Technical Field

The present invention relates generally to outdwelling control of medical liquid flow in a

cannula and, more particularly, to novel normally closed outdwelling slit valves and slit valve

assemblies and related methods for selective slit valving of medical liquid flow, including but not

limited to bi-direction flow, along a hollow cannula, such as a catheter tube or needle.

Background Art

In the past, slit valves have traditionally been used in the side walls of otherwise closed

indwelling catheter tube ^' s to infuse or aspirate fluid. Use of such side wall slit valves has been

directed to infusion and aspiration of liquids in the cardiovascular systems of medical patients,

infusion and aspiration of fluids in the respiratory systems of medical patients, and infusion and

aspiration in other body cavities.

Disadvantageously, sometimes the central passageway within an indwelling catheter tube

comprising one or more side wall slit valves is partially or totally occluded when the slit valve is

flexed inwardly from its normally closed position to an open position. Also, interference can

occur between the lips of the slit, as they are flexed outwardly, and the wall of the body cavity in

which the catheter tube and indwelling slit valve are disposed, which either prevents the slit

valve from opening or undesirably limits the extent to which it is permitted to open or prevents

or unduly limits flow.

Outdwelling slit valves have been proposed in the past. For example, see U.S. Patent

Nos. 5,201,722 and 5,984,902, which disclose transversely directed disc-shaped slit valve

diaphragms each having a central slit, the axial flexural displacement of which is mandatorily

constrained by abutment structure fore and/or aft of each transverse disc-shaped diaphragm.

Prior outdwelling slit valves leave unanswered problems of interior dead space and provision of

greater rates of flow without compromising the level of back pressure.

Disclosure of the Invention

In brief summary, the present invention overcomes or substantially alleviates past

problems in the cannula-related slit valve field. One or more novel outdwelling nipple-shaped

slit valves and outdwelling slit valve assemblies are provided, as well as related methods. The

problems of dead space and increased flow rates without compromising back pressure are

addressed by the present invention.

With the foregoing in mind, it is a primary object to overcome or substantially alleviate

past problems in the cannula-related slit valve field.

Another paramount object is the provision of one or more novel outdwelling nipple-

shaped slit valves, outdwelling slit valve assemblies and related methods.

A further valuable object is the provision of novel outdwelling slit valves, slit valve

assemblies and related methods, which address the problems of dead space and increased flow

rates without compromising the adequacy of back pressure.

These and other objects and features of the present invention will be apparent from the

detailed description taken with reference to accompanying drawings.

Brief Description of the Drawings

Figure 1 is a diagrammatic representation of one outdwelling slit valve assembly in

accordance with the present invention for infusion and aspirating into and from an internal cavity

of a medical patient;

Figure 2 is a perspective of a hub, adaptor or two-part housing in which a slit valve,

embodying principles in accordance with the present invention, is contained;

Figure 3 is a cross-section taken along the lines of 3-3 of Figure 2;

Figure 4 is an exploded fragmentary cross-section of the assembly of Figure 3;

Figure 5 is an exploded perspective of the slit valve assembly similar to the one

illustrated in Figure 2;

Figure 6 is a fragmentary exploded perspective of another split valve assembly,

embodying principles of the present invention;

Figure 7 is a fragmentary exploded perspective of still another slit valve assembly, in

accordance with principles of the present invention;

Figures 8A and 8B are fragmentary cross-sections illustrating the manner in which a

nipple-shaped slit valve of the present invention is expanded from a normally closed to an

outwardly open position, accommodating influent fluid flow or infusion into a medical patient;

Figure 8 C is a fragmentary cross-section of the slit valve of Figure 8B in an inwardly

open position, accommodating effluent fluid flow or aspiration from a body cavity of the medical

patient;

Figure 9 is an enlarged perspective of the nipple-shaped slit valve of Figure 5;

Figure 10 is a fragmentary perspective of the nipple-shaped slit valve of Figure 9, shown

largely in cross section taken along line 10-10 of Figure 9;

Figure 11 is an enlarged perspective of the nipple-shaped slit valve of Figure 7;

Figures 12 and 13 are fragmentary perspective of the nipple-shaped valve of Figure 11,

shown largely in cross section taken along lines 12-12 and 13-13 of Figure 11, respectively;

Figure 14 is an enlarged perspective of the nipple-shaped outdwelling slit valve of Figure

6;

Figure 15 is a fragmentary perspective of the nipple-shaped slit valve of Figure 14, shown

largely in cross section taken along lines 15-15 of Figure 14;

Figure 16 is an enlarged perspective of one more nipple-shaped outdwelling slit valve,

embodying principles of the present invention;

Figure 17 is a fragmentary perspective of the nipple-shaped slit valve of Figure 16, shown

largely in cross section taken along lines 17-17 of Figure 16;

Figure 18 is an enlarged perspective of a further outdwelling nipple-shaped slit valve of the present invention;

Figure 19 is a fragmentary perspective of the nipple-shaped slit valve of Figure 18, shown

largely in cross section taken along lines 19-19 of Figure 18;

Figure 20 is an enlarged perspective of still another outdwelling nipple-shaped slit valve,

in accordance with principles of the present invention; and

Figure 21 is a fragmentary perspective of the nipple-shaped slit valve of Figure 20, as

shown largely in cross section taken along lines 21-21 of Figure 20.

Best Mode for Carrying Out the Invention

The present invention solves or reduces past problems in the catheter-related slit valve

field, applicable to the human respiratory system, the human circulatory system, and other body

cavities. One or more normally closed nipple-shaped slit valves, which may be in a variety of

forms, are disposed remote from the distal end of each catheter tube of a medical patient whereby

problems of the past are greatly reduced, if not eliminated. The term outdwelling is used to mean

placement of the slit valve at the proximal end of a cannula, the distal end of which is disposed

^■ within a body cavity for fluid flow purpose. Thus, the term outdwelling embraces both

placement of the slit valve outside the body of a patient or placed subcutaneously at a non-cavity

site for safety purposes only, such as in conjunction with an implanted port to control, at the

proximal end of a cannula, the flow of liquid from the port to a body discharge site remote from

the port and the slit valve. The slit valves, in proximal regions of catheter tubes, comprise one or

more normally closed slit valves disposed in a two-part housing. The slit valves may be either

one-way or two-way valves. By two-way, it is meant that a given proximal outdwelling slit-

valve both aspirates and infuses fluid from and into the associated catheter tube or cannula. By r

one-way, it is meant a proximal outdwelling slit valve which either aspirates or infuses, but does not do both.

Accordingly, an outdwelling nipple-shaped slit valve may comprise from one normally

closed slit up to several normally closed slits. One or more slits may be located in a rounded

portion or in a flat region (a flat) of the nipple-shaped outdwelling slit valve, as deemed

appropriate by those having skill in the art. It is not necessary that all slits have the same length or thickness. Some may extend into or across the apex of the nipple-shaped slit valve. The slits,

in any of the nipple-shaped slit valves, may have a uniform thickness or a thickness which varies,

as deemed most appropriate for an intended purpose.

The preferred materials for forming the nipple-shaped slit valve comprise silicone rubber,

polyurethane and other suitable natural and synthetic elastomeric materials. The material at each

slit valve must have sufficient flexibility for the lips forming the normally closed slit to flex

inwardly or outwardly or both when predetermined pressure differentials are imposed thereon, in

order to accommodate fluid flow in the direction desired. Treating the lips with a softening

composition is known in the art and may take place to provide the desired flexibility.

The slits in the nipple-shaped slit valve may be parallel, perpendicular, staggered, radially

disposed or otherwise oriented, as deemed most appropriate by those having skill in the art.

Opposing or offset slit valves located on different sides of a lumen maybe used.

The present invention provides catheter assemblies which may be inserted into a medical

patient over a guide wire. Pressures required for infusion and aspiration may be lower than in the

past. The nipple-shaped slit valves may be formed in any suitable fashion, zero pressure molding

being one mode.

This invention comprises a slit valve located in a nipple-shaped hub attached at the proximal

end of a catheter, the distal end of which is indwelling. For example, the catheter may be used to

control fluid flow in and out of the body. Infusaids such as saline, blood, hyper alimentation, or

any medication prescribed for a patient may be administered intravenously through the catheter.

A paramount purpose of slit valves according to the present invention is to provide safety to the

patient while the catheter is in use. Pressures inside and outside of the body can cause blood to

enter the catheter which may clot or air in an open system to enter the body. Since the early

1980's valves of different types have been employed on the distal end (indwelling) ^' of catheters

and more recently certain types of proximal valves have been devised. Slit valves of the present

invention have more flexibility to withstand pressures and allow greater controllability of the

opening and closing of the slit valves during times of use and non-use when protection is needed.

Several configurations of this invention are disclosed. In all of these configurations there

is at least one normally closed slit located in an outdwelling nipple-shaped slit valve. The

location, length of each slit and wall thickness allow for variation in valve functions. For

instance, the varying of the wall thickness and or slit length has an effect, to some extent, on

opening pressure of the valve. The use of more than one slit valve in the same annular location

will affect flows but not necessarily opening or closing pressures. Also, one slit which

transverses two or more valve surfaces can impact opening pressures in one direction and not the

other. Material properties also have an effect on the opening and closing of valves, i.e., if the

material is soft, the valves will act different than if the material is of higher durometer. This

creates the ability to adjust the configuration of the slit valve or valves and select a material to produce an effective valve for the purpose intended.

The prior art, such as U.S. Patent Nos. 5,205,834 and 5,984,902, comprises a disc of

material which has a slit of a certain length placed in the center of the disc. This disc is placed in

annular compression within a hub. Valve function is varied by the opening diameter on either

side of the disc. The disc can also be varied in thickness and material durometer which allows

some flexibility in valve function. However, the length of the valve can only be increased by increasing the diameter of the disc itself. This "slit diameter" of disc with the area needed to

hold the disc in place can create a large and bulky hub and makes it very difficult to make it

small and compact. Also over pressurization of the system can dislodge the disc causing valve

malfunction. In contrast, the present invention provides a very small and compact outdwelling

slit valve. More valve slits along different surfaces of the valve allow reduction in valve size. It

also allows the valve pressures to vary without restricting the diameters within the hub housing itself.

The present invention accommodates the following:

1. Valves in flats only:

One or more slits can be placed on flat surfaces only to create

valves. External surface and internal surface of flats maybe

different in that the internal flat will be smaller in area. Therefore,

if the valve slit is in length of the external flat, the valve will by its

nature have different operating pressures depending on whether it is opening outwardly or inward. If the valve slit is the length of the

internal flat surface, the valve function will be identical inward or

outward.

2. Valves on flat and wall:

One or more slits can be placed so as to transverse flat surfaces and

the outer diameter and/or end surfaces to create the valves. Slits

that extend beyond the flat valve surfaces will create a larger flow

outwardly than inwardly. This creates a larger flow of fluid

outward, therefore increasing flow rate or ease of infusion of fluid into the body.

3. Crossing valves:

One or more slits can be placed in a crossing orientation with one

another or intersect one another. This also can create in effect a

longer slit in the outwardly direction while maintaining a

controlled inwardly slit length. Also, some crossing slits may not

function at all in one direction, but when combined with another

slit creates a larger opening for infusion.

4. Number of valves:

One or more slits can be on more than one surface creating many

valves. The number of slit valves in each valve unit is the most

significant feature, because each slit valve acts independently from

the others. The more valve slits the higher combined infusion

which is a plus. However, more slits do not effect the at rest valve

functions which keeps internal and external pressures from opening the valves.

5. Wall thickness of valves:

Wall thickness can vary to change valve function. Wall thickness

can be different on each valve as determined by those skilled in the art.

6. Length of slits:

Length of slits can vary to change valve function. The length of

the slit has a large effect on valve function. Varying slit lengths

could also be used as a way of controlling valve functions. ^•

7. Flushing of dead space:

Dead space that cannot be flushed clean presents a problem in any

aspiration and infusion system. The present slit valves expand to

constrain the amount of dead space so that flushing keeps the

interior clean and free of blood and other contaminates.

Reference is now made to the drawings, wherein like numerals are used to designate like

parts throughout. Any normally closed nipple-shaped outdwelling slit valve of this invention

may be used for infusing, aspirating or both and may be any one of many configurations. Each of

the nipple-shaped slit valves shown in Figures 1-21 comprises one-piece construction, with each

slit valve placed within an outdwelling housing positioned external of a medical patient in

proximal relation to a hollow cannula, which selectively accommodates fluid flow to and from a

medical patient.

Figure 1 is intended to be representative of placement of outdwelling slit valves in

accordance with the present invention external of the medical patient where a hollow cannula 30

comprising an open end 32 is disposed within a body cavity 34 of a medical patient 36. The slit

valve of Figure 1 is concealed within a housing, generally designated 38, comprising

interconnected distal and proximal housing parts 40 and 42. The slit valve within housing 38

accommodates selective fluid flow into and from the patient 36, based upon the slit valve being

subjected to a predetermined pressure differential, i.e., the pressure on the distal side in tube 30

when compared to the pressure on the proximal side in tube 44. While in most instances the

body cavity 34 would likely be a cardiovascular vein, where the fluid flow comprises liquid

displacement, liquid displacement in other body cavities is contemplated, as is gaseous flow from

and to other body cavities.

Figures 2-4 illustrate enlarged views of the two-part housing 38 of Figure 1 and slit valve

60 within the housing 38. The exterior of the proximal housing part 42 comprises an exposed

hier lock thread 46 and a hollow interior 48 to accommodate selective fluid flow. Thread 46

accommodates luer lock threaded connection with a luer lock fitting at the distal end of hollow

proximal tube 44 (Figure 1) in a conventional manner. Distal housing part 40 comprises a

tapered elongated tip 50 sized to accommodate a press fit overlapping connected relationship

with the proximal end of the cannula 30, the cannula 30 being illustrated as a hollow tube of

synthetic resinous material of medical grade. The interior of the distal housing part 40 comprises

the hollow passageway 52 accommodating selective fluid flow and an enlarged slit valve- receiving compartment 54.

The proximal and distal housing parts 42 and 40 are connected at interface 56 in an

interlocking male-female relationship, with or without a bonding agent, as determined by those

skilled in the art. Thus, when assembled as shown in Figure 3, the housing parts 40 and 42 may be either separable or inseparable.

Contained in compartment 54, as shown in Figures 3 and 4, is a one-piece normally

closed nipple-shaped slit valve, generally designated 60. The slit valve 60 comprises a proximal

flange 62, which, when assembled, is compressively trapped between and compressively secured between the two housing parts 40 and 42, as best shown in Figure 3. Figure 3 illustrates that

flange 62 is firmly retained between a distal shoulder 64 of housing part 40 and proximal

shoulder 66 of housing part 42. While the central portion 68 of the slit valve 60 is annular at the

outside, it comprises an interior shoulder 70, with the hollow 48 of valve 60, followed by a

tapered interior surface 72, which is divergent in a distal direction.

The nipple-shaped slit valve 60 comprises a tapered distal section 74 ending in a tip or

apex 76. The converging section 74 is equipped with at least one normally closed slit 78

comprised of opposed flexible lips 80. While the slit 78 may be placed in a flat region (a flat) of

the slit valve, it may also be positioned in a rounded (or non-flat) portion of the slit valve. Where

only one slit is used in the slit valve, that slit accommodates both influent and effluent fluid flow

when predetermined pressure differentials are reached. In other embodiments, as explained

hereinafter, nipple-shaped slit valves in accordance with the present invention may comprise

separate influent and effluent slits. Influent flow is sometimes referred to as infusion and

effluent is sometimes referred to as aspiration.

The nipple-shaped slit valve 84 of Figure 5 is comprised of previously-described

proximal flange 62, central portion 68 and a tapered portion 74, but comprised of four flats 82,

each flat being equipped with a slit valve 78, each of which is spaced from the tip 76 but shown

to extend proximally a short distance into the central portion 68. Any of the four slits 78 of

nipple-shaped slit valve 84 are sized, shaped and formulated to accommodate infusion, while the

other two slits accommodate aspiration, when in each case a threshold pressure differential is

required to accommodate fluid flow, or any of the four slits could accommodate a two-way

functioning valve.

With respect to Figure 6, a somewhat different nipple-shaped outdwelling slit valve,

generally designated 86, is illustrated which comprises the previously mentioned flange 62 and

central portion 68 a distally extending convergingly shaped tapered distal portion and a tip 76.

The nipple-shaped slit valve 86 comprises a single two-way slit which continuously traverses

through two flats 82, across tip 76 and proximally beyond both flats 82. This slit accommodates

both infusion and aspiration.

Reference is made to Figure 7 which illustrates a nipple-shaped slit valve, in the form of a

duckbill configuration, generally designated 88. Nipple-shaped slit valve 88 comprises the

previously described flange 62 and intermediate or central hollow portion 68 as well as a distal

portion 74' defining opposed U-shaped flats 90, each comprising a slit 78 which extends

proximally beyond the associated flat 90 into the central portion 68. The distal portion 78'

comprises a duckbill end 92 in which is defined a slit 78 running at both ends thereof into the

distal cylindrical central portion of the slit valve 88. The two opposed slits 78 in flats 90

accommodate aspiration, while all three slits 78 accommodate infusion.

Figures 8A through 8C illustrate the manner in which the normally closed slits 78 are

flexed at respective pressure differential thresholds to accommodate infusion and aspiration,

respectively. Specifically, as shown in Figures 8 A and 8B, infusion fluid, shown by arrows 100

reaches a pressure which compared to the pressure in passageway 52 and compartment 54 creates

the necessary pressure differential threshold to accommodate opening of the slit 78 by flexing the

lips 80 away from the normally closed contiguous relation to the open condition illustrated in

Figure 8B accommodating infusion flow at a selected rate. The rate may be controlled to less

than a maximum by spacing the slit 78 in question in close proximity to the adjacent housing

surface defining the compartment 54, as illustrated in Figure 8A.

To the contrary, when the pressure within the passageway 52 and the compartment 54

exceeds the pressure within the interior of the nipple-shaped slit valve by an amount equal to or

greater than the threshold differential pressure, the lips of the slit will flex inwardly as shown in

Figure 8 C to accommodate aspiration in a proximal direction, as indicated by arrow 102.

Figures 9 and 10 illustrate the above-described nipple-shaped slit valve 84 of Figure 5, in

enlarged presentation.

Reference is made to Figures 11 through 13, which illustrate a slight modification of the

nipple-shaped slit valve 88 of Figure 7. The embodiment of Figures 11 and 12 is generally 88'.

The presentation in Figures 11 and 12 shows the slit valve 88 of Figure 7 rotated by 90 degrees

with the two slits 78 exposed in the U-shaped flats 90 terminating proximally within the flats so

as not to extend into the cylindrical portion 68. It should be noted that the step or shoulder 70,

described in conjunction with slit valve 60, has been replaced by solid material at the same

location in the slit valve 88 of Figures 11-13.

Reference is now made to Figures 14 and 15, which in enlarged form illustrate the

previously described nipple-shaped slit valve 86 of Figure 6. However, Figures 14 and 15

illustrate nipple-shaped slit valve 86 rotated through 90 degrees from the position of Figure 6.

Reference is now made to Figures 16 and 17, which illustrate a further nipple-shaped slit

valve, generally designated 100, in accordance with the principles of the present invention. The

configuration comprises an extension of the cylindrical central region 68 and further comprises a

blunt distal end 102 comprising a flat transversely-directed distal wall 104 and in which a single

slit 78 exists so as to span the entire diameter of the distal end wall 104 and to further extend a

short distance into the cylindrical portion 68, both top and bottom. In effect, the wall 104

comprises a flat, with the single valve 78 accommodating both infusion and aspiration. As can

been seen from Figure 17, the wall thickness of central cylindrical portion 68 decreases internally

at tapered wall 106 so that the wall thickness is less at the distal region of the central portion 68

and across the end wall 104.

Reference is now made to Figures 18 and 19 which illustrate a further nipple-shaped

outdwelling slit valve, generally designated 120, in accordance with principles of the present

invention. Slit valve 120 comprises the previously described proximal flange 62 and hollow

intermediate central cylindrical section 68. The distal end of the slit valve 120 comprises a

diagonally-directed or beveled end wall 122 integrally joined at interface 124 to the cylindrical

central section 68. End wall 122 comprises a normally closed slit 78, which extends centrally

across the entire end wall 122 and a short distance, top and bottom, proximally into the

cylindrical wall 68. Thus, the end-to-end length of the slit 78 of Figures 18 and 19 exceeds the

diameter of the cylindrical wall 68, thereby accommodating substantial fluid flow when a

pressure differential of a specific threshold or greater magnitude causes the lips 80 to flex away

from each other and the normally closed slit 78 to open.

Reference is now made to Figures 20 and 21 which illustrate an additional nipple-shaped

outdwelling slit valve, generally designated 130. Slit valve 130 comprises previously described

proximal flange 62 and central hollow cylindrical section 68. A frusto-conical distal end

segment 132 is integral, preferably as one piece, at interface 134 with cylindrical section 68.

The distal end segment 132 comprises a hollow frusto-conical wall 136 which tapers in a

distal direction and in which at least one side flat 82 is disposed with a slit 78 thereon. The

thickness of conical wall 136 decreases progressively in a distal direction. The wall 136 is closed

by an integral blunt transversely directed end wall 138. Wall 138 defines a normally closed slit

78, which extends centrally across the entire diameter of end wall 138 and proximally into the

wall 136, top and bottom.

The invention may be embodied in other specific forms without departing from the spirit

of the central characteristics thereof. The present embodiments therefore are to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the

appended claims rather than by the foregoing description, and all changes which come within the

meaning and range of equivalency of the claims are therefore intended to be embraced therein.

What is claimed and desired to be secured by Letters Patent is: