Vascular access device and method of installing same

• US 5,919,160 A
• Filed: 10/10/1996
• Issued: 07/06/1999
• 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:
  US08/728,825
• Time in Patent Office: 999 Days
• Field of Search: 604/19, 604/27, 604/48, 604/93, 604/51, 604/52, 604/175, 604/267, 604/165, 604/891.1, 604/124, 128/DIG. 12
• US Class Current: 604/93.01
• 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 vascular access device for inserting into the body of a patient, said vascular access device adapted to be used for periodic delivery of medical treatment to a preselected location in the body of the patient, such as delivery of a fluid to a treatment site, said vascular access device comprising:

an elongated implant body having a top wall, a bottom wall, opposed side walls, a first end, a closed second end, and at least one access chamber formed therein, said first end defining a first opening in communication with said access chamber, and said top wall defining a second opening in communication with said access chamber, said elongated implant body having a width and a length greater than said implant body width, said top wall, said side walls, and said bottom walls converging to form said first and second ends of said implant body, at least said first end being generally pointed an amount sufficient to ease insertion of said elongated implant body through an incision formed in the skin of the patient and generally pointed an amount sufficient to separate tissue during the insertion, and said second end including a retrieval surface for engaging a cooperating structure on a retrieval device whereby engagement between the retrieval device and the retrieval surface permits remote removal of said vascular access device from the body of the patient;

a tubular member having at least one lumen extending therethrough, said tubular member connected to said first end of said elongated implant body, said lumen in fluid communication with said access chamber through said first opening for delivery of material from said access chamber along said tubular member to the preselected location in the body; and

a membrane sealing said elongated implant body second opening, said membrane adapted to receive a percutaneous needle puncture without leakage from the puncture, whereby said elongated implant body is adapted to be implanted through an incision which will accommodate said width of said elongated implant body but is less than said length thereof.

2. A vascular access device according to claim 1, wherein said first end of said elongated implant body tapers to said tubular member to provide a smooth transition between said tubular member and said elongated implant body to ease insertion of the elongated implant body into the passage.

3. A vascular access device according to claim 1, wherein said second opening is an elongated opening extending longitudinally along said elongated implant body.

4. A vascular access device according to claim 1, wherein said elongated implant body has a lower surface and an upper surface, said lower surface having a generally planar region so as to reduce rotation of said elongated implant body when implanted, and said second opening is disposed in said upper surface.

5. A vascular access device according to claim 4, further comprising a tactile identification structure disposed on said elongated implant body in preselected registry with said second opening, whereby when implanted said tactile identification structure is used to tactilely locate said second opening.

6. A vascular access device according to claim 5, wherein said elongated implant body has longitudinal sides between said upper surface and said lower surface, said elongated implant body including one of recesses and protrusions disposed on said longitudinal sides in lateral alignment with said second opening, and said tactile identification structure comprises said one of recesses and protrusions.

7. A vascular access device according to claim 1, wherein said access chamber is a first access chamber, said tubular member with said lumen is a first tubular member with a first lumen, and membrane is a first membrane, and further comprising:

a second access chamber formed in said elongated implant body, said elongated implant body defining a third opening and a fourth opening, each of said third and fourth openings in communication with said second access chamber;

a second tubular member with a second lumen extending therethrough, said second tubular member connected to said elongated implant body with said second lumen in fluid communication with said second access chamber through said third openings;

a second membrane sealing said fourth opening, said second membrane adapted to receive a percutaneous needle puncture without leakage from the puncture.

8. A vascular access device according to claim 7, wherein said elongated implant body includes a tactile differentiation structure disposed thereon in registry with said second opening and said fourth opening, whereby when said elongated implant body is implanted, said tactile differentiation structure is used to tactilely locate and differentiate said second opening and said fourth opening.

9. A vascular access device according to claim 8, wherein said tactile differentiation structure comprises a raised surface disposed between said second opening and said fourth opening.

10. A vascular access device according to claim 1, wherein said retrieval surface is provided by one of a recess and a transverse aperture for engaging the cooperating structure on the retrieval device, with the retrieval device being inserted into the body of the patient through an incision remote from said access device.

