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EP-3600488-B1 - APPARATUS AND METHOD FOR CANNULATION OF VASCULAR ACCESS GRAFT

EP3600488B1EP 3600488 B1EP3600488 B1EP 3600488B1EP-3600488-B1

Inventors

  • GAGE, Shawn M.
  • LAWSON, JEFFREY H.
  • KNIGHT, JOSEPH
  • NICHOLS, Craig

Dates

Publication Date
20260506
Application Date
20180330

Claims (6)

  1. A guiding apparatus (50) for guiding cannulation with a dialysis needle of an arteriovenous dialysis access graft (40) subcutaneously implanted in a body of a subject, the arteriovenous dialysis access graft (40) including a flexible conduit (42) defining a longitudinal flow passageway and having a first end portion configured to connect to a first blood vessel of the subject and a second end portion configured to connect to a second blood vessel of the subject such that blood flows through the longitudinal flow passageway of the flexible conduit (42) from the first end portion to the second end portion, and a cannulation chamber (44) defining a cannulation port (47), the flexible conduit (42) extending through the cannulation chamber (44) for receiving the needle inserted through the cannulation port (47), the guiding apparatus (50) comprising: an elongated body member having a longitudinal axis and an inner surface and having a substantially oval profile, the body member comprising a base portion (52) terminating in longitudinal edges substantially parallel to the longitudinal axis of the body member, a distance between the longitudinal edges of the base portion (52) being substantially equal to a lateral dimension of the cannulation chamber (44), and legs (54) forming generally planar side walls extending from the longitudinal edges of the base portion (52) in a direction perpendicularly along a length of the longitudinal edges (53) of the base portion (52) such that the base portion spans between the generally planar side walls, the legs terminating in longitudinal edges, the base portion (52) and legs (54) defining an open longitudinal channel for receiving the cannulation chamber (44), wherein the body member is adapted to be secured adjacent the subcutaneous cannulation chamber (44) such that the legs (54) operatively engage the cannulation chamber (44) for aligning the inner surface of the base portion (52) with the cannulation port (47) for guiding location of the needle insertion through the body member and into the cannulation chamber (44).
  2. The guiding apparatus (50) as recited in claim 1, wherein the body member has a first end and a second end, and wherein the body member is adapted to extend from the first end to the second end of the cannulation chamber (44).
  3. The guiding apparatus (50) as recited in claim 1, wherein the body member has at least one passage opening into the inner surface of the body member for passing the dialysis needle.
  4. A system for guiding cannulation with a dialysis needle, the system comprising: an arteriovenous dialysis access graft (40) including a flexible conduit (42) defining a longitudinal flow passageway and having a first end portion configured to connect to a first blood vessel of the subject and a second end portion configured to connect to a second blood vessel of the subject such that blood flows through the longitudinal flow passageway of the flexible conduit (42) from the first end portion to the second end portion, and a cannulation chamber (44) defining a cannulation port (47), the flexible conduit (42) extending through the cannulation chamber (44) for receiving the needle inserted through the cannulation port (47); and a guiding apparatus (50, 80) according to claim 1, wherein an upper peripheral rim (48) of the cannulation chamber (44) defines spaced notches (48) for receiving the legs (54) such that the body member is secured adjacent the subcutaneous cannulation chamber (44) operatively engaging the cannulation chamber (44) through the skin of the subject for aligning the inner surface of the base portion (52, 82) with the cannulation port (47) for guiding location of a needle insertion through the body member and into the cannulation chamber (44).
  5. The cannulation guiding system as recited in claim 4, wherein the body member has a first end and a second end, and wherein the body member is adapted to extend from the first end to the second end of the cannulation chamber (44).
  6. The cannulation guiding system as recited in claim 4, wherein the body member has at least one passage opening (84) into the inner surface of the body member for passing a needle.

Description

Cross-References This application is related to United States provisional application number 62/479,791, filed March 31, 2017, entitled "APPARATUS AND METHOD FOR CANNULATION OF VASCULAR ACCESS GRAFT", naming Shawn M. Gage and Jeffrey H. Lawson as the inventors. The benefit of the filing date of the provisional application is hereby claimed for all purposes that are legally served by such claim for the benefit of the filing date. Background An apparatus and method is described for needle access of a surgically created vascular access for use as a means to receive hemodialysis and other procedures requiring vascular access and, more particularly, an apparatus and method for vascular access of an arteriovenous graft or arteriovenous fistula that enables location of cannulation sites post-implant. Hemodialysis is a life-sustaining treatment for patients with end stage renal disease. Hemodialysis is a process whereby large amounts of blood are removed from the body, filtered through a machine that removes wastes, and then returned into the body. A vascular access site on the body where blood will be removed and returned during dialysis is prepared before starting hemodialysis. Creation of an arteriovenous fistula ("AVF") is achieved in a surgical procedure in which a vein is connected directly to an artery. The connection between the artery and the vein may be formed using an arteriovenous graft ("AVG") made from a synthetic material and implanted just under the skin. Placement sites for AVG's include, without limitation, the forearm, upper arm, neck, chest, and thigh, in either straight or looped configurations. Once surgically positioned, an AVG becomes a conduit that can be used repeatedly for blood access during hemodialysis. graft. In conventional hemodialysis, two cannulas are placed in the access graft, with one needle puncture being made in the graft wall in the arterial side and another needle puncture being made in the venous side. During dialysis, blood is withdrawn from the arterial side of the graft, passed through a hemodialysis machine, and then returned to the patient through the second needle inserted in the venous side of the graft. A significant step in the hemodialysis procedure is "finding" the proper position within the graft to perform the needle sticks. Moreover, conventional dialysis protocols require a patient to undergo a dialysis procedure at least three times a week. As a result, the skin and underlying tissue are punctured numerous times per week to gain entry into the implanted AVG. The technique of cannulating an AVF or AVG for hemodialysis requires considerable skill. A vascular access often lies several centimeters below the surface of the skin and cannot be located by visual inspection. A medical technician is required to locate the AVF or AVG by palpation, which can prove to be extremely difficult. The punctures of the vascular access are prone to error and complication. Punctures done incorrectly may promote rupture of the access, bleeding, hematoma formation, pseudoaneurysm formation, severe pain or the development of organized thrombi within the lumen of the graft. The formation of such blood clots may result not only in multiple graft thromboses, but may eventually lead to graft failure. Missing the vascular access entirely or improperly positioning of the needle within the lumen of the AVF or AVG device are two contra indications, which adversely affect the time the graft remains patent. Locating the cannulation area simply by using conventional methods of palpating through the skin is sometimes unreliable. US 2012/245536 A1 discloses vascular access ports including implantable ports being configured to facilitate blood flow. An insertion guide is used to ensure a specific angle of trocar cannula insertion into the access port and blood vessel. The for a straight trocar cannula fits over the portion of a patient's skin residing above an access port, and mates with the port frame collar to ensure proper alignment over the port plug. US 2014/336682 A1 discloses vascular access devices, implantable dialysis grafts and systems including them. A portion of the implanted graft contains one or more paramagnetic materials (metal bands/rings 3) that magnetically interact with a magnetic detector (wand with annular magnet). WO 2011/112755 A2 discloses a self-closing device for implantation within a patient's body. A locator device includes a similar arrangement of ferromagnetic elements that correspond to elements in an access port. The locator device includes an alignment hole to guide a needle through an access port. The locator device may include an antiseptic pad thereon. US 2011/275930 A1 discloses a system for identifying an attribute of an implanted access port. For the forgoing reasons, there is a need for an apparatus and method for proper cannulation of a vascular access graft or fistula, including correct identification of an access region of the vascular access followin