JP2010533052A - Methods and apparatus for the treatment of blood vessels and prostate - Google Patents

Abstract

A method of closing a venous network providing a drain to the testis comprising: (a) inserting a therapeutic catheter into the main vein of the network; and (b) any forward movement of the therapeutic catheter. Disclosed is a method comprising the step of closing the vein over at least a length by a single application of a vein stimulator so that it is not required. Also disclosed are treatment catheters adapted to perform sclerotherapy and guide catheters having a pre-set shape for use in the present invention.
[Selection figure] None

Description

RELATED APPLICATION This application is specifically filed on July 13, 2007 by Yigal Gat, a benefit based on section 119 (e) of 61/664511 filed March 10, 2008, and by Yigal Gat in particular. Insist on a privilege based on Article 120 of No. 11/826283. This application is also a PCT application filed on the same day as the present application and shares at least inventor Yigal Gat and is an international patent application teaching representative of methods and apparatus that can be used with the following description, Attorney Docket No. 43699, Title of Invention It also relates to “DIAGNOSIS AND TREAMENT OF VARICOCELE AND PROSTATE DISORDERS”, and the agent reference number 44564, the name of the invention “METHODS AND APPARATUS FOR TREATING THE PROSTATE”. The entire disclosure of these applications is incorporated herein by reference.

Field and Background of the Invention The present invention relates in some embodiments to the diagnosis and / or treatment of disorders involving varicocele, benign prostatic hyperplasia (BPH), prostate cancer and / or testosterone hormone. Some embodiments also relate to the diagnosis and treatment of testicular venous drainage disorders.

  Degradation of the one-way valve in the internal spermatic vein, which manifests clinically as a varicocele, may cause a decrease in the drainage of venous blood into the testis and sometimes even lead to reflux.

  The left internal spermatic vein (ISV) enters the left renal vein at a right angle near the potential compression site by the superior mesenteric artery, while the right spermatic vein enters the inferior vena cava (IVC) at an acute angle To drain. These anatomical factors, along with the effects of additional gravity, promote blood reflux in the left internal spermatic vein (more than in the right spermatic vein). As a result, diagnosis of varicocele in the left ISV is made relatively easy, and varices in the left ISV are widely associated with male infertility in the medical literature. For example, “Loss of infertility in men with variant” (Ferrity and Sterility 59, 613-616 (1993)) by Goreick JL, Goldstein M; -70 (1977)).

  More recently, it has been recognized that right ISV varicocele plays a similar role in male infertility. See, for example, “Varicosele: a bilateral disease” by Fert Steal 81, 424-42 (2004) by Gat Y, Bachar GN, Zukerman Z and Gornish M.

  Several previous studies have shown a correspondence between varicocele and serum testosterone levels, but these findings have not converged to a consistent and plausible correlation. For example, Gat Y, Gornish M, Belenky due to A and Bachar GN "Elevation of serum testosterone and free testosterone after embolization of the internal spermatic vein for the treatment of varicocele in infertile men" (Human Reproduction Vol.19, No.10 pp. 2303-2306, 2004).

  The varicocele is associated with testosterone levels anyway, and testosterone has long been known to play a role in prostate cancer (see, for example, Cambell's Urology (Principal Editor, Walsh, P. et al. ) 1245-1249, 77, 2566 (Saunders Eight Edition, Philadelphia, USA, (2002)), but there is no proven causal relationship between varicocele and prostate disease, paradoxically, the prostate Relatively low levels of serum testosterone have been found in patients suffering from cancer (eg, Raivio T, Santi H, Schatzl G, Gsur A, Haidinger G, Palvimo JJ, Janne OA, Madersbach According to the r S. "Reduced circulating androgen bioactivity in patients with prostate cancer" (Prostate 2003; 15: 194-8) see).

  A similar paradox was found for BPH. For example, Roberts RO, Jacobson DJ, Rhodes T, Klee GG, Leiber MM, Jacobsen SJ. See “Serum sex harmones and measures of benign prostatic hyperplasma” (Prostate. 2004 Oct 1; 61 (2): 124-31).

