JP2584597B2 - Catheter introduction device with blood seal - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a catheter introduction device. More specifically, the present invention relates to a catheter introducer having a blood seal for reducing blood leakage when introducing a catheter into a blood vessel.

[0002]

BACKGROUND OF THE INVENTION Catheters are commonly used in medical procedures as a means of providing access to a patient's conduit. Typically, a catheter is introduced into a blood vessel with the aid of a needle that punctures the blood vessel to form a hole through which the catheter can be inserted into the blood vessel. During such a process the needle may become contaminated with blood. Since the advent of AIDS, there has been increasing awareness of the possible presence of blood from patients carrying other pathogens, such as AIDS virus or hepatitis virus. Blood leaks during the introduction of the catheter into the patient's body may increase the risk of transmission of such blood-associated pathogens.

[0003]

It is an object of the present invention to reduce the risk of such transmissions by providing a catheter introducer with a blood seal that minimizes blood leakage.

[0004]

SUMMARY OF THE INVENTION A catheter introducer assembly of the present invention includes a needle having a proximal end and a distal end. A hub is attached to the proximal end of the needle. A catheter assembly formed by a cannula and a catheter adapter attached to the cannula is axially slidably mounted about the needle. The cannula can be mounted concentrically around the needle such that the catheter assembly can slide about the needle and the needle can be withdrawn from the catheter assembly. The catheter introducer assembly is provided with a seal assembly on the outer periphery of the needle adjacent the catheter adapter, the seal assembly being slidable about the needle. ing. The seal assembly supports a seal adapted to restrict blood flow from the catheter adapter.

[0005]

DESCRIPTION OF THE PREFERRED EMBODIMENTS A catheter introducer assembly 10 includes a needle hub 1.
2, a needle 14 having a distal end 15 and a proximal end 17 secured to the needle hub 12, and a needle tip cover 16 slidably mounted on the needle shaft. Cannula 19 and adapter 52
Is slidably mounted on the needle shaft. Cannula 19 has lumen 13. The catheter assembly 18 is slidably mounted on the needle shaft and releasably mounted on the needle tip cover 16.

[0006] The needle hub 12 is a transparent body 2 which is integrally molded.
0, the transparent body 20 has a substantially flat top surface 22a, a bottom surface 22b, and a pair of side walls 24, 26, the pair of side walls 24, 26 providing a needle between fingers. It is generally concave to facilitate operation of the hub. Each end of the side wall includes a stepped portion 28. The rear end of the needle hub is bifurcated. A cylindrical tube 29 extends into the forked end and communicates with the rear end of the needle. The plug 30 can be fixed to the rear end of the tube 29.

[0007] The needle tip cover 16 is formed of an elongated hollow main body 3.
8 is included. The needle cover 16 supports a seal 100 described below. Needle tip cover 16 is seal 10
The term "seal assembly" will be used interchangeably with the term "needle tip cover" since it supports the needle 14 and protects the needle 14. An elongated hole 40 extends through one of the sides of the body 38, and a rectangular hole 42 extends through the opposite side. A pair of flat planes forms the other two sides of the body.

A cylindrical passage 32 is formed inside needle hub 12. The proximal end 38b of the needle tip cover 16 can be positioned within this passage. Hole 36 is needle hub 12
Hole 3 extends into needle hub 12 adjacent to bottom surface 22b of
4 (see FIG. 3). Needle tip cover 16
Has a protruding portion 70 extending into the hole 34 and slidably extending in the radial direction. This prevents the needle tip cover 16 from rotating with respect to the needle hub 12.

A radially extending flange 48 extends from the needle cover body 38 and forms one end of the elongated aperture 40. The flange 48 is substantially annular except that it has a flat surface 48a on one side and a tab 48b protrudes from the other side. This tab 48
b is provided to allow the user to separate and push the needle tip cover and catheter assembly away from the needle hub when introducing the catheter and withdrawing the needle. A plurality of arcuate projections 50 extend from the flange 48, and these arcuate projections form a structure 53 for holding the catheter adapter 52. The ends of these projections
Includes an inwardly projecting lip 54 for releasably coupling flange 56 of catheter adapter 52 to seal assembly 16. The arcuate protrusion 50 and the lip 54 engage the flange 56 so that the tab 48b makes it easier to remove the needle tip cover from the needle hub than to remove the catheter adapter 52 from the retaining mechanism 53. ing. Accordingly, the user is discouraged from removing the catheter adapter 52 to expose the tip of the needle 15, and is forced to take advantage of the shielding properties according to the present invention, as described below. One end of the tubular body 38 of the needle tip cover forms a protrusion or nose 38a that extends into the catheter adapter.

