Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/32—Surgical cutting instruments
  • A61B17/3209—Incision instruments
  • A61B17/3211—Surgical scalpels, knives; Accessories therefor
  • A61B17/3213—Surgical scalpels, knives; Accessories therefor with detachable blades
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/32—Surgical cutting instruments
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/32—Surgical cutting instruments
  • A61B17/3209—Incision instruments
  • A61B17/32093—Incision instruments for skin incisions
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/32—Surgical cutting instruments
  • A61B17/3209—Incision instruments
  • A61B17/3211—Surgical scalpels, knives; Accessories therefor
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/34—Trocars; Puncturing needles
  • A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00477—Coupling
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
  • A61B2017/22038—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with a guide wire
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/32—Surgical cutting instruments
  • A61B2017/320052—Guides for cutting instruments

Definitions

• Insertion of central venous catheters (“CVCs”) into patients is a multi-step process. For example, after a percutaneous puncture with a needle at a chosen insertion site, whereby a needle tract is established from an area of skin to a blood-vessel lumen, a guidewire is inserted through the needle into the blood-vessel lumen. Subsequently, the needle is removed leaving the guidewire in place. At this point, a scalpel is typically used to perform a skin nick in which both skin and facia are cut about the insertion site to ease insertion of the CVC.
• Such a skin nick is performed with a traditional scalpel by placing a back edge of a scalpel blade against the guidewire and running a blade edge of the scalpel blade into the skin and fascia to make a larger hole.
• a skin-nicking means and method to facilitate clean skin-nicking about an insertion site is needed for at least the insertion of CVCs into patients in view of the foregoing.
• scalpel blade including, in some embodiments, a blade edge and a back edge including a pair of guidewire clips configured to clip onto a guidewire.
• the blade edge terminates with 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 for slidably guiding the scalpel blade along the guidewire when skin-nicking a patient’s skin and fascia around an insertion site established by a percutaneous puncture.
• the pair of guidewire clips are disposed under the back edge of the scalpel blade or along a side of the back edge of the scalpel blade.
• each clip of the pair of guidewire clips includes an opening that opens toward the back edge of the scalpel blade and away from a side of the scalpel blade opposite the other clip of the pair of guidewire clips.
• each clip of the pair of guidewire clips is approximately a three-quarter sector of a circle in transverse cross section.
• each clip of the pair of guidewire clips includes an opening that opens along a side of the scalpel blade or opposite thereto on a same side of the scalpel blade.
• Each clip of the pair of guidewire clips is mutually exclusive of the other clip of the pair of guidewire clips with respect to the opening thereof.
• each clip of the pair of guidewire clips is approximately a semicircle in transverse cross section.
• each clip of the pair of guidewire clips is sufficiently separated along the back edge of the scalpel blade from the other clip of the pair of guidewire clips to allow the guidewire to easily cross over the back edge of the scalpel blade without appreciably bending the guidewire when loading the guidewire into each clip of the pair of guidewire clips.
• the guidewire is coaxial with the pair of guidewire clips when the guidewire is loaded therein.
• the guidewire is sufficiently coaxial with the pair of guidewire clips for rotating the scalpel blade around the guidewire to a desired rotational angle for the skin-nicking of the patient’s skin and fascia around the insertion site.
• the scalpel blade further includes a handle-attachment slot configured for attaching a scalpel handle to the scalpel blade to form a scalpel.
• a scalpel including, in some embodiments, a scalpel handle and a scalpel blade coupled to the scalpel handle.
• the scalpel blade includes a blade edge and a back edge including a pair of guidewire clips configured to clip onto a guidewire.
• the blade edge terminates with 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 for slidably guiding the scalpel along the guidewire when skin-nicking a patient’s skin and fascia around an insertion site established by a percutaneous puncture.
• the scalpel handle includes a blade-attachment fixture, and the scalpel blade further includes a handle-attachment slot.
• the blade-attachment fixture is disposed in the handle-attachment slot coupling the scalpel blade to the scalpel handle.