11. A vascular access device according to claim 10, wherein said second end of said elongated body includes one of a transverse opening and a recess defining said structure for engaging the cooperating structure of the retrieval device.

12. A vascular access device for inserting into the body of a patient said vascular access device adapted to be used for periodic delivery of medical treatment to a preselected location in the body of the patient, such as delivery of a fluid to a treatment site, said vascular access device comprising:

an elongated implant body having a wall, a first end, a second end, and at least one access chamber formed therein, said first end defining a first opening in communication with said access chamber, and said wall defining a second opening in communication with said access chamber, said elongated implant body having a width and a length greater than said implant body width;

a tubular member having at least one lumen extending therethrough, said tubular member connected to said first end of said elongated implant body, said lumen in fluid communication with said access chamber through said first opening for delivery of material from said access chamber along said tubular member to the preselected location in the body; and

a membrane sealing said elongated implant body second opening, said membrane adapted to receive a percutaneous needle puncture without leakage from the puncture, whereby said elongated implant body is adapted to be implanted through an incision which will accommodate said width of said elongated implant body but is less than said length thereof, and said second end being generally pointed in an amount sufficient to ease removal of said elongated body from the body of the patient and including a receiving structure adapted for engaging a cooperating structure of a retrieval device.

13. A vascular access device according to claim 12, wherein said receiving structure comprises an indent.

14. A vascular access device according to claim 13, wherein said indent is defined by a withdrawal aperture extending transversely of said second end of said elongated implant body.

15. A vascular access device according to claim 14, wherein said second end includes a groove adjacent said withdrawal aperture for guiding the cooperating structure of the retrieval device into to said aperture.

16. A vascular access device according to claim 15, wherein said second end includes a distal end, said groove extending from said distal end longitudinally of said elongated body to said withdrawal aperture.

17. A vascular access device according to claim 12, wherein said first end is generally pointed in an amount sufficient to ease insertion of said elongated implant body into a passage formed in the body of the patient.

18. A vascular access device according to claim 12, further comprising a tactile identification structure disposed on said elongated implant body in preselected registry with said second opening, whereby when implanted said tactile identification structure is used to tactilely locate said second opening.

19. A vascular access device according to claim 18, wherein said elongated implant body has an upper surface and a lower surface and longitudinal sides between said upper surface and said lower surface, said elongated implant body including one of recesses and protrusions disposed on said longitudinal sides in lateral alignment with said second opening, and said tactile identification structure comprises said one of recesses and protrusions.

20. A vascular access device according to claim 12, wherein said access chamber is a first access chamber, said tubular member with said lumen is a first tubular member with a first lumen, and membrane is a first membrane, and further comprising:

a second access chamber formed in said elongated implant body, said elongated implant body defining a third opening and a fourth opening, each of said third and fourth openings in communication with said second access chamber;

a second tubular member with a second lumen extending therethrough, said second tubular member connected to said elongated implant body with said second lumen in fluid communication with said second access chamber through said third opening;

a second membrane sealing said fourth opening, said second membrane adapted to receive a percutaneous needle puncture without leakage from the puncture.

21. A vascular access device for inserting into a passage in the body of a patient, said vascular access device for delivering medical treatment to a preselected location in the body of the patient, said vascular access device comprising:

an elongated body having a closed end, an open end, a wall extending therebetween, and at least a first access chamber formed therein for receiving the medical treatment, said first access chamber in fluid communication with said open end, said elongated body further including an elongated access opening in said wall, said elongated access opening being longitudinally aligned with said elongated body and in fluid communication with said access chamber, said elongated body further having a length to width ratio of at least about four to one to minimize the size of incision required in the body for insertion of said vascular access device, said open end being adapted to separate tissue when said elongated body is inserted into an incision formed in the skin of the patient, said closed end being adapted to separate tissue when said elongated body is removed through an incision formed in the skin of the patient, and said elongated body including a retrieval structure for engaging a cooperating structure on a retrieval device whereby engagement between said retrieval structure and the retrieval device permits removal of said vascular access device from the body of the patient;

a catheter tube having a first lumen extending therethrough, said catheter tube coupled to said open end of said elongated body, said first lumen of said catheter tube in fluid communication with said first access chamber of said elongated body for delivering the medical treatment from said first access chamber of said elongated body to the preselected location in the body, said open end of said elongated body defining an insertion end; and

a membrane sealing said elongated access opening, said membrane adapted to receive a percutaneous needle puncture without leakage from the puncture.

