WO2001074416A2

WO2001074416A2 - Tubular intravenous set

Info

Publication number: WO2001074416A2
Application number: PCT/US2001/010056
Authority: WO
Inventors: David S. Utterberg
Original assignee: Dsu Medical Corporation
Priority date: 2000-04-03
Filing date: 2001-03-29
Publication date: 2001-10-11
Also published as: US6616635B1; WO2001074416A3; AU2001251087A1

Abstract

A medical needle protector sheath comprises a tubular body (50) for surrounding and shielding a needle, with the sheath defining an anchor member (58) integrally attached to the front of the body for manual holding, plus a closure cap (60) for the front end which is integrally attached to the body. Also, a manually removable wing member (18) may be carried about the hub of the needle. A tunnel member (38), typically of the inverted U cross section, provides longitudinal securance to the needle and hub while penetrating the skin of the patient while at the same time permitting axial rotation of the needle.

Description

TUBULAR INTRAVENOUS SET

Inventors: David Bell

William J. Schnell and David S. Utterberg

BACKGROUND OF THE INVENTION 0 The invention relates to a tubular intravenous set having various improvements.

Such sets are commonly used to gain access to the vascular system of the patient for purposes of blood access for extracorporeal blood processing such as hemodialysis, or for the administration of parenteral solutions, blood, or other medical solutions to the patient. In the prior art sets for intravenous access to a patient, a medical needle is attached 5 to typically a winged hub, which hub, in turn, is attached to the flexible tubing of the set. The wings of the hub are flexible, being generally folded up, to be gripped by the fingers as the needle is inserted into the vascular system. Then, the wings are folded down and taped to the skin to retain the needle in position.

However, certain drawbacks exist with this system despite its widespread clinical o use. For example, if the needle enters the vascular system at an angle that is slightly steeper than normal, the patient may experience discomfort when the wings of the hub are taped down, in that such taping will tend to rotate the needle tip upwardly, resulting in chronic discomfort and even damage to the vein wall while the needle remains in position. Also, the wings are flexible, causing an uncertainty in the process of needle insertion resulting 5 from an absence of rigidity as the wings are gripped.

By this invention, a substantially rigid wing system for the needle hub is provided, which improves the ability of the technician to make an effective and proper entry of the needle into the vascular system. Then, by this invention, the wing member can be removed after the needle has been emplaced, and the needle hub may be taped in position. o Alternatively, this invention provides a securance system of the needle hub to the skin in which an angular variation of the needle and hub may be permitted and protected by a rigid system, so that the tip of the needle within the blood vessel is not urged by taping of the hub to the skin into an angular direction that can cause discomfort to the patient and even blood vessel damage.

Additionally, this invention relates to a new design of needle protector sheath for use with preferably wingless needle hubs, in which, after use, the needle can be retracted from the vascular system of a patient, withdrawing into the sheath of this invention so that the sharp tip of the needle is enclosed in the sheath to eliminate the possibility of accidental needle sticks. In the large body of prior art, among others, see Utterberg et al. U.S. Patent No. 5,112,311; Utterberg U.S. Patent Nos. 5,562,637; 5,290,264; 5,562,636; 5,951,529; 5,704,917; and Utterberg et al. Patent Nos. 5,704,924 and 5,772,638. These patents all disclose needle protector sheaths for use with winged needles, with the sheaths carrying slots through which the wings project.

DESCRIPTION OF THE INVENTION

In accordance with this invention a tubular medical needle set is provided which comprises: a needle and needle hub connected to an end of flexible tubing plus a wing member positioned to facilitate manual gripping of the needle and hub, either by gripping the hub directly or by gripping flexible tubing which is positioned outside of the hub.

The wing member comprises a hub gripping portion (which may grip the tubing adjacent to the hub), and a wall portion attached to the hub gripping portion. The wall portion extends laterally outwardly from the hub gripping portion for manual gripping as the needle is being manipulated. The hub gripping portion is manually disengageable from the hub, for manual removal of the wing member after the needle has been emplaced in a patient. Then, the needle may be directly taped to the skin, or may be placed in a tunnel member on the skin, which is described below along with the advantages thereof.

Preferably, the wing member comprises a pair of walls and attached hub gripping members which grip the hub, each attached hub gripping member being respectively positioned on an opposed side of the hub to the other hub gripping member. The pair of walls extend in generally parallel, adjacent manner laterally outwardly from the hub, each extending from one of the hub gripping members. The pair of walls define the wall portion described above. The walls are integrally attached together by a hinge wall. The walls also each define a squeeze portion extending laterally outwardly beyond the hinge wall. Thus, manual squeezing of the squeeze portion disengages the hub gripping members from the hub, to permit removal of the wing member. The hinge wall flexes to an extent, but is

5 biased to force the hub gripping members into their gripping relation.

