Vascular access

Patent metadata

Field	Value
Publication number	US-11179556-B2
Application number	US-201515517937-A
Country	US
Kind code	B2
Filing date	Oct 2, 2015
Priority date	Oct 7, 2014
Publication date	Nov 23, 2021
Grant date	Nov 23, 2021

Abstract

A system for providing vascular access in a patient's body may comprise at least one hemostatic valve ( 610 ) and at least one clamp ( 210 ) to be used with a vascular graft ( 110 ). The vascular graft ( 110 ) comprises a tubular body having a proximal end ( 110 A) and a distal end ( 110 B), the proximal end ( 110 A) being configured to be attached to a vessel in a patient's body. The at least one valve ( 610 ) is configured to be attached to the distal end ( 110 B) of the graft's tubular body and comprises a housing ( 616 ) including a flexible membrane ( 611 ) that allows a medical device ( 810 ) to be inserted through the membrane ( 611 ) into said vascular graft ( 110 ). The valve ( 610 ) further comprises an introducer sheath ( 615 ) configured to be inserted into the distal end ( 110 B) of the graft's tubular body. The at least one clamp ( 210 ) is configured to be disposed around the graft's tubular body and has a first configuration that allows insertion of the valve's introducer sheath ( 615 ) into the distal end ( 110 B) of the graft's tubular body and a second configuration that allows clamping of the graft ( 110 ) against the valve's introducer sheath ( 615 ), when inserted in the graft's tubular body.

First claim

The invention claimed is:

1. A system for providing vascular access in a patient's body, comprising:
a vascular graft comprising a tubular body having a proximal end and a distal end, the proximal end being configured to be attached to a vessel in a patient's body;
at least two valves, comprising at least:
a first valve configured to be attached to the distal end of the vascular graft's tubular body, the first valve comprising a housing, the housing including a flexible membrane configured to maintain hemostasis when the proximal end of the vascular graft is attached to a vessel in a patient's body and a medical device is inserted through the membrane into said vascular graft, the first valve further comprising a first projecting portion configured to be inserted into the distal end of the vascular graft's tubular body; and
a second valve comprising a second projecting portion configured to be connectable to a distal end of the first valve so that the first valve and the second valve may be attached in series at the distal end of the vascular graft, the second projecting portion having a length that is at least ten times an outer diameter of the second projecting portion; and

at least one clamp comprising an annular ring with first and second ends, the at least one clamp being configured to be disposed around the vascular graft's tubular body and having a first configuration that allows insertion of the first projecting portion into the distal end of the vascular graft's tubular body, and a second configuration that allows clamping of the vascular graft against the first projecting portion when the first projecting portion is inserted in the vascular graft's tubular body, the second configuration being one in which the first end of the annular ring overlaps the second end of the annular ring.

2. The system of claim 1 , wherein an outer surface of the first projecting portion includes at least one retention structure so as to prevent removal of the first valve from the vascular graft.

3. The system of claim 2 , wherein the retention structure is formed as a ramped surface.

4. The system of claim 3 , wherein the retention structure comprises at least one barb that tapers away from the outer surface of the first projecting portion in a direction towards the housing.

5. The system of claim 1 , wherein, in addition to the membrane, at least a portion of the housing is made of a flexible material.

6. The system of claim 5 , wherein the first projecting portion is stiffer with respect to radial compression forces than a portion of the housing where the membrane is located.

7. The system of claim 5 , wherein the flexible material is an elastic material.

8. The system of claim 1 , wherein the housing is cylindrical.

9. The system of claim 1 , wherein an inner diameter of the first projecting portion does not decrease at a proximal end of the first projecting portion.

10. The system of claim 1 , wherein the flexible membrane has at least one passage that extends along a portion of a diameter of the membrane, or along an entire diameter of the membrane.

11. The system of claim 1 , wherein the membrane has a hole extending through the membrane.

12. The system of claim 1 , wherein the first valve includes at least one seam extending along a length of the first valve and forming a predetermined breaking line to allow breaking of the first valve.

13. The system of claim 1 , wherein the housing has at least one handle extending radially outwards from the housing.

14. The system of claim 1 , wherein the second projecting portion is configured to be inserted into the housing of the first valves.

15. The system of claim 1 , wherein the first valve and the second valve both haves a membrane with a central hole, and wherein a diameter of the central hole in the membrane of the first valve is larger than a diameter of the central hole in the membrane of the second valve.

16. The system of claim 1 , wherein the medical device is a catheter.

17. The system of claim 16 , wherein the medical device comprises an axial blood pump arranged at a tip of the catheter.

18. The system of claim 1 , wherein an inner diameter of the first projecting portion is constant along an entire length of the first projecting portion.

19. The system of claim 1 , wherein the flexible membrane has at least one passage in the membrane, the at least one passage comprising at least two slits extending diametrically through the membrane and crossing each other.

20. The system of claim 1 , wherein the first valve includes two diametrically opposing seams, each seam extending along a length of the first valve and forming a predetermined breaking line to allow breaking of the first valve into two halves along the length of the first valve.

21. The system of claim 1 , wherein the housing has two diametrically opposed handles, each handle extending radially outwards from the housing.

22. A system for providing vascular access in a patient's body, comprising:
a vascular graft comprising a tubular body having a proximal end and a distal end, the proximal end being configured to be attached to a vessel in a patient's body;
at least two valves, comprising at least:
a first valve configured to be attached to the distal end of the vascular graft's tubular body, the first valve comprising a housing, the housing including a flexible membrane configured to maintain hemostasis when the proximal end of the vascular graft is attached to a vessel in a patient's body and a medical device is inserted through the membrane into said vascular graft, the first valve further comprising a first projecting portion configured to be inserted into the distal end of the vascular graft's tubular body; and
a second valve comprising a second projecting portion configured to be connectable to a distal end of the first valve so that the first valve and the second valve may be attached in series at the distal end of the vascular graft;

at least one clamp comprising an annular ring with first and second ends, the at least one clamp being configured to be disposed around the vascular graft's tubular body and having a first configuration that allows insertion of the first projecting portion into the distal end of the vascular graft's tubular body, and a second configuration that allows clamping of the vascular graft against the first projecting portion when the first projecting portion is inserted in the vascular graft's tubular body, the second configuration being one in which the first end of the annular ring overlaps the second end of the annular ring; and
at least one secondary clamp configured to be disposed around the housing of the first valve.

23. The system of claim 22 , wherein the at least one secondary clamp is configured to be joined together with the at least one clamp.

Assignees

• Abiomed Europe Gmbh

Inventors

• Fantuzzi Glen
• Mraz Dion
• Raess Daniel A
• Brousseau David A
• Mayo Susanna

Classifications

• A61M60/237

  the blood flow through the rotating member having mainly axial components, e.g. axial flow pumps · CPC title

• A61M60/13

  by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system · CPC title

• A61M2039/062

  used with a catheter · CPC title

• A61M39/0247

  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 title

• A61M2039/0633

  the seal being a passive seal made of a resilient material with or without an opening · CPC title