Pre-slit injection site and tapered cannula

Abstract
A pre-slit injection site includes a housing with a flow path therethrough. A first end of the housing carries a pre-slit septum. One form of a blunt cannula, usable with the injection site, carries a locking member. When the pre-slit injection site slidably receives the blunt cannula, the locking member latches to the injection site and creates a mechanically coupled unit. Another form of the cannula includes a tube having a tapered distal end region and having elongate discharge slots for reducing contact surface area and for directing the flow laterally out of the cannula. The cannula may also include a rounded lead post, an annular barb, and axially oriented grooves.
Description




FIELD OF THE INVENTION




The invention pertains to coupling systems usable to transfer materials from one flow conduit to another. More particularly, the invention pertains to two-part coupling members with a first part including a pre-slit septum and a second part including a blunt cannula. The pre-slit septum slidably receives the blunt cannula to effect the coupling.




BACKGROUND OF THE INVENTION




Injection sites usable with pointed cannulae have long been known. For example, such sites can be formed with a housing having a fluid flow path therein. A septum is positioned in the housing closing the fluid flow path.




One injection site usable with a piercing cannula is disclosed in U.S. Pat. No. 4,412,573 to Zdeb entitled “Injection Site.” The Zdeb patent is assigned to the assignee of the present invention.




The pointed cannula can be forced through the septum into fluid flow communication with the flow path in the housing. Known injection sites usable with a piercing cannula can be physically damaged by repetitive piercing caused by the sharp cannula. This damage, known as coring or laceration, can result in subsequent leakage.




Due to problems associated with infectious agents, personnel using such pointed cannulae do so with great care. Notwithstanding careful and prudent practice, from time to time, accidents do occur and individuals using such pointed cannulae jab themselves.




Injection sites usable with a blunt cannula are also known. For example, U.S. Pat. No. 4,197,848 issued to Garrett et al. entitled “Closed Urinary Irrigation Site” and assigned to the assignee of the present invention discloses one such injection site. That injection site is a relatively low pressure device having a relatively thin, molded, sealing member. The sealing member has an opening therethrough.




A blunt cannulae can be forced through the sealing member placing the cannulae into fluid flow communication with a fluid flow pathway in the injection site.




Injection sites of the type noted above usable with a blunt cannula have the advantage that the blunt cannula will not pierce the skin of a user. On the other hand, it is important that the pre-slit injection site reseal with enough force that fluids do not ooze therefrom and that airborne particulate matter, bacterial or viral matter do not enter therethrough.




Hence, there continues to be a need for a pre-slit injection site which can be used with a variety of solutions and over a range of fluid pressures. Further, there continues to be a need for such a pre-slit injection site which will reliably reseal even after many insertions of the blunt cannula.




Such an injection site should be able to receive a large number of insertions of the cannula without displaying reseal failure. Such an injection site should provide for improved alignment of the cannula on insertion. Improved alignment will result in less chance of damage to the injection site after repeated insertions of the cannula. Preferably, the injection site would also be usable with a pointed cannula. Preferably, a pre-slit injection site usable with a blunt cannula will provide a reasonable level of insertion force such that health care personnel will readily be able to insert the blunt cannula, yet the cannula will not easily fall from or drop out of contact with the septum.




SUMMARY OF THE INVENTION




In accordance with the invention, an easily wipeable injection site usable with a blunt cannula is provided. The injection site includes a housing which defines a fluid flow channel therethrough. The housing has a first and a second end.




A flexible sealing member is carried by the housing for sealing the first end. The sealing member has a resealable opening therein. The sealing member also is formed with a curved exterior peripheral surface such that the blunt cannula can be sealingly inserted through the opening and placed in fluid flow communication with the flow path. Further, the blunt cannula can be removed from the opening with the sealing member then interacting with the housing so as to reseal the opening.




The housing can also be formed with the first end including an annular channel underlying the sealing member. The sealing member is subjected to radially directed forces by a tapered surface of the first end of the housing. These forces tend to reseal the opening in the sealing member.




The sealing member can be a cylindrically shaped rubber member. The first end of the housing can include an interior tapered surface for receiving the sealing member and for applying the radially directed forces to the sealing member.




A retaining member carried by the first end of the housing can be used to retain the sealing member within the housing. The retaining member can be generally U-shaped. Alternately, the retaining member can be formed as a coiled spring.




The retaining member applies axially directed forces to the sealing member. In one embodiment of the invention, the retaining member deflects the sealing member and forms a curved exterior peripheral surface thereon. The curved exterior peripheral surface is an easily wipeable surface.




The retaining member deflects or distorts the upper and lower peripheral edges slightly as a result of applying axial forces thereto. When the blunt cannula is inserted into the slit in the sealing member, an annular interior peripheral region of the sealing member deforms further and fills, at least in part, the annular channel.




Deformation of this annular peripheral region results in an insertion force in a range of 2.0 to 5 pounds. Preferably, the insertion force will have a value of the order of 2.0 pounds.




The resealable opening in the sealing member can extend entirely through that member. Alternately, the resealable opening can extend only partway therethrough. In this embodiment, the end of the blunt cannula will be used to tear through the remainder of the sealing member.




The sealing member can be formed in two parts. An exterior cylindrical portion can be slit completely. An interior cylindrical unslit portion can be provided to seal the site until the blunt cannula is inserted therethrough the first time.




The interior surface of the first end can be formed with the taper in a range on the order of 5 degrees to 20 degrees. Preferably, the interior surface will have a taper on the order of 12 degrees. This tapered surface permits the use of a cylindrically shaped sealing member.




To provide for leak-free insertion, the length of the slit in the sealing member must be less than one-half the circumference of the cannula being inserted therethrough. Hence, the slit length may exceed the diameter of the cannula being inserted. In addition, the slit length must be great enough, given the elastic limit of the sealing member, to prevent tearing during insertion.




Further in accordance with the invention, a coupling system for coupling first and second fluid flow members together is provided. The coupling system includes an injection site which is affixed to the first fluid flow member. The injection site includes a housing. The housing has a fluid flow path therethrough.




A sealing member is carried by the housing. The sealing member has a resealable opening therein.




