INTRODUCER SHEATH
The invention provides an introducer sheath (1, 21, 51), whose distal end is to be positioned inside a vessel (10, 32, 62), at a predetermined distance from the wall (9, 31, 61) of the vessel (10, 32, 62). The introducer sheath (1, 21, 51) comprises a distal portion (2, 22, 52) with a first diameter and a proximal portion (3, 23, 53) with a second diameter, the first diameter being smaller than the diameter of the puncture hole and the second diameter being larger than the diameter of the puncture hole.
This application is a continuation of U.S. application Ser. No. 10/341,599, filed Jan. 14, 2003, the entire contents of all of which are incorporated herein by reference.
FIELD OF THE INVENTIONThe present invention relates generally to an introducer sheath to be used together with a sealing device in the sealing of a percutaneous puncture in a vessel, and more particularly to an introducer sheath being provided with an enlarged portion, which, during introduction into the puncture, stops against the vessel wall, so that the sealing device can be deployed at the desired location inside the vessel.
BACKGROUND OF THE INVENTIONA system for sealing a percutaneous puncture in a vessel may comprise an introducer sheath; and if the system belongs to the class of sealing devices wherein an inner seal is deployed inside the vessel, the distal portion of this introducer sheath extends through the vessel wall and into the vessel. During the introduction phase, the inner seal is folded inside the introducer, and to ensure proper unfolding of the inner seal, the inner seal has to be deployed some distance away from the vessel wall before the inner seal is retracted to be securely seated against the inner surface of the vessel wall. In other words, the distal end of the introducer sheath should be positioned at a desired location inside the vessel, with a known distance from the vessel wall, which, in turn, implies that the position of the vessel wall has to be determined.
An example of such a puncture closure system is disclosed in U.S. Pat. No. 6,090,130. This closure system comprises a vessel locator that includes means for enabling blood from an artery to flow therethrough, so that the position of the artery wall can be determined. Basically, the vessel locator comprises an introducer sheath and a dilator provided with a canal, through which blood can flow from a hole provided in the distal portion of the vessel locator to the proximal portion, where a user can observe a flow of blood out from a hole provided in the proximal portion. In order to correctly position the introducer sheath, the user has to perform several steps. First the introducer sheath is inserted into the artery such that blood can be observed at the proximal end of the introducer sheath. The introducer sheath is then retracted until the flow of blood out of the proximal end just stops, which indicates that the distal end of the introducer sheath has just left the arterial lumen. Thereafter, the introducer sheath is reinserted approximately 10 mm into the puncture to ensure that the distal end of the introducer sheath is at the desired location within the artery. Blood flow should be re-established from the proximal end at this time. From this point, the introducer sheath must be kept fixed.
This known vessel locator and the corresponding way of determining the position of the vessel wall have at least the following disadvantages. It is a messy procedure, with a rather large amount of blood flowing from the distal end of the introducer sheath. Secondly, and more importantly, it can, in praxis, be difficult to exactly determine the position at which the flow of blood just stops, i.e. for some patients the transition from a large flow of blood to essentially no flow of blood is not a readily observable discrete transition but a gradual transition, which makes it difficult to accurately determine the exact position of the vessel wall. Since the determination of the position of the vessel wall is the starting point for the reinsertion of the introducer sheath, the position of the distal end of the introducer sheath suffers from the same uncertainty. Furthermore, the somewhat arbitrary 10 mm reinsertion of the introducer sheath enhances this uncertainty. Finally, it should be noted that a user has to hold the introducer sheath fixedly without any assistance from a natural stop, i.e. the introducer sheath is free to move in the distal direction as well as in the proximal direction.
SUMMARY OF THE INVENTIONAn object of the present invention is therefore to provide an improved introducer sheath, the distal end of which is to be positioned at a predetermined location in relation to a vessel wall and with which it is possible to overcome or reduce the disadvantages of the known device and method described above.
The present introducer sheath can, but is not limited to, be used together with the sealing and wound closure device shown in WO 0078226 A1, and the reader is referred to this reference for additional information about the closure system as a whole.
