This invention generally relates to devices, systems and methods for transferring a device from a first location, such as an initial insertion site on the body, to a second location, such as a different insertion site on the body.
The placement of a permanently or temporarily implantable device in the left side of the heart, and particularly the left atrium, may be difficult at a particular site of insertion because an operator must contend with the anatomical obstacles or equipment limitations presented by the catheter's route to the left heart. For example, it is more difficult to access the left atrium by performing an atrial transseptal puncture from an insertion point on the neck or near the shoulder than it is to perform a standard transfemoral Brockenbrough needle puncture of the intra-atrial septum from the right groin region. Because of the rigidity of the Brockenbrough catheter/needle system, the insertion site must provide a relatively straight path to the intra-atrial septum. A superior insertion site, however, provides a significantly tortuous and winding pathway to the intra-atrial septum, which makes the use of a Brockenbrough needle puncture technically more difficult from this insertion site. Still, there may be advantages to performing a medical procedure through a certain route that is difficult to catheterize. For example, it can be difficult to perform mitral balloon valvuloplasty from the inferior venous approach because an abrupt curve must be made in the left atrium to reach the mitral valve. When a valvuloplasty balloon is passed from a superior venous approach through the intra-atrial septum, there is a generally straight pathway to the mitral valve. Likewise, the implantation of certain medical devices may benefit from implantation through routes that are difficult to catheterize. One example is a medical device as described in U.S. Pat. No. 6,328,699, herein incorporated by reference, whereby a pressure transducer is placed on the left atrial side of the intra-atrial septum using transseptal catheterization. In some embodiments of the '699 patent, the pressure transducer is in continuity with a lead to a proximal housing that is more convenient when implanted in the subcutaneous tissue near the shoulder. Thus, although the catheterization is more readily performed from the groin region, insertion of the implanted device from the shoulder is preferred.
Several embodiments of the current invention provide a new method that allows transseptal catheterization of the left atrium from the standard transfemoral route via the groin that places the distal end of a guidewire in the vicinity of the left atrium followed by transfer of the proximal end from the groin to exit from a superior vein (subclavian or jugular).
In one embodiment, a method for transferring an implanted medical component (such as a guidewire) from an initial insertion site of the vasculature to an exit site of the vasculature in a patient with pre-existing implanted device, such as a pacemaker, defibrillator or diagnostic sensor system, is provided. In one embodiment, a guidewire is inserted into the vasculature at an insertion site and externalized at a separate exit site of the vasculature. Guidewire insertion is performed using a protective barrier (such as a sheath) having one or more ports or lumena to, for example, reduce the risk of entanglement with the pre-existing implanted device.
In one embodiment, the implantable component is inserted from the insertion site and anchored to its target location, such as the left atrium or left ventricle. The proximal portion of the implanted component proximate to the insertion site is connected to the pull member and pulled through the vasculature and out the exit site. A coupling device may be used to facilitate attachment of the pull member and vasculature. The pull member may be connected to the implanted component before or after the insertion of the implantable component to the target location. The insertion and exit sites may be external sites, such as the skin, or internal sites, such as a wall of a blood vessel.
In a further embodiment, the protective sheath is further configured or provided in conjunction with a puncturing assembly for penetrating through various tissue structures to facilitate access to the target location. In some embodiments, the puncturing assembly is located at the distal end of the protective sheath, but in other embodiments, the puncturing assembly is located anywhere between the proximal end and distal end of the sheath.
In some embodiment, a guide wire or lead with a puncturing or sharpened tip is provided in addition to or instead of the puncturing assembling.
In some embodiments, a method for positioning the distal end of an implantable lead in a target site and providing access to the proximal end of the implantable lead at a site different than the insertion site in a patient is provided, comprising providing a sheath, a pull wire, a guidewire, and an implantable lead, wherein said sheath has a proximal end, a body, and a distal end, wherein said guidewire has a proximal end, a body, and a distal end, wherein said transfer has a proximal end, a body, and a distal end, and wherein said implantable lead has a proximal end, a body, and a distal end; inserting the sheath into the vasculature of a patient at an insertion site; passing the distal end of the pull wire through the distal end of the sheath and toward a second access site of said vasculature while maintaining at least a portion of the pull wire body within the vasculature; passing the distal end of the guidewire through the sheath and through the side port of the sheath body to a target site; removing the sheath from the vasculature; passing the implantable lead to the target site using the guidewire; coupling the proximal end of the pull wire to a proximal end of the implantable lead; and externalizing the proximal end of the implantable lead out of said vasculature, thereby providing access to the proximal end of the implantable lead at an exit site different than the insertion site.
The sheath may comprise a tissue penetration member configured to extend from the side port. The method may further comprise penetrating a body tissue structure with the tissue penetration member to provide a tissue pathway to the target site. The method may further comprise using a snare to pull the distal end of the pull wire out of the vasculature. The method may further comprise piercing through a body structure with a penetration member. Externalizing the proximal end of the implantable lead out of said vasculature may comprise removing the proximal end of the implantable lead from the body of the patient. Coupling may comprise using a connector to connect the proximal end of the pull wire with the proximal end of the implantable lead. The pull wire includes, but is not limited to a guidewire, a snare, and a suture. The implantable lead includes, but is not limited to a pressure sensor lead or a pacemaker/defibrillator lead. The method target site may be selected from a group consisting of the left atrium, the left ventricle, the right atrium, the right ventricle, a pulmonary artery, the coronary sinus, and the left atrial appendage. In some embodiments, at least one of the first and second access sites may be selected from a group consisting of a jugular vein or carotid artery or their branch vessels, a subclavian blood vessel, an axillary blood vessel, a femoral blood vessel, an iliac blood vessel, a brachiocephalic vein, a superior vena cava and an inferior vena cava, a right atrial wall, a left atrial wall, a left ventricular wall, a left ventricle apex, a right ventricular wall or outflow tract or apex.
In several embodiments, a method for placing an elongate member in a body space is provided. Suitable body spaces include, but are not limited to, blood vessels, heart chambers, the spinal canal, the nasopharynx, the oropharynx, the hypopharynx, the esophagus, the biliary tract, the stomach, small intestine, large intestine, rectum, the genitourinary tract, the bronchial tree, etc.
In one embodiment, the protective sheath comprises a tubular conduit that is inserted into a body space at an insertion site, such as at an incision site, orifice, duct, or other opening. Tubular conduits include, but are not limited to catheters, introducers and sheaths, sleeve or other coverings. The distal end of a first elongate member is inserted into the tubular conduit and externalized from the body space at an exit site. Elongate members include, but are not limited to, guidewires, snares or suture lines. The distal end of a second elongate member is then inserted into the conduit and positioned at a target site accessible from the body space. The proximal end of the first elongate member is attached to a proximal end of the second elongate member. The proximal end of the second elongate member is externalized from the exit site of the body lumen.
In another embodiment, a method for placing an elongate member in a body space is provided, comprising inserting a tubular conduit into a body space at an insertion site, inserting a distal end of a first elongate member into the tubular conduit, externalizing the distal end of the first elongate member from the body space at an exit site, inserting a distal end of a second elongate member into the conduit, positioning the distal end of the second elongate member at a target site accessible from the body space, attaching a proximal end of the first elongate member to a proximal end of the second elongate member, and moving the proximal end of the second elongate member toward the exit site of the body space. The body space may be a lumen of the cardiovascular system. The body space may contain a pre-existing implant at least partially positioned in the body space between the insertion site and the exit site. The pre-existing implant may be positioned in the body cavity prior to externalizing the proximal end of the second elongate member. Inserting the distal end of the second elongate member into the conduit may occur before externalizing the distal end of the first elongate member from the body space at an exit site. The method may further comprise passing the distal end of the second elongate member through a side opening of the tubular conduit. Attaching the proximal end of the first elongate member to the proximal end of the second elongate member may comprise attaching the proximal end of the first elongate member to a first end of a coupler and attaching proximal end of the second elongate member to a second end of the coupler. The method may further comprise passing the distal end of a second elongate member out of a middle aperture of the tubular conduit. The method may further comprise passing a puncture structure out of the middle aperture of the tubular conduit. The method may further comprise puncturing a through a tissue with the puncture structure to access the target site. Inserting the distal end of the first elongate member into the tubular conduit may comprise inserting the distal end of the first elongate member into a common lumen of the tubular conduit, and wherein inserting the distal end of the second elongate member into the tubular conduit may comprise inserting the distal end of the second elongate member into the common lumen of the tubular conduit.
