Urology catheter

• US 20050192560A1
• Filed: 09/27/2004
• Published: 09/01/2005
• Est. Priority Date: 09/26/2003
• Status: Active Grant

• Current Assignee: Kpr U.S., LLC (Cardinal Health, Inc.)
• Original Assignee: Tyco Healthcare Group LP (Medtronic Plc)
• Inventors: Walls, James A., Morris, Robert A., Green, Kurt, Murray, Stephen, Karl, Cliff, Sacchetti, Tony, Morris, Rita Ann, Dubeau, Chris
• Granted Patent: US 7,655,000 B2
• Time in Patent Office: Days
• US Class Current: 604/544
• CPC Class Codes: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 2039/1077 Adapters, e.g. couplings adapting a connector to one or several other connectors
• CPC Class Codes: A61M 2202/0496 Urine
• CPC Class Codes: A61M 25/0015 Making lateral openings in a catheter tube, e.g. holes, slits, ports, piercings of guidewire ports; Methods for processing the holes, e.g. smoothing the edges
• CPC Class Codes: A61M 25/0017 specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0069 Tip not integral with tube
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/008 Strength or flexibility characteristics of the catheter tip
• 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: B29C 45/14598 Coating tubular articles
• CPC Class Codes: B29C 45/2614 for manufacturing bent tubular articles using an undercut forming mould core
• CPC Class Codes: B29K 2083/00 Use of polymers having silicon, with or without sulfur, nitrogen, oxygen, or carbon only, in the main chain, as moulding material
• CPC Class Codes: B29L 2031/7542 Catheters

Abstract

A urology catheter is provided that includes an elongated body extending from a proximal end to a distal end. The body defines at least one lumen. A tip has a proximal end that is disposed in abutting relation with the distal end of the body such that the body is fixed with the tip. The tip defines a lateral opening that is defined by a wall including an external radius disposed in transition with an outer surface of the tip and an internal radius disposed in transition with an inner surface of the tip. The external radius has a non-perpendicular profile with the outer surface of the tip. An expandable member has a proximal portion disposed about the body and a distal portion disposed about the tip. A method of manufacturing the urology catheter is provided.

Claims

1. A catheter comprising:

an elongated body extending from a proximal end to a distal end, the body defining at least one lumen;

a tip having a proximal end that is disposed in abutting relation with the distal end of the body such that the body is fixed with the tip, the tip defining a lateral opening that is defined by a wall including an external radius disposed in transition with an outer surface of the tip and an internal radius disposed in transition with an inner surface of the tip, the external radius having a non-perpendicular profile with the outer surface of the tip; and

an expandable member having a proximal portion disposed about the body and a distal portion disposed about the tip.

2. A catheter as recited in claim 1, wherein the distal end of the body defines a planar face that has a substantially perpendicular orientation relative to a longitudinal axis of the body.

3. A catheter as recited in claim 2, wherein the proximal end of the tip defines a planar face, the planar face of the tip being disposed in abutting relation with the planar face of the body such that the body is fixed with the tip.

4. A catheter as recited in claim 1, wherein the lateral opening is formed by a molding process.

5. A catheter as recited in claim 1, wherein the body defines a first lumen and the tip defines a central lumen in fluid communication with the first lumen.

6. A catheter as recited in claim 5, wherein a cross sectional area of the central lumen is greater than a cross sectional area of the first lumen.

7. A catheter as recited in claim 1, wherein the tip and the body are fabricated from a material including silicone.

8. A catheter as recited in claim 1, wherein the body defines a first lumen and a second lumen configured for fluid flow to inflate the expandable member.

9. A catheter as recited in claim 1, wherein an expansion device is disposed within the body adjacent to the expandable member.

10. A catheter comprising:

a body defining a longitudinal axis and having a distal end;

a tip having a proximal end, the proximal end of the tip being disposed in abutting relation with the distal end of the body such that the body is fixed with the tip; and

an expandable member having a proximal securing portion disposed about the body and a distal securing portion disposed about the body and the tip, wherein the distal securing portion of the expandable member is bonded over an abutment region of the body and the tip.

11. A catheter as recited in claim 10, wherein the distal securing portion of the expandable member is adhesively bonded over a region of fixation between the body and tip.

12. A catheter as recited in claim 10, wherein the tip further defines a lateral opening.

13. A catheter as recited in claim 12, wherein the lateral opening is defined by a wall having a non-perpendicular profile with an outer surface of the tip.

14. A catheter as recited in claim 12, wherein the lateral opening is defined by a wall having a radius of curvature, the radius of curvature including an external radius disposed in transition with an outer surface of the tip and an internal radius disposed in transition with an inner surface of the tip.