Preferably, a groove may extend around the needle hub. The hub gripping members may define projections that fit in the groove, to restrict axial sliding of the wing member while gripping the hub. Typically, the groove is defined between the hub and the connected, flexible tubing end carried on the hub. 0 The wing member may be substantially rigid when mounted on the hub, to be manually gripped as the needle is used in a phlebotomy procedure to enter a blood vessel of the patient. Then, the wing member may be removed. A substantially rigid tunnel member may be applied to enclose at least a portion of the hub resting on the skin of the patient. The tunnel member has a cross section of substantially the shape of an inverted U, to define s two tunnel edges for resting on the skin of a patient, while the needle of the enclosed needle hub penetrates the patient's skin.

The tunnel member may have front and rear apertures through which the hub and tubing extend. The rear aperture may be larger than the front aperture, to accommodate a range of angular needle positions in the tunnel member. The tunnel member provides o protection and retention to the needle hub, while having a tolerance for a variation in the angle of penetration of the needle through the skin.

The tunnel member may be secured to the skin of a patient by a strip of medical tape, thus securing the needle and hub in position, while permitting the needle and hub to rotate if desired, and protecting the needle and hub even if there is a variation of angle of 5 entrance into the skin, without biasing or otherwise forcing the needle tip to move in an undesirable direction.

To secure the needle and hub longitudinally in position, the front aperture of the tunnel member may at least in part be defined by a front, inwardly extending flange. A groove is defined in the hub, typically the same groove that is engaged by the wing member o which may have been previously removed. This groove receives the front flange of the tunnel member, and thus prevents longitudinal movement between the tunnel member and the needle hub. Accordingly, protection of the needle and hub is provided by the tunnel member, while permitting rotatability of the needle and hub about the needle axis, and with tolerance of a variety of needle entrance angles of the needle to the vascular system relative to the skin of the patient.

Further in accordance with this invention, a medical needle protector sheath is 5 provided, which comprises a tubular body for surrounding and shielding a needle. The body has front and rear ends, with the sheath defining a substantially flat anchor member, which is integrally attached to a first attachment portion of the front end of the body, and extends forwardly from the front end of the body, to be manually held to retain the protector sheath from movement as the needle is being withdrawn from the skin of a patient 0 into the tubular body. This has similarity to that which is described in the previously cited Utterberg et al. U.S. Patent No. 5,112,311 and Utterberg U.S. Patent Nos. 5,562,637 and 5,772,638.

Additionally, the protector sheath of this invention carries a closure cap for the front end. The cap is also integrally attached to the tubular body. Specifically, the closure s cap may be integrally attached to another portion of the front end of the body through a hinged connector member, so that the closure cap may be moved by hinge action to close after the tip of the needle has been retracted into the protector sheath, upon withdrawal of the needle from the patient. The needle tip is more reliably enclosed and may be effectively sealed, particularly in slot-free sheath designs, with the closure cap being preferably thick o enough so that the needle cannot penetrate through it. Thus blood drops do not leak from the sheath. Also, the present sheath may be smaller in diameter than corresponding slotted designs.

The closure cap may specifically be attached to the front end of the body at an end portion which forms about a 40 to 140 degree angle to the area of the first attachment 5 portion of the anchor member at the front end. Thus, the closure cap closes in a transverse direction relative to the transverse direction which the anchor member moves when held or pressed downwardly with the finger, for retaining the protector sheath as the needle is withdrawn from the patient into the sheath.

The rear end of the protector sheath may carry at least one gripper to retain the o sheath in position surrounding and shielding the needle. The gripper may comprise at least a pair of spaced flanges that engage tubing surrounding the needle hub. The flanges maybe diametrically spaced, straight inner edge portions of a ring-shaped flange member. As is common with respect to the protector sheaths for winged needles, the sheath may initially reside on a length of the set tubing which is spaced from the needle and hub. Then, when it is desired to withdraw the needle from the patient, the sheath may be moved forward along the set tubing. Before the sheath gets to the vicinity of the needle hub, the two diametrically spaced, straight irmer edge portions of the flange, which are of reduced distance from each other relative to the remaining inner diameter of the protector sheath, compress the set tubing slightly in one dimension, causing it to assume a slightly oval shape. This permits easy sliding of the sheath along the tubing. However, when the sheath and its flange member at the back arrive at the needle hub, with the set tubing surrounding the needle hub, the tubing can no longer be pushed into an oval configuration because of the inner radial support of the needle hub. Therefore, the straight inner edge portions of the ring-shaped flange member bite into the soft tubing and become fixed in position, so that the sheath is no longer easily withdrawn.

Alternatively, the protector sheath of this invention may have a gripper which comprises an inwardly extending projection to engage a recess in the needle hub, in typically a snap-fit retention for retaining the protector sheath in an advanced position on the needle hub and enclosing the point of the needle.

The tubular body of the protector sheath may be substantially cylindrical, with optionally a flat, external surface portion defined along one side thereof. The one side is typically positioned in circumferentially opposed relation to the first portion of the front end of the body that connects with the anchor. Thus, a flat surface is provided upon which the sheath rests against the skin or a bandage over the skin. The added, integral front end closure of the protector sheath is desirable for avoiding any spillage of blood after withdrawal of the needle from the patient. This closure is provided in conjunction with the anchor, which greatly facilitates the safe withdrawal of the needle and its entry into the protector sheath.

While the protector sheath of this invention is illustrated as being free of slots, it may also have slots if desired, to accommodate needles having winged hubs for the safe storage of the needle tips. Thus, a tubular, intravenous set is provided in which a rigid wing on the hub gives improved ability for an optimum phlebotomy with the needle, when compared with the flexible wings which are gripped in the prior art winged needles. The wing member of this invention may then be removed to permit taping down as desired. As a preferred alternative, a tunnel member is provided to permit taping and retention of the needle in position without bending the needle out of its natural angle of approach to the skin, and also permitting the needle and hub to be axially rotated if needed.

The wing member of this invention can be attached to conventional wigless needle hubs to provide them with the advantages of a rigid wing.

Furthermore, a protector sheath is provided for the needle tip which carries the desired anchor at its front end, and also a hinged front end closure to seal the front end of the protector sheath after the needle has been safely stored inside.

DESCRIPTION OF THE DRAWINGS

In the drawings, Fig. 1 is a back perspective view of a medical needle and needle hub set, connected to an end of flexible tubing, incorporating the invention of this application;

Fig. 2 is a sectional view taken along line 2-2 of Fig. 1;

Fig. 3 is a sectional view taken along line 3-3 of Fig. 2;

Fig. 4 is a front perspective view of the needle set of Fig 1 emplaced within the skin of a patient and showing the front of the protector sheath carried thereon, and with the removable wing member taken away;

Fig. 5 is a front perspective view showing the needle set of this invention emplaced within the skin of a patient and utilizing the tunnel member of this invention;

Fig. 6 is a sectional view taken along line 6-6 of Fig. 5;

Fig. 7 is an enlarged, elevational, rear end view of the protector sheath shown in the previous drawings;

Fig. 8 is a fragmentary, longitudinal sectional view of the front end of the protector sheath, the view shown rotated 90 degrees and advanced into its needle-enclosing position; and

Fig. 9 is a fragmentary, partially longitudinal sectional view of another design of the needle and hub set usable in this invention, showing it to be enclosed with another embodiment of the protector sheath of this invention. Fig. 10 is a fragmentary, partially longitudinal sectional view shown in perspective, of another design of the needle and hub set usable in this invention, showing it to be enclosed with another embodiment of the protector sheath of this invention.

Fig. 11 is a fragmentary, longitudinal sectional view of the needle and hub of Fig. 10. with the sheath in a different position.

Fig. 12 is a fragmentary, longitudinal sectional view similar to Fig. 11, showing a modification thereof.

Fig. 13. Is a fragmentary, longitudinal sectional view similar to Fig. 11, showing a different modification thereof.

DESCRIPTION OF THE SPECIFIC EMBODIMENTS

Referring to the drawings, tubular medical needle set 10 comprises a needle 12, needle hub 14, and flexible set tubing 16 which is secured on needle hub 14 in conventional manner.

In accordance with this invention, needle set 10 may carry a wing member 18 which is positioned to manually grip hub 14, as particularly shown in Figs. 2 and 3.

Wing member 18 comprises a hub gripping portion 20 which portion is carried by needle hub 14. Wing member 18 also comprises a wall portion 22, which is attached to the hub gripping portion 20. Wall portion 22 extends laterally outwardly from hub gripping portion 20 to permit manual gripping by the user. Thus, needle 12 can be manually controlled with ease as it is inserted into the venous system of a patient.