• the pair of guidewire clips are disposed under the back edge of the scalpel blade or along a side of the back edge of the scalpel blade.
• each clip of the pair of guidewire clips includes an opening that opens toward the back edge of the scalpel blade and away from a side of the scalpel blade opposite the other clip of the pair of guidewire clips.
• each clip of the pair of guidewire clips is approximately a three-quarter sector of a circle in transverse cross section.
• each clip of the pair of guidewire clips includes an opening that opens along a side of the scalpel blade or opposite thereto on a same side of the scalpel blade.
• Each clip of the pair of guidewire clips is mutually exclusive of the other clip of the pair of guidewire clips with respect to the opening thereof.
• each clip of the pair of guidewire clips is approximately a semicircle in transverse cross section.
• each clip of the pair of guidewire clips is sufficiently separated along the back edge of the scalpel blade from the other clip of the pair of guidewire clips to allow the guidewire to easily cross over the back edge of the scalpel blade without appreciably bending the guidewire when loading the guidewire into each clip of the pair of guidewire clips.
• the guidewire is coaxial with the pair of guidewire clips when the guidewire is loaded therein.
• the guidewire is sufficiently coaxial with the pair of guidewire clips for rotating the scalpel around the guidewire to a desired rotational angle for the skin-nicking of the patient’s skin and fascia around the insertion site.
• a scalpel assembly including, in some embodiments, a guidewire, a scalpel handle, and a scalpel blade coupled to the scalpel handle to form a scalpel.
• the scalpel blade includes a blade edge and a back edge including a pair of guidewire clips clipped onto the guidewire.
• the blade edge terminates with a blade tip at a distal end of the scalpel blade.
• the pair of guidewire clips are clipped onto the guidewire with sufficient clearance for slidably guiding the scalpel along the guidewire when skin-nicking a patient’s skin and fascia around an insertion site established by a percutaneous puncture.
• the scalpel handle includes a blade-attachment fixture, and the scalpel blade further includes a handle-attachment slot.
• the blade-attachment fixture is disposed in the handle-attachment slot coupling the scalpel blade to the scalpel handle.
• the pair of guidewire clips are disposed under the back edge of the scalpel blade or along a side of the back edge of the scalpel blade.
• each clip of the pair of guidewire clips includes an opening that opens toward the back edge of the scalpel blade and away from a side of the scalpel blade opposite the other clip of the pair of guidewire clips.
• each clip of the pair of guidewire clips is approximately a three-quarter sector of a circle in transverse cross section.
• each clip of the pair of guidewire clips includes an opening that opens along a side of the scalpel blade or opposite thereto on a same side of the scalpel blade.
• Each clip of the pair of guidewire clips is mutually exclusive of the other clip of the pair of guidewire clips with respect to the opening thereof.
• each clip of the pair of guidewire clips is approximately a semicircle in transverse cross section. [0031] In some embodiments, each clip of the pair of guidewire clips is sufficiently separated along the back edge of the scalpel blade from the other clip of the pair of guidewire clips to allow the guidewire to easily cross over the back edge of the scalpel blade without appreciably bending the guidewire when loading the guidewire into each clip of the pair of guidewire clips.
• the guidewire is coaxial with the pair of guidewire clips when the guidewire is loaded therein.
• the guidewire is sufficiently coaxial with the pair of guidewire clips for rotating the scalpel around the guidewire to a desired rotational angle for the skin-nicking of the patient’s skin and fascia around the insertion site.
• the method includes, in some embodiments, a needle tract-establishing step, a guidewireinserting step, a needle-withdrawing step, a skin-nicking step, a scalpel blade-removing step, and a catheter-inserting step.
• the needle tract-establishing step includes establishing a needle tract from an area of skin to the blood-vessel lumen of a patient with a needle at a chosen insertion site for inserting the catheter.
• the guidewire-inserting step includes inserting a guidewire through the needle into the blood-vessel lumen.