An annular retaining member is carried by the housing and cooperates with the housing to retain the sealing member therein. Radially directed forces are applied to the sealing member by the housing, thereby urging the opening into a resealed condition.




A blunt cannula, affixed to second fluid flow member, has a fluid flow path therethrough. The cannula carries a locking member for lockingly engaging the housing when the cannula extends through the opening of the sealing member. When so positioned, the two fluid flow members are placed into fluid flow communication.




The locking member can include a luer-type twist lock fitting. Alternately, the locking member can include slidably engageable members which are responsive to axial movement of the injection site and the cannula toward one another.




In accordance with further aspects of this invention, the blunt cannula may be provided with features that facilitate insertion into the injection site, enhance fluid flow or dispersion, increase tug resistance, and reduce kickback.




In particular, one embodiment of the cannula includes a tube with a plurality of elongate discharge slots adjacent the distal end. The fluid changes direction as it passes laterally through the slots and out of the tube. The flow area of the slots exceeds the flow area inside the tube. This slot structure enhances fluid flow and dispersion characteristics. In addition, the slots decrease the contact surface area on the tube exterior so as to facilitate insertion.




In a further modification, the cannula includes a lead post on the tube distal end to guide the cannula through the slit in the injection site.




In another cannula embodiment, the tube is generally cylindrical and the fluid discharges directly from an open end of the tube. The exterior surface of the tube is provided with grooves to reduce the contact surface area.




In still another cannula embodiment, the tube has a cylindrical portion and a tapered distal end portion which are each about equal in length. The taper facilitates insertion, and the remaining cylindrical portion reduces kickback.




In yet another embodiment, the cannula includes an annular barb which functions to reduce kickback.




Other advantages of a blunt plastic cannula in accordance with the invention, relative to conventional steel needles include a higher fluid flow rate capacity and a simpler one-piece plastic design.











Numerous other advantages and features of the present invention will become readily apparent from the following detailed description of the invention and the embodiments thereof, from the claims and from the accompanying drawings in which the details of the invention are fully and completely disclosed as a part of this specification.




BRIEF DESCRIPTION OF THE DRAWINGS





FIG. 1

is a side elevational view, partly in section, of a prior art pre-slit injection site and an associated blunt cannula;





FIG. 2A

is a view in perspective of a catheter positioned in the hand of a patient with a pre-slit injection site in accordance with the present invention positioned adjacent thereto;





FIG. 2B

is a perspective view of the catheter of

FIG. 2A

with a pre-slit injection site in accordance with the present invention rotatably affixed thereto;





FIG. 3

is an enlarged side elevational view in a section of a pre-slit injection site in accordance with the present invention formed on a body having a luer twist-lock type connector for coupling to a catheter;





FIG. 4A

is an exploded view of a pre-slit injection site, a shielded blunt cannula and a syringe prior to being coupled together;





FIG. 4B

is an enlarged, side elevational view in section of the pre-slit injection site, the shielded blunt cannula and the syringe of

FIG. 4A

coupled together to form a sealed fluid flow system;





FIG. 5A

is a view in perspective of a pre-slit injection site prior to engaging a blunt cannula carrying a locking member;





FIG. 5B

is an enlarged side elevational view, partly broken away, illustrating the interrelationship between the pre-slit injection site and the blunt cannula of

FIG. 5A

;





FIG. 6

is an overall view of a container, an associated solution administration set and a pre-slit injection site in accordance with the present invention;





FIG. 7

is an enlarged side elevational view, partly broken away illustrating the relationship between selected elements of

FIG. 6

;





FIG. 8

is a side elevational view, partly broken away illustrating an alternate shielded cannula in accordance with the present invention;





FIG. 9

is a side elevational view, partly in section, of a pre-slit injection site mounted on a fragment of a solution container;





FIG. 10

is a side elevational view of a fragment of a solution container carrying, as a single port, a pre-slit injection site;





FIG. 11

is a side elevational view of the injection site and the fragmentary container of

FIG. 10

prior to being engaged with a shielded cannula carried by a syringe;





FIG. 12

is an enlarged side elevational view, partly in section, of a coupling system with a pre-slit injection site partly coupled to a blunt cannula;





FIG. 13

is an enlarged side elevational view, partly in section, of the coupling system of

FIG. 12

subsequent to engagement of the two coupling members;





FIG. 14

is a side elevational view, partly broken away, of a spike connector carrying a pre-slit injection site in accordance with the present invention;





FIG. 15

is an enlarged side elevational view of a Y-connector in section carrying a pre-slit injection site in accordance with the present invention;





FIG. 16

is an enlarged fragmentary side elevational view in section of a coupling member carrying a pre-slit injection site where the slit extends only partway through the septum;





FIG. 17

is a perspective view of a burette solution administration set carrying a pre-slit injection site in accordance with the present invention;





FIG. 18

is a view of part of a burette solution administration set carrying a pre-slit injection site being coupled to a shielded blunt cannula;





FIG. 19

is a step in the method of making a pre-slit injection site in accordance with the present invention;





FIG. 20

is another step in the method of making a pre-slit injection site in accordance with the present invention;





FIG. 21

is an initial phase of a final step in making a pre-slit injection site in accordance with the present invention;





FIG. 22

is an intermediate phase of the final step in a method of making a pre-slit injection site in accordance with the present invention;





FIG. 23

is a final phase of the final step in a method of making a pre-slit injection site in accordance with the present invention;





FIG. 24

illustrates an initial phase in an alternate step of making a pre-slit injection site in accordance with the present invention;





FIG. 25

illustrates a final phase of the alternate step in a method of making an injection site in accordance with the present invention;





FIG. 26

illustrates yet another alternate step in a method of making a pre-slit injection site in accordance with the present invention;





FIG. 27

is an enlarged, fragmentary cross-sectional view of another embodiment of an injection site in accordance with the present invention;





FIG. 28

is a cross-sectional view taken generally along the plane


28





28


in

FIG. 27

;





FIG. 29

is an end view of another embodiment of the cannula in accordance with the present invention;





FIG. 30

is a cross-sectional view taken generally along the plane


30





30


in

FIG. 29

;





FIG. 31

is an end view of another embodiment of the cannula in accordance with the present invention;





