FR2710541A1 - Together for the introduction of a catheter. - Google Patents

Abstract

The invention relates to an assembly for the introduction of a catheter. It has a blood seal. The assembly is formed of a needle (14) having a section (14c) of enlarged diameter which prevents a needle seal assembly (16) from sliding out thereof. A catheter assembly (18) is axially mounted on the needle. The seal assembly carries a seal (100) for restricting the flow of blood from the catheter adapter (52). Field of application: catheters for blood vessels.

Description

The invention relates generally to the field of devices

catheter introduction. She has

  In particular, there is provided a catheter introducer having a blood seal to reduce blood leakage during introduction of the catheter into a blood vessel.

  Catheters are commonly used in the practice of medicine as a means of

  to the vascular system of a patient. Usually, a catheter is introduced into a blood vessel using a needle that pierces the blood vessel, creating an opening through which the catheter can enter the vessel. During this process, blood may contaminate the needle. With the advent of AIDS, there has been increased awareness of the possibility of blood from a patient containing the AIDS virus or other agents.

  pathogens such as the hepatitis virus. Blood leakage during introduction of a catheter into a patient's body may increase the risk of transmitting bloodborne pathogens.

  The object of the invention is to reduce the risk of such a transmission by using a blood seal

which minimizes the leakage of blood.

  The present invention relates to an assembly for introducing a catheter. The assembly consists of a needle having proximal and distal ends. A guard

  is attached to the needle at the proximal end thereof.

  A catheter assembly formed of a cannula and a catheter adapter connected to the cannula is axially mounted on the needle. The cannula can be concentrically mounted around the needle so that the catheter assembly can slide on the needle and the needle can be

  removed from the catheter assembly. The set for the introduction

  duction is provided with a sealing assembly mounted on the needle in the immediate vicinity of the catheter adapter

  so that the sealing assembly can slide on the

  guille. The seal assembly carries a seal for limiting the flow of blood from the catheter adapter. The invention will be described in more detail with reference to the accompanying drawings as examples. in no way limiting and in which: Figure 1 is a perspective view of the assembly of the invention, Figure 2 is a detailed perspective view showing the needle cover and the blood seal according to the invention; ; Figure 3 is a detailed longitudinal sectional view of a portion of the needle cover; Fig. 4 is a perspective view of the locking mechanism which secures the needle cover to the needle; Figures 5, 6, 7 and 8 are views in longitudinal section of the assembly according to the invention, according to the line 5-5, showing the operation of the device; Figure 9 is an exploded perspective view

  of a second embodiment of the protective device

  needle and blood seal; and FIG. 10 is a longitudinal sectional view

  partial of the second embodiment.

  An introducer assembly 10 includes a needle guard 12, a needle 14 having a distal end 15 and a proximal end 17 attached to the needle guard 12, and a needle tip cover 16 slidably mounted on the needle guard 12. needle stalk. A catheter assembly 18 comprising a cannula 19 and an adapter 52 is slidably mounted on the needle shaft. The cannula 19 has a lumen 13. The catheter assembly 18 is slidably mounted on the needle shaft and

  is releasably connected to the hood 16 of the end of the

guille.

  The needle guard 12 includes a transparent body

  As shown in FIGS. 1 to 5, there is shown an embodiment of the invention, which is substantially integrally molded and has substantially planar upper and lower surfaces 22a, 22b and two side walls 24, 26 which are generally concave to facilitate handling of the guard between thumb and forefinger. Each end of the side walls comprises a shoulder portion 28. The rear end of the needle guard is divided into a fork. A cylindrical tube 29 passes into the forked end portion and communicates with the rear end of the needle. A plug 30 can be attached to the end

rear of the tube 29.

  The cap 16 of the tip of the needle comprises an elongated body 38, generally hollow. The needle cover 16 carries a seal 100 described hereinafter. Since the cover 16 of the tip of the needle has the function of carrying a seal 100 and protecting the needle 14, the expressions "sealing assembly" and "cover of the needle tip" can be used indifferently. A longitudinal slot 40 extends through one side of the body 38 and a rectangular opening 42 extends to

  across its opposite end. Two flat surfaces defined

  parts of the other two sides of the body.

