WO2018217781A1

WO2018217781A1 - Catheter hub with injection port and valve

Info

Publication number: WO2018217781A1
Application number: PCT/US2018/033930
Authority: WO
Inventors: Timothy Joseph Erskine
Original assignee: Individual
Current assignee: Individual
Priority date: 2017-05-25
Filing date: 2018-05-22
Publication date: 2018-11-29
Anticipated expiration: 2019-11-25

Abstract

A catheter hub comprising a side injection port with a luer-actuated hemostatic valve is disclosed. A catheter hub with an injection port comprises a body and a luer, a valve with a septum and a tubular seal, and a valve opener whereby insertion of a luer into the catheter hub opens the valve allowing subsequent infusions through the injection port. A valve opener with a metal penetrating tip for providing an opening through a valve septum is further disclosed.

Description

PATENT APPLICATION OF TIMOTHY JOSEPH ERSKINE

for

CATHETER HUB WITH INJECTION PORT AND VALVE

CROSS REFERENCE TO RELATED APPLICATION

This patent application claims the benefit of U.S. Provisional Patent Application Ser. No.

62/510,892 filed on May 25, 2017.

BACKGROUND

This patent application describes and relates to IV (intravenous) catheter hubs used to interface with needles, syringes and fluid management couplings to infuse or withdraw fluids into or from the body. The disclosure further relates to valves and seals integrated into catheter hubs to prevent the unwanted leakage of blood during or after the catheter insertion procedure. The disclosure further relates to catheter hubs comprising an injection port integrated into the body of the catheter hub.

SUMMARY OF THE INVENTION

A first aspect of the disclosure provides a catheter hub with an injection port comprising a body and a luer, a valve with a septum and a tubular seal, and a valve opener whereby insertion of a luer into the catheter hub opens the valve allowing subsequent infusions through the injection port.

Another aspect of the disclosure provides for a valve opener comprising a metal penetrating tip.

Another aspect of the disclosure provides for the valve to automatically return into a sealed position upon the removal of the opening luer device.

These and numerous other aspects will be apparent from the detailed description, which is not intended to be limiting, and when taken altogether with the drawings and the other information herein, disclose embodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

Fig. 1 is a cross section view of a catheter hub with side port and valve in a starting position;

Fig. 2 is three external views of a valved catheter hub with a side port;

Fig. 3 is a cross section view of a catheter hub with side port and valve in an actuated position;

Fig. 4 is a cross section of a catheter hub with side port and valve in an actuated position with fluid being infused into the side port;

Fig. 5 is an exploded view of a catheter hub with side port and one-piece valve;

Fig. 6 is a shaded cross section view of a catheter hub with side port and valve in a starting position ;

Fig. 7 is a shaded cross section view of a catheter hub with side port and valve in an actuated position;

Fig. 8 is a shaded cross section view of an alternative embodiment of a catheter hub with side port and one-piece valve in an actuated position;

Fig. 9 is a shaded exploded view of an alternative embodiment of a catheter hub with side port and valve; Fig. 10 is a shaded cross section view of an alternative embodiment of a catheter hub with side port and valve in a starting position;

Fig. 11 is a shaded cross section view of an alternative embodiment of a catheter hub with side port and valve in an actuated position;

Fig. 12 is a shaded cross section view of an alternative embodiment of a catheter hub with side port and valve with a valve actuator penetrating member formed in steel;

Fig. 13 is an isometric view of a valve actuator with a penetrating member formed in steel;

Fig. 14 is a shaded exploded view of an alternative embodiment of a catheter hub with side port and valve with valve actuator penetrating member formed in steel;

Fig. 15 is a shaded cross section view of an alternative embodiment of a catheter hub with side port and valve with a valve actuator penetrating member formed in steel;

Fig. 16 is a shaded exploded view of an alternative embodiment of a catheter hub with side port and valve with a return cone;

Fig. 17 is a shaded cross section view of an alternative embodiment of a catheter hub with side port and valve with a return cone in a starting position;

Fig. 18 is a shaded cross section view of an alternative embodiment of a catheter hub with side port and valve with a return cone in an actuated position;

Fig. 19 is a shaded cross section view of an alternative embodiment of a catheter hub with side port and valve with a return cone in a starting position;

Fig. 20 is a shaded cross section view of an alternative embodiment of a catheter hub with side port and valve with a return cone in an actuated position showing a deformed septum;

DETAILED DESCRIPTION

The description is not intended to be limiting, and one skilled in the art will recognize the extensive variations possible based on the drawings and specification that now follow.

