HK1142839A - System and method for effecting non-standard fluid line connections - Google Patents

Description

System and method for implementing non-standard fluid line connections

Technical Field

The present invention generally relates to systems and methods for achieving non-standard fluid line connections.

Background

Intravascular catheters have been introduced to control patient temperature. Typically, a coolant, such as saline, is circulated through an intravascular heat exchange catheter positioned in the patient's bloodstream to cool or heat the blood appropriately depending on the patient's condition. The coolant is heated or cooled by a computer-controlled heat exchanger located outside the patient's body and in fluid communication with the catheter.

For example, intravascular heat exchange catheters may be used to combat potentially harmful fever in patients with neurological or cardiac disorders such as stroke, subarachnoid hemorrhage, intracerebral hemorrhage, cardiac arrest, and acute myocardial infarction, or may be used to therapeutically cool such patients. Furthermore, such catheters may be used to re-warm a patient, for example after a cardiac procedure or for other reasons such as to keep the patient warm during a skin graft procedure. Intravascular catheters have advantages over external cooling and heating methods, including more precise temperature control and greater convenience to medical personnel.

The following U.S. patents disclose various intravascular catheters/systems/methods: 6,419,643, respectively; 6,416,533, respectively; 6,409,747, respectively; 6,405,080, respectively; 6,393,320, respectively; 6,368,304, respectively; 6,338,727, respectively; 6,299,599, respectively; 6,290,717; 6,287,326, respectively; 6,165,207, respectively; 6,149,670, respectively; 6,146,411, respectively; 6,126,684, respectively; 6,306,161, respectively; 6,264,679, respectively; 6,231,594, respectively; 6,149,676, respectively; 6,149,673, respectively; 6,110,168, respectively; 5,989,238, respectively; 5,879,329, respectively; 5,837,003, respectively; 6,383,210, respectively; 6,379,378, respectively; 6,364,899, respectively; 6,325,818, respectively; 6,312,452, respectively; 6,261,312, respectively; 6,254,626, respectively; 6,251,130, respectively; 6,251,129, respectively; 6,245,095, respectively; 6,238,428, respectively; 6,235,048, respectively; 6,231,595, respectively; 6,224,624, respectively; 6,149,677, respectively; 6,096,068, respectively; and 6,042,559. The entire contents of these patent documents are incorporated herein by reference.

As particularly appreciated herein, it is desirable to effect fluid line connections for medical devices such as the catheters described above in order to avoid inadvertent connection of a component such as a syringe having a standard connector such as a standard Luer (Luer) fitting to a lumen not intended to receive fluid in the component with a connector.

Disclosure of Invention

A medical fluid connector system is provided comprising a unitary male connector body defining: a male cone with a hollow interior; and an outer annular sleeve surrounding and radially spaced from the male cone. The sleeve has internal threads, and the male cone axially extends out of the sleeve. The body includes structure that prevents engagement of a standard female luer fitting with the body.

The structure that prevents engagement with a standard female luer connector may include an outer diameter of the male cone that is greater than the outer diameter of the male cone of a standard male luer connector. Additionally or alternatively, the structure may include an inner diameter of the barrel that is greater than an inner diameter of a barrel of a standard male luer fitting. Also, in addition or as an alternative, the structure may include a thread pitch of the sleeve that is greater than a thread pitch of a sleeve of a standard male luer fitting. A unitary female connector body may also be provided that defines a female cone having an outer radially elongated triangular thread configured to engage the threads of the sleeve.

In another aspect, a medical fluid connector system is provided that includes a unitary female connector body defining a female cone having an external radially elongated triangular thread configured to engage a thread of a sleeve of a male connector body.

In yet another aspect, a method is provided that includes providing a male connector having a central hollow male cone spaced from an annularly surrounding internally threaded sleeve. The method also includes providing a female connector having a female cone with a radially elongated triangular thread for engaging the sleeve. The male connector cannot accept a standard female luer and the female connector cannot engage a standard male luer.

Drawings

The details of the present invention, both as to its structure and operation, can best be understood in reference to the accompanying drawings, in which like reference numerals refer to like parts, and in which:

FIG. 1 is a perspective view of a non-limiting intravascular heat exchange catheter schematically showing a drug source and a heat exchange fluid source in exploded relation to the catheter;

FIG. 2 is a perspective view showing two sets of male and female connectors according to the present invention; and

fig. 3 is a cross-sectional view taken along line 3-3 of fig. 2.

