Overmold technique for peel-away introducer design

Patent metadata

Field	Value
Publication number	US-12076497-B2
Application number	US-202318211610-A
Country	US
Kind code	B2
Filing date	Jun 20, 2023
Priority date	Dec 8, 2016
Publication date	Sep 3, 2024
Grant date	Sep 3, 2024

Abstract

A method for manufacturing a medical introducer includes placing an introducer sheath onto a mandrel, and overmolding an introducer hub onto a proximal end of the introducer sheath. The introducer sheath has one or more score lines formed on an inner surface and the mandrel has a number of surface protrusions so that when the introducer sheath is positioned on the mandrel, each of the surface protrusions contacts one of the score lines formed on the introducer sheath. The surface protrusions on the mandrel prevent plastic material from the introducer hub from contacting the score lines thereby maintaining the score lines during the overmolding.

First claim

The invention claimed is:

1. A method of manufacturing a medical introducer, comprising:
placing an introducer sheath on a mandrel, the introducer sheath having a plurality of score lines formed on an inner surface thereof, the introducer sheath having more than one type of score line; the mandrel including a plurality of surface protrusions; and
overmolding a plastic material onto a proximal end of the introducer sheath to form an introducer hub using a mold surrounding the proximal end of the introducer sheath,
wherein, when the introducer sheath is positioned on the mandrel, each of the plurality of surface protrusions matches a type of corresponding score line.

2. The method of claim 1 , wherein a number of the plurality of surface protrusions on the mandrel is equal to a number of the plurality of score lines formed on the introducer sheath.

3. The method of claim 2 , wherein the introducer hub includes a number of notches.

4. The method of claim 3 , wherein the number of notches is both equal to the number of the plurality of score lines formed on the introducer sheath and equal to the number of the plurality of surface protrusions on the mandrel.

5. The method of claim 4 , wherein at least one notch of the number of notches is aligned with one score line of the plurality of score lines formed on the introducer sheath.

6. The method of claim 5 , wherein the introducer hub includes at least a first notch and a second notch, the first notch being aligned with a first score line of the plurality of score lines formed on the introducer sheath, and the second notch being aligned with a second score line of the plurality of score lines formed on the introducer sheath.

7. The method of claim 6 , wherein the introducer hub and the introducer sheath are both configured to be broken into at least two pieces along the first and second notches and the first and second score lines.

8. The method of claim 1 , wherein a number of the plurality of surface protrusions on the mandrel is not equal to a number of the plurality of score lines formed on the introducer sheath.

9. The method of claim 8 , wherein at least one score line of the plurality of score lines formed on the inner surface of the introducer sheath is removed during the overmolding.

10. The method of claim 9 , wherein the number of the plurality of surface protrusions on the mandrel is less than the number of the plurality of score lines formed on the introducer sheath.

11. An introducer hub manufacturing assembly, the assembly comprising:
an introducer sheath formed as a cylindrical tube having a first end and a second end, the introducer sheath including on an inner surface thereof a plurality of score lines extending from the first end to the second end, the introducer sheath having more than one type of score line;
a mold surrounding a first end of the introducer sheath and configured to enable overmolding of a plastic material onto the first end of the introducer sheath to form a hub; and
a mandrel inserted into the introducer sheath, wherein the mandrel includes a plurality of surface protrusions on an exterior surface that extends along a length of the mandrel, each of the plurality of surface protrusions being aligned with a corresponding score line,
wherein each of the plurality of surface protrusions matches a type of the corresponding score line.

12. The assembly of claim 11 , wherein the plurality of surface protrusions extend longitudinally down the mandrel.

13. The assembly of claim 11 , wherein at least one of the plurality of surface protrusions is configured as a continuous protrusion.

14. The assembly of claim 11 , wherein at least one of the plurality of surface protrusions is configured as a series of protrusions extending down a length of the mandrel.

15. The assembly of claim 11 , wherein the hub is formed from a heated plastic.

16. The assembly of claim 15 , wherein the introducer sheath is formed from a plastic which reflows when subject to heat above a melting temperature of the plastic.

17. The assembly of claim 11 , wherein the hub includes a first notch and a second notch arranged at opposite sides of the hub.

18. The assembly of claim 17 , wherein the hub is configured to break at the first notch and the second notch.

19. The assembly of claim 11 , wherein the introducer sheath is configured to tear along at least one of the plurality of score lines when the hub is broken.

20. The assembly of claim 11 , wherein a number of the plurality of surface protrusions is greater than a number of the plurality of score lines.

21. The assembly of claim 11 , wherein a number of the plurality of surface protrusions is less than a number of the plurality of score lines.

22. The assembly of claim 11 , wherein a number of the plurality of surface protrusions is equal to a number of the plurality of score lines.

Assignees

• Abiomed Inc
• Oscor Inc

Inventors

• Fantuzzi Glen
• Tafone Michael
• Drum Jeffrey

Classifications

• A61M25/0014

  Connecting a tube to a hub · CPC title

• B29C45/14065

  Positioning or centering articles in the mould · CPC title

• A61M25/0668

  splittable, tear apart · CPC title

• A61M25/0097

  characterised by the hub (connectors A61M39/10) · CPC title

• B29L2031/7542

  Catheters · CPC title