DEVICE FOR ACHIEVING HEMOSTASIS

Abstract

A percutaneous device for achieving hemostasis in a vessel, particularly a device for achieving hemostasis following the failure of a vascular closure device has a catheter with an attached inflation device. The catheter preferably has two different lumens, one for a guide wire and one for fluid used to inflate the inflation device. When inflated, the inflation device unfurls to block the puncture in the blood vessel. Distal blood flow continues uninterrupted with the device in the furled and unfurled state, preventing any issues distally from the puncture site.

Claims

1. A hemostasis device comprising: a catheter having a proximal portion, a middle portion, and a distal portion, the distal portion having a distal end; the catheter having a first lumen and a second lumen, the first lumen being sealed at the distal end of the catheter; at least one opening in an outer wall of the catheter between the middle portion and the distal end and into the second lumen; and an inflatable element attached to and in fluid communication with the second lumen of the catheter through the at least one opening, the inflatable element expanding in a radial direction upon insertion of a fluid into the first lumen of the catheter and the at least one opening.

2. The hemostasis device according to claim 1, wherein the catheter has an outside wall forming the first lumen and an inside wall within the first lumen and forming the second lumen inside the second lumen.

3. The hemostasis device according to claim 1, wherein the catheter has an outside wall and the first lumen and the second lumen are separated by a septum.

4. The hemostasis device according to claim 1, wherein the inflatable element is attached along only a portion of a length of the catheter.

5. The hemostasis device according to claim 1, wherein the second lumen receives a guide wire to guide the catheter in a blood vessel.

6. The hemostasis device according to claim 1, wherein the inflatable element includes at least one channel that is in fluid communication with the at least one opening in the catheter.

7. The hemostasis device according to claim 1, wherein the inflatable element expands in a radial direction upon introduction of a fluid into the first lumen, the inflatable element expanding to contact an internal surface of a blood vessel into which it is inserted.

8. The hemostasis device according to claim 6, wherein the at least one opening includes a plurality of openings and the at least one channel includes a plurality of channels, a respective one of each of the plurality of openings being in fluid communication with a respective one of the plurality of channels.

9. A method of sealing a sealing an opening in the wall of a blood vessel, the blood vessel having an interior wall surface, exterior wall surface, and a vessel lumen comprising the steps of: providing a hemostasis device that includes a catheter having a proximal portion, a middle portion, and a distal portion, the distal portion having a distal end, the catheter having a first lumen and a second lumen, at least one opening in an outer wall of the catheter between the middle portion and the distal end and into the second lumen, and an inflatable element attached to and in fluid communication with the second lumen of the catheter through the at least one opening; inserting at least a portion of the hemostasis device into an insertion blood vessel away from the opening in the blood vessel and moving the inflatable element to the location of the opening in the blood vessel, introducing a fluid into the inflatable element through the catheter to expand the inflatable element to block the opening in the wall of the blood vessel.

10. The method of sealing a sealing an opening in the wall of a blood vessel according to claim 9, wherein the insertion blood vessel is the same as the blood vessel with the opening in the wall thereof.

11. The method of sealing a sealing an opening in the wall of a blood vessel according to claim 9, wherein the insertion blood vessel is a different blood vessel as the blood vessel with the opening in the wall thereof.

12. The method of sealing a sealing an opening in the wall of a blood vessel according to claim 9, wherein the inflatable element expands radially to block the opening in the wall of the blood vessel.

13. The method of sealing a sealing an opening in the wall of a blood vessel according to claim 12, wherein blood passes by the inflatable element to reach a distal portion of the blood vessel.

14. A hemostasis device for sealing an opening in the wall of a blood vessel, the blood vessel having an interior wall surface, exterior wall surface, and a lumen, the hemostasis device comprising: a catheter having a proximal portion, a middle portion, and a distal portion, the distal portion having a distal end; the catheter having a first catheter lumen and a second catheter lumen, the first catheter lumen being sealed at the distal portion of the catheter; at least one opening in the catheter between the middle portion and the distal end and in fluid communication with the first catheter lumen; and an inflatable element attached to and wrapped around the catheter, the inflatable element being in fluid communication with the first catheter lumen through the at least one opening, the inflatable element expanding radially upon insertion of a fluid into the first catheter lumen and at least one opening causing an outer wall of the inflatable element to contact the interior wall surface of the blood vessel to at least partially seal an opening in the blood vessel while simultaneously allowing blood to flow past the hemostasis device.

15. The hemostasis device according to claim 14, wherein the first lumen is sealed at the distal end of the catheter.

16. The hemostasis device according to claim 14, wherein the inflatable element is attached along only a portion of a length of the catheter.

17. The hemostasis device according to claim 14, wherein the second lumen receives a guide wire to guide the catheter in a blood vessel.

