Catheterization system

• US 8,187,231 B2
• Filed: 06/23/2010
• Issued: 05/29/2012
• Est. Priority Date: 06/26/2009
• Status: Active Grant

• Current Assignee: Mozarc Medical US LLC
• Original Assignee: Tyco Healthcare Group LP (Medtronic Plc)
• Inventors: Bellisario, Marc, Lotito, Mark, Green, Kurt E., McElroy, Geoffrey
• Primary Examiner(s): Ho, Jackie
• Assistant Examiner(s): Stohr, Leah
• Application Number:
  US12/821,640
• Publication Number:
  US 20100331780A1
• Time in Patent Office: 706 Days
• Field of Search: 604/6.16, 604/43, 604/44, 604/6.06, 604/4.01, 604/5.01, 604/27, 604/164.01, 60416405-16409, 604/164.13, 604/165.01, 604/165.02, 604/171, 604/272, 604/273, 604/523, 604/524
• US Class Current: 604/164.06
• CPC Class Codes: A61B 17/32093 for skin incisions
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 2017/32113 with extendable or retractable guard or blade
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 1/3661 for haemodialysis
• CPC Class Codes: A61M 2025/0031 characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0069 Tip not integral with tube
• CPC Class Codes: A61M 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/0668 splittable, tear apart
• 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

The present disclosure relates to catheterization systems and components thereof. In one embodiment of the present disclosure, a catheterization system is disclosed that includes a catheter including a body with proximal and distal ends and defining first and second lumens extending therethrough, and a stylet. The stylet includes first and second stylet portions each having proximal and distal end regions, wherein the distal end regions of the first and second stylet portions together define a tapered penetrating portion. The first and second stylet portions are configured and dimensioned to be slidably positioned within the first and second lumens of the catheter, respectively. The first and second stylet portions extend from the proximal end of the catheter and beyond the distal end of the catheter, and are independently movable in relation to each other to facilitate selective removal of the first stylet portion and/or the second stylet portion from the catheter.

Claims

1. A stylet, comprising:

a first stylet portion having proximal and distal end regions, the first stylet portion being configured and dimensioned to be slidably positioned within a first lumen of a catheter; and

a second stylet portion having proximal and distal end regions, the second stylet portion being configured and dimensioned to be slidably positioned within a second lumen of the catheter which is separated from the first lumen by a septum wall, wherein the first and second stylet portions extend from a proximal end of the catheter to beyond a distal end of the catheter, the first and second stylet portions including corresponding mating structure fixedly secured thereto for releasably joining the distal end regions of the first and second stylet portions, the first and second stylet portions being independently movable in relation to each other to facilitate selective removal of the first stylet portion and/or the second stylet portion from the catheter, the distal end regions of the first and second stylet portions together defining a tapered penetrating portion.

2. The stylet of claim 1, wherein the distal end regions of the first and second stylet portions are substantially coterminous.

3. The stylet of claim 1, wherein the stylet is formed from a material that is more rigid than the catheter such that positioning of the stylet within the catheter increases rigidity of the catheter.

4. The stylet of claim 1, wherein the corresponding mating structure is positioned at the distal end regions of the first and second stylet portions.

5. The stylet of claim 1, wherein the corresponding mating structure included on the first and second stylet portions is configured to facilitate relative slidable movement between the first and second stylet portions.

6. The stylet of claim 1, wherein the corresponding mating structure includes a frangible weld common to the distal end regions of the first and second stylet portions, the weld being configured and dimensioned for engagement with the septum wall upon withdrawal of the first and second stylet portions from the catheter, whereby the distal end region of the first stylet portion is separated from the distal end region of the second stylet portion.

7. The stylet of claim 1, wherein the mating structure included on the first stylet portion includes a rib and the mating structure included on the second stylet portion includes a channel configured and dimensioned to slidably receive the rib.

8. The stylet of claim 7, wherein the rib and the channel are configured and dimensioned to allow relative transverse movement between the first and second stylet portions.

9. The stylet of claim 7, wherein the rib and the channel are configured and dimensioned to prevent relative transverse movement between the first and second stylet portions.

10. The stylet of claim 9, wherein the rib and the channel each include a dovetail configuration.

11. The stylet of claim 1, wherein the first stylet portion defines a channel configured and dimensioned to receive a guidewire.

12. The stylet of claim 1, wherein the first stylet portion corresponds in configuration to the first lumen of the catheter and the second stylet portion corresponds in configuration to the second lumen of the catheter.

19. The stylet of claim 1, wherein the penetrating portion includes an external wall surface defining a transverse cross-sectional dimension decreasing in a distal direction.