• the needle-withdrawing step includes withdrawing the needle from the needle tract leaving the guidewire in place in the blood-vessel lumen.
• the skin-nicking step includes skin-nicking skin and fascia of the patient around the insertion site with a scalpel blade guided along the guidewire.
• the scalpel blade includes a blade edge and a back edge including a pair of guidewire clips clipped onto the guidewire. The blade edge terminates with a blade tip at a distal end of the scalpel blade.
• the pair of guidewire clips are clipped onto the guidewire with sufficient clearance for slidably guiding the scalpel blade along the guidewire during the skin-nicking step.
• the scalpel bladeremoving step includes removing the scalpel blade from the guidewire.
• the catheter-inserting step includes inserting the catheter into the blood-vessel lumen over the guidewire.
• the method further includes a guidewire-loading step.
• the guidewire-loading step includes loading the guidewire into the pair of guidewire clips of the scalpel blade by rotating the scalpel blade and placing the guidewire in an opening of each clip of the pair of guidewire clips for each clip of the pair of guidewire clips.
• the opening of each clip of the pair of guidewire clips opens toward the back edge of the scalpel blade and away from a side of the scalpel blade opposite the other clip of the pair of guidewire clips.
• each clip of the pair of guidewire clips is approximately a three-quarter sector of a circle in transverse cross section.
• each clip of the pair of guidewire clips opens along a side of the scalpel blade or opposite thereto on a same side of the scalpel blade.
• Each clip of the pair of guidewire clips is mutually exclusive of the other clip of the pair of guidewire clips with respect to the opening thereof.
• each clip of the pair of guidewire clips is approximately a semicircle in transverse cross section.
• the scalpel blade-removing step includes unloading the guidewire from the pair of guidewire clips of the scalpel blade by rotating the scalpel blade and extracting the guidewire from the opening of each clip of the pair of guidewire clips for each clip of the pair of guidewire clips.
• the scalpel blade-removing step includes withdrawing the scalpel blade over a proximal end of the guidewire.
• the method further includes a scalpel-forming step.
• the scalpel-forming step includes coupling the scalpel blade to a scalpel handle to form a scalpel by inserting a blade-attachment fixture of the scalpel handle into a handle-attachment slot of the scalpel blade.
• the method further a scalpel blade-rotating step.
• the scalpel blade-rotating step includes rotating the scalpel blade or scalpel around the guidewire to a desired rotational angle for the skin-nicking of the skin and fascia of the patient around the insertion site.
• the guidewire is sufficiently coaxial with the pair of guidewire clips for the rotating of the scalpel or scalpel around the guidewire.
• FIG. 1 illustrates a scalpel blade while clipped onto a guidewire with a first pair of guidewire clips in accordance with some embodiments.
• FIG. 2 illustrates a distal end of the scalpel blade while clipped onto a guidewire with the first pair of guidewire clips in accordance with some embodiments.
• FIG. 3 illustrates a perspective view from a proximal end of the scalpel blade while clipped onto a guidewire with the first pair of guidewire clips in accordance with some embodiments.
• FIG. 4 illustrates a perspective view from a distal end of the scalpel blade while clipped onto a guidewire with the first pair of guidewire clips in accordance with some embodiments.
• FIG. 5 illustrates a detailed view from a side of the scalpel blade while clipped onto a guidewire with the first pair of guidewire clips in accordance with some embodiments.
• FIG. 6 illustrates the scalpel blade with a second pair of guidewire clips in accordance with some embodiments.
• FIG. 7A illustrates a simplified distal end-on view of the scalpel blade and a distal guidewire clip of the first pair of guidewire clips in accordance with some embodiments.
• FIG. 7B illustrates a simplified proximal end-on view of the scalpel blade and a proximal guidewire clip of the first pair of guidewire clips in accordance with some embodiments.
• FIG. 8A illustrates a simplified distal end-on view of the scalpel blade and the distal guidewire clip of the first pair of guidewire clips in accordance with some other embodiments.
