A uretheral stent is a medical device used within a patient population which experience one or more complications associated with the urinary system which includes the kidneys, ureters, and bladder. A host of complications may affect urinary flow and how these organs handle this function; these complications ranging from decreased urine flow to swelling of the kidneys or bladder, with many of these conditions being adversely impacted by the formation of kidney stones. To alleviate urinary system complications, a device or device(s) are placed either within the bladder, one or both of the kidneys, and/or one or both of the patient's ureters. The devices used in these areas are known as nephrostomy catheters (delivered percutaneously within a kidney collecting system), nephrouretheral catheters (delivered percutaneously and extending distally into the bladder), urinary catheters (delivered through the urethra), or uretheral stents (delivered percutaneously or through the urethra).
The present disclosure relates to the delivery method and use of the nephrouretheral catheter and the uretheral stent, which are often used one after the other in percutaneous cases to deal with a patient's urinary system complications. Once a patient has exhibited urinary complications and a uretheral stent implantation is recommended, a urologically delivered stent placement will often be attempted. In some cases, this cannot be achieved by the urologist due to a variety of possible factors, resulting in the patient being sent to the interventional radiologist (IR). The IR may then attempt to deliver a nephrouretheral stent percutaneously though the backside of the patient and into the impacted kidney, with said device extending distally into the bladder. The proximal end of the nephrouretheral catheter thereby remains outside of the patient for up to 2 weeks, giving the access site sufficient time to heal before removal. Once the access site has fully healed, the patient is typically sent back to the operating room for a second interventional procedure whereby the nephrouretheral stent is removed and a uretheral stent is then delivered. This uretheral stent differs from the nephrouretheral stent in that its proximal tip terminates within the kidney's renal pelvis. This uretheral stent has a curl at its distal end which resides in the bladder and a proximal curl which resides in the renal pelvis. This device may reside in the patient for up to 6 months or in some cases longer and may be removed urologically. This two-step approach and the devices used may be less than ideal in many cases.
The present disclosure will also be related to the delivery method and use of a catheter and stent as used to maintain the patency of any bodily lumen. For example, a catheter and stent can be used to maintain the patency of a bile duct, as an ileal conduit catheter, a pancreatic stent to, e.g., drain a pancreatic pseudocyst into the stomach or intestine, to maintain the patency of a ureter where the gall bladder has been surgically removed, and at generally any part of the patient's anatomy where patency of the lumen is desired and maintained. Currently used catheters and stents to maintain bodily lumen patency may be less than ideal in at least some cases.
There are needs to overcome at least some of the drawbacks discussed above.
According to many embodiments, integrating the functionalities of two existing devices used for the percutaneous treatment of urinary and other complications (e.g., maintaining the patency of a bile duct, or draining various cysts) into a single device has been devised, with particular focus on the methods, designs, and materials which may be utilized to couple these two devices together in a fashion which allows a decoupling at a later time state. Many embodiments provide a single device which may combine the functionalities of a nephrouretheral or other catheter and uretheral or other stent, but can maintain the ability to perform the full removal of the proximal (catheter) portion of the device extending out of the patient's body during the early stages of implantation (for example, up to 2 weeks).
The decoupling (release) mechanism can allow the proximal portion of this combination device to be removed without the need for a second interventional procedure. The primary modes of function of this coupling mechanism include, but are not limited to, the following: (1) to maintain connection of proximal (catheter) portion of device to distal (stent) portion of device, and (2) to permit the removal of the proximal portion of device at a later time leaving behind distal portion of device within the patient's urinary collecting system or the patient's desired anatomical location. The decoupling nature of the proximal portion of the device may be achieved by providing an input to the proximal hub of the device which extends out of the patient's body. This input to decouple catheter from stent may be performed by the push of a button, the rotation of a luer, the insertion of a tool, the removal of a wire or a series of similar events occurring at the proximal hub, or the like. Additionally, independently of the coupling mechanism, a strand of material, typically with a circular cross-section, can be used to assist in the closure of the stent's proximal loop once the device has been delivered into the patient. This may be necessary due to the tighter space the renal pelvis or other target organ provides for this proximal loop to reside. This strand of material may be called the ‘proximal loop suture’ and may pass through side holes cut into the stent allowing for proximal loop closure. This ‘proximal loop suture’ may be fully removed from the device without inhibiting the functionality of the coupling interface between the proximal and distal portions of the device.
Several depictions of the coupling interface between the catheter and stent are shown in the Figures. This coupling interface would permit the utilization of a single surgical procedure as opposed to two, putting the patient at significantly less risk for complications in the operating room environment. The decoupling may be achieved by an input to the proximal hub performed at bedside or by the insertion of a decoupling tool, thereby removing catheter portion of device once deemed necessary. A coupled device may be achieved in many ways as described herein. An example of a coupling may include an expandable inner member which retains the distal member with the proximal member by expanding within the stent lumen to couple and once an input is applied to proximal hub, said expanded element may collapse and decouple the device. Some of the depictions below may provide a safe and effective way to combine the nephrouretheral or other catheter and the uretheral or other stent while still providing the utility of separate devices and two surgical procedures.
