Safety catheter insertion apparatus and methods

• US 5,957,892 A
• Filed: 03/12/1998
• Issued: 09/28/1999
• Est. Priority Date: 03/12/1998
• Status: Expired due to Term

• Current Assignee: Specialized Health Products, Inc. (Becton, Dickinson & Co)
• Original Assignee: Specialized Health Products, Inc. (Becton, Dickinson & Co)
• Inventors: Thorne, David L.
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): KENNEDY, SHARON E
• Application Number:
  US09/041,553
• Time in Patent Office: 565 Days
• Field of Search: 604/110, 604/192, 604/197, 604/198, 604/263, 604/162, 604/164, 604/167
• US Class Current: 604/162
• CPC Class Codes: A61M 2005/3247 Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
• CPC Class Codes: A61M 5/3275 being connected to the needle hub or syringe by radially deflectable members, e.g. longitudinal slats, cords or bands

Abstract

Parts integrally associated with a shortened I.V. insertion needle handle to provide, in as few as one molded part, an extendable safety guard for a catheter insertion needle and its sharpened tip. The safety guard comprises a plurality of rigid segments serially connected by a plurality of living hinges. The segments are disposed about the insertion needle, folded upon each other during the medical procedure and extended at the end of the procedure to form a secure, substantially fixed length safety sheath which conforms to the long axis of the needle. During the procedure, the safety guard is folded and conveniently disposed about a proximal portion of the needle. At the end of the procedure, the safety guard is extended by a relatively short motion associated with an arc distance of a proximal segment of the enclosure to protectively guard and secure the needle. The needle becomes a part of a structure which is cooperatively formed by both needle and enclosure. The resulting structure has a fixed, predetermined length and protects from inadvertent exposure to the needle tip.

Claims

1. A safety IV catheter insertion device comprising:

a handle by which the device is manipulated in the process of inserting an IV catheter into a patient;

a catheter insertion needle which is securely affixed to said handle, said needle comprising a distally disposed sharpened tip and a hollow bore which communicates with an interior portion of said handle;

a sheath comprising a plurality of foldable parts, at least one of which comprises an orifice disposed about said needle, said sheath being hingeably affixed to said handle on a proximal end and comprising a catheter connecting part disposed about the needle on a distal end;

a catheter disposed about said needle such that said needle tip is exposed for use in catheter insertion, said catheter further being in communication with the catheter connecting part of said sheath;

each of said foldable parts comprising an interconnecting hinge to at least one other foldable part such that the sheath is proximally disposed in a folded state during a medical procedure to provide distal access to the needle and the sharpened tip and then unfolded by manual rotation of one foldable part to extend and slideably displace the catheter from the needle and consequently sandwich the needle between at least two foldable parts thereby forming a substantially rigid structure and covering the needle tip by the catheter connecting part;

a latch associated with said sheath which securely affixes the sheath in relation to the needle such that the sheath and needle combine to form an essentially inconstrictable structure, thereby providing a protective shield which safeguards the needle tip from further access.

2. A safety IV catheter insertion device according to claim 1 wherein said interconnecting hinge comprises a molded living hinge.

3. A safety IV catheter insertion device according to claim 1 wherein said hinge and said foldable parts, in combination, comprise but a single integrally molded part.

4. A safety IV catheter insertion device according to claim 1 wherein said foldable parts and said handle, in combination, comprise but a single integrally molded part.

5. A safety IV catheter insertion device according to claim 1 wherein said handle, said foldable parts and said connector, in combination, comprise but a single integrally molded part.

6. A safety IV catheter insertion device according to claim 1 wherein said handle, said foldable parts, said interconnecting hinges and said connector, in combination, comprise but a single integrally molded part.

7. A method for actuating a safety sheath for a safety I.V. catheter insertion apparatus comprising the steps of:

providing an I.V. catheter insertion needle having a first end whereat a sharpened tip is disposed and a second end whereat the catheter insertion needle is affixed to a needle hub;

providing an I.V. catheter which is disposed about the catheter insertion needle during a catheter insertion process with said sharpened tip extending distally from said catheter during percutaneous entry, said I.V. catheter comprising a proximally disposed medical fluid flow connector;

providing a housing having a surface for gripping and handling said apparatus said housing comprising

an insertion needle hub, distally disposed in said housing, wherein said second end of the catheter insertion needle is securely affixed; and

a foldable and unfoldable safety sheath, comprising a plurality of serially hinged rigid arms with at least one of said arms being disposed about said I.V. catheter needle and, while the apparatus is being used in a needle and catheter insertion process, said arms being folded to a proximally disposed state to permit facile access to the needle and catheter with a most distal arm comprising a fitting which is disposed to be in communicative contact with said medical fluid flow connector;

using the needle, inserting an I.V. catheter into a vessel of a patient;

following I.V. catheter inserting step, rotating one of said arms to thereby unfold said sheath to an unfolded state by rotating at least one of said arms about said needle, whereat the sharp tip is shrouded by the sheath and at least one of said arms is securely latched in the unfolded state whereby said unfolded shroud combines with said needle to form a substantially rigid and inconstrictable structure which safeguards the tip, and concurrently, as a consequence of unfolding said sheath, distally displacing said most distal arm and resultingly displacing the I.V. catheter from said needle as the needle and tip are shrouded by the sheath.

8. A method for actuating a safety sheath for a safety I.V. catheter insertion apparatus according to claim 7 wherein the displacing step comprises continuing to unfold said sheath until at least one click is heard.

9. A method for actuating a safety sheath for a safety I.V. catheter insertion apparatus according to claim 7 wherein the foldable and unfoldable sheath providing step comprises providing a plurality of foldable parts, all of which are displaced to an unfolded state when one part is so displaced.

10. A method for actuating a safety sheath for a safety I.V. catheter insertion apparatus according to claim 9 wherein the unfolding step comprises displacing the one part by a digit of one hand a distance which is less than one-third the length of an unfolded sheath.

11. A catheter insertion needle safety apparatus comprising:

a handle by which an operator inserts a catheter in a medical procedure;

a catheter insertion needle securely affixed to said handle and having a sharpened tip distally disposed relative to said handle;

a catheter disposed about said needle having a having a proximal end securely affixed to a medical fitting;

a sheath hingeably affixed to said handle and comprising a plurality of serially, hingeably interconnected, substantially rigid parts, said parts being disposed in a folded state while said catheter insertion needle is used as a tool for inserting said catheter and being unfoldable by manual rotation of one of the folded parts and comprising at least one latch which affixes the sheath relative to the catheter insertion needle when the sheath is unfolded about the needle; and

said sheath further comprising a fitting complementary to said medical fitting, said complementary fitting being disposed about said needle such that unfolding the sheath displaces the catheter along the needle over a linear distance greater than the length of any of the individual rigid parts.