Patent Application
20140257359
The present disclosure relates to tissue puncture closure devices, and more specifically relates to tissue puncture closure devices having temporary sealing and blood flashback features.
Various surgical procedures are routinely carried out intravascularly or intraluminally. For example, in the treatment of vascular disease, such as arteriosclerosis, it is a common practice to access the artery and insert an instrument (e.g., a balloon or other type of catheter) to carry out a procedure within the artery. Such procedures usually involve the percutaneous puncture of the artery so that an insertion sheath may be placed in the artery and thereafter instruments (e.g., a catheter) may pass through the sheath and to an operative position within the artery. Intravascular and intraluminal procedures unavoidably present the problem of stopping the bleeding at the percutaneous puncture after the procedure has been completed and after the instruments (and any insertion sheaths used therewith) have been removed. Bleeding from puncture sites, particularly in the case of femoral vascular punctures, may be stopped by utilizing vascular closure devices.
Typical closure devices position a sealing material adjacent to the vascular puncture along an exterior of the vessel wall. Positioning the sealing material too far proximally of the vascular puncture may lead to problems in stopping blood flow through the vascular puncture and maintaining hemostasis. In order to properly position the sealing material, the vascular puncture is first located. Puncture location may be determined in a number of ways, including, for example, positioning a vessel location device, which includes an expandable anchor member, through the vascular puncture with the expanded anchor abutting against an inner wall of the vessel. Challenges exist in properly positioning the expanded anchor relative to the vascular puncture and maintaining a position of the expanded anchor, particularly during delivery of the sealing material to the vascular puncture. Known location devices rely primarily on tactile feedback or a marker on the location device to help determine a position of the vessel location device relative to the vessel puncture.
One aspect of the present disclosure relates to a vessel location device including a catheter, an expandable member, and an inflation member. The catheter includes a distal end portion, a proximal end portion and a blood flashback lumen, wherein the blood flashback lumen has a distal opening positioned at the distal end portion and a proximal opening at the proximal end portion. The expandable member is positioned at the distal end portion at a location distal of the distal opening of the blood flashback lumen. The inflation member is configured to deliver a flow of inflation fluid to the expandable member to selectively expand the expandable member within a vessel to temporarily seal a vessel puncture.
The inflation member may include an inflation tube extending through the blood flashback lumen, the expandable member being mounted to a distal end portion of the inflation tube. The catheter and inflation member may be connected to each other at the distal end portion of the catheter. The catheter and inflation member may be connected to each other at the proximal end portion of the catheter. The catheter and inflation member may be connected to each other at a proximal bond location, and the proximal opening of the blood flashback lumen may be positioned distal of the proximal bond location.
The catheter may include a dual lumen construction having first and second lumens, wherein the blood flashback lumen includes the first lumen and the inflation member includes the second lumen. The first lumen may have a circular cross-sectional shape and the second lumen may have a non-circular cross-sectional shape. The first lumen may have a non-circular cross-sectional shape and the second lumen may have a circular cross-sectional shape. The inflation member may include an inflation lumen and the inflation member may be arranged coaxial with the blood flashback lumen.
Another aspect of the present disclosure relates to a vessel location device including a catheter and an expandable member. The catheter includes first and second lumens, a distal end portion, and a proximal end portion. The expandable member is positioned at the distal end portion and arranged in flow communication with the first lumen. The second lumen includes a distal opening arranged proximal of the expandable member at the distal end portion, and a proximal opening at the proximal end portion. The vessel location device is configured to advance through a vessel puncture and into a vessel wherein the expandable member is expanded to limit blood flow through the vessel puncture, and the second lumen provides blood flashback to indicate a position of the vessel location device relative to blood flow in the vessel.
The catheter may include first and second tubes defining the first and second lumens, respectively. The first and second tubes may be bonded to each other at the distal and proximal end portions of the catheter. The second tube may extend through the first lumen. The expandable member may include an inflation balloon having a distal waist and a proximal waist, wherein the inflation balloon is connected to the catheter at a distal bond formed between the proximal waist and the first and second tubes. The first and second tubes may be connected together at a proximal bond, and the proximal opening of the second lumen may be positioned distal of the proximal bond. The vessel location device may include a support core wire extending through one of the first and second lumens to the distal end portion. The catheter may include an integrally formed, dual lumen construction.