Aspects of the present disclosure provide surgically delivered medical devices. An exemplary medical device may comprise a proximal portion which extends outside of a patient's surgical access site. The proximal portion of device may be removed at a later date, converting the distal portion of device into an implant. The device may comprise a distal (stent) member and a proximal (catheter) member. The proximal and distal members may be coupled to one another in a concentric fashion via an inner member extending out from the proximal member. The proximal and distal members may be coupled in one of or a combination of many embodiments.
In many embodiments, the device may employ suture loop lock(s) to couple the proximal member to the distal member. The suture loop lock(s) may wrap around one or more pull wire(s) at the inner member to stent interface. Furthermore, suture tail(s) may extend proximally to the hub of device and may be locked into place with tension applied to achieve leveraged coupled interface.
In many embodiments, the device may employ suture loop lock(s) which wrap around the inner member at the stent interface region to achieve coupling of proximal and distal members. Furthermore, suture tail(s) may extend proximally to hub of device and may lock into place with tension applied to achieve leveraged coupled interface.
In many embodiments, the device may comprise an inner member which is fixed at the distal region of proximal catheter. The inner member may contain a smaller tube affixed within its lumen. The smaller tube may be used as a receiver for a ball wire, which may extend from distal member, and a pull wire, which may extend from proximal member. Once the ball wire has passed through the smaller tube, the pull wire may be passed through which may prevent passing of ball until pull wire is removed from device.
In many embodiments, the device may comprise an inner member which is fixed at the distal region of the proximal catheter. The inner member may include a superelastic/shape memory element which may be used as a receiver described above.
In many embodiments, the proximal and distal members of the device may be coupled to one another using a ring locking style mechanism, with one ring element affixed to distal member and another ring element affixed to proximal member. The ring members may be held coincident using an inner member and a pull wire.
In many embodiments, the device may comprise a keyed locking system, such as mating hexagonal elements, with one hex element affixed to proximal member and another hex element affixed to distal member to achieve coupling. The hex elements may be engaged or disengaged using a counter rotating tool.
In many embodiments, the inner member may extend fully from proximal hub to achieve concentric junction between the distal and proximal members. In addition, the inner member may be fixed or movable at hub and along entire catheter length.
In many embodiments, the inner member may be a component which is affixed to the distal or proximal member and only extends for a fractional portion of the device's length.
In many embodiments, the inner member may be formed as a necking of the distal region of the catheter itself which is then inserted into the lumen of the distal (stent) member.
In many embodiments, the proximal and distal members of the device may be coupled to one another through the employment of an adhesive layer on the inner member region which extends into the distal member.
In many embodiments, the proximal and distal members of the device may be coupled to one another through the employment of an oversized diameter of the inner member resulting in a frictional fit with the stent.
In many embodiments, the proximal and distal members of the device may be coupled to one another through the employment of a metallic or polymeric crimp which may be applied to the outside of the stent which overlaps the inner member extending into its lumen.
In many embodiments, the proximal and distal members of the device may be coupled to one another through the employment of a superelastic/shape memory alloy affixed to the distal member which may interface with protrusions on the outer surface of the inner member. Thereby, the inner member may not be movable until the catheter or peel-away sheath has been removed and shape memory alloy mechanism releases inner member.
In many embodiments, an inner tube extends inside and along the lumen of the catheter and the lumen of the stent. The proximal and distal members of the device may be coupled to each other by means of a flap on the catheter fitted into a complementary shaped slot on the stent. The flap may be biased radially inward toward the lumen, and thereby be abutting the slot when the catheter and stent are pulled apart while the inner tube is present in the lumens thereof (i.e., crosses through the lumens of both the catheter and the stent), preventing the proximal and distal members from decoupling. When the inner member is retracted, the flap may be allowed to return to its radially inward oriented position such that it no longer abuts the slot such that the catheter and stent may be decoupled. In other embodiments, the flap may instead be on the stent and the complementary shaped slot may be on the catheter.
In many embodiments, the proximal and distal members of the device may be coupled to one another through the use of a mechanically modified surface of the inner member which, once inserted into distal member, an interfacing region of the distal member may be heated and a polymer may be allowed to flow into the mechanical alterations of inner member. The polymer may furthermore be allowed to cool, forming a permanent mechanical interface between the two elements until the inner member is pulled away from distal member using a light to moderate pull force.
In many embodiments, the proximal and distal members of the device may be coupled to one another through the use of a female to male thread style arrangement at the coupling interface.
In many embodiments, the proximal and distal members of the device may be coupled to one another using electrically releasable metallic element(s), which may couple the proximal and distal members until a tool can be used to electrically disengage said elements.
