical device.

[0041] Each clip of the pair of guidewire clips 110 includes an opening 114 that opens in an opposite direction from the other clip of the pair of guidewire clips 110. In one example, each clip of the pair of guidewire clips 110 can include an opening 114 configured to open toward the trailing edge 104 of the scalpel blade 100 and away from the side of the scalpel blade 100 opposite the other clip of the pair of guidewire clips 110, as shown at least in Figures 7A and 7B. In another example, each clip of the pair of guidewire clips 110 can include an opening 114 configured to open toward one side of the scalpel blade 100 or toward the opposite side of the same side of the scalpel blade 100, as shown in Figures 8A and 8B. In another example, each clip of the pair of guidewire clips 110 can include an opening 114 configured to open along a side of the scalpel blade 100 or toward the opposite side of the same side of the scalpel blade 100, as shown in Figures 9A and 9B. In the above-described configuration, each clip of the pair of guidewire clips 110 is mutually exclusive with the other clip of the pair of guidewire clips 110 with respect to its opening 114. In such a configuration, the path of disengagement of the guidewire 112 is a tortuous path, which ensures that the scalpel blade 100 remains clipped to the guidewire 112 after it has been clipped to the guidewire 112, as shown in FIGS. 1-5. In particular, the guidewire 112 is loaded from both sides of the scalpel blade 100, as described in the guidewire loading step of the method described below. For this reason, each clip of the pair of guidewire clips 110 is sufficiently spaced along the trailing edge 104 of the scalpel blade 100 from the other clip of the pair of guidewire clips 110 so that the guidewire 112 can easily straddle the trailing edge 104 of the scalpel blade 100 without significantly bending the guidewire 112 as the guidewire 112 is loaded into or withdrawn from each clip of the pair of guidewire clips 110.Such a configuration of the pair of guidewire clips 110 is noteworthy with respect to loading or unloading the guidewire relative to the guidewire clip, since excessive bending of the guidewire 112 can result in kinking of the guidewire 112. Furthermore, excessive manipulation of the guidewire 112 can result in dislodging the guidewire 112 from the patient's vascular lumen, which may require another percutaneous puncture to gain access to the vascular lumen with the guidewire 112.

[0042] The pair of guidewire clips 110 may be "C" shaped clips ranging from approximately a semicircular cross section to approximately a three-quarter sector of a circle cross section. When the guidewire 112 is loaded into the pair of guidewire clips 110, the guidewire 112 is coaxial with the pair of guidewire clips 110. In fact, the guidewire 112 is sufficiently coaxial with the pair of guidewire clips 110 to rotate the scalpel blade 100, or scalpel 116 when the scalpel blade 100 is coupled to a scalpel handle 118, described below, about the guidewire 112 to a desired angle of rotation to incise the patient's skin and fascia around the insertion site.

[0043] Each clip of the pair of guidewire clips 110 may be metal or a plastic such as a thermoplastic. If the pair of guidewire clips 110 is metal, the pair of guidewire clips 110 may be die cut together with the scalpel blade 100 and machined to the desired shape such that the pair of guidewire clips 110 is integral with the remainder of the scalpel blade 100. Alternatively, the pair of guidewire clips 110 may be die cut separately from the scalpel blade 100, machined to the desired shape, and coupled to the scalpel blade 100, such as by welding (e.g., micro welding, laser welding, etc.) or riveting through holes die cut or drilled in both the scalpel blade 100 and the pair of guidewire clips 110. If the pair of guidewire clips 110 is plastic, the pair of guidewire clips 110 may be molded such that each clip of the pair of guidewire clips 110 includes a roll-up or meltable rivet shank extending therefrom in addition to being appropriately shaped. Such roll-up or meltable rivet shanks can be inserted into corresponding through holes die-cut or drilled in the scalpel blade 100 and either rolled up, for example using a rivet press, or melted, for example using a sonotrode of an ultrasonic welding machine, respectively.

[0044] The handle attachment slot 106 is configured to attach a scalpel handle 118 to the scalpel blade 100 to form a scalpel 116, described below. Such a handle attachment slot may be die cut along with the scalpel blade 100.

[0045] Scalpel FIG. 10 illustrates a scalpel 116, according to some embodiments. As shown, the scalpel 116 includes a scalpel handle 118 and a scalpel blade 100 coupled to the scalpel handle 118 .