• FIG. 8B illustrates a simplified proximal end-on view of the scalpel blade and the proximal guidewire clip of the first pair of guidewire clips in accordance with some other embodiments.
• FIG. 9A illustrates a simplified distal end-on view of the scalpel blade and a distal guidewire clip of the second pair of guidewire clips in accordance with some embodiments.
• FIG. 9B illustrates a simplified proximal end-on view of the scalpel blade and a proximal guidewire clip of the second pair of guidewire clips in accordance with some embodiments.
• FIG. 10 illustrates a scalpel including the scalpel blade coupled to a scalpel handle with the scalpel blade clipped onto a guidewire with the first pair of guidewire clips in accordance with some embodiments.
• proximal a “proximal portion” or “proximal section” of, for example, a scalpel includes a portion or section of the scalpel intended to be near a clinician when the scalpel is used on a patient.
• a “proximal length” of, for example, the scalpel includes a length of the scalpel intended to be near the clinician when the scalpel is used on the patient.
• a “proximal end” of, for example, the scalpel includes an end of the scalpel intended to be near the clinician when the scalpel is used on the patient.
• the proximal portion, the proximal section, or the proximal length of the scalpel can include the proximal end of the scalpel; however, the proximal portion, the proximal section, or the proximal length of the scalpel need not include the proximal end of the scalpel. That is, unless context suggests otherwise, the proximal portion, the proximal section, or the proximal length of the scalpel is not a terminal portion or terminal length of the scalpel.
• a “distal portion” or a “distal section” of, for example, a scalpel includes a portion or section of the scalpel intended to be near or on a patient when the scalpel is used on the patient.
• a “distal length” of, for example, the scalpel includes a length of the scalpel intended to be near or on the patient when the scalpel is used on the patient.
• a “distal end” of, for example, the scalpel includes an end of the scalpel intended to be near or on the patient when the scalpel is used on the patient.
• the distal portion, the distal section, or the distal length of the scalpel can include the distal end of the scalpel; however, the distal portion, the distal section, or the distal length of the scalpel need not include the distal end of the scalpel. That is, unless context suggests otherwise, the distal portion, the distal section, or the distal length of the scalpel is not a terminal portion or terminal length of the scalpel.
• the insertion of CVCs into patients is a multi-step process. For example, after a percutaneous puncture with a needle at a chosen insertion site, whereby a needle tract is established from an area of skin to a blood-vessel lumen, a guidewire is inserted through the needle into the blood-vessel lumen. Subsequently, the needle is removed leaving the guidewire in place. At this point, a scalpel is typically used to perform a skin nick in which both skin and facia are cut about the insertion site to ease insertion of the CVC.
• Such a skin nick is performed with a traditional scalpel by placing a back edge of a scalpel blade against the guidewire and running a blade edge of the scalpel blade into the skin and fascia to make a larger hole.
• a skin-nicking means and method to facilitate clean skin-nicking about an insertion site is needed for at least the insertion of CVCs into patients in view of the foregoing.
• a scalpel blade can include a blade edge and a back edge, which back edge can include a pair of guidewire clips configured to clip onto a guidewire.
• the blade edge can terminate with a blade tip at a distal end of the scalpel blade.
• the pair of guidewire clips can be configured to clip onto the guidewire with sufficient clearance for slidably guiding the scalpel blade along the guidewire when skin-nicking a patient’s skin and fascia around an insertion site established by a percutaneous puncture.
• the scalpels and scalpel assemblies can include the example scalpel blade.
• the methods can include methods of using any of the scalpel blades, scalpels, or scalpel assemblies disclosed herein.
• FIGS. 1-6, 7A, 7B, 8A, 8B, 9A, and 9B illustrate various views of a scalpel blade 100 in accordance with some embodiments.
• the scalpel blade 100 includes a sharp or blade edge 102 and a dull or back edge 104.
• the scalpel blade 100 further includes a handle-attachment slot 106.
• Such a scalpel blade can be formed of surgical steel.
