Vascular access kit

• US 6,210,366 B1
• Filed: 05/26/1999
• Issued: 04/03/2001
• 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): Nguyen, Anh-Tuan T.
• Assistant Examiner(s): RODRIGUEZ, CRIS LOIREN
• Application Number:
  US09/318,878
• Time in Patent Office: 678 Days
• Field of Search: 604/19, 604/502, 604/93, 604/104, 604/160, 604/163, 604/175, 604/177, 604/264, 604/273, 604/274, 604/239, 604/263, 604/164, 604/166, 604/890.1, 604/891.1 , 604/93.01, 604/164.01, 604/164.03, 604/166.01, 604/165.01, 604/165.03, 604/164.05, 606/108, 206/570, 206/339, 206/438, 128/DIG. 26
• US Class Current: 604/104
• 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 kit comprising:

a vascular access device comprising;

an elongated implant body having a wall and first and second ends, said first end defining an insertion end and being sufficiently pointed to ease insertion of said implant body through an incision formed in a patient to a location remote from the incision, at least one access chamber formed therein for receiving medical treatment, a first opening provided in said first end in communication with said access chamber, and a second opening provided in said wall, said second opening in communication with said access chamber;

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 of said tubular member in fluid communication with said access chamber through said first opening for delivering the medical treatment from said access chamber to a preselected location in the patient remote from the incision;

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

a dilator comprising;

a handle portion and a shaft, said shaft having a distal end portion and a proximate end portion, said proximate end portion disposed toward said handle portion and having an enlarged cross-section dimensioned and adapted to form a passage in the patient which accommodates said elongated implant body of said vascular access device, said handle portion and said shaft including coextensive passageways defining a guide lumen extending from said handle to said distal end of said shaft for receiving a guide wire therethrough, said distal end portion adapted for inserting a sheath into an opening in the patient; and

a sheath comprising;

a tubular sheath body including a first end and a second end, said first end of said tubular sheath body having a first diameter and adapted for inserting into an incision in the patient, said second end of said tubular sheath body having a second diameter and defining an entrance, said second end of said tubular sheath body dimensioned and adapted to receive said enlarged proximate end portion of said dilator, said tubular sheath body being formed of flexible material and being adapted to tear along a longitudinal path extending between said first and second ends of said tubular sheath body; and

pull members disposed on said second end at opposed sides of said entrance for pulling and splitting said tubular sheath body along said longitudinal path.

2. A vascular access kit according to claim 1, wherein said first end of said elongated implant body is tapered to ease insertion of the elongated implant body into said entrance of said sheath.

3. A vascular access kit according to claim 2, wherein said second end of said elongated implant body is tapered to ease removal of said vascular access device from the patient.

4. A vascular access kit according to claim 2, wherein said dilator proximate end portion tapering down to the cross-section of said distal end portion.

5. A vascular access kit according to claim 1, further comprising a retrieval device having a handle and a shaft extending from said handle, said shaft having a cooperating structure for selectively engaging said second end of said elongated implant body, said second end of said elongated implant body including an indent selectively engaged by said retrieval device cooperating structure.

6. A vascular access kit according to claim 1, wherein said second end of said elongated implant body includes a groove adjacent said indent for guiding said cooperating structure of said retrieval device into said indent.

7. A vascular access kit according to claim 6, wherein said indent is defined by an aperture extending transversely of said second end of said elongated implant body.

8. A vascular access kit according to claim 7, wherein said second end of said elongated body includes a distal end, said groove extending from said distal end longitudinally of said elongated body to said aperture.

9. A vascular access kit according to claim 8, wherein said retrieval device having a cutting edge disposed at a distal end of said shaft.

10. A vascular access kit according to claim 9, wherein said cooperating structure comprises a hook.

11. A vascular access kit according to claim 1, wherein said elongated implant body of said vascular access device includes a second access chamber formed therein, said first end of said elongated body having a second aperture in fluid communication with said second access chamber, said tubular member having a second lumen extending therethrough, said second lumen of said tubular member in fluid communication with said second access chamber through said second aperture.

12. A vascular access kit according to claim 11, further comprising a needle assembly comprising:

a mounting body;

a first noncoring needle extending from said mounting body, said first noncoring needle having a needle lumen extending therethrough and for communicating with a tube lumen of a tube;

a second noncoring needle extending from said mounting body, said second noncoring needle having a needle lumen extending therethrough and for communicating with a tube lumen of a tube; and

said mounting body maintaining said needles in spaced relationship in registry with the spacing of said access chambers of said elongated implant body.

13. A vascular access kit according to claim 12, wherein each said needle extends generally orthogonally relative to the corresponding one of said needle tubes.

14. A vascular access kit according to claim 12, wherein each said needle forms an angle of approximately 30°

, relative to said mounting body.

15. A vascular access kit according to claim 1, further comprising a retrieval tool for removing the vascular access device from the body of a patient, said retrieval tool including a handle and a shaft extending from said handle, said shaft having a cooperating structure thereon adapted for engaging said vascular access device.

16. A vascular access kit according to claim 15, wherein said shaft includes a pointed distal end to ease insertion of said retrieval device into the body of the patient.

17. A vascular access kit according to claim 16, wherein said shaft includes a sharp leading edge extending from said pointed distal end of said shaft so that when said retrieval device is inserted into the incision, said sharp leading edge is adapted for dissecting tissue and forming a tunnel in the body of the patient.

18. A vascular access kit according to claim 17, wherein said cooperating structure comprises a hook structure.

19. A vascular access kit according to claim 18, wherein said hook structure is spaced from said pointed distal end, said shaft including a guiding edge extending from said pointed distal end to said hook structure.