  A cylindrical passage 32 is defined in the

  laughing at the needle guard. The proximal end 38b of the

  cover 16 of the needle tip can be positioned at the

  laughter of this passage. A slot 34 extends inside the guard 12 near the inner surface 22b and joins the passage 34 (see Figure 3). The proximal end 38b of the

  cover 16 of the needle end has a protrusion 70 extending

  radially, which penetrates and can slide inside the slot 34. Thus, the cap 16 of the tip of the needle does not

  can not turn relative to the guard 12 of the needle.

  A radially extending flange 48 projects from the edge and meets one end of the longitudinal slot 40. The flange 48 has a generally annular configuration except for a flat surface 48a on one of its sides and a tab 48b protruding from the opposite side. This tab 48b is intended to allow the user to push the needle cap cover and catheter assembly away from the needle guard during catheter insertion and needle removal. . Several curved protrusions 50 start from the flange 48 and define together

  a housing 53 for retaining an adapter 52 of the catheter

  b. The ends of the projections have lips 54 projecting inwardly to connect

  removable a flange 56 from the catheter adapter to the assembly.

  The curved projections 50 and the lips 54 are adapted to engage the flange 56 to make it easier to push the needle cap cover and the needle guard gap by means of the tab 48b that removing the catheter adapter 52 from the housing 53. The user is therefore not prompted to remove the catheter adapter 52 and thus to expose the distal end of the needle 15 and he is encouraged to use the protective device

  passive of the invention as described in more detail below.

  One end of the tubular body 38 defines a projection or a

  spout 38a penetrating into the catheter adapter.

  A seal 100 is placed in the spout 38a of the cover 16 of the tip of the needle. The seal is a generally cylindrical element formed of a

  an elastomeric material, advantageously silica-rubber

  born. It is generally cylindrical and provided with a circumferential lip 106 to facilitate the introduction of the seal 100 in the nozzle 30a. A front portion 104 of the circumferential lip 106 is in contact with the interior of the catheter adapter 52, thereby ensuring

  the seal between the nozzle 38a and the adapter 52 of the catheter.

  An elongate rear portion 102 extends inside the spout 38a. The front portion 104 is provided with an opening 108 sized so that the seal 100 fits tightly around the needle 14, thereby forming a blood-tight seal. The seal 100 is placed in the spout 38a in radial compression to facilitate closure of the opening 108 as the needle 14 passes therethrough. The opening 108 is also sized and designed so that when the distal end 15

  the needle 14 is removed as shown in FIG. 8, the opening 108 substantially closes, preventing the blood from entering the spout 38a.

  Prior to use, the needle 14 passes tightly into the opening 108 of the seal 100 as shown in FIG. 5. Once the venipuncture has been performed by means of the needle 14, the needle 14 is removed and the distal end is pulled by the user

  towards the needle cover 16 as shown in FIGS. 6-8.

  While the needle 14 is moving within the lumen 13 of the cannula 9, a third rod portion 14c of the needle 14 forms a seal 100 because it fits tightly within the the light 19 (the

  structure of the needle 14 is described in detail below).

  However, when the distal end 15 enters the catheter adapter 52 and the third shaft section 14c is no longer in contact with the lumen 19 (see FIG. 7), blood may enter the housing 53 of the catheter. 52. In the absence of the seals 100, this blood can leak from the adapter 52 of the catheter and penetrate

  in the cover 16 of the tip of the needle.

  During the passage of the distal end 15 into the opening 108 of the seal 100, the opening 108 closes, thus preventing blood from leaking into the cover 16 of the tip of the needle. As the needle 14 moves from the position shown in Figure 5 to the position shown in Figure 8, the walls 110 of the opening 108 rub on

  the needle 14, thereby causing the needle 14 to feel

  if freed from the blood when she comes out of the set

with catheter 18.

  A second embodiment of the invention is shown in Figures 9 and 10. The second embodiment differs from the first advantageous embodiment by the fact that the spout 38a is eliminated. Except to the extent that they are otherwise identified, the elements

  numbered in FIGS. 9 and 10 are substantially identical

  those in Figures 1 to 8, except that they are preceded by

  Figure 1 "2" in Figures 9 and 10.

  A seal 200 is housed in a

  238 recess located in the hood 116 of the tip of the needle.