• the blade edge 102 terminates with a blade tip 108 at a distal end of the scalpel blade 100.
• the back edge 104 includes a pair of guidewire clips 110 configured to clip onto a guidewire 112.
• the back edge 104 is not limited to the pair of guidewire clips 110.
• the back edge 104 can include a single guidewire clip or a set of three or more guidewire clips with optionally alternating openings like those of the pair of guidewire clips 110 set forth below.
• the pair of guidewire clips 110 can be disposed under the back edge 104 of the scalpel blade 100 (see FIGS. 7 A and 7B) or along a side of the back edge 104 (see FIGS. 8 A and 8B or FIGS. 9A or 9B) of the scalpel blade 100.
• the pair of guidewire clips 110 are configured to clip onto the guidewire 112 with sufficient clearance for slidably guiding the scalpel blade 100 on top of the guidewire 112 or along the guidewire 112 when skin-nicking a patient’s skin and fascia around an insertion site established by a percutaneous puncture.
• the pair of guidewire clips 110 assist a clinician in holding the scalpel blade 100 flush against such a guidewire during the skin-nicking, thereby reducing or even eliminating an occurrence of a skin bridge when expanding the insertion site for a CVC or some other medical device.
• Each clip of the pair of guidewire clips 110 includes an opening 114 that opens in an opposite direction from that of the other clip of the pair of guidewire clips 110.
• each clip of the pair of guidewire clips 110 can include the opening 114 configured to open toward the back edge 104 of the scalpel blade 100 and away from a side of the scalpel blade 100 opposite the other clip of the pair of guidewire clips 110 as shown between at least FIGS. 7 A and 7B.
• each clip of the pair of guidewire clips 110 can include the opening 114 configured to open into a side of the scalpel blade 100 or opposite thereto on the same side of the scalpel blade 100 as shown between FIGS. 8 A and 8B.
• each clip of the pair of guidewire clips 110 can include the opening 114 configured to open along a side of the scalpel blade 100 or opposite thereto on the same side of the scalpel blade 100 as shown between FIGS. 9A and 9B.
• Each clip of the pair of guidewire clips 110 is mutually exclusive of the other clip of the pair of guidewire clips 110 with respect to the opening 114 thereof in the foregoing configurations.
• Such an arrangement provides a tortured path of escape for the guidewire 112, thereby ensuring the scalpel blade 100 remains clipped on the guidewire 112 once clipped thereon as shown in FIGS. 1-5.
• the guidewire 112 is loaded from both sides of the scalpel blade 100 as set forth in the guidewire-loading step of the method set forth below.
• each clip of the pair of guidewire clips 110 is sufficiently separated along the back edge 104 of the scalpel blade 100 from the other clip of the pair of guidewire clips 110 to allow the guidewire 112 to easily cross over the back edge extracting the guidewire 112 from each clip of the pair of guidewire clips 110.
• Such a configuration for the pair of guidewire clips 110 is notable with respect to loading or extracting the guidewire therefrom because appreciably bending the guidewire 112 can kink the guidewire 112.
• overmanipulating the guidewire 112 can lead to loss of the guidewire 112 from a blood-vessel lumen of a patient, which loss could require another percutaneous puncture in order to secure access to the blood-vessel lumen with the guidewire 112.
• the pair of guidewire clips 110 can be ‘C’-shaped clips, ranging from approximately a semicircle in transverse cross section up to approximately a three-quarter sector of a circle in transverse cross section.
• the guidewire 112 is coaxial with the pair of guidewire clips 110.
• the guidewire 112 is sufficiently coaxial with the pair of guidewire clips 110 for rotating the scalpel blade 100 — or the scalpel 116 set forth below when the scalpel blade 100 is coupled to the scalpel handle 118 — around the guidewire 112 to a desired rotational angle for the skinnicking of the patient’s skin and fascia around the insertion site.
• Each clip of the pair of guidewire clips 110 can be metal or plastic such as a thermoplastic.