A further aspect of the present disclosure relates to a method of locating a vessel. The method includes providing a catheter having a distal end portion, a proximal end portion, a blood flashback lumen, and an inflation lumen, and an expandable member positioned at the distal end portion at a location distal of a distal opening of the blood flashback lumen. The method further includes positioning the expandable member through a vessel puncture, providing a flow of blood through the blood flashback lumen, inflating the expandable member via the inflation lumen, and abutting the inflated expandable member into contact with an inner surface of the vessel adjacent to the vessel puncture to temporarily seal the vessel puncture. Temporarily sealing the vessel puncture stops blood flow through the blood flashback lumen.
The expandable member may include an inflation balloon having a distal waist and a proximal waist, and the catheter may include first and second tubes defining the inflation lumen and blood flashback lumen, respectively, and the method may further include providing a distal bond between the proximal waist and first and second tubes. Providing a flow of blood through the blood flashback lumen may include flowing blood into the distal opening of the blood flashback lumen, and flowing blood out of a proximal opening of the blood flashback lumen at a location distal of a proximal end of the inflation lumen. The catheter may be formed as an extruded dual lumen structure.
The foregoing and other features, utilities, and advantages of the invention will be apparent from the following detailed description of the invention with reference to the accompanying drawings.
As mentioned above, vascular procedures are conducted throughout the world and require access to a vessel through a puncture. Most often, the vessel is a femoral artery. Many times a closure device is used to deliver a sealing plug to close the puncture following completion of the procedure. However, sometimes the sealing plug is difficult to position against an exterior situs of the arteriotomy. The plug and anchor need to seat properly against the arteriotomy to close the vascular access opening. The present disclosure describes methods and apparatuses that facilitate locating a vessel puncture intravascularly using an expandable anchor and providing additional visual indicators to the operator of a position of the anchor relative to a flow of blood through the vessel.
While the vascular instruments shown and described below are directed primarily to vessel locating devices and puncture sealing devices, the application of principles described herein are not limited to the specific devices shown. The principles described herein may be used with any medical device. Therefore, while the description below is directed primarily to arterial procedures and certain embodiments of a vascular closure device, the methods and apparatus are only limited by the appended claims. Applications of closure devices including those implementing principles described herein include closure of a percutaneous puncture or incision in tissue separating two internal portions of a living body, such as punctures or incisions in blood vessels, ducts or lumens, gall bladders, livers, hearts, etc.
As used in this specification and the appended claims, the term “engage” and “engagable” are also used broadly to mean interlock, mesh, or contact between two devices. A “tube” is an elongated device with a passageway. The passageway may be enclosed or open (e.g., a trough). A “lumen” refers to any open space or cavity in a bodily organ, especially in a blood vessel. The words “including” and “having,” as used in the specification, including the claims, have the same meaning as the word “comprising.”
The present disclosure is directed to a vessel location device that provides a bleed indication lumen (also referred to as a blood flashback lumen) in conjunction with a balloon or other temporary sealing device. The bleed indication port provides a secondary visual indication via cessation of pulsatile blood flow from the vessel location device of a correct artery location. The visual indication may be used in addition to tactile feedback provided by the balloon via contact with a wall of the vessel.
As soon as blood begins flowing through the bleed indication lumen and is expelled at a proximal portion of the device, the operator has a visual indication that the expandable member is positioned within the vessel and knows to stop advancing the device further into the vessel, thereby reducing the chance of damaging the vessel. The bleed indication lumen may also indicate when the expandable member (e.g., balloon) has been inserted into the vessel and operated into an expanded position, and then properly positioned to stop blood flow through the vessel puncture. When no blood is flowing through the blood indication lumen, the operator has a visual indication that the expandable member has properly seated in the vessel. The operator may then adjust an amount of withdrawal force being applied to the device in order to avoid causing damage to the vessel.