In a first embodiment, the introducer sheath according to the present invention has a distal portion with a first diameter and a proximal portion with a second diameter, the second diameter being larger than the first diameter. The diameter of the distal portion is smaller than the diameter of a puncture hole in the wall of a vessel, thereby allowing the distal portion to be inserted through the puncture hole and into the vessel. The diameter of the enlarged proximal portion, on the other hand, is larger than the diameter of the puncture hole, so that, during introduction of the introducer, the enlarged portion stops against the vessel wall. By choosing a suitable length for the distal portion, an inner seal introduced in the introducer can be deployed at the desired location inside the vessel.
In another embodiment, the introducer sheath is further provided with a canal that connects a first hole in the distal portion of the introducer sheath with a second hole in the proximal portion of the introducer sheath. Preferably, the distance from the first, distal hole to the edge of the enlarged proximal portion corresponds to the thickness of the wall of a blood vessel. With such an arrangement, the correct positioning of the introducer sheath can be verified by observing a flow of blood out from the second hole in the proximal portion of the introducer sheath.
A first embodiment of an introducer sheath 1 is shown in
The special features and advantages of the introducer sheath according to the present invention will now be described with reference to the steps in a specific method for positioning the distal end of the introducer sheath at a desired location inside a blood vessel. It should, however,, be understood that other positioning methods, which involve other steps, could be used, and that the introducer sheath according to the present invention is not limited to be used in blood vessels.
The first step in the positioning of an introducer sheath according to the present invention is illustrated in
In the second step of the positioning operation, the introducer 6 is retracted over the dilator 11 and can then be disposed, so that only the dilator 11 is left in place in the puncture hole, as is illustrated in
In
Now with reference to
In
For the specific embodiment of an introducer sheath described above, the actual sealing of the puncture hole in the wall of the blood vessel is illustrated in
In
The introducer sheaths 1 and 21, shown in
In
Although the present invention has been described with reference to specific embodiments, also shown in the appended drawings, it will be apparent for those skilled in the art that many variations and modifications can be done within the scope of the invention as described in the specification and defined with reference to the following claims. So could, for example, the canal, which leads blood from a hole in the distal portion of the introducer sheath to the proximal portion, instead of being provided in the wall of the introducer sheath be provided as a longitudinal recess or hole in the dilator or guide rod over which the introducer sheath is threaded, i.e. the canal is provided by the combination of a longitudinal recess or hole in the dilator or guide rod and the inner surface of the introducer sheath.
Claims
1. An introducer sheath, whose distal end is configured to be positioned inside a vessel, at a predetermined distance from a puncture hole in the wall of the vessel, wherein the introducer sheath comprises a distal portion with a first diameter and a proximal portion with a second diameter, the first diameter being smaller than the diameter of said puncture hole and the second diameter being larger than the diameter of said puncture hole.
2. An introducer sheath according to claim 1, wherein the distance from the distal end of the introducer sheath to a distal edge of the proximal portion is adapted such that the distal end of the introducer sheath is at said predetermined distance when said distal edge is in contact with an outer surface of the vessel wall.
3. An introducer sheath according to claim 1, further comprising a transition portion between the distal portion and the proximal portion, the transition portion being configured to prevent the proximal portion from entering the vessel.
4. An introducer sheath according to claim 1, wherein the introducer sheath further comprises a first hole provided in the distal portion and a second hole provided in the proximal portion, said first and second holes being in fluid communication with each other through a canal, which is provided in the wall of the introducer sheath.
5. An introducer sheath according to claim 1, wherein the introducer sheath further comprises a first hole provided in the distal portion and a second hole provided in the proximal portion, said first and second holes being in fluid communication with each other through a canal, which is provided by a longitudinal recess or hole in a dilator or guide rod over which the introducer sheath is threaded.
6. An introducer sheath according to claim 4, wherein the distance from the first hole to a distal edge of the proximal portion is slightly larger than the thickness of the vessel wall, so that, when said distal edge is in contact with an outer surface of the vessel wall, fluid can flow into the first hole, through the canal and out from the second hole.