• the pair of guidewire clips 110 can be die-cut with the scalpel blade 100 and machined to a desired shape such that the pair of guidewire clips 110 are integral with a remainder of the scalpel blade 100.
• the pair of guidewire clips 110 can be die-cut separately from the scalpel blade 100, machined to a desired shape, and coupled to the scalpel blade 100 such as by welding (e.g., microwelding, laser welding, etc.) or riveting through through holes die-cut or drilled into both the scalpel blade 100 and the pair of guidewire clips 110.
• each clip of the pair of guidewire clips 110 in addition to being appropriately shaped — includes a roll-up or meltable rivet shank extending therefrom.
• a roll-up or meltable rivet shank can be inserted into a corresponding through hole die-cut or drilled into the scalpel blade 100 and respectively rolled up by way of, for example, a rivet press or melted by way of, for example, a sonotrode of an ultrasonic welder.
• the handle-attachment slot 106 is configured for attaching the scalpel handle 118 to the scalpel blade 100 to form the scalpel 116 set forth below. Such a handle-attachment slot can be die-cut with the scalpel blade 100. Scalpels
• FIG. 10 illustrates a scalpel 116 in accordance with some embodiments.
• the scalpel 116 includes a scalpel handle 118 and the scalpel blade 100 coupled to the scalpel handle 118.
• the scalpel handle 118 includes a blade-attachment fixture 120.
• the bladeattachment fixture 120 is configured to be disposed in the handle-attachment slot 106 such as inserted into the handle-attachment slot 106 and proximally slid in the handle-attachment slot 106 until seated.
• FIG. 10 shows the blade-attachment fixture 120 disposed in the handle-attachment slot 106 coupling the scalpel blade 100 to the scalpel handle 118 to form the scalpel 116.
• a scalpel handle can be formed of surgical steel.
• FIG. 10 illustrates a scalpel assembly 122 in accordance with some embodiments.
• the scalpel assembly 122 includes the guidewire 112 and the scalpel 116 with the pair of guidewire clips 110 of the scalpel blade 100 clipped onto the guidewire 112.
• a scalpel-blade assembly including the guidewire 112 and the scalpel blade 100 with the pair of guidewire clips 110 of the scalpel blade 100 clipped onto the guidewire 112. (See FIGS. 1-5 for such a scalpel-blade assembly.)
• the scalpel assembly 122 or even the scalpel-blade assembly can be provided in a kit in a protected, but ready-to-use state, for example, with a plastic scalpel-blade shield over the blade edge 102 of the scalpel blade 100 and a pair of stops such as a pair of doubled- over sticker tabs over the guidewire 112 flanking the pair of guidewire clips 110 and stopping any sliding of the scalpel blade 100 over the guidewire 112.
• a ready-to-use scalpel assembly is useful with at least a slotted needle, which includes a side slot from which the guidewire 112 can be easily pulled out of following a percutaneous puncture with the needle.
• the scalpel assembly 122 or the scalpel-blade assembly is assembled after the needlewithdrawing step of the method set forth below.
• the more traditional, nonslotted needle needs to be withdrawn over a proximal end of the guidewire 112, which obviates use of the scalpel assembly 122 or scalpel -blade assembly in the foregoing ready -to-use state with at least the scalpel blade 100 already clipped onto the guidewire 112.
• Methods include a method for inserting a medical device such as a catheter (e.g., CVC) into a blood-vessel lumen, which utilizes a skin-nicking step with the scalpel blade 100.
• a medical device such as a catheter (e.g., CVC)
• Such a method includes one or more steps selected from a needle tract-establishing step, a guidewire-inserting step, a needle-withdrawing step, a scalpel-forming step, a guidewireloading step, a scalpel- or scalpel blade-rotating step, the skin-nicking step, a scalpel- or scalpel blade-removing step, and a catheter-inserting step.
• the needle tract-establishing step includes establishing a needle tract from an area of skin to the blood-vessel lumen of a patient with a needle at a chosen insertion site for inserting the catheter.