  The anatomical parts involved in this problem are schematically depicted in FIGS. FIG. 1 schematically depicts a typical testicular and prostate venous drainage system for a human male. One drain path from testis 104 includes a venous plexus 118 that leads to ISV 102, which is connected to IVC 106 through a one-way valve 108. Normally, the valve 108 promotes venous blood from flowing upward toward the vena cava 106 and inhibits backflowing downward toward the testis 104.

  Another drain path includes the venous plexus 118 towards the vas deferens 110, the bladder vein 112, the internal iliac vein 114 and the common iliac vein 116 leading to the IVC 106. The latter path is shared by the drain path of the prostate 120 leading from the bladder venous plexus 128 to the bladder vein 112 and beyond.

  The artery 122 supplies arterial blood to the microcirculation 124 of the prostate 120 and the microcirculation 126 of the testis 104.

  FIG. 2 schematically depicts typical testicular and prostate vein drain pathways in the normal left side of a human male, where the direction of the arrows in the figure indicates the venous blood flow as described above. . Because the one-way valves 108 in the ISV 102 prevent backflows down towards the testis 104, they isolate the hydrostatic pressure of the individual sections located between them, and hence the inlet 142 to the left ISV 102. The typical pressure at is about 5-6 mm Hg and may be somewhat lower at the inlet 144 to the right ISV 130.

  FIG. 3 shows a typical left side of a human male when the one-way valve in the ISV 102 is not functioning properly, for example due to mechanical degradation such as weakening of the valve material, wear on operation or the effects of aging. 1 schematically depicts the testicular and prostate vein drain pathways.

  Since the one-way valve 108 in the ISVs 102 and 130 does not block the backflow (reverse flow, reflux) that goes down toward the testis 104, the ISVs 102 and 130 form a continuous blood column, and hydrostatic pressure is generated in the blood column. However, when the patient is in an upright position, such as standing, the entrance 142 to the left ISV 102 can be up to about 31 mmHg and the entrance 144 to the right ISV 130 can be up to about 27 mmHg (typically standard under normal conditions). About 4-6 times the typical pressure). Excessive hydrostatic pressure, or a similar amount of pressure, may also be present in blood vessels leading to ISV 102, such as vas deferens 110 or venous plexus 118. This is because the pressure propagates from the testicular vein drain system to the prostate vein drain system and is hydrodynamically balanced between the two drain systems. The pressure may decrease as the blood vessel moves away from the inlet 142 or 144, but may still be higher than the normal range on the order of about 5 mmHg.

  Excessive high pressure inhibits the drainage of venous blood from the testis 104 and vine venous plexus 118 to the ISV 102. More precisely, this pressure pushes testicular venous blood rich in free testosterone (about 130 times higher than serum levels) towards the bladder venous plexus 128 and further towards the prostate 120 ahead. And limit the drain of venous blood from the prostate.

  Because the blood is still circulated, venous blood from the testis is at least via other routes, such as the vagina vein 110, the scrotal vein 128, or the bypass vein 136 that is believed to have been generated by its excessive pressure. Partially drained.

Excessive pressure can have at least some of the following effects:
(A) Venous blood that is redirected and directed to the prostate 120, causing the prostate 120 to become congested and enlarged (dilated). Expansion of the prostate 120 can be manifested, at least in part, as a BPH or other prostate failure.
(B) Venous blood from testis 106 rich in free testosterone (compared to a range of normal levels in blood circulation) bathes prostate cells with testosterone, thereby resulting in BPH. About 90% of free testosterone is irreversibly converted to dihydrotestosterone (DHT), which has about 5 times higher affinity for androgen receptor than free testosterone, and accelerates prostate cells Can result in increased proliferation. Note that due to the short passage from testis 104 to prostate 120 (about 10-15 cm), only a small amount of free testosterone is bound to SHBG or albumin before exposure to their prostate receptors. It is.
(C) Excessive pressure and prostate congestion suppress or reduce arterial blood from entering the microcirculation 124 of the prostate and disturb the biological balance. Excess amounts of testosterone and DTH present in the prostate can induce accelerated proliferation of prostate cells and can promote the development of cancer. Free testosterone at extreme concentrations in the prostate (approximately 100 times or more compared to normal) can overload the DNA hormone feedback system and mutates in their accelerated cell division Can increase the probability of occurrence.
(D) Excessive venous pressure inhibits or reduces arterial blood from entering the testicular microcirculation 126. The blood is at least somewhat stagnant and oxygen-rich arteriole blood cannot normally flow into the testis, resulting in a degenerative process in the testis tissue, which causes the testicular Testosterone production decreases.
(E) A reduced ability to produce testosterone can result in a decrease in the concentration of testosterone in the serum, resulting in the appearance of aging or aging symptoms.

  The following papers are generally themed on varicocele, male infertility and male infertility treatment and / or venous embolism.

  One aspect in some embodiments of the invention relates to providing a method of performing sclerotherapy using a single shot sclerosing agent. In one embodiment of the invention, the method of performing sclerotherapy with a single shot is faster than the conventional multi-shot method. In one embodiment of the invention, occlusion of at least a portion of one or more internal spermatic veins involved in undesired hydrostatic pressure and / or regurgitation prevents or impedes fluid flow in the vasculature. It is done.

  In one embodiment of the present invention, single shot sclerotherapy is achieved by injecting a sclerosing agent into the occluded vein while simultaneously retracting the therapeutic catheter along the occluded portion of the vein. To be implemented. In some cases, or alternatively, some or all veins where undesirable reflux occurs are occluded using a single shot technique with infusion / retraction. In some cases, or in addition, bypass veins that may have occurred (eg, as a result of hydrostatic pressure) are occluded using a single shot technique with infusion / retraction when carrying undesired blood flow. The In one embodiment of the invention, the chemical sclerosing agent has a tendency to flow down and / or occlude the branch vein and / or branch vein at least to some extent, otherwise the vein is the bypass conduit. Such chemical hardeners are used when they are likely to function or when veins can become bypass conduits.

  In one embodiment of the present invention, multiple “shots” of the sclerosing agent are performed, but the overall sclerotherapy procedure uses fast venous access techniques and / or fast venous access devices and / or Or faster than conventional sclerotherapy as a result of using combined unidirectional movement and / or optionally performing occlusion confirmation while performing sclerotherapy injection procedures.

  In one embodiment of the invention, the treatment catheter is provided with at least a distal balloon, wherein the distal balloon at least partially impedes flow within the vasculature being treated. Injecting into the treatment site by reducing the amount of sclerosing agent that is washed away by the fluid flow and / or preventing the sclerosing agent from occluding veins that should remain open Increase the effectiveness of the cured sclerosant. In one embodiment of the present invention, at least a distal balloon is provided to the treatment catheter during sclerotherapy, eliminating the need to handle fluid flow at the treatment site, and personal medical expertise By reducing the dependence of the treatment procedure on the level, a more standardized treatment process is provided.

  In one alternative embodiment of the present invention, single shot sclerotherapy seals the opposite ends of the treated area of the vein, thereby defining the lumen present therein, after which This is accomplished by injecting a sclerosing agent into the cavity. In some embodiments of the present invention, the opposite end is a tandem balloon with a distal balloon positioned near the groin and a proximal balloon positioned near the inlet orifice to the ISV. Occluded by a catheter. In some embodiments of the present invention, a treatment catheter with a distal balloon (but no proximal balloon) is used in combination with a guide catheter with an inflatable balloon, Here, the balloon of the guiding catheter works close to the shape and / or function of the proximal balloon of the tandem balloon catheter. In some embodiments of the invention, the therapeutic catheter is adapted to inject a sclerosing agent between the distal balloon and the proximal balloon. In some cases, the treatment catheter is provided with side holes for infusion of sclerosants and / or for aspiration of the lumen. In some embodiments of the invention, at least one port is provided at the distal tip of the treatment catheter. In one telescopic embodiment of the therapeutic catheter, the catheter remains in place, while the balloon is near the catheter in order to push the valve aside and / or withdraw the sclerosing agent. It is moved toward the distal end.

  In one alternative embodiment of the invention, occlusion of the vasculature with a single shot may be performed alone or mechanically stimulate other irritants, such as the vessel wall, to expand. It may be performed with the help of brushes and / or wires that cause and thereby cause occlusion.