Detailed Description

Referring initially to FIG. 1, a therapeutic catheter system, generally designated 10, is shown for establishing and maintaining hypothermia in a patient, or for relieving the peak of fever in the patient, and then maintaining the normal body temperature of the patient. The catheter may also be used to maintain the body temperature of the patient during surgery.

While FIG. 1 illustrates an exemplary embodiment of a heat exchange catheter, it should be understood that the present invention is applicable to any catheter and accompanying heat exchange controller disclosed in the above-referenced patent documents, including but not limited to the spiral-shaped devices disclosed in U.S. Pat. Nos. 6,451,045 and 6,520,933 to Alsius. In addition, spiral or convoluted catheters as disclosed in U.S. Pat. Nos. 6,749,625 and 6,796,995 to Alsius, both of which are incorporated herein by reference, may be used.

It should also be understood that while the novel fluid connectors shown and described herein are illustratively used with intravascular temperature control catheters, they may also be used with other medical devices.

Describing the proximal end of the system 10 first, as shown, the exemplary non-limiting system 10 includes a heat exchange fluid source 12, which may be a water bath heat exchange system or a TEC-based heat exchange system, such as the systems disclosed in one or more of the above-referenced patents. Alternatively, the source 12 may be a source of compressed gas. In any event, the heat exchange fluid source provides heated or cooled heat exchange fluid through a heat exchange fluid supply line 14, and the heat exchange fluid is returned to the source 12 via a heat exchange fluid return line 16. The catheter, generally designated 18, includes a source tube 20, the source tube 20 terminating in a female connector 22, as will be described further below. In addition, the conduit 18 has a return tube 24, the return tube 24 terminating in a male fitting 26, as will be further described below. The fittings 22, 26 may be selectively engaged with complementary fittings 28, 30 (shown schematically in fig. 1) of the lines 14, 16, which are also described in detail below, to establish a closed loop of heat exchange fluid path between the conduit 18 and the heat exchange fluid source 12. As contemplated herein, the fittings 22, 26, 28, 30 are quick disconnect fittings that cannot be engaged with standard luer fittings to avoid improper connections.

More specifically, the non-limiting catheter 18 may include a guidewire and a first infusion tube 32, the first infusion tube 32 terminating in a fitting, such as a standard female luer fitting 34. A standard male luer 35 (shown schematically in fig. 1) may be engaged with the female luer 34 to advance a guidewire 36 through the tube 32 in accordance with central venous catheter placement principles, or a drug or other fluid may be infused through the guidewire and the first infusion tube 32 via the standard luers 34, 35.

Additionally, a second infusion tube 38 having a standard female luer fitting 40 may be selectively engaged with a standard male luer fitting 41 (shown schematically in FIG. 1) of a drug source 42 for infusing fluid from the source 42 through the second tube 38.

The source 42 may be an IV bag. Alternatively, the source 42 may be a syringe. In any event, because the coolant line fittings 22, 26, 28, 30 cannot be engaged with standard luer fittings, the coolant in the source 12 cannot be mistakenly connected to the infusion lines 32, 38. Similarly, for the same reason, the source 42, e.g., a syringe, will not erroneously engage the coolant lines 20, 24.

By "standard luer" is meant that it is a quick disconnect component, typically a hard plastic, wherein the standard male luer embodiment of the standard luer has an internal cone surrounded by an externally threaded sleeve spaced from the cone, the diameter of the tip of the cone being about 3.93mm, the minimum internal thread diameter of the sleeve being about 7.00mm, and the pitch being about 2.50 mm. The standard female luer connector embodiment of the standard luer connector is a female cone having external staked protrusions that act as threads, sized and shaped to engage the internally threaded sleeve of the standard male luer connector described above.

The tubes 20, 24, 32, 38 may be held in a distally tapered connector manifold 44. The connector manifold 44 establishes respective passageways for fluid communication between the tubes 20, 24, 32, 38 and respective lumens in the catheter body 46.