FIG. 32

is a cross-sectional view taken generally along the plane


32





32


in

FIG. 31

;





FIG. 33

is a cross-sectional view taken generally along the plane


33





33


in

FIG. 32

;





FIG. 34

is an end view of another embodiment of the cannula in accordance with the present invention;





FIG. 35

is a fragmentary, side elevational view of the embodiment of the cannula illustrated in

FIG. 34

;





FIG. 36

is a cross-sectional view taken generally along the plane


36





36


in

FIG. 34

;





FIG. 37

is a cross-sectional view taken generally along the plane


37





37


in

FIG. 36

;





FIG. 38

is an end view of another embodiment of the cannula according to the present invention;





FIG. 39

is a cross-sectional view taken generally along the plane


39





39


in

FIG. 38

;





FIG. 40

is a cross-sectional view taken generally along the plane


40





40


in

FIG. 39

;





FIG. 41

is an end view of another embodiment of the cannula according to the present invention;





FIG. 42

is a cross-sectional view taken generally along the plane


42





42


in

FIG. 41

;





FIG. 43

is an end view of another embodiment of the cannula according to the present invention;





FIG. 44

is a cross-sectional view taken generally along the plane


44





44


in

FIG. 43

; and





FIG. 45

is a view in section of another insertion member for a blunt cannula.











DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS




While this invention is susceptible of embodiment in many different forms, there are shown in the drawing and will be described herein in detail specific embodiments thereof with the understanding that the present disclosure is to be considered as an exemplification of the principles of the invention and is not intended to limit the invention to the specific embodiments illustrated.




A prior art pre-slit injection site


10


and associated blunt cannula


12


are illustrated in FIG.


1


. The prior art injection site


10


has a cylindrical housing


14


with a fluid flow path


16


therethrough. A first end


18


of the housing


14


is closed with a relatively thin disc-shaped resealable member


20


. The member


20


has a resealable opening


22


therein.




The member


20


is a molded septum with an integrally formed skirt


20




a


. The skirt


20




a


is oriented generally perpendicular to the portion of the septum with the opening


22


.




The cannula


12


includes a body portion


24


which carries at a first end a hollow, cylindrical, blunt piercing member


26


. As the cannula


12


is moved in a direction


28


toward the first end


18


of the injection site


10


, the member


26


slidably engages the opening


22


. The sealing member


20


is then deformed adjacent the opening


22


and the member


26


extends into the flow path


16


. A fluid flow path through the cannula


12


will then be in fluid flow communication with the flow path


16


via the hollow piercing member


26


.




In contradistinction to the prior art pre-slit injection site


10


of

FIG. 1

,

FIGS. 2A and 2B

illustrate a pre-slit injection site


34


being coupled to a peripheral venous catheter


36


. The catheter


36


is shown in fluid flow communication with a vein in a hand H of a patient. The catheter


36


carries at a proximal end


38


a luer-type female twist lock connector


41


.




The pre-slit injection site


34


is formed with a cylindrical housing


40


having a first end


42


and a second end


44


.




Carried by the housing


40


, adjacent the second end


44


is a hollow cylindrical fluid flow member


46


. The member


46


slidably engages a receiving member in the housing


38


of the catheter


36


, thereby providing a sterile fluid flow coupling as is well known and conventional.




A plurality of internal male luer-type threads


48


is carried by the housing


40


adjacent the second end


44


. The threads


48


will engage the flange member


41


when the injection site


34


is rotated in a direction


50


. When so coupled together, the catheter


36


and the injection site


40


provide a sealed coupling through which fluids may be injected into the vein of the hand H.





FIG. 3

illustrates, in section, further details of the injection site


34


. A resealable septum


52


is carried by the first end


42


of the housing


40


. The septum


52


includes first and second spaced apart surfaces


54


and


56


respectively. The surface


54


has been forced into a dome-like shape by annular, U-shaped, swaged end members


58


carried by the first end


42


. The dome-like shape of the surface


54


can extend beyond a surface


42




a


of the first end


42


. This facilitates cleaning the surface


54


.




The septum


52


has a generally cylindrical shape. The septum


52


can be formed of a latex or synthetic rubber material. Alternately, the septum can be formed of a thermoplastic elastomer. The material used for the septum


52


should be non-toxic and sterilizable such as by means of radiation, steam or EtO.




Because the septum


52


is generally cylindrical in shape, it can be die-cut from a sheet, cut from an extruded rod or molded. The septum


52


can have an exemplary diameter on the order of 0.30 inches. The height of the septum


52


can be, for example, on the order of 0.125 inches.




The first end


42


is also formed with a tapered interior surface


60


which terminates in an annular channel


62


. The tapered interior surface


60


has a taper in a range of 5 degrees to 20 degrees. Preferably, the taper will be on the order of 12 degrees. With the indicated size of the above noted exemplary septum


52


and a 12 degree taper, diametric resealing compression of the septum


52


adjacent the channel


62


is on the order of 10%.




The channel


62


is bounded in part by a septum supporting ridge


62




a


. The channel


62


can typically have a depth in a range of 0.050-0.070 inches.




A peripheral surface


64


of the septum


52


slidably engages the tapered interior surface


60


as the septum


52


slides into the first end


42


. The annular channel


62


which underlies the interior peripheral surface


56


of the septum


52


is provided to permit the septum


52


to deform when a blunt cannula is inserted through an opening


66


therein.




The housing


40


is also formed with a fluid flow path


68


such that fluids injected via a blunt cannula inserted through the resealable opening


66


can flow into the catheter


36


for delivery to hand H of the patient.




The swaged end members


58


apply axial forces to the septum


52


thereby creating the domed exterior peripheral surface


54


. The axial forces applied by the end members


58


slightly deform the regions


52




a


and


52




b


. In contradistinction, the tapered internal surface


60


applies radially directed forces to the septum


52


, thereby forcing the opening


66


into a resealed condition.




In an alternate embodiment, the surface


52


could be formed as a flat, as opposed to a domed, surface.




Once the injection site


34


is lockingly engaged with the catheter


36


, a sealed system is formed through which fluids can be infused into the catheter


36


. The resealable septum


52


closes the fluid flow path


68


.