  The recess 238 is circular and is centered on the axis of the needle 214. The seal 200 is an elastomeric disc, preferably of silicone rubber. The seal 200 has an opening in the form

  a slot 208 sized so that the seal of

  Chest 200 fits tightly around the needle 214, thus sealing the blood. When the distal end of the needle 214 passes through the opening 208 of the seal 200, the opening 208 closes tightly, thus minimizing the leakage of blood to the outside of the cap 216 of the tip of the needle. The seal 200 rubs the needle 214 in the manner described above for the

  first embodiment. The Luer fitting of the adapter

  252 of the catheter has a surface 219. Before the introduction

  the catheter in a vessel, surface 219

  against the front surface 202 of the seal 200, thereby forming a seal between the catheter adapter 252 and the assembly comprising the needle tip cover 216 and the seal 200. This minimizes the blood flow between the cap 216 of the tip of the needle

  and keeping the catheter during actuation of the device.

  In the preferred embodiment, the assembly

  10 for the introduction of a catheter is provided with a

  protect the tip of the needle. A description

  A complete device is given in U.S. Patent No. 5,215,528. Referring to Fig. 5, a needle 14 includes a first rod portion 14a connected to the guard 12 of the needle and a second section of rod 14b connected to the tapered end 15. The first and second rod sections have substantially the same outer diameters. A third rod portion 14c is located between the first and second rod sections. This rod section has an outside diameter greater than that of the first and second rod sections. The diameter of the passage (not shown) extending into

the rod is substantially constant.

  A fourth rod portion 14b having a substantially conical configuration is provided between the first and third rod sections. The widened end of the fourth rod section 14d joins the third rod section 14c. As shown in Fig. 5, the fourth rod section 14d provides a smooth and uniform transition between the first rod section and the third rod section of the needle. A fifth section 14e rod may be placed between the second and third rod sections 14b, 14c of the needle. Like the fourth section of stem 14d, it

  has a substantially constant configuration.

  The third rod portion 14c is located near the beveled end. It is advantageously of an outside diameter greater than about 0.102 mm to the nominal diameter of the needle, that is to say the diameter of the first and second rod sections. It may also advantageously have a length of about 0.762 to about

3.05 mm.

  The fourth rod portion 14d has advantageous

  The length is about 0.381 to 1.143 mm, and is about 7.6 mm from the end of the beveled end. Since the overall length of the needle is 61 to 76 mm, the third and fourth shaft sections are substantially closer to the distal end 15 than they are to the needle guard 12. The fifth section of rod 14e may be substantially identical to the fourth

stem section.

  The shape and dimensions of the needle 14, including the sections 14a14e, are such that the needle 14 can easily be inserted into and removed from a vessel and that the catheter 18 can be easily removed by

sliding of the needle.

  The third enlarged stem portion 14c forms a seal between the interior of the lumen 13 of the cannula 19 and the remaining portion of the needle shaft. The seal opposes further blood until the needle has been completely removed from the cannula. As shown in FIGS. 3 and 4, the tapered forward end of the catheter extends beyond the third stump section. This is designed to prevent blood from leaking beyond the third stalk section while the needle enters a

blood vessel.

  Another function of the third enlarged section 14c of rod is to prevent the cover 16 of the tip of the needle from being removed from the needle shaft. Since the needle tip cover 16 is removably attached to the catheter adapter 62, it remains attached to the catheter adapter until the enlarged fourth section 14d of the catheter adapter shaft is secured to the catheter adapter 62. The needle engages the end wall of a flat spring 58. This engagement prevents the cover 16 from being removed from the needle 14 and traps the distal end 15 in the cover 16, thereby minimizing the risk of needlesticking by the needle. Continued removal of the guard from this point brings the hood of the tip of the needle to

  be separated from the catheter adapter. The set of introductions

  duction is completely separated from the catheter 18 and is rejected.

  The enlarged area of the needle may be formed by electrochemical etching of the material above or below

  below this area to reduce the diameter of the remaining part of the needle. Centerless grinding5 and coldfilling are other variants for shaping the needle into the desired configuration. Each technique provides a shaped needle made in one piece, which is advantageous. Other possible techniques include plating the area that has been chosen to expand

  or the molding on prison of a ring of polymeric material

only around the needle.

  Since the catheter 18 extends above the third enlarged stem section 14c of the needle both during insertion of the needle into the blood vessel and for most of the time during which the catheter is pushed back from the needle, virtually preventing any leakage between the catheter and the needle. The frictional contact between the third rod portion 14c and the inner wall of the catheter cannula portion is

  noticeable while the catheter is removed from the needle.

