Patent Application
20150327871
The present invention relates generally to apparatus and methods for the closing of an access passage opened within a body lumen. More particularly, the present invention relates to techniques for closure of arterial and venous puncture sites, particularly, a radial artery access site.
A number of diagnostic and interventional vascular procedures are now performed translumenally. A catheter is introduced into the vascular system at a convenient access location and guided through the vascular system to a target location using established techniques. Such procedures require vascular access, which is usually established during the well-known Seldinger technique. Vascular access is generally provided through an introducer sheath, which is positioned to extend from outside the patient body into the vascular lumen.
Accessing the vasculature through the radial artery, rather than the larger femoral artery has become increasingly popular as the structures employed in such procedures and introduced into the vasculature become smaller. No matter the access site, when vascular access is no longer required, the introducer sheath is removed and bleeding at the puncture site stopped. Various techniques are currently available for providing hemostasis (the cessation of bleeding).
One approach is to use fasteners, suturing, etc. to close the site. Such techniques can be problematic due to the need to target suture capture for retrieval through the artery or other body lumen wall, which often requires complicated mechanisms. In addition, where the site is a radial artery access site, such fastening or closure devices are typically designed for use in larger access sites, such as a femoral access site, and may thus represent “overkill” in closing a radial access site. In addition, such techniques demand a high level of practitioner skill. Finally, even when performed properly, such procedures may still result in minor oozing from the access tract adjacent the site.
Another approach is to apply external force near and upstream from the puncture site, typically by manual or “digital” compression. This approach is time consuming, frequently requiring one-half hour or more of practitioner compression before hemostasis is assured. Additionally, such compression techniques rely on clot formation, which can be delayed until anticoagulants used in vascular therapy procedures (such as for heart attacks, stent deployment, non-optical PTCA results, and the like) wear off. This can take two to four hours, thereby increasing the time required before completion of a typical compression technique. The compression procedure is further often uncomfortable for the patient, frequently requiring analgesics to be tolerable. Moreover, the application of excessive pressure can at times totally occlude the underlying blood vessel, resulting in ischemia thrombosis, and/or nerve damage.
Thus, compression techniques often require significant time of highly trained individuals, while dedicating such personnel to this task is both expensive and inefficient. As such, there continues to be a need for devices and methods that might provide improved closure of radial access sites.
The present disclosure describes devices, systems and methods for applying targeted force to a radial access puncture site to provide hemostasis and closure of the site. The device may comprise a cuff (e.g., band) for placement over (e.g., around) a wrist of a patient, and an inflatable balloon attached to the cuff and disposed over the radial access puncture site during use. During use, upon inflation, the inflatable balloon applies pressure to the radial access puncture site. The device further includes targeting indicia disposed on at least one of the inflatable balloon or on an optional rigid or semi-rigid member (e.g., the device may optionally include a rigid or semi-rigid member disposed as a backing layer relative to the inflatable balloon). A related system may include such a device, and a fluid source from which an inflating fluid may be delivered into the inflatable balloon associated with the cuff.
The targeting indicia identifies that portion of the balloon to be positioned on the radial access puncture site so that the inflatable balloon applies pressure to the radial access puncture site once inflated. For example, by positioning the indicia over the puncture site, the position and orientation of the inflatable balloon may be precisely positioned for effective hemostasis, as the balloon applies a targeted pressure over the puncture site until hemostasis is achieved. Because the pressure is applied by the balloon and accompanying cuff device of such a device, continuous attendance of a highly trained medical practitioner may not be required.
Another embodiment of a device may include a cuff for placement over a wrist of a patient, an inflatable balloon attached to the cuff and disposed over the radial access puncture site during use, such that the balloon applies pressure to the puncture site during use, a rigid or semi-rigid member disposed between the cuff and the inflatable balloon, and targeting indicia disposed on both the inflatable balloon and the rigid or semi-rigid member. The targeting indicia identifies that portion of the balloon to be positioned over the puncture site so that the balloon applies pressure to the puncture site once inflated, during use.