7. An introducer sheath according to claim 5, wherein the distance from the first hole to a distal edge of the proximal portion is slightly larger than the thickness of the vessel wall, so that, when said distal edge is in contact with an outer surface of the vessel wall, fluid can flow into the first hole, through the canal and out from the second hole.
8. An introducer sheath according to claim 1, wherein the introducer sheath is a separate introducer.
9. An introducer sheath according to claim 8, wherein the proximal end of the introducer sheath is provided with a hub to which a tool for closing a puncture wound in the wall of a vessel can be connected.
10. An introducer sheath according to claim 1, wherein the introducer sheath is a part of a tool for closing a puncture wound in the wall of a vessel.
11. An introducer sheath according to claim 10, wherein the distal portion of the introducer sheath is provided with a first hole and that a housing of the tool is provided with a second hole, said first and second holes being in fluid communication with each other through a canal, which is provided in the wall of the introducer sheath.
12. An introducer sheath according to claim 10, wherein the distal portion of the introducer sheath is provided with a first hole and that a housing of the tool is provided with a second hole, said first and second holes being in fluid communication with each other through a canal, which is provided by a longitudinal recess or hole in a dilator or guide rod over which the introducer sheath is threaded.
13. An introducer sheath according to claim 11, wherein the distance from the first hole to a distal edge of the proximal portion is slightly larger than the thickness of the vessel wall, so that, when said distal edge is in contact with an outer surface of the vessel wall, fluid can flow into the first hole, through the canal and out from the second hole.
14. An introducer sheath according to claim 12, wherein the distance from the first hole to a distal edge of the proximal portion is slightly larger than the thickness of the vessel wall, so that, when said distal edge is in contact with an outer surface of the vessel wall, fluid can flow into the first hole, through the canal and out from the second hole.
15. A method of positioning an introducer sheath with respect to a vessel having a puncture hole, comprising:
- providing an introducer sheath having a distal portion with a first diameter and a proximal portion with a second diameter, the first diameter being smaller than the diameter of said puncture hole and the second diameter being larger than the diameter of said puncture hole; and
- inserting the introducer sheath into the puncture hole such that the proximal portion contacts an outer surface of the vessel to position a distal end of the introducer sheath at a predetermined distance from an inner surface of the vessel.
16. A method according to claim 15, wherein the method further comprises confirming positioning of the distal end by observing fluid flow from the distal portion to the proximal portion at the proximal portion.
17. A method according to claim 16, wherein the introducer sheath further comprises a first hole provided in the distal portion and a second hole provided in the proximal portion, said first and second holes being in fluid communication with each other through a canal, which is provided in the wall of the introducer sheath.
18. A method according to claim 16, wherein the introducer sheath further comprises a first hole provided in the distal portion and a second hole provided in the proximal portion, said first and second holes being in fluid communication with each other through a canal, which is provided by a longitudinal recess or hole in a dilator or guide rod over which the introducer sheath is threaded.
19. A method according to claim 17, wherein the distance from the first hole to a distal edge of the proximal portion is slightly larger than the thickness of the vessel wall, so that, when said distal edge is in contact with the outer surface of the vessel wall, fluid can flow into the first hole, through the canal and out from the second hole.
20. A method according to claim 18, wherein the distance from the first hole to a distal edge of the proximal portion is slightly larger than the thickness of the vessel wall, so that, when said distal edge is in contact with the outer surface of the vessel wall, fluid can flow into the first hole, through the canal and out from the second hole.
21. A method according to claim 15, wherein the introducer sheath further comprises a transition portion between the distal portion and the proximal portion, the transition portion being configured to prevent the proximal portion from entering the vessel.
Type: Application
Filed: Feb 1, 2013
Publication Date: Jun 6, 2013
Inventors: Per EGNELOV (Phuket), Fredrik PREINITZ (Uppsala)
Application Number: 13/756,752
International Classification: A61B 17/00 (20060101);