FIGS. 4A and 4B

illustrate in combination the injection site


34


, a blunt shielded cannula


80


and a syringe of a conventional type


82


. The syringe


82


, as is well known, can be formed with a cylindrical hollow end


84


which carries a male luer-type twist lock thread


86


. A hollow centrally located cylindrical fluid flow member


88


is in fluid flow communication with an interior region


90


of the syringe


82


.




The shielded blunt cannula


80


carries at a first end


92


a female luer twist-lock flange


94


. The flange


94


will slidably engage the threads


86


of the end


84


. Hence, the shielded blunt cannula


80


can be locked to the syringe


82


forming a closed fluid flow pathway. The shielded cannula


80


could alternately be formed fixedly attached to the syringe


82


.




The shielded blunt cannula


80


carries a cylindrical hollow protective shield


96


which surrounds a centrally located hollow, elongated cylindrical blunt piercing member


98


. The cylindrical blunt piercing member


98


has a total length on the order of 3 times the thickness of the septum


52


in order to ensure complete penetration. The cylindrical blunt piercing member


98


has a diameter on the order of ⅓ the diameter of the septum


52


. The shield


96


is desirable and useful for maintaining the piercing member


98


in an aseptic condition by preventing touch contamination prior to the shielded cannula


80


engaging the pre-slit septum


52


. Also, the shield helps to align the piercing member with the pre-slit septum.




The cylindrical blunt piercing member


98


can slidably engage the pre-slit septum


52


, best illustrated in

FIG. 4B

, thereby extending through the preformed opening


66


therein. As illustrated in

FIG. 4B

, when the piercing member


98


slidably engages and pierces the septum


52


, the region


52




a


deforms by expanding into and filling, at least in part, the annular channel


62


.




The deformation facilitates insertion of the piercing member


98


through the slit


66


. Subsequent to the piercing member


98


slidably engaging the injection site


34


, the interior region


90


of the syringe


82


is in fluid flow communication with the flow path


68


of the injection site


34


via flow paths


88




a


and


99


a respectively of the syringe and the blunt piercing member


98


.




In this engagement condition, the septum


52


seals completely around the piercing member


98


. Hence, exterior gases, liquids or airborne matter will be excluded from the channel


68


.




Subsequent to infusing fluid from the syringe


82


into the fluid flow pathway


68


, hence into the catheter


36


and the hand H of the patient, the syringe


82


with lockingly engaged shielded cannula


80


can be slidably withdrawn from the injection site


34


. Subsequent to this withdrawal, the septum


52


reseals the opening


66


therein.




The opening


66


will repeatedly reseal, when the piercing member


98


is removed, provided that the pressure (in the septum


52


of the opening


66


) created by interaction of the septum material properties and compression supplied by the housing exceeds the pressure challenge of the fluid contained within. Blunt cannula do not haphazardly core, lacerate, or otherwise damage the sealing interface


66


as conventional needles do, thereby allowing repeatable resealability. However, septum material properties, thickness, and compression allow resealability for a finite number of conventional needle insertions. The combination injection site


34


and catheter


36


then return to its pre-infusion, sealed condition.





FIGS. 5A and 5B

illustrate the pre-slit injection site


34


used in combination with a blunt cannula


80




a


. The cannula


80




a


includes a hollow body portion


92




a


with a Luer flange


94




a


, a piercing member


98




a


, and manually operable elongated locking members


100




a


and


100




b


. Alternately, a tubing member could be affixed to the hollow body portion


92


.




Curved end regions


100




c


of the members


100




a


and


100




b


slidably engage the second end


44


of the housing


40


when the piercing member


98




a


of the blunt cannula


80




a


has been forced through the pre-formed opening


66


, best illustrated in FIG.


5


B. The embodiment illustrated in

FIGS. 5A and 5B

has the advantage that the infusing cannula


80




a


cannot accidentally disengage from the pre-slit septum


34


during the fluid infusion process. It will be understood that while spring-like deflecting members


100




a


and


100




b


are illustrated in

FIGS. 5A and 5B

that other forms of locking members are within the spirit and scope of the present invention.





FIG. 6

illustrates an alternate pre-slit injection site


34




a


. A tubing member


102


can be fixedly attached to the cylindrical hollow fluid flow member


46


. The embodiment


34




a


of

FIG. 6

utilizes the same structure for the septum


52


including the tapered surface


60


and the underlying annular channel


62


as does the embodiment


34


in FIG.


3


. The shielded cannula


80


can be utilized with the injection site


34




a


as previously described.




In the event that it is desirable to infuse solution from a container


104


with a conventional port


106


, a fluid administration set


110


of a conventional variety may be utilized. The set


110


includes a spike connector


112


at a first end. The spike connector


112


is designed to pierce the port


106


of the container


104


. The set


110


can also carry a slidably engageable connector


114


of a known type at a second end. As illustrated in

FIG. 7

, the connector


114


can slidably engage the hollow cylindrical member


98


of the shielded cannula


80


, thereby placing the interior fluid of the container


104


into fluid communication with the tubing member


102


.





FIG. 8

illustrates yet another alternate


80




b


to the shielded cannula


80


. The piercing member


98




b


carries a tubing member


118


fixedly attached thereto. The tubing member


118


could be coupled at a second end to a container such as the container


104


.




The present pre-slit injection site can be directly affixed to a container


120


as illustrated in FIG.


9


. The container


120


includes a rigid hollow cylindrical access port


122


affixed thereto. The access port


122


includes a fluid flow channel


124


in fluid flow communication with the interior of the container


120


. Sealingly affixed to the port


122


is a pre-slit injection site


126


.




The site


126


includes a cylindrical housing


128


which carries at a first end


130


a septum


132


with a slit


134


formed therein. The first end


130


has been swaged to form an annular U-shaped retaining member


136


. The retaining member


136


in turn forms a domed exterior peripheral surface


138


on the septum


132


.




The first end


130


also includes a tapered interior force applying surface


140


and an annular channel


142


underlying the septum


132


. As discussed previously, the channel


142


provides a space into which the septum


132


can deform when a blunt cannula is forced through the resealable opening


134


.




Further, as illustrated in

FIG. 9

, the injection site


126


can be covered by a removable cover


146


of a type used with the conventional port


106


of the bag


120


.




While the bag


120


is illustrated formed with two ports, the conventional pierceable port


106


and the pre-slit injection site


126


, it will be understood that as an alternate (FIG.


10


), a container


150


could be formed which includes only the pre-slit injection port


126


. The removable cover


146


could be used in combination with the container


150


.




As illustrated in

FIG. 11

, the pre-slit injection site


126


can be utilized for the purpose of injecting fluid from the syringe


82


, coupled to the shielded cannula


80


, into the container


150


. When so utilized, the blunt piercing member


98


is used to place the interior fluid containing region


90


of the syringe into fluid flow communication with the interior of the container


150


.





FIGS. 12 and 13

illustrate a fluid flow coupling system


151


having as a first element a pre-slit injection site


126




a


. The site


126




a


is the same as the site


126


except for a plurality of exterior threads


153


formed on an exterior peripheral surface


155


of the housing


128




a


. A second element of the coupling system


151


is a shielded blunt cannula


157


.




The shielded blunt cannula


157


is sealingly affixed to a flexible tubing member


159


by means of a proximal hollow cylindrical member


161


. The member


161


extends into a hollow cylindrical shield


163


to form a blunt piercing member


165


.




The shield


163


carries, on an interior peripheral surface, a set of coupling threads


149


. The threads


149


match the threads


153


.




The two connector elements


126




a


and


157


slidably engage one another when the shielded cannula


157


moves in an axial direction


167


toward the injection site


126




a


. The blunt piercing member


165


penetrates the septum


132




a.






The coupling member


157


can then be rotated in a direction


169


such the interior set of threads


149


carried thereon engages the exterior set of threads


153


. As a result, the two coupling members


126




a


and


157


are lockingly engaged together with the insertion member


165


extending through the opening


134




a


in the septum


132




a


. Hence, fluids can flow from the container


150




a


via the connector system


126




a


and


157


through the tubing member


159


to the recipient.




Injection sites of the type described above are also usable in connection with other fluid flow coupling components. For example, with respect to

FIG. 14

, a pre-slit injection site


160


of the type described above can be used in combination with a spike connector


162


of a conventional variety. Spike connectors such as the spike connector


162


can be used to pierce conventional ports such as the port


106


of the container


104


(FIG.


6


). When the spike connector


162


is so used, the pre-slit injection site


160


can then be utilized for the purpose of coupling to other fluid administration sets.




The injection site


160


illustrates an alternate form of swaging the first end


42




c


for the purpose of retaining the septum


52




c


therein. The first end


42




c


can be swaged so as to form an annularly shaped, spiral, spring-like member


164


. The member


164


has a free end


164




a


which engages the exterior dome-shaped peripheral surface


54




c


of the septum


52




c


. The spiral, spring-like swaged member


164


will tend to uncoil, thereby continuously applying axial force to the septum


52




c


and maintaining the domed exterior peripheral surface


54




c.






In yet another alternate,

FIG. 15

illustrates a pre-slit injection site


166


formed in a Y-junction member


168


. The Y-junction member


168


is fixedly attached to first and second tubing members


170


and


172


respectively.




As an alternate to forming the slit


66


completely through the septum


52


, as illustrated in

FIG. 16

, a slit


66




e


can be formed only partly through the septum


52




e


. Such a structure has the further advantage that, until used for the first time, the septum


52




e


is completely sealed.




The septum


52


can be formed in two parts. One part can have a slit, such as the slit


66


, extending entirely therethrough. A second part can be formed without a slit. These two parts can be located adjacent one another in the first end


42


of the injection site.




The slit


66


may be longer on the top of the septum than the bottom. This feature aids blunt cannula alignment with the slit upon insertion, and aids resealability by minimizing the critical slit sealing interface area.




In accordance with the present invention, the slit could have a length with a range on the order of 0.03 to 0.150 inches. Preferably, a slit length on the order of 0.07 inches will be used in combination with a blunt cannula having a diameter on the order of 0.1 inches.




When initially used, the blunt cannula piercing member, such as the member


98


, will be forced through the slit


66




a


. The lower peripheral surface


56




e


will then be punctured, providing access for the blunt cannula piercing member


98


into the fluid flow pathway


68




e.






Pre-slit injection sites of the type described above can be utilized in combination with burette solution administration sets. One such set


176


is illustrated in FIG.


17


. The set


176


includes a pre-slit injection site


178


of the type described above. The injection site


178


is affixed to an exterior planar surface


180


of the burette


182


. A removable cover


184


can be used to maintain the injection site


178


in an aseptic condition until blunt cannula


186


or


188


is inserted therethrough.





FIGS. 19-23

disclose a method of making a pre-slit injection site in accordance with the present invention. In a first step, a housing


200


is provided. The housing


200


has an interior tapered surface


202


at a first end


200




a


thereof. The interior peripheral surface terminates in an annular channel


204


. A cylindrical septum


206


can be provided adjacent the end


200




a.






In a second step, the septum


206


can be forced into the end


200




a


of the housing


200


and slightly deformed by the tapered peripheral surface


202


using an axially moving die


210


. When positioned by the die


210


, the septum


206


is located adjacent an internal annular ring


212


which bounds the annular channel


204


.




In a third step, a second die


214


can be utilized to swage the end


200




a


into spiral-shaped, spring-like members


200




b


which apply axially directed forces against an exterior peripheral surface


206




a


of the septum


206


. The axially directed forces form the flat surface


206




a


into a domed exterior peripheral surface


206




b


as illustrated in FIG.


23


.




Simultaneously, with swaging the end members


200




a


so as to lock the septum


206


into the housing


200


and to form the domed exterior peripheral surface


206




b


, a knife


216


can be utilized to form a slit in the septum


206


. Alternatively, the slit may be cut by a separate die in a separate step. If the septum


206


is formed as an extrusion, the slit can be created during the extrusion process. If the septum


206


is formed by stamping from a rubber sheet, the slit can be cut during the stamping process. If the septum


206


is formed by compression molding, the slit can be cut during the trimming process.




In order to extrude the slit into rod, a flat pin extrusion bushing can be used. A trailing ribbon may be attached to the bushing. The ribbon would prevent curing material across the slit. The ribbon or wire could be placed in the rod core and later stripped out leaving a slit. An inert substance, such as silicone oil, could be coextruded in the center of the rod to prevent curing across the slit and provide lubrication and a visible target for cannula insertion.





FIGS. 24 and 25

illustrate alternate swaging steps wherein a die


220


moving axially toward the housing


200


swages the end region


200




a


so as to form an annular U-shaped region


200




c


and the exterior domed peripheral surface


206




c.






The dies


214


or


220


can be formed with various alternate shaped swaging surfaces


224


, as illustrated in

FIG. 26

, depending on the precise shape of the end swage which is desired. It will be understood that all such variations in the swaging operation are within the spirit and scope of the present invention.




The injection site configuration need not be limited to the configurations depicted in

FIGS. 3-5B

,


9


,


12


-


16


. Rather, several configurations could be constructed without departing from the scope of this invention. Any such configuration would provide a flexible preslit sealing member captured in a housing which provides compression to create a seal against pressure and a void region to accommodate deformed portions of the sealing member material only when the material is deformed or displaced by a blunt cannula piercing member. One such possible configuration is depicted in

FIGS. 27 and 28

.





FIGS. 29 and 30

illustrate a tapered cannula structure


250


which is an alternate to the tapered cannula


98


. The cannula


250


includes a proximal end


252


with an interior region


254


. The region


254


is in part bounded by an internal peripheral wall


256


which is formed with a standard Luer taper. The tapered cannula


250


can be formed with a Luer-type coupling flange


257


at the proximal end so as to be releasably connectable to the syringe


82


as was the tapered cannula


98


previously discussed.




Extending from the proximal end


252


is a cylindrical tube having a cylindrical mid-region


258


and a distal end member


260


. The member


260


has a generally elongated, cylindrical shape with an exterior side wall


262


. A centrally located, cylindrical, internal fluid flow path


264


extends through the distal end member


260


and mid-region


258


in fluid flow communication with the interior region


254


.




The distal end of the end member


260


has a tapered exterior surface


266


. The tapered exterior surface


266


minimizes insertion force as the cannula


250


is being forced through a slit of a septum, such as the slit


66


in the septum


52


. The angle of taper of the surface


266


is preferably in a range between 1 to 15 degrees.




The member


260


is also provided with a plurality of elongated grooves


268


. The grooves


268


in the exterior wall of the member


260


decrease the surface area of contact at the cannula/septum interface during insertion of the cannula into the injection site


34


. This reduced exterior contact surface area decreases the frictional component of the insertion force.




In one embodiment, the tapered blunt cannula


250


may have overall insertion length, corresponding to combined axial lengths of mid-region


258


and end member


260


, on the order of 0.375 inches.




An alternate cannula structure


280


is illustrated in

FIGS. 31

,


32


and


33


. The cannula structure


280


includes a proximal end region


282


corresponding to the end region


252


of the cannula


250


. The region


282


includes a Luer flange


283


. The cannula


280


also includes a central, elongated, cylindrical region


288


.




The central region


288


carries at a distal end thereof an elongated cylindrical end member


290


. The member


290


includes an exterior, peripheral, cylindrical-surface


292


(FIG.


31


). The surface


292


is interrupted by a plurality of spaced-apart, elongated slots or apertures


294


. The slots


294


are defined by first and second spaced-apart, elongated, parallel side surfaces


294




a


and


294




b


. Each of the slots terminates in an end surface


294




c


at the central region


288


.




A fluid flow path


294


d extends through the cannula


280


. The flow path


294


d is in fluid flow communication with the slots


294


.




Between the slots


294


, at a distal end of the region


290


, the exterior surface


292


terminates in tapered end regions


298


to facilitate insertion of the cannula into a pre-slit injection site. The slots


294


themselves also function to decrease the surface contact area, and this further minimizes the insertion force.




The slots


294


are oriented substantially 90 degrees apart around a longitudinal axis


300


. The slots


294


increase the internal flow path cross-section. This increases the fluid flow rate.




The slots


294


also provide for enhanced dispersion characteristics owing to the fluid flowing radially out through the slots


294


. This radial flow, effecting a change in fluid flow direction of about 90 degrees, promotes flushing and dispersion of fluid through the injection site


34


.




Another embodiment of a blunt cannula


310


is illustrated in

FIGS. 34-37

. The cannula


310


is formed with an enlarged proximal connection region


312


corresponding to the region


252


of the cannula


250


. The region


312


includes a Luer flange


313


and a central fluid flow region


314


.




An intermediate, cylindrical region


318


extends from the proximal connection region


312


. The cylindrical intermediate region


318


includes a fluid flow path


320


in communication with the fluid flow region


314


.




The end region


324


extends from the region


318


and includes a first cylindrical portion


326


into which the fluid flow path


320


extends. The region


326


terminates in a tapered exterior surface


328


. The tapered exterior surface


328


merges with a centrally located lead post or guide post


330


. The lead post


330


terminates in a hemispherical end surface


332


.




The lead post


330


helps locate the septum slit


66


prior to insertion and facilitates penetration of the septum slit


66


by the cannula. The lead post


330


facilitates insertion by providing a very low insertion force at the beginning of the insertion step as the cannula is pushed through the slit, such as the slit


66


.




In a preferred embodiment, the guide post


330


can have a length on the order of 0.060 inches and a diameter on the order of 0.050 inches.




The end region


318


includes a novel structure for increasing the flow rate and enhancing dispersion characteristics. In particular, the region


318


includes three radially oriented slots


338


. Each slot


338


has sides


339




a


and


339




b


which each lie along a radius of the cylindrical portion


326


as best illustrated in FIG.


37


. The fluid flowing through the cannula


310


undergoes a change in direction (of up to about 90 degrees relative to the cannula center line


337


) in the slots


338


. This change in direction increases fluid dispersion. Further, since the slots


338


open radially, fluid flow can be maintained even if the end surface


332


of the cannula is pushed up against any material in the system in which the cannula is inserted.




Another embodiment of the tapered cannula of the present invention is illustrated in

FIGS. 38-40

and is designated generally therein by reference numeral


340


. The cannula


340


includes a proximal end


342


which can include a Luer coupling flange


344


for cooperating with a suitable mating structure on a syringe. The proximal end


342


also defines an interior region


346


.




Extending from the proximal end


342


is a generally cylindrical mid-region


348


. Extending from the mid-region


348


is an end member or region


350


which includes a tapered surface


352


.




The distal end of the end region


352


terminates in a blunt, arcuate end surface


356


. Defined within the mid-region


348


and end region


350


is an internal fluid flow channel


354


which communicates with the interior region


346


. Fluid discharges from the flow channel


354


via grooves or apertures


358


in the end region


350


. The change in direction of the fluid flow as the fluid passes from the interior channel


354


through the apertures


358


improves fluid dispersion with respect to mixing or flushing in the system downstream of the cannula (e.g., the injection site, drug vial, etc.). The apertures


358


may also function to increase withdrawal force or tug resistance.




Moreover, since the fluid passes radially out through the apertures


358


, fluid flow through the cannula


340


can be maintained even when the distal end surface


356


of the cannula is bottomed out or pushed against any material in the system in which the cannula is inserted.




The structure of the cannula


340


is adapted to be constructed with a minimal lead post length (i.e., the portion of the cannula distal end between the end surface


356


and the interior flow channel


354


). Further, the design accommodates the use of a minimal tip diameter, minimal taper angle, and minimal cannula diameter. The minimization of these parameters results in a decrease in the peak insertion force required to properly install the cannula in the injection site.




Preferably, the total cross-sectional flow area through the three apertures


358


is about three times the cross-sectional flow area of the interior channel


354


. This enhances the flow rate capability compared with a simple open ended cylindrical flow channel of equal length.




The design of the cannula


340


also is effective in reducing or limiting “kick back” or recoil of the cannula after insertion. The resilient material of the septum in an injection site can subject the cannula to forces tending to push the cannula back out of the septum. The kick back forces on the cannula


340


are minimized by the provision of the generally cylindrical mid-region


348


.




Another embodiment of the cannula of the present invention is illustrated in

FIGS. 41 and 42

wherein the cannula embodiment is designated generally therein by the reference numeral


360


. The cannula


360


includes a proximal end


362


defining an interior region


364


and having a Luer flange


366


for connection to a suitable mating engaging structure.




A generally cylindrical mid-region


366


extends from the proximal end


362


, and a end region


368


extends from the mid-region


366


. As with the previous embodiment of the cannula


340


illustrated in

FIGS. 38-40

, the embodiment of the cannula


360


minimizes kick back or recoil owing to the provision of a substantially cylindrical mid-region


366


. This design also increases withdrawal or tug resistance.




A generally cylindrical internal flow channel


370


extends through the end region


368


and mid-region


366


in communication with the interior region


364


of the proximal end region


362


. The end region


368


is provided with a tapered surface


372


. The design permits the use of a very small taper to minimize the insertion force.




Further, the design permits the cannula


360


to be constructed with a small tip diameter, small taper angle, and small cannula diameter so as to reduce the peak insertion force.




Another embodiment of the cannula of the present invention is illustrated in

FIGS. 43-44

and is designated generally therein by reference numeral


380


. The cannula


380


includes a proximal end


382


with a Luer flange


384


. An interior fluid flow region


386


is defined on the interior of the proximal end


382


.




Extending from the proximal end


382


is a mid-region


388


. A distal end region


390


extends from the mid-region


388


. An internal fluid flow channel or path


392


extends through the end region


390


and mid-region


388


, and is in communication with the interior flow region


386


.




The end region


390


has an exterior tapered surface


394


. This facilitates insertion of the cannula into the injection site. In contrast, the mid-region


388


is generally cylindrical so as to minimize kick back and increase the withdrawal force or tug resistance.




Further, to provide even greater withdrawal force, the mid-region


388


includes an annular barb


396


. The barb


396


has a sufficient radius so as to preclude damage to the septum of the injection site and so as to accommodate molding in a straight-draw tool. The maximum diameter of the annular barb


396


may typically be on the order of 0.02 inches greater than the diameter of the cylindrical mid-region


388


. Although the barb


396


functions to prevent inadvertent removal of the cannula


380


from the septum of the injection site, removal of the cannula


380


can still be achieved by exerting a sufficiently great axially directed removal force on the cannula


380


.




Still another embodiment is illustrated in

FIG. 45

which includes a blunt tapered cannula insertion member


400


for insertion into a pre-slit injection site, the cannula


400


having a distal end region


402


with a tapered exterior surface which in the preferred embodiment is an approximately 8° taper. The defined aperture


404


for fluid flow is disposed at the end


406


of the distal end region


402


. The end


406


includes a radiused tip defined by a radius of approximately 0.01 inch. The radiused tip reduces insertion force, assists in locating the slit in the injection site and in addition has the practical advantage of facilitating complete filling of the cannula mold cavity.




The tapered surface of the distal end region


402


has an axial length of approximately 0.10″ in the preferred embodiment. Adjacent to the tapered distal end region is a generally cylindrical region


408


for entering into the injection site behind the distal end region


402


, thereby reducing kick back during insertion. The generally cylindrical region


408


has a small draft angle such as about one-half degree.




The force required to insert any of the above-discussed embodiments of the blunt tapered cannula into the septum of the injection site depends upon a number of factors: friction at the cannula/septum interface, cannula diameter, cannula taper angle, and degree of septum compression. The cannula/septum interface friction is, in turn, dependent upon-lubrication, if any, material properties, and surface finish. It will be understood that the friction at the cannula/septum interface can be reduced by providing a smoother surface finish on the cannula (e.g., by sand blasting the cannula exterior surface) or by molding the cannula so as to produce a matte finish. Conventional lubricants can also be used to further reduce the friction and thereby lower the insertion force required.




In the embodiments of the cannulae described herein, the mid-region and the tapered distal end region may be alternatively characterized as together forming at least one tube defining a fluid flow path therein with the tube having a distal end region for penetrating the injection site.




In preferred contemplated embodiments, the exterior surface of the distal end region may have a taper angle as small as between one and fifteen degrees.




