# Patent

## Title
Catheter connection systems

## Abstract

A catheter connection system is disclosed. In one embodiment, a catheter connection system may include at least two components and a deformable sealing element positioned between the at least two components configured to allow, upon deformation, fluid flow through the at least two components. In another embodiment, the catheter connection system may include a sealing element positioned between at least two components, wherein the components are coupled to one another by a locking member.

## Background
PRIORITY
This application is a continuation of U.S. patent application Ser. No. 11/535,245, filed Sep. 26, 2006, which claims priority to U.S. Provisional Patent Application No. 60/720,443, filed Sep. 26, 2005, each of which is incorporated by reference into this application as if fully set forth herein.


BACKGROUND OF THE INVENTION
Catheters may be employed for draining fluids from various organs or other locations within a patient. For example, catheters may be used for draining urine, a surgical wound, or any other body location that may be beneficial. Further, it may be desirable to selectively couple and decouple such a catheter to and from a drainage system or other system (e.g., aspiration system, cleansing system, etc.), respectively, for cleaning or for any other suitable reason. Such a connection system can enable an increase in ambulation for the patient and thereby increase quality of life.
BRIEF SUMMARY
One aspect of the instant disclosure relates to a catheter connection system comprising at least two components and a deformable sealing element positioned between the at least two components configured to allow, upon deformation, fluid flow through the at least two components. Another aspect of the instant disclosure relates to a catheter connection system comprising a sealing element positioned between at least two components, wherein the components are coupled to one another by a locking member.
Features from any of the above-mentioned embodiments may be used in combination with one another in accordance with the instant disclosure. In addition, other features and advantages of the instant disclosure will become apparent to those of ordinary skill in the art through consideration of the ensuing description, the accompanying drawings, and the appended claims.



BRIEF DESCRIPTION OF THE DRAWINGS
Advantages of the present invention will become apparent upon review of the following detailed description and drawings, which illustrate representations (not necessarily drawn to scale) of various embodiments of the invention, wherein:
FIG. 1 is a perspective view of one embodiment of a catheter coupling system;
FIG. 2 is an exploded view of the catheter coupling system of FIG. 1;
FIG. 3a is a side, cross-sectional view of the catheter coupling system shown in FIG. 1;
FIG. 3b is a side, cross-sectional view of the catheter coupling system shown in FIG. 1 but with the catheter hub disconnected from the coupling member; and
FIG. 4 is a perspective view of one embodiment of a seal post.