As can be seen particularly in Fig. 2, hub gripping portion 20 and the entire wing member 18 is manually disengageable from needle hub 14 so that the entire wing member 18 can be manually removed after needle 12 has been emplaced in the patient. As shown, this may be accomplished when hub gripping portion 20, as shown, comprises a pair of hub gripping members 24, which grip hub 14 respectively on opposed sides thereof. A pair of walls 26, which respectively comprise the wall portion 22 extend in generally parallel manner laterally outward, each from one of the hub gripping members 24. Walls 26 are integrally attached together by hinge wall 28, and each define a squeeze portion 30 extending laterally outwardly beyond hinge wall 28. Hub 14 may define an opposed pair of projections 25 which snap fit into corresponding recesses 27 defined in the hub gripping members 24. Thus, hub 14 may be secured within wing member 18 in a bevel-up needle position which is securely rotatably maintained with respect to wing member 18 for easy cannulation into the vascular system of the patient 36. Then, wing member 18 may be removed as described above.

Thus it can be seen that wing member 18 may be made of a single piece of molded plastic having a certain degree of flexibility. Manual squeezing of squeeze portions 30 permits disengagement of hub gripping member 24 from the hub per arrows 31, to permit removal of the wing member. Wing member 18 is designed so that hub gripping members 24 are biased inwardly to be normally retained in engagement with the hub 14.

Referring to Fig. 3, it can be seen that tubing 16 and hub 14 together define an annular groove 32 into which projections 34 of the respective hub gripping members 24 can reside. Thus, axial sliding of wing member 18 is restricted in its normal hub gripping position. Thus, the set of this invention may initially be in the configuration of Fig. 1, in which the user grips wing member 18 to pass needle 12 through the skin 36 of a patient, thus occupying the position shown in Fig. 4. Then, wing 18 may be removed as described above, as shown in Fig. 4, and a tunnel member 38 may be applied as shown in Fig. 5. Tunnel member 38 has the cross section of substantially an inverted U, defining a pair of runnel edges 40 which rest against the skin 36. Tunnel member 38 also has front aperture

42 and rear aperture 44 through which the hub 14 and tubing 16 extend as shown in Fig. 5. Rear aperture 44 is larger than front aperture 42, to permit needle 10 occupy a range of angular needle positions in tunnel member 38 as particularly shown in Fig. 6. Needle 12 and hub 14 are occupying a near maximum vertical rotational position as shown in Fig. 6, but it would be possible for the needle to occupy a position closer to the horizontal, and to still occupy tunnel member 38 without rotational or bending stress on the needle, so that less discomfort or damage is experienced by the patient.

As shown, tunnel member 38 is secured to the skin of the patient by a strip of medical tape 46, while needle 12 penetrates the skin of the patient 36. It can be noted that the set and needle 12 can be rotated about their major axis while occupying the position of

Fig. 5 and retained by tunnel 38 and tape 46, which may be desirable in some clinical circumstances. Also, needle 12 and set 10 are axially retained in tunnel member 38 by flange 48 at front end 42 of tunnel member 38, which flange fits into annular groove 32 of the set, the same annular groove that is used with wing member 18. Thus, the needle and set are firmly secured on the patient while at the same time axial rotation is permitted.

Referring again particularly to Figs. 1, 4 and 7, flexible tubing 16 carries a protector 5 sheath 50, which is broadly similar in function to the protector sheaths of the patents cited above, but shown here in a slotless version. Sheath 50 comprises a hollow body 52 having a front end 54 and a rear end 56. Sheath 50 defines an anchor member 58, of generally conventional design, being integrally attached by hinge 59 to the front end of body 52 and extending forwardly from the front end 54, to be manually held to retain the protector o sheath as the needle is being withdrawn from the skin of a patient into the tubular body, in a manner that is known practice.

Also, a hinged closure cap 60 is provided at front end 54, being integrally attached to body 50 through hinge 62.

It can be seen that closure cap 60 is connected to front end 54 of sheath 50 by a 5 hinge 62 which is substantially perpendicular to hinge 59 of anchor member 58, so that two members 58, 60 swing on their hinges in substantially perpendicular directions. Thus, neither will interfere with the other.

Protector sheath 50 carries a gripper to retain the sheath in position surrounding and shielding the needle. Specifically as one embodiment, Fig. 7 shows a pair of spaced o flanges 66, which may comprise diametrically spaced, straight inner edge portions of a ring- shaped flange member 68, which is positioned adjacent to rear end 56 of sheath 50 as previously described. Ring flange 68 and the flat edge portions 66 may be proportioned so that the tubing normally passes through the flange with ease. The tubing may deflect slightly inwardly as it encounters straight edges 66, since the tubing has a diameter slightly 5 greater than the spacing between edges 66. However, the tubing 16a which is carried on hub 14 has a slightly enlarged outer diameter over other tubing lengths and is resistant to inward deflection, because of the presence of hub 14. Thus, when edge portions 66 encounter tubing at this point, they bite into the soft tubing to form a secured retention, which resists radial retraction of sheath 50. This occurs when needle 10 has been retracted 0 to be enclosed within sheath 50, as shown in Fig. 8, taking place upon the retraction of the needle from the skin while one retains sheath 50 by means of anchor 58. Then, one manually releases the anchor and closes cap 60, so that the needle is reliably sealed (particularly when free of slots) so that any drops of blood that leak will be retained within sheath 50, and the enclosed needle may not require disposal in a "sharps" container.

