Patent Application
20160174952
The field of the invention is systems and methods for providing patent hemostasis in arteries after an interventional procedure, such as angioplasty, guided by a medical imaging technique, such as angiography. More particularly, the invention relates to systems and methods for providing occlusive pressure to one artery in a patient's wrist (e.g., the ulnar artery or the radial artery) and patent hemostasis to another artery in the patient's wrist (e.g., the radial artery or the ulnar artery) using a vascular hemostatic device that is configured to simultaneously compress both the ulnar and radial arteries.
When a procedure involving the percutaneous insertion of an instrument, such as a catheter into a blood vessel, is carried out for medical treatment, examination or diagnosis, bleeding at the puncture site following subsequent withdrawal and removal of the catheter must be stopped. Hemostatic devices that are attached by being wrapped around the portion of an arm where the puncture site is located, thereby compressing the puncture site where bleeding is to be stopped, are known. However, many conventional hemostatic devices are configured to stop bleeding at the puncture site by applying pressure only to the site where percutaneous insertion of an instrument occurred by using an inflatable balloon to apply the pressure to the puncture site.
Radial artery occlusion (RAO) is a common complication post trans-radial access (TRA) catheterization, affecting up to ten percent of the patients. As most parts of the hands have a dual blood supply through the ulnar and radial artery, RAO remains undetected for various reasons. First, the ulnar artery provides collateral feeding to the affected part of the hand, thereby making RAO more difficult to detect. In addition, patients are often not checked for the patency of the radial artery post TRA intervention. RAO not only poses ischemic complication to the hand, if blood flow through the ulnar artery is significantly diminished or blocked, but also prevents any future interventions through TRA. Undetected RAO may also render the ipsilateral ulnar artery unusable for instrumenting and cannulating the ulnar artery, which is the last remaining major artery supplying blood to the hand, as any compromise in the ulnar artery patency can expose the patient's hand at further risk of ischemia.
To prevent RAO, a delicate balance needs to be achieved between stopping the bleeding at the vascular access site and simultaneously allowing blood to flow through the radial artery, what is described as “patent hemostasis.” In addition to RAO, after TRA intervention the radial artery caliber reduces, likely due to intimal hyperplasia, and such vascular changes can potentially interfere with any future intervention through the same vascular access. While conventional hemostatic devices stop the bleeding, these devices are not adapted to ensure that the necessary blood flow through the radial artery is maintained, thereby leading to RAO or affecting radial artery caliber.
It would therefore be desirable to provide a system and method for a vascular hemostatic system aimed at maintaining patent hemostasis by compressing radial artery adequately enough to stop bleeding, while still allowing blood flow through the artery at the same time. Such mechanism will significantly reduce RAO or reduction in caliber of the vessel and eventually ischemic complications to the hand.
The present invention overcomes the aforementioned drawbacks by providing a system for applying occlusive pressure to the ulnar and radial artery using a vascular hemostatic device capable of simultaneously or independently compressing the ulnar and radial arteries. The vascular hemostatic device creates sufficient pressure on the radial and ulnar artery, but not the tissue in-between, resulting in patent hemostasis.
It is an aspect of the invention to provide a hemostatic device including a flexible band, which includes an inner surface, for enclosure about the wrist at a puncture site. A first balloon and a second balloon are coupled to the inner surface of the flexible band. The second balloon is positioned relative to the first balloon such that a distance between the first balloon and the second balloon results in the first balloon being positioned proximal a first artery and the second balloon being positioned proximal a second artery when the flexible band is enclosed about the wrist. Upon inflation of the first balloon and the second balloon, patent hemostasis can be achieved in the first artery while occlusive pressure is generated on the second artery. By adjusting pressure in the first balloon, the second balloon, or both, patent hemostasis can therefore be achieved. As one example, the first artery may be the radial artery and the second artery may be the ulnar artery. As another example, the first artery may be the ulnar artery and the second artery may be the radial artery.
The foregoing and other aspects and advantages of the invention will appear from the following description. In the description, reference is made to the accompanying drawings, which form a part hereof, and in which there is shown by way of illustration a preferred embodiment of the invention. Such embodiment does not necessarily represent the full scope of the invention, however, and reference is made therefore to the claims and herein for interpreting the scope of the invention.
Described here are systems and methods for achieving patent hemostasis in the arteries of a patient's wrist following an interventional procedure, such as an angioplasty. In general, the system includes a flexible band to which two balloons are coupled. The balloons are positioned relative to each other such that when the flexible band is enclosed around the patient's wrist, the first balloon is positioned proximal to the radial artery and the second balloon is positioned proximal to the ulnar artery. The pressure in the balloons can be controlled such that occlusive pressure can be achieved in the ulnar artery while maintaining non-occlusive pressure in the radial artery, thereby achieving patent hemostasis in the radial artery.