15. A catheter as recited in claim 12, wherein the lateral opening is formed by a molding process.

16. A catheter as recited in claim 10, wherein the body defines a first lumen and the tip defines a central lumen in fluid communication with the first lumen.

17. A catheter as recited in claim 16, wherein a cross sectional area of the central lumen is greater than a cross sectional area of the first lumen.

18. A catheter as recited in claim 10, wherein the tip and the body are fabricated from a material including silicone.

19. A catheter as recited in claim 10, wherein the body defines a first lumen and a second lumen configured for fluid flow to inflate the expandable member.

20. A catheter as recited in claim 10, wherein an expansion device is disposed within the body adjacent to the expandable member.

21. A catheter comprising:

an elongated body defining a longitudinal axis and extending from a proximal end to a distal end, the distal end defining a planar face that has a substantially perpendicular orientation relative to the longitudinal axis, the body further defining a first lumen and a second lumen;

a tip having a proximal end that defines a planar face, the planar face of the tip being disposed in abutting relation with the planar face of the body such that the body is secured with the tip, the tip further defining a central lumen that is in fluid communication with the first lumen, the tip having a lateral opening that is defined by a wall having a radius of curvature, the radius of curvature including an external radius disposed in transition with an outer surface of the tip and an internal radius disposed in transition with an inner surface of the tip; and

a cuff having a proximal securing portion disposed about the body and a distal securing portion disposed about the tip, wherein the distal securing portion of the cuff is bonded over an abutment region of the body and the tip, the cuff defining an inflation cavity with an outer surface of the body that is in fluid communication with the second lumen.

22. A method of manufacturing a catheter having a body and a tip, the method comprising the steps of:

providing a mold that defines a mold cavity and a post cavity that communicates with the mold cavity, the post cavity defining a predetermined transition configuration;

providing a pin having a post extending therefrom, the post cooperating with the predetermined transition configuration of the post cavity to form the tip;

inserting the pin with a distal end of the body;

disposing the distal end of the body and the pin into the mold cavity such that the post is disposed with the post cavity and extends to engage a wall of the post cavity;

injecting a material into the mold cavity to simultaneously mold the tip with the distal end of the body, and to mold a lateral opening with the tip in relation to the predetermined transition configuration such that the lateral opening is defined by a wall including an external radius disposed in transition with an outer surface of the tip and an internal radius disposed in transition with an inner surface of the tip, the external radius having a non-perpendicular profile with the outer surface of the tip;

removing the body and the pin from the mold cavity; and

removing the pin from the catheter through the lateral opening.

23. A method as recited in claim 22, wherein the mold includes a removable block that forms a portion of the mold cavity and defines the post cavity.

24. A method as recited in claim 23, wherein the step of removing the body and the pin from the mold cavity further includes removing the block, having the pin disposed therewith, from the mold.

25. A method as recited in claim 22, wherein the step of disposing includes disposing the pin with the mold cavity such that the pin is spaced apart from walls of the mold cavity.

26. A method as recited in claim 22, wherein the material includes a silicone based rubber.

27. A method as recited in claim 22, wherein the step of injecting includes molding a tip that defines a central lumen in communication with the lateral opening.

28. A method as recited in claim 22, further comprising the step of mounting an expandable member about the body and the tip.

29. A method of manufacturing a catheter having a body and a tip, the method comprising the steps of:

providing a mold assembly that includes a mold cavity, the mold assembly having a removable spring block that forms a portion of the mold cavity and defines a post cavity that communicates with the mold cavity, the post cavity defining a non-perpendicular transition configuration;

providing a pin having a core and a post extending therefrom, the post cooperating with the non-perpendicular transition configuration to form the tip;

inserting the core with a distal end of the body;

disposing the distal end of the body and the pin with the mold cavity such that the core is spaced apart from walls of the mold cavity and the post is disposed with the post cavity and extends to engage a wall of the post cavity;

injecting a silicone based material into the mold cavity to simultaneously mold the tip with the distal end of the body such that the tip defines a central lumen, and to mold a lateral opening with the tip in relation to the non-perpendicular transition configuration such that the lateral opening is defined by a wall including an external radius disposed in transition with an outer surface of the tip and an internal radius disposed in transition with an inner surface of the tip, the external radius having a non-perpendicular profile with the outer surface of the tip and the internal radius having a non-perpendicular profile with the inner surface of the tip;

removing the body and the spring block, having the pin disposed therewith, from the mold cavity;

removing the pin from the tip through the lateral opening; and

mounting an expandable sleeve about the body and the tip.