Medical connectors and methods of use

• US 10,391,293 B2
• Filed: 11/30/2017
• Issued: 08/27/2019
• Est. Priority Date: 03/25/2009
• Status: Active Grant

• Current Assignee: ICU Medical Incorporated
• Original Assignee: ICU Medical Incorporated
• Inventors: Fangrow, Thomas F.
• Primary Examiner(s): Osinski, Bradley J
• Application Number:
  US15/828,317
• Publication Number:
  US 20180099137A1
• Time in Patent Office: 635 Days
• CPC Class Codes: A61M 2039/1033 Swivel nut connectors, e.g. threaded connectors, bayonet-connectors
• CPC Class Codes: A61M 2039/2406 designed to quickly shut upon the presence of back-pressure
• CPC Class Codes: A61M 2039/2433 Valve comprising a resilient or deformable element, e.g. flap valve, deformable disc
• CPC Class Codes: A61M 2039/262 having a fluid space within the valve remaining the same upon connection and disconnection, i.e. neutral-drawback valve
• CPC Class Codes: A61M 2039/263 where the fluid space within the valve is decreasing upon disconnection
• CPC Class Codes: A61M 2039/266 where the valve comprises venting channels, e.g. to insure better connection, to help decreasing the fluid space upon disconnection, or to help the fluid space to remain the same during disconnection
• CPC Class Codes: A61M 2039/267 having a sealing sleeve around a tubular or solid stem portion of the connector
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/30 Blood pressure A61M2230/04 takes precedence
• CPC Class Codes: A61M 2230/40 Respiratory characteristics
• CPC Class Codes: A61M 39/02 Access sites
• CPC Class Codes: A61M 39/10 Tube connectors; Tube couplings A61M39/02 takes precedence; connecting needles to syringes or hubs A61M5/34; connecting catheter tubes to hubs A61M25/0014
• CPC Class Codes: A61M 39/1011 Locking means for securing connection; Additional tamper safeties A61M39/16 takes precedence
• CPC Class Codes: A61M 39/22 Valves or arrangement of valves A61M39/02, A61M39/0247, A61M39/16 take precedence; regulating valves in infusion systems A61M5/16881; in devices worn by the patient for the reception of urine, faeces, catamenial or other discharge, or in colostomy devices A61F5/4405
• CPC Class Codes: A61M 39/221 Frangible or pierceable closures within tubing A61M39/14 takes precedence; frangible closures for containers A61J1/14
• CPC Class Codes: A61M 39/24 Check- or non-return valves
• CPC Class Codes: A61M 39/26 Valves closing automatically on disconnecting the line and opening on reconnection thereof check valves A61M39/24
• CPC Class Codes: Y10T 137/87917 Flow path with serial valves and/or closures
• CPC Class Codes: Y10T 29/494 Fluidic or fluid actuated device making

Abstract

Some embodiments disclosed herein relate to medical connectors with a housing comprising a proximal body member and a base member that form an internal cavity with a proximal abutment surface. A seal member and a rigid, hollow elongated portion are located within the internal cavity such that a proximal tip of the elongated member extends proximally within the internal cavity further than the abutment surface.

Claims

1. A medical connector configured to be removably attached to a medical implement having a male luer tip, the medical connector comprising:

a housing comprising a proximal body member and a base member;

the proximal body member comprising a proximal opening, a distal end, and an internal abutment surface that is located distal from the proximal opening of the body member, but closer to the proximal opening of the body member than to the distal end of the body member, the abutment surface comprising a proximal end, a distal end, and a slanting wall extending between the proximal and distal ends such that the distal end of the abutment surface is wider than the proximal end of the abutment surface;

a base member coupled to the proximal body member, the base member comprising a distally extending male end;

an internal cavity formed between the proximal body member and the base member;

an elastomeric seal member located within the internal cavity, the seal member comprising a proximal end with a septum having a vertical thickness and a slit biased to a closed position, a distal end, an interior region, and an elastomeric collar located distal from the proximal end of the seal member but closer to the proximal end of the seal member than to the distal end of the seal member, a vertical thickness of the collar being greater than the vertical thickness of the septum, the seal member being configured to move between a closed position and a compressed open position when the male luer tip of the medical implement is inserted into the proximal opening of the proximal body member, such that the proximal end of the seal member moves distally in transitioning from the closed position to the open position; and

a rigid, hollow elongated portion located within the seal member, the elongated portion comprising a closed, non-sharp proximal tip with a proximally facing top surface with a transverse width positioned within the interior region of the seal member distally below the septum of the seal member in the closed position, such that an open space is provided in the interior region of the seal member between the proximal tip of the elongated portion and a distal side of the septum, the open space not being narrower than the transverse width of the proximally facing top surface of the proximal tip of the elongated portion, permitting the compressing seal member to advance unimpeded distally with respect to the elongated portion from the closed to the open position to expose the elongated portion proximally outside of the seal member, one or more side openings spaced distally from the proximal tip, and an internal fluid passageway in fluid communication with the one or more side openings, each of the side openings comprising a proximal end and a distal end, the proximal end of at least one of the side openings being located more proximal than the distal end of the abutment surface of the proximal body, the elongated portion extending proximally from the base member, the proximal tip of the elongated portion being located further in the proximal direction than the proximal end of the abutment surface;

wherein, in the closed position, the elastomeric collar of the seal member contacts the abutment surface of the body member, thereby limiting proximal axial movement of the seal member, but not distal axial movement of the seal member, such that the proximal end of the seal member is at or near the proximal opening of the body member in the closed position; and

wherein, in the open position, the elastomeric collar is separated from the abutment surface and the proximal opening of the proximal body member and the one or more side openings of the elongated portion are sized and positioned to permit the male luer tip of the medical implement to be advanced into the proximal body member a sufficient distance to permit the one or more side openings of the elongated portion to be positioned inside of the male luer tip of the medical implement and outside of the interior region of the seal member after the proximal tip of the elongated portion penetrates the proximal end of the seal member such that the proximal end of the seal member is distal from the proximal tip of the elongated portion and fluid in the medical implement is permitted to pass directly from within the male luer tip to the interior of the fluid passageway of the elongated portion without passing through the seal member.

2. The medical connector of claim 1, wherein the collar of the seal member is annular.

3. The medical connector of claim 1, wherein the elongated portion is rounded at the proximal tip.

4. The medical connector of claim 3, wherein the collar is continuous around the entire outside surface of the seal member.

5. The medical connector of claim 4, wherein the seal member is integrally formed from a single piece of material from the proximal end to the distal end.

6. The medical connector of claim 5, wherein the seal member comprises an undulating contour on an outside surface in a region between the collar and the distal end of the seal member.

7. The medical connector of claim 6, wherein the undulating contour is formed by a series of generally circular o-ring-shaped structures.

8. The medical connector of claim 7, wherein the seal member comprises a region between the collar and the proximal end of the seal member with a straight vertical wall.

9. The medical connector of claim 8, wherein a majority of the region between the collar and the proximal end of the seal member comprises the straight vertical wall.

10. The medical connector of claim 4, wherein the maximum cross-sectional width of the seal member is on the collar.

11. The medical connector of claim 3, wherein the one or more side openings of the elongated portion extend no further in the proximal direction than the abutment surface.

12. The medical connector of claim 1, wherein the seal member is not affixed to the housing.

13. The medical connector of claim 1, wherein the proximal end of the seal member fills the proximal opening in the body member in the closed position.

14. The medical connector of claim 13, wherein the proximal end of the seal member comprises a lip configured to contact the inside surface of the proximal opening of the body member to provide a seal.

15. The medical connector of claim 1, wherein the abutment surface has a proximal edge and a distal edge.

16. The medical connector of claim 15, wherein the abutment surface is slanted.

17. The medical connector of claim 15, wherein the abutment surface is not horizontal.

18. The medical connector of claim 1, wherein in the open position the proximal end of the seal element is spaced distally from the distal end of at least one of the side openings.

19. A combination of the medical connector of claim 1 and the medical implement.

20. A medical connector comprising:

a housing comprising a proximal body member and a base member;

the proximal body member comprising a proximal opening, a distal end, and an internal abutment surface that is located distal from the proximal opening of the body member, but closer to the proximal opening of the body member than to the distal end of the body member;

a base member coupled to the proximal body member, the base member comprising a distally extending male end;

an internal cavity formed between the proximal body member and the base member;

an elastomeric seal member integrally formed of a single piece of material, the seal member being located within the internal cavity, the seal member comprising proximal and distal ends and a collar, the proximal end being thinner than the collar, and the collar being located distal from the proximal end of the seal member but closer to the proximal end of the seal member than to the distal end of the seal member, the seal member being configured to move between a closed position and a compressed open position, such that the proximal end of the seal member moves distally in transitioning from the closed position to the open position; and

a rigid, hollow elongated portion located within the seal member, the elongated portion comprising a proximal region with a closed non-sharp proximal tip positioned within an interior region of the seal member in the closed position, at least one side opening with a proximal end that is located more proximal than a distal end of the abutment surface of the body member, and an internal fluid passageway, the elongated portion extending proximally from the base member, the proximal tip of the elongated portion being located further in the proximal direction than the abutment surface;

wherein, in the closed position, an open space is located around the proximal region of the elongated portion to the proximal end of the seal member that has a minimum width that is about the same as the width of the proximal tip of the elongated portion, and the collar of the seal member contacts the abutment surface of the body member, thereby limiting proximal axial movement of the seal member, but not distal axial movement of the seal member, such that the proximal end of the seal member is at or near the proximal opening of the body member in the closed position; and

wherein, in the open position, the collar is configured to be separated from the abutment surface by a distally advancing male portion of a medical implement when inserted into the proximal opening of the proximal body member, and the proximal tip of the elongated portion penetrates the proximal end of the seal member, such that the proximal end of the seal member is distal from the proximal tip of the elongated portion, and the at least one side opening of the elongated portion is sized and positioned to be outside of the seal member and received within the male portion of the medical implement.

21. The medical connector of claim 20, wherein the seal member comprises a wall in a region between the proximal end of the seal member and the collar that is thicker than a portion of a wall in the seal member that is distal from the collar.

22. A combination of the medical connector of claim 20 and the medical implement.