18. The hemostasis device according to claim 14, wherein the inflatable element includes at least one channel that is in fluid communication with the at least one opening in the catheter.

19. The hemostasis device according to claim 18, wherein the at least one opening includes a plurality of openings and the at least one channel includes a plurality of channels, a respective one of each of the plurality of openings being in fluid communication with a respective one of the plurality of channels.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0021] FIG. 1 is a perspective view of a proximal end of one embodiment of a hemostasis device according to the current invention;

[0022] FIG. 2 is an elevational view from the proximal end of the hemostasis device of FIG. 1 in the furled state;

[0023] FIG. 2A is a cross section of a proximal end of the hemostasis device in FIG. 1;

[0024] FIG. 3 is a plan view of the distal end of the hemostasis device of FIG. 1;

[0025] FIG. 4 is a cross section of the distal end of an alternative catheter according to another embodiment of the present invention

[0026] FIG. 5 is a top perspective view of the distal end of the catheter of FIG. 1 before attachment of the inflation element;

[0027] FIG. 6 is a plan view of the inflation element before sealing and installation on the catheter;

[0028] FIG. 7 is a view of the inflation element attached to the catheter with 8 sealed channels for inflation fluid; and

[0029] FIG. 8 is end view from the proximal end in a blood vessel with the inflation element unfurled and blocking an opening in the blood vessel.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0030] Illustrated in FIG. 1 is a first embodiment of a hemostasis device 10 according to the present invention. The hemostasis device 10 is preferably a catheter 12 that has a proximal portion 14, a middle portion 16 and a distal portion 18, the distal portion 18 having a distal end 20. The catheter 12 may be of any appropriate length for the situation that the device 10 will be used in, as discussed in more detail below. The proximal portion 14 of the hemostasis device 10 includes two ports 22,24 that preferably include Luer Lock connections, although any type of appropriate connectors could be used with the two ports 22,24. The hemostasis device 10 preferably comprises at least two lumens or channels—a first catheter lumen or channel 26 and a second catheter lumen or channel 28, hereinafter first lumen or channel and second lumen or channel. The first lumen 26 is preferably sealed at the distal end thereof. Each of the first lumen or channel 26 and the second lumen or channel 29 are associated with one of the ports 22,24, respectively. The lumens 26,28 may run the length of the catheter 12, but the first lumen 26 may stop short thereof. As illustrated, the second lumen 28 can be centered within the first lumen 26. However, other configurations are also possible as illustrated in FIG. 4 and discussed below. Lumen 28 is a through-channel that begins at the proximal portion 14 of the catheter 12 and extends the length of the catheter 12 to and through the distal end 20. Second lumen 28 is in fluid communication with the port 24. First lumen 26, surrounding second lumen 28, is in fluid communication with port 22, but does not communicate with second lumen 28. Port 22 is used for the introduction of inflation fluid to inflate an inflation element 40 through first lumen 26, as discussed in more detail below.

[0031] The catheter 12 has an outer wall 30 that forms the first lumen 26 and an inside wall 32 that forms the second lumen 28 within the first lumen 26. There may be extensions 34 that are used to connect the outside wall 30 to the inside wall 32 (thus being in the first lumen 26) to keep second lumen 28 centered and allow fluid to flow within the first lumen 26 and around the second lumen 28. The second lumen 28 accepts a guide wire 50 through port 24, the guide wire 50 preferably extending beyond the distal end 20 and at least to the opening in the vessel.

[0032] An alternative design of a catheter 12′ according to the present invention is illustrated in FIG. 4. Rather than having concentric lumens, the lumens in this catheter are side by side and separated by a septum. The catheter 12′ has a first lumen 26′ and a second lumen 28′. The catheter 12′ also has an outer wall 30′ to form the two lumens. The first lumen 26′ is separated from the second lumen 28′ by a septum 32′. The first lumen 26′ is sealed at the distal end thereof. A guide wire (not illustrated but can be the same as the one illustrated above) is disposed in the second lumen 28′ and extends beyond the distal end of the catheter 12′. Other configurations of the catheter are also possible.

[0033] The catheter 12 has at least one opening 42 in the outer wall 30 to allow for the fluid in the first lumen 26 to be routed to the inflation element 40. Preferably, there are a number of openings 42 in the outer wall, six are illustrated in FIG. 3, but there could be more or fewer openings 42 and still fall within the scope of the present invention. It is also contemplated that there could be an elongated opening extending along a length of the catheter 12.