Further, a locking means, such as the locking arms


100




a


,


100




b


discussed with reference to

FIGS. 5A and 5B

, may be provided on the cannula embodiments illustrated in

FIGS. 29-44

to permit the cannulae to be releasably locked to the injection site.




The above described insertion members, usable as part of a blunt cannula, are preferably molded of a plastic formulation including silicone or other lubricant. The use of silicone or other lubricant increases the ease of insertion of that member into the pre-slit injection site.




From the foregoing, it will be observed that numerous variations and modifications may be effected without departing from the spirit and scope of the novel concept of the invention. It is to be understood that no limitation with respect to the specific apparatus illustrated herein is intended or should be inferred. It is, of course, intended to cover by the appended claims all such modifications as fall within the scope of the claims.



Claims
  • 1. A cannula insertion member for being inserted into a pre-slit resealable injection site, said insertion member comprising:a tube having a central bore that extends throughout said tube for an entire length of said tube and terminates at an aperture that has substantially the same cross-sectional circumference as at least portions of the central bore, the central bore defining a fluid flow path therein, said tube having a distal end region for penetrating said resealable injection site: said distal end region defining the aperture in the distal end of said distal end region through which fluid can flow to or from said fluid flow path; and said distal end region including a tapered exterior surface to facilitate insertion, said tube also including a generally cylindrical region extending from said tapered distal end region for entering into said resealable injection site behind said distal end region and reducing kick back during insertion, said distal end being so constructed and arranged to allow multiple insertions into said resealable injection site and allowing the injection site to reseal after each such insertion.
  • 2. An insertion member as in claim 1 in which said exterior surface is tapered between 1 and 15 degrees.
  • 3. An insertion member as in claim 1 in which said tapered distal end region has a length of no more than about one-half the length of said generally cylindrical region.
  • 4. A cannula insertion member for being inserted into a pre-slit resealable injection site, said insertion member comprising:locking means for removably locking said insertion member to said injection site; a tube having a central bore through said tube, defining a fluid flow path therein, said tube having a distal end region for penetrating said resealable injection site; said distal end region defining at least one aperture in the distal end of said distal end region through which fluid can flow to or from said fluid flow path; and said distal end region including a tapered exterior surface to facilitate insertion, said tube also including a generally cylindrical region extending from said tapered distal end region for entering into said resealable injection site behind said distal end region and reducing kick-back during insertion, said distal end being so constructed and arranged to allow multiple insertions into said resealable injection site and allowing the injection site to reseal after each such insertion.
  • 5. An insertion member as in claim 4 in which said locking means includes an elongate, deflectable arm that is engageable with said injection site.
  • 6. A cannula and injection site in combination comprising:a resealable injection site having a housing defining fluid flow path therein and having a pre-slit sealing means for sealing said housing; a blunt cannula having a tube with a central bore that extends throughout said tube and terminates at an aperture, the central bore defining a fluid flow path therein, said tube extending through said sealing means to establish a sealed fluid flow connection with said injection site, said tube having a distal end region extending beyond said injection site with a tapered surface and a blunt radiused tip that circumscribes the aperture; said tube having a generally cylindrical region merging with said tapered distal end region, said cylindrical region being received within said sealing means to provide reduced kick back and increased tug resistance; and said sealing means sealing the injection site upon removal of the cannula from the sealing means.
  • 7. A cannula insertion member for being inserted into a pre-slit resealable injection site, said insertion member comprising:a tube having a central bore throughout said tube, defining a fluid flow path therein, said tube having a distal end region for penetrating said injection site; said distal end region defining at least one aperture in the distal end of said distal end region through which fluid can flow to or from said fluid flow path; said distal end region including a tapered exterior surface to facilitate insertion; said distal end further including a radiused tip adjacent said tapered surface, said radiused tip circumscribing and defining, at least in part, the at least one aperture, the radiused tip reducing the insertion force into and assisting in locating the slit of said injection site, upon contacting the injection site with said cannula; and said distal end including means for allowing said resealable injection site to reseal upon removal of the distal end from the injection site.
  • 8. A cannula insertion member as in claim 7 including an insertion easing lubricant.
  • 9. A cannula insertion member as in claim 7 with said tube formed of a plastic containing silicone.
  • 10. A cannula insertion member for being inserted into a pre-slit resealable injection site, said insertion member comprising:a tube having a central bore throughout said tube defining a fluid flow path therein, said tube having a distal end region terminating in an aperture and including a blunt radiused tip for penetrating said injection site; said-distal end region including a tapered surface; and said tube also including a generally cylindrical region extending from said distal end region for entering into said injection site behind said distal end region, said distal end and cylindrical region cooperating with the resealable injection site to maintain a seal after removal of the cannula from the site.
  • 11. A cannula and injection site in combination comprising:an injection site having a housing defining a fluid flow path therein and having a pre-slit resealable sealing means for sealing said housing; a blunt cannula having a tube with a central bore throughout said tube, defining a fluid flow path therein, said tube extending through said sealing means to establish a sealed fluid flow connection with said sealing means to establish a sealed fluid flow connection with said injection site, said tube having a distal end region extending beyond said injection site and having a tapered surface on said distal end region, said distal region defining, at an extreme distal end thereof, an aperture; said tube having a generally cylindrical region merging with said tapered distal end region, said cylindrical region being received within said sealing means; and the sealing means and cannula cooperating to allow the sealing means to seal the injection site upon removal of the cannula from the injection site.
CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation, of application Ser. No. 08/183,110, filed Jan. 18, 1994 now abandon which is a continuation of 07/639,773 filed Jan. 10, 1991 now abandoned, which is a continuation of 07/217,004 filed Jul. 8, 1988 now abandoned. This application is a continuation-in-part application of the and commonly assigned U.S. patent application Ser. No. 07/147,414 entitled “Pre-Slit Injection Site and Associated Cannula” filed Jan. 25, 1988.

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Continuations (3)
Number Date Country
Parent 08/183110 Jan 1994 US
Child 08/699083 US
Parent 07/639773 Jan 1991 US
Child 08/183110 US
Parent 07/217004 Jul 1988 US
Child 07/639773 US
Continuation in Parts (1)
Number Date Country
Parent 07/147414 Jan 1988 US
Child 07/217004 US