DETAILED DESCRIPTION
One aspect of the instant disclosure relates to apparatuses and systems for selective coupling of a tubular member to another tubular element. Specifically, the instant disclosure contemplates that a catheter may include a connection structure for selectively coupling the catheter to another tubular element by way of a sealing element that forms a seal between the catheter and tubular element.
One aspect of the present invention, as shown in FIG. 1, includes a catheter connection system 10 comprising a catheter hub 20, a coupling member 30, and at least one deformable sealing element positioned within the catheter hub. The deformable sealing element is configured to allow fluid flow through catheter hub 20 upon deformation. As illustrated in FIGS. 1 through 3b, the catheter connector system 10 comprises catheter hub 20 having a cannula 40 on a proximal end thereof sized for insertion into a lumen of a catheter 50, and a housing 45 on a distal end thereof. Further, catheter hub 20 has a distal interface 60 having a seal post 70 positioned within a deformable sealing element 80 positioned further within a retention collar 90. As illustrated in FIG. 2, the coupling member 30 includes a cavity 100 for receiving at least a portion of the distal interface 60 of catheter hub 20 and an actuating member 110 for engaging at least a portion of deformable sealing element 80.
Referring now to FIGS. 3a and 3b, deformable sealing element 80 may abut seal post 70 to effectively seal a bore 115 of catheter hub 20 at one end. In an unbiased position 80a, deformable sealing element 80 creates a seal wherein any fluids attempting to pass through catheter hub 20 are precluded from movement past the seal. When engaged by coupling member 30, deformable sealing element 80 deforms to a biased position 80b thereby allowing fluid to flow through or by deformable sealing element 80 and into coupling member 30. When coupling member 30 is removed from catheter hub 20, deformable sealing element 80 reversibly returns to its unbiased position 80a. The ability of deformable sealing element 80 to reversibly return to its unbiased position 80a permits reuse of catheter hub 20. Furthermore, it advantageously creates a flush surface which facilitates cleaning of distal interface 60 of catheter hub 20. Referring now to FIGS. 3a and 3b, catheter hub 20 can further comprise an open space 120 between retention collar 90 and deformable sealing element 80. Open space 120 provides an area for deformable sealing element 80 to deform when it is engaged by coupling member 30. In one aspect of the invention, retention collar 90 may extend beyond deformable sealing element 80 and seal post 70. Such a configuration may minimize inadvertent deformation of deformable sealing element 80 by a user.
In one embodiment, actuating member 110 can be disposed concentrically within cavity 100. Further, coupling member 30 can be configured with a through-center bore 130 for communicating a fluid from catheter hub 20 through coupling member 30. In an additional embodiment, actuating member 110 comprises a raised surface located within cavity 100 of coupling member 30. The raised surface of actuating member 110 can be shaped to approximate the shape of deformable sealing element 80 such that when coupling member 30 and catheter hub 20 are secured together, as shown in FIG. 3a, actuating member 110 deforms deformable sealing element 80 thereby allowing fluid to pass through catheter hub 20 and into coupling member 30. In another embodiment, actuating member 110 may be configured to deform only a portion of deformable sealing element 80.
In an additional embodiment, seal post 70 may be positioned near deformable selling sealing element 80 to facilitate deformation of deformable sealing element 80 and passage of fluids through catheter hub 20 to coupling member 30. In one embodiment, as shown in FIG. 4, seal post 70 comprises a top planar surface 140 that, when seated in the body of catheter hub 20 and within the center of deformable sealing element 80, creates a flush surface. The body of seal post 70 can be tapered such that the diameter of a distal top planar surface 140 is larger than the diameter of the proximal end 150 of seal post 70. The body of seal post 70 can also comprise at least one channel 160, wherein, when deformable sealing element 80 is deformed, fluid passes through channel 160 of seal post 70 and into coupling member 30. In such a configuration, seal post 70 can be affixed (e.g., adhesively bonded, ultrasonically welded, solvent welded, or otherwise affixed) to the body of catheter hub 20. In another embodiment, seal post 70 may be formed integrally or monolithically with the body of catheter hub 20.
In another embodiment of the present invention, coupling member 30 and catheter hub 20 may be secured together with a locking member 180. The locking member 180 may be any device for securing catheter hub 20 and the coupling member 30 together, for example, a so-called “living hinge clip” or any cantilevered pivoting element. FIGS. 1-3b illustrate a coupling member 30 comprising a biased hinge member 190 integrally formed with the wall of coupling member 30. The hinge member 190 includes an engagement feature 200 configured to engage at least a portion of retention collar 90 of the body of catheter hub 20. Additionally, handles 210 may be formed with hinge member 190 to facilitate removal and attachment of coupling member 30. In one aspect of the invention, as shown in FIGS. 1 and 2, the catheter connection system 10 may comprise an aperture 220 positioned on an outer portion of coupling member 30. Advantageously, aperture 220 allows the user to verify engagement of deformable sealing element 80 by actuating member 110. In another embodiment, the catheter hub 20 also comprises a cover member 230 configured to reduce the likelihood of accidental removal of catheter 50 from cannula 40 of catheter hub 20. A proximal end of coupling member 30 may further comprise a luer fitting 240 configured to receive a device, for example, for vacuum assisted removal of fluids from the patient. In another embodiment, the proximal end of coupling member 30 may be configured for gravity evacuation of fluids from the patient.
The catheter hub 20 and coupling member 30 described above can be formed from any material suitable for connection to any elongated tubular member placed within the corpus of a patient. By way of example, the connector system 10 may be prepared from of any suitable thermo-plastically formed material. The deformable sealing element 80 can be formed from a resilient material that is flexible, inert, and impermeable to fluid, such as silicone or polyurethane.
The above embodiments may be used, for example, in connection with a pleural drainage system. One example of components of a pleural drainage system are disclosed in U.S. patent application Ser. No. 10/595,450 entitled “Portable Hand Pump for Evacuation of Fluids” which is incorporated herein in its entirety. More specifically, the present invention may be used to connect a catheter placed within the corpus of a patient for the purposes of evacuating fluid from the corpus of the patient to a manually-operated pump and a device for storage of the evacuated fluid. The pump may be adapted to connect to an inflow conduit and an outflow conduit. For purposes of clarity, the pump, outflow conduit, and inflow conduit are all downstream from the connection system of the present invention. Near the connection of the inflow conduit, the pump can be provided with a one-way inflow valve that acts to permit flow of fluids from the inflow conduit into the interior of the pump but limits or restricts any back flow of the same into the inflow conduit. Similarly, near the connection of the outflow conduit, a one-way outflow valve permits flow of fluids out of the pump interior and into and through a lumen of the outflow conduit. This outflow one-way valve also serves to limit or restrict the back flow of fluids from the outflow conduit into the pump interior.
While certain embodiments and details have been included herein for purposes of illustrating aspects of the instant disclosure, it will be apparent to those skilled in the art that various changes in the systems, apparatuses, and methods disclosed herein may be made without departing from the scope of the instant disclosure, which is defined, in part, in the appended claims. The words “including” and “having,” as used herein including the claims, shall have the same meaning as the word “comprising.”