[0046] The scalpel handle 118 includes a blade mounting fixture 120. The blade mounting fixture 120 is configured to be disposed within the handle mounting slot 106, such as by being inserted into the handle mounting slot 106 and slid proximally within the handle mounting slot 106 until seated. Indeed, Figure 10 shows the blade mounting fixture 120 being disposed within the handle mounting slot 106 and coupling the scalpel blade 100 to the scalpel handle 118 to form a scalpel 116. Such a scalpel handle may be formed from surgical steel.

[0047] Female Assembly FIG. 10 illustrates a scalpel assembly 122 according to some embodiments. As shown, scalpel assembly 122 includes a guidewire 112 and a scalpel 116 having a pair of guidewire clips 110 of scalpel blade 100 clipped to guidewire 112. However, other assemblies are contemplated, such as a scalpel blade assembly including a guidewire 112 and a scalpel blade 100 having a pair of guidewire clips 110 of scalpel blade 100 clipped to guidewire 112 (see Figures 1-5 for such scalpel blade assemblies).

[0048] The scalpel assembly 122, or even the scalpel blade assembly, may be provided in a protected, yet ready-to-use kit, for example, with a plastic scalpel blade shield covering the cutting edge 102 of the scalpel blade 100, and a pair of stops, such as a pair of bi-fold sticker tabs on the guidewire 112 that flank a pair of guidewire clips 110 to prevent any sliding of the scalpel blade 100 over the guidewire 112. Such a ready-to-use scalpel assembly may be used with at least a slotted needle, which includes a side slot through which the guidewire 112 can be easily withdrawn therefrom following the needle's percutaneous puncture. Alternatively, such as when a more conventional non-slotted needle is used for the percutaneous puncture, the scalpel assembly 122 or scalpel blade assembly may be assembled after the needle withdrawal step of the method described below. This is because more conventional, non-slotted needles must be threaded over the proximal end of the guidewire 112 and removed, eliminating the need for the use of the previously described ready-to-use scalpel assembly 122 or scalpel blade assembly, in which at least the scalpel blade 100 is already clipped to the guidewire 112.

[0049] method The method includes utilizing a scalpel cutting step with a scalpel blade 100 to insert a medical device, such as a catheter (e.g., a CVC), into a blood vessel lumen. Such a method includes one or more steps selected from a needle path establishment step, a guidewire insertion step, a needle removal step, a scalpel formation step, a guidewire loading step, a scalpel or scalpel blade rotation step, a scalpel cutting step, a scalpel or scalpel blade removal step, and a catheter insertion step.

[0050] The needle pathway establishment step includes establishing a needle pathway with a needle from an area of ​​the patient's skin to a blood vessel lumen at a selected insertion site for inserting the catheter. The guidewire insertion step involves inserting a guidewire 112 through the needle and into the blood vessel lumen.

[0051] The needle removal step involves removing the needle from the needle track leaving the guidewire 112 in place in the vessel lumen. As mentioned above, if the needle is a slotted needle, the guidewire 112 can be easily withdrawn from the side slot of the slotted needle immediately after the needle is removed from the needle track. However, if the needle is a more traditional non-slotted needle, the needle must be threaded over the proximal end of the guidewire 112 and withdrawn.

[0052] The knife forming step occurs when the knife 116 is not already formed, such as the knife assembly 122 described above. The knife forming step involves coupling the knife blade 100 to the knife handle 118 by inserting the blade mounting fixture 120 of the knife handle 118 into the handle mounting slot 106 of the knife blade 100 to form the knife 116.

[0053] The guidewire loading step is performed when the scalpel blade 100 is not already clipped onto the guidewire 112, such as the scalpel assembly 122 described above. The guidewire loading step includes loading the guidewire 112 into the pair of guidewire clips 110 of the scalpel blade 100 by appropriately rotating the scalpel blade 100, and for each clip of the pair of guidewire clips 110, placing the guidewire 112 into the opening 114 of each clip of the pair of guidewire clips 110. In fact, the guidewire loading step includes rotating the scalpel blade 100 by hand to facilitate access to the distal clip opening 114 of the pair of guidewire clips 110, loading the guidewire 112 into the distal clip opening 114, rotating the scalpel blade 100 around the guidewire 112 to facilitate access to the proximal clip opening 114 of the pair of guidewire clips 110, and loading the guidewire 112 into the proximal clip opening 114. (See FIGS. 3 and 4, with the understanding that any order of loading guidewire 112 into the pair of guidewire clips 110 of scalpel blade 100 may be utilized.) Again, the opening 114 of each clip of the pair of guidewire clips 110 is open on either side of scalpel blade 100, which necessitates rotating scalpel blade 100 through opposite rotational angles when rotating scalpel blade 100 to position guidewire 112 into opening 114 of each clip of the pair of guidewire clips 110.