In many embodiments, the proximal and distal members of the device may be coupled to one another using magnets affixed to proximal and distal members and may be disengaged by pulling proximal member away from distal member or by rotating one or both of magnetic components within said members using a tool or other components incorporated within device.
In many embodiments, the proximal and distal members of the device in their coupled state may be disengaged using a separate tool which may decouple proximal and distal members by an input of rotation, electrical stimulus or ultrasonic vibration.
Aspects of the present disclosure also provide further stent delivery systems. An exemplary stent delivery system may comprise a catheter body, a stent member, an inner member, and a tether. The catheter body may have an inner lumen and a proximal end and a distal end. The stent member may have an inner lumen and a proximal end releasably coupled with the distal end of the catheter body. The inner member assembly may be disposed in the inner lumen of the catheter body and may extend into the inner lumen of the stent member to concentrically align the catheter body and the stent member. The tether may extend through or along the catheter body and into the inner lumen of the stent member to form a loop over at least a portion of the inner member assembly, thereby securing the stent member to the catheter body. Retraction of the inner member from the inner lumen of the stent member may free the inner member assembly from the loop such that the stent member is released from the stent body.
The inner member assembly may comprise a locking pull wire. The locking pull wire may be threadable through the loop of the tether. The inner member assembly may comprise a hypotube. The inner member assembly may be configured to be actuated with one or more pull tabs or rotatable caps at a hub coupled to the proximal end of the catheter body.
The tether may extend through the inner lumen of the catheter body. The tether may extend out of a lateral port of the catheter body near the distal end of the catheter body. The loop formed by the tether may extend into stent member through a lateral port of the stent member to be threaded through by the at least a portion of the inner member assembly within the inner lumen of the stent member. The tether may have a fixed end near the distal end of the catheter body and a free end. The tether may extend proximally toward the free end and the proximal end of the catheter body. The tether may have a first end and a second end. The tether may extend proximally toward both the first and second ends and the proximal end of the catheter body.
The stent member may comprise a proximal loop and a distal loop. One or more of the proximal loop or the distal loop of the stent member may have a straightened configuration and a looped configuration. One or more of the proximal loop or the distal loop may be biased to assume the looped configuration. The stent delivery system may further comprise a loop pull wire extending through the inner lumen of the catheter body and coupled to the proximal loop. Retracting the loop pull wire may pull the proximal loop into the loop configuration or may lower a radius of the proximal loop. The loop pull wire may extend out from a first lateral port of the stent member near the proximal end of the stent member and may extend back into a second lateral port of the stent member near a distal end of the proximal loop. The loop pull wire may be retractable from a pull tab or rotatable cap at a hub coupled to the proximal end of the catheter body.
Other exemplary stent delivery systems may comprise a catheter body, a catheter member, and an inner member assembly. The catheter body may have an inner lumen and a proximal end and a distal end. The catheter member may have an inner lumen and a proximal end which is fixed or releasably coupled with a stent element extending from within the lumen of the proximal end of the stent body. The inner member assembly may be disposed in the inner lumen of the catheter body and may extend into the inner lumen of the stent member to concentrically align the catheter body and the stent member.
In some embodiments, the stent delivery system further comprises a wire extending through or along the entire or a portion of the catheter body and into the inner lumen of the stent body to interface the catheter member, with the stent element thereby securing the stent body to the catheter body. Retraction of the wire from the inner lumen of the catheter member may free the inner member assembly from the stent element such that the catheter member is released from the stent body.
In some embodiments, the stent delivery system may further comprise a wire extending through or along the entire or a portion of the catheter body and into the inner lumen of the stent member, subsequently interfacing with the superelastic assembly in a releasable fashion to secure the stent member to the catheter body. Retraction of the wire from the inner lumen of the stent member may free the superelastic inner member assembly from such that the stent member is released from the stent body.
In some embodiments, the stent delivery system may further comprise a tether extending through or along the catheter body and into the inner lumen of the stent member to form a loop over at least a portion of the inner member assembly, thereby securing the stent member to the catheter body. Retraction of the inner member from the inner lumen of the stent member may free the inner member assembly from the loop such that the stent member is released from the stent body.
In some embodiments, the stent delivery system may further comprise a tether extending through or along the catheter body and into the inner lumen of the stent member to form a loop over at least a portion of the inner member assembly, thereby securing the stent member to the catheter body. Retraction of the inner member from the inner lumen of the stent member may free the inner member assembly from the loop such that the stent member is released from the stent body.
In some embodiments, the stent delivery system may further comprise an adhesive which is applied to the inner lumen of the stent member to affix the inner member assembly to the stent member extending through or along the catheter body and into the inner lumen of the stent member, thereby securing the stent member to the catheter body. Retraction of the inner member at a threshold load may allow a break away from the bonded surface of the stent member such that the inner member is released from the stent body.
In some embodiments, the stent delivery system may further comprise a frictional interference between the inner member and the stent member. The frictional interference may be applied to the inner lumen of the stent member to affix the inner member assembly to the stent member extending through or along the catheter body and into the inner lumen of the stent member, thereby securing the stent member to the catheter body. Retraction of the inner member at a threshold load may allow a breakaway of the frictional interference with the stent member such that the inner member is released from the stent body.
