METHODS AND APPARATUS FOR INHIBITING INTRODUCTION OF AIR INTO THE VASCULATURE DURING A PERCUTANEOUS PROCEDURE
Apparatus and methods for inhibiting the introduction of air into the body during a percutaneous procedure.
This application claims the benefit of U.S. Provisional Application Ser. No. 61/036,437 filed Mar. 13, 2008 and entitled “Methods And Apparatus For Inhibiting Introduction Of Air Into The Vasculature During A Percutaneous Procedure,” which is incorporated herein by reference in its entirety.
FIELD OF THE INVENTIONSThe disclosed inventions pertain to methods and apparatus for inhibiting the introduction of air into the vasculature of a patient during percutaneous procedures such as, for example, percutaneous diagnostic, therapeutic and interventional procedures.
BACKGROUNDFor many diagnostic, therapeutic, or interventional percutaneous procedures involving the human vasculature, maintaining hemostasis is critical not only to prevent loss of blood, but also to prevent the introduction of air into the patient's vasculature system. Devices such as angioplasty balloon catheters, coronary guidewires, radio frequency (RF) ablation catheters, cryo-therapy catheters, and neurovascular occlusive device delivery catheters are just a sample of what is commonly used percutaneously to treat a wide variety of illnesses. The introduction of air into the blood stream can be quite serious, resulting in a stroke if it is allowed to migrate to the heart or brain (depriving the tissue of oxygenated blood).
The present inventor has determined that introduction of air through the hemostasis valve E into the hub H for possible downstream migration to the vasculature may happen for a number of reasons. With reference to
The present inventor has also determined that it would be desirable to avoid this introduction of air into the interior hub H of the access device D, since this air can migrate through the distal shaft F and into the patient's vasculature.
SUMMARYThe present methods and apparatus inhibit the above-described introduction of air into the vasculature during percutaneous procedures by, in at least some embodiments, creating a sterile fluid flow (mixing with the patient's blood) in a proximal portion of the access device or of an adjunct device coupled to the proximal end of the vascular access device, through which the various instruments are passed. The present methods and apparatus are suitable for a wide range of percutaneous applications, including ones not involving the vasculature, whenever inhibiting the introduction of air into the body is desired.
In one embodiment, a “degassing section” is located in a proximal end portion of the vascular access device, for example just distally of the hemostasis valve through which the various instruments may be introduced. The degassing section may be part of a system for inhibiting the introduction of air into the body during a percutaneous procedure that also includes a container supplied with sterile fluid (e.g., a plastic bag of hepanized saline). The system may also include a supply line, which has a first end in fluid communication with the sterile fluid container and a second end in fluid communication with the degassing section, and a return line, which has a first end in fluid communication with the degassing section and a second end in fluid communication with the sterile fluid container. A closed-loop fluid circulation system may be formed by the degassing section of the access device, the container, and the supply and return lines. A pump, such as a peristaltic pump, may be provided along the supply line to cause circulation of the sterilized fluid through the degassing section, for example in a distal-to-proximal direction, i.e., with the supply line in fluid communication with a more distal portion of the degassing section than the return line. In particular, air bubbles that may be introduced into the access device through the proximal end hemostasis valve are collected by the circulating flow of sterile fluid in the degassing section and pushed through the return line into the sterile fluid container.
In one embodiment, the degassing section is incorporated into a proximal handle of a vascular access sheath. The sheath may be of a type introduced “bareback” into the vasculature (as is well-known), and has an interior working lumen passing through the handle through which various elongate instruments (e.g., stylet/dilator sets, guidewires and catheters) are introduced into the vasculature through a hemostasis valve located in a proximal end of the handle. The respective supply and return lines are coupled to the handle, with the supply line placed in fluid communication with the interior working lumen of the sheath in a distal portion of the handle, and the return line placed in fluid communication with the interior working lumen in a proximal portion of the handle, the section of the working lumen between the respective supply and return lines defines the degassing section.
In another embodiment, the degassing section is incorporated into an adjunct device that is coupled to a distal end of a standard vascular access device (or sheath). The adjunction device has a distal end opening that is coupled in a fluidly-sealed manner to the proximal hemostasis valve of the vascular access device (or sheath). The adjunct device comprises its own proximal end hemostasis valve through which the various elongate instruments are introduced, passing through the adjunct device degassing section, which may be defined by a lumen within the device, then through the access device hemostasis valve and into the vasculature. The respective supply and return lines may be coupled to the adjunct device with the supply line in fluid communication with a distal end portion of the interior degassing section and the return line in fluid communication with a proximal end portion of the interior degassing section.
