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Patent · US11717640B2 · B2 · US

Overmold technique for peel-away introducer design

(11) Publication number
US11717640B2
(21) Application number
17/741,627
(22) Filing date
2022-05-11
(30) Priority date
2016-12-08
(43) Publication date
2023-08-08
(45) Date of grant
2023-08-08
(51) IPC
A61M 25/00; A61M 25/06; B29C 45/14
(52) CPC
  • A61M Devices for introducing media into, or onto, the body; devices for transducing body media or for taking media from the body; devices for producing or ending sleep or stupor {}: 25/0009, 25/0014, 25/0097, 25/0668
  • B29C Shaping or joining of plastics; shaping of material in a plastic state, not otherwise provided for; after-treatment of the shaped products, e.g. repairing: 45/14065, 45/14336
  • B29L Indexing scheme associated with subclass B29C, relating to particular articles: 2031/7542
(73) Assignee
Abiomed Inc; Oscor Inc
(72) Inventors
Glen Fantuzzi; Michael Tafone; Jeffrey Drum
(54) Title
Overmold technique for peel-away introducer design
(57) 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.

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Claims (23)

  1. A method of manufacturing a medical introducer, comprising: placing an introducer sheath on a mandrel, the introducer sheath having one or more score lines formed on an inner surface thereof; and overmolding a plastic material onto a proximal end of the introducer sheath to form an introducer hub using a mold that: (i) surrounds the proximal end of the introducer sheath, and (ii) includes at least one projection aligned with a given score line of the one or more score lines, wherein the mandrel includes one or more surface protrusions, and wherein the introducer sheath is positioned on the mandrel such that a given surface protrusion of the one or more surface protrusions is aligned with the given score line and causes the plastic material deposited over the inner surface of the introducer sheath during the overmolding to be thinner along at least a portion of the given score line than at an area adjacent to the given score line.
  2. The method of claim 1, wherein a number of the one or more surface protrusions on the mandrel is equal to a number of the one or more 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 introducer hub includes a number of notches equal to the number of the one or more score lines formed on the introducer sheath and to the number of the one or more surface protrusions on the mandrel.
  5. The method of claim 4, wherein at least one of the number of notches is aligned with a score line of the one or more 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 one or more score lines formed on the introducer sheath, and the second notch being aligned with a second score line of the one or more score lines formed on the introducer sheath.
  7. The method of claim 6, wherein the introducer hub and introducer sheath are 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 one or more surface protrusions on the mandrel is not equal to a number of the one or more score lines formed on the introducer sheath.
  9. The method of claim 8, wherein at least one score line of the one or more 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 one or more surface protrusions on the mandrel is less than the number of the one or more 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 at least one score line extending from the first end to the second end; 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, the mold including at least one projection aligned with a given score line of the at least one score line; and a mandrel inserted into the introducer sheath, wherein the mandrel includes at least one surface protrusion on an exterior surface that extends along a length of the mandrel and that is aligned with the given score line, wherein a given surface protrusion of the at least one surface protrusion is configured to cause the plastic material deposited over the inner surface of the introducer sheath during overmolding to form the hub to be thinner along at least a portion of the given score line than at an area adjacent to the given score line.
  12. The assembly of claim 11, wherein the given surface protrusion extends longitudinally down the mandrel.
  13. The assembly of claim 11, wherein the given surface protrusion extends helically around the mandrel.
  14. The assembly of claim 11, wherein the given surface protrusion is configured as a continuous protrusion.
  15. The assembly of claim 11, wherein the given surface protrusion is configured as a series of protrusions extending down a length of the mandrel.
  16. The assembly of claim 11, wherein the hub is formed from a heated plastic.
  17. The assembly of claim 16, wherein the introducer sheath is formed from a plastic which reflows when subject to heat above a melting temperature of the plastic.
  18. The assembly of claim 11, wherein the hub includes a first notch and a second notch arranged at opposite sides of the hub.
  19. The assembly of claim 18, wherein the hub is configured to break at the first notch and the second notch.
  20. The assembly of claim 11, wherein the introducer sheath is configured to tear along at least the given score line when the hub is broken.
  21. The assembly of claim 11, wherein a number of the at least one surface protrusion is greater than a number of the at least one score line.
  22. The assembly of claim 11, wherein a number of the at least one surface protrusion is less than a number of the at least one score line.
  23. The assembly of claim 11, wherein a number of the at least one surface protrusion is equal to a number of the at least one score line.

Description

Peel-away introducers are disposable medical devices used in a cardiac catheterization or other medical setting to deliver medical devices into the vasculature. Standard peel-away introducers include a proximal plastic hub coupled to a sheath. Medical devices can be inserted through the plastic hub and into the sheath, through which the device can be placed in a patient's body. Intravascular medical devices, such as intracardiac blood pumps, catheters, guidewires, or leads, can be introduced into a patient's vasculature through a peel-away introducer. Once the medical device has been positioned, the peel-away introducer can be removed. In one approach, the operator breaks the introducer by cracking the plastic introducer hub and peeling down the shaft of the sheath body. In order to break the peel-away introducer, the operator grasps the molded hub and breaks it at the proximal end of the sheath along axial notches or scorings. The sheath tears along perforations or scorings down one or both sides of the sheath and can be peeled axially. The peel-away introducer allows the introducer to be removed after a medical device is inserted into a patient through the introducer without disturbing or removing the medical device.

In a common manufacturing technique, peel-away introducers are formed from an extruded plastic tube with axial notches in a hub body. A hub body including notches and/or wings to facilitate breaking is overmolded onto an extruded plastic sheath or tube.

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Record as JSON 
{
  "publication_number": "US11717640B2",
  "country": "US",
  "kind": "B2",
  "title": "Overmold technique for peel-away introducer design",
  "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.",
  "claims": [
    "1. A method of manufacturing a medical introducer, comprising: placing an introducer sheath on a mandrel, the introducer sheath having one or more score lines formed on an inner surface thereof; and overmolding a plastic material onto a proximal end of the introducer sheath to form an introducer hub using a mold that: (i) surrounds the proximal end of the introducer sheath, and (ii) includes at least one projection aligned with a given score line of the one or more score lines, wherein the mandrel includes one or more surface protrusions, and wherein the introducer sheath is positioned on the mandrel such that a given surface protrusion of the one or more surface protrusions is aligned with the given score line and causes the plastic material deposited over the inner surface of the introducer sheath during the overmolding to be thinner along at least a portion of the given score line than at an area adjacent to the given score line.",
    "2. The method of claim 1, wherein a number of the one or more surface protrusions on the mandrel is equal to a number of the one or more 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 introducer hub includes a number of notches equal to the number of the one or more score lines formed on the introducer sheath and to the number of the one or more surface protrusions on the mandrel.",
    "5. The method of claim 4, wherein at least one of the number of notches is aligned with a score line of the one or more 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 one or more score lines formed on the introducer sheath, and the second notch being aligned with a second score line of the one or more score lines formed on the introducer sheath.",
    "7. The method of claim 6, wherein the introducer hub and introducer sheath are 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 one or more surface protrusions on the mandrel is not equal to a number of the one or more score lines formed on the introducer sheath.",
    "9. The method of claim 8, wherein at least one score line of the one or more 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 one or more surface protrusions on the mandrel is less than the number of the one or more 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 at least one score line extending from the first end to the second end; 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, the mold including at least one projection aligned with a given score line of the at least one score line; and a mandrel inserted into the introducer sheath, wherein the mandrel includes at least one surface protrusion on an exterior surface that extends along a length of the mandrel and that is aligned with the given score line, wherein a given surface protrusion of the at least one surface protrusion is configured to cause the plastic material deposited over the inner surface of the introducer sheath during overmolding to form the hub to be thinner along at least a portion of the given score line than at an area adjacent to the given score line.",
    "12. The assembly of claim 11, wherein the given surface protrusion extends longitudinally down the mandrel.",
    "13. The assembly of claim 11, wherein the given surface protrusion extends helically around the mandrel.",
    "14. The assembly of claim 11, wherein the given surface protrusion is configured as a continuous protrusion.",
    "15. The assembly of claim 11, wherein the given surface protrusion is configured as a series of protrusions extending down a length of the mandrel.",
    "16. The assembly of claim 11, wherein the hub is formed from a heated plastic.",
    "17. The assembly of claim 16, wherein the introducer sheath is formed from a plastic which reflows when subject to heat above a melting temperature of the plastic.",
    "18. The assembly of claim 11, wherein the hub includes a first notch and a second notch arranged at opposite sides of the hub.",
    "19. The assembly of claim 18, wherein the hub is configured to break at the first notch and the second notch.",
    "20. The assembly of claim 11, wherein the introducer sheath is configured to tear along at least the given score line when the hub is broken.",
    "21. The assembly of claim 11, wherein a number of the at least one surface protrusion is greater than a number of the at least one score line.",
    "22. The assembly of claim 11, wherein a number of the at least one surface protrusion is less than a number of the at least one score line.",
    "23. The assembly of claim 11, wherein a number of the at least one surface protrusion is equal to a number of the at least one score line."
  ],
  "description_excerpt": "Peel-away introducers are disposable medical devices used in a cardiac catheterization or other medical setting to deliver medical devices into the vasculature. Standard peel-away introducers include a proximal plastic hub coupled to a sheath. Medical devices can be inserted through the plastic hub and into the sheath, through which the device can be placed in a patient's body. Intravascular medical devices, such as intracardiac blood pumps, catheters, guidewires, or leads, can be introduced into a patient's vasculature through a peel-away introducer. Once the medical device has been positioned, the peel-away introducer can be removed. In one approach, the operator breaks the introducer by cracking the plastic introducer hub and peeling down the shaft of the sheath body. In order to break the peel-away introducer, the operator grasps the molded hub and breaks it at the proximal end of the sheath along axial notches or scorings. The sheath tears along perforations or scorings down one or both sides of the sheath and can be peeled axially. The peel-away introducer allows the introducer to be removed after a medical device is inserted into a patient through the introducer without disturbing or removing the medical device.\n\nIn a common manufacturing technique, peel-away introducers are formed from an extruded plastic tube with axial notches in a hub body. A hub body including notches and/or wings to facilitate breaking is overmolded onto an extruded plastic sheath or tube.",
  "cpc": [
    "A61M 25/0009",
    "A61M 25/0014",
    "A61M 25/0097",
    "A61M 25/0668",
    "B29C 45/14065",
    "B29C 45/14336",
    "B29L 2031/7542"
  ],
  "ipc": [
    "A61M 25/00",
    "A61M 25/06",
    "B29C 45/14"
  ],
  "assignees": [
    "Abiomed Inc",
    "Oscor Inc"
  ],
  "inventors": [
    "Glen Fantuzzi",
    "Michael Tafone",
    "Jeffrey Drum"
  ],
  "filing_date": "2022-05-11",
  "publication_date": "2023-08-08",
  "grant_date": "2023-08-08",
  "priority_date": "2016-12-08",
  "application_number": "US-202217741627-A",
  "family_id": "60703245",
  "cited_by_count": 16,
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Record 701 of 8,000 in Patents full text (MLC-0201). Request the full dataset.