In some embodiments, the stent delivery system may further comprise a metallic crimp or swaged band element. The metallic crimp or swaged band element may be applied over the outside of the stent body toward its distal end to affix the inner member assembly to the stent member extending through or along the catheter body and into the inner lumen of the stent member thereby securing the stent member to the catheter body. Retraction of the inner member at a threshold load may allow a breakaway from the frictional interference resulting from the crimp element such that the inner member is released from the stent body.
In some embodiments, the stent delivery system may further comprise a superelastic mechanism extending from the stent body. The superelastic mechanism may interface with the inner member in a locked state until the catheter body is removed, at which point the superelastic mechanism may release the inner member from its locked state allowing its complete removal.
In some embodiments, the stent delivery system may further comprise a thermoforming process applied to the inner member allowing it to interface with the stent member to affix the inner member assembly to the stent member extending through or along the catheter body and into the inner lumen of the stent member, thereby securing the stent member to the catheter body. Retraction of the inner member at a threshold load may allow a breakaway from the thermoformed surface of the stent member such that the inner member is released from the stent body.
In some embodiments, an inner member and stent member may interface and lock together via threaded surfaces to affix the inner member assembly to the stent member extending through or along the catheter body and into the inner lumen of the stent member, thereby securing the stent member to the catheter body. Rotation of the inner member out from the stent member may enable inner member to be released from the stent body.
The stent delivery systems may further be configured in any number of ways described above and herein.
Aspects of the present disclosure also provide methods for delivering nephrouretheral or other stents. A stent delivery system may be advanced through a percutaneous access site so that a distal end of a stent member of the stent delivery system is positioned in a bladder or other target organ and a proximal end of the stent member is positioned in a renal pelvis or other target organ. The distal end of the stent member may form a distal loop in the bladder or other target organ. The proximal end of stent member may be actuated to form a proximal loop in the renal pelvis or other target organ. The stent member may be decoupled from a catheter body of the stent delivery system. The catheter body of the stent delivery system may be retracted from the percutaneous access site, leaving the stent member in place.
To actuate the proximal end of the stent member to form a proximal loop in the renal pelvis or other target organ, a loop pull wire extending through the catheter body may be retracted to reduce a radius of the proximal end of the stent member.
To decouple the stent member from the catheter body, a lock pull wire may be retracted from the stent member to free a tether loop extending into the stent member from the catheter body and/or an inner member may be retracted from the stent member. The inner member may be configured to concentrically align the catheter body with the stent member when advanced therethrough.
The member and the catheter body of the stent delivery system may be left in place for at least 3 days before the stent member is decoupled from the catheter body and the catheter body is retracted from the percutaneous access site. In some embodiments, urine is be drained through the catheter body of the stent left in place. In some embodiments, the catheter body of the stent left in place is capped.
Aspects of the present disclosure also provide methods of delivering a convertible stent. A stent delivery system may be advanced through a percutaneous access site so that a distal end of a stent member of the stent delivery system is positioned in an intestine, and a proximal end of the stent member is positioned in a common bile duct, wherein the distal end of the stent member forms a distal loop in the intestine. The proximal end of stent member may be actuated to form the proximal end into a proximal loop in the common bile duct. The stent member may be decoupled from a catheter body of the stent delivery system. The catheter body may be retracted from the percutaneous access site, leaving the stent member in place.
In some embodiments, a loop suture may be pulled to actuate the proximal end of the stent member to form the proximal loop.
In some embodiments, one or more of the proximal or distal end of the stent member may be straightened prior to advancing the stent delivery system.
In some embodiments, to straighten the one or more of the proximal or distal end of the stent member, a hypotube or other straightener may be advanced through inner lumens of the stent member and the catheter body
In some embodiments, the hypotube or other straightener may be removed, thereby allowing the one or more of the proximal or distal end of the stent member to form the proximal loop or the distal loop, respectively.
In some embodiments, the stent member and the catheter body of the stent delivery system may be left in place until hemostasis is achieved, before decoupling the stent member from the catheter body.
In some embodiments, at least a portion of the catheter body may be coated with a hemostatic agent.
Aspects of the present disclosure also provide further methods of delivering a convertible stent. A stent delivery system may be advanced through a percutaneous access site so that a distal end of a stent member of the stent delivery system is positioned in a pseudocyst, and a proximal end of the stent member is positioned in a stomach, wherein the distal end of the stent member forms a distal loop in the pseudocyst. The proximal end of stent member may be actuated to form the proximal end of the stent member into a proximal loop in the stomach. The stent member may be decoupled from a catheter body of the stent delivery system. The catheter body may be retracted from the percutaneous access site, leaving the stent member in place.
In some embodiments, a loop suture may be pulled to actuate the proximal end of the stent member to form the proximal loop.