In variations of the above embodiments, the respective supply and return lines may be provided in a co-axial arrangement to reduce the number of individual fluid flow lines coupled to the vascular access device. Alternatively, the fluid supply line may be gravity fed into the degassing section of the vascular access device or adjunct device (with no pump needed), and instead of a return line to the sterile fluid container, the fluid outflow from the degassing section may be gravity expelled to a drain line.
The above described and many other features of the present inventions will become apparent as the inventions become better understood by reference to the following detailed description when considered in conjunction with the accompanying drawings.
Detailed descriptions of exemplary embodiments will be made with reference to the accompanying drawings. The systems and apparatus shown in the drawings are not necessarily drawn to scale, with emphasis instead being placed on illustrating the various aspects and features of the depicted embodiments.
The following is a detailed description of the best presently known modes of carrying out the inventions. This description is not to be taken in a limiting sense, but is made merely for the purpose of illustrating the general principles of the inventions.
A return line 56 has a first end 64 in fluid communication with the degassing section 66 of the device 58 (e.g. by way of a port) and a second end 61 in fluid communication with the sterile fluid container 50. A closed-loop fluid circulation system is defined by the fluid container 50, the supply and return lines 53 and 56, and the degassing section 66. A peristaltic pump 54, or other suitable pump, is provided along the supply line 56 to cause circulation of sterilized fluid 52 through the degassing section 66 in a distal-to-proximal direction that is the same direction as blood flow from the patient (i.e. is antegrade), as indicated by arrows 55 and 57. In particular, air bubbles B that may be introduced into the access device through the proximal end hemostasis valve 69 are collected by the circulating flow of sterile fluid 52 in the degassing section 66 and pushed through the return line 53 into the sterile fluid container 50. The locations of the junctions 51 and 61 of the respective supply and return lines 53 and 56 may be spaced apart on the container 50, as shown, to prevent the air bubbles B pushed into the container 50 through the return line 56 from re-entering the degassing section 66 through the supply line 53.
The return line 56 and container 50 may be formed from a clear plastic material to allow for visual confirmation that air bubbles B are being removed from the degassing section 66 and pushed through the return line 56 into the container 50. It should also be appreciated that many variations of the exemplary embodiment illustrated in
Referring to
The exemplary connector 30 includes a tubular portion 31 with a lumen 32, which may be connected to the supply line 53, and an annular portion 33, which delivers fluid to the sheath lumen 70. Referring more specifically to
It should be noted that the connectors 30 and 39 are located at the distal and proximal ends 77 and 85 of the handle 75 and define the distal and proximal ends of the degassing section 66a. As such, all fluid flow though the degassing section 66a is distal-to-proximal, i.e. away from the vasculature. As such, air bubbles B that may be introduced into the sheath lumen 70 through the proximal end hemostasis valve 84 are collected by the circulating flow of sterile fluid in the degassing section 66a, as indicated by flow arrows 72, 74 and 76, and are pushed into the return line 56. A variety of modifications may be made to this embodiment. By way of non-limiting example, the fluid connection between the supply line 53 and the sheath lumen 70 may be accomplished by means other than the openings 78, for example, by using a convention “Y” connector or other type of inlet port. It should also be noted that the exemplary embodiment illustrated in
The exemplary handle 75a illustrated in
One example of an adjunct device that may be coupled to the distal end of standard vascular access device, and employed in the system illustrated in
The exemplary adjunct device 100 illustrated in
Another exemplary system for inhibiting the introduction of air into a vascular access device and a patient's vasculature is generally represented by reference numeral 180 in
In contrast to the exemplary system 40 illustrated in
A specialized peristaltic pump 240 is provided along the coaxial supply/return line 210/225, to cause circulation of the sterilized fluid 202 through the degassing section 66a a distal-to-proximal direction, as indicated by the flow arrows 207 and 217. Air bubbles B that may be introduced into the access device through the proximal end hemostasis valve 84 are collected by the circulating flow of sterile fluid 202 in the degassing section 66a (arrow 207) and pushed through the return line 225 into the sterile fluid container 200 (arrows 228). With reference also to
The respective ends of the supply and return lines 210 and 225 may be spaced apart sufficiently within the container 200 to prevent the air bubbles B being pushed out the return line 225 from re-entering the degassing section 66a through the supply line 210. This may be accomplished in a variety of ways. Foe example, as illustrated in
It will be apparent to those skilled in the art that the inventions may be embodied in other specific forms besides and beyond those described herein. The foregoing embodiments are therefore to be considered in all respects illustrative rather than limiting.