[0054] The scalpel or scalpel blade rotation step involves rotating the scalpel 116 or scalpel blade 100 about the guidewire 112 to a desired rotation angle to incise the patient's skin and fascia about the insertion site. Again, the guidewire 112 is sufficiently coaxial with the pair of guidewire clips 110 to rotate the scalpel 116 or scalpel blade 100 about the guidewire 112.

[0055] The incision step involves using a scalpel blade 100 guided along a guidewire 112 to incise the patient's skin and fascia around the insertion site. The scalpel or scalpel blade removal step includes removing the scalpel 116 or scalpel blade 100 from the guidewire 112. In practice, the scalpel or scalpel blade removal step includes removing the guidewire 112 from the pair of guidewire clips 110 of the scalpel blade 100 by rotating the scalpel blade 100 and, for each clip of the pair of guidewire clips 110, pulling the guidewire 112 out of the opening 114 of each clip of the pair of guidewire clips 110. However, the scalpel or scalpel blade removal step may alternatively include withdrawing the scalpel 116 or scalpel blade 100 over the proximal end of the guidewire 112.

[0056] The catheter insertion step involves inserting a catheter over the guidewire 112 into the lumen of the blood vessel. Although some specific embodiments are disclosed herein, and the specific embodiments are disclosed in some detail, the specific embodiments are not intended to limit the scope of the concepts provided herein. Additional improvements or modifications may be apparent to those skilled in the art, and the broader aspects of the present invention encompass these improvements or modifications as well. Thus, one may depart from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. a scalpel blade, a cutting edge terminating in a blade tip at the distal end of the scalpel blade; a trailing edge; The scalpel blade, wherein the trailing edge includes a pair of guidewire clips configured to clip onto the guidewire with sufficient clearance to slidably guide the scalpel blade along the guidewire as it incises the patient's skin and fascia around an insertion site established by a percutaneous puncture.

2. The scalpel blade of claim 1 , wherein the pair of guidewire clips are positioned below or along the sides of the trailing edge of the scalpel blade.

3. 2. The scalpel blade of claim 1, wherein each clip of the pair of guidewire clips includes an opening that opens toward the trailing edge of the scalpel blade and away from a side of the scalpel blade opposite the other clip of the pair of guidewire clips.

4. 4. The scalpel blade of claim 3, wherein each clip of said pair of guidewire clips has a cross section that is approximately a three-quarter sector of a circle.

5. 2. The scalpel blade of claim 1, wherein each clip of the pair of guidewire clips includes an opening that opens along a side of the scalpel blade or on the same side of the scalpel blade but on opposite sides thereof, and each clip of the pair of guidewire clips is mutually exclusive with the other clip of the pair of guidewire clips with respect to the opening.

6. The scalpel blade of claim 5 , wherein each clip of the pair of guidewire clips is approximately semicircular in cross section.

7. 2. The scalpel blade of claim 1, wherein each clip of the pair of guidewire clips is sufficiently spaced along the trailing edge of the scalpel blade from the other clip of the pair of guidewire clips so that the guidewire can easily straddle the trailing edge of the scalpel blade without significantly bending the guidewire when the guidewire is loaded into each clip of the pair of guidewire clips.

8. The scalpel blade of claim 1 , wherein the guidewire is coaxial with the pair of guidewire clips when the guidewire is loaded within the pair of guidewire clips.

9. 9. The scalpel blade of claim 8, wherein the guidewire is sufficiently coaxial with the pair of guidewire clips to rotate the scalpel blade about the guidewire to a desired rotational angle to incise the patient's skin and fascia about the insertion site.

10. The scalpel blade of claim 1 , further comprising a handle attachment slot configured to attach a scalpel handle to the scalpel blade to form a scalpel.

11. It is female, A scalpel handle and a scalpel blade coupled to the scalpel handle, The scalpel blade is a cutting edge terminating in a blade tip at the distal end of the scalpel blade; a trailing edge; The scalpel, the trailing edge of which includes a pair of guidewire clips configured to retain on the guidewire with sufficient clearance to slidably guide the scalpel along the guidewire as it incises the patient's skin and fascia around an insertion site established by a percutaneous puncture.