  One aspect of some embodiments of the invention relates to a distal balloon-equipped treatment catheter adapted to perform sclerotherapy. In one embodiment of the invention, the distal balloon has a side hole in the presence of a fluid connection between the balloon inflation / deflation lumen provided in the treatment catheter and the interior region of the balloon. Can be selectively inflated and deflated. In one embodiment of the invention, the distal balloon is adapted to be inflated to a degree sufficient to substantially obstruct fluid flow through the vasculature in which the therapeutic catheter is located. . In some cases, the vasculature is an ISV. In some embodiments of the present invention, the treatment catheter is adapted for use in a single shot sclerotherapy procedure, the treatment catheter delivering sclerosant injection and withdrawal with the balloon inflated. Can be done simultaneously. In some embodiments of the invention, the therapeutic catheter is adapted for use in a small venous space, eg, a small venous space found around a venous plexus such as the venous venous plexus.

  In some embodiments of the present invention, the therapeutic catheter also includes a lumen for the contrast agent and / or sclerosing agent, through which the contrast agent and / or sclerosing agent passes through the therapeutic catheter. It is sent to the treatment site in the tube structure. In one embodiment of the present invention, the therapeutic catheter is adapted to inject contrast and / or sclerosant into the proximal side of the distal balloon (ie, downstream from the balloon). In some cases, the treatment site is aspirated / exhausted using a suction force applied to the contrast agent and / or sclerosant lumen.

  In one embodiment of the present invention, the treatment catheter includes a guidewire lumen, and the guidewire passes through the lumen when the treatment catheter is moved to the treatment site. In some cases, the guidewire is withdrawn from the lumen when the therapeutic catheter reaches the proper position for performing the treatment.

  In some embodiments of the present invention, a distal balloon-equipped therapeutic catheter inflates the balloon immediately downstream of the valve to create a vacuum effect and opens the valve so that the therapeutic catheter passes through the valve. By allowing movement, the valve breakthrough procedure is adapted to be performed. In one embodiment of the invention, the balloon is deflated after the passage of the valve is complete.

  In some embodiments of the present invention, the distal balloon-equipped therapeutic catheter also includes a proximal balloon, where the distal balloon and the proximal balloon are between them. Define a space. In one embodiment of the invention, the therapeutic catheter is adapted to inject a sclerosing agent between the distal balloon and the proximal balloon via the injecting side hole. In one embodiment of the invention, the proximal balloon is selectively inflatable and deflated.

  One aspect in some embodiments of the present invention is adapted to allow single shot sclerotherapy to be performed using a proximal balloon and a distal balloon without moving the therapeutic catheter during injection of the sclerosing agent. The present invention relates to a tandem type therapeutic catheter. In one embodiment of the invention, the proximal balloon and the distal balloon are fluidic between the respective balloon inflation / deflation lumen provided in the treatment catheter and the balloon interior region. By using side holes in the presence of connections, they can be selectively expanded and contracted. In one embodiment of the invention, the distal balloon is adapted to be inflated to a degree sufficient to substantially obstruct fluid flow through the vasculature in which the therapeutic catheter is located. . In some cases, the vasculature is an ISV. In one embodiment of the invention, when inflated, the distal balloon and the proximal balloon define a lumen or space that exists between them. In one embodiment of the invention, the therapeutic catheter is adapted to inject a sclerosing agent between the distal balloon and the proximal balloon via the injecting side hole.

  In one embodiment of the present invention, a tandem treatment catheter includes a lumen for transporting contrast and / or sclerosing agents. In some cases, the space present between the balloons is aspirated or evacuated using a contrast and / or sclerosant delivery lumen by applying a suction force. In some embodiments of the present invention, each balloon is provided with a respective inflation / deflation lumen, which allows each balloon to be individually inflated / deflated. In some cases, tandem treatment catheters have a guidewire lumen through which the guidewire is passed when the treatment catheter is moved to the treatment site. In some cases, the guidewire is withdrawn from the lumen when the tandem treatment catheter has reached the proper position for treatment.

  One aspect in some embodiments of the invention relates to a procedure and / or apparatus for fast venous access that is adapted to provide fast venous access. In some embodiments of the present invention, a guide catheter that is pre-shaped for ISV access is used. In some embodiments of the present invention, a guiding catheter adapted to provide access to the right ISV is provided with an engaging tip, wherein the engaging tip is IVC and It has a protrusion that engages with a recess at a portion where the ISV intersects. This depression is where the ISV valve is believed to be. In one embodiment of the invention, the depression is found by inserting the catheter and moving it in small increments. Once the depression is found, access to the ISV is obtained by pulling a vacuum, pushing through the valve, and / or deforming the ISV so that the valve is open.

  One aspect of some embodiments of the invention relates to a guiding catheter that includes, at least in part, a balloon that is selectively inflatable at the distal end (ie, tip) of the catheter. In one embodiment of the invention, the balloon is adapted such that it can substantially impede fluid flow through the vascular structure in which the balloon is located. In some cases, the vasculature is an ISV. In some embodiments of the present invention, a guide catheter balloon is used in combination with a therapeutic catheter distal balloon, and the two balloons define a lumen between them. In one embodiment of the invention, the lumen defined to exist between the two balloons is a treatment site for sclerotherapy. In one embodiment of the invention, the guide catheter is adapted to provide a plurality of lumens for at least one of a guidewire, a therapeutic catheter, and / or a balloon inflation / deflation.

  In some embodiments of the present invention, at least one guide catheter is pre-shaped to match a particular anatomical feature. In some cases, the anatomical feature is a right ISV. In some cases, the anatomical feature is the left ISV. Further, in some cases, the anatomical feature is the right renal vein. In some cases, the anatomical feature is the left renal vein.

  One aspect in some embodiments of the present invention is to use a specific vein and / or vein orifice and / or a guide catheter pre-shaped for the approach angle to the vein and / or It relates to a method for obtaining a rapid venous access by combining a shaped guiding catheter and a rapid valve breakthrough procedure. In one embodiment of the present invention, a distal balloon equipped therapeutic catheter is advanced through and into the vein to be treated and into the vein. In one embodiment of the present invention, the rapid valve breakthrough procedure inflates a balloon provided on the treatment catheter just downstream of the bypassed valve to create a vacuum effect, opens the valve, and passes through the valve. Achieved by allowing movement of the catheter. In one embodiment of the invention, the balloon is deflated after the passage of the valve is complete.

  One aspect in some embodiments of the invention relates to a stimulator for causing at least temporary vessel occlusion using mechanical stimulation of a vessel wall.

  In one embodiment of the invention, the stimulator is adapted to cause occlusion of the blood vessel by providing a brush structure at the distal end of the stimulator. In one embodiment of the present invention, the brush structure consists of a plurality of short bristles that extend along the length of the device from the distal end of the device to the periphery of the device, similar to a pipe cleaner. In one embodiment of the invention, the bristles are flexible. In some cases, the bristles are made of a biocompatible material such as nylon. In one embodiment of the invention, the bristles are adapted to rub against the inner surface of the vessel wall. In one embodiment of the invention, the brush stimulator is adapted to be inserted into and / or deployable from the delivery catheter, the delivery catheter being adapted by the stimulator. A shielding housing for the stimulator is provided that prevents stimulation of the vessel wall when inside. In one embodiment of the present invention, deployment from the delivery catheter and withdrawal of the brush stimulator along the occluding section of the vessel is performed as a single operation.

  In one embodiment of the invention, the stimulator is adapted to cause occlusion of the blood vessel using an arm assembly attached to the distal end of the stimulator. In one embodiment of the present invention, a plurality of arms extend radially and / or longitudinally (ie, along the axis of the device) from the distal end. In some cases, the arm is gently curved. In some embodiments of the present invention, the arms are arranged (radially) equally spaced from one another. In some cases, the arm is made of a biocompatible metallic material. In some cases, the arm is made of a biocompatible plastic material. In one embodiment of the present invention, the arm is adapted not to puncture the wall of the blood vessel. For example, the end of the arm is rounded. In some embodiments of the invention, the arm of the device is adapted to extend from the device to the vessel wall and rub against the inner surface of the vessel wall with sufficient tension. In one embodiment of the present invention, the arm assembly type stimulation device is adapted to be inserted into and / or deployable from the delivery catheter, the delivery catheter comprising: A shielding housing for the stimulator is provided that prevents stimulation of the vessel wall when the stimulator is inside. In one embodiment of the invention, deployment from the delivery catheter and withdrawal of the arm assembly stimulator along the occluding section of the blood vessel is performed as a single operation.