Claims
1. A system, comprising:
- a device defining a distal end and a proximal end and including a distal hemostasis valve associated with the distal end, a proximal hemostasis valve associated with the proximal end, an instrument passage lumen located between the hemostasis valves and defining a degassing region with a distal end and a proximal end, an inlet port in fluid communication with degassing region distal end and an outlet port in fluid communication with degassing region proximal end;
- a source of fluid; and
- a supply line having a first end in fluid communication with the fluid source and a second end in fluid communication with the inlet port.
2. A system as claimed in claim 1, wherein
- the fluid source comprise a container at least partially filled with fluid; and
- the system further comprises a return line having a first end in fluid communication with the outlet port and a second end in fluid communication with the container such that fluid flowing through the outlet port is discharged into the container.
3. A system as claimed in claim 2, wherein the return line is at least partially disposed coaxially within the supply line.
4. A system as claimed in claim 1, further comprising:
- a circulation pump along the supply line.
5. A system as claimed in claim 1, wherein
- the device comprises an introducer sheath including a proximal handle and a guide sheath that defines the instrument passage lumen; and
- the inlet and outlet ports are associated with the handle.
6. A system as claimed in claim 1, wherein
- the degassing region distal end abuts the distal hemostasis valve; and
- the degassing region proximal end abuts the proximal hemostasis valve.
7. A system, comprising:
- a device defining a distal end and a proximal end and including a proximal hemostasis valve associated with the proximal end, an instrument passage lumen extending through the device and defining a perimeter and a degassing region with a distal end and a proximal end, an inlet port that delivers fluid into degassing region from a plurality of locations around the perimeter of the instrument passage lumen and an outlet port in fluid communication with degassing region proximal end
- a container at least partially filled with a fluid;
- a supply line having a first end in fluid communication with the fluid container and a second end in fluid communication with inlet port; and
- a return line having a first end in fluid communication with the instrument passage lumen and a second in fluid communication with the fluid container.
8. A system as claimed in claim 7, further comprising:
- a circulation pump operatively coupled to the supply line.
9. A system as claimed in claim 7, wherein
- the device comprises an introducer sheath including a proximal handle and a guide sheath that defines the instrument passage lumen; and
- the inlet and outlet ports are associated with the handle.
10. A system as claimed in claim 7, wherein the return line is at least partially disposed coaxially within the supply line.
11. A system as claimed in claim 7, wherein the inlet port includes an annular lumen that extends around the perimeter of the instrument passage and a plurality of spaced openings that are connected to the annular lumen.
12. A system as claimed in claim 11, wherein the inlet port is associated with the distal end of the degassing region.
13. A system as claimed in claim 12, further comprising:
- a distal hemostasis valve associated with the distal end of the device.
14. A method for inhibiting the introduction of air into a body passage during a percutaneous procedure, the method comprising the step of:
- pushing air bubbles out of a vascular access device by circulating a fluid in only an antegrade direction in a proximal portion of the vascular access device to an outlet port.
16. A method as claimed in claim 14, further comprising the steps of:
- supply fluid from a container to the vascular access device; and
- returning fluid from the outlet port to the container.
17. A device for use in a vascular access procedure, the device comprising:
- a housing defining a distal end and a proximal end and having an instrument passage lumen extending from the distal end to the proximal end;
- a distal hemostasis valve associated with the distal end of the housing;
- a proximal hemostasis valve associated with the proximal end of the housing;
- an inlet port associated with the housing distal end, proximal of the distal hemostasis valve and in fluid communication with the instrument passage lumen; and
- an outlet port proximal of the inlet port and in fluid communication with the instrument passage lumen.
18. A device as claimed in claim 17, wherein
- the instrument passage lumen defines a longitudinal axis and a perimeter that extends around the longitudinal axis; and
- the inlet port delivers fluid from a plurality of locations around the perimeter of the instrument passage lumen.
19. A device as claimed in claim 18, wherein the inlet port includes an annular lumen that extends around the perimeter of the instrument passage lumen and a plurality of spaced openings that are connected to the annular lumen.
20. A device as claimed in claim 19, wherein the inlet port is associated with the distal end of the instrument passage lumen.
21. A device as claimed in claim 17, further comprising:
- at least one brush located within the instrument passage lumen.
22. A device as claimed in claim 17, wherein
- the housing comprises a vascular access device handle; and
- the instrument passage lumen is defined by a sheath having a portion thereof within the vascular access device handle.
23. A device as claimed in claim 17, wherein the housing is configured to be secured to a vascular access device.
Type: Application
Filed: Sep 14, 2012
Publication Date: Apr 25, 2013
Inventor: James R. Watson (Santa Rosa, CA)
Application Number: 13/620,695
International Classification: A61M 5/36 (20060101);