Another embodiment of the present disclosure is directed to a method for applying targeted force to a radial access puncture site. The method may include placing a cuff of a device for applying targeted force over a wrist of a patient. The device may include a cuff for placement over a wrist of a patient, and an inflatable balloon structure attached to the cuff that is disposed over the radial access puncture site during use. The device further includes targeting indicia disposed on at least one of the inflatable balloon or on an optional rigid or semi-rigid member disposed as a backing layer relative to the inflatable balloon. The targeting indicia identifies that portion of the balloon that should be positioned over the puncture site so that the inflatable balloon applies pressure to the puncture site once inflated. The structures of the cuff device (e.g., the cuff, the balloon structure, a rigid or semi-rigid member, etc.) may be adjusted in position to position the targeting indicia over the puncture site. The inflatable balloon structure may be inflated with an inflating fluid, so that the inflated balloon applies pressure to the puncture site to provide hemostasis of the puncture site while limiting risk of damage to nerves adjacent the puncture site.
These and other objects and features of the present disclosure will become more fully apparent from the following description and appended claims, or may be learned by the practice of the embodiments of the invention as set forth hereinafter.
To further clarify the above and other advantages and features of the present disclosure, a more particular description of the invention will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It is appreciated that these drawings depict only illustrated embodiments of the invention and are therefore not to be considered limiting of its scope. Embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
In one aspect, the present disclosure describes methods, systems, and devices that may be included as part of such systems for applying targeted force to a radial access puncture site to arrest bleeding at the puncture site. Such a device may include a cuff (e.g., band) for placement over a wrist of a patient, and an inflatable balloon attached to the cuff and disposed over the radial access puncture site during use, such that the inflatable balloon applies pressure to the radial access puncture site during use. The device includes targeting indicia disposed on at least one of (i) the inflatable balloon, or (ii) a rigid or semi-rigid member that may optionally be provided (e.g., as a backing layer for the balloon). The targeting indicia identifies that portion of the balloon to be positioned on the puncture site so that the inflatable balloon applies pressure to the puncture site once inflated during use. An associated system may include a cuff device, and a fluid source from which an inflation fluid may be delivered into the inflatable balloon during use.
Referring to
In another embodiment, the cuff 102 may be configured as a continuous round band (e.g., generally circular or other hollow rounded shape) that is received over the wrist. For example, the cuff 102 could comprise an elastic material that would allow it to be expanded as it is advanced over the hand, where it retracts to its original un-expanded configuration once over the wrist. Such a continuous round band could be provided by attaching opposed ends of an elongate band (e.g., as seen in
Inflatable balloon structure 104 may be attached to cuff 102, where balloon 104, and particularly indicia 116 is positioned over the radial access puncture site 106 (e.g., somewhat above the center of the wrist W on the inside of the arm), as seen in
Balloon 104 may be any suitable inflation structure, e.g., that can be inflated upon introduction of an inflation fluid. Inflation of balloon 104 may be achieved using fluid source 110 (e.g., a syringe or other suitable source). In an embodiment, inflation fluid may be delivered through line 108 to balloon 104. In another embodiment, a syringe or other fluid source may be coupled to balloon 104 directly, without an intervening fluid delivery line 108. In an embodiment, a liquid inflation fluid (e.g., water, saline, etc.) is employed, which may provide greater pressure to puncture site 106 than a gaseous fluid (e.g., air, nitrogen, etc.).
In an embodiment, the inflation fluid may be cooled below ambient temperature, to provide cooling to puncture site 106, e.g., to limit inflammation and/or accelerate hemostasis at the site. In another embodiment, cooling may be provided by passing a cooling fluid separate from the inflation fluid through channels formed within the inflation balloon, cuff, rigid or semi-rigid member that backs the balloon, etc. Such cooling channels may be configured to provide separation between the inflation fluid and any cooling fluid. An ice pack or other cooling pack could also be included within the cuff device (e.g., a compartment in the cuff device that receives and retains an ice or cooling pack). In other embodiments, heating could alternatively be provided through similar mechanisms (e.g., heating the inflation fluid, a separate heating fluid, a heating pack, etc.), where heating may be desirable.