A seal 100 is positioned within the nose 38a of the needle tip cover 16. Seal 100 is a substantially cylindrical member made of an elastic material, preferably silicone rubber. The seal 100 is substantially cylindrical and has a circumferential lip 106 that assists in positioning the seal 100 within the nose 38a of the body of the needle tip cover. The forward portion 104 of the circumferential lip 106 contacts the inside of the catheter adapter 52 to provide a seal between the nose 38a and the catheter adapter 52. The elongated rear portion 102 extends into the nose 38a.
The front portion 104 is provided with a hole 108 sized such that the seal 100 fits tightly around the needle 14 to provide a blood seal. The seal 100 is a needle 1
4 is placed in the nose 38a in a radially compressed manner to help close the hole 108 as it passes.
The aperture 108 is also sized and designed to substantially occlude the aperture 108 when the tip 15 of the needle 14 is withdrawn as shown in FIG. 1 to prevent blood from flowing into the nose 38a. Has become.

Prior to use, holes 108 in seal 100
Is in contact with the needle 14 as shown in FIG. When the vein is punctured by the needle 14, as shown in FIGS.
The needle 14 is withdrawn and the tip 15 is pulled by the user towards the needle cover 16. Needle 14 is cannula 19
Of the needle 14 when moved through the lumen 13 of the needle 14
c fits tightly with the lumen 13 of the cannula 19 to provide a blood seal. The structure of the needle 14 will be described later in detail.
However, when the tip 15 of the needle 14 enters the catheter adapter 52, the third shaft portion 14c of the needle 14 does not come into contact with the lumen 13 of the cannula 19 (FIG. 7), and the blood flows into the holding mechanism 53 of the adapter 52. May flow into. Without the seal 100, this blood may leak out of the catheter adapter 52 and flow into the needle tip cover 16.

The tip 15 of the needle 14 is
After passing through 8, the hole 108 is closed again to prevent blood from leaking into the needle tip cover 16. When the needle 14 moves from the position shown in FIG. 5 to the position shown in FIG. 8, the wall 110 of the hole 108 wipes the surface of the needle 14 so that the needle 1
Substantially no blood adheres as 4 exits catheter assembly 18.

A second embodiment of the present invention is shown in FIGS. This second embodiment differs from the first preferred embodiment in that the nose 38a is omitted. Since the other parts shown in FIGS. 9 and 10 are the same as those of the first embodiment, the numbers of the parts shown in FIGS. 9 and 10 are prefixed with the numbers of the parts shown in FIGS. The same numbers are given except for 2 ″.

The seal 200 is seated in a recess 238 in the needle tip cover 216. Recess 238 is circular and coaxial with the axis of needle 214. The seal 200 is preferably an elastic disk made of silicone rubber. Seal 20
0 is provided with a slit-like hole 208 dimensioned such that the seal 200 fits tightly around the outer circumference of the needle 214 to provide a blood seal. As the tip of needle 214 passes through hole 208 of seal 200, hole 208 closes again to minimize leakage of blood into needle tip cover 216. The seal 200 wipes the surface of the needle 214 in a manner as described with respect to the first embodiment. The luer connector of the catheter adapter 252 has a surface 219. Before inserting the catheter into the blood vessel, face 2
19 abuts against the front surface 202 of the seal 200, the catheter adapter 252, the needle tip cover 216 and the seal 2
00 to form an seal with the assembly that contains the 00. This minimizes blood flow between the needle tip cover 216 and the catheter hub during operation of the device.

In the preferred embodiment, the catheter introducer assembly 10 is provided with a needle tip shield. Such members are described in detail in US Pat. No. 5,215,528, which is incorporated herein by reference.

Referring to FIG. 5, the needle 14 is
A first shaft portion 14a and a sharp tip 1
5 and a second shaft portion 14b connected thereto. These first and second shaft portions have substantially the same outer diameter. A third shaft is provided between the first shaft portion and the second shaft portion.
Is disposed. The third shaft portion has a larger outer diameter than the first and second shaft portions. The diameter of a passage (not shown) extending through the shaft portion of these needles is substantially constant.

The first shaft portion 14a and the third shaft portion 14c
A fourth shaft portion 14d having a substantially conical shape is provided between the fourth shaft portion 14d and the fourth shaft portion 14d. The larger end of the fourth shaft portion 14d is connected to the third shaft portion 14c. As shown in FIG. 5, the fourth shaft portion 14d provides a smooth and uniform boundary from the first shaft portion to the third shaft portion of the needle.

