Needle and suture automatic pull-test system

• US 5,487,308 A
• Filed: 01/13/1994
• Issued: 01/30/1996
• Est. Priority Date: 01/13/1994
• Status: Expired due to Term

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Blanch, John F., Demarest, David, Lenihan, Timothy
• Primary Examiner(s): RAEVIS, ROBERT R
• Application Number:
  US08/181,601
• Time in Patent Office: 747 Days
• Field of Search: 73/826-828, 73/830, 73/831, 73/834, 73/837, 73/842, 73/845, 73/846, 73/856, 73/827, 29/517, 606/224, 606/225, 606/227
• US Class Current: 73/827
• CPC Class Codes: A61B 17/06004 Means for attaching suture to needle tipping A61B17/06195; connecting wire to other metallic objects B21F15/00

Abstract

An automatic pull-testing apparatus for testing the strength of an armed surgical needle comprises a supporting blade for supporting a suture receiving end of the armed needle and having at least one suture receiving guide therein. A first gripping device is provided for releasably retaining the armed needle in an oriented position, and for positioning the armed needle at the supporting blade to enable the suture strand depending therefrom to be threaded at the suture receiving guide. A second suture gripping device grips the suture at a position below the suture receiving guide of the supporting blade. A slide block counterweighted to a predetermined weight is connected to the second suture gripping device for applying a controlled positive downward force upon the suture strand. When the first gripping device releases its grip upon the armed needle and the second gripping device and the slide block is released, a positive downward force is applied to the suture strand to perform a minimum pull-test of the armed needle. A destructive pull test is also performed by a device that generates a positive force against the slide block that is sufficient to dislodge the suture from the needle.

Claims

1. An apparatus for automatically testing the swage bond strength of an armed needle having a suture strand depending from a suture receiving end thereof, said apparatus comprising:

(a) blade means for supporting said suture receiving end of said armed needle when a positive downward gravitational force of predetermined controllable value is applied to said suture strand, said blade means having at least one suture receiving guide therein;

(b) indexing means for releasably engaging said armed needle and for positioning said armed needle at said blade means to enable said suture strand to be received within said suture receiving guide thereof; and

(c) gripping means for positively gripping said suture strand at a first position below said suture receiving opening of said blade means, said gripping means including a vertically suspended slide block means consisting of a mass of predetermined weight for applying said positive downward force of predetermined value to said gripped suture strand, said gripping means and said slide block means being vertically slidably mounted along a fixed mounting means, said fixed mounting means being positioned substantially parallel with a vertical axis defined by said suture strand.

2. The apparatus for automatically testing the swage bond strength of an armed needle according to claim 1 further including a means for maintaining said gripping means and said slide block means at a first position along said mounting means prior to applying said positive downward force to said gripped suture.

3. The apparatus for automatically testing the swage bond strength of an armed needle according to claim 2 wherein said maintaining means includes a first air cylinder means for applying pressure against a first side of said slide block means to maintain said gripping means and said slide block means thereof at said first position.

4. The apparatus for automatically testing the swage bond strength of an armed needle according to claim 3 wherein said pressure applied to said first side of said slide block means is ceased to enable said slide block means to slide along said mounting means to a second position that is lower than said first position to effect said positive downward force to said gripped suture.

5. The apparatus for automatically testing the swage bond of said armed needle according to claim 4 further including a means for applying a positive downward force against a second side of said slide block means that is sufficient to dislodge said suture from said needle.

6. The apparatus for automatically testing the swage bond strength of an armed needle according to claim 5, further including means for measuring the value of said positive downward force applied by said slide block means to said gripped suture strand.

7. The apparatus for automatically testing the swage bond strength of an armed needle according to claim 6, wherein said measuring means includes a transducer means for measuring the deflection of said blade means when said positive downward force is applied to said gripped suture strand.

8. The apparatus for automatically testing the swage bond strength of an armed needle according to claim 7 further including a computer control means connected with said transducer means for outputting a test fail signal if said suture becomes dislodged from said needle after application of said downward force.

9. The apparatus for automatically testing the swage bond strength of an armed needle according to claim 8 wherein said computer control means utilizes said measured value of said positive downward force for process control.

10. The apparatus for automatically testing the swage bond strength of an armed needle according to claim 1, wherein said slide block means further includes a means for controlling the application of said downward force applied to said suture strand.

11. The apparatus for automatically testing the swage bond strength of an armed needle according to claim 10, wherein said means for controlling the application of said downward force is a counterweight means, positioned to oppose a gravitational force generated by said slide block means.

12. The apparatus for automatically testing the swage bond strength of an armed needle according to claim 1 further including a plurality of said blade means selectively positionable by said indexing means in said apparatus for each supporting armed surgical needles having different barrel sizes.

13. The apparatus for automatically testing the swage bond strength of an armed needle according to claim 1, wherein said gripping means includes a pair of retractable gripper arms.

14. The apparatus for automatically testing the swage bond strength of an armed needle according to claim 1, further including means for measuring the value of said positive downward force applied by said slide block means to said gripped suture strand.

15. The apparatus for automatically testing the swage bond strength of an armed needle according to claim 14, wherein said measuring means includes a transducer means for measuring the deflection of said blade means when said positive downward force is applied to said gripped suture strand.

16. The apparatus for automatically testing the swage bond strength of an armed needle according to claim 14 further including a computer control means connected with said transducer means for outputting a test fail signal if said suture becomes dislodged from said needle after application of said downward force.

17. The apparatus for automatically testing the swage bond of said armed needle according to claim 15, said apparatus further including means for removing said needle from said gripping means upon receipt of said test fail signal from said computer control means.

18. The apparatus for automatically testing the swage bond of said armed needle according to claim 1, wherein said indexing means is actuated to release its engagement of said needle as said gripping means applies said positive downward force of predetermined value to said suture strand to thereby test the strength of said swage bond.

19. A method for automatically testing the attachment strength of an armed surgical needle having a suture strand depending therefrom, said method comprising the steps of:

(a) positioning a suture receiving end of said armed needle above a blade means for supporting said needle, wherein a first gripper means is gripping said armed needle in an oriented position above said blade means;

(b) positively gripping said depending suture strand at a first position below said blade means with a second gripper means, said second gripper means having a predetermined weight means connected thereto; and

(c) generating a positive downward gravitational force upon said suture strand gripped by said second gripper means while concurrently releasing said armed needle from the grip of said first gripper means to enable said weight means to impart a downward tensile force to said needle and suture.

20. The method for automatically testing the attachment strength of an armed surgical needle according to claim 19 further including the step of measuring the value of said force applied to said suture strand.

21. The method for automatically testing the attachment strength of an armed surgical needle according to claim 20 further including the step of comparing said measured force value with predetermined values and generating a test fail signal if the measured value is not within a predetermined range.