Hollow body 52 may be substantially cylindrical, preferably with a flat, external surface portion 61, defined along the side of the cylindrical body 52, that is positioned in 5 diametrically opposed relation to hinge 59 of the anchor 58. Thus surface portion 61 serves as flat stand on which sheath 50 can rest.

Turning to Fig. 9, another design of needle hub and needle protector sheath is shown. Needle 12a and hub 14a are shown, with the design of hub 14a being somewhat different, in that the hub defines an annular groove 70 without making use of the front end 0 of tubing 16, as in the previous embodiment. Instead, tubing 16 may fit within a flared portion 72 of the lumen of hub 14a in a conventional manner. Sheath 50a may be of a design generally similar to that of the previous embodiment, except for a different design of gripper to retain the sheath in position. In this embodiment, sheath 50a carries an inwardly extending annular projection 74, or a series of circumferentially disposed projections as an s equivalent design. As sheath 50a is advanced forwardly relative to the hub and needle, annular projection 74 snaps into groove 70 in a snap-fit relation, to secure hub 14a and sheath 50a together.

Referring to Figs. 10 and 11, a modified design of sheath 50b, carried on needle hub 14a and flexible tubing 16a, is shown. The components of Fig. 10 are essentially similar to o their corresponding components in the previous embodiment of Figs. 1 through 8, except as otherwise disclosed herein.

In Fig. 10, sheath 50b is shown in a partially retracted position with respect to hub 14a and needle 12a, in a position where sheath 50b is generally freely longitudinally slideable, particularly in the forward direction toward needle 12a. As shown, protector 5 sheath 50b carries at its rear end 56a an annular, inwardly projecting sealing member 80, which may be an integral part of the molded sheath 50b. While only half of tubular sheath 50b is shown, sealing member 80 extends in this embodiment completely around the tubular bore 82 of sheath 50b in a closed circle, although spaces between sections of sealing member 80 maybe provided if desired. o Unlike the previous embodiment, tubing 16a is of a diameter typically slightly less than the diameter of annular, projecting sealing member 80, so that tubing 16a freely slides through annular member 80 with its reduced diameter portion 84, which comprises most of the length of tubing 16a. However, as in the previous embodiment, where tubing 16a encounters hub 14a, a front section 86 of the tubing is formed which is of slightly larger outer diameter, being of generally unchanged wall thickness, but expanded outwardly by the dimensions of hub 14a within the bore 88 of tubing 16a and as indicated by annular outward slope portion 90 in the outer diameter of tubing 16a.

Accordingly, as shown in Fig. 11, when sheath 50b is advanced so that inwardly projecting edge 80 encounters the slightly enlarged outer diameter of front segment 86 of tubing 16a, the increased outer diameter of front tubing section 86 is sufficient to cause annular projecting edge 80 to dig into the outer surface of tubing section 86, causing sheath 50b to be retained in position on hub 14a. This takes place at a position where the outer tip of needle 12a is enclosed within sheath 50b in a conventional manner for protection against needle stick. Furthermore, the ring-shaped sealing flange which defines annular edge 80 further may comprise an inner face 92, which inner face comprises an angled surface facing forwardly of the protector sheath, although located in this embodiment at the rear end 56a thereof, thus forming the inward, annular edge 80 at a rear end of angled surface 92.

Thus, when desired to place protector sheath 50b over needle 12a to protect against the sharp needle point, protector sheath may be advanced toward the needle tip, passing first through the position of Fig. 10 and finally arriving at the position of Fig. 11. This may be accomplished by holding sheath 50b and pulling flexible tubing 16a until the position of Fig. 11 is achieved. This takes place easily, with the tubing passing in a rearward direction through the inwardly projecting flange defined by annular face 92 and annular edge 80, until inward edge 80 digs into the tubing in tubing section 86 surrounding the hub, to interfere with sheath advancement and to secure sheath 50b in position.