The subject of this disclosure is a new and heretofore unforeseen valve for a catheter hub comprising a side port. Aspects of this disclosure show several embodiments of valves comprised of one or several elements such that a radially compressed tubular section conventional to injection port catheter hub designs known to one skilled in the art is integrated with a blocking septum that restricts return blood flow from a patient until a luer device such as a syringe or a cap with a luer tip is inserted into proximal end of the catheter hub.

It is contemplated that the various aspects of the embodiments may be combined in different ways and no limitation regarding such combinations is intended.

Referring now to Fig. 1, catheter hub 1 is comprised of two components, body 3, and luer 2 with a passage therebetween. The manner of dividing the hub into portions suitable for mass production and facilitation of molding is familiar to one skilled in the art and such a dividing line can be located anywhere along the length of the catheter hub body assembly. Body 3 and luer 2 are hermetically attached with an ultrasonic weld, adhesive or snap fit using methods and designs familiar to one skilled in the art. Wing 54 is attached to the assembly of body 3 and luer 2 providing a support platform for fastening catheter hub 1 to the patient. Catheter 6 is hermetically compressed and attached to body 3 by eyelet 4. Injection port 42 provides a fluid passage 29 (see Fig. 4) into the passage between body 3 and luer 2, and is covered by replaceable cap 7 attached to body 3 by retaining ring 28.

Valve 11 is compressed into body 3 forming a fluid-tight seal and abuts proximal shoulders 48. Valve 11 comprises a septum 27 and a tubular seal 26 that covers the radial opening between injection port 42 and the passage between body 3 and luer 2. In the preferred embodiment, valve 11 is formed in a single piece from a suitable elastomeric material such as silicone, but may be comprised of more than one piece as will be shown in alternative embodiments in subsequent figures.

Valve opener 9 is comprised of a penetrating tip 25 with barb 50, streamlined prongs 24, detents 23, and side openings 31. In Fig. 1, valve opener 9 and eyelet 4 are not shown in cross- section. Valve opener 9 comprises a longitudinal passage from a distal end to a proximal end through penetrating tip 25 as shown in Figs. 5, 9, 13, 14, 16, 19 and 20.

In Fig. 1, valve opener 9 is shown rotated ninety-degrees about a longitudinal axis through the catheter hub 1 for clarity, but the preferred embodiment of orientation for valve 9 is shown in Fig. 4, which maximizes the distance between prongs 24 and tubular seal 26 such that prongs 24 can not limit the deflection of tubular seal 26 under fluid pressure from injection port 42 through radial opening 29.

Valve opener 9 is retained inside the cavity formed between body 3 and luer 2 in the distal direction by valve 11 and in the proximal direction by detents 23 against proximal shoulders 44 of luer 2. Valve opener 9 is preferably assembled into the body assembly of body 3 and luer 2 by snap fit through luer opening 46, but may alternatively be assembled prior to attachment of luer 2 to body 3. Prongs 24 are preferably flexible enough in the inward radial direction to deflect slightly to allow detents 23 to snap through the distal opening of luer opening 46. Streamlined prongs 24 are preferably designed to minimize adhesion of blood or other fluids, and preferably comprise a circular cross section as shown in Fig. 2, such that fluid flowing in the distal direction has minimal eddies and a uniform velocity along the prong length. Side openings 31 allows fluid to circulate inside the proximal volume of valve 11 to maximize fluid rinsing. While valve opener 9 is shown with separate prongs 24, one skilled in the art will recognize that the prongs may alternatively be connected at the proximal end with a ring or other supporting structure, and the specific configuration of the valve opener 9 depicted in the figures is not intended to be limiting.