The second shaft portion 14b and the third shaft portion 14c
And a fifth shaft portion 14e is provided between the first shaft portion and the second shaft portion. Like the fourth shaft portion 14d, the fifth shaft portion is also substantially conical.

The third shaft portion 14c is located near the beveled tip. The outer diameter of the third shaft portion 14c is about 0.102 mm (0.004 inches) greater than the nominal diameter of the needle, i.e., the outer diameter of the first and second shaft portions.
It is preferably larger only. Also, the length of the third shaft portion is from about 0.730 mm (0.030 inch) to about 3.048.
mm (0.12 inches).

The length of the fourth shaft portion 14d is about 0.38
1 mm (0.015 inch) to 1.143 mm (0.0
45 inches) and preferably 0.3 inches from the angled tip. Since the overall length of the needle is about 2.4 inches to 3.0 inches, the third and fourth shaft portions are closer to the needle tip 15 than the needle hub 12. . The fifth shaft portion 14e is substantially the same as the fourth shaft portion.

The shape and size of the needle 14, including the shaft portions 14a-14e, is such that the needle 14 can be easily inserted into and withdrawn from the blood vessel, and the catheter 18 can be easily slid from the needle by sliding the catheter 18. It has been made removable.

An elongated third shaft portion 14c provides a seal between the lumen 13 of the cannula 19 and the rest of the needle shaft. This seal prevents blood leakage until the needle is completely removed from the cannula. As shown in FIGS. 3 and 4, the tapered forward end of the catheter extends beyond the third shaft portion. This is to prevent blood from leaking beyond the third shaft portion when the needle punctures the blood vessel.

Another function of the elongated third shaft portion 14c is as follows.
The purpose is to prevent the needle tip cover 16 from coming off the axis of the needle. When the needle tip cover 16 is releasably attached to the catheter adapter 52, the needle cover remains attached to the catheter adapter until the elongated fourth portion 14d of the needle shaft engages the wall 60 of the leaf spring 58. Up to. This engagement prevents the cover 16 from disengaging from the needle 14 and the tip 15 of the needle is retained within the cover 16 to minimize the risk of puncturing by the needle.
By further withdrawing the needle hub from this state, the needle tip cover is removed from the catheter adapter. In this manner, the catheter introducer assembly is
Completely separated from the waste and disposed of.

The elongated portion of the needle can be formed by reducing the diameter of the remaining portion of the needle by electroetching above and below this portion.
Other methods for forming the needle into the desired shape include centerless grinding and cold upswing.
etting). Both techniques provide the preferred monolithic molded needle. Other possible techniques include plating the selected portion to make it thicker or insert molding a band of polymeric material around the needle.

When introducing the needle into a blood vessel and during most of the time the catheter is pushed away from the needle, the catheter 1
Since 8 extends beyond the elongate third shaft portion 14c of the needle, leakage between the catheter and the needle is substantially prevented. As the catheter moves away from the needle, the frictional engagement between the third shaft portion 14c and the inner wall of the cannula portion of the catheter becomes significant.

The tip 15 of the needle 14 is protected when the cannula 19 is introduced into a blood vessel. The needle tip 15 is positioned within the catheter 18 when first withdrawn,
Then it is finally positioned in the needle tip cover. As the tip of the needle is pulled past the transverse wall portion 63 of the spring 58, the spring 58 moves to the position shown in FIG. This prevents the needle tip cover from moving in the direction of the needle hub along the axis of the needle. Elongated third shaft portion 14c
Is smaller than the distance between the transverse wall portion 63 of the leaf spring 58 and the end wall 60 of the leaf spring 58. Thus, the third shaft portion 14c reaches the end wall 60 shortly after the leaf spring has passed the tip of the needle. The third shaft portion 14c has a smaller diameter hole 59 in the end wall 60.
The needle tip cover 16 is prevented from moving and moving away from the end of the needle.

The flange 48 also serves to prevent the needle tip 15 from reappearing from the needle tip cover 16. When a force is applied to pull the needle tip cover back along the needle 14 toward the hub 22, the tip 15 of the needle will
Pressing 3 will turn clockwise (see FIG. 8). Should this occur, the wall portion 63 would be prevented from hitting the inside of the flange 48 and bending further. In this way, the exit path of the tip 15 will be reliably blocked.

Although the embodiments of the present invention shown in the drawings have been described above with reference to the accompanying drawings, the present invention is not limited to these embodiments themselves, and various modifications may be made without departing from the scope of the present invention. It should be understood that modifications and variations of this may be made by those skilled in the art.

