Implantable vascular device

• US 5,562,617 A
• Filed: 01/18/1994
• Issued: 10/08/1996
• Est. Priority Date: 01/18/1994
• Status: Expired due to Term

• Current Assignee: Vasca Inc.
• Original Assignee: Vasca Inc.
• Inventors: Kuiper, Hendrik K., Finch, Charles D. Jr.
• Primary Examiner(s): JONES, MARYBETH O
• Application Number:
  US08/183,151
• Time in Patent Office: 994 Days
• Field of Search: 604/9, 604/93, 604/175, 604/183, 604/244, 604/247, 604/891.1, 604/905, 623/1
• US Class Current: 604/288.02
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61M 2039/0211 with multiple chambers in a single site
• CPC Class Codes: A61M 2039/0223 having means for anchoring the subcutaneous access site
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: Y10S 604/905 Aseptic connectors or couplings, e.g. frangible, piercable
• CPC Class Codes: Y10S 623/903 Blood vessel

Abstract

An implantable device grafted directly to vascular structures for high volume blood and/or fluid infusion and/or removal for such purpose as hemodialysis, apheresis, exchange transfusion, or large volume fluid infusion. The device is also adaptable to intermittent access to the venous or arterial circulations for purpose of blood sampling or giving medications. The device is comprised of an implantable fluid chamber connected to a vascular shunt which is then grafted directly to the vascular structure (e.g. artery or vein). The vascular end of the device employs a valve to prevent reflux of blood and subsequent washout of anticoagulant during periods when the device is not in use. The device is accessed percutaneously with a needle or needle-introduced catheter and is filled with anti-coagulant prior to needle withdrawal to prevent thrombosis.

Claims

1. A method for using an implantable device for accessing a vascular structure in a living being, the implantable device including a hematologic chamber containing a needle-penetrable diaphragm which forms a wall of said hematologic chamber, said diaphragm being tolerant of multiple penetrations with needles or needle-introduced catheters without sacrificing the integrity of said diaphragm, said hematologic chamber being connected to one end of a cannula, the other end of said cannula being grafted to the vascular structure, whereby said hematologic chamber is in hydraulic communication with the vascular structure, said cannula containing valve means whereby hydraulic communication between said hematologic chamber and the vascular structure is prevented when said implantable device is not in use, said method comprising the steps of:

surgically implanting the implantable device in a living being, whereby the end of said cannula of the implantable device not attached to said hematologic chamber is grafted to the vascular structure and whereby said hematologic chamber is attached to subcutaneous tissues such that said diaphragm is adjacent the skin of the living being,

percutaneously introducing a needle or needle-introduced catheter through said diaphragm of said hematologic chamber into said hematologic chamber,

altering the pressure in said hematologic chamber to initiate fluid flow, wherein decreasing the pressure is accomplished by withdrawing fluid from said hematologic chamber using the needle or needle-introduced catheter, whereby fluid is caused to flow from the vascular structure into said cannula, through said valve, into said hematologic chamber, and then into the needle or needle-introduced catheter, and wherein increasing the pressure is accomplished by injecting fluid into said hematologic chamber using the needle or needle-introduced catheter, whereby the injected fluid is caused to flow from said hematologic chamber, into said cannula, through said valve, and into the vascular structure,

injecting sterile anti-coagulant fluid into said hematologic chamber of sufficient quantity to displace the fluid in said hematologic chamber and said cannula,

removing the needle or needle-introduced catheter from said diaphragm.

2. A method for simultaneously using two implantable devices for accessing a vascular structure in a living being, the implantable devices each including a hematologic chamber containing a needle-penetrable diaphragm which forms a wall of said hematologic chamber, said diaphragm being tolerant of multiple penetrations with needles or needle-introduced catheters without sacrificing the integrity of said diaphragm, said hematologic chamber being connected to one end of a cannula, the other end of said cannula being grafted to the vascular structure, whereby said hematologic chamber is in hydraulic communication with the vascular structure, said cannula containing valve means whereby hydraulic communication between said hematologic chamber and the vascular structure is prevented when said implantable device is not in use, said method comprising the steps of:

surgically implanting one of the implantable devices in a living being, whereby the end of said cannula not attached to said hematologic chamber is grafted to the vascular structure, wherein the vascular structure is a vein, and whereby said hematologic chamber is attached to subcutaneous tissues such that said diaphragm is adjacent the skin of the living being,

surgically implanting the other of the implantable devices in a living being, whereby the end of said cannula not attached to said hematologic chamber is grafted to the vascular structure, wherein the vascular structure is an artery, and whereby said hematologic chamber is attached to subcutaneous tissues such that said diaphragm is adjacent the skin of the living being,

percutaneously introducing a needle or needle-introduced catheter through said diaphragm of said hematologic chamber into said hematologic chamber of the implantable device said cannula of which is grafted to the vascular structure, wherein the vascular structure is a vein,

percutaneously introducing a needle or needle-introduced catheter through said diaphragm of said hematologic chamber into said hematologic chamber of the implantable device said cannula of which is grafted to the vascular structure, wherein the vascular structure is an artery,

hydraulically connecting said percutaneously introduced needles or needle-introduced catheters with each other whereby an extra-corporeal circuit is created, said circuit containing blood handling or treating equipment such as hemodialysis equipment,

decreasing the pressure in said hematologic chamber of the implantable device said cannula of which is grafted to the vascular structure, wherein the vascular structure is an artery by withdrawing fluid from said hematologic chamber using the needle or needle-introduced catheter, whereby fluid is caused to flow from the artery into said cannula, through said valve, into said hematologic chamber, and then into the needle or needle-introduced catheter, and into the extra-corporeal circuit containing blood handling or treating equipment such as hemodialysis equipment,

increasing the pressure in said hematologic chamber of the implantable device said cannula of which is grafted to the vascular structure, wherein the vascular structure is a vein by injecting fluid from the extra-corporeal circuit containing blood handling or treating equipment such as hemodialysis equipment, into said hematologic chamber using the needle or needle-introduced catheter, whereby fluid is caused to flow from said hematologic chamber, into said cannula, through said valve, and into the vein,

maintaining the flow of blood through the extra-corporeal circuit containing blood handling or treating equipment such as hemodialysis equipment for the time period required to adequately treat or handle the desired quantity of blood,

hydraulically disconnecting said percutaneously introduced needles or needle-introduced catheters from each other,

injecting sterile anti-coagulant fluid into both of said hematologic chambers of sufficient quantity to displace the fluid in said hematologic chambers and said cannula, and

removing the needles or needle-introduced catheters from said diaphragms.