• the guidewire-inserting step includes inserting the guidewire 112 through the needle into the blood-vessel lumen.
• the needle-withdrawing step includes withdrawing the needle from the needle tract leaving the guidewire 112 in place in the blood-vessel lumen.
• the needle is a slotted needle the guidewire 112 can be easily pulled out of the side slot of the slotted needle immediately after withdrawing the needle from the needle tract; however, if the needle is the more traditional, non-slotted needle, the needle needs to be withdrawn over the proximal end of the guidewire 112.
• the scalpel-forming step is performed if the scalpel 116 is not already formed like that of the scalpel assembly 122 set forth above, for example.
• the scalpel -forming step includes coupling the scalpel blade 100 to the scalpel handle 118 to form the scalpel 116 by inserting the blade-attachment fixture 120 of the scalpel handle 118 into the handle-attachment slot 106 of the scalpel blade 100.
• the guidewire-loading step is performed if the scalpel blade 100 is not already clipped onto the guidewire 112 like that of the scalpel assembly 122 set forth above, for example.
• the guidewire-loading step includes loading the guidewire 112 into the pair of guidewire clips 110 of the scalpel blade 100 by rotating the scalpel blade 100 as convenient and placing the guidewire 112 in the opening 114 of each clip of the pair of guidewire clips 110 for each clip of the pair of guidewire clips 110.
• the guidewire-loading step includes rotating the scalpel blade 100 in hand as convenient for access to the opening 114 of a distal clip of the pair of guidewire clips 110, loading the guidewire 112 into the opening 114 of the distal clip, rotating the scalpel blade 100 around the guidewire 112 as convenient for access to the opening 114 of a proximal clip of the pair of guidewire clips 110, and loading the guidewire 112 into the opening 114 of the proximal clip. (See FIGS.
• the opening 114 of each clip of the pair of guidewire clips 110 opens on opposite sides of the scalpel blade 100, which calls for rotating the scalpel blade 100 through opposite rotation angles when rotating the scalpel blade 100 and placing the guidewire 112 in the opening 114 of each clip of the pair of guidewire clips 110 for each clip of the pair of guidewire clips 110.
• the scalpel- or scalpel blade-rotating step includes rotating the scalpel 116 or the scalpel blade 100 around the guidewire 112 to a desired rotational angle for the skin-nicking of the skin and fascia of the patient around the insertion site.
• the guidewire 112 is sufficiently coaxial with the pair of guidewire clips 110 for the rotating of the scalpel 116 or the scalpel blade 100 around the guidewire 112.
• the skin-nicking step includes skin-nicking skin and fascia of the patient around the insertion site with the scalpel blade 100 guided along the guidewire 112.
• the scalpel- or scalpel blade-removing step includes removing the scalpel 116 or the scalpel blade 100 from the guidewire 112.
• the scalpel- or scalpel blade-removing step includes unloading the guidewire 112 from the pair of guidewire clips 110 of the scalpel blade 100 by rotating the scalpel blade 100 and extracting the guidewire 112 from the opening 114 of each clip of the pair of guidewire clips 110 for each clip of the pair of guidewire clips 110.
• the scalpel- or scalpel blade-removing step can alternatively include withdrawing the scalpel 116 or the scalpel blade 100 over the proximal end of the guidewire 112.
• the catheter-inserting step includes inserting the catheter into the blood-vessel lumen over the guidewire 112.

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• 2023
  • 2023-01-18 EP EP23706157.7A patent/EP4465910A1/en active Pending
  • 2023-01-18 JP JP2024543092A patent/JP2025502418A/ja active Pending
  • 2023-01-18 CN CN202320161256.5U patent/CN219439344U/zh active Active
  • 2023-01-18 WO PCT/US2023/011067 patent/WO2023141170A1/en not_active Ceased
  • 2023-01-18 US US18/098,607 patent/US20230233227A1/en active Pending
  • 2023-01-18 CN CN202310075246.4A patent/CN116473631A/zh active Pending

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