Thermally softening stylet

• US 5,762,630 A
• Filed: 12/23/1996
• Issued: 06/09/1998
• Est. Priority Date: 12/23/1996
• Status: Expired due to Term

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Johnson & Johnson Medical Incorporated (Johnson & Johnson)
• Inventors: Kubacki, Glenn, Bley, Robert
• Primary Examiner(s): Rimell, Sam
• Assistant Examiner(s): Racunas, Robert V.
• Application Number:
  US08/772,401
• Time in Patent Office: 533 Days
• Field of Search: 604/110, 604/158, 604/164, 604/264-5, 604/280, 604/272, 128/768, 128/772
• US Class Current: 604/164.01
• CPC Class Codes: A61L 29/14 Materials characterised by their function or physical properties , e.g. lubricating compositions
• CPC Class Codes: A61M 2025/0064 which become stiffer or softer when heated
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility

Abstract

The present invention describes a stylet that softens dramatically upon insertion into a living body with a temperature of about 37° C. The stylet has a distal end and a proximal end. Upon insertion of the distal end into a living body, the distal end softens from a stiffness of about 78 Durometer Shore D units to 25 Durometer Shore D units in a preferred embodiment. Moreover, the proximal end of the stylet, which is not inserted into the living body, retains its stiffness to aid a physician or a nurse in inserting and placing the catheter and stylet assembly.

Claims

1. A catheter stylet having a proximal end and a distal end, comprising:

an elongated member having a substantially uniform cross-section and a cross-sectional area, wherein upon insertion of the distal end into a living body, the distal end of the stylet softens by at least a factor of three in response to a body temperature of the living body and substantially maintains the cross-sectional area.

2. The stylet of claim 1, wherein upon insertion of the distal end into the living body, the distal end of the stylet softens by at least 50 Durometer Shore D units.

3. The stylet of claim 1, wherein the distal end softens in a few seconds after being inserted into the living body.

4. The stylet of claim 1, wherein the elongated member has a glass transition temperature of approximately 35°

C.

5. The stylet of claim 1, wherein a component has been added to the elongated member to modify the stiffness throughout the elongated member.

6. The stylet of claim 1, wherein a component has been added to the elongated member to modify the stiffness at least at one point in the elongated member.

7. A vascular access device, comprising:

a catheter having a lumen; and

a stylet having a cross-sectional area and a physical property such that the stylet is capable of softening by at least a factor of three and substantially maintaining the cross-sectional area when exposed to a predetermined temperature, wherein the stylet is disposed within the lumen of the catheter.

8. The vascular access device of claim 7, wherein the catheter also softens when exposed to the predetermined temperature by at least 50 Durometer Shore D units.

9. The vascular access device of claim 7, wherein the predetermined temperature is about 35°

C.

10. The vascular access device of claim 7, wherein the stylet comprises a distal end and a proximal end and wherein upon insertion of the distal end into a living subject, the distal end softens.

11. The vascular access device of claim 10, wherein the distal end of the stylet softens in a few seconds when inserted into the living subject.

12. The vascular access device of claim 10, wherein the distal end of the stylet softens so that its stiffness decreases at least 50 Durometer Shore D units.

13. The vascular access device of claim 8, wherein the stylet has a distal end and a proximal end, and wherein upon insertion of the distal end into a living body and exposure to the predetermined temperature of approximately 35°

C., the distal end of the stylet softens.

14. The vascular access device of claim 7, wherein a radiopacifier has been added to the stylet.

15. The vascular access device of claim 14, wherein the radiopacifier is selected from a group consisting of barium sulfate, bismuth subcarbonate, bismuth trioxide, tungsten and tantalum.

16. A stent stylet comprising:

an elongated member having a proximal end and a distal end and a substantially uniform cross-section, the distal end of the stylet having a physical property such that upon insertion into a living body, the distal end of the stylet softens by at least a factor of three in response to a body temperature of the living body.

17. The stent stylet of claim 16, wherein upon insertion of the distal end into the living body, the distal end of the stylet softens by at least 50 Durometer Shore D units.