Prior to insertion into the patient, needle (cannula) 5 extends the entire length of catheter hub 1 and the sharp distal tip of needle 5 extends slightly beyond the distal end of catheter 6. Needle 5 is attached to a needle hub at a proximal end (not shown). Needle 5 penetrates septum 27 of valve 11. Septum 27 is configured such that the elastomeric properties of valve 11 combined with the radial compression created during insertion of valve 11 at assembly into body 3 is sufficient to prevent blood to flow through the opening previously occupied by needle 5 upon insertion of catheter hub 1 into the patient and subsequent withdrawal of needle 5. Septum 27 may be pre-slit to accommodate needle 5 or the sharp distal tip of needle 5 may be used to puncture septum 27. The slit may be a single cut or in a star or other pattern for example a cross or three radial slits.

Referring now to Fig. 3, catheter 6 has been inserted into the vein or artery of a patient (not shown) and needle 5 removed. Blood entering catheter hub 1 through catheter 6 is prevented from flowing past the valve 11 by septum 27. Syringe 13 is inserted into luer opening 46 and applies distal pressure against valve opener 9 at the proximal end of prongs 24. Penetrating tip 25 is forced through the slit configuration previously occupied by needle 5 until barb 50 is past the distal wall of septum 27, barb 50 preventing the proximal movement of penetrating tip 25 back through septum 27. Syringe 13 may be removed and replaced by a hermetic cap or a fluid coupling to an IV set or other extension tube configuration.

Referring now to Fig. 4, cap 7 is removed and syringe 15 is inserted into injection port 42. Upon fluid pressure from the syringe through radial opening 29, tubular seal 26 is inwardly radially displaced at the location of radial opening 29 and fluid flows around the proximal end of tubular seal 26 at 30, through the proximal cavity in valve 11, through penetrating tip 25 and into the patient through catheter 6.

Referring now to Fig. 8, an alternative embodiment is shown where luer 2 extends further in a distal direction into body 3 such that radial opening 29 from injection port 42 is part of luer 2.

Furthermore, valve 11 is in radially compression inside luer 2 instead of body 3.

Referring now to Figs. 9-11, in an alternative embodiment, valve 11 as shown in Fig. 1 is divided into a separate septum 12 and tubular seal 14. One advantage of this embodiment provides for differing elastomeric materials for septum 12 and tubular seal 14, so that the material for each component's function may be optimized, for example to minimize compression set of septum 12 under the presence of needle 5 while minimizing the wall thickness of tubular seal 14. Furthermore, tubular seal 14 may be formed by cutting a length from a long extrusion, thereby offering a potential production cost reduction. Septum 12 is trapped in the annular space created between a proximal shoulder of body 3 and a distal end of luer 2.

Referring now to Figs. 12 and 13, in another alternative embodiment, penetrating tip 17 is comprised of a copy of the same eyelet 4 used to attach catheter 6 to body 3. In this embodiment, valve opener 18 is comprised of a copy of eyelet 4 snap fit into prongs 16. One advantage of this embodiment is that each gauge size of catheter requires a unique eyelet size, such eyelets produced in high volume and for low cost. A single prong component may then be combined with varying eyelet sizes to produce a range of valve openers at low cost. Furthermore, the eyelets are produced already to exactly fit over their corresponding needle and with a smoothly tapered distal end facilitating smooth penetration of septum 12. One skilled in the art will recognize the many possible ways the metal eyelet may be integrated with another molded or stamped metal component to form a valve opener 18. For example, a different embodiment has the eyelet assembled from a proximal direction instead of a distal direction as shown in Fig. 12, or prongs 18 are insert-molded over the eyelet/ penetrating tip 17.

Referring now to Figs. 14 and 15, another alternative embodiment comprises a penetrating tip 22 formed in metal that is snap fit or insert molded to form valve opener 20, the dimensions of penetrating tip 22 similar per gauge to the dimensions of the distal tip portion of corresponding eyelet 4.

In many of the embodiments disclosed, one skilled in the art will recognize that the entire valve opener may be formed as a single piece using a progressive die stamping process similar to that used to commonly form eyelet 4, comprising detents 23 and slots or openings as necessary. Referring now to Figs. 17-20, another alternative embodiment comprises a self-returning valve opener 19 that upon removal of a syringe 13, fluid coupling or sealing cap with a luer plug, allows valve opener 19 to be moved proximally back into a starting position by elastic forces in septum 12 acting against conical penetrating tip 35 causing septum 12 to reseal preventing blood from leaking from luer opening 46. The thickness, profile and elastomeric material design of septum 12 may be configured to either require the presence of an actuating luer to move the valve opener 19 into a distal position before fluid may be infused via the injection port, or the over-pressure of the injection port infusion is sufficient to open the slit or slits in septum 12 during infusion, such that valve opener 19 remains in the starting position.

Claims

What is claimed is:

1. A catheter assembly comprising:

a catheter cannula;

a catheter hub;

wherein the cannula and the hub are in fluid communication with each other, and are coaxial, having a first axis;

a side port in fluid communication with the catheter hub, the side port having a second axis angled relative to the first axis;

a valve member comprising a first valve part associated with the catheter hub and a second valve part associated with the side port;

a valve actuator operably coupled to the valve member such that insertion of an object into the catheter hub actuates the valve member, thereby permitting fluid flow through the cannula via the catheter hub and through the cannula via the side port.

2. The catheter assembly of claim 1 wherein the catheter hub comprises a first hub part and a second hub part, the first and second hub parts being coaxial, and wherein the second hub part is provided with a side opening, the side opening allowing fluid communication between the side port and the catheter hub.

3. The catheter assembly of claim 2 wherein the first valve part comprises a septum, the septum being secured between the first hub part and the second hub part.

4. The catheter assembly of claim 1 wherein the first valve part is substantially perpendicular to the first axis and the second valve part is coaxial with the first axis.

5. The catheter assembly of claim 4 wherein the first valve part is provided with a hole substantially coaxial with the first axis.

6. The catheter assembly of claim 5 wherein the valve actuator comprises a penetrating member that penetrates the hole, thereby permitting fluid flow through the cannula via the catheter hub.

7. The catheter assembly of claim 5 wherein the hole is a slit.

8. The catheter assembly of claim 6 further comprising a detent for preventing movement of the penetrating member in a proximal direction when the penetrating member has penetrated the hole in a distal direction.

9. The catheter assembly of claim 6 wherein the penetrating member is provided with a side opening, the side opening allowing fluid communication between the side port and the first valve part.

10. The catheter assembly of claim 4 wherein the catheter hub comprises a first hub part and a second hub part, the first and second hub parts being coaxial, and wherein the second hub part is provided with an opening radially displaced from the second axis, the opening allowing fluid communication between the side port and the catheter hub and further wherein the first valve part is secured between the first hub part and the second hub part.

11. The catheter assembly of claim 4 wherein the first valve part comprises a septum member and the second valve part comprises a tubular member.

12. The catheter assembly of claim 1 wherein the first valve part comprises an elastomer.

13. The catheter assembly of claim 1 wherein the second valve part comprises an elastomer.

14. The catheter assembly of claim 6 wherein the penetrating member comprises a metal tube.

15. The catheter assembly of claim 12 further comprising a metal eyelet that secures the cannula to the catheter hub and wherein the penetrating member comprises a member substantially identical to the metal eyelet.

16. The catheter assembly of claim 1 wherein the catheter hub and the object comprise male and female luers.

17. The catheter assembly of claim 4 wherein the first valve part is a septum with an opening, penetrable by the valve actuator when the object is inserted into the catheter hub thereby permitting fluid flow through the hole.

18. The catheter assembly of claim 4 wherein at least part of the second valve part adjacent the side port is elastically deformable.

19. A catheter assembly comprising:

a catheter cannula;

a catheter hub;

a valve member comprising:

a first valve part associated with the catheter hub, the first valve part being substantially perpendicular to the first axis;

a second valve part associated with the side port, the second valve part being coaxial with the first axis;

a valve actuator operably coupled to the valve member and at least partially in the catheter hub, the valve actuator comprising a penetrating member that penetrates the first valve part and actuates the valve member, thereby permitting fluid flow through the cannula via the catheter hub and through the cannula via the side port.