In one embodiment, a method for manipulating an implanted component is provided, comprising accessing a body space of a body, the body space containing at least one pre-existing foreign body, placing a protective barrier into the body space, wherein the protective barrier comprises a protected pathway and a wall separating the protected pathway from the at least one pre-existing foreign body, placing an elongate member through the protected pathway, such that the elongate member has a first end and a second end located outside the body space, inserting at least a portion of an implantable component through at least a portion of the protected pathway and into the body, such that the implantable component has a first end located outside the body and a second end located at a target site in the body, and connecting the first end of the elongate member to the first end of the implantable component. The method may further comprise removing the protective barrier from the body space, which, in some embodiments, may be performed before connecting the first end of the elongate member to the first end of the implantable component.
In one embodiment, a device for manipulating an implantable lead member is provided, comprising a biocompatible elongate member having a first section and a second section, wherein the first section comprises a pull member attachment interface and the second section comprises a selective coupling interface configured to selectively attach to a section of an implantable lead member. The pull member interface may be a guidewire attachment interface or snare attachment interface. The pull member interface may comprise a cavity configured to accept the pull member, a collet structure about the cavity, and a locking member configured to selectively compress the collet structure. The selective coupling interface may comprise a cavity configured to accept the implantable lead member, a collet structure about the cavity, and a locking member configured to selectively compress the collet structure. The biocompatible elongate member may comprise a flexible or rigid material.
In some embodiments, a kit, system or compilation of materials for manipulating an implantable lead member is provided, comprising a biocompatible elongate member having a first section and a second section, wherein the first section comprises a pull member attachment interface and the second section comprises a selective coupling interface configured to selectively attach to a section of an implantable lead member. The kit may further comprise a pull member, snare and/or a transfer guidewire. The kit may further comprise a sheath having a proximal end, a distal end, and a first lumen comprising a first section extending at least between the proximal end and a side opening between the proximal end and the distal end. The kit may further comprise a tissue wall puncture member configured to movably reside at least within the puncture lumen. The first lumen comprises a second section between the side opening and the distal end of the sheath. The sheath may further comprise a second lumen between the proximal end and the distal end of the sheath, wherein the second lumen is separate from the first lumen. The kit may further comprise at least one vascular sheath, and in some embodiments comprises two vascular sheaths. The vascular sheaths may have different dimensions. The kit may also comprise instructions for using one or more kit components. In one embodiment, the kit further comprises instructions for using the biocompatible elongate member with a pull member and the implantable lead member.
In one embodiment, a method of transferring a guidewire from one insertion site to another insertion site is provided. In one embodiment, the method comprises the steps of introducing a first guidewire to a first insertion site, wherein the first guidewire has a proximal and distal end, introducing the distal end of the first guidewire to a target site, introducing a catheter having a proximal end and a distal end from a second insertion site and advancing the distal end of the catheter to the proximity of the first insertion site, introducing a second guidewire, wherein the second guidewire has a proximal and a distal end, through the catheter such that the distal end of the second guidewire extends out through the first insertion site, advancing the catheter over the second guidewire whereby a portion of the catheter emerges from the body through the first insertion site, and removing the second guidewire entirely from the catheter and inserting the proximal end of the first guidewire into the distal end of the catheter, whereby the proximal end of the first guidewire exist the proximal end of the catheter at the second insertion site. This method may further comprise snaring of distal end of the second guidewire with a snare and pulling the snare and the distal end of the second guidewire out from the first insertion site. In some embodiments of the invention, an introducer is placed at the first insertion site and/or second insertion site. In some embodiments, the introduction of the distal end of the first guidewire to a target site comprises introducing the distal end of the first guidewire to a site in the left atrium, right ventricle, pulmonary artery or renal artery. In some embodiments, the introduction of the catheter over the second guidewire from the second insertion site to the first insertion site comprises introducing a catheter from the second insertion site to a right femoral vein or right common carotid artery, or from a left femoral vein or left axillary vein to the first insertion site.
In one embodiment, another method of transferring a guidewire from one insertion site to another insertion site using a second guidewire is provided. In one embodiment, the method comprises the steps of introducing a first guidewire to a first insertion site, wherein the guidewire has a proximal end and a distal end, introducing the distal end of the first guidewire to a target site, introducing a catheter having a proximal end and a distal end from a second insertion site and advancing the distal end to the proximity of the first insertion site, introducing a second guidewire, wherein the second guidewire has a proximal end and a distal end, through the catheter such that the distal end of the second catheter extends out through the first insertion site, advancing the catheter over the second guidewire whereby a portion of the catheter emerges from the body through the first insertion site, engaging the proximal end of the first guidewire to the distal end of the second guidewire and withdrawing the catheter, second guidewire and the proximal end of the first guidewire from the second insertion site.
In one embodiment, another method of transferring a guidewire from one insertion site to another insertion site is provided, comprising the steps of introducing a guidewire through a first insertion site, introducing a catheter through a second insertion site to the first insertion site and inserting the proximal end of the guidewire into the distal end of the catheter whereby the proximal end of the guidewire exits the proximal end of the catheter at the second insertion site. In a further embodiment, the guidewire is introduced to a target site when the guidewire is introduced through the first insertion site. In another embodiment, when introducing the distal end of the catheter through a second insertion site to the first insertion site, the distal end of the catheter exits from the first insertion site.
In another embodiment, a method of transferring a guidewire from one insertion site to another insertion site using a conduit is provided. In one embodiment, the method comprises the steps of introducing the distal end of a guidewire through a first insertion site, establishing access to a second insertion site, introducing a conduit between the first insertion site and the second insertion site, where the conduit has a first end at the first insertion site and a second end at the second insertion site, inserting the proximal end of the guidewire into the first end of the conduit whereby the proximal end of the guidewire exists the second end of the conduit. In further embodiments of the invention, the conduit is a catheter. In still further embodiments, the step of introducing the conduit between the first insertion site and the second insertion site comprises introducing the catheter from the second insertion site to the first insertion site.
In another embodiment, another method of transferring a guidewire is provided, comprising the steps of providing a guidewire having a proximal end and a distal end, passing the proximal end and the distal end of the guidewire through a first insertion site in the body, where the distal end is passed before the proximal end, and externalizing the proximal end through a second insertion site of the body while the distal end remains in the body. This method may further comprise the step of passing a medical device over the guidewire into the body. The medical device may be a therapeutic or diagnostic medical device. The passing step may also involve a transseptal puncture. The externalizing step may involve inserting a snare through the second insertion site to engage the proximal end of the guidewire with the snare and withdrawing the snare and the proximal end of the guidewire from the second insertion site. One example of the first insertion site is the femoral vein, while one example of the second insertion site includes the subclavian vein.
In another embodiment, another method of transferring a guidewire from a first insertion site to another insertion site is provided. In one embodiment, the method comprises the steps of providing a guidewire with a proximal end, middle segment and a distal end, passing the proximal end and the distal end of the guidewire through a first insertion site into the body, wherein the distal end of the guidewire is passed before the proximal end of the guidewire and at least some portion of the middle segment remains external to the first insertion site, externalizing the proximal end of the guidewire through a second insertion site of the body while the distal end of the guidewire remains in the body and drawing the external portion of the middle segment into the body through the first insertion site. The method may further comprise the step of maintaining at least a portion of the middle segment of the guidewire outside the body while the proximal end and the distal end are inside the body.
In another embodiment, a method of transferring a guidewire from one insertion site to another is provided, comprising the steps of providing a guidewire having a proximal end and a distal end, inserting the distal end through a first insertion site of a body and through a pivot point in the body, inserting the proximal end through the first insertion site and externalizing the proximal end through a second insertion site without passing the proximal end through the pivot point.
In still another embodiment of the invention, a method of transferring a guidewire from one insertion site to another insertion site is provided. In one embodiment, the method comprises the steps of providing a guidewire having a proximal end and a distal end, passing the distal end the guidewire from a first insertion site in a body to a target site in the body, passing the proximal end of the guidewire from the first insertion site to a second insertion site, where the proximal end does not enter the target site when passing to the second insertion site. The method may further comprise the steps of providing a medical device and passing at least a portion the medical device along the guidewire from the second insertion site to the target site. The medical device may be a therapeutic or diagnostic medical device. One example of the first insertion site is a femoral vein, while one example of the second insertion site is a subclavian vein.
In one embodiment, a method of inserting a pacemaker lead through a sheath to the proximity of the left atrium is provided. In one embodiment, the method comprises the steps of providing a guidewire having a proximal end and a distal end, defining a first pathway from the right femoral vein to the left atrium through the right atrium, defining a second pathway from the right femoral vein to a subclavian vein through the right atrium; wherein the second pathway does not traverse the left atrium, defining a third pathway from the subclavian vein to the left atrium through the right atrium, passing the distal end of the guidewire along the first pathway, passing the proximal end of the guidewire along the second pathway, providing a sheath for passing a pacemaker lead, passing the sheath over the guidewire along the third pathway, withdrawing the guidewire from the sheath, providing a pacemaker lead and passing the pacemaker lead through the sheath along the third pathway, thereby inserting the pacemaker lead into the left atrium.
In other embodiments, a method of transferring a guidewire from one insertion site to another insertion site is provided. In one embodiment, the method comprises the steps of providing a guidewire having a proximal end and a distal end, defining a first pathway in a body from a first insertion site on a body to a target area in the body, defining a second pathway from the first insertion site to a second insertion site on the body, wherein the second pathway does not traverse the target area, defining a third pathway from the second insertion site to the target area, passing the distal end along the first pathway and passing the proximal end along the second pathway. The method may further comprise the steps of providing a medical device and passing at least a portion of the medical device along the third pathway. In further embodiments, the first pathway crosses the intra-atrial septum. In other embodiments, the first, second and third pathways each pass through a junction area such as the right atrium. The medical device can be a therapeutic and/or diagnostic medical device. One example of the first insertion site is the femoral vein, while one example of the second insertion site includes the subclavian vein.
In another embodiment, a method of transferring a medical device component from one insertion site to another insertion site is provided. In one embodiment, the method comprises the steps of introducing a medical device component to a first insertion site, wherein the component has a proximal end and a distal end, introducing a guidewire to a second insertion site, wherein the guidewire has a proximal end and a distal end, introducing the distal end of the medical device component to a target site, introducing a catheter having a proximal end and a distal end over the second guidewire from the second insertion site to the first insertion site, wherein the distal end of the catheter exits the first insertion site, and inserting the proximal end of the medical device component into the distal end of the catheter whereby the proximal end of the medical device component exits the proximal end of the catheter at the second insertion site. Medical devices in this and other embodiments include, but are not limited to, clinical, diagnostic and therapeutic devices. Therapeutic devices include, but are not limited to, drug delivery devices, radiation agents, brachytherapy agents, pacemakers, defibrillators, valves, stents, sensors and pumps, and combinations thereof.
In another embodiment, a method of transferring a medical device component from one insertion site to another insertion site is provided. In one embodiment, the method comprises the steps of introducing the distal end of a medical device component through a first insertion site, wherein the component has a proximal end and a distal end, removably engaging the distal end of an extension device to the proximal end of the medical device component, wherein the extension device has a proximal end and a distal end, advancing the distal end of the medical device component to a target site, introducing a guidewire to a second insertion site, wherein the guidewire has a proximal end and a distal end, introducing a catheter having a proximal end and a distal end over the second guidewire from said second insertion site to said first insertion site, wherein the distal end of said catheter exits said first insertion site, inserting the proximal end of the extension device into the distal end of the catheter whereby the proximal end of the extension device exits the proximal end of the catheter at the second insertion site, and withdrawing the catheter and the extension device from the second insertion site whereby the proximal end of the medical device component is externalized through the second insertion site. In a further embodiment of the invention, in the step of advancing the medical device component to the target site, the proximal end of the extension device remains outside the body at the first insertion site when the medical device component is advanced entirely inside the body. The embodiment may also comprise the steps of snaring the distal end of the guidewire with a snare from the first insertion site and pulling the snare and the distal end of the second guidewire from the first insertion site. An introducer may also be placed at the first and/or the second introducer site. The target sites may comprise in the left atrium, right ventricle, pulmonary artery and coronary sinus. The first insertion sites may comprise the right femoral vein and right carotid artery. The second insertion sites may comprise the left femoral vein and the left axillary artery. The medical device component may comprise a second guidewire, an implantable sensor lead, or a temporary sensor lead.
Another embodiment provides a method of transferring a pacemaker lead from the right femoral vein to the right subclavian vein, comprising the steps of introducing the distal end of a pacemaker lead having a proximal end and a distal end through the right femoral vein, introducing the distal end of a catheter having a proximal end and a distal end through the right femoral vein and advancing the proximal end of the catheter to exit from the right subclavian vein, and inserting the proximal end of the pacemaker lead into the proximal end of the catheter whereby the proximal end of the pacemaker lead exits the distal end of the catheter at the right subclavian vein.
Another embodiment provides a method of transferring a medical device component from one insertion site to another insertion site, comprising the steps of introducing the distal end of a medical device component having a proximal end and a distal end through a first insertion site, introducing the distal end of a catheter having a proximal end and a distal end through the first insertion site and adjacent to a second insertion site, and inserting the proximal end of the medical device component into the proximal end of the catheter whereby the proximal end of the medical device component exits the distal end of the catheter at said second insertion site. The medical device component could be a pacemaker lead. One example of the first insertion site is the right femoral vein, while the second insertion site may be selected from the group consisting of one or more of the following, including the right subclavian vein, left subclavian vein, right jugular vein and left jugular vein.
In another embodiment, a method of transferring a medical device component from one insertion site to another insertion site is provided. In one embodiment, this method comprises the steps of providing a medical device component having a proximal end and a distal end, passing both the proximal end and the distal end of the medical device component through a first insertion site into a body, wherein the distal end is passed before the proximal end, externalizing the proximal end through a second insertion site of the body while the distal end remains in the body.
Another embodiment provides a method of transferring a medical device component from one insertion site to another insertion site. In one embodiment, this method comprises providing a medical device component having a proximal end and a distal end, passing both the proximal end and the distal end of the medical device component through a first insertion site into a body, wherein the distal end is passed before the proximal end, and externalizing the proximal end of the medical device component through a second insertion site of the body while the distal end remains in the body.
In another embodiment, a method of transferring a medical device component from one insertion site to another insertion site is provided. In one embodiment, this method comprises providing a medical device component having a proximal end and a distal end, passing the distal end of said medical device from a first insertion site of a body to a target site in the body; and passing the proximal end of the medical device through the body from the first insertion site to a second insertion site, wherein the proximal end does not enter the target site when passing to the second insertion site. Furthermore, the step of passing the proximal end of the medical device component of the comprises passing a snare from the second insertion site to the first insertion site, snaring the proximal end of the medical device component with the snare and withdrawing the snare and the medical device component from the second insertion site. One example of the medical device component is a pacing lead of a cardiac pacemaker. One example of the target site is the coronary sinus.
In another embodiment, a method of manipulating a device insertion pathway from one insertion site to another insertion site is provided. In one embodiment, this method comprises providing an insertion pathway between a first insertion site and a target site in the body, wherein the insertion pathway comprises a proximal segment, a distal segment and a pivot point between the proximal segment and the distal segment; and manipulating the proximal segment by pivoting the proximal segment at the pivot point from the first insertion site to a second insertion site, wherein the proximal segment does not overlap the distal segment.
In one embodiment, a kit for performing a transfer of a guidewire from one insertion site to another insertion site is provided. In one embodiment, the kit, system, collection, or combination of materials, comprises at least two guidewires and a catheter. The kit may also comprise a snare, at least one introducer and/or a Brockenbrough needle catheter. In some embodiments of the kit, at least one guidewire comprises a movable inner core mandrel.