This is easily accomplished, as said above, by grasping sheath 50b and pulling flexible tubing 16a, causing sheath 50b to relatively advance into the position of Fig. 11, where it becomes secured in rigid retention. However, if it were desired by someone to retract sheath 50b so that needle 12a again advances outwardly from the outer end of sheath 50b, this is a good deal more difficult, since tubing 16a is flexible with relatively low columnar strength against axially applied compressive forces, and thus cannot be used to push hub 14a to the right relative to sheath 50b, as seen in Fig. 11. Thus, accidental disengagement of the connection between sheath 50b and hub 14a becomes very unlikely, so that the system has a high degree of security, coupled with substantial simplicity. If desired, the inwardly projecting member defined by face 92 and annular edge 80 may be positioned within sheath 50b at a position between the ends thereof, to provide a rearwardly extending section covering, for example, the entire hub 14a to make the system even more difficult to disconnect. Furthermore, annular edge 80 and annular face 92 may compromise a sealing member so that blood or the like cannot leak out of end 56a of sheath 50b when in the secured position of Fig. 11. Then, at the other end of sheath 50b, a closure cap 60 may seal the end, to seal the sheath interior and prevent any spilling of blood or the like.

Furthermore, other designs of inwardly projecting members of similar function to annular face 92 and annular edge 80 may be used in accordance with this invention to secure sheath 50b upon the front section 86 of tubing 16a, making use of the slight increase in outer diameter, while the same inwardly projecting edge 80 allows free sliding of sheath

50b on the narrower portions 84 of tubing 16a.

Figs. 12 and 13 show modifications of Fig. 11, in which similar reference numerals identify similar parts. However, sheath 50c in the Fig. 12 embodiment carries a tubular extension or shroud 95, extending in the direction opposed to needle 12a so that annular edge 80 may be in a position substantially spaced from both ends of sheath 50c when sheath 50c is in its advanced position, similar to Fig. 11, in closing the needle tip. In the embodiment of Fig. 12, the rear end 97 of hub 14a is recessed within sheath 50c in this configuration, so that it becomes difficult to push hub 14a in a manner to cause sheath 50c to retract again and to re-expose the needle tip. Flexible tubing 86 may be pulled from the left (of Fig. 12) to cause sheath 50c to relatively advance with respect to the retracting needle hub 14a and its needle. However, the converse is not easy, since flexible tubing 86 is flexible, and thus cannot be used as a pusher. Referring to Fig. 13, another embodiment is disclosed, being shown in the position approximating that of Fig. 10, prior to a complete advancement of sheath 50d. In this embodiment, sheath 50d carries a convolution 98 on its end opposed to the point of needle 12a, to serve as a shroud as in the embodiment of Fig. 12, when annular edge 80 is advanced into engagement with hub 14a and the slight expansion of flexible tubing 86 which is caused by hub 14a. Tubing 86 may have a constant wall thickness, and may be expanded as indicated at area 90 by the presence of hub 14a. Convolution 98 has an inner extending wall portion 100 that extends back toward hub 14a and the needle, and carries annular edge 80, so that the entire hub 14a may be enclosed within sheath 50d. Once annular edge 80 has reached the enlarged, outer diameter portion 90 of tubing 86 and digs in, per the previous embodiments, it is difficult to dislodge it and to re-expose the needle tip which, in that position, is retracted within sheath 50d.

The above has been offered for illustrative purposes only and is not intended to limit the scope of the invention of this application, which is as defined in the claims below.

Claims

THAT WHICH IS CLAIMED:

1. A medical needle protector sheath which comprises: a hollow body for surrounding and shielding a needle, said body having a front end and a rear end; said sheath defining an anchor member integrally attached to a first portion of the front end of the body, and extending forwardly from the front end of the body, to be manually held to retain said protector sheath as the needle is being withdrawn from the skin of a patient into said tubular body; and a closure cap for said front end, said cap being also integrally attached to said body.

2. The protector sheath of Claim 1 in which said closure cap is integrally attached to another portion of the front end of the body through a hinged connector member.

3. The protector sheath of Claim 2 in which said closure cap is attached to the front end of the body at an end portion which forms about a 40 to 140 degree angle to the area of the first, attached portion of the anchor member.

4. The protector sheath of Claim 1 in which said protector sheath carries at least one gripper to retain said sheath in position surrounding and shielding the needle.

5. The protector sheath of Claim 4 in which said gripper comprises at least a pair of spaced flanges that engage tubing surrounding a hub for said needle.

6. The protector sheath of Claim 5 in which said flanges are diametrically spaced, straight inner edge portions of a ring-shaped flange member.

7. The protector sheath of Claim 4 in which said gripper comprises an inwardly extending projection to engage a recess in a hub for said needle.

