Graft-port hemodialysis systems, devices, and methods

• US 10,456,570 B2
• Filed: 06/10/2016
• Issued: 10/29/2019
• Est. Priority Date: 06/11/2015
• Status: Active Grant

• Current Assignee: Proviflo LLC
• Original Assignee: Proviflo LLC
• Inventors: Finch, Jr., Charles David
• Primary Examiner(s): Lee, Brandy S
• Application Number:
  US15/179,688
• Publication Number:
  US 20160361529A1
• Time in Patent Office: 1,236 Days
• CPC Class Codes: A61M 1/285 Catheters therefor
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 1/3661 for haemodialysis
• CPC Class Codes: A61M 2039/0018 designed for flushing a line, e.g. by a by-pass
• CPC Class Codes: A61M 2039/0258 for vascular access, e.g. blood stream access
• CPC Class Codes: A61M 2039/027 having a particular valve, seal or septum septum A61M2039/0036
• CPC Class Codes: A61M 2039/0273 for introducing catheters into the body
• CPC Class Codes: A61M 2039/0285 with sterilisation means, e.g. antibacterial coatings, disinfecting pads, UV radiation LEDs or heating means in the port
• CPC Class Codes: A61M 2039/0291 method or device for implanting it in the body
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 39/0247 Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053
• CPC Class Codes: A61M 39/22 Valves or arrangement of valves A61M39/02, A61M39/0247, A61M39/16 take precedence; regulating valves in infusion systems A61M5/16881; in devices worn by the patient for the reception of urine, faeces, catamenial or other discharge, or in colostomy devices A61F5/4405
• CPC Class Codes: A61M 5/427 Locating point where body is to be pierced, e.g. vein location means using ultrasonic waves, injection site templates
• CPC Class Codes: B29C 45/0081 of objects with parts connected by a thin section, e.g. hinge, tear line
• CPC Class Codes: B29K 2995/006 Bio-degradable, e.g. bioabsorbable, bioresorbable or bioerodible
• CPC Class Codes: B29L 2031/753 Medical equipment; Accessories therefor bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008

Abstract

The present invention relates to subcutaneously implanted graft-port systems, devices and methods for establishing access to the vascular system of a patient requiring multiple blood treatments over an extended period of time. The systems, devices and methods disclosed herein reduce miscannulation, promote intra-session hemostasis, and decrease the incidence of bacteremia and sepsis among other improvements and advantages. The devices include a port with a flattened plateau-like surface for receiving an access tube. The flat surface may include a tactile or visual guide to assist with placement of the access tube into the tapered seat. Optional valve mechanisms reduce the size and form factor of the implantable graft-port device and seals the conduit of the port closed to physiologic pressures until the valve is opened upon percutaneous insertion of the access tube. The access tube does not pass into the conduit. A mismatch fit between the access tube and tapered seat causes a decrease in the cross-sectional sealing area, a reduction in the overall device size, and an increase in blood flow during treatment. Lock solutions to prevent fowling and infection are also disclosed.

Claims

1. An implantable port device for establishing access to a blood vessel of a patient, the device comprising:

a tapered seat configured to receive a tip of an access tube, the seat having a proximal portion, a distal portion, and a conical surface extending between the proximal portion and the distal portion;

a guide configured to engage the tip of the access tube and to assist in directing the tip of the access tube toward the seat; and

an interface surface configured to engage (i) the blood vessel of the patient or (ii) a vascular access catheter, the interface surface having an aperture in fluid communication with the distal end of the seat;

wherein the conical surface includes a taper angle having a value within a range from about 0.5 degrees to about 4.0 degrees; and

wherein the proximal portion of the seat is configured to receive the tip of the access tube therethrough.

2. The device of claim 1, wherein the distance between the proximal portion and the distal portion of the tapered seat is between about 1.0 mm and 5.0 mm.

3. The device of claim 1, wherein the tapered seat creates a mismatch fit with a diameter of the access tube when the tapered seat receives the access tube in use, the mismatch fit creating a decrease in the cross-sectional sealing area, a reduction in the overall device size, and an increase in blood flow during treatment.

4. The device of claim 1, wherein the tapered seat creates a match fit with a diameter of the access tube when the tapered seat receives the access tube in use, the match fit conducive to performing procedures requiring flow rates less than normal physiological pressures.

5. The device of claim 1, wherein the tapered seat creates a mismatch fit with a diameter of the access tube when the tapered seat receives the access tube in use, the mismatch fit conducive to performing procedures requiring flow rates greater than normal physiological pressures.

