Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-12-07
2001-08-14
Kennedy, Sharon (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
Reexamination Certificate
active
06273871
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to a device for introducing a long, thin and flexible medical device, such as a catheter, into a patient's vasculature. More particularly, this invention relates to an improved catheter introducer that facilitates insertion of the catheter introducer into a patient's vasculature and that allows easy insertion of a catheter through the catheter introducer and into the patient's vasculature.
Catheter introducers are typically used in conjunction with peripherally inserted central catheters (PICC), or other relatively long, thin and flexible medical devices, to facilitate insertion and placement of the catheter or other medical device into the patient's vasculature. Current catheter introducers include a splittable cannula and a hub with a pair of wings fixed to the proximal end of the cannula. In addition, such a catheter introducer includes an introducer needle that is disposed in the splittable cannula with the sharp distal tip of the needle extending distally of the distal end of the splittable cannula and with the needle hub extending proximal of the wings and hub on the cannula. As used herein, the term “proximal” refers to a location on the device closest to the clinician using the device. Conversely, the term “distal” refers to a location on the device farthest from the clinician and closest to the patient into whom the device is to be inserted.
When using a typical catheter introducer, the clinician grasps the needle hub so the needle bevel is facing away from the patient's skin and proceeds to insert the distal portion of the needle and cannula at the desired site in the patient's skin. The clinician continues to advance the device until venipuncture has been confirmed. This confirmation is usually done visually when the clinician sees blood entering a flashback chamber formed in the needle hub at the proximal end of the needle. After venipuncture has been confirmed, the clinician advances the cannula distally into the patient's vein and the needle is withdrawn. With the catheter introducer properly placed, the clinician can then insert the PICC, or other relatively long, thin and flexible medical device, into the proximal opening of the cannula and continue to advance the catheter through the catheter introducer until the catheter is properly placed in the patient's vasculature. Alternatively, the introducer needle can be first placed into the patient's vasculature without the catheter introducer. A guidewire is then inserted through the introducer needle into the patient's vasculature. The introducer needle is then removed leaving the guidewire in place to provide a track or guide for the catheter introducer, and dilator if used, to follow into the patient's vasculature. A catheter is then inserted into the catheter introducer over the guidewire. This greatly facilitates the placement of a PICC into a patient's vasculature. After placement of the PICC, the clinician grasps the wings and pulls them apart to split the splittable introducer. In this way, the splittable introducer can be removed from the patient over any hub located on the proximal end of the PICC.
Although currently available catheter introducers generally work in accordance with their intended purpose, they could be improved. For example, when the catheter introducer is inserted into the patient, the hub is adjacent to the patient's skin and blood flows out of the open proximal end of the splittable cannula. This makes it difficult for the clinician to line up the distal end of the catheter with the open proximal end of the splittable cannula. This is especially problematic since the clinician must always approach the open proximal end of the splittable cannula with the distal end of the catheter along the longitudinal axis of the splittable cannula and since the outer diameter of the catheter is only slightly smaller than the inner diameter of the splittable cannula. In addition, the location and configuration of the wings on the splittable cannula require a certain minimum insertion angle for the device that in some cases may be too large.
SUMMARY OF THE INVENTION
It is therefore an object of the invention to provide a catheter introducer that facilitates aligning the distal end of a catheter or other long, thin and flexible medical device with the open proximal end of the cannula.
It is another object of the invention to provide a catheter introducer that allows the clinician to approach the open proximal end of the splittable cannula with the distal end of a catheter or other long, thin and flexible medical device along a line other than coincident with the longitudinal axis of the splittable cannula.
It is still a further object of this invention to provide a catheter introducer that allows a clinician to use a low insertion angle during venipuncture.
The catheter introducer of this invention comprises an introducer needle having a needle hub and integrated flashback chamber connected to the proximal end of the introducer needle and a splittable introducer with a hub and a pair of wings connected to the proximal end of the splittable introducer. The introducer needle has a sharp distal end and is initially disposed in the splittable introducer such that the sharp distal end of the introducer needle extends distally of the distal end of the splittable introducer. In addition, in this position the needle hub is proximal of the proximal end of the wings of the splittable introducer.
The bevel at the distal end of the introducer needle is a standard B bevel but a short bevel could also be used. A short bevel minimizes the chances for piercing the back of the vein during venipuncture on certain patients such as pediatric and neonatal patients. Such a complication can cause discomfort to the patient and result in a hematoma in the area of the vein puncture. The introducer needle also includes a notch, or a side hole, located in the introducer needle wall along the distal portion but proximal of the bevel. This notch and its distal location allows blood to flow into the annular space between the introducer needle and the splittable introducer cannula. In this manner, where the splittable introducer cannula is at least translucent, the clinician can immediately observe flashback upon venipuncture rather than having to wait for blood to flow through the entire needle and then into the flashback chamber. This is especially important where the patient has a low blood pressure and low bloodflow such as in certain oncology and neonatal patients. Furthermore, the introducer needle is connected to the needle hub at a location that is below the center of mass of the needle hub. Thus, the bottom of the introducer needle is closely aligned with the bottom of the needle hub. This allows the clinician to approach the venipuncture site at a low insertion angle since there is minimal interference by the bottom of the needle hub. In addition, this configuration still provides enough surface area on the needle hub for grasping by the clinician.
As used herein the terms “above” and “top” refer to a location on the device away from the patient's skin where the device rests during use, while the terms “below” and “bottom” refer to a location on the device adjacent to the patient's skin on which the device rests during use.
The splittable introducer includes a pair of wings connected to the cannula. The cannula is formed such that it will easily tear along the longitudinal axis. One mechanism for ensuring such tearing is to form the cannula from a longitudinal tear material. Alternatively, the cannula could include longitudinally extending preferential tear lines formed by scoring or perforating the cannula. Collectively, the mechanisms used to ensure that the cannula will easily tear along the longitudinal axis are called preferential tear lines. Such preferential tear lines are preferably about 165° apart. These preferential tear lines facilitate splitting of the cannula. Each wing is located along
Crawford Mark A.
Davis Bryan G.
Howell Glade H.
Becton Dickinson and Company
Kennedy Sharon
Lee Eric M.
Serke Catherine
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