  The distal end of the needle 14 is protected by the introduction of the cannula 13 into the blood vessel. It is positioned inside the catheter 18 during the initial withdrawal and is finally positioned within the needle hole cover. Once the tip of the needle is withdrawn beyond the transverse wall portion 63 of the spring 58, the spring moves to the position shown in FIG. 8. The tip of the needle can thus not descend. along the needle shaft towards the needle guard. The distance between the third expanded stem section 14c and the tip 15 of the needle 14 is

  less than the distance between the transverse wall part

  dirty 63 of the spring and the end wall 60 of the flat spring 58.

  The third rod portion 14c therefore reaches the end wall 60 just after the spring has passed above the tip of the needle. Since this stem section

  14c can not pass into the aperture 59 of smaller diameter of the end wall 60, the cover 16 of the end of

  guille can not be removed from the tip of the needle. The flange 48 also plays a role in preventing the tip of the needle from coming out of the cover 16 of the needle tip. If a force is applied to pull back the needle tip cover along the needle 14 toward the guard 22, the distal end 15 tends to push against the enlarged wall portion 63, which is attempting to flex. clockwise (see Figures 5 and 6). If this happens, the extended wall portion 63 does not

  can not bend further when it is against the

  flange 48. The exit path of the end

  distal 15 is blocked safely.

  It goes without saying that many modifications can be made to the assembly for the introduction of a catheter described and shown without departing from the scope of the invention.

Claims (13)

  1. A set for the introduction of a catheter, characterized in that it comprises a needle (14) having proximal ends (17) and distal (15) and a zone (14c) 5 of enlarged diameter; a needle guard (12) connected to the needle at the proximal end thereof; a catheter assembly (18) including a cannula (19) and a catheter adapter (52) connected to the cannula, which can be concentrically mounted around the needle so that the catheter assembly can slide on the catheter needle and that the needle can be removed from the catheter assembly; and a seal assembly (16) releasably secured to   the catheter adapter so that the set of   the needle can be slid, the seal assembly including a seal (100) or (200) for limiting the flow of blood from the catheter adapter and having means for engaging the enlarged diameter on the needle to secure the sealing assembly in close proximity to the distal end of the needle   when the catheter assembly slides on the needle.   2. The catheter introduction set according to claim 1, characterized in that the sealing assembly extends between the needle guard and the assembly. catheter.   The catheter introducer assembly of claim 1, characterized in that the seal is located within the catheter adapter. 4. The catheter introduction set according to claim 1, characterized in that the sealing assembly comprises a projection (38a) which penetrates into the catheter adapter.   5. Set for the introduction of a catheter according to claim 4, characterized in that the seal   sealing is carried by the projection.   6. The catheter introduction set according to claim 1, characterized in that the seal concentrically adjusts to the needle. 7. A set for the introduction of a catheter, characterized in that it comprises a needle (14) having proximal (17) and distal (15) ends, and a zone (14c)   enlarged diameter; a guard (12) connected to the needle at the proximal end thereof; a catheter assembly (18) comprising a cannula (19) having proximal ends   male and distal and a catheter adapter (52) to the cannula, at the proximal end of the cannula, which can be concentrically mounted on the needle so that the catheter assembly can slide on the needle; a needle cap (16) mounted proximally of the distal end of the needle, the cap being slidable over the needle and having means for engaging the enlarged diameter area of the needle to   to secure the needle cap cover in close proximity   mediate the distal end of the needle when the whole   Catheter bleeds on the needle; and a seal of   (100) or (200) mounted on the hood of the end of the   guille so as to form a blood-tight seal between the   tip cover and catheter adapter.   8. Set for the introduction of a catheter according to claim 7, characterized in that it further comprises means for connecting the cover of the tip of the needle to the catheter assembly.   9. A catheter introducer assembly as claimed in claim 7, characterized in that the tip cap extends between the guard and the catheter assembly. 10. The catheter introduction set according to claim 11, characterized in that the seal is located inside the adapter of the catheter.   The catheter introducer assembly as claimed in claim 7, characterized in that the tip cap comprises a projection (38a) which penetrates in the catheter adapter.   12. Set for the introduction of a catheter according to claim 11, characterized in that the seal   sealing is carried by the projection.   13. Set for the introduction of a catheter according to claim 7, characterized in that the seal   seal concentrically adjusts to the needle.