In some embodiments, one or more of the proximal or distal end of the stent member may be straightened prior to advancing the stent delivery system.
In some embodiments, to straighten the one or more of the proximal or distal end of the stent member, a hypotube, or other straightener may be advanced through inner lumens of the stent member and the catheter body.
In some embodiments, the hypotube or other straightener may be removed, thereby allowing the one or more of the proximal or distal end of the stent member to form the proximal loop or the distal loop, respectively.
In some embodiments, the stent member and the catheter body of the stent delivery system may be left in place until hemostasis is achieved, before decoupling the stent member from the catheter body.
In some embodiments, at least a portion of the catheter body may be coated with a hemostatic agent.
Aspects of the present disclosure also provide further stent delivery systems. An exemplary stent delivery system may comprise a catheter body, a stent member, and an inner member. The catheter body may have a lumen and a terminal end and a flap at the terminal end, the flap being biased radially inward toward the lumen. The stent member may have a lumen and a terminal end and a slot at the terminal end, the slot having a shape complementary to the flap of the catheter body to receive the flap. The inner member may be translatable through the lumens of the catheter body and the stent member. The catheter body and the stent member may be coupled to one another by matching the terminal ends thereof to one another and crossing the inner member between the lumens of the catheter body and the stent member, with the flap being received by the slot to restrict separation of the catheter body and the stent member, and the inner member pushing the flap radially outward to maintain a position of the flap within the slot.
Aspects of the present disclosure also provide further stent delivery systems. An exemplary stent delivery system may comprise a catheter body, a stent member, and an inner member. The catheter body may have an inner lumen and may be configured to couple to the stent member. The stent member may have an inner lumen and may be configured to couple to the catheter body. The stent member may comprise a proximal loop and a distal loop. The inner member assembly may extend through the inner lumens of the catheter body and the stent member, concentrically aligning and coupling the catheter body and the stent member to one another.
In some embodiments, the distance between the proximal loop and the distal loop may be between 25 cm and 35 cm. In some embodiments, the distance between the proximal loop and the distal loop may be between 20 cm to 28 cm. The distance between the proximal loop and the distal loop may generally be any length appropriate for a desired application. The distance ranges of 25 cm to 35 cm and 20 cm to 28 cm may be appropriate for use of the convertible stent as a nephrouretheral stent.
In some embodiments, the distance between the proximal loop and the distal loop may be between 5 cm and 10 cm. which may be appropriate for use of the convertible stent as a biliary stent.
In some embodiments, the catheter body and stent member may be tapered distally, i.e., gradually tapered to facilitate advancement.
In some embodiments, a diameter of the catheter body may be larger than a diameter of the stent member at the proximal loop, and a diameter of the stent member at the proximal loop may be larger than a diameter of the stent member at the distal loop.
In some embodiments, the diameter of the catheter body may be 10F, the diameter of the stent member at the proximal loop may be 9F, and the diameter of the stent member at the distal loop may be 8F. The different portions of the assembly of the catheter and stent members may instead have other dimensions or diameters to provide the gradual tapering in the distal direction.
In some embodiments, the stent member may comprise polymer, UHMW polyethylene, PTFE, or any combination thereof.
In some embodiments, the inner member assembly comprises a stent inner tube and a catheter inner tube. The stent inner tube may be coupled to the stent member and disposed within the inner lumen of the stent member near a proximal end of the stent member. The stent inner tube may comprise a lock window. The catheter inner tube may be coupled to and protruding from a distal end of the catheter member. The catheter inner tube may comprise a locking element. The catheter inner tube may be configured to fit at least partially within the stent inner tube such that the locking element is in a position to be urged to fit within the lock window of the stent inner tube, thereby coupling the catheter body with the stent member.
In some embodiments, the catheter inner tube comprises a strut coupled to the locking element, the strut being biased to urge the locking element radially inward to be away from the lock window when the catheter inner tube is fit at least partially within the stent inner tube. The inner member assembly may comprises a slider tube configured to be advanced through an inner lumen of the catheter inner tube to urge the lock element radially outward to fit within the lock window of the stent inner tube when the catheter inner tube is fit at least partially within the stent inner tube. The slider tube may further comprise a pull wire configured to be retracted to retract the slider tube from the inner lumen of the catheter inner tube.
In some embodiments, the inner member assembly further comprises a stent outer tube coupled to the stent member and positioned within the inner lumen of the stent member to couple the stent inner tube to the stent member.
In some embodiments, the inner member assembly further comprises a catheter outer tube coupled to the catheter member and positioned within the inner lumen of the catheter member to couple the catheter inner tube to the catheter member.
