WO2000048663A1

WO2000048663A1 - Needleless injection site and guidewire assembly

Info

Publication number: WO2000048663A1
Application number: PCT/US2000/003614
Authority: WO
Inventors: Dan Hyun; Bruno Franz P. Mayer
Original assignee: Becton, Dickinson And Company
Priority date: 1999-02-17
Filing date: 2000-02-11
Publication date: 2000-08-24
Also published as: AU3229800A

Abstract

A needleless injection site and guidewire assembly for use with a catheter. The injection site and guidewire assembly comprises a housing that defines a substantially linear fluid passage, a reseal member with an elastically openable and closable aperture disposed within the housing, and a guidewire insertable into and extensible through a guidewire passage defined by the fluid passage and the aperture. The housing and the catheter are configured such that the guidewire is insertable into and extensible through the injection site and catheter while coupled together. Additionally, the injection site and guidewire assembly coupled to a catheter may be used with a Y-site infusion device.

Description

NEEDLE ESS INJECTION SITE AND GUIDEWIRE ASSEMBLY

Field of the Invention

The present invention generally relates to the medical arts, and more particularly to a needleless injection site and guidewire assembly for use in the insertion of catheters or other fluid lines into a blood vessel of a patient.

Background of the Invention It is common medical practice to intravenously infuse various fluids or medicaments into a blood vessel of a patient (e.g., a vein or artery). Such infusion is typically accomplished by the insertion of a hollow introducer needle into a target blood vessel. The introducer needle is fluidly connected to one end of an elongate, flexible tube or fluid line, the opposite end of which is fluidly connected to a solution bag. The solution bag itself is typically suspended above the patient so as to allow gravity to facilitate the flow of fluid downwardly through the fluid line and into the patient's blood vessel via the introducer needle which remains operatively positioned therewithin. The fluid tube and solution bag are connected to each other via a metering apparatus which controls the infusion rate of fluid from the bag into the tube . In order to directly infuse medicament to a target organ of the patient, an elongate central catheter may be slidably insertable within the patient's blood vessel such that a distal end of the catheter is positioned near the target organ. In order for the catheter to be inserted into the patient's blood vessel, a flexible guidewire is placed within the lumen of the patient's blood vessel and then the catheter is "snaked" or slid over the guidewire in order to facilitate positioning the catheter within the patient's body. After positioning the catheter in the desired area proximal the target organ, the guidewire is then removed so as to allow the passage of fluid through the lumen of the catheter. The proximal end of the catheter, which will exit the patient at the insertion site of the introducer needle, may then be fluidly connected to the fluid line of the solution bag containing the fluid to be delivered.

Furthermore, a short infusion catheter may be placed within the blood vessel of the patient to aid in the delivery of a fluid or medicament. As such, the short infusion catheter is used in place of the introducer needle wherein the infusion catheter is inserted into the blood vessel of the patient with an introducer needle that is subsequently removed. Then the infusion bag is fluidly coupled to the short catheter through the use of the fluid tube as previously mentioned. If fluid is to be delivered directly to a target organ, the elongate central catheter with an outside diameter slightly smaller than the inside diameter of the short catheter may be inserted into the short catheter and positioned proximal the target organ with the aide of a guidewire as previously described.

In many intravenous infusion assemblies, an injection site is fluidly coupled to the fluid tubing intermediate the catheter and the solution bag. The injection site typically has a Y-shaped configuration and comprises a tubular main body portion having a tubular side arm portion in fluid communication therewith. The distal end of the side arm portion may be fluidly connected to the solution bag via an upper segment of the tubing, with the bottom end of the main body portion being fluidly connected to the patient's catheter via a lower segment of the tubing. The side arm portion may also be configured to accept a central catheter positionable with a guidewire near a target organ. The top end of the main body portion is itself covered by a diaphragm which is typically fabricated from rubber or a similar resilient material.

The inclusion of the injection site within the fluid line allows various medications to be selectively infused into the blood vessel of the patient. This infusion is typically accomplished through the utilization of a conventional syringe, the needle of which pierces and is extended through the diaphragm disposed on the top end of the main body portion of the injection site. Subsequent to the expulsion of the medication, the needle is retracted from the main body portion of the injection site, with the aperture created in the diaphragm due to the passage of the needle therethrough being substantially closed upon such retraction due to the resiliency of the diaphragm. As will be recognized, the inclusion of the injection site within the fluid line allows various medications to be intravenously administered to the patient through the existing infusion site within the blood vessel, thus eliminating the need to subject the patient to additional needle sticks. Though providing certain benefits to the patient, the injection sites constructed in accordance with the prior art possess certain deficiencies which detract from their overall utility. As previously explained, the use of such injection sites typically requires that the needle of the conventional syringe be extended through (i.e., puncture) the diaphragm attached to the top end of the main body portion of the injection site. As such, the necessity of having to utilize a syringe with a needle to facilitate the introduction of the medication into the solution flow is undesirable due to the risk of inadvertent needle sticks. In recognition of this deficiency, there has also been developed in the prior art needleless injection sites which incorporate a diaphragm adapted to assume open and closed configurations without having a needle inserted thereinto. Though these needleless injection sites eliminate the necessity of having to puncture the diaphragm with a needle, they also possess certain deficiencies which detract from their overall utility.

Specifically, the prior art needleless injection sites cannot accommodate the use of a central catheter with guidewire in one easy to use unit. The prior art injection sites were manufactured such that a guidewire is not insertable into the injection site because a blockage is formed within the fluid passage. Specifically, the prior art devices include a piston movable by a fluid introducer such that fluid is allowed to flow around the piston and into the injection site when the piston is distally moved by the fluid introducer. However, the piston prevents a straight unobstructed fluid path from being formed within the needleless injection site. Therefore, fluid flow can flow through the prior art injection site, but a guidewire is prevented from entering and exiting the site because the piston blocks straight access therethrough.

In order to use a central catheter with the prior art needleless injection site, the guidewire would be inserted within the hollow lumen of the patient's blood vessel and then the catheter would be "snaked" thereover as previously described. The guidewire would then be removed such that the catheter would remain inserted in the blood vessel of the patient. Subsequent to the removal of the guidewire, the prior art needleless injection site would then be coupled to the catheter through a standard coupling method. Therefore, to use a central catheter with a prior art needleless injection site, the catheter and the injection site must be coupled together subsequent to the removal of the guidewire. As such, this method adds the risk of foreign contamination of the catheter and injection site while being coupled together which could lead to an infection in the patient. Additionally, after removal of the guidewire from the catheter, there is the risk of exposure for the medical technician to the bodily fluids of the patient back-flowing through the open end of the catheter because the end of the catheter is not closed.

In an effort to overcome the deficiencies associated with the prior art injection sites and catheter applications, Applicant has developed a needleless injection site and guidewire assembly for use in conjunction with catheters. Specifically, Applicant's injection site can be concurrently used with a guidewire and catheter such that coupling of the catheter to the injection site after removal of the guidewire is not necessary. Therefore, Applicant's invention reduces the risk of contamination and therefore infection in the patient. Additionally, the needleless injection site prevents inadvertent needle sticks and yet can still be used with a conventional needle and syringe in case of emergencies. Furthermore Applicant's invention prevents inadvertent contact with the patient's bodily fluids by keeping the catheter sealed at all times.

Summary of the Invention In accordance with the present invention, there is provided a needleless injection site and guidewire assembly for use with a peripherally inserted central catheter or mid-catheter application. The assembly comprises a needleless injection site having a housing that defines a substantially linear fluid passage and a reseal member disposed within the housing and having an elastically openable and closable aperture coaxially aligned with the fluid passage. The assembly further comprises a guidewire that is insertable into and extensible through a guidewire passage collectively defined by the fluid passage and the aperture .

In accordance with the preferred embodiment of the present invention, the housing of the injection site and guidewire assembly comprises an interior chamber and a central opening coaxially aligned therewith. Furthermore, the housing comprises an elongate, proximally extending projection portion coaxially aligned with the central opening and an elongate distally extending adaptor portion coaxially aligned with the dilator projection portion wherein the dilator projection portion and the adaptor portion collectively define the fluid passage. The reseal member is disposed within the interior chamber and the central opening such that the aperture is coaxially aligned with the fluid passage so as to allow the guidewire to be insertable into and extensible through the aperture and the fluid passage. The housing further defines an outer surface with Luer threads formed thereon about the central opening.

The injection site and guidewire assembly constructed in accordance with the preferred embodiment further includes a tubing connection with a tapered outer surface and blunt distal tip on the adaptor portion. Accordingly, the housing further defines a distal lock region surrounding the tubing connection for facilitating the connection of the housing to an annular surface . The distal lock region may comprise Luer threads for facilitating engagement to the tubing connection. The injection site and guidewire assembly further comprises a catheter assembly engageable to the tubing connection of the adaptor portion. The catheter assembly comprises an elongate, flexible tube having a proximal end and a hollow lumen extending axially therethrough. A connector is attached to the proximal end of the tube and is in fluid communication with the lumen. The catheter connector is engagable to the tubing connection of the adaptor portion such that the guidewire is insertable into and extensible through the catheter assembly when engaged to the tubing connection. It is contemplated that the catheter may be a peripherally inserted central catheter as will be recognized by those of ordinary skill in the art.

The injection site and guidewire assembly constructed in accordance with the preferred embodiment of the present invention may be used in combination with a Y-site infusion device. The Y-site infusion device has a hollow, generally Y-shaped tube with a main body portion and a side arm portion. Therefore, the catheter assembly is insertable into and extensible through the Y-site infusion device while coupled to the injection site and guidewire assembly.

Brief Description of the Drawings These as well as other features of the present invention, will become more apparent upon reference to the drawings wherein:

Figure 1 is a perspective view illustrating the manner in which the needleless injection site and guidewire assembly constructed in accordance with the present invention is used to facilitate the insertion of a catheter into an anatomical passage;

Figure 2 is a perspective view of the needleless injection site and guidewire assembly constructed in accordance with the present invention and used in conjunction with a catheter assembly; Figure 3 is a perspective view of the needleless injection site and guidewire assembly coupled to the catheter assembly shown in Figure 2;

Figure 4 is a cross-sectional view of the needleless injection site and guidewire assembly coupled to the catheter assembly;

Figure 5 is a perspective view of the needleless injection site and guidewire assembly coupled to the catheter assembly and used in conjunction with a Y- site infusion device.

Detailed Description of the Preferred Embodiment Referring now to the drawings wherein the showings are for purposes of illustrating a preferred embodiment of the present invention only, and not for purposes of limiting the same, Figure 1 illustrates a needleless injection site and guidewire assembly 10 constructed in accordance with the present invention and coupled to a catheter assembly 12. The catheter assembly 12 is insertable into the blood vessel of a patient 16 and slidably positioned therein to directly deliver fluid or medicament to a target organ without absorption into the other areas of the body of patient 16. As seen in Figure 1, the needleless injection site and guidewire assembly 10 comprises the catheter assembly 12, a needleless injection site 100, and a guidewire 20.

CATHETER ASSEMBLY AND GUIDEWIRE

As shown in Figures 2 and 4, the needleless injection site and guidewire assembly 10 includes the catheter assembly 12 and the guidewire 20. Specifically, the catheter assembly 12 comprises a flexible catheter tube 22 with a distal end, a proximal end 26, and a hollow interior lumen 28 extending axially therebetween. Additionally a catheter connector 30 is fluidly connected to the proximal end 26 of the catheter tube 22 to form the catheter assembly 12.

The catheter tube 22 is an elongate flexible tube fabricated from a flexible silicone material such that it is insertable into and can remain within the blood vessel of the patient 16. The length of the catheter tube 22 is preferably such that the distal end is positionable near the target organ to which medicament is to be delivered. In order to aid in the placement of the catheter 22 near the target organ, the distal end may be radiopaque such that it is viewable using X-ray techniques.

The catheter connector 30 is a cylindrical structure fluidly attached to the catheter tube 28 using traditional connection methods. The connector 30 contains a coupling portion 31 with an interior bore 32 formed therein that is coaxially aligned with the interior lumen 28 of the catheter tube 22 such that a straight fluid passage is formed therein. Additionally, the bore 32 is tapered such that it is frictionally engageable to a corresponding surface of the injection site 100 that will be explained in more detail below. The connector 30 may contain Luer threads disposed on an exterior surface of the coupling portion 31 in order to facilitate connection of the bore 32 with other medical devices and/or injection site 100. Furthermore, the connector 30 may contain two finger tabs 34 radially projecting from the connector 30 to aide in coupling the connector 30 to other medical devices.

In accordance with the preferred embodiment of the present invention, the connector 30 additionally contains a reduced diameter portion 36 disposed adjacent to the coupling portion 31. The reduced diameter portion 36 is sized to be insertable into an interior bore 37 of a catheter hub 38 that is fluidly attached to a short or infusion catheter 40. As shown in Figure 1, the infusion catheter 40 is inserted into the lumen of the patient's 16 blood vessel in order to provide access thereto with a short fluid path into the blood vessel. The infusion catheter 40 is fluidly coupled to the catheter hub 38 such that the interior bore 37 and an interior lumen 42 of the infusion catheter 40 form a coaxially aligned hollow passage for fluid. The diameter of the interior lumen 42 of the infusion catheter 40 is sized slightly larger than the outside diameter of the catheter tube 22. Therefore, the catheter tube 22 is insertable into and extensible through the hollow fluid passage formed within the infusion catheter 40. As will be recognized by those of ordinary skill in the art, the above-described catheter assembly 12 may be a peripherally inserted central catheter (PICC) or a mid-catheter application. The guidewire 20 constructed in accordance with the preferred embodiment of the present invention comprises an elongate flexible wire 44 with a distal end and a proximal end 48. The diameter of wire 44 is sized such that the wire 44 is insertable into and extensible through the interior lumen 28 of the catheter tube 22. Furthermore the wire 44 is approximately the same length of the catheter tube 22 such that the wire 44 adds the necessary rigidity to the full length of the catheter tube 22 for insertion into the patient 16. As such, it is preferable for wire 44 to be fabricated from a plurality of twisted metallic wires such that the wire 44 can flex yet still be rigid to strengthen catheter tube 22 for insertion and maneuvering within the blood vessel. Disposed on the proximal end 48 of wire 44 is an endcap 50 for facilitating insertion and removal of the guidewire 20 into the catheter assembly 12 and the injection site 100.

NEEDLELESS INJECTION SITE Referring to Figure 4, the needleless injection site 100 used in the present invention is constructed in accordance with Applicant's U.S. Pat. No. 5,820,601 which is incorporated by reference herein. Specifically, the injection site 100 comprises a hollow housing 116 with an upper section 118 defining a reduced diameter portion 120 having Luer threads 122 formed on the outer surface thereof. In addition to the upper section 118, the housing 116 includes a lower section 124 which is rigidly attached to the upper section 118. When attached to each other, the upper and lower sections 118, 124 collectively define an interior chamber 126. In this respect, the proximal portion 120 of the upper section 118 defines a central opening 128 which communicates with the interior chamber 126.

In the preferred embodiment of the needleless injection site 100, the lower section 124 includes a central portion 132 defining a generally planar, circularly configured proximal surface 134 which is circumvented by an annular flange portion 136. Formed within the outer surface of the central portion 132 and extending thereabout is a continuous, annular shoulder 138. When the upper and lower sections 118, 124 are attached to each other, the distal rim of the upper section 118 is abutted against the shoulder 138, with the flange portion 136 extending along the inner surface of the upper section 118 in direct contact therewith. The attachment of the upper and lower sections 118, 124 to each other is preferably facilitated by a sonic weld between the distal rim of the upper section 118 and the shoulder 138 defined by the lower section 124. However, it will be recognized by those of ordinary skill in the art that alternative attachment methods, such as the use of adhesives, may be employed in the injection site 100. The upper and lower sections 118, 124 are sized such that when rigidly attached to each other in the aforementioned manner, the outer surface of the upper section 118 is substantially flush with the outer surface of the central portion 132 of the lower section 124.

Extending proximally from the proximal surface 134 of the central portion 132 in substantially perpendicular relation thereto is an elongate dilator projection portion 140 which is coaxially aligned with the central opening 128 of the upper section 118. The dilator projection portion 140 has a generally cylindrical configuration, and defines a blunt proximal tip 142. In addition to the dilator projection portion 140, formed on the lower section 124 and extending distally from a distal surface 144 of the central portion 132 thereof is an elongate adaptor portion 146. In the injection site 100, the adaptor portion 146 preferably comprises a tubing connection which defines a tapered outer surface and a blunt distal tip 148. Also extending distally from the distal surface 144 of the central portion 132 is a distal lock region 150 which circumvents the adaptor portion 146 and is used to facilitate the connection of the housing 116 to an annular surface. In the preferred embodiment, the distal lock region 150 includes Luer threads 152 formed on its inner surface and is sized such that the distal tip 148 of the adaptor portion 146 protrudes beyond the distal rim thereof. The dilator projection and the adaptor portions 140 and 146 of the lower section 124 collectively define an elongate fluid passage 156 which extends through the lower section 124 and is co-axially aligned with the central opening 128 of the upper section 118.

The injection site 100 constructed in accordance with the present invention further comprises a reseal member 158 which is disposed within the central opening 128 and the interior chamber 126 of the housing 116. The reseal member 158 comprises a resilient body 160 having a generally cylindrical proximal portion 162 which defines a proximal end 164, and a generally cylindrical distal portion 166 which defines a distal end 168.

In the preferred embodiment, the proximal end 164 of the body 160 defines a recessed, circularly configured outer surface 176 which has a generally planar configuration. In addition to the outer surface 176, the proximal end 164 defines a generally semi-spherical inner surface 178. Extending axially through the proximal end 164 from the outer surface 176 to the apex of the inner surface 178 is an aperture 180 coaxially aligned with the fluid passage 156. Additionally formed about and extending radially inward from the distal end 168 of the body 160 is a continuous annular flange 182, the inner peripheral edge of which defines an enlarged bead. The body 160 is preferably fabricated from silicone, though the same may alternatively be fabricated from a similar resilient material such as rubber.

The reseal member 158 further comprises a radial leaf spring 184 which is disposed within the body 160. The radial leaf spring 184 comprises a generally cylindrical base portion which transitions into three identically configured, equidistantly spaced leaf portions 188 via a beveled shoulder.

As seen in Figure 4, the radial leaf spring 184 is disposed within the body 160 in a manner wherein the outermost ends of the leaf portions 188 are received into an annular channel circumventing the semispherical inner surface 178 of the proximal end 164. The radial leaf spring 184 is preferably fabricated from polysulfone or polycarbonate, though similar rigid materials with memory may be utilized as an alternative.

In addition to the body 160 and radial leaf spring 184, the reseal member 158 of the injection site 100 comprises an elongate, generally cylindrical axial donut spring 196 which has a splined outer surface and includes a bore 198 extending longitudinally (i.e., axially) therethrough and over dilator projection portion 140. The donut spring 196 defines a first or proximal end which is normally abutted against the distal end 168 of the body 160, and a second or distal end which is normally abutted against the housing 116 and, in particular, the proximal surface 134 of the central portion 132 of the lower section 124. Like the body 160, the donut spring 196 is preferably fabricated from silicone, though the same may alternatively be fabricated from a similar resilient material such as rubber .

In the injection site 100, the aperture 180 extending through the proximal end 164 of the body 160 is elastically openable and closable. In this respect, the reseal member 158 of the injection site 100 normally resides in a first or closed position, as seen in Figure 4, wherein the aperture 180 is in a closed configuration. Importantly, the reseal member 158 is selectively deformable such that the application of distally directed pressure thereto from a fluid introducer (not shown) will cause the same to distally advance to a second or open position within the housing 116 wherein the aperture 180 assumes an open configuration. Due to the resiliency of the reseal member 158, and in particular the donut spring 196 thereof, the removal of the distally directed pressure from the proximal end 164 will cause the reseal member 158 to resiliently return to the first position wherein the aperture 180 reassumes the closed configuration.

When the reseal member 158 is disposed in its normal, closed position within the housing 116, the dilator projection portion 140 of the lower section 124 is extended through the bore 198 of the donut spring 196 and into the hollow interior of the radial leaf spring 184. When extended into the radial leaf spring 184, the dilator projection portion 140 passes through the opening defined by the annular flange 182 of the body 160, and in particular the bead defined thereby. Importantly, the diameter of the opening defined by this bead is less than the outer diameter of the dilator projection portion 140. As such, when the dilator projection portion 140 passes through this opening, the bead is sealed in a fluid-tight manner against the outer surface thereof.

As is further explained in Applicant's U.S. Patent No. 5,820,601, the injection site 100 prevents a vacuum being created within a fluid line coupled thereto such that fluid is not drawn back up into the injection site 100 subsequent to the removal of the distally directed pressure. In this respect, the injection site 100 creates zero or positive pressure within the fluid passage 156 and the fluid line or catheter assembly 12 coupled thereto. Advantageously, the absence of blood within the fluid line or catheter assembly 12 prevents any undesirable coagulation therewithin and eliminates the risk of an inadvertent obstruction of the catheter assembly 12. Due to the configuration of the reseal member 158, in an emergency situation a medicament may be passed into the fluid passage 56 via a needled introducer device. In this respect, when a needled introducer device is utilized, distally directed pressure will not be applied to reseal member 158 such that aperture 180 will not open. Rather, the needle of the needled introducer device is simply forced through the closed aperture 180 and into the fluid passage 156 of the housing 116.

NEEDLELESS INJECTION SITE AND GUIDEWIRE ASSEMBLY

As seen in Figure 3, the needleless injection site and guidewire assembly 10 constructed in accordance with the preferred embodiment of the present invention is used by initially inserting the guidewire 20 into and through the interior of the needleless injection site 100. Specifically, a guidewire passage 200 is collectively defined within the interior of the injection site 100 by the coaxially aligned fluid passage 156 and the aperture 180 of reseal member 158. Therefore, in order to assemble the present invention, the distal end of the guidewire 20 is inserted through the elastic aperture 180 and into the guidewire passage 200. The aperture 180 is formed from an elastic material such that the aperture 180 is openable as the distal end of guidewire 20 is inserted, yet the aperture 180 remains sealable around the wire 44 when disposed within the aperture 180. As such, the guidewire 20 slides through the guidewire passage 200 until the guidewire distal end exits from the adaptor portion 146 of the injection site 100. Therefore, because the guidewire passage 200 is defined by the hollow interior area of the fluid passage 156, the guidewire 20 is extensible through the injection site 100.

After the guidewire 20 has been inserted through the injection site 100, the guidewire 20 must be inserted into the catheter assembly 12 for proper operation. As previously described, the catheter assembly 12 comprises a straight fluid passage defined by the lumen 28 of catheter tube 22 and the bore 32 of catheter connector 30. Therefore the guidewire 20 is insertable into the bore 32 and catheter tube 22 such that the guidewire 20 will strengthen and add rigidity to catheter tube 22 from within the interior of the catheter assembly 12. Subsequent to the insertion of the guidewire 20 into the catheter assembly 12, the catheter connector 30 can be coupled to the injection site 100.

Specifically, in the preferred embodiment of the present invention, the adaptor portion 146 of injection site 100 is configured to facilitate the connection of the catheter connector 30 thereto. Such connection is achieved by the advancement of the adaptor portion 146 into the bore 32 of connector 30. The adaptor portion 146 is sized and configured so as to be frictionally retained within the bore 32 on the connector 30. For additional security of the coupling, the Luer threads 152 formed on the inner surface of the distal lock region 150 of injection site 100 can be engaged to an annular surface or corresponding set of Luer threads formed on the connector 30, if so provided. Therefore, as seen in Figure 3, a needleless injection site and guidewire assembly 10 is formed when the injection site 100 is coupled to the catheter assembly 12 and the guidewire 20 is disposed therein.

For proper operation of the needleless injection site and guidewire assembly 10, the short infusion catheter 40 with the catheter hub 38 fluidly connected thereto is inserted into the blood vessel of patient 16 as seen in Figure 1. As will be recognized by those of ordinary skill in the art, the short infusion catheter 40 is inserted into the interior lumen of the patient's 16 blood vessel with an introducer needle that is removed subsequent to insertion of the infusion catheter 40. Next, the needleless injection site and guidewire assembly 10 with the catheter assembly 12 coupled thereto is inserted into the infusion catheter 40. Specifically, the distal end of catheter tube 22 is inserted into the patient's 16 blood vessel through the catheter hub 38 of infusion catheter 40, and is advanced to an area near the target organ, such as the heart, so as to deliver medication or fluid directly via catheter tube 22. Once in position, the guidewire 20 is removed from the catheter assembly 12 and the needleless injection site 100 by proximally pulling the wire 44 from therewithin. The catheter assembly 12 remains within the blood vessel of the patient 16 in order to deliver medication. The medication is delivered via the needleless injection site 100 wherein various devices, such as a syringe, can be coupled to the reduced diameter portion 120 and set of Luer threads 122 formed on injection site housing 116. If a syringe is used to deliver fluid, then the syringe will distally advance reseal member 158 such that aperture 180 will be openable to deliver fluid via the fluid passage 156 to the catheter assembly 12. It will be recognized that other means of delivering fluid to catheter assembly 12 are available such as coupling a fluid line to the needleless injection site 100.

The needleless injection site and guidewire assembly 10 constructed in accordance with the preferred embodiment of the present invention provides a safe and reliable system of use for a peripherally inserted central catheter or a mid-catheter application. Specifically, by coupling the needleless injection site 100 with the guidewire 20 to the catheter assembly 12 before insertion into the patient 16, the risk of exposure to the patient's bodily fluids for the medical technician is greatly reduced. Therefore, the medical technician only needs to insert the catheter assembly 12 with guidewire 20 and injection site 100 coupled thereto into the short or infusion catheter 40 of the patient 16 and slide the catheter assembly 12 into position. Next the guidewire 20 is removed and the medicament or fluid delivery source is connected to the reduced diameter portion 120 of housing 116. The technician does not need to couple the catheter assembly 12 directly to a fluid delivery source after insertion into the blood vessel of patient 16 thereby reducing the risk of exposure to bodily fluids back- flowing from the catheter assembly 12. The needleless injection site 100 therefore acts as a valve to prevent bodily fluid from escaping the catheter assembly 12 after insertion. Additionally after the guidewire 20 is removed, fluid can be infused into the patient in a safe manner without the use of needles through the injection site 100 as previously described.

The preferred embodiment of the present invention can also be used in conjunction with a Y-site infusion device 202 as shown in Figure 5. Specifically, the Y-site infusion device 202 is a multiple injection site used for the infusion of various fluids or medicaments simultaneously. The Y-site device 202 comprises a hollow tubelike main body portion 204 and a hollow side arm portion 206 fluidly attached to and projecting from the main body portion 204 in a generally Y-shaped configuration. The main body portion 204 includes multiple infusion sites 208 that may be a conventional diaphragm that is pierced with a needle or a needleless injection site. Typically the Y-site device 202 is attached with an intermediate fluid line to the short infusion catheter 40 or to a needle inserted into the patient's blood vessel in order to deliver fluid therein.

As shown in Figure 5, the needleless injection site and guidewire assembly 10 coupled to a catheter assembly 12 can be inserted into the blood vessel of a patient through the Y-site device 202. Specifically, the central catheter 12 with guidewire 20 contained therein and coupled to the injection site 100 is inserted into the side arm portion 206 of Y-site device 202. The Y-site infusion device 202 is coupled to the short infusion catheter 40 (not shown) inserted into a blood vessel of the patient 16 thru an intermediate fluid line (not shown) . Therefore, the Y-site device 202 allows the infusion of multiple fluids and medicaments, as well as insertion of the catheter assembly into a single blood vessel of the patient 16.

Additional modifications and improvements of the present invention may also be apparent to those of ordinary skill in the art. Thus, the particular combination of parts described and illustrated herein is intended to represent only certain embodiments of the present invention, and is not intended to serve as limitations of alternative devices within the spirit and scope of the invention.

Claims

WHAT IS CLAIMED IS:

1. A needleless injection site and guidewire assembly, comprising: a housing defining a substantially linear fluid passage; a reseal member disposed within the housing and having an elastically openable and closable aperture which is coaxially aligned with the fluid passage, the fluid passage and the aperture collectively defining a guidewire passage; and an elongate guidewire insertable into and extensible through the guidewire passage.

2. The needleless injection site and guidewire assembly of Claim 1 wherein the housing comprises : an interior chamber; a central opening communicating with the interior chamber; an elongate, proximally extending dilator projection portion coaxially aligned with the central opening; and an elongate, distally extending adaptor portion coaxially aligned with the dilator projection portion; wherein the dilator projection portion and the adaptor portion collectively define the fluid passage and the reseal member is disposed within the interior chamber and the central opening such that the aperture is coaxially aligned with the fluid passage so as to allow the guidewire to be insertable into and extensible through the aperture and the fluid passage.

3. The injection site and guidewire assembly of

Claim 2 wherein: the adaptor portion includes a tubing connection having a tapered outer surface and a blunt distal tip; and the housing further defines a distal lock region surrounding the tubing connection for facilitating the connection of the housing to an annular surface.

4. The injection site and guidewire assembly of Claim 3 wherein the distal lock region comprises Luer threads .

5. The injection site and guidewire assembly of Claim 3 further comprising: a catheter assembly comprising: an elongate, flexible tube having a proximal end and a hollow lumen extending axially therethrough; and a connector attached to the proximal end of the tube and in fluid communication with the lumen, the connector being engagable to the tubing connection; wherein the guidewire is insertable into and extensible through the catheter assembly when engaged to the tubing connection.

6. The injection site and guidewire assembly of Claim 5 further in combination with: a Y-site infusion device including a hollow, generally Y-shaped tube with a main body portion and a side arm portion; wherein the catheter assembly is insertable into and extensible through the Y-site infusion device.

7. The injection site and guidewire assembly of Claim 5 wherein the catheter assembly is a peripherally inserted central catheter.

8. The injection site and guidewire assembly of Claim 2 wherein the housing further defines an outer surface having Luer threads formed thereon about the central opening.