22. A vascular access device according to claim 21, said wall of said elongated body tapering to said open and closed ends of said elongated body to ease insertion and removal of the elongated body through an incision formed in the skin of the patient.

23. A vascular access device according to claim 21, wherein said closed end includes said retrieval structure for engaging the cooperating structure of the retrieval device whereby said vascular access device can be removed from the body of the patient with the retrieval device.

24. A vascular access device according to claim 21, wherein said open end is generally pointed to ease insertion of said vascular access device through an incision in the body of the patient.

25. A vascular access device according to claim 24, wherein said closed end of said vascular access device is generally pointed to ease removal of said vascular access device through the incision in the body of the patient.

26. A vascular access device for inserting and implanting into a passage in the body of a patient, said vascular access device for delivering medical treatment to a preselected location in the body of the patient, said vascular access device comprising:

an elongated body having a closed end, an open end, a wall extending therebetween, at least a first access chamber formed therein for receiving the medical treatment, said access chamber in fluid communication with said open end, and an elongated access opening in said wall, said elongated access opening longitudinally aligned with said elongated body and in fluid communication with said access chamber, said closed end of said elongated including a retrieval surface for cooperating with a retrieval device so that said vascular access can be removed from the body of the patient with the retrieval device, with the retrieval device being inserted through an incision in the body of the patient remote from the vascular access device;

a catheter tube having a first lumen extending therethrough, said catheter tube coupled to said open end of said elongated body, said first lumen of said catheter tube in fluid communication with said first access chamber of said elongated body for delivering the medical treatment from said first access chamber of said elongated body to the preselected location in the body, and

a membrane sealing said elongated access opening, said membrane adapted to receive a percutaneous needle puncture without leakage from the puncture.

27. A vascular access device according to claim 26, wherein said elongated body includes a second access chamber therein and in fluid communication with said open end, said open end having a pair of adjacent openings, said tubular member having a second lumen extending therethrough, said first access chamber of said elongated body in fluid communication with said first lumen of said tubular member through one of said adjacent openings, said second access chamber of said elongated body in fluid communication with said second lumen of said tubular member through the other of said adjacent openings.

28. A vascular access device according to claim 26, wherein said open end is generally pointed to ease insertion of said elongated body into the body of the patient and sufficiently pointed to separate tissue during the insertion of said elongated body into the body of the patient.

29. A vascular access device according to claim 28, wherein said second end is generally pointed to ease removal of said elongated body from the body of the patient and sufficiently pointed to separate tissue during the removal of said elongated body from the body of the patient.

30. A vascular access device for inserting into a passage in the body of a patient, said vascular access device for delivering medical treatment to a preselected location in the body of the patient said vascular access device comprising:

an elongated body having a closed end, an open end, a wall extending therebetween, at least a first access chamber formed therein for receiving the medical treatment, said access chamber in fluid communication with said open end, and an elongated access opening in said wall, said elongated access opening longitudinally aligned with said elongated body and in fluid communication with said access chamber, said wall of said elongated body tapering to said open and closed ends of said elongated body, and said open and closed ends being generally pointed to ease insertion and removal of said elongated body trough an incision formed in the skin of the patient and further being sufficiently pointed an amount sufficient to separate tissue when inserted or removed through the incision and said elongated body including a retrieval structure for cooperating with a cooperating structure of a retrieval device whereby registration between the retrieval device and the elongated body permits remote removal of said vascular access device from the body of the patient;

a catheter tube having a first lumen extending therethrough, said catheter tube coupled to said open end of said elongated body, said first lumen of said catheter tube in fluid communication with said first access chamber of said elongated body for delivering the medical treatment from said fist access chamber of said elongated body to the preselected location in the body; and

a membrane sealing said elongated access opening, said membrane adapted to receive a percutaneous needle puncture without leakage from the puncture.