Aspects of the present disclosure also provide further methods of delivering a convertible stent. A stent delivery system may be advanced through a percutaneous access site so that a distal end of a stent member of the stent delivery system is positioned in first bodily lumen, a proximal end of the stent member is positioned in a second bodily lumen, and a catheter member proximal to the stent member and coupled thereto is positioned in a tissue tract leading to the first and second bodily lumens. The distal end of the stent member may be allowed to form a distal loop. The proximal end of the stent member may be allowed to form a proximal loop. Bleeding in the tissue tract may be reduced using a hemostatic element of the catheter member. The stent member may be decoupled from the catheter member. The catheter member may be retracted from the percutaneous access site, leaving the stent member in place.
In some embodiments, the hemostatic element may comprise a hemostatic coating on the catheter member.
In some embodiments, the hemostatic element may comprise an electrocauterizing electrode.
In some embodiments, a loop suture may be pulled to actuate the proximal end of the stent member to form the proximal loop.
In some embodiments, one or more of the proximal or distal end of the stent member may be straightened prior to advancing the stent delivery system.
In some embodiments, to straighten the one or more of the proximal or distal end of the stent member, a hypotube, or other straightener may be advanced through inner lumens of the stent member and the catheter body.
In some embodiments, the hypotube or other straightener may be removed, thereby allowing the one or more of the proximal or distal end of the stent member to form the proximal loop or the distal loop, respectively.
In some embodiments, the stent member and the catheter body of the stent delivery system may be left in place until hemostasis is achieved, before decoupling the stent member from the catheter body.
While the present disclosure describes the device in the context of a ureter obstruction, this is for example only. The device of may also be used in other contexts where it is desired to maintain the patency of a lumen. For example, the device may be used as a device which converts into a biliary stent to maintain the patency of a bile duct, a pancreatic stent to, for example, drain a pancreatic pseudocyst into the stomach or intestine, a nephrouretal stent where the bladder has been surgically removed, or generally with any part of the body where patency of a lumen is desirable and is to be maintained.
All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference.
The novel features of the present disclosure are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the present disclosure are utilized, and the accompanying drawings which display various embodiments of the coupling mechanism to be used in the fabrication of the convertible nephrouretheral catheter and are described as follows.
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In some embodiments, the coupled junction 150 may be provided by the flap 1210 being on the stent member 120 instead of the catheter member 110, and with the slot 1220 being on the catheter member 110 instead of the stent member 120. In some embodiments, the stent member 120 may include both the flap 1210 and the slot 1220, which are diametrically opposed to one another, and the catheter member may include a complementary set of the flap 1210 and the slot 1220 such that the junction 150 can be formed. While a single flap and a single complimentary slot are shown, multiple flaps and complimentary slots may be used. While the catheter member is shown as having the flap and the stent member is shown as having the complimentary slot, the attachment mechanism may be reversed, with the stent member having the flap and the catheter member having the complimentary slot. In some embodiments, the catheter and stent members may have multiple flap and complimentary slot mechanisms, with one or more being in the reserve orientation.
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U.S. Pat. Nos. 8,657,884 and 9,387,312, which described convertible stents and catheters similar to those described herein, are each incorporated herein by reference. Referring to
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In some embodiments, the diameter of the lumen of the tube may be 10F. The diameter of the lumen may remain constant throughout the length of the lumen. In other embodiments, the diameter of the lumen can vary throughout the length of the lumen. For example, the diameter of the lumen may taper from the proximal end to the distal end. In some embodiments, referring to
In some embodiments, the method of using the device comprises advancing the device through a percutaneous access site so that the distal end of the catheter portion of the device is positioned in at or near a first bodily lumen, such as a bladder, with the proximal end of the stent member 120 being positioned in the first bodily lumen. In some embodiments, the catheter member 110 is left in the patient's body for a few days before the catheter member 110 is removed. In many cases, it can be desirable to achieve hemostasis at the tissue area where the catheter member 110 is placed. In some instances, hemostasis can be achieved at this tissue area by coating the catheter member 110 with hemostatic coating agents (for example, a hemostatic element 2e at the proximal catheter member 2 as shown in
Further nephrouretheral stent systems and joining or coupling mechanisms are described below. Many of the elements of the figures and their corresponding reference numbers are listed below.