In addition, where desired, a hemostatic or coagulating agent may be applied to the puncture site and/or the balloon 104 (e.g., to that portion of balloon 104 that may contact puncture site 106, on indicia 116a, etc.). Examples of such hemostatic and coagulating agents include, but are not limited to aluminum compounds, iron-based compounds, and combinations thereof. Specific examples of such include, but are not limited to potassium aluminum sulfate, aluminum ammonium sulfate, aluminum sulfate, aluminum chlorohydrate, aluminum acetate, aluminum chloride, ferric sulfate, ferric subsulfate, ferric chloride, and mixtures thereof. Other such agents may include permanganates, tannins, zinc chloride, chitosan, etc. In one embodiment a vasoconstrictor such as epinephrine and/or propylhexedrine may also be provided. Such agents may be coated on the balloon, or delivered through pores in an outer layer of the balloon, etc. for delivery to puncture site 106.
In an embodiment, system 100 or device 101 may be provided in a single sterilized kit (e.g., a package including the cuff, attached balloon, fluid delivery lines, fluid source, etc.) In another embodiment, the cuff and balloon device 101 may be employed with existing tubing, syringes, other fluid sources, etc. commonly found in a catheterization lab, hospital, or similar clinical facility.
Cuff device 201 is further shown as including alignment notches 236 on one or both peripheral edges of the elongate cuff 202, formed in the perimeter edge of a rigid or semi-rigid member 114 which acts as a backing member for balloon 104. Notches 236 may be positioned so that the vertex of notches 211 are aligned with one another, and with the portion of inflatable balloon 104 (e.g., indicia 116b) to be positioned over puncture site 106. Such notches 211 may further aid the practitioner in correctly placing and positioning cuff 202. It will be appreciated that markings visible on the perimeter edge, rather than necessarily notches, may be employed for the same purpose. Of course, both may be provided (e.g., notches with marked or colored edges). One or both of respective ends of strap shaped cuff 202 may include self-adhesive, VELCRO 103, or other suitable mechanism for attachment of the opposed ends together.
Member 114 may be localized (e.g., smaller than cuff 102 and/or balloon 104), or may generally match the configuration or surface area (e.g., footprint) covered by balloon 104. For example, rigid or semi-rigid member 114 may extend to or past an outer peripheral edge 105 of balloon 104. In another embodiment, the outer peripheral edge of member 114 may be disposed within the perimeter defined by balloon 104 (e.g., being localized to the puncture site 106 and immediate surrounding tissue). For example, in such an embodiment, the footprint of balloon 104 may be larger than that of member 114. In the illustrated embodiment, rigid or semi-rigid member 114 is configured so as to be a backing support layer on which balloon 104 is disposed.