  Thus, according to one illustrative embodiment of the present invention, a method is provided for closing a network of veins providing a drain to the testis, the method comprising: (a) inserting a therapeutic catheter into the main vein of the network And (b) closing the vein for at least a length by a single application of the venous stimulator in a manner that does not require any forward movement of the therapeutic catheter.

  In one embodiment of the invention, the single application includes pulling back the catheter while applying a sclerosing agent. In some embodiments of the present invention, the distal balloon provided on the catheter is inflated prior to application of the venous stimulator. In some cases, the effectiveness of the venous stimulator is enhanced by a distal balloon that at least partially obstructs flow in the main vein.

  In one embodiment of the invention, the single application includes injecting a sclerosant into the lumen defining the length to be closed. In some cases, a distal balloon and a proximal balloon, one at each end of the aforementioned length, are inflated, thereby defining a lumen. In some cases, the distal balloon and the proximal balloon are inflated using a therapeutic catheter. In some cases, the distal balloon is inflated using a therapeutic catheter, while the proximal balloon is inflated using a guiding catheter.

  In one embodiment of the present invention, the catheter is used to map a venous network by injecting a contrast agent from the catheter into the network. In some cases, the above length is selected to be closed based on a map of the vein network.

  In one embodiment of the invention, network closure is performed to treat at least one of BPH, varicocele, cancer, and venous blood return from the testis to the prostate.

  In one embodiment of the invention, the curing agent is a chemical agent.

  One illustrative embodiment of the present invention further provides a therapeutic catheter adapted to perform sclerotherapy, the therapeutic catheter comprising: a shaft defining a longitudinal axis of the catheter; provided on the shaft A selectively inflatable and deflatable distal balloon; a balloon inflating / deflating element in fluid communication with the distal balloon and for selectively inflating and deflating the distal balloon; A side hole in fluid communication with the cavity; a side hole in fluid communication with the lumen of the contrast agent and sclerosing agent and the lumen of the vein to be treated; contrast agent and hardening downstream in the lumen as seen from the distal balloon Side holes adapted to allow injection of a drug.

  In one embodiment of the invention, aspiration of the lumen of the vein to be treated is achieved by applying suction through the contrast agent and sclerosant lumens.

  In one embodiment of the invention, the treatment catheter further includes a guidewire lumen adapted to move the guidewire therein.

  In one embodiment of the present invention, the treatment catheter further includes a selectively inflatable and deflatable proximal balloon, wherein the distal balloon and the proximal balloon are treated therebetween. Defining the lumen of the vein to be In some cases, the therapeutic catheter is adapted to inject a sclerosant into the lumen of the vein being treated between the proximal balloon and the distal balloon.

  In one embodiment of the invention, the treatment catheter further includes an engagement tip provided at the distal end of the shaft and adapted to engage the orifice of the ISV.

  One illustrative embodiment of the present invention further provides a therapeutic catheter adapted to perform sclerotherapy, the therapeutic catheter: a selectively inflatable and deflatable proximal balloon; As well as a selectively inflatable and deflatable distal balloon; the proximal balloon and the distal balloon define a lumen between them to be treated by sclerotherapy.

  In one embodiment of the invention, the treatment catheter further includes dedicated inflation / deflation lumens for the proximal balloon and the distal balloon. In one embodiment of the present invention, the treatment catheter further includes a dedicated inflation / deflation lumen and side holes in fluid communication with the proximal and distal balloons. In some cases, the at least one balloon is adapted to substantially inhibit flow within the lumen. In some cases, the lumen is an ISV lumen.

  In one embodiment of the invention, the therapeutic catheter is adapted to inject a sclerosant into a lumen between the proximal balloon and the distal balloon.

  In one embodiment of the invention, the treatment catheter further includes a guidewire lumen adapted to move the guidewire therein.