1: Stent
2: Detachable drainage/delivery catheter
3: Hub
4: Loop suture lock
5: Loop suture
6: Proximal loop
7: Distal loop
8: Distal radiopaque marker
9: Proximal radiopaque marker
10: Junction stent to drainage catheter (shown with gap for clarity)
11: Lock Suture
12: Coupler, retractable
13: Protective cap (pull wire)
14: Protective cap (for loop suture 5)
15: Lure thread connector (standard)
16: Tapered tip
17: Drainage holes (interior of loops)
18: Lock/Release wire
19: Lock/Release wire pull tab
20: Lock suture proximal exit hole
21: Lock Suture Distal entry hole
22: Distal reinforcement on stent (e.g., SS hypotube)
23: Proximal reinforcement on catheter (e.g., SS hypotube)
24: Alternative reinforcement or in combination with other reinforcement, higher durometer or tougher tubing than main body
25: Advancement Stop
26: Lock suture tie down reinforcement (swaged hypotube, for example, not shown swaged flush for clarity)
27: Separate lock/release wire
28: Inner member
29: Fixed coupler
30: Coupler to catheter attachment
31: Slip fit
32: Lock wire
33: Wire
As shown in
A straightener (e.g., a hypotube with a hub) can be put in to straighten the loops 6, 7 of the stent 1 out and the system 200 can be put over a guidewire in the body to be placed. The straightener can be then removed allowing the proximal and distal loops 6, 7 of the stent 1 to form. Usually, the proximal loop 6 will not form on its own in tight spaces and may need to be formed by pulling on the loop suture 5 similarly described above with reference to
As shown in
In some embodiments, the nephrouretheral systems may not need the loop suture 5 removed. In such systems, the loop suture lock 4 can be unlocked to free up the proximal loop 6 and the whole catheter 2 including the loop suture mechanism can be removed. Such systems may not require the distal lock suture tie down 5c and the lock suture proximal exit home 20; and instead, the ends of the loop suture 5 may be un-accessibly tied down in the hub 3. Nevertheless, it can be critical to be able to withdraw the loop suture 5 entirely before converting and releasing the stent 1. Hence, the distal lock suture tie down 5c and the lock suture proximal exit home 20 can be accessible.
The tension in the loop suture 5 can be relieved by unlocking the loop suture lock 4, which can allow the proximal loop 6 to relax and un-fold as the system 200 is removed through an access channel/hole.
Referring to
In some embodiments, a coupler cylinder 29 may be affixed to the catheter 2 through the coupler to catheter attachment 30 and may not be able to be independently pulled back (
In some embodiments, the coupler 12 may be connected to a wire 33 that is separate from the lock/release wire 27, and the wire 33 may be pulled as an additional step (which could be mitigated by interlocking the pullback actions).
In some embodiments, the coupler 12 may be attached to a co-axial inner member 28, which may be affixed to the hub so that it can be pulled back. The coupler 12 may comprise an inner member, which may be solid polymer, nitinol, braided or coiled shafts (not shown).
Referring back to
As shown in
The lock suture 11 may be made of a high tensile strength, low elongation material and flexible material like UHMW PE (Spectra, Honeywell) or other material, including stainless steel or other metallic materials, or a combination of materials. It could be a single ribbon with a hole at the end to pass lock wire through, or other configurations.
The stiff coupler 12 may be made of implant grade materials such as stainless steel, NiTi, PEEK, or other materials know in the art. More flexible couplers are possible, but do not support the catheter 2 and stent 1 at the junction 10 under bending, resulting in splaying open of the junction 10.
Various configurations of hubs are also disclosed, including a triple arm hub 220 which may be preferred in at least some cases (
In the side or triple arm hubs described above, the wire or sutures could be affixed directly to the caps, but may twist and bind if not provided a anti twist feature in cap. Since ports 15 on these devices 200 may need to be flushed periodically, a person un-familiar with the devices 200 might unscrew a cap inadvertently. Hence in preferred embodiments, pull tabs are separate from caps.
In some embodiments, the catheter 2 and the stent 1 may be decoupled from one another electrolytically or by electrical resistance based melting of a connector. The device 200 may comprise a sacrificial joint between the catheter 2 and the stent 1 that may dissolve in the presence of urine when an electrical charge is applied, similar to the mechanisms described in U.S. Pat. Nos. 5,122,136 and 5,643,254. The device 200 may use current resistance to soften or melt a connector, and since the connector may be internal to the catheter, no tissue may be affected by the temperature and the volume of body fluids flowing through the catheter may keep fluid temperatures within acceptable ranges. The device 200 may comprise shape memory component(s) and heating these components by electrical current can cause them change shape to release the catheter 2 and stent 1 from one another.
As shown in
Lock Suture Distal Termination Methods: At least one or both ends of the lock suture 11 may be terminated toward the distal end of the catheter 2 to prevent separation of the stent-catheter junction under loading scenarios during delivery of the device.
The suture 11 may be terminated on pull wire 19 by passing through the braid of the suture 11 itself or tie knot to pull wire shaft. The knot or braid may slide longitudinally over the wire 18 as it is displaced or removed during a detachment event.
The knotted suture 11 may terminate within the lumen of the catheter 2 which may leverage against a small diameter hole. The hole which suture knot leverages against may be covered with an adhesive, marker band, and/or other polymeric sheathing.
A hypotube or marker band may be applied or crimped to the outer diameter, inner diameter, or embedded within the surface of the catheter 2 and/or stent 1 polymer. The metallic surfaces of the applied hypotube or marker band may be utilized for attaching suture material.