Cuff 102 may include multiple discontinuous portions, with member 114 disposed therebetween, as seen in
In the embodiment illustrated in
While shown with a rigid or semi-rigid member 114, it will be appreciated that in another embodiment no such member 114 may be present. For example, balloon 104 may be attached directly to cuff 102, without any member 114, and indicia 116 may be provided on balloon 104. In an embodiment, such a cuff may be transparent or translucent to allow viewing therethrough. In another embodiment, the cuff could be discontinuous or include a hole or window therethrough, allowing viewing of the indicia on balloon 104. Even where a rigid or semi-rigid member 114 is present, in an embodiment, at least a portion of balloon 104 may be directly attached to cuff 102 (e.g., as seen in
Balloon 104 may be particularly configured to apply a compression force to puncture site 106, while indicia 116 (e.g., cross-hairs as shown, or other markings, such as a bulls-eye, target, a letter, symbol, or other character) may aid in positioning balloon 104 and cuff 102 so as to target the applied force to site 106. For example, in accessing the radial artery through a radial access puncture site, a relatively small needle (e.g., about 0.03 inch in outside diameter) may be used, and introducer wires, catheters, sheaths, and other structures employed in forming the small puncture site and initiating access to the radial artery may be typically quite small (e.g., up to about 0.04 or 0.05 inch in outside diameter). A catheter sheath introduced into the radial artery may be somewhat larger, but still significantly smaller than those introduced into the femoral artery, as the radial artery is much smaller. For example, such a sheath may be up to about 6 Fr (about 2 mm, or about 0.08 inch) in outside diameter. Because the puncture site is typically relatively small in area, bleeding from puncture site 106 may be arrested through compression, and the patient may even be allowed to stand and walk soon after the intravascular procedure. This is in sharp contrast to closure after femoral access, where the patient may be required to remain still for several hours (e.g., at least about 5 hours) after the intravascular procedure is complete.
Balloon 104 may be configured to apply pressure to puncture site 106 and a small adjacent area surrounding puncture site 106 on wrist W. For example, in an embodiment, system 100 and device 101 may apply targeted pressure to a region having an area of about 5 in2 or less, 3 in2 or less, about 2 in2 or less, about 1 in2 or less, about 0.75 in2 or less, or about 0.5 in2 or less. The magnitude of applied pressure may be sufficient to provide hemostasis and closure of the puncture site, while not being so great as to cause nerve damage.
By providing indicia 116 on both balloon 104 and rigid or semi-rigid backing member 114, the practitioner may be provided an indication as to when the appropriate magnitude of pressure is achieved by alignment of indicia 116a, 116b and puncture site 106. For example, As seen in
Indicia 116a may be particularly provided so that upon inflation of balloon 104 to a level where indicia 116a becomes aligned with puncture site 106 (e.g., and indicia 116b where indicia is also provided on member 114), an appropriate magnitude of force is applied to site 106 so as to result in the desired hemostasis and closure of puncture site 106. By providing a configuration where alignment (e.g., coaxial alignment between site 106 and one or more indicia 116) corresponds to application of an appropriate force level, risk of nerve damage due to application of excessive compressive force may be reduced.
As seen in
Inflation of balloon 104 may be achieved by introducing a suitable inflation fluid from a fluid source 110 (e.g., a syringe or other source) directly into balloon 104, or through delivery line 108, inflating balloon 104 so as to cause balloon 104 to extend from cuff 102 and compress against wrist W, particularly site 106.
Indicia 116 may include any marking (e.g., symbol, character, etc.) or other indication (e.g., providing a portion of balloon 104 with a color that differs as compared to adjacent portions of balloon 104) providing a visually differentiable “landmark” to be aligned over puncture site 106 that can be referenced by a practitioner during placement and use. For example, the balloon 104 may include regions of different colors (e.g., colored (e.g., red, green, blue, yellow, pink, white, etc. in one portion, and another color or clear in another portion) to aid in targeting. Colored portions may be lightly tinted, so as to still be transparent or translucent, allowing a practitioner to see therethrough. The vicinity surrounding one or more of indicia 116 may be of a color that differs from the rest of the balloon. In an embodiment, indicia 116a and 116b may be of different colors, so that when they align, a third color results. For example, where one is blue, and one is yellow, and on alignment, the aligned indicia appears green, or one is blue, and one is red, and on alignment, the aligned indicia appears purple.
In an embodiment, the balloon may exhibit one color under a first inflation pressure and another color under a second inflation pressure, the second inflation pressure signifying a desired pressure to aid with hemostasis while limiting risk of damage to nerves adjacent the puncture site. For example, a lighter shade of color, or greater degree of transparency or translucency (e.g., red to pink, or opaque red to transparent/translucent red) may be apparent at the second, higher inflation pressure as compared to a first (e.g., nearly deflated) pressure. Upon visually seeing the second color, lighter color shade, or greater degree of transparency/translucency (all referred to herein as a second color for simplicity), the practitioner knows that the desired pressure is being applied.