  In one embodiment of the invention, the therapeutic catheter further includes a lumen for transport of contrast and sclerosing agents. In some cases, aspiration of the lumen of the vein treated by sclerotherapy is accomplished by applying a suction force through the lumen for the contrast agent and sclerosant.

  In one embodiment of the invention, the treatment catheter further includes an engagement tip provided at the distal end of the shaft and adapted to engage the orifice of the ISV.

  Further, according to one illustrative embodiment of the present invention, a guide catheter having a preset shape is provided, the guide catheter comprising: receiving a treatment catheter therethrough at a proximal end. And an elongate tube defining a lumen suitable for the at least one projection at the distal end of the tube, the projection adapted to engage a recess in the right ISV valve.

  In one embodiment of the present invention, the guide catheter further includes a selectively inflatable and deflatable balloon provided at the distal end of the guide catheter. In some cases, the balloon is at least one protrusion at the tip.

  In one embodiment of the invention, the tube defines a first bend of at least 170 degrees.

  In one embodiment of the present invention, the guide catheter includes a second bend opposite to the first bend, the second bend adapted to approximate the angle at which the right ISV enters the IVC. And provided on the distal side of the first bend.

  In some cases, the length of the catheter is 600 mm to 700 mm.

  In one embodiment of the invention, the distal balloon is adapted in a manner that substantially occludes the vasculature in which the balloon is located, thereby impeding fluid flow. In some cases, the vasculature is an ISV.

  In one embodiment of the present invention, the guide catheter is provided with a lumen for at least one of a guide wire or air for selectively inflating and deflating the balloon.

  In one embodiment of the present invention, the guide catheter further includes an engagement tip provided at the distal end of the elongate tube and adapted to engage the orifice of the ISV.

  In one embodiment of the invention, the selectively inflatable and deflated balloon is at least a portion of the engagement tip.

  In some cases, the guide catheter is flexible.

  According to one illustrative embodiment of the present invention, a guide catheter having a preset shape is further provided, the guide catheter comprising: receiving a treatment catheter therethrough at a proximal end. An elongated tube defining a suitable lumen, the shape of the elongated tube being adapted to be placed in the left renal vein and the left ISV. In one embodiment of the invention, the elongated tube has a first bend of 70-130 degrees close to the angle where the left renal vein enters the IVC and about 100-125 degrees close to the angle where the left ISV enters the left renal vein. Has a second bend. In some cases, the length of the guiding catheter is 650 mm.

  In one embodiment of the present invention, the guide catheter further includes a selectively inflatable and deflatable balloon provided at the distal end of the guide catheter. In some cases, the balloon is at least one protrusion at the tip.

  In one embodiment of the invention, the distal balloon is adapted to substantially occlude the vascular structure in which the balloon is placed, thereby impeding fluid flow. In some cases, the vasculature is an ISV.

  In one embodiment of the present invention, the guide catheter is provided with a lumen for at least one of a guide wire or air for selectively inflating and deflating the balloon.

  One illustrative embodiment of the present invention further provides a method for obtaining rapid venous access to a vein draining to the testis, the method comprising: inserting a pre-shaped guide catheter into the access point Manipulating the guiding catheter to place it at a location opposite the anatomical feature of interest; aligning the guiding catheter with the anatomical feature; inserting the therapeutic catheter into the guiding catheter; Advancing the treatment catheter to the first valve of the anatomical feature; inflating the distal balloon of the treatment catheter immediately downstream of the first valve, thereby creating a vacuum effect on the valve and opening the valve Opening the treatment catheter; passing the therapeutic catheter past the valve; and deflating the balloon after traversing the valve.

  In one embodiment of the invention, the method for obtaining rapid venous access to the vein draining to the testis further comprises advancing the treatment catheter toward the treatment site.

  In one embodiment of the present invention, a method for obtaining rapid venous access to a vein draining to the testis includes an inflation step, advancing the treatment catheter past the valve, deflation until the treatment site is reached. It further includes repeating the steps and advancing the treatment catheter toward the treatment site.

  According to one illustrative embodiment of the present invention, a stimulator is further provided, the stimulator comprising: a shaft, and a brush structure provided at a distal end of the shaft; It is adapted to stimulate the inner wall of the blood vessel.

