Method of installing vascular access device

• US 6,074,377 A
• Filed: 04/15/1999
• Issued: 06/13/2000
• Est. Priority Date: 10/10/1996
• Status: Expired due to Term

• Current Assignee: Dominic Joseph Ii Sanfilippo
• Original Assignee: Dominic Joseph Ii Sanfilippo
• Inventors: Sanfilippo, Dominic Joseph II
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): RODRIGUEZ, CRIS LOIREN
• Application Number:
  US09/292,472
• Time in Patent Office: 425 Days
• Field of Search: 604/500, 604/506, 604/507, 604/511, 604/502, 604/93, 604/19, 604/891.1, 604/104, 604/164, 604/175, 604/264, 604/263, 604/890.1, 604/510, 606/108, 623/11
• US Class Current: 604/500
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2039/0211 with multiple chambers in a single site
• CPC Class Codes: A61M 2039/0232 having means for facilitating the insertion into the body
• CPC Class Codes: A61M 2209/04 Tools for specific apparatus
• CPC Class Codes: A61M 25/0668 splittable, tear apart
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276

Abstract

A vascular access device is provided which can be used for chronic venous or organ access. When implanted, the device facilitates repeated intermittent infusions of medical treatment while reducing the risk of infection at the implant site. The vascular access device comprises an elongated body and a delivery tube coupled to the elongated body for delivering the medical treatment to a preselected site in a patient'"'"'s body, which permits subcutaneous implanting of the device with a minimally invasive procedure. A sheath and a dilator are adapted to form an access tunnel in the patient'"'"'s body commensurate in configuration with the elongated body of the device. A guide wire is provided to guide the sheath and dilator from a first opening to a second opening in the patient'"'"'s body. The introduction of the sheath eases the placement of the device and reduces access site trauma to the vein, organ, or any other location in the body to which the medicine or therapy is to be applied. Once implanted, the delivery tube of the device cooperates with another sheath, which is inserted and guided along another guide wire that extends to the preselected site in the patient'"'"'s body. Furthermore, a retrieval tool is provided which cooperates with the elongated body of the device for removal of the device from the body.

Claims

1. A method of implanting a vascular access device in the body of a patient comprising the steps of:

forming a body access opening;

providing a body access guide wire;

inserting the body access guide wire into the body access opening and directing the body access guide wire to a preselected site in the patient;

forming a tunnel between said body access opening and a tunnel opening remote from said body access opening;

providing a tunnel guide wire;

inserting the tunnel guide wire into one opening of the body access opening and the tunnel opening and directing the tunnel guide wire out of the body through the other opening of the body access opening and the tunnel opening;

providing a tunnel sheath with a forward distal end and an enlarged diameter region toward a trailing end of the tunnel sheath;

inserting the tunnel sheath into the tunnel opening;

guiding the tunnel sheath along the tunnel guide wire until the distal end of the tunnel sheath exits from the body access opening and the enlarged diameter region is inserted through the tunnel opening;

removing the tunnel guide wire from the patient;

providing an elongated vascular access device having a delivery tube operatively coupled to a first end of the elongated vascular access device;

inserting the delivery tube of the vascular access device into the open enlarged diameter region of the tunnel sheath;

pushing the elongated vascular access device into the tunnel sheath so that the delivery tube exits from the body access opening and the elongated vascular access device is received through the tunnel opening;

removing the tunnel sheath;

providing a body access sheath;

guiding the body access sheath down the body access guide wire to the preselected site in the patient;

removing the body access guide wire;

directing the delivery tube into the body access sheath to guide the delivery tube to the preselected site in the patient; and

removing the body access sheath.

2. A method of implanting a vascular access device according to claim 1, further including the step of submerging any section of the delivery tube protruding from the body access opening back into the body access opening beneath the skin of the patient.

3. A method of implanting a vascular access device according to claim 2, further including the step of stitching the body access opening closed.

4. A method of implanting a vascular access device according to claim 1, further including the step of stitching the tunnel opening closed.

5. A method of implanting a vascular access device according to claim 1, wherein the step of forming a body access opening includes the step of inserting an introducer needle into the patient.

6. A method of implanting a vascular access device according to claim 5, wherein the step of inserting the body access guide wire includes the step of inserting the body access guide wire into the body access opening through the introducer needle.

7. A method of implanting a vascular access device according to claim 5, wherein the step of inserting the tunnel guide wire includes the steps of inserting an introducer needle into the tunnel opening and inserting the tunnel guide wire into the introducer needle.

8. A method of implanting a vascular access device according to claim 1, wherein the step of guiding a body access sheath along the body access guide wire includes the step of pushing the body access sheath along the body access guide wire with a dilator.

9. A method of implanting a vascular access device according to claim 1, wherein said tunnel sheath inserting step and guiding step are performed before said body access sheath guiding step.

10. A method of implanting a vascular access device according to claim 1, wherein said tunnel guide wire inserting step comprises inserting the tunnel guide wire into the tunnel opening and out of the body access opening.

