Disposable urinary catheterization assembly

• US 6,090,075 A
• Filed: 03/31/1998
• Issued: 07/18/2000
• Est. Priority Date: 03/31/1998
• Status: Expired due to Term

• Current Assignee: Colorado Catheter Company, Inc.
• Original Assignee: House Jamie Glen
• Inventors: House, Jamie Glen
• Primary Examiner(s): Polutta, Mark O.
• Assistant Examiner(s): Hayes, Michael J.
• Application Number:
  US09/052,309
• Time in Patent Office: 840 Days
• Field of Search: 604/167, 604/170, 604/171, 604/172, 604/256, 604/265, 604/523, 604/533, 604/544, 206/571, 600/581, 600/574
• US Class Current: 604/172
• CPC Class Codes: A61M 2025/0062 having features to improve the sliding of one part within another by using lubricants or surfaces with low friction
• CPC Class Codes: A61M 2210/1085 Bladder
• CPC Class Codes: A61M 25/0017 specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections

Abstract

A disposable self-lubricating catheterization assembly for inserting a catheter into the urethra of an individual for the purpose of evacuating the bladder is disclosed. The catheter assembly includes a substantially rigid catheter introducer member for positioning the introducer against the urethral opening, a flexible catheter and a flexible thin-walled sheath surrounding the catheter and partially covering the catheter introducer. The catheter introducer comprises a reservoir portion, a guide portion, lubricant and a membrane. The lubricant essentially fills the reservoir and is prevented by the membrane from prematurely coating the catheter, in order to facilitate grasping of the catheter and feeding of the tube along the urethra and into the bladder. A catheterization assembly in accordance with the present invention is suitable for use for self-catheterization in the home or in a public restroom, and deters contamination and subsequent infection of the urinary tract. The improved easy-to-use disposable catheterization kit is also economically practical for use for temporary catheterizations in hospitals, mobile emergency facilities, doctors'"'"' offices, rehabilitation facilities, nursing homes and the like.

Claims

1. A urinary catheterization assembly comprising:

a catheter introducer member having a first end adapted for contacting a urethral opening and a second end adapted for receiving a catheter;

a throughbore extending from a first opening at said first end to a second opening at said second end;

a reservoir portion containing a lubricant chamber, said lubricant chamber disposed within said throughbore and terminating adjacent said first opening;

a guide portion joined to said reservoir portion and terminating at said second end;

a piercable membrane disposed in said throughbore at a position between said lubricant chamber and said guide portion and capable of retaining a lubricant in said lubricant chamber,

wherein said first end of said catheter introducer member includes a body-contacting collar, and wherein said introducer member includes a frustoconical segment having its smallest outer diameter adjacent to said collar.

2. The catheterization assembly of claim 1 wherein said throughbore is of essentially uniform diameter from said first opening to said second opening.

3. The catheterization assembly of claim 1 wherein said lubricant chamber comprises an enlarged diameter portion of said throughbore.

4. The catheterization assembly of claim 1 wherein said reservoir portion and said guide portion are releasably joined together.

5. The catheterization assembly of claim 1 further comprising:

a sheath having first and second ends, said first end being attached to said guide portion such that said throughbore second opening is enveloped by said sheath, said sheath second end being attached to a urinary catheter having proximal and distal ends such that when the proximal end of the catheter is situated in said throughbore, a length of the catheter between said proximal and distal ends is also enclosed by said sheath.

6. The catheterization assembly of claim 5 further comprising:

a catheter having a first end extending through said throughbore second opening and into said throughbore, said first catheter end being capable of piercing said membrane when forced against said membrane.

7. The assembly of claim 6 wherein said throughbore has a portion with a tapered surface capable of guiding said catheter first end into said throughbore second opening.

8. The catheterization assembly of claim 6 wherein said sheath is of a length approximating said length of enveloped catheter such that when said sheath is fully extended lengthwise said sheath and said guide portion together maintain said catheter first end in an initial position within said throughbore that is between said second end and said pierceable membrane.

9. The catheterization assembly of claim 1 wherein said catheter introducer further comprises lubricant in said lubricant chamber, a removable closure on said first opening and a roughened outer surface portion.

10. The assembly of claim 1 wherein said lubricant chamber has a tapered surface and said membrane is disposed at the widest end of said tapered lubricant chamber.

11. The catheter assembly of claim 1 wherein said membrane is capable of being pierced by a catheter proximal end to form an aperture in said membrane.

12. The assembly of claim 1 wherein said membrane is disk-like.

13. The assembly of claim 12 wherein said membrane is scored.

14. The assembly of claim 12 wherein said membrane is slit.

15. The assembly of claim 12 wherein said membrane includes an annular ridge.

16. A urinary catheterization assembly comprising:

a flexible catheter having a proximal end;

a catheter guide portion having proximal and distal ends and a first throughbore;

a reservoir portion having proximal and distal ends, said proximal end including a body-contacting collar adapted for contacting a urethral opening, an aperture in said proximal end, and a second throughbore defining an interior cavity, said reservoir portion being releasably joined to said catheter guide portion such that said first and second throughbores are aligned, and said reservoir portion including a frustoconical segment having its smallest outer diameter adjacent to said collar;

a membrane disposed between said guide portion and said interior cavity;

a lubricant initially disposed in said interior cavity; and

a flexible sheath covering a predetermined length of said catheter and said guide portion distal end, said sheath having

a proximal end circumferentially enclosing and fixedly joined to said guide portion distal end,

a distal end circumferentially enclosing and fixedly joined to said catheter at a predetermined point spaced apart from said catheter proximal end, said sheath length being such that said sheath and said guide portion throughbore initially hold said catheter proximal end within said guide portion throughbore between said guide portion proximal and distal ends, said throughbores being able to slidingly receive said catheter.

17. The assembly of claim 16 wherein said guide portion and said reservoir portion are together a single monolithic structure and said membrane is fixedly disposed between said guide and reservoir portions.

18. The assembly of claim 16 wherein said guide portion and said reservoir portion are separate members that are detachably joined together.

19. The assembly of claim 18 wherein said guide portion further comprises an annular ridge and said reservoir further comprises an annular recess and said annular ridge and said annular recess are capable of being matingly and releasably joined.

20. The assembly of claim 18 wherein said membrane further comprises a raised resilient annular ring, said membrane and said annular ring being together a single monolithic structure, and said guide portion further comprises an annular lip capable of sealingly engaging said raised annular ring.

21. A kit for catheterizing a urinary bladder comprising:

a sterilizable catheterization assembly having a catheter introducer assembly with a catheter receiving end and a urethra contacting end;

a throughbore in said introducer assembly extending from a first opening adjacent said urethra contacting end to a second opening adjacent said catheter receiving end,

a reservoir portion disposed between said first and second openings and comprising a lubricant chamber that is axially aligned with said reservoir portion in said throughbore, said reservoir portion including a body-contacting collar adjacent said first opening and said reservoir portion including a frustoconical segment having its smallest outer diameter adjacent to said collar,

a lubricant in said lubricant chamber, and

a guide portion disposed between said reservoir and said second opening,

a membrane in said throughbore disposed at a location between said lubricant chamber and said guide portion and capable of retaining said lubricant in said lubricant chamber, and

a catheter having a proximal end, a body insertable portion and a distal end,

a sheath member joined to said catheter guide and covering at least all of said catheter insertable portion, said sheath and said guide together holding said catheter proximal end in place within said catheter guide portion until said catheter is forced through said membrane when said catheter is used for its intended purpose;

a sterility maintaining package enclosing said catheterization assembly; and

at least one antiseptic swab.

22. A catheter introducer comprising:

a catheter receiving end and a body contacting end, said body contacting end including a body-contacting collar, and said introducer member including a frustoconical segment having its smallest outer diameter adjacent to said collar;

a throughbore extending from a first opening adjacent said body contacting end to a second opening adjacent said catheter receiving end;

a reservoir portion containing a lubricant chamber in said throughbore and terminating adjacent said first opening;

a guide portion joined to said reservoir portion and containing an elongated restricted diameter portion of said throughbore commencing adjacent said second opening and terminating adjacent said lubricant chamber, said restricted diameter portion adapted for supporting a sliding catheter tip; and

a membrane sealingly disposed in said throughbore between said lubricant chamber and said guide portion.