Lock Suture Hole Reinforcement: The holes punched (e.g., punched using a coring tool) through the wall of the catheter 2 and stent 1 in which the lock suture 11 passes through may require reinforcement to enhance the tear resistance of the thermoplastic used in many device applications which may cause the catheter 2 and/or stent 1 to soften at body temperature for optimal patient comfort. Locking suture materials usable in some applications may have the propensity to tear through the holes in the wall of the device under high load scenarios. A stiff metallic, polymeric, or fibrous braid or coil may be embedded, extruded, or laminated within the wall of one or more of the stent 1 or the catheter 2 to prevent such tearing. A segment of hypotube or other high strength material may be embedded, overlaid, or affixed near the holes of interest, but typically only near that region so as to not greatly impact the overall comfort characteristics of the device, so the suture may leverage against this stiff substrate under load.
Referring to
FIG. 30B1 shows the proximal outer tube 3021 for placement at the distal end of the inner lumen 3002a of the catheter 3002. The proximal outer tube 3021 may couple the proximal end of the proximal inner tube 3005 to the distal end of the catheter 3002. The proximal outer tube 3021 may have multiple holes 3021a (e.g., laser) drilled or cut for the material of the catheter 3002 (e.g., pellethane) to reflow into. The proximal outer tube may comprise a stainless tube, for example.
FIG. 30B2 shows the proximal inner (lock) tube 3005 comprising the lock key 3011 which may be (e.g., laser) welded, two (e.g., laser cut) windows 3007, where the windows 3007 may form opposing flexible struts 3009a, 3009b. The lock key 3011 may be welded at or near the center of the strut 3009a. The proximal end of the proximal inner lock tube 3005 may be (e.g., laser) welded to the inner lumen of the proximal outer tube 3021.
FIG. 30B3 shows the sliding tube assembly 3017. The sliding tube assembly 3017 may comprise a tube 3017t (typically nitinol, steel, or other metal) with a pull wire 3017w (typically nitinol, steel, or other metal) laser welded to the inside of the tube 3017.
FIG. 30B4 shows the distal outer tube 3023 which may be similar to the proximal outer tube 3021. The distal outer tube 3023 may have multiple holes 3023a (e.g., laser) drilled for the material of the stent 3001 (e.g., pellethane) to reflow into.
FIG. 30B5 shows the distal inner tube 3015 with the lock window 3013. The lock window 3013 may comprise a rectangular window (e.g., laser) cut in dimensions that will correspond to a loose fit around the lock key 3011. This tube 3015 may be (e.g., laser) welded to the inner lumen of the distal outer tube 3023, such that the lock window 3013 is covered and protected from reflow from the material of the stent 3001 (e.g., pellethane).
Once the lock key 3011 is in the lock window 3013 with the slide tube 3005 below, the complete assembly may be locked together. The pull wire 3017w may be retracted to pull the slide tube 3005 back to release the stent 3002. While assembled, the struts 3009a, 3009b may be contain by both the inner and outer diameters of the slide tube 3017 and outer tubes 3021, 3023 such that the assembly is strong and can have near one-to-one torque-ability.
While the convertible catheter devices are described above as being used to deliver a nephrouretheral stent, the convertible catheter devices and their methods of use may be applicable for other anatomical structures as well. The dimensions and/or material properties of the convertible catheter devices may be modified to be appropriate for the other anatomical structures. For example, convertible catheter devices according to many embodiments may be suitable for use as a biliary stent to maintain the patency of a bile duct; and, the convertible catheter device usable to deliver a biliary stent may have a smaller proximal loop or a J-hook configuration of the proximal hook suitable for the shape of the gallbladder and/or gallbladder neck. In another example, convertible catheter devices according to many embodiments may be suitable for use as an ileal conduit catheter. While the convertible catheter devices adapted for use as a nephrouretheral stent may have a proximal to distal loop distance ranging from about 20 cm to about 28 cm, the convertible catheter devices adapted for use as ileal conduit catheters would have a longer loop to loop distance.
While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.
This application claims priority to U.S. Provisional Application No. 62/461,443, filed Feb. 21, 2017, which is incorporated herein by reference. The subject matter of this application is related to the subject matter of PCT Application No. PCT/US2014/063758, filed Nov. 3, 2014; and U.S. application Ser. No. 15/175,436, filed Jun. 7, 2016, which is a divisional application of U.S. patent application Ser. No. 14/159,221, filed Jan. 20, 2014 and now issued as U.S. Pat. No. 9,387,312, which is a continuation-in-part of U.S. patent application Ser. No. 12/559,946, filed Sep. 15, 2009 and now issued as U.S. Pat. No. 8,657,884, which claims priority to U.S. Provisional Patent Application No. 61/096,902, filed Sep. 15, 2008. The subject matter of this application is also related to the subject matter of PCT Application No. PCT/US2015/044580, filed Aug. 11, 2015, which claims priority to U.S. Provisional Patent Application No. 62/036,377, filed. Aug. 12, 2014; and U.S. patent application Ser. No. 14/823,243, filed Aug. 11, 2015, which claims priority to U.S. Provisional Patent Application No. 62/036,377, filed Aug. 12, 2014. Each of the above applications is incorporated herein by reference.
Number | Date | Country | |
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62461443 | Feb 2017 | US |