8. A medical needle and needle hub, said hub being connected to flexible tubing, and a tubular protector sheath of Claim 1 carried thereon with a portion of the tubing positioned within said sheath.

9. The protector sheath of Claim 1 in which said tubular body is substantially cylindrical with a flat, external surface portion defined along one side thereof, said one side being positioned in diametrically opposed relation to the first portion.

10. A medical needle protector sheath, which comprises: a hollow body for surrounding and shielding a needle, said body having a front end and a rear end, and a gripper flange positioned adjacent to said rear end, said gripper flange comprising a pair of diametrically spaced, inwardly extending flange portions to grip and be retained by flexible tubing adjacent to a hub of a medical needle to be carried within said sheath.

11. The protector sheath of Claim 10 in which said gripper flange comprises a ring, said flange portions having straight inner edges of less spacing between the inner

5 edges than the remaining ring inner diameter.

12. A medical needle protector sheath which comprises: a hollow body for surrounding and shielding a needle, said body having a front end and a rear end; a closure cap for said front end, said cap being integrally attached to said body, and a ring-shaped sealing flange for sealing and retaining said hollow body in a fixed position on said tubing, 0 said hollow body being carried on flexible tubing and surrounding said tubing, said tubing having a medical needle and needle hub connected at one end with the tubing surrounding at least a portion of said needle hub to define a slightly enlarged tubing outer diameter around said needle hub compared with other adjacent portions of said tubing, whereby relative retraction of said tubing and needle to cause the needle and needle hub to enter said 5 protection sheath causes said ring-shaped flange member to easily slide along the lesser diameter portion of said tubing but to engage the portion of said tubing surrounding said hub to fixedly engage the protector sheath and the needle in a position where the needle is within the protector sheath, so that the needle may be sealed within the protector sheath by closing of said closure cap. 0

13. The protector sheath of Claim 12 which is free of longitudinal slots.

14. The protector sheath of Claim 12 in which said sheath defines an anchor member integrally attached to the front end of the body and extending forwardly from the front end of the body, to be manually held to retain said protector sheath as the needle is being withdrawn from the skin of a patient into 5 said tubular body.

15. A medical procedure kit which comprises the needle, needle hub, and protector sheath of Claim 12, plus packaging and instructions for use.

16. The protector sheath of Claim 12 which is free of longitudinal slots and in which said sheath defines an anchor member integrally attached to the front end of the body o and extending forwardly from the front end of the body, to be manually held to retain said protector sheath as the needle is being withdrawn from the skin of a patient into said tubular body, and an integral closure cap for closing the front end.

17. The protector sheath of claim 12 in which the hollow body completely encloses the entire length of the needle and hub when the flange member engages the portion of the tubing surrounding the hub.

18. A medical needle protector sheath and needle assembly which comprises :

5 a hollow body for surrounding and shielding a needle, said body having a front end and a rear end; an inwardly projecting member for sealing and retaining said sheath in a fixed position on said tubing, said sheath being carried on flexible tubing and surrounding said tubing, said tubing having a medical needle and needle hub connected at one end with the tubing surrounding at least a portion of said needle hub to define a slightly enlarged tubing o outer diameter around said needle hub, compared with other adjacent portions of said tubing, whereby relative retraction of said tubing and needle, to cause the needle and needle hub to enter said protection sheath, causes said inwardly projecting member to easily slide along the lesser diameter portion of said tubing but to engage the portion of said tubing surrounding said hub to fixedly engage the protector sheath and the needle in a position 5 where the point of the needle is enclosed within the protector sheath.

19. The protector sheath and needle assembly of Claim 18 in which said inwardly projecting member substantially comprises a ring-shaped flange.

20. The medical needle protector sheath and needle assembly of Claim 18 in which said ring-shaped flange comprises an inner face, said face comprising an angled o surface facing forwardly of said protector sheath, to form an inward, annular edge at a rear end of said angled surface, whereby said protector sheath is advanced with tubing passing easily in a rearward direction through said flange, but, upon attempts to withdraw said sheath, the inward edge digs into said tubing surrounding said hub to interfere with sheath advancement. 5

21. The protector sheath of claim 18 in which the hollow body completely encloses the entire length of the needle and hub when the flange member engages the portion of the tubing surrounding the hub.

