Tunneler-needle combination for tunneled catheter placement

• US 6,994,693 B2
• Filed: 07/17/2002
• Issued: 02/07/2006
• Est. Priority Date: 07/17/2001
• Status: Expired due to Fees

• Current Assignee: Yale University
• Original Assignee: Yale University
• Inventors: Tal, Michael
• Primary Examiner(s): Lucchesi, Nicholas D.
• Assistant Examiner(s): WILLIAMS, CATHERINE SERKE
• Application Number:
  US10/197,746
• Publication Number:
  US 20030088212A1
• Time in Patent Office: 1,301 Days
• Field of Search: 604/158, 604/164.01, 604/164.05, 604/164.06, 604/506, 604/49, 604/6.16, 604/510, 604/53, 604/170, 604/264, 604272-274, 604/93.01, 604/160, 604/161, 604/164.07, 604/164.13, 604/166.01, 604/170.01, 606/108, 606/167, 606/190, 606/185
• US Class Current: 604/183
• 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 17/3421 Cannulas
• CPC Class Codes: A61M 25/0194 Tunnelling catheters

Abstract

An access system for providing subcutaneous access to a vessel, organ, or body cavity comprises a needle and a rigid or semi-rigid tunneler arranged coaxially around the needle, such that the needle moves slidably within the tunneler. Optionally a sheath may be positioned coaxial to the tunneler. The tunneler-needle system is inserted through an incision in a patient'"'"'s skin to initiate a procedure whereby a catheter is inserted into the vessel, organ, or body cavity.

Claims

1. An access system for providing access to a vessel, organ or body cavity through a subcutaneous tunnel, which comprises:

a) a needle having a distal end and a proximal end, and

b) a rigid or semi-rigid tunneler arranged coaxially around the needle and having a distal end and a proximal end, the distal end having a blunt shape for dissection of a subcutaneous tunnel, the distal end of the tunneler further having an opening to facilitate passing of the needle and the needle exits the opening at an oblique angle with respect to a plane in which the opening lies, and

c) a guidewire shaped and dimensioned for passage through the needle,

wherein the needle moves slidably within the tunneler, the needle proximal end has a gripping member for advancing the needle, which needle proximal end has a port for receiving the guidewire, and the tunneler proximal end has a gripping member.

2. The system of claim 1, wherein the tunneler is a hollow tube.

3. The system of claim 1, wherein the tunneler is straight, angled or slightly curved.

4. The system of claim 1, wherein the tunneler is comprised of a physiologically acceptable metal or polymer.

5. The system of claim 4, wherein the tunneler comprises stainless steel.

6. An access system for providing access to a vessel organ, or body cavity through a subcutaneous tunnel, which comprises:

a) a needle having a distal end and a proximal end,

b) a rigid or semi-rigid tunneler arranged coaxially around the needle and having a distal end and a proximal end, wherein the distal end of the tunneler is blunt to facilitate blunt dissection of a subcutaneous tunnel, and

c) a sheath arranged coaxially around the tunneler,

wherein the needle moves slidably within the tunneler and the needle proximal end has a port and a gripping member for advancing the needle, and wherein the port receives a guidewire.

7. The system of claim 6, wherein the tunneler is straight, angled, or slightly curved.

8. The system of claim 6, wherein the distal end of the tunneler has an opening to facilitate passage of the needle.

9. The system of claim 6, wherein the tunneler is comprised of a physiologically acceptable metal or polymer.

10. The system of claim 9, wherein the tunneler comprises stainless steel.

11. The system of claim 6, wherein the proximal end of the tunneler has a gripping member.

12. The system of claim 6, wherein the sheath is a peelaway sheath, catheter or tubular structure.

13. The system of claim 6, wherein the distal end of the tunneler has an opening to facilitate passing of the needle and the needle exits the opening at an oblique angle with respect to a plane in which the opening lies.

14. An access system for providing access to a vessel organ, or body cavity through a subcutaneous tunnel, which comprises:

a) a needle having a distal end and a proximal end,

b) a rigid or semi-rigid tunneler arranged coaxially around the needle and having a distal end and a proximal end, wherein the distal end of the tunneler is blunt to facilitate blunt dissection of a subcutaneous tunnel, and

c) a sheath arranged coaxially around the tunneler,

wherein the needle moves slidably within the tunneler and the needle proximal end has a port and a gripping member for advancing the needle, and wherein the sheath is a peelaway sheath.

15. A method for providing subcutaneous access to a vessel, organ, or body cavity, which comprises the steps of:

a) creating an incision in the skin of a patient a substantial distance from a vessel, organ, or body cavity;

b) inserting an access system which comprises;

i. a needle having a distal end and a proximal end, and

ii. a rigid or semi-rigid tunneler arranged coaxially around the needle and having

a distal end and a proximal end, the distal end having a blunt shape for dissection of a subcutaneous tunnel, wherein the needle moves slidably within the tunneler, the needle proximal end has a gripping member for advancing said needle, which needle proximal end has a port for receiving a guidewire, and the tunneler proximal end his a gripping member, the gripping member is for advancing through the incision and advancing the access system under the skin to create a subcutaneous tunnel to cause the distal end of the tunneler to be adjacent to the vessel, organ, or body cavity;

c) advancing the distal end of the needle through the tunneler into the vessel, organ or body cavity;

d) advancing a guidewire through the needle into the vessel, organ, or body cavity;

e) withdrawing the tunneler and needle;

f) advancing a flexible catheter through the subcutaneous tunnel over the guidewire into the vessel, organ, or body cavity; and

g) withdrawing the guidewire.

16. A method for providing subcutaneous access to a vessel, organ, or body cavity, which comprises the steps of:

a) creating an incision in the skin of a patient a substantial distance from a vessel, organ, or body cavity;

b) inserting an access system which comprises;

i. a needle having a distal end and a proximal end,

ii. a rigid or semi-rigid tunneler arranged coaxially around the needle and having

a distal end and a proximal end,

iii. a sheath arranged coaxially around the tunneler, wherein the needle moves slidably within the tunneler, the needle proximal end has a port and a gripping member for advancing said needle,

through the incision and advancing the access system under the skin to create a subcutaneous tunnel to cause the distal end of the tunneler to be adjacent to the vessel, organ, or body cavity;

c) advancing the distal end of the needle through the tunneler into the vessel, organ or body cavity;

d) advancing a guidewire through the needle into the vessel, organ, or body cavity;

e) withdrawing the tunneler and needle;

f) advancing a flexible catheter through the subcutaneous tunnel over the guidewire and through the sheath into the vessel, organ, or body cavity;

g) withdrawing the guidewire; and

h) peeling the sheath away.

17. An access system for providing access to a vessel, organ, or body cavity through a subcutaneous tunnel, which comprises:

a) a needle having a distal end and a proximal end,

b) a rigid or semi-rigid tunneler arranged coaxially around the needle and having a distal end and a proximal end, wherein the distal end of the tunneler is blunt to facilitate blunt dissection of a subcutaneous tunnel, and

c) a sheath arranged coaxially around the tunneler,

wherein the needle moves slidably within the tunneler and the needle proximal end has a port and a gripping member for advancing the needle, and, wherein the tunneler is curved.

18. An access system for providing subcutaneous access to a vessel, organ, or body cavity, which comprises:

a) a substantially rigid tunneler having a distal end and a proximal end and having a lumen therethrough, the tunneler being curved and the distal end having a blunt shape for dissection of a subcutaneous tunnel,

b) a needle positioned within the lumen, the needle having a distal end and a proximal end; and

c) a sheath arranged coaxially around the tunneler,

wherein the needle moves slidably within the tunneler, the needle proximal end has a gripping member for advancing the needle, which needle proximal end has a port for receiving a guidewire, and the tunneler proximal end has a gripping member.

19. A method for providing subcutaneous access to a vessel, organ, or body cavity, which comprises the steps of:

a) creating an incision in the skin of a patient a substantial distance from a vessel, organ, or body cavity;

b) inserting an access system which comprises;

a rigid or semi-rigid tunneler having a distal end and a proximal end and having a lumen therethrough,

ii. a needle positioned within said lumen, said needle having a distal end and a proximal end, and

iii. a sheath arranged coaxially around the tunneler,

wherein the needle moves slidably within the tunneler, the needle proximal end has a gripping member for advancing said needle, which needle proximal end has a port for receiving a guidewire, and the tunneler proximal end has a gripping member, through the incision and advancing the access system under the skin to create a subcutaneous tunnel to cause the distal end of the tunneler to be adjacent to the vessel, organ, or body cavity;

c) advancing the distal end of the needle through the tunneler into the vessel, organ or body cavity;

d) advancing a guidewire through the needle into the vessel, organ, or body cavity;

e) withdrawing the tunneler and needle;

f) advancing a flexible catheter through the subcutaneous tunnel over the guidewire and through the vessel, organ, or body cavity;

g) withdrawing the guidewire; and

h) peeling the sheath away.

20. An access system for providing access to a vessel, organ or body cavity through a subcutaneous tunnel, which comprises:

a) a needle having a distal end and a proximal end, and

b) a substantially rigid tunneler arranged coaxially around the needle and having a distal end and a proximal end, the tunneler being curved and the distal end having a blunt shape for dissection of a subcutaneous tunnel, and

c) a guidewire shaped and dimensioned for passage through the needle,

wherein the needle moves slidably within the tunneler, the needle proximal end has a gripping member for advancing the needle, which needle proximal end has a port for receiving a guidewire, and the tunneler proximal end has a gripping member.

21. An access system for providing access to a vessel, organ or body cavity through a subcutaneous tunnel, which comprises:

a) a needle having a distal end and a proximal end, and

b) a rigid or semi-rigid tunneler arranged coaxially around the needle and having a distal end and a proximal end, the distal end of the tunneler having an opening to facilitate passing of the needle and the needle exits the opening at an oblique angle with respect to a plane in which the opening lies, and

c) a guidewire shaped and dimensioned for passage through the needle,

wherein the needle moves slidably within the tunneler, the needle proximal end has a gripping member for advancing the needle, which needle proximal end has a port for receiving a guidewire, and the tunneler proximal end has a gripping member.

22. An access system for providing access to a vessel, organ, or body cavity through a subcutaneous tunnel, which comprises:

a) a needle having a distal end and a proximal end,

b) a rigid or semi-rigid tunneler arranged coaxially around the needle and having a distal end and a proximal end, the distal end of the tunneler includes an opening to facilitate passage of the needle and the needle exits the opening at an oblique angle with respect to a plane in which the opening lies, and

c) a sheath arranged coaxially around the tunneler,

wherein the needle moves slidably within the tunneler and the needle proximal end has a port and a gripping member for advancing the needle.