## Claims

1. A catheter connector system, comprising:
a catheter hub, comprising:
a cannula on a proximal end of the catheter hub sized for insertion into a lumen of a first tubular element,
a bore to communicate a fluid from the cannula through the first tubular element,
a housing on a distal end of the catheter hub, and
a distal interface having:
a retention collar,
a deformable sealing element positioned within the retention collar, and
a tapered seal post longitudinally fixed relative to the catheter hub and positioned within the deformable sealing element,
each of the retention collar, deformable sealing element, and tapered seal post extending past a distal end of the housing; and


a coupling member, comprising:
a cavity receiving at least a portion of the distal interface of the catheter hub,
at least one locking member formed on an outer surface of the cavity, the locking member having a ledge formed on an inner surface of the cavity to engage at least a portion of the retention collar,
an actuating member disposed within the cavity to engage at least a portion of the deformable sealing element, and
a bore to communicate a fluid from the catheter hub through the coupling member into a second tubular element.

2. The catheter connector system of claim 1, wherein the cavity, the deformable sealing element, the distal interface of the catheter hub, the retention collar, and the actuating member are substantially annular.

3. The catheter connector system of claim 1, wherein the locking member and the ledge are integrally formed on the surface of the cavity.

4. The connector system of claim 1, wherein the deformable sealing element surrounds and abuts the seal post to seal a bore of the connector hub.

5. The connector system of claim 4, the connector system comprising a sealed configuration where a sealing surface of the deformable sealing element is in contact with the seal post to prevent fluid flow through the connector hub, and an open configuration where the deformable sealing element is deformed such that the sealing surface is longitudinally displaced with respect to the connector hub and the seal post to open a fluid flow path through the connector hub.

6. The catheter connector system of claim 1, wherein a distal end of the tapered seal post, deformable sealing element, and retention collar are longitudinally co-extensive in a sealed position.

7. The catheter connector system of claim 6, wherein the deformable sealing element is retained between the retention collar and the housing of the catheter hub to longitudinally fix a proximal end of the deformable sealing element with respect to the catheter hub.

8. The catheter connector system of claim 7, wherein the retention collar comprises an internal indention creating an open space between the deformable sealing element and the retention collar to provide a volume for the deformable sealing element to deform when engaged by coupling member.