13. A catheterization system, comprising:

a catheter including a body having proximal and distal ends and defining first and second lumens extending therethrough, wherein the first and second lumens are separated by a septum wall; and

a stylet including a first stylet portion having proximal and distal end regions, and a second stylet portion having proximal and distal end regions, the first stylet portion being configured and dimensioned to be slidably positioned within the first lumen of the catheter and the second stylet portion being configured and dimensioned to be slidably positioned within the second lumen of the catheter, wherein the first and second stylet portions extend from the proximal end of the catheter to beyond the distal end of the catheter, the first and second stylet portions including corresponding mating structure fixedly secured thereto for releasably joining the distal end regions of the first and second stylet portions, the first and second stylet portions being independently movable in relation to each other to facilitate selective removal of the first stylet portion and/or the second stylet portion from the catheter, the distal end regions of the first and second stylet portions together defining a tapered penetrating portion.

14. The catheterization system of claim 13 further comprising a sheath having proximal and distal ends and defining a sheath lumen configured and dimensioned to receive the catheter, wherein the stylet is dimensioned to extend beyond the distal end of the sheath when the stylet is positioned within the catheter such that the sheath forces the distal end regions of the first and second stylet portions into engagement with each other to define the penetrating portion of the stylet.

15. The catheterization system of claim 14, wherein the sheath further includes a perforated section to facilitate tearing of the sheath.

20. The catheterization system of claim 13, wherein the penetrating portion includes an external wall surface defining a transverse cross-sectional dimension decreasing in a distal direction.

16. A method of positioning a catheter within a tissue site comprising the steps of:

positioning a first stylet portion of a stylet within a first lumen of the catheter and positioning a second stylet portion of the stylet within a second lumen of the catheter, the first and second stylet portions extending from a proximal end of the catheter and beyond a distal end of the catheter, wherein at least the first stylet portion defines a channel therethrough configured to receive a guidewire;

attaching corresponding mating structure provided at distal end regions of the first and second stylet portions to thereby connect a distal end region of the first stylet portion to a distal end region of the second stylet portion such that the first and second stylet portions are independently movable;

advancing the stylet and the catheter distally over a guidewire positioned within the tissue site until a distal end of the catheter is positioned within the tissue site; and

withdrawing the stylet from the catheter by detaching the corresponding mating structure at the distal end regions of the first and second stylet portions.

17. A catheterization system, comprising:

a catheter including a body having proximal and distal ends and defining first and second lumens extending therethrough, wherein the first and second lumens are separated by a septum wall; and

a stylet including a first stylet portion with proximal and distal end regions configured and dimensioned for insertion into the first lumen of the catheter, and a second stylet portion with proximal and distal end regions configured and dimensioned for insertion into the second lumen of the catheter, wherein the proximal end regions of the first and second stylet portions are separated from one another, and the distal end regions of the first and second stylet portions are connected by conjoining structure to thereby inhibit relative longitudinal movement between the distal end regions of the first and second stylet portions until a predetermined force is applied to the stylet, wherein the conjoining structure is a weld.

18. A catheterization system, comprising:

a catheter including a body having proximal and distal ends and defining first and second lumens extending therethrough, wherein the first and second lumens are separated by a septum wall; and

a stylet including a first stylet portion with proximal and distal end regions configured and dimensioned for insertion into the first lumen of the catheter, and a second stylet portion with proximal and distal end regions configured and dimensioned for insertion into the second lumen of the catheter, wherein the proximal end regions of the first and second stylet portions are separated from one another, and the distal end regions of the first and second stylet portions are connected by conjoining structure to thereby inhibit relative longitudinal movement between the distal end regions of the first and second stylet portions until a predetermined force is applied to the stylet, wherein the conjoining structure is configured and dimensioned such that the predetermined force is applied to the conjoining structure by the septum wall of the catheter upon withdrawal of at least one of the first and second stylet portions from the catheter, whereby the first stylet portion is separated from the second stylet portion to permit relative longitudinal movement therebetween.

21. A catheterization system, comprising:

a catheter including a body having proximal and distal ends and defining first and second lumens extending therethrough, wherein the first and second lumens are separated by a septum wall; and

a stylet including a first stylet portion with proximal and distal end regions configured and dimensioned for insertion into the first lumen of the catheter, and a second stylet portion with proximal and distal end regions configured and dimensioned for insertion into the second lumen of the catheter, wherein the proximal end regions of the first and second stylet portions are separated from one another, and the distal end regions of the first and second stylet portions are connected by conjoining structure to thereby inhibit relative longitudinal movement between the distal end regions of the first and second stylet portions until a predetermined force is applied to the stylet, the conjoining structure being configured and dimensioned such that the predetermined force acts on the conjoining structure to separate the distal end regions of the first and second stylet portions without damaging the first and second stylet portions thereby enabling relative longitudinal movement between the distal end regions of the first and second stylet portions.