An example embodiment of a vessel location device in accordance with the present disclosure may include a coaxial construction in which the inflation and blood flashback lumens are provided by two separate tubes arranged concentric with each other. The balloon inflation lumen may have a smaller diameter defined by an inflation tube, which is inserted through a larger diameter blood flashback lumen defined by a second tube. The balloon inflation lumen may have a core wire extending along at least a portion of a length thereof to provide additional support and kink resistance in the device. A balloon or other expandable member may be mounted to a distal end portion of the tube defining the balloon inflation lumen. The balloon may be positioned distal of a distal opening into the blood flashback lumen so that blood flow ceases as the balloon is abutted against the vessel wall adjacent to the vessel puncture. Providing an axial spacing between the balloon and distal opening into the blood flashback lumen may provide reduced risk of the inflated balloon getting hung up on plaque in the vessel, a vessel side branch, or other obstruction, which may result in the blood flashback lumen providing a false indication to the operator of the actual position of the balloon. Positioning the distal opening of the blood flashback lumen spaced proximal of the balloon may provide these and other advantages as compared to a design in which the distal opening of the blood flashback lumen is positioned distal of the balloon or directly adjacent to a proximal surface of the balloon.
In the dual tube design described above, the two tubes may be attached to each other at a proximal end by bonding the two tubes together to form a proximal bond. The bonding may be done using, for example, an adhesive or thermal bonding technique. A hole may be formed in the tube defining the blood flashback lumen at a location distal of the proximal bond. The hole may be used as a proximal blood flow outlet for the blood flashback lumen.
The two tubes may be attached to each other at a distal end portion of a tube defining the blood flashback lumen. The balloon inflation tube may extend distally beyond the distal end of the blood flashback tube. The two tubes may be connected to each other using various bonding methods and connections at various locations. In one example, the two tubes are connected to each other along only one side of the balloon inflation tube. In another example, the distal bond is defined in part by a proximal waist of the balloon. The distal bond may include a connection between the balloon inflation tube, the blood flashback tube and the proximal waist. The two tubes may be attached to each other at additional locations along the length of the two tubes in order to reduce the chance of buckling and kinking of the vessel location device.
In another example, the vessel location device comprises a dual lumen tube such as a dual lumen tube formed by a single extrusion. One lumen of the dual lumen tube provides a balloon inflation lumen for delivery of inflation fluid to the balloon or other expandable member at a distal end portion of the device. The other lumen may provide a blood flashback lumen. The two lumens may have any desired cross-sectional shape such as, for example, circular, semicircular, or crescent shape. The lumens may have a cross-sectional shape that varies along a length of the dual lumen tubing. A portion of the tubing having only a single lumen formed therein may extend distally beyond a distal opening into the blood flashback lumen to provide structure for mounting the balloon to the tubing.
The example vessel location devices disclosed herein may provide a secondary visual feedback mechanism for locating a vessel puncture when using a temporary sealing device. The vessel location devices may utilize blood flashback to provide the secondary visual feedback to the operator of a correct position of the device relative to the vessel puncture, which may be provided in addition to tactile feedback from the inflated balloon within the vessel. The vessel location devices include an integrated blood flashback feature, whereas other systems and methods may provide blood flashback via other mechanisms such as, for example, a separate insertion sheath. The integrated nature of the blood flashback features in a vessel location device as disclosed herein may provide immediate visual indication that the balloon has entered the vessel lumen. As such, the operator may recognize that the device does not require further insertion into the vessel and the expandable member may be expanded and pulled back into contact with the vessel to close the vessel puncture. Without the immediate visual indication provided by the blood flashback features of the present disclosure, the operator may inadvertently advance the balloon too far into the vessel lumen, which may result in undue damage to the vessel when the expandable member is expanded and pulled back along the length of the vessel lumen toward the vessel puncture. Furthermore, the cessation of blood flashback through the blood flashback lumen may provide immediate feedback to the operator that the vessel puncture has been properly located in a position that temporarily seals the vessel puncture.
Referring now to
The catheter 12 may include an inflation tube 20 and a blood flashback tube 22. The inflation tube 20 may include distal and proximal ends 28, 30, an inflation outlet 32, and an inflation lumen 34 (see
The distal opening 40 of the blood flashback tube 22 may be positioned proximal of the expandable member 14. The distal opening 40 may be provided as an open end into the flashback lumen 44 and may face in a distal direction. The distal opening 40 may be defined in other ways such as, for example, forming a hole in a sidewall of the blood flashback tube 22 proximal of the distal end 36. The distal opening 40 may face in a lateral direction.
The proximal opening 42 may be positioned at the proximal end of the catheter 12 at a location such as, for example, distal of the hub 16 and distal of a proximal end 38 of the blood flashback tube 22. The proximal opening 42 may be formed by cutting or otherwise forming a hole through a sidewall of the blood flashback tube 22. In other embodiments, the proximal opening 42 may be positioned at a proximal end of the blood flashback tube 22 and may face in a proximal direction.
At least
The distal bond 24 may be formed in a similar manner as the proximal bond 26 shown in
The distal bond 24 may also include a connection with the proximal waist 52 of the expandable member 14. The proximal waist 52 may be concurrently bonded to the inflation tube 20 and a portion of the blood flashback tube 22.
Referring to
The expandable member 14 may be mounted to the inflation tube 20 in bonding steps separate from formation of the distal bond 24A. The heat H may be applied in any number of ways including, for example, a hot jaw, laser welding, or ultrasound. In other examples, the bonding between inflation tube 20 and blood flashback tube 22 may occur using other bonding techniques besides application of heat including, for example, an adhesive or a sonic welding.
Referring now to
The expandable member 114 may include distal and proximal waists 150, 152. The expandable member 114 may be connected to the catheter 112 at a location distal of the distal opening 140 of the flashback lumen 144. The distal and proximal waists 150, 152 may be bonded to the catheter 112 using, for example, a heat bonding technique or an adhesive. A distal end of the inflation lumen 134 may be closed such that the inflation fluid flowing through the inflation lumen 134 is directed to the expandable member 114.
The proximal opening 142 of the flashback lumen 144 may be positioned in a sidewall of the catheter 112. The proximal opening 142 may be positioned at a location distal of the hub 116. In other examples, the proximal opening 142 is positioned in the hub 116 or at a location proximal of the hub 116.
In at least some examples, the flashback lumens 44, 144 described herein may serve a dual purpose, wherein a first purpose is to provide a blood flashback as a visual indicator to the operator, and a second purpose is to provide a path for delivery of sealing material to a vessel puncture. The sealing material may be delivered through the flashback lumen 44, 144. Alternatively, a separate tube may be inserted through the flashback lumen 44, 144, wherein the separate tube provides delivery of a volume of sealing material to the vessel puncture. The sealing material may flow out of the distal opening 40, 140 of the vessel location device, or the separately inserted tube, at a location adjacent to the vessel puncture.
Referring now to
Referring to
The operator may then apply a withdrawal force to the vessel location device 10 and the insertion sheath 80 to abut the expandable member 14 against an inner surface of the vessel 90 adjacent to the vessel puncture 94 as shown in
The operator, having located and temporarily sealed the vessel puncture 94, may use the vessel location device 10 in various ways to further treat the patient. In one example, the insertion sheath 80 is further withdrawn along a length of the vessel location device 10 and a sealant delivery device may be advanced through the incision 98 to deliver sealing material to the vessel puncture 94. The sealant delivery device may connect to or track along the catheter 12 to a position adjacent to the vessel puncture 94. In another example, a separate sealant delivery device is advanced through the insertion sheath 80 to a position adjacent to the vessel puncture 94 for delivery of a sealing material.
In a still further example, sealing material is delivered through the vessel location device 10 to the vessel puncture 94.
After the sealing material 4 is delivered, the sealing material 4 may be allowed to cure to form a sealing plug 6. The sealing plug 6 may have sufficient shape and structure to avoid inadvertently advancing into the vessel lumen 96 after the expandable member 14 has been operated into an unexpanded state as shown in
After removal of the vessel location device 10, a channel or tract may remain formed through the sealing plug 6 upon removal of the vessel location device 10. The channel may be filled by further expansion of the sealing material 4. Alternatively, an additional volume of sealing material may be injected into the incision 98 using the vessel location device 10 or other sealant delivery device. This additional volume of sealing material may seal the channel in the sealing plug 6.
While this invention has been described with reference to certain specific embodiments and examples, it will be recognized by those skilled in the art that many variations are possible without departing from the scope and spirit of this invention. The invention, as defined by the claims, is intended to cover all changes and modifications of the invention which do not depart from the spirit of the invention. The words “including” and “having,” as used in the specification, including the claims, shall have the same meaning as the word “comprising.”