6. The device of claim 1, wherein the guide includes at least one ridge elevated from a flat surface and wherein the at least one ridge is configured in a spiral pattern, a ray pattern, or a cross pattern with each pattern terminating adjacent the proximal portion of the tapered seat.

7. The device of claim 1, wherein a stabilizer base is reversibly attached to the device to increase the footprint of the device when implanted and reduce movement during use.

8. The device of claim 1, wherein the device does not require a valve.

9. The device of claim 1, wherein the access tube includes a swivel attachment configured to rotate 360 degrees about an axis.

10. A subcutaneously implanted graft-port device used to establish access to a blood vessel of a patient, the patient requiring repeated vascular access over a period of time, the device comprising:

a housing having an inlet opening, an outlet opening and an interior conduit defined therein between, the conduit configured to accept a vascular blood flow;

wherein the housing includes a flat surface, the flat surface oriented nearest to and substantially parallel with a skin of the patient when the device is subcutaneously implanted;

a guide located on the flat surface;

a tapered seat located in the center of the flat surface;

wherein the tapered seat includes an outer perimeter, an inner perimeter smaller than the outer perimeter, and a conical surface extending between the outer and inner perimeters; and

wherein the tapered seat includes a taper of between about 2.5 degrees to 3.5 degrees from the outer perimeter to the inner perimeter, the tapered seat configured to receive an access tube first through the outer perimeter;

a valve mechanism configured to seal the conduit closed to physiologic pressures while allowing the vascular blood flow until the valve is opened via percutaneous insertion of the access tube into the tapered seat by a health care professional;

wherein opening the valve allows continued vascular blood flow through the conduit, the flow unobstructed by the access tube; and

wherein the valve is closed upon removal of the access tube from the tapered seat at a treatment conclusion.

11. The device of claim 10, wherein the device is produced using an injection molding process such that turbulence of the vascular blood flow is minimized when the valve is open during use.

12. The device of claim 10, wherein the device includes a substantially uniform cross-sectional area such that turbulence of the vascular blood flow is minimized when the valve is open during use.

13. The device of claim 10, wherein the access tube locks in place within the tapered seat for preventing dislodgment of the access tube prior to a treatment conclusion.

14. The device of claim 13, wherein the access tube forms an angle of about 90 degrees relative to the flat surface when the access tube is locked in place.

15. The device of claim 10, wherein the device includes a transparent material and the guide includes LED lights and a receiver coil for receiving an electrical current.

16. A method for establishing access to a blood vessel of a patient, the patient requiring repeated vascular access over a period of time, the method comprising:

subcutaneously implanting a graft-port device, the device comprising;

a housing having an inlet opening, an outlet opening and an interior conduit defined therein between, the conduit configured to accept a vascular blood flow;

wherein the housing includes a flat surface, the flat surface oriented nearest to and substantially parallel with a skin of the patient when the device is subcutaneously implanted;

a guide located on the flat surface;

a tapered seat located in the center of the flat surface;

wherein the tapered seat includes an outer perimeter, an inner perimeter smaller than the outer perimeter, and a conical surface extending between the outer and inner perimeters; and

wherein the tapered seat includes a taper of between about 0.5 degrees to 4.0 degrees from the outer perimeter to the inner perimeter, the tapered seat configured to receive an access tube first through the outer perimeter;

a valve mechanism configured to seal the conduit closed to physiologic pressures while allowing the vascular blood flow through the conduit;

percutaneously inserting the access tube into the tapered seat of the device to open the valve and allow continued vascular blood flow through the conduit, the flow unobstructed by the access tube; and

removing the access tube from the tapered needle seat of the device to close the valve at a treatment conclusion.

17. The method of claim 16, wherein the guide includes at least one ridge, the ridge elevated from the flat surface.

18. The method of claim 17, wherein the at least one ridge is a spiral pattern, a ray pattern, or a cross pattern with each pattern terminating adjacent an outer perimeter of the tapered seat.

19. The method of claim 17, wherein the device includes a transparent material and the guide includes LED lights and a receiver coil for receiving an electrical current;

and wherein placing an electromagnetic induction chip external to the patient and substantially above the subcutaneously implanted device induces a voltage in the receiver coil, the voltage powering the lights to visually reveal a location of the subcutaneously implanted device to a health care professional.

20. The method of claim 17, further including:

separately attaching a stabilizer base to the housing.