In any event, the connector manifold 44 establishes a pathway for fluid communication between the heat exchange fluid supply tube 20 of the catheter and the heat exchange fluid supply lumen. Similarly, the connector manifold 44 establishes a passageway for fluid communication between the heat exchange fluid return tubes 24 and the heat exchange fluid return lumen. In addition, the connector manifold 44 establishes a pathway for fluid communication between the guidewire and the first infusion tube 32 and a guidewire lumen, which may terminate in an open distal aperture 62 defined by a distally tapered and chamfered distal tip 63 of the catheter body 46. In addition, the connector manifold 44 establishes a pathway for fluid communication between the second infusion tube 38 and a second infusion lumen, which may terminate in an infusion port 64 in the distal section of the catheter body 46. Other ports may be provided along the length of the catheter.

The exemplary non-limiting catheter 18 has a distally positioned heat exchange member for effecting heat exchange with a patient when the catheter is positioned in the vasculature or rectum or other orifice of the patient. The heat exchange member may be any of the heat exchange members disclosed in the above-referenced patent documents. By way of example, the non-limiting catheter shown in fig. 1 may have proximal and distal thin-walled heat exchange membranes 66, 68 disposed along the last approximately 15 centimeters of the catheter body 46 and bonded to the outer surface of the catheter body 46 with the infusion port 64 located between the heat exchange membranes 66, 68. Accordingly, each of the preferred non-limiting heat exchange membranes has a length of about 6 centimeters to about 7.5 centimeters, and in the preferred embodiment shown, the heat exchange membranes are spaced longitudinally from each other along the catheter body 46. Essentially, the heat exchange membranes 66, 68 extend along most or all of the portion of the catheter 46 that is inserted into the patient. The heat exchange membrane may be formed from a medical balloon material.

The heat exchange membranes 66, 68 may be filled with heat exchange fluid from the heat exchange fluid source 12, which is supplied from the heat exchange fluid supply lumen, and the heat exchange fluid from the heat exchange membranes 66, 68 is returned to the heat exchange fluid source 12 via the heat exchange fluid return lumen.

If desired, a temperature sensor 70 such as a thermistor or other suitable device may be connected to the illustrated catheter 18. The sensor 70 may be mounted to the catheter 18 at a location proximal to the heat exchange membranes 66, 68 by means of solvent bonding. Alternatively, the sensor 70 may be disposed within the lumen of the catheter 18 or attached to a wire disposed within the lumen of the catheter 18, with the sensor depending from the exterior of the catheter 18. Alternatively, a separate temperature probe may be employed, such as the esophageal probe disclosed in U.S. Pat. No.6,290,717, which is incorporated herein by reference. Alternatively, a rectal probe or tympanic temperature sensor may be employed. In any case, the sensor is electrically connected to the source of heat exchange fluid 12 for controlling the temperature of the heat exchange fluid, as described in the various references mentioned above.

As contemplated by the present invention, the above-described structures may be used in a variety of medical applications to cool a patient and/or maintain the temperature of a normothermic or hypothermic patient for improving the outcome of treatment of, for example, a patient with cardiac arrest, a patient with myocardial infarction or stroke, or the like. As another example, head trauma may be treated by and after reducing the patient's body temperature and maintaining the patient's body temperature at normal body temperature. Preferably, the heat exchange portion is advanced into the vena cava of the patient, particularly in the case of a myocardial infarction, in order to cool the blood flowing to the heart. The catheter may be used to keep the patient warm during a skin graft procedure or other procedure.

Referring now to fig. 2 and 3, details of the male and female connectors of the present invention can be seen. Fig. 2 shows the male and female connectors 26, 30 described above having large sleeves 80, 82 for receiving relatively large tubes 84, 86, respectively. Also shown are male and female connectors 88, 90, which are substantially identical to the other connectors 26, 30, except for having smaller sleeves for receiving smaller tubes. Therefore, in view of these differences, the first set of connectors 26, 30 is described with emphasis.

As shown, the male connector includes an inner hollow cone 92 that extends slightly beyond an outer sleeve 94. Although referred to as a "cone" for simplicity, the cone 92 is technically a truncated cone, as shown. The cone 92 is spaced from the sleeve 94 so that the female connector 30 can be advanced between the sleeve 94 and the cone 92, as will be described later. To this end, the interior of the sleeve 94 is formed with threads 96, preferably double start threads. As shown, the sleeve 94 is connected with the sleeve 80, and a gripping flange 98 is formed longitudinally along the sleeve 80 and the sleeve 94 to assist an operator in gripping and rotating the connector 26.