While two indicia 116 are shown, one on balloon 104 and one on member 114, it will be appreciated that a similar coaxial alignment may be achieved with placement of indicia 116a on an upper surface of balloon 104 as shown, and placement of indicia 116 on a lower surface of the balloon 104.
The geometry of balloon 104 may be as desired. For example, in an embodiment, balloon 104 may cover about 50% or more of the inside of wrist W, as seen in
In an embodiment, balloon 104 may have a size and shape so as to be disposed only over a small area surrounding puncture site 106, rather than the entire wrist W. For example, typically, the radial access puncture site is disposed in an upper left quadrant of the wrist W (or upper right for a wrist of a left hand). As such, balloon 104 may simply cover this portion of the wrist, surrounding the puncture site, rather than the entire, or a large fraction (e.g., 50% or more) of wrist W. In any case, balloon 104 may be such so as to correspond to the position of the radial access puncture site, as cuff 102 is placed over wrist W. The balloon 104 may represent only a relatively small fraction of the overall surface area of wrist W as a whole, so as to apply force to only a small target area at the puncture site 106. For example, balloon 104 may have a footprint that is less than about 50%, less than about 40%, less than about 30%, less than about 25%, or less than about 20% of the surface area of the inside surface of wrist W.
The geometric shape of balloon 104 may be of any desired shape. For example, while
The balloon 104 as a whole may have a size that is not larger than so as to cover the inside surface of the wrist (e.g., without wrapping around towards the front of the arm). For example, it may be not more than about 1 inch wide and about 2 inches long. As described above, alternatively, the balloon may cover only a small fraction of the inside surface of the wrist W, which is generally planar. The rigid or semi-rigid member 114 may be similarly sized and shaped as a generally planar sheet-like member, particularly where its rigidity may prevent it from readily wrapping around the arm towards the front of the arm. In another embodiment, member 114 may include a non-planar portion, pre-shaped with a curvature to accommodate curvature of the wrist associated with the transition from the inside of the wrist towards the opposite face of the wrist.
Placement of indicia 116 on balloon 104 and/or member 114 may be as desired. For example, particularly where at least those portions of balloon and member 114 surrounding indicia 116a and 116b, respectively, are transparent or translucent, indicia may be disposed on an outside and/or inside surface of balloon 104 and/or member 114, as desired. For example,
The system and device may be specifically configured to apply targeted pressure over the relatively small puncture site, and optionally a small area surrounding the puncture site, so as to achieve hemostasis and close puncture site 106, while limiting unneeded pressure so as to reduce risk of nerve damage or other unwanted complications or side-effects. Embodiments including features as part of the balloon or other portions of such a device or system, such features applying a targeted force, are disclosed in a U.S. patent application Ser. No. ______ bearing attorney Docket No. 16497.260, filed the same day as the present application, and herein incorporated by reference in its entirety. Such features may include, but are not limited to (i) providing the balloon with varying wall thickness, with a thinner-walled portion that applies a focused pressure to the puncture site, (ii) two balloons where one applies focused force, or (iii) an outer sheath with a hole placed over the balloon so that a portion of the balloon protrudes through the hole and applies focused force. In such embodiments, the targeting indicia may be disposed on or over the feature providing focused, targeted force (e.g., (i) on the thin-walled portion of the balloon, (ii) on the (e.g., smaller) balloon applying focused force, or (iii) on the portion of the balloon that protrudes through the hole of an accompanying sheath. The targeting indicia on the balloon or other portions of the cuff device described herein could be thickened, shaped or stiffened (e.g., relative to structure adjacent to the indicia) to apply focused pressure, e.g., similar to the embodiments described in application Ser. No. ______ Docket No. 16497.260.
The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.