31. A vascular access device for inserting and implanting into a passage in the body of a patient, said vascular access device for delivering medical treatment to a preselected location in the body of the patient, said vascular access device comprising:

an elongated body having a closed end, an open end, a wall extending therebetween, at least a first access chamber formed therein for receiving the medical treatment, said access chamber in fluid communication with said open end, and an elongated access opening in said wall, said elongated access opening longitudinally aligned with said elongated body and in fluid communication with said access chamber, said wall of said elongated body tapering to said open and closed ends of said elongated body to ease insertion of the elongated body into a passage formed in the patient, and said open and closed ends being generally pointed to ease insertion and removal of said elongated body from the passage in the patient, and said closed end including a retrieval aperture extending transversely of said closed end of said elongated body for registering with a cooperating structure on a retrieval tool;

a catheter tube having a first lumen extending therethrough, said catheter tube coupled to said open end of said elongated body, said first lumen of said catheter tube in fluid communication with said first access chamber of said elongated body for delivering the medical treatment from said first access chamber of said elongated body to the preselected location in the body; and

a membrane sealing said elongated access opening, said membrane adapted to receive a percutaneous needle puncture without leakage from the puncture.

32. A vascular access device according to claim 31, wherein said closed end includes a distal end and a groove extending from said distal end longitudinally of said elongated body to said aperture.

33. A vascular access device for inserting into the body of a patient, said vascular access device adapted to be used for periodic delivery of medical treatment to a preselected location in the body of the patient, such as delivery of a fluid to a treatment site, said vascular access device comprising:

an elongated implant body having a top wall, a bottom wall, opposed side walls, a first end, a closed second end, and at least one access chamber formed therein, said first end defining a first opening in communication with said access chamber, and said top wall defining a second opening in communication with said access chamber, said elongated implant body having a width and a length greater than said implant body width, said top wall, said side walls, and said bottom walls converging to form said first and second ends of said implant body, at least said first end being generally pointed an amount sufficient to ease insertion of said elongated implant body into a passage formed in the body of the patient, said elongated body including an indent for engaging the cooperating structure of the retrieval device;

a tubular member having at least one lumen extending therethrough, said tubular member connected to said first end of said elongated implant body, said lumen in fluid communication with said access chamber through said first opening for delivery of material from said access chamber along said tubular member to the preselected location in the body; and

a membrane sealing said elongated implant body second opening, said membrane adapted to receive a percutaneous needle puncture without leakage from the puncture, whereby said elongated implant body is adapted to be implanted through an incision which will accommodate said width of said elongated implant body but is less than said length thereof.

34. A vascular access device for inserting into the body of a patient, said vascular access device adapted to be used for periodic delivery of medical treatment to a preselected location in the body of the patient, such as delivery of a fluid to a treatment site, said vascular access device comprising:

an elongated implant body having a wall, a distal end, a proximal end, and at least one access chamber formed in said body, said proximal end including a first opening in communication with said access chamber, said wall including a second opening in communication with said access chamber, and said proximal end defining an insertion end and being generally pointed an amount sufficient to ease insertion of said elongated body into a passage formed on the body of the patient and, further, being pointed an amount sufficient to separate tissue when said elongated implant body is inserted into the body of the patient, and said elongated implant body including a retrieval structure for registering with a cooperating structure of a retrieval device whereby registration of the retrieval device and said structure permits removal of said vascular access device;

a tubular member having at least one lumen extending therethrough, said tubular member coupled to said proximal end of said elongated body, said lumen being in communication with said access chamber through said first opening for delivery of material from said access chamber along said tubular member to the preselected location in the body; and

a membrane sealing said elongated implant body second opening, said membrane adapted to receive a percutaneous needle puncture without leakage from the puncture.

35. A vascular access device according to claim 34, wherein said second end of said elongated body is generally pointed in an amount sufficient to ease removal of said elongated body from the passage formed in the body of the patient.

36. A vascular access device according to claim 34, wherein said retrieval structure comprises a recess for engaging the cooperating structure of the retrieval device.

37. A vascular access device according to claim 34, wherein said elongated body has a length to width ratio of at least about four to one to minimize the size of an incision required in the body for insertion of said vascular access device.