Currently available hemostatic devices utilize a single balloon to achieve occlusive pressure following an interventional procedure. The pressure in this balloon is reduced in incremental steps and at timed intervals following a procedure. At each reduced pressure level, if there is no bleeding present, then the reduced pressure will be maintained until the next pressure reduction. Otherwise, an increased pressure is maintained until the next time interval has passed. This process can be very time consuming, often requiring up to two hours and multiple checks on the patient and adjustments of the pressure supplied by the device.
The systems and methods described here, however, overcome the drawbacks of these earlier devices by providing control over the pressures applied to both the radial and ulnar arteries in a patient's wrist. With this dual control, patent hemostasis can be achieved in the radial artery while maintaining occlusive pressure in the ulnar artery. The advantage of this setup is that these pressures can be maintained until bleeding has stopped, which can be achieved without the frequent checkups and pressure changes require by currently available devices.
Referring now to
In general, the hemostatic device 10 is configured such that the first balloon 20 and the second balloon 22 are coupled to the flexible band 16 and spaced apart by a distance, D. This distance is selected such that when the flexible band 16 is enclosed around a patient's wrist 14, the first balloon 20 will be positioned proximal to a first artery and the second balloon 22 will be positioned proximal to a second artery. As an example, the first and second arteries can include the radial and ulnar arteries.
Referring again to
The band fasteners 18a, 18b may be positioned on opposing ends of the flexible band 16, as shown in
The first balloon 20 may be positioned on the inner surface 28 of the flexible band 16 adjacent the band fastener 18b, as shown in
The first balloon 20 may be in the form of one or more sheets, for example, that are sealed together by any suitable process, such as adhesion, to form a first cavity 32, as shown in
The first balloon 20 may be coupled to the flexible band 16 by a first connector 34 provided on the inner surface 28 of the flexible band 16. The first connector 34 may be a fixed connector, such that the first balloon 20 remains stationary relative to movement of the second balloon 22. In one example, the first connector 34 may secure the first balloon 20 to the inner surface 28 of the flexible band 16 via any suitable adhesion technique. As one example, the first connector 34 may include welding the first balloon 20 to the inner surface 28 of the flexible band 16. Other suitable securing mechanisms include, but are not limited to Velcro®, snaps, buttons, clips, and the like.
As shown in
In some embodiments, the first balloon 20 may include a first bladder 40 positioned in the first cavity 32. The first bladder 40 may be liquid-filled, for example. As in other embodiments, inflation of the first cavity 32 may result in occlusive pressure applied to the radial artery 42, as will be described in further detail below. Upon inflation of the first cavity 32, the first bladder 40 may be positioned or otherwise located proximal to a radial artery 42 that is positioned above a radius bone 43 of the wrist 14. As will be described below, the first bladder 40 can be configured to allow visual inspection of the patient's pulse. For example, the first bladder 40 can be filled with a liquid or gel having a viscosity that is suitable to indicate pulsations caused by the patient's pulse. In some embodiments, the liquid or gel used to fill the first bladder 40 can be colored to provide additional visualization of the patient's pulse. In this configuration, the hemostatic device 10 thus includes a simple visual indication of whether there is pulsatile flow passing through the radial artery 42. Absence of a visual indication of a pulse in the first bladder 40 can thus indicate occlusion in the radial artery 42.
To help align the first bladder 40 with the radial artery 42, a first marker 44 may be provided on the first balloon 20 for positioning the first balloon 20 at the puncture site 12 where bleeding is to be stopped (i.e., the radial artery 42). In one non-limiting example, the first marker 44 may be characterized by a color that enables the first balloon 20 to be properly positioned at the puncture site 12.
Similar to the first balloon 20, the second balloon 22 may be positioned on the inner surface 28 of the flexible band 16 adjacent the band fastener 18a, as shown in
In some embodiments, the second balloon 22 may be in the form of one or more sheets that are sealed together by any suitable process, such as adhesion, to form a second cavity 48, as shown in
The second balloon 22 may be coupled to a second connector 50 provided on the outer surface 30 of the flexible band 16. The second connector 50 may be an adjustable connector configured to engage a plurality of fasteners 52a, 52b, 52c, 52d. In one example, the plurality of fasteners 52a, 52b, 52c, 52d can be provided on the outer surface 30 of the flexible band 16 in order to connect the second balloon 22 to the flexible band 16. In the example shown in
By utilizing an adjustable connector for the second connector 50, the second balloon 22 may be translated along, and re-attached to, the flexible band 16 such that a distance, D, between the first balloon 20 and the second balloon 22 may be adjusted. Advantageously, this configuration of the hemostatic device 10 allows the device to be used on various sizes and shapes of wrists 14, and to accommodate varying locations of the radial artery 42 and the ulnar artery 46 to which the first balloon 20 and the second balloon 22, respectively, should align.
