Medical component insertion device including a retractable needle

• US 9,095,683 B2
• Filed: 02/24/2012
• Issued: 08/04/2015
• Est. Priority Date: 02/25/2011
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Hall, John W., Patterson, Ryan C.
• Primary Examiner(s): Stigell, Theodore
• Assistant Examiner(s): KOO, BENJAMIN K
• Application Number:
  US13/405,096
• Publication Number:
  US 20120220942A1
• Time in Patent Office: 1,257 Days
• Field of Search: 60416401-16601
• US Class Current: 1/1
• CPC Class Codes: A61M 2025/0656 having a tip larger than the rest of the body
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/0687 having means for atraumatic insertion in the body or protection of the tip of the sheath during insertion, e.g. special designs of dilators, needles or sheaths
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 25/0631 having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 29/00 Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00

Abstract

An insertion device for use in assisting with the placement of a medical device within the body of a patient is disclosed. For example, the insertion device can be employed to assist with the placement of an introducer, which provides a conduit for insertion of a catheter into the body. In one embodiment, the insertion device comprises a needle that is removably disposed within a bore defined by the medical device, and a needle retraction assembly. The needle retraction assembly can position the needle in any one of a first position wherein a distal tip of the needle is disposed a predetermined distance distal to a distal end of the medical device, a second position wherein the needle distal tip is disposed distal but proximate to the distal end of the medical device, and a third position wherein the needle distal tip is retracted within the medical device bore.

Claims

1. An insertion device for inserting an introducer assembly into a body of a patient, the introducer assembly including a sheath and a dilator coaxially disposed in the sheath, the dilator defining a bore, the sheath and dilator each having a hub, the sheath hub threadably engaging a distal end of the dilator hub, the insertion device comprising:

a needle removably disposed within the bore of the dilator; and

a retraction assembly including a housing in which a needle hub is disposed, the needle hub attached to a proximal end of the needle, the housing threadably engaging a proximal end of the dilator hub, the retraction assembly and dilator being removable from the sheath after placement thereof within the patient body is complete, the removal of the retraction assembly causing removal of the needle from the sheath, the retraction assembly capable of producing relative positions of the needle and the introducer assembly, the relative positions including;

a first locked position wherein a distal tip of the needle is disposed a predetermined distance distal to a distal end of the introducer assembly,

a second locked position wherein the needle distal tip is disposed proximal to the needle distal tip in the first locked position and distal but proximate to the distal end of the introducer assembly, and

a third locked position wherein the needle distal tip is retracted within the dilator bore,

the needle hub movably disposed in the housing to move the needle between the first, second, and third locked positions, the needle hub including at least one protruding feature to engage at least one recessed feature of the housing to releasably lock the needle hub and maintain the needle in each of the first, second, and third locked positions.

2. The insertion device as defined in claim 1, wherein the dilator includes a tapered distal portion, the distal tip of the needle in the second locked position providing a transition for the tapered distal portion.

3. The insertion device as defined in claim 1, wherein the needle is hollow for passage of a guidewire therethrough, the guidewire also passing through the retraction assembly housing, the guidewire able to remain with the introducer assembly after the retraction assembly and the needle are removed from the introducer assembly.

4. The insertion device as defined in claim 1, wherein the needle in the first locked position is used to gain needle access to an interior portion of the body of the patient, in the second locked position is used to assist a first distal portion of the introducer assembly to gain access to the interior portion, and in the third locked position is used to enable a second distal portion of the introducer assembly to gain access to the interior portion.

5. The insertion device as defined in claim 1, wherein the needle hub includes a distally extending handle to enable one-handed grasping of the insertion device and movement of the needle between the first, second, and third locked positions.

6. The insertion device as defined in claim 1, wherein the retraction assembly includes:

a biasing element disposed within the housing of the retraction assembly, the biasing element configured for moving the needle between at least two of the first, second, and third locked positions;

a guidewire; and

a guidewire handle extending from the housing and configured to enable manual advancement of the guidewire.