22. A medical procedure kit which comprises the needle, needle hub, and protector sheath of Claim 18, plus packaging and instructions for use. 0

23. A medical needle protector sheath which comprises: a tubular body for surrounding and shielding a needle, said body having a front end and a rear end; a closure cap for said front end, said cap being integrally attached to said body, and a ring-shaped sealing flange for sealing and retaining said sheath in a fixed position on said tubing, said sheath being carried on flexible tubing and surrounding said tubing, said tubing having a medical needle and needle hub connected at one end with the tubing surrounding at least a portion of said needle hub to define a slightly enlarged tubing outer diameter around said needle hub compared with other adjacent portions of said tubing, whereby relative retraction of said tubing and needle to cause the needle and needle hub to enter said tubular body also causes said ring-shaped flange member to easily slide along the lesser diameter portion of said tubing but to engage the portion of said tubing surrounding said hub, to fixedly engage the protector sheath and the needle in a position where the needle is within the protector sheath, so that the needle may be sealed within the protector sheath by closing of said closure cap.

24. The protector sheath of Claim 23 which is free of longitudinal slots.

25. The protector sheath of Claim 23 in which said sheath defines an anchor member integrally attached to the front end of the body and extending forwardly from the front end of the body, to be manually held to retain said protector sheath as the needle is being withdrawn from the skin of a patient into said tubular body.

26. A medical procedure kit which comprises the needle, needle hub, and protector sheath of Claim 23, plus packaging and instructions for use.

27. The protector sheath of claim 23 in which the tubular body completely encloses the entire length of the needle and hub when the flange member engages the portion of the tubing surrounding the hub.

28. The method of obtaining needle access to the vascular system of a patient, which comprises: attaching a removable wing member to the hub of said needle in a manner to prevent axial rotation of said hub relative to the wing member; effecting needle access through the skin of the patient; removing the wing member from the hub; applying about the hub a tunnel member, said tunnel member having a cross section of substantially the shape of an inverted U to define two tunnel edges resting on the skin of a patient while the needle of the enclosed needle hub penetrates the patient's skin, said tunnel member providing longitudinal retention of said needle and needle hub while allowing axial rotatability to said needle and needle hub; and temporarily securing said tunnel member to the skin of the patient.

29. The method of Claim 28 in which said tunnel member has front and rear apertures through which said needle hub and attached tubing extend, the rear aperture being larger than the front aperture to accommodate a range of angular needle positions of the needle hub in the tunnel member.

30. A medical procedure kit for performing the process of Claim 28, which medical procedure kit comprises said needle and hub, said tubing, said wing member, and said tunnel member incorporated in a package with instructions for use.

31. A tubular medical needle set which comprises: a needle and needle hub connected to an end of flexible tubing, plus a wing member positioned to facilitate manual gripping of said needle and hub, said wing member comprising a hub gripping portion carried by said needle hub, and a wall portion attached to said hub gripping portion, said wall portion extending laterally outwardly from said hub gripping portion for manual gripping, said hub gripping portion being manually disengageable from said hub for manual removal of the wing member after said needle has been emplaced in a patient.

32. The set of Claim 31 in which said wing member comprises a pair of walls and a hub gripping portion comprising attached hub gripping members gripping said hub, each attached hub gripping member being respectively positioned on opposed sides of the hub, with said pair of walls extending in generally parallel manner laterally outwardly each from one of said hub gripping members to define said wall portion, said walls being integrally attached together by a hinge wall, said walls each having a squeeze portion extending laterally outwardly beyond said hinge wall, whereby manual squeezing of said squeeze portion disengages said hub gripping members from the hub, to permit removal of the wing member.

33. The set of Claim 32 which defines a groove extending at least partially around said needle hub, and said hub gripping members defining projections that fit in the groove, to restrict axial sliding of said wing member while gripping said hub.

34. The set of Claim 33 in which said groove is defined between said hub and the connected, flexible tubing end.

35. A medical needle and needle hub connected to an end of flexible tubing, plus a substantially rigid tunnel member enclosing at least a portion of said hub, said tunnel member having a cross section of substantially the shape of an inverted U to define two tunnel edges for resting on the skin of a patient while the needle of the enclosed needle hub penetrates the patient's skin, said tunnel member having front and rear apertures through which said hub and tubing extend, the rear aperture being larger than the front aperture to accommodate a range of angular needle positions in the tunnel member.

36. The needle and hub of Claim 35 in which the front aperture of said tunnel member is at least in part defined by an inwardly extending flange, and a groove is defined at said hub that receives said flange, to prevent longitudinal movement between the tunnel member and hub.

37. The needle and hub of Claim 36 in which said tunnel member is secured to the skin of a patient by a strip of medical tape and the needle penefrates the skin of said patient.

38. The needle and hub of Claim 37 with the tunnel member resting on the skin of a patient and enclosing at least a portion of said hub, the needle of said hub penetrating the patient's skin.