As shown in
In some embodiments, the second balloon 22 may include a second bladder 62 positioned in the second cavity 48. The second bladder 62 may be liquid-filled, for example. As in other embodiments, inflation of the second cavity 48 may result in occlusive pressure applied to the ulnar artery 46, as will be described in further detail below. Upon inflation of the second cavity 48, the second bladder 62 may be proximal to the ulnar artery 46 that is positioned above an ulnar bone 47 of the wrist 14. As will be described below, the second bladder 62 can be configured to allow visual inspection of the patient's pulse. For example, the second bladder 62 can be filled with a liquid or gel having a viscosity that is suitable to indicate pulsations caused by the patient's pulse. In some embodiments, the liquid or gel used to fill the second bladder 62 can be colored to provide additional visualization of the patient's pulse. In this configuration, the hemostatic device 10 thus includes a simple visual indication of whether there is pulsatile flow passing through the ulnar artery 46. Absence of a visual indication of a pulse in the second bladder 62 can thus indicate occlusion in the ulnar artery 46.
To help align the second bladder 62 with the ulnar artery 46, a second marker 64 may be provided for positioning the second balloon 22 at the ulnar artery 46 where intra-arterial blood flow is to be stopped. In one non-limiting example, the second marker 64 may be characterized by a color that enables the second balloon 22 to be properly positioned and aligned with the ulnar artery 46.
Having generally described several different embodiments of a hemostatic device for achieving patent hemostasis, an example of a method for using such a hemostatic device 10 to achieve patent hemostasis is now described. Once the interventional procedure (e.g., angioplasty) is completed and the sheath (not shown) is removed, the hemostatic device 10 is attached to the patient's wrist 14. To attach the hemostatic device 10 to a patient's wrist 14, the first balloon 20 and the second balloon 22 are placed in a deflated state over the radial artery 42 and ulnar artery 46, respectively. A user may then wrap the flexible band 16 around the wrist 14, and secure the flexible band 16 near both ends thereof with the band fasteners 18a, 18b. Once the hemostatic device 10 is securely attached to the patient's wrist 14, the first balloon 20 covering the radial artery 42 may be filled with air, for example, to apply a first occlusive pressure P1 (see
Once the first balloon 20 and the second balloon 22 are filled to the desired pressure to achieve occlusion of the radial artery 42 and ulnar artery 46, respectively, the corresponding valves 38, 60 may be closed to inhibit leakage of air from the first cavity 32 and/or the second cavity 48. Thus, the first balloon 20 and the second balloon 22 will maintain compression against the radial artery 42 and the ulnar artery 46 (see
Subsequently, pressure P1 may be released from the first balloon 20 covering the radial artery 42 until a blood spurt from the puncture site 12 of the radial artery 42 underneath the first balloon 20 is seen. In this manner, the amount of pressure required to completely occlude the radial artery 42 is demonstrated, and the spurt of blood that is flowing ante-gradely will flush out any thrombus present at the site of sheath insertion. Once blood flow has been observed, the pressure P1 in the first balloon 20 may be increased to stop any further bleeding by introducing additional air (e.g., a few cc) through the first inflator 24 into the first balloon 20 covering the punctured, radial artery 42.
At this point, blood supply to the hand is maintained only through the radial artery 42, as the adequate pressure P2 on the ulnar artery 46 has been maintained to completely stop the ante-grade flow. In one example, the transition from a pale hand (i.e., lack of blood supply) at the time of occlusion of both the radial artery 42 and the ulnar artery 46 changing to red demonstrates that the blood supply to the hand has been restored by reducing the pressure P1 on the radial artery 42. In alternative embodiments, pulse oximetry on the fingers or thumb can be used to provide appropriate tracking of the blood supply. Similarly, observing the color in the palm of the hand can indirectly demonstrate maintained blood supply to the hand.
The pressure P1 from the first balloon 20 covering the radial artery 42 may be gradually released, thereby removing the pressure P1. As one example, the pressure P1 can be gradually released in about an hour. The timing for complete removal of the pressure P1 depends on several factors. Some example factors include, but are not limited to, how much heparin is given to the patient during the procedure and the systemic blood pressure. Once it is confirmed that good hemostasis has been achieved in the radial artery 42, the pressure P2 from the second balloon 22 covering the ulnar artery 46 can be removed. At this point, secured hemostasis will have been achieved and patent and ante-grade flow through the radial artery 42 will have been maintained.
In one non-limiting example, the first balloon 20 and the second balloon 22 may incorporate the first bladder 40 and the second bladder 62, respectively. The first bladder 40 and the second bladder 62, as previously described, may be liquid-filled bladders on the side proximal to the radial artery 42 and the ulnar artery 46. Once the pressure P1, P2 in the balloon 20,22 reaches a predetermined pressure, but before the artery 42, 46 is occluded, the liquid-filled bladder 40, 62 may provide visual inspection of the pulse. Occlusion of the artery 42, 46 may be indicated by the absence of a pulse. Additionally or alternatively, the liquid within the bladder 40, 62 may be colorful for better observation of the pulse. In yet another example, the liquid may be a gel characterized by a viscosity allowing visualization of the pulse.
The present invention has been described in terms of one or more preferred embodiments, and it should be appreciated that many equivalents, alternatives, variations, and modifications, aside from those expressly stated, are possible and within the scope of the invention.