12. 12. The scalpel of claim 11, wherein the scalpel handle includes a blade mounting fixture, and the scalpel blade further includes a handle mounting slot, the blade mounting fixture being disposed within the handle mounting slot to couple the scalpel blade to the scalpel handle.

13. The scalpel of claim 11 , wherein the pair of guidewire clips are positioned below or along the sides of the trailing edge of the scalpel blade.

14. 12. The scalpel of claim 11, wherein each clip of the pair of guidewire clips includes an opening that opens toward the trailing edge of the scalpel blade and away from a side of the scalpel blade opposite the other clip of the pair of guidewire clips.

15. 15. The scalpel of claim 14, wherein each clip of said pair of guidewire clips has a cross section that is approximately a three-quarter sector of a circle.

16. 12. The scalpel of claim 11, wherein each clip of the pair of guidewire clips includes an opening that opens along a side of the scalpel blade or on the same side of the scalpel blade but on opposite sides thereof, and each clip of the pair of guidewire clips is mutually exclusive with the other clip of the pair of guidewire clips with respect to the opening.

17. 17. The scalpel of claim 16, wherein each clip of said pair of guidewire clips is approximately semicircular in cross section.

18. 12. The scalpel of claim 11, wherein each clip of the pair of guidewire clips is sufficiently spaced along the trailing edge of the scalpel blade from the other clip of the pair of guidewire clips so that the guidewire can easily straddle the trailing edge of the scalpel blade without significantly bending the guidewire when the guidewire is loaded into each clip of the pair of guidewire clips.

19. 19. The scalpel of any one of claims 11 to 18, wherein the guidewire is coaxial with the pair of guidewire clips when the guidewire is loaded within the pair of guidewire clips.

20. 20. The scalpel of claim 19, wherein the guidewire is sufficiently coaxial with the pair of guidewire clips to rotate the scalpel about the guidewire to a desired angle of rotation to incise the patient's skin and fascia around the insertion site.

21. A female assembly comprising: A guide wire; A scalpel handle and a scalpel blade coupled to the scalpel handle to form a scalpel; The scalpel blade is a cutting edge terminating in a blade tip at the distal end of the scalpel blade; a trailing edge; the trailing edge of the scalpel assembly including a pair of guidewire clips that are secured to the guidewire with sufficient clearance to slidably guide the scalpel along the guidewire as it incises the patient's skin and fascia around an insertion site established by a percutaneous puncture.

22. 22. The scalpel assembly of claim 21, wherein the scalpel handle includes a blade mounting fixture, and the scalpel blade further includes a handle mounting slot, the blade mounting fixture being disposed within the handle mounting slot to couple the scalpel blade to the scalpel handle.

23. 22. The scalpel assembly of claim 21, wherein the pair of guidewire clips are positioned below or along the sides of the trailing edge of the scalpel blade.

24. 22. The scalpel assembly of claim 21, wherein each clip of the pair of guidewire clips includes an opening that opens toward the trailing edge of the scalpel blade and away from a side of the scalpel blade opposite the other clip of the pair of guidewire clips.

25. 25. The scalpel assembly of claim 24, wherein each clip of the pair of guidewire clips has a cross section that is approximately a three-quarter sector of a circle.

26. 22. The scalpel assembly of claim 21, wherein each clip of the pair of guidewire clips includes an opening that opens along a side of the scalpel blade or on the same side of the scalpel blade but on opposite sides thereof, and wherein each clip of the pair of guidewire clips is mutually exclusive with the other clip of the pair of guidewire clips with respect to the opening.

27. 27. The scalpel assembly of claim 26, wherein each clip of the pair of guidewire clips is approximately semicircular in transverse cross section.

28. 22. The scalpel assembly of claim 21, wherein each clip of the pair of guidewire clips is sufficiently spaced along the trailing edge of the scalpel blade from the other clip of the pair of guidewire clips so that, when the guidewire is loaded into each clip of the pair of guidewire clips, the guidewire can easily straddle the trailing edge of the scalpel blade without significantly bending the guidewire.

29. 29. The scalpel assembly of any one of claims 21 to 28, wherein the guidewire is coaxial with the pair of guidewire clips when the guidewire is loaded within the pair of guidewire clips.

30. 30. The scalpel assembly of claim 29, wherein the guidewire is sufficiently coaxial with the pair of guidewire clips to rotate the scalpel about the guidewire to a desired angle of rotation to incise the patient's skin and fascia about the insertion site.

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