In another embodiment, a guidewire for manipulating the insertion pathways to target sites in the body is provided. In one embodiment, this guidewire comprises a guidewire body with a proximal end, distal end and a middle segment, and an internal lumen comprising a movable core mandrel. The mandrel is operable to be inserted into the internal lumen during guidewire insertion and extracted from the internal lumen during guidewire transfer. The guidewire is at least about 180 cm in length. In further embodiments of the guidewire, the guidewire has a length of about 240 cm. In other embodiments of the guidewire, the internal lumen extends substantially through the length of the guidewire. In still other embodiments of the guidewire, the distal end of the guidewire is capable of a first configuration when the mandrel is in a retracted position and a second configuration when the mandrel is in an extended position. In some embodiments, the first configuration is a spiral coiled configuration or a J-shaped configuration. In some embodiments, the second configuration is a straight configuration or angled configuration.
In another embodiment, a guidewire with adjustable flexibility is provided. In one embodiment, this guidewire comprises a first component having a proximal end, a distal end and an elongate flexible body extending therebetween, and a second component, axially movably associated with the first component, the second component having a proximal end, a distal end and an elongate flexible body extending therebetween. The axial movement of one of the first and second components with respect to the other of the first and second components changes the lateral flexibility of the guidewire. At least one component of the guidewire has a length of at least about 180 cm. The first component may comprise a tube or a core. In some embodiments, the second component has an axial length within the range of about 20% to about 200% of the axial length of the first component. In other embodiments, the second component has an axial length of about 110% of the axial length of the first component. In still other embodiments, the guidewire is dimensioned to percutaneously enter and translumenally navigate a lumen for directing at least a component of a medical device to a remote target site.
In another embodiment, another guidewire with adjustable flexibility is provided. This guidewire comprises an elongate flexible tubular body having a proximal end and a distal end, a central lumen extending distally into the tubular body from the proximal end, and an elongate flexible core wire axially moveable within the central lumen. Axial proximal retraction of the core wire with respect to the tubular body increases the flexibility of at least a portion of the guidewire, and axial distal advance of the core wire with respect to the tubular body decreases the flexibility of at least a portion of the guidewire. The length of the elongate flexible tubular body is at least about 180 cm. In some embodiments, the portions of the guidewire capable of changes in flexibility define a flexibility zone of the guidewire. In some embodiments, the flexibility zone comprises at least about the proximal 90% length of the elongate tubular body. In other embodiments, the flexibility zone comprises generally the entire length of the elongate tubular body.
In another embodiment, another method of treating a patient is provided, comprising the steps of introducing a guidewire through a first access site into the patient's body, advancing the guidewire translumenally to a target site, adjusting the flexibility of the guidewire, and moving at least a portion of the guidewire to a second access site. In some embodiments, the step of adjusting the flexibility of the guidewire comprises distally advancing a core wire within the guidewire, while in other embodiments, it comprises distally advancing a tubular support around the outside of the guidewire.
In still another embodiment, a method of accessing a target site is provided. In one embodiment, this method comprises introducing a guidewire into a patient through an introduction site, the guidewire having a first, reduced flexibility, externalizing at least a portion of the guidewire through a different site of the body, and adjusting the guidewire to have a second flexibility. In further embodiments, the method also comprises the step of introducing a catheter along the guidewire after adjusting the guidewire to have a second flexibility.
In yet another embodiment, a transfer guidewire assembly is configured to manipulate an implanted elongate body. Transfer guidewire assembly includes a flexible elongate body and a coupler. The flexible elongate body has a proximal end and a distal end. The coupler is attached to the flexible elongate body's distal end. The coupler is configured to be removably attached to the end of an implanted elongate body.
In one embodiment, the flexible elongate body includes a guidewire. In another embodiment, the coupler includes a screw. In another embodiment, the coupler is configured to rotate about the flexible elongate body. In another embodiment, the coupler is configured to prevent rotational forces from acting upon the implanted elongate body as the flexible elongate body is withdrawn from the patient's body while attached to the implanted elongate body. In another embodiment, the transfer guidewire assembly also includes a stylet extending from the distal end of the flexible elongate body. In another embodiment, the coupler includes a rotational coupling. In yet another embodiment, the implanted elongate body comprises a sensor lead.
In another embodiment, a transfer guidewire assembly is configured to reposition an end of an implanted lead from a first access point at a patient's body to a second access point at the patient's body. In one embodiment, the transfer guidewire assembly includes a flexible guidewire and a rotational coupling. The flexible guidewire has a proximal end and a distal end, and the rotational coupling is attached to the guidewire's distal end. The rotational coupling is configured to removably attach to a lead implanted in a patient's body.
In one embodiment, the rotational coupling includes a housing having an atraumatic surface configured to be pulled through the patient's body from a first access point to a second access point while attached to the implanted lead without damaging tissue within the patient's body In another embodiment, the rotational coupling includes a screw configured to mate with the implanted lead. In another embodiment, the transfer guidewire assembly also includes a stylet extending from a distal end of the rotational coupling that is sized to enter the implanted lead.
In another embodiment, a transfer guidewire assembly is configured to reposition an end of an implantable, flexible, elongate body from a first access point at a patient's body to a second access point at the patient's body. The transfer guidewire assembly includes a flexible guidewire and a catheter. The flexible guidewire has a proximal end and a distal end. The catheter is attached to the guidewire's proximal end. The catheter is configured to form an interference fit over an end of a flexible, elongate body implantable within a medical patient.
In one embodiment, the distal end of the flexible guidewire is retrievable with a snare. In another embodiment, the distal end of the flexible guidewire includes a J-tip. In another embodiment, the catheter is configured to form an interference fit over an end of the flexible, elongate body. For example, in one embodiment, the interference fit allows the catheter to remain attached to the implantable, flexible, elongate body when at least 1.5-times a rated pull force is exerted upon the catheter.
In another embodiment, the transfer guidewire assembly also includes a stylet configured to be inserted into the implantable, flexible, elongate body. In another embodiment, the stylet includes an elongate shaft of nickel titanium. In one embodiment, the stylet is integrally formed with the catheter and guidewire. For example, in one embodiment, a portion of the stylet is wrapped around the proximal end of the guidewire. In another embodiment, the wrapped proximal portion of the guidewire is surrounded by an end region of the catheter.
Several embodiments of the invention provide these advantages, along with others that will be further understood and appreciated by reference to the written disclosure, figures, and claims included herein.
The operation of the invention will be better understood with the following detailed description of embodiments of the invention, along with the accompanying illustrations, in which:
Several embodiments of the present invention generally relate to a system and method for performing catheterization of a body structure from a standard catheter insertion site, advancing a guidewire or other flexible member (e.g., an electrical lead, conduit, tube, etc.) into the body structure from that insertion site, and transferring the proximal end of the guidewire to an alternative insertion site while leaving the distal end of the guidewire within the body structure. The transferred guidewire may then be used for the placement of a second device or to perform a desired procedure from the alternative insertion site. Some embodiments relate to methods for standard transseptal puncture of the left atrium from a femoral vein, where the guidewire is then transferred from the femoral insertion site to a subclavian vein insertion site for the implantation of a left atrial pressure-monitoring device. Several embodiments described herein are also generally applicable to other sites of catheter and device insertion. Methods for transferring a medical device or a medical device component, such as a pacemaker lead, between different insertion sites are also provided.
In one embodiment as shown in
In one embodiment, after successful cannulation of the left atrium 8 from the femoral route, a guidewire 10 with a length between about 150 cm to about 300 cm can be placed in the left atrium 8 through the Mullins sheath 6. In another embodiment, the guidewire 10 has a length between about 180 cm to about 280 cm. In another embodiment, the guidewire 10 has a length between about 200 cm to about 260 cm. In yet another embodiment, the guidewire 10 has a preferred length of between about 220 cm to about 250 cm, preferably about 240 cm. The guidewire 10 may also have a length of less than about 150 cm or greater than about 300 cm. In one embodiment, the guidewire 10 includes a moveable or removable core mandrel. Such guidewires include, but are not limited to, a stiffer type of movable core guidewire with a tapered tip on the distal core. In one embodiment, the guidewire distal portion 12 is soft and curled, and can be coiled in either the left atrium 8, left ventricle 11, left atrial appendage (not shown), or a pulmonary vein (not shown) to provide a stable distal position. One skilled in the art will understand that many types of such coils can be used to achieve a stable anchoring position for the distal end of the guidewire 10. In one embodiment, the core can be at least partially pulled back to increase the coiling propensity of the wire. The Mullins sheath 6 or catheter is then withdrawn while maintaining the distal guidewire 12 position.
As shown in
As shown in
In one embodiment, as shown in
In another embodiment, the catheter tip 15 is advanced to the inferior insertion site in the right femoral vein 4 but it does not exit the inferior introducer sheath 3. The guidewire 10 may be backloaded into the distal tip 15 of the catheter 13 under fluoroscopic or ultrasonic guidance, or by using a snare 19 inserted through the catheter 13 from its superior proximal end 2.
In yet another embodiment, the proximal end 21 of the inferior guidewire is docked into or attached to the distal end of the superior guidewire 14 such that the two wires 10, 14 form a single continuous loop from the superior subclavian entry site, out through the femoral sheath 3, back through the femoral sheath, and ending in the target site 8. Other docking mechanisms may be used to attach the two guidewires 10, 14 together.
In one embodiment, advancement of the guidewire 10 through the catheter 13 is continued until a small loop 22 is left exiting the femoral sheath 3, as depicted in
In one embodiment, the guidewire 10 is sufficiently flexible without the core such that it is capable of creating at least a tight 180 degree bend 23 in the venous system without injuring the wire or the venous system, as illustrated in
As shown in
Referring now to
In a further embodiment of the invention, the inferior guidewire 10 is not positioned in any particular target site when the guidewire transfer is performed, but is advanced to the target site after the guidewire transfer is performed. In another embodiment, the distal position of the guidewire 10 is not maintained in any particular position or body structure but a middle portion of the guidewire 10 passes through and is constrained by a body structure, such as the intra-atrial septum. This body structure may act as a pivot point to allow movement of the guidewire portion between the pivot point and the proximal end of the guidewire 10 while constraining at least a portion of the movement of the guidewire 10 at the body structure.
Several embodiments of the present invention are particularly advantageous because of their applicability to the general case of transferring a wire from one insertion site in the venous or arterial circulation to another exit site for that wire in the same circulation. Other insertion sites that may be used with several embodiments of the invention include, but are not limited to, the radial arteries, dorsalis pedis arteries, axillary arteries and internal jugular veins. Access to these sites are known to those in the art and are described by Herbert Chen et al. in “Manual of Common Bedside Surgical Procedures”, 29-76 (Herbert Chen et al. eds., 1996), herein incorporated by reference. Several embodiments of the invention also provide for other target sites, including the right ventricle, left ventricle, pulmonary arteries, pulmonary veins, renal arteries, renal veins, portal veins, hepatic arteries, carotid arteries, jugular veins, axillary arteries, axillary veins and pathological sites such as an abdominal aortic aneurysm.
Several embodiments of the invention are also advantageous because of their general applicability to the concept of transferring the proximal end of a guidewire from a first insertion site to a second insertion site, after inserting the distal end of the guidewire from the first insertion site toward a target site or in proximity of a target site. In one embodiment, the insertion and transfer of a guidewire defines a series of pathways in the body taken by the proximal and distal ends of the guidewire. The initial insertion of the distal end of the guidewire is capable of defining a first pathway between the first insertion site and a target site. The transfer of the proximal end of the guidewire from the first insertion site and the second insertion site is capable of defining a second pathway taken by the proximal end of the guidewire. By transferring the proximal end of the guidewire, a third pathway is then defined along the new guidewire position, from the second insertion site to the target site. The third pathway may be used to access the target site.
In some embodiments of the invention, a conduit is placed between the first insertion site and second insertion site to facilitate transfer of the proximal end of the guidewire. In the preferred embodiment, the conduit includes a catheter inserted from the second insertion site to first insertion site, but one skilled in the art will understand that the conduit may comprise any structure that provides a lumen generally between the first insertion site and the second insertion site and that the conduit may be inserted between the insertion sites in other ways. For example, the conduit may be placed from the first insertion site to the second insertion site. In other embodiments, a conduit is not used to transfer the proximal end of the guidewire and the guidewire is transferred by other devices, such as a snare that pulls the proximal end of the guidewire from the first insertion site to the second insertion site.
In some embodiments, portions of the first pathway and the third pathway may overlap. For example, in one embodiment, the first insertion site is the right femoral vein, the second insertion site is the right subclavian vein and the target site is the left atrium. The first pathway from the right femoral vein to the left atrium, and the third pathway, from the right subclavian vein to the left atrium, share a common distal portion from the intra-atrial septum to the left atrium. The most proximal point common to both the first and third pathways define a pivot point whereby the distal portions of the first and third pathways are constrained to at least partially overlap and where the portions proximal to the pivot point do not overlap. In one embodiment, the second pathway taken by the proximal end of the guidewire does not cross or intersect the pivot point or the target site, but may pass through structures that the first and third pathways also pass through. Such structures are defined as junction areas and typically, but not always are situated proximal to the pivot point and/or target area. In the example mentioned above, all three pathways will pass through a junction that includes the right atrium.
In another embodiment, a patient is treated by introducing a guidewire into a patient at a first access site and advancing the guidewire translumenally to a target site. The flexibility of at least a portion of the guidewire is adjusted and is transferred to a second access site. In one embodiment, the adjustment of the guidewire flexibility is performed by moving a core wire within the guidewire. In another embodiment, the flexibility is adjusted by advancing a tubular support around the outside of the guidewire.
In another embodiment, a method for accessing a target site is provided, where a guidewire is introduced into a patient through an introduction site, the guidewire having a first, reduced flexibility. The guidewire is then adjusted to a second flexibility to advantageously externalize at least a portion of the guidewire through a different introduction site of the body. A catheter is then introduced along the guidewire.
In one embodiment, this procedure may be used to cannulate the coronary sinus in the right atrium from the usual superior venous approach. Using the methodology of one embodiment of the present invention, once a guidewire is placed in the coronary sinus, a catheter can be threaded from an inferior venous approach to exit from the superior introducer site. A withdrawal of the guidewire core creates a soft bend, followed by backloading of the wire into the distal end of the catheter until it exits the proximal end of the catheter shaft in the groin. The catheter is subsequently withdrawn and accomplishes transfer of the wire from a superior insertion site to an inferior insertion site. This approach could be used for placing the left ventricular lead of a cardiac resynchronization pacemaker (biventricular pacemaker) when the rhythm management system generator must be placed in the lower abdominal wall. Similar approaches can be performed on the arterial side of the circulation as well. In accordance with many embodiments of the current invention, similar approaches can be performed when cannulating any orifice in any hollow viscus in the body of an organism, including but not limited to the gastrointestinal system, urinary system, reproductive system and central nervous system. For example, in some embodiments of the invention, the oropharynx, nasopharynx, rectum, urethra may be used as insertion sites. In other embodiments of the invention, artificial locations, such as a ventriculoperitoneal shunt, nephrostomy tube or gastric tube, may be used as insertion sites.
In addition to embodiments of the invention for transferring guidewires, several embodiments of the invention may be adapted to provide for the transfer of at least a portion of a device from one insertion site to another insertion site, with or without the device on a guidewire. Devices capable of such transfer include but are not limited to sensor leads, pacing leads, catheters and any other medical device or portion of a medical device that is capable of movement through a body lumen of an organism. For example,
In addition, if the lead 27 lacks sufficient length to be backloaded into the catheter 13 or if the lead connector 30 cannot fit through the catheter 13 lumen, a snare 19 (such as a guidewire with a snare at one end, or other device capable of releasably engaging the proximal end of the lead 27) may be extended between the first and second insertion sites and used to pull the proximal end of lead 27 from the first insertion site to the second insertion site.
In another embodiment, an extension device such as a guidewire or stylet is removably engaged to the proximal end of the lead 27 to allow the distal end of the lead to be advanced to its target location even when the length of the lead is shorter than the distance from the first insertion site to the target location.
In some embodiments, the procedure for transferring one or more guidewires, sensors leads, or other medical devices may be performed in patients with pre-existing components within the vasculature or body lumen. The pre-existing implant components may have been implanted either in a prior procedure or earlier in the same procedure. One example of this is a patient with a pre-existing implanted cardiac pacemaker who is undergoing the implantation of a left atrial pressure sensor. In such circumstances, performing the guidewire transfer or lead-transfer procedure may cause snagging, dislodgement or damage to the existing leads or sensors, or to the components being implanted. Such risks may be reduced by providing a protected pathway for the guidewires and/or leads involved in the transfer procedure. The protected pathway provides a space for the transfer procedure to take place while excluding at least a portion of the existing vascular or implanted components from interfering with the transfer procedure. The common protected pathway, which may be in the form of a protective sheath or other conduit, can provide a barrier between the transfer procedure and the existing implanted leads or sensors. The protective sheath may be placed along at least a portion of the transfer pathway to reduce interference between the existing components and the new components. The protected pathway need not extend along the entire length between the two entry sites or extend along the entire section of the body lumen or body cavity where the existing components reside.
In one embodiment, a protective sheath may be placed from a left subclavian access site to the superior or inferior vena cava, or more distally to the right ventricular apex, the left ventricle coronary sinus and/or the right atrial appendage, for example. Other target and insertion sites, as mentioned elsewhere, may be used. The selection of the insertion sites for the protective sheath may be based upon a variety of factors, including avoidance of stenotic lesions, valvular insufficiency and unstable plaques. A sleeve or other covering may be used instead of or in addition to the protective sheath.
In other embodiments, due to the size of the new components to be implanted, providing a protective sheath or barrier between the new components and existing components may be impractical. In still other instances, impracticality may result from the proximity between the target implantation site and the existing leads or sensors. In these circumstances, the risks of snagging or dislodging of the existing leads or sensors may still be reduced by providing a protected common pathway at least during the insertion of the components involved in the transfer procedure. Even though the protected common pathway is removed prior to the pullthrough step of the transfer procedure, for example, as long as the guidewires or other components involved in the transfer procedure are protected during insertion from looping or intertwining with the existing sensor leads by a protective sheath, the transfer pathways formed during insertion will still be free of looping or intertwining even after the protective sheath is removed.
Referring to
Referring still to
In other embodiments, the pre-existing implanted components may involve vascular devices unrelated to cardiac rhythm management, and/or may lack a housing and/or lack lead-like members. One such example is a percutaneously implantable annuloplasty ring as that described in U.S. Patent Pub. No. 2007/0051377, herein incorporated by reference in its entirety.
With the pull wire 144 externalized at the exit site, the transfer guidewire may be inserted to the target location. Referring to
Referring to
The coupling of the proximal end 152 of the pull wire 144 and the proximal end 160 of the sensor lead 156 forms a loop 22 external to the vascular sheath 3. As the distal end 145 of pull member 144 is pulled from the vascular sheath 2 located at the exit site, the proximal end 152 of pull wire 144 will pull the coupler 162 and the proximal end of the implantable sensor lead 156 into the insertion site sheath 3. The turn or loop 22 formed by the guidewire 144, coupler 162 and/or implantable sensor lead 156 will then pass through the hemostatic valve 20 of the vascular sheath 3. The turn 22 will move progressively more distally relative to the sheath 3 at the insertion until the turn 22 passes the target location and begins to unfold and straighten out. The proximal end 160 of the sensor lead 156 will then be pulled through the vasculature until it exits the circulation through the vascular sheath 2 in the subclavian vein 1 or other exit site. Preferably, the implantable sensor lead 156 body has sufficient flexibility to reduce the tension or force exerted on the distal sensor 158 during the procedure that may adversely affect the performance or calibration of the sensor 158.
Although the pull wire 144 and proximal end 160 of sensor lead 156 may be joined during the transfer procedure using any of a variety of methods or devices known in the art,
The main body 166 of the connector 162 is depicted in
In other embodiments, the connector end of the coupler 162 may be configured to form a complementary interfit with the lead connector configuration of the implantable lead 156 and does not require a locking cap. Such lead connector configurations may include but are not limited to AO (American Optical Special), Bay (Biotronik Special/Bayonet), CCS (Cardiac Control Systems Special), ED (Edwards Special), GE (General Electric Special), IS-1 (3.2 mm connector, short pin, sealing rings), PSI (Pacesetter Special), SE (Siemens Special Threaded), TRI (Sorin Tripolar), and any of a variety of 3.2 mm, 5 mm and 6 mm lead connectors known in the art. Embodiments of the coupler comprising complementary connector interfit configurations may be preferred in the embodiments where the pull wire 144 is integrated with the coupler 162. In further embodiments, known lead connectors may be modified to facilitate the lead transfer process without affecting the integrity of the connection to the pacemaker/defibrillator or other implantable unit. For example, the inner wall of a hollow proximal IS-1 pin on an implantable lead could be configured with screw threads or other retaining features, and the proximal end of the pull wire had mating screw threads, or other features that reversibly mated with the proximal pin.
In some embodiments, the coupler has an average diameter of about 0.08″ to about 0.20″ preferably about 0.11″ to about 0.14″ or most preferably about 0.12″ to about 0.13″ The connector preferably has a length of about 0.6″ to about 3.0″ preferably about 0.8″ to about 2.0″ or most preferably about 0.9″ to about 1.1″. The size and shape of the connector may vary according to the particular use, organ system or body lumen or cavity. The coupler may comprise any of a variety of biocompatible materials known in the art, including metals and polymers.
In another embodiment, a transfer guidewire is provided to transfer the proximal end of an implantable elongate component, such as a guidewire, lead, etc., from a first location to a second location. One such transfer guidewire is illustrated in
A cross-sectional view of a portion of the transfer guidewire 200 is illustrated in
As illustrated in
The rotational coupling 208 advantageously provides simpler, safer, quicker mechanism for intra corporeal lead transfer. For example, the transfer guidewire 200 may be used in accordance with any of the lead or guidewire transfer methods described herein. For example, with respect to
One embodiment of an implantable sensor lead that may be used as the implanted lead 156 of
For example, once the sensor lead 230 is delivered to the atrial septum of the patient's heart (for example, as described above with respect to the implantation of the sensor lead 156 of
Once attached, the handle 212 and screw 214 of the transfer guidewire 200 is rigidly attached to the sensor lead 230, but the guidewire 202 and stylet 216 may be rotated with respect to the sensor lead 230. Such configuration advantageously allows the proximal end of the sensor lead 230 to be drawn superiorly through the patient's vasculature without providing torque or twisting of the sensor lead 230. Such torque or twisting could be transferred to the sensor 158 secured to the atrial septum 7, which could cause it to become dislodged, misaligned, or miscalibrated. The rotational coupling assembly 208 helps avoid these potentially serious complications.
The first end 316 of the second elongate body 312 resides outside of the patient's body 300 at the first access point 302. The first end 316 of the second elongate body 312 is attached to the second end 308 of the first elongate body 304. Once attached, the second elongate body 312 is withdrawn from the patient's body 300 via the second access point 314. As the second elongate body 312 is withdrawn, the second end 308 of the first elongate body 304 is withdrawn through the patient's body, as well. When the second end 308 of the first elongate body 304 reaches (or is externalized at) the second access point 314, the first and second elongate bodies 304, 312 are disconnected from each other. Once disconnected, the second end 308 of the first elongate body 304 is positioned at or near the second access point 314, as shown in
The first and second access points 302, 314 can include any of a variety of locations for entering the patient's body 300. For example, in some embodiments, the first and second access points 302, 314 include a vein, an artery, a bodily lumen, a bodily cavity, an air passage, a portion of the digestive tract, a femoral vein, a subclavian vein, the nose, the mouth, and/or other bodily location. The first and second access points 302, 314 may also include any of the access points described herein.
The first elongate body 304 includes any of a variety of devices for entering and/or treating the patient's body 300. For example, in some embodiments, the first elongate body 304 includes an implantable lead, an electrode, conductors, a tube, a cannula, a catheter, an aspiration line, a wire, and/or a guidewire. The first elongate body 304 may also include any of the devices described herein.
The first end 306 of the first elongate body 304 can include any of a variety of devices for treating, measuring, and/or manipulating the patient's body 300. For example, in some embodiments, the first end 306 includes an electrode, a sensor, an anchor, a clamp, a sensor, a pressure sensor, and/or a thermometer. The first end 306 may also include any of the devices described herein.
The second end 308 of the first elongate body 304 can include any of a variety of devices for coupling to the first elongate body 304 and/or treating, measuring, and/or manipulating the patient's body 300, as well. For example, in some embodiments, the second end 308 includes a connector, a header, a pacemaker connector, a CRM connector, an antenna connector, a joint, a ball joint, a rotational coupling, a swivel, and/or a clip. The second end 308 may also include any of the devices described herein.
The flexible body portion 310 can include any of a variety of devices for treating, measuring, and/or manipulating the patient's body 300. For example, in some embodiments, the flexible body portion 310 includes a lead, wires, a tube, a cannula, a catheter, and/or an aspiration line, etc. The flexible body portion 310 may also include any of the devices described herein.
The second elongate body 312 includes any of a variety of devices for entering and/or treating the patient's body 300. For example, in some embodiments, the second elongate body 312 includes a guidewire, a transfer guidewire, as well as any of devices used with the first elongate body 304, including an implantable lead, an electrode, conductors, a tube, a cannula, a catheter, an aspiration line, and/or a wire. The second elongate body 312 can also include a stiffening member, such as a reinforced portion, a stylet, etc. The second flexible body 312 may also include any of the devices described herein.
The first end 316 of the second elongate body 312 can include any of a variety of devices for coupling to the second elongate body 312 to the first elongate body 304. For example, in some embodiments, the first end 316 includes a connector, a header, a pacemaker connector, a CRM connector, an antenna connector, a joint, a ball joint, a rotational coupling, a swivel, and/or a clip. The first end 316 may also include any of the devices described herein.
The second end 318 of the second elongate body 312 can include any of a variety of devices for manipulating the second elongate body 312. For example, in some embodiments, the second end 318 includes a guidewire, a pullwire, a wire, a tube, a line, a cable, etc. The second end 318 may also include any of the devices described herein.
At block 406, the ends of the first and second flexible elongate bodies at the first access point are secured to each other. In one embodiment, at least one of the ends includes a swivel or rotational decoupler such that the first and second elongate bodies may be rotated with respect to each other. At block 408, the second flexible elongate body is withdrawn from the patient via the second access point until the attached end of the first flexible elongate body reaches the second access point or exits the patient via the second access point.
At block 410, the first and second elongate bodies are disconnected from each other. At optional block 412, the end of the second elongate body is attached to a device at or near the second access point.
Another embodiment of a transfer guidewire is illustrated in
The catheter 432 at the guidewire 430 proximal end 434 has a chamber or lumen 446 that is sized to form an interference fit over the outside diameter of an implantable elongate body, such as a lead, pacemaker lead, catheter, cannula, tube, wire assembly, cable, etc. The catheter 432 has an outside wall 442 and an inside wall 444, which defines a chamber 446. The chamber 446 and inside wall 444 are sized to form an interference fit with an elongate body to which the transfer guidewire 430 is to be attached. In one embodiment, the interference fit is designed to keep the transfer guidewire 430 and elongate body to which is attached coupled together when at least 1.5 times the maximum pull force provided during a transfer procedure, as described herein.
The cavity 446 is also configured and sized to receive the proximal end of a stylet. A stylet, such as the stylet 420 illustrated in
The stylet 420 includes a handle 422 at its proximal end 424 and a wire 426 extending to the stylet's distal end 428. The stylet's wire 426 is preferably made from nickel titanium or another metal, alloy, or other material, that is flexible but will not kink when inserted into a patient's body.
The transfer guidewire 430, or other transfer guidewire described herein, can be used in one embodiment to transfer the proximal end of an implanted, flexible elongate body from first to second locations at the patient's body without removing its implanted distal end. For example, the transfer guidewire can be used to transfer the proximal end of an implantable sensor lead from a femoral location to a subclavian location.
In yet another embodiment, a stylet 420 is integrated into the transfer guidewire 430 itself. For example, as illustrated in
In the embodiment illustrated as
The following dimensions can apply to any one or more of the embodiments described herein. In some embodiments, the wrapped portion of the guidewire 436 is about 1″ or 2.5 cm long. In some embodiments, the guidewire is about 150 cm long. In some embodiments, the larger diameter proximal end of the catheter is about 10 cm long. In some embodiments, the stylet extends for about 55 cm from the end of the transfer guidewire catheter. In some embodiment, the guidewire has an outside diameter of about 0.038″ or about 9.6 mm. In some embodiments, the stylet wire's diameter is about 0.008″ or about 2 mm at the end that wraps around the guidewire, and about 0.014″ or about 3.6 mm in diameter at its opposite end. Furthermore, in some embodiments, the inside diameter of one end of the transfer guidewire's catheter is sized to receive and form an interference fit with the connector pin and/or proximal end of an implantable lead (e.g., a pressure sensor lead, cardiac pacing lead, etc.).
One method of transferring the proximal end of an implanted, flexible elongate body includes placing an introducer (e.g., a 16F introducer or other introducer) or other delivery catheter in the patient's femoral vein at a femoral vein insertion location, and a short delivery sheath in a subclavian vein at a subclavian vein insertion location. The implantable sensor and lead are percutaneously advanced to the patient's heart via the femoral vein insertion location. The patient's atrial septum is punctured, and access to the patient's left atrium is secured by using a guidewire such as a Toray guidewire. The opening to the septum is dilated with a dilator. Once dilated, a long delivery sheath is percutaneously advanced from the femoral vein insertion location to the dilated opening in the patient's septum. The distal end of an implantable sensor is advanced to the left atrium via the femoral insertion location through the long delivery sheath and anchored to the atrial septum. The distal end of the implantable sensor is coupled to an implantable lead at the lead's distal end. The proximal end of the implantable lead remains externalized with respect to the patient at the femoral insertion location.
The long delivery sheath is removed from the patient's vasculature and a stylet, such as a nitinol transfer stylet, or stylet 420 is inserted into a lumen of the implantable sensor lead. The proximal end of a transfer guidewire, such as the transfer guidewire 430 described above, is slipped over the proximal end of the stylet and implantable sensor lead. For example, in one embodiment, the proximal end of the transfer guidewire includes a catheter that forms an interference fit with the outside diameter of the implantable sensor lead's proximal end.
The distal end of the transfer guidewire is inserted into the patient via the introducer at the femoral insertion point, and advanced until its distal end reaches the patient's inferior vena cava. The distal end includes a J-tip end, or other feature that allows the transfer guidewire to be snared. A snare is inserted into the patient's vasculature at the subclavian insertion point. The snare is advanced inferiorly until it reaches the inferior vena cava. The snare is used to snare or otherwise attach to the J-tip end (or other feature) of the transfer guidewire. The snare is retracted superiorly through the patient's vasculature until it and the distal end of the transfer guidewire are externalized from the patient at the subclavian insertion location.
Lead transfer is performed by pulling or otherwise advancing the transfer guidewire in the superior direction. As the transfer guidewire is advanced superiorly the proximal end of the implantable sensor lead is also advanced superiorly, due to the connection between the transfer guidewire and the implantable sensor lead at their proximal ends. The implantable sensor lead is “pulled” superiorly until its proximal end is brought near, to, or past the subclavian access point. The proximal ends of the transfer guidewire and implantable sensor lead are separated. In one embodiment, the proximal end of the implantable sensor lead is attached to one or more implantable medical devices, such as a cardiac rhythm management device, pacemaker, defibrillator, pressure sensing system, etc. The proximal ends of the transfer guidewire and implantable sensor lead can be separated from one another by using a lead transfer slitter, as described below with respect to
One embodiment of a lead transfer slitter is illustrated in
The lead transfer slitter 500 includes a housing 502 that contains a blade 504. The housing exposes just enough of the blade 504 to control cutting depth into the transfer guidewire catheter while shielding the blade 504 from the user. For example, in one embodiment the housing 502 includes a projection 506 in which an end portion of the blade 504 extends. The blade tip 508 is fixed a predetermined distance from the bottom edge 510 of the projection 506. In addition, the blade's cutting edge 512 is spaced a predetermined distance from the projection's leading edge 514.
The projection 506 defines a cavity 516 into which the catheter portion of a transfer guidewire is inserted. The transfer guidewire includes a catheter at its proximal end. An implantable elongate body, such as an implantable lead, is inserted into the catheter. As the lead transfer slitter 500 is drawn over the transfer guidewire, the blade 504 slices through the wall of the transfer guidewire's catheter without piercing or cutting the implantable, flexible elongate body, or lead. The catheter, and transfer guidewire, may then be separated from the lead.
Although certain procedures discussed above relate to a transseptal procedure wherein an elongate sensor component is inserted across the intra-atrial septum, the procedure may be adapted to any of a variety of body lumens, cavities or spaces, including other cardiac structures, the peripheral vascular system, the central nervous system, the gastrointestinal system, pulmonary system, urogenital system and other organ systems.
In one example,
In another embodiment, the method of manipulating insertion pathways for accessing target sites further comprises providing a kit, or system, for performing the guidewire and/or medical device transfer. In one embodiment, the kit, or system, is a combination, assemblage and/or compilation of materials suitable for a common purpose and comprises an introducer sheath for each insertion site, a torqueable catheter and two guidewires. In another embodiment, the kit further comprises at least one of the guidewires having a coilable soft curled tip. In another embodiment, the kit further comprises at least one of the guidewires having a movable inner core mandrel. In another embodiment, the kit or system further comprises a snare. In another embodiment, the kit further comprises a thin-walled introducer. In a further embodiment, the kit includes a Brockenbrough needle catheter. In yet another embodiment, the kit further includes a Mullins sheath.
In another embodiment, a guidewire for manipulating insertion pathways to access target sites in the body is provided. In one embodiment, the guidewire 10 (
As used herein, the term guidewire shall be given its ordinary meaning and shall include a wire positioned in, on, or through the body (for example, in, on, or through an organ, vessel, or duct) in order to direct the passage of another device over or along its length. The term pull wire as used herein shall be given its ordinary meaning and shall also include guidewires, polymeric and metallic sutures, snares or other elongate structures that may be used to push, pull, twist or otherwise manipulate a device.
Guidewires may be configured as single piece or multi-piece constructions. In one embodiment, the guidewire has a single-piece construction and comprises a tapered core mandrel with a stiffer proximal end and a flexible, shaped distal end. Such wires are often coated with a hydrophilic substance that increases lubricity on contract with blood. One example of this type of wire construction is the Glidewire® by Terumo of Japan. This type of wire is particularly useful for advancing through blood vessels that are blocked by thrombus or atherosclerosis.
In one embodiment, the guidewire has a multi-piece construction comprising a moveable inner core and an outer helical wound coil, with an opening at its proximal end and a closed-off distal end, creating a closed-tip lumen for the moveable core. In another embodiment, the distal tip is open-ended and the guidewire has a through-lumen that may be used for injecting or withdrawing diagnostic or therapeutic substances. The distal end of the coil may be preshaped into a “J”, “hockey-stick” or other configuration, or may contain a deformable inner strip or a shaping ribbon that allows the operator to create a desired tip configuration. In one embodiment, the core provides variable stiffness to at least a portion of the guidewire body. In one embodiment, the distal tip of the core may be tapered to create a smooth transition from the stiff portion to the flexible portion of the guidewire. In another embodiment, the tip may be rounded to improve passage of the core through the coil. In yet another embodiment, movement of the core may be facilitated with lubrication such as silicone oil or a polymeric coating. In one embodiment, the outer coil may be coated or bonded with a material such as Teflon to alter lubricity and/or an anticoagulant such as heparin. In one embodiment, the distal end of the core is capable of forming a friction fit or a mechanical interfit with the distal end of the coil with respect to rotation and facilitate the transmission of torque applied at the proximal core to the distal tip. This allows the user to alter the orientation of the distal tip and allow selection of vessels or other lumens as the wire is advanced and “torqued.” Moveable core guidewires may be advantageously used to position catheters in the body through a tortuous path while reducing trauma to body structures.
In another example of multi-piece construction, the core is fixed to a distal flexible coil that covers the distal tapered portion of the core transitioning into a shapeable tip. In one embodiment, such guidewires provide improved torque control. In another embodiment, the guidewire has a radio-opaque plating (such as a platinum or gold plating) applied to at least the distal end of the coil to aid in fluoroscopic visualization. In one embodiment, up to about 15 cm of the distal end is rendered radio-opaque. In a preferred embodiment, the distal 2 cm to 10 cm end of the coil is radio-opaque. These wires are used to selectively steer into small branches and provide a trackable path for interventional devices such as balloons or stents. Another variant of this type of construction is the wire described by Inoue as manufactured by the Toray Corporation of Japan. This wire has about a 0.025″ outer diameter stainless steel mandrel that tapers, with the distal portion covered by a flexible coil and configured in a spiral shape. This wire is particularly useful for securing a stable position in the left atrium after transseptal catheterization.
As shown in
In one embodiment, the movable core mandrel 33 has a proximal end 35 with a tab 36 or other type of handle to facilitate manipulation of the mandrel 33. In another embodiment, the mandrel 33 lacks a tab 36 so that a device can be passed over guidewire 10 without having to remove mandrel 33. The movable core mandrel 33 may have a tapered distal end 37 to facilitate insertion and extension of the mandrel 33 through the internal lumen 32 of the guidewire 10. In one embodiment, the mandrel 33 is made from stainless steel or nickel titanium alloy (e.g., Nitinol). One skilled in the art will understand that the material and structure selected for the mandrel 33 can be based upon the desired stiffness, ductility, elastic deformation and other characteristics desired.
In one embodiment, the guidewire 10 is flexible or deformable, and the mandrel 33 is more rigid. In another embodiment, the mandrel 33 is flexible or deformable, and the guidewire 10 is more rigid. In one embodiment, the more rigid guidewire 10 comprises an opening at the distal end so that it can be passed over the proximal end of the mandrel and into the target site.
In one embodiment, the guidewire 10 is uniformly flexible along its length. In another embodiment, the pliancy of the guidewire 10 is not uniform throughout the length of the guidewire 10, even when the mandrel 33 is completely removed from the internal lumen 32. In a preferred embodiment, the middle portion of the guidewire 10 is more flexible than the distal end and/or the proximal end of the guidewire 10. One advantage of this alternating flexibility is that it facilitates bending and/or sharp turns in the body lumen.
In one embodiment, the guidewire comprises a material and structure with sufficient ductility capable of withstanding deformation of at least about 180 degrees to about 540 degrees of bending within a body or sheath lumen without breakage. In another embodiment, the guidewire comprises a material and structure with sufficient ductility and a yield point capable of withstanding deformation of at least about 220 degrees in a body or sheath lumen without breakage or plastic deformation. The guidewire may be made in whole or in part from a material selected from one or more of the following: stainless steel alloys such as NP35-N, nickel titanium (nitinol), tantalum, or a combination thereof. Similarly, the guidewire may be constructed from polymeric or composite materials including but not limited to polyethylenes, polyurethanes, carbon fibers, or blended combinations thereof. In another embodiment, the guidewire may be constructed of a combination of metallic and polymeric/composite materials. In another embodiment, the guidewire is coated with a hydrophilic coating or a polymer such as ePTFE to facilitate the passage of the guidewire through the body. One skilled in the art can select the guidewire material and structure to provide the desired characteristics, including but not limited to torqueability, stiffness, ductility, friction coefficient, radio-opacity and deformation characteristics.
While this invention has been particularly shown and described with references to embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the scope of the invention. For all of the embodiments described above, the steps of the methods need not be performed sequentially.
The present application is a continuation-in-part of U.S. application Ser. No. 11/622,654, filed on Jan. 12, 2007, which claims priority under 35 U.S.C. §119(e) to U.S. Provisional Application No. 60/764,878 filed on Feb. 3, 2006, the disclosures of which are herein incorporated by reference in their entirety.
Number | Date | Country | |
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60764878 | Feb 2006 | US |
Number | Date | Country | |
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Parent | 11622654 | Jan 2007 | US |
Child | 12842917 | US |