[Brief description of the drawings]

FIG. 1 is a perspective view of a catheter introduction device assembly of the present invention.

FIG. 2 is a detailed perspective view showing a needle cover and a blood seal of the present invention.

FIG. 3 is a detailed sectional view of a part of the needle cover.

FIG. 4 is a perspective view of a latch mechanism for attaching a needle cover to a needle.

FIG. 5 is a cross-sectional view along the line 5-5 ′ in FIG. 1, showing the operating state of the device of the present invention.

FIG. 6 is a cross-sectional view taken along line 5-5 ′ in FIG. 1, showing the operating state of the device of the present invention.

FIG. 7 is a cross-sectional view taken along line 5-5 ′ in FIG. 1, showing the operating state of the device of the present invention.

FIG. 8 is a cross-sectional view taken along line 5-5 ′ in FIG. 1, showing the operating state of the device of the present invention.

FIG. 9 is an exploded perspective view showing a second embodiment of the needle shield and the blood seal according to the present invention.

FIG. 10 shows a line 10- in the second embodiment shown in FIG. 9;
It is sectional drawing along 10.

[Explanation of symbols]

10 catheter introducer assembly, 12 needle hub,
14 needle, 16 needle tip cover, 18 catheter assembly, 19 cannula, 20 needle hub body, 52 catheter adapter, 58 leaf spring, 100 seal

 ────────────────────────────────────────────────── ─── Continued on the front page (72) Inventor Timothy Jay Eskin, Stonebury, Stoney 184094, Utah, USA 1160 (72) Inventor Gerald H. Peterson Salt Lake City, 84124, Utah, USA , Hermosa Way 2858 (72) Inventor Edmunds Earl Purdy East Raymond Road, Fruits Heights, 84027, Utah, USA 1102

Claims (13)

(57) [Claims] 1. A catheter set comprising: a needle having a proximal end, a distal end, and a region of increased diameter; a needle hub attached to the proximal end of the needle; a cannula; and a catheter adapter attached to the cannula. Three-dimensional, the cannula being concentrically mounted on the outer periphery of the needle such that the catheter assembly is slidable about the needle and the needle can be withdrawn from the catheter assembly. A catheter assembly, and a seal assembly releasably attached to the catheter adapter so as to be able to slide around the outer periphery of the needle,
On the needle to restrict blood flow from the catheter adapter and to secure the seal assembly adjacent the tip of the needle as the catheter assembly slides around the needle. A seal assembly including a seal having means for engaging the increased diameter region of the catheter introducer assembly. 2. The catheter introducer assembly of claim 1, wherein said seal assembly is located between said needle hub and said catheter assembly. 3. The catheter introducer assembly according to claim 1, wherein said seal is located within said catheter adapter. 4. The catheter introducer assembly of claim 1, wherein said seal assembly includes a protrusion extending into the catheter adapter. 5. The catheter introducer assembly according to claim 4, wherein said seal is supported by said protrusion. 6. The catheter introduction device assembly according to claim 1, wherein said seal is fitted concentrically around the outer periphery of said needle. 7. A needle having a proximal end, a distal end, and a region of increased diameter; a hub attached to the proximal end of the needle; a cannula having a proximal end and a distal end; and attached to the proximal end of the cannula. A catheter assembly including a catheter adapter, wherein the cannula is concentrically mounted on the outer periphery of the needle such that the catheter assembly is slidable on the outer periphery of the needle. A three-dimensional, needle tip cover that can be attached to the base end of the tip of the needle, wherein the needle tip cover is slidable on the outer circumference of the needle and the catheter assembly slides on the outer circumference of the needle. A needle tip cover including means for engaging a region of increased diameter on the needle to secure the needle tip cover adjacent the tip of the needle; and mounting on the needle tip cover. Being A seal providing a blood seal between the needle tip cover and the catheter adapter. 8. The catheter introducer assembly of claim 7, further comprising means for coupling said needle tip cover to said catheter assembly. 9. The catheter introducer assembly of claim 7, wherein said needle tip catheter is located between said hub and said catheter assembly. 10. The catheter introducer assembly of claim 7, wherein said seal is located within said catheter adapter. 11. The catheter introducer assembly of claim 7, wherein the needle tip cover includes a protrusion extending into the catheter adapter. 12. The catheter introducer assembly according to claim 11, wherein said seal is supported by said protrusion. 13. The catheter introducer assembly of claim 7, wherein said seal is fitted concentrically on said needle.