With respect to the female connector 30, the sleeve 82 is hollow and frustoconical, terminating in an annular end flange 100, the flange 100 extending radially beyond the sleeve 82, as shown. On the outside of the flange 100, at least one, preferably diametrically opposed, radially elongated male thread 102 is formed. In a preferred embodiment, the male threads 102 have a substantially triangular shape such that one end 104 of the threads 102 is substantially pointed, the male threads 102 are axially flared as they extend radially around the flange 100 to an opposite wide end 106, the end 106 having a flat, axially oriented base 108, as shown. Similar to the male connector 206, the female connector 30 is formed with a gripping flange 110 formed longitudinally along the sleeve 82 to assist an operator in gripping and rotating the connector 30.

With the above-described structure, the female connector 30 can be advanced between the sleeve 94 and the cone 92 of the male connector 26 while rotating the connectors 26, 30 relative to one another so that they engage in an interference fit relationship.

Although the connectors 26, 30 may engage each other, they may not engage a complementary standard luer fitting, in part because of the structure described above, such as the radially elongated male threads 102. Other factors that prevent the connectors 26, 30 from engaging a standard luer fitting include preferred dimensions and thread geometry, as will be described below.

With particular reference to fig. 3, the outer diameter "D1" of the open end of cone 90 is about 5.97mm, while the diameter of the tip of the previously described cone of a standard male luer connector is about 3.93mm, which means that the cone 92 of the male connector 26 as shown in fig. 2 and 3 is too large to allow a standard female luer connector to slide over it. Furthermore, the minimum internal thread diameter "D2" of the sleeve 94 is about 9.68mm, whereas the minimum internal thread diameter of the sleeve of the standard male luer described above is about 7.00mm, which means that the male protrusion of a standard female luer cannot extend radially far enough to reach the threads 96 of the male connector 26. Further, the pitch "P" of the male connector 26 is about 3.45mm, compared to a standard pitch of about 2.50 mm.

The connectors described herein may be a unitary, molded structure made of a plastic, such as nylon, polypropylene, polyethylene, or other suitable medical plastic.

Although specific systems and methods for achieving non-standard fluid line connections have been illustrated and described in detail herein, it is to be understood that the subject matter encompassed by the present invention is limited only by the claims.

Claims (8)

1. A medical fluid connector system comprising: a unitary male connector body (26), said body (26) defining:

a male cone (92) hollow inside; and

an outer annular sleeve (94) surrounding the male cone (92) and radially spaced from the male cone (92), the sleeve (94) having internal threads, the male cone (92) axially projecting out of the sleeve (94),

wherein the body (26) includes structure (D1; D2; P) that prevents engagement of a standard female luer fitting (40) with the body (26).

2. The system of claim 1, wherein the structure comprises an outer diameter (D1) of the cone (92), the outer diameter (D1) being greater than an outer diameter of a male cone of a standard male luer fitting (35).

3. The system of claim 1, wherein the structure comprises an inner diameter (D2) of the sleeve (94), the inner diameter (D2) being greater than an inner diameter of a sleeve of a standard male luer fitting (35).

4. The system of claim 1, wherein the structure comprises a pitch (P) of the barrel that is greater than a pitch of a barrel of a standard male luer fitting (35).

5. The system of claim 2, wherein the structure further comprises:

an inner diameter (D2) of the sleeve, the inner diameter (D2) being greater than an inner diameter of the sleeve of a standard male luer fitting (35); and

a thread pitch (P) of the sleeve that is greater than a thread pitch of a sleeve of a standard male luer fitting (35).

6. The system of claim 1, including a unitary female connector body (30), the unitary female connector body (30) defining:

a female cone (82); and

a radially elongated triangular thread (102) located outside the female cone (92), the triangular thread (102) configured to engage a thread of the sleeve (94).

7. A medical fluid connector system comprising: a unitary female connector body (30), the unitary female connector body (30) defining:

a female cone (82); and

a radially elongated triangular thread (102) radially beyond the female cone (82), the triangular thread (102) configured to engage a thread of a sleeve (94) of a male connector body (26).

8. The system of claim 7, including a unitary male connector body (26), the unitary male connector body (26) defining:

a male cone (92) hollow inside; and

an outer annular sleeve (94) surrounding the male cone (92) and radially spaced from the male cone (92), the sleeve (94) having internal threads for receiving radially elongated threads (102) of a female body (30), the male cone (92) projecting axially out of the sleeve (94), wherein the male body (26) includes structure (D1; D2; P) that prevents engagement of a standard female luer fitting (40) with the body (26).