[0034] The inflation device 40 can be made from a sheet 44 of polyester or nylon, but the sheet 44 could also be made of other materials, including Pebax, polyurethane, and silicone. Turning to FIG. 6, the sheet 44 has a center line 46 that corresponds to the where the catheter 12 will be located along the sheet 44. While a particular shape of the sheet 44 is illustrated in FIG. 6, any appropriate shape may be used, as long as it performs the functions discussed herein. After the catheter 12 is disposed along the center line 46, the sheet 44 is sealed along its edges 44a,44b,44c, and 44d. As illustrated in FIG. 7, there are also other seals 62 that extend from the catheter 12 outward to the edge 44c. These seals 62 create the channels 64 in the inflation device 40 that allow the inflation device 40 to expand radially outward as the channels 64 are in fluid communication with the first lumen 26. Preferably the largest outside diameter, D.sub.MAX, (see also FIG. 2) of the hemostasis device 10, in the furled state is small enough to be accepted in a 6 French or smaller access sheath, about 2 mm or less.

[0035] As illustrated in FIG. 5, there is a hemostasis device 10 that has been inserted into a vessel 70 of a patient with a vessel puncture 72. The hemostasis device 10 has been inserted from a different location in the patient's body and delivered by conventional techniques to the location of the vessel puncture 72. Once positioned adjacent the vessel puncture 72, fluid can be introduced to the first lumen 26, which then passes through the opening(s) 42 and into the channels 64 to cause the hemostasis device 10 to radially expand and engage the vessel 70 at the vessel puncture 72. The hemostasis device 10 can remain in position as long as necessary because the blood in the vessel 70 can flow beyond the vessel puncture 72 through the radial expansions of the hemostasis device 10. Once sealed, the hemostasis device 10 can have the fluid removed from the channels 64 and the hemostasis device 10 can be removed from the vessel 70.

[0036] It should be noted that the port 24 is for the introduction of the guide wire 50. The device used to inflate and deflate (for removal) the inflation element 40 of the hemostasis device 10 can be any of a number of commercially available devices, such as the BIG60 from Merit Medical. Typically, the fluid used to inflate the device is heparinized saline, but could be inflated with other appropriate fluids as well, such as heparinized saline and contrast mix. The device would be connected to the hemostasis device 10 at port 24, via a standard Luer Lock fitting. Contrast fluid for making the location of the distal end of catheter 12 more visible on a fluoroscope upon insertion into a vessel, can be introduced into either ports 22 or 24 by attaching a standard header used for such tasks (not shown) to either Luer Locks.

[0037] There may be other ways in which to locate the various portions of the hemostasis device 10. For example, radio-opaque markers 74 serve to guide, via fluoroscopy, the distal end of catheter 12 such that inflation device 40 is located in juxtaposition with puncture 72 for the purpose of applying pressure for hemostasis at the puncture 72.

[0038] The method of use of the invention as a back up device for obtaining hemostasis in case of failure of a LB closure device in a structured heart procedure, for example, is as follows: The structured heart procedure, aorta valve replacement for example, is accomplished by positing and deploying the replacement valve via a 14 F or 18 F catheter from the left or right groin. A 6 F catheter placed in the right or left groin is used to insert contrast fluid aiding visualization under fluoroscopy. After successful replacement the valve catheter is removed from its access sheath. The contrast catheter with the guide wire in place is repositioned to the valve access sight by passing through the femoral artery to the corresponding iliac, entering the valve side iliac, and femoral artery and stationing it upstream of the valve side arrteriotomy. The LB VCD is then deployed and a SB VCD or MC is used to close the contrast side arrteriotomy provided there is no failure of the LB closure. If the LB VCD fails to provide adequate hemostasis catheter 12 of the current invention is rapidly delivered contralaterally via guide wire near the valve side arrteriotomy and inflation device 40 is centered longitudinally on the puncture 72 by means of the radio-opaque markers 74 and contrast fluid, if needed, from a header connected to port 22 or 24. Inflation fluid is injected through first lumen 22 and is distributed through openings 42 and begins to fill channels 62 which causes inflatable element 40 to unfurl. The outer surface of inflation device 40 stops unfurling when the vessel wall is contacted. Inflation fluid flow is terminated when adequate pressure against the puncture site 72 results in hemostasis. Blood continues to flow between the folds to lower extremities. The number of folds in the inflation device 40 is such that full circumference coverage of the largest expected femoral artery diameter, about 12 mm. Hemostasis is achieved in femoral arteries smaller than 12 mm by fewer folds of inflation device 40 unfurling.

[0039] In cases of rupture or dissection of cardiac or peripheral procedures the current invention can be used to provide emergency hemostasis by removing the procedure catheter, leaving the guide wire and inserting hemostasis device 10 over the wire. Positioning and unfurling the inflation device 40 is accomplished as described above. As above described, following hemostasis blood is allowed to flow around the furls to the body extremities while the damaged vessel is repaired by surgery or other means.

[0040] It will be apparent to those skilled in the art that various modifications and variations can be made to the present invention without departing from the spirit and scope of the invention. Thus, it is intended that the present invention cover the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents.