Apparatus and method for injecting a viscous material into the tissue of a patient

• US 5,385,561 A
• Filed: 01/18/1994
• Issued: 01/31/1995
• Est. Priority Date: 01/18/1994
• Status: Expired due to Term

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: Bard International, Inc. (New Jersey) (Becton, Dickinson & Co)
• Inventors: Cerny, David E.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US08/183,172
• Time in Patent Office: 378 Days
• Field of Search: 604/264, 604/164, 604/165, 604/274, 604/239, 604/240, 604/111, 604/272, 128/4
• US Class Current: 604/264
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2090/067 for measuring angles
• CPC Class Codes: A61B 90/06 Measuring instruments not otherwise provided for

Abstract

An apparatus and method are disclosed for injecting a viscous material into periurethral tissues as a treatment for urinary incontinence. The apparatus comprises a non-coring needle mounted to the forward end of a catheter. A hub with a luer adapter is fitted to the rearward end of the catheter. To provide the physician with a readily visible indicator of the orientation of the needle orifice, the catheter has a stripe running longitudinally on the catheter in predetermined angular relationship with the needle orifice. Further, the needle hub also has indicia located thereon in predetermined angular relationship with the needle orifice. Thus the physician can ascertain the orientation of the needle orifice through the cystoscope by observing the location of the stripe, or he can determine the orientation of the needle orifice externally by observing the indicia on the needle hub. The physician can therefore maneuver the catheter/needle assembly while noting the angular location of the stripe or hub indicia to position the needle orifice at the optimum orientation for injecting the viscous material.

Claims

1. A method for injecting a viscous material into the tissues of a patient, comprising the steps of:

inserting an endoscope having a working channel into the body of a patient to a point proximate to an injection location;

inserting an apparatus comprising a cannula having a non-coring needle disposed at the forward end thereof through said working channel of said cystoscope and into the tissues of said patient to a point immediately adjacent said injection location, said non-coring needle having an orifice on one side thereof, and said apparatus further comprising indicia inscribed thereon in predetermined alignment with said one side of said non-coring needle upon which said orifice is located, said indicia being visible to said physician when said needle is positioned adjacent said injection location;

observing the orientation of said indicia to determine the orientation of said needle orifice;

rotating said cannula and said needle until said orifice on said needle is aligned toward said injection location; and

injecting a viscous substance through said cannula and said needle into said injection location.

2. The method of claim 1, wherein said indicia is inscribed on said cannula in predetermined alignment with said one side of said non-coring needle upon which said orifice is located, and wherein said step of observing the orientation of said indicia to determine the orientation of said needle orifice comprises the step of observing said indicia on said cannula through said endoscope when said needle positioned adjacent said injection location.

3. The method of claim 2, wherein said indicia on said cannula comprises a stripe placed on said cannula in predetermined alignment with said one side of said non-coring needle upon which said orifice is located, and wherein said step of observing said indicia on said cannula through said endoscope when said needle is positioned adjacent said injection location comprises the step of observing said stripe on said cannula through said endoscope when said needle is positioned adjacent said injection location.

4. The method of claim 1, wherein said apparatus further comprises a needle hub disposed at a rearward end of said cannula, said needle hub remaining outside said patient when said cannula and needle are inserted through said working channel of said endoscope, said needle hub having indicia inscribed thereon in predetermined alignment with said orifice of said needle;

and

wherein said step of observing the orientation of said indicia to determine the orientation of said needle orifice comprises the step of observing said indicia on said needle hub outside said patient.

5. The method of claim 1, wherein said method comprises a method for injecting a viscous material into the periurethral tissues of a patient as a treatment for urinary incontinence;

wherein said step of inserting an endoscope having a working channel into the body of a patient to a point proximate to an injection location comprises the step of inserting a cystoscope having a working channel into the body of a patient to a point proximate to an injection site within the periurethral tissues of said patient; and

wherein said step of inserting an apparatus comprising a cannula having a non-coring needle disposed at the forward end thereof through said working channel of said cystoscope and into the tissues of said patient to a point immediately adjacent said injection location comprises inserting said apparatus into the periurethral tissues of said patient.

6. The method of claim 5, wherein said step of inserting a cystoscope into the body of a patient to a point proximate to an injection site within the periurethral tissues of said patient comprises the step of inserting said cystoscope into the body of said patient transurethrally.

7. The method of claim 5, wherein said step of inserting a cystoscope into the body of a patient to a point proximate to an injection site within the periurethral tissues of said patient comprises the step of inserting said cystoscope into the body of said patient periurethrally.

8. The method of claim 1, wherein said step of injecting a viscous substance through said cannula and said needle into said injection location comprises the step of injecting collagen through said cannula and said needle into said injection location.

9. The method of claim 1, wherein said apparatus comprises a fitting disposed at the rearward end of said cannula for coupling said cannula to a syringe, and wherein said step of injecting a viscous substance through said cannula and said needle into said injection location comprises the step of coupling a syringe charged with said viscous substance to the rearward end of said cannula and depressing the plunger of said syringe.

10. An apparatus for injecting a viscous material into the tissues of a patient, comprising:

a needle having forward and rearward ends, said forward end of said needle including a non-coring tip with an orifice formed on one side of said needle;

a cannula having forward and rearward ends, said forward end of said cannula being coupled to said rearward end of said needle, said cannula having indicia located thereon in predetermined alignment with said orifice of said needle and disposed such that when said apparatus is inserted through the working channel of an endoscope and the needle advanced into the tissues of a patient, said indicia on said cannula are visible to a physician; and

a hub coupled to said rearward end of said cannula, said needle hub remaining outside said patient when said cannula and needle are inserted through the working channel of an endoscope, and said hub having indicia located thereon in predetermined alignment with said orifice of said needle;

whereby when said cannula and needle are inserted through the working channel of an endoscope and said needle is advanced into the tissues of a patient, the orientation of said needle orifice can be determined by observing said indicia on said cannula through said endoscope or by observing said indicia on said hub outside said endoscope.

11. The apparatus of claim 10, wherein said indicia on said cannula comprises a longitudinal stripe marked on said cannula.

12. The apparatus of claim 10, wherein said hub further comprises a fitting for coupling said hub to a syringe.