11. A method of implanting a vascular access device according to claim 1, further including making an incision at said tunnel opening prior to said tunnel sheath inserting step.

12. A method of implanting a vascular access device according to claim 1, further including purging said elongated vascular access device and delivery tube with a solution after said step of pushing the elongated vascular access device through the tunnel opening.

13. A method of implanting a vascular access device in the body of a patient comprising the steps of:

inserting an introducer needle into a first location of the body, the needle having a lumen extending therethrough;

inserting a first guide wire into the needle through said lumen and extending the first guide wire to the desired location in the body;

removing said needle;

inserting an introducer needle into the body at a second location to extend through and protrude from the body at the first location;

inserting a second guide wire into the needle through the lumen of the second needle and extending the second guide wire to exit from the body at the first location;

removing the introducer needle;

guiding a tunnel sheath along the second guide wire using a dilator, the tunnel sheath having a distal end and an open proximate end;

pushing the tunnel sheath with a dilator so that the distal end of the tunnel sheath exits from the body at the first location;

removing the dilator and the second guide wire from the body;

inserting a vascular access device into the open proximate end of the tunnel sheath, the vascular access device having a delivery tube extending therefrom;

directing the delivery tube to exit through the first location;

removing the tunnel sheath;

guiding a second sheath along the first guide wire with a dilator, the second sheath having an open proximate end and a distal end;

removing the dilator and the first guide wire from said body;

directing the delivery tube down the second sheath through the open proximate end of the second sheath; and

removing the second sheath.

14. A method of implanting a vascular access device according to claim 13, wherein the step of guiding the tunnel sheath along the second guide wire includes the step of making an incision in the body at the second location.

15. A method of implanting a vascular access device according to claim 14, further including the step of closing the incision at the second location by stitching.

16. A method of implanting a vascular access device in the body of a patient comprising the steps of:

providing a first guide wire;

inserting the first guide wire into the body of the patient, thereby forming a first opening;

directing the first guide wire to a preselected site in the patient;

providing a second guide wire;

inserting the second guide wire into the body of the patient;

projecting a distal end of the second guide wire out of the body through the first opening and a proximate end of the second guide wire through a second opening remote from said first opening;

providing a first sheath and a dilator;

guiding the first sheath down the first guide wire with the dilator;

removing the first guide wire and the dilator;

providing a second sheath with a forward distal end and an enlarged proximate end;

inserting the distal end of the second sheath with the dilator into the second opening;

guiding the second sheath with the dilator along the second guide wire until the distal end of the second sheath exits from the first opening and the enlarged proximate end is inserted into the second opening;

removing the dilator and the second guide wire from the patient;

providing a vascular access device having a first end and a delivery tube operatively coupled to the first end of the vascular access device;

inserting the delivery tube of the vascular access device into the open enlarged diameter region of the second sheath;

pushing the vascular access device into the second sheath so that the delivery tube exits from the first opening and the vascular access device is received through the second opening;

directing the delivery tube into the first sheath to guide the delivery tube to the preselected site in the patient; and

removing the first sheath and the second sheath.

17. A method of inserting a vascular access device according to claim 16, wherein the step of inserting a first guide wire includes the steps of inserting an introducer needle having a guide lumen into the patient and pushing the guide wire down the guide lumen of the introducer needle.

18. A method of inserting a vascular access device according to claim 16, wherein the step of inserting the second guide wire includes the step of inserting second guide wire into the second opening.

19. A method of inserting a vascular access device according to claim 18, wherein the step inserting second guide wire into the second opening includes the steps of inserting an introducer needle having a guide lumen into the second opening and pushing the second guide wire down the guide lumen of the introducer needle to project from the first opening.

20. A method of inserting a vascular access device according to claim 16, further including the step of submerging any section of the delivery tube protruding from the first opening back into the first opening beneath the skin of the patient.

21. A method of inserting a vascular access device according to claim 16, filter including the step of stitching closed at least one of the first and second openings.

22. A method of inserting a vascular access device according to claim 16, further comprising sequencing the steps of inserting the second sheath into the second opening and removing the second guide wire before the steps of inserting the first sheath into the first opening and removing the first guide wire.

23. A method of inserting a vascular access device according to claim 16, wherein the step of guiding a first sheath along the first guide wire includes the step of pushing the first sheath along the first guide wire with a dilator.

24. A method of removing a vascular access device comprising:

providing a vascular access device implanted in the body of a patient, the vascular access device having a retrieval surface;

providing a retrieval tool;

inserting a portion of the retrieval tool into the body of the patient at a location remote from the vascular access device;

guiding the portion of the retrieval tool towards the vascular access device;

engaging the retrieval surface of the retrieval device with the retrieval tool; and

withdrawing the vascular access device from the body of the patient with the retrieval tool.

25. A method of removing a vascular access device according to claim 24, further comprising making a removal incision in the body of the patient remote from the vascular access device;

and

inserting the retrieval tool through the removal incision.

26. A method of removing a vascular access device according to claim 25, further comprising closing the removal incision.

27. A method of removing a vascular access device according to claim 26, wherein closing includes stitching the removal incision closed.