  In one embodiment of the invention, the brush structure consists of a plurality of short bristles. In some cases, the brush structure is composed of nylon. In some cases, the brush structure is flexible.

  In one embodiment of the invention, the stimulation device is adapted to be inserted into and deployed from the delivery catheter.

  In addition, according to one illustrative embodiment of the present invention, a stimulation device is provided, the stimulation device comprising: a shaft; and an arm assembly provided at a distal end of the shaft; It is adapted to stimulate the inner wall of the blood vessel.

  In one embodiment of the invention, the arm assembly consists of a plurality of arms. In some cases, the plurality of arms extends radially and / or longitudinally from the distal end of the shaft. In some cases, the arm is gently curved. In some cases, the arms are arranged radially and equally spaced from one another.

  In one embodiment of the invention, the arm assembly is made of metal.

  In one embodiment of the invention, the arm assembly is made of plastic.

  In one embodiment of the invention, the arm is adapted to prevent puncturing the vessel wall.

  In one embodiment of the invention, the stimulation device is adapted to be inserted into and deployed from the delivery catheter.

  According to one illustrative embodiment of the present invention, there is further provided a method for treating varicocele, wherein: (a) determining that the patient has a failure valve in the venous plexus; (B) inserting a catheter into the venous plexus; (c) closing the venous plexus by performing a single injection of a sclerosing agent using the catheter, thereby reducing venous pressure on the testis; .

  In one embodiment of the invention, the method confirms that the venous plexus is closed by (d) injecting a contrast agent into the venous plexus and observing fluid flow therein. A step is further included.

  In some cases, the venous network is closed in 20-30 minutes.

  In some cases, the venous network is closed in 30-45 minutes.

  In some cases, the venous network is closed in less than an hour.

  In accordance with one illustrative embodiment of the present invention, there is further provided a method of closing a network of veins providing a drain to the testis, the method comprising: (a) inserting a therapeutic catheter into the main vein of the network And (b) closing the vein for at least a length by applying a venous stimulus source multiple times without changing the direction of withdrawal of the therapeutic catheter.

  In one embodiment of the invention, the method further comprises stopping after the valve in the vein and immediately before at least one of the multiple applications. In some cases, the pull back action causes flattening of the valve as the catheter passes through the valve.

  Further, according to one illustrative embodiment of the present invention, a kit for performing sclerotherapy is provided, the kit comprising: at least one therapeutic catheter; and allowing the therapeutic catheter to pass therethrough. Adapted, pre-shaped at least one guide catheter.

  In one embodiment of the invention, the kit further comprises a venous sheath.

  In one embodiment of the invention, the kit further comprises a sclerosing agent for use with a therapeutic catheter.

  In one embodiment of the invention, the kit further comprises a contrast agent.

  In one embodiment of the invention, the kit further comprises instructions for using at least one of a therapeutic catheter, a pre-shaped guide catheter, a venous sheath, a sclerosing agent or a contrast agent.

  Unless defined otherwise, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the present invention, exemplary methods and / or materials are described below. The In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.

Several embodiments of the invention are merely illustrated herein and described with reference to the accompanying drawings. With particular reference to the drawings in particular, it is emphasized that the details shown are for the purpose of illustrating only exemplary embodiments of the invention by way of example. In this regard, the manner in which embodiments of the present invention are implemented will become apparent to those skilled in the art from the description given with reference to the drawings. The illustrations and names on the left side of the human anatomy also apply to the right side unless otherwise indicated.
FIG. 1 schematically illustrates a typical testicular and prostate venous drainage system in a human male. FIG. 2 schematically illustrates a typical testicular vein and prostate vein drain pathway in the normal left side of a human male. FIG. 3 schematically illustrates a typical testicular vein and prostate vein drain pathway on the left side of a human male when the one-way valve in the internal spermatic vein is not functioning. FIG. 4A is a flowchart illustrating a single shot sclerotherapy procedure, according to one illustrative embodiment of the invention. FIG. 4B is a flowchart illustrating a single shot sclerotherapy procedure using a dual occlusion configuration, according to one illustrative embodiment of the invention. 5A-5B are illustrations of a guiding catheter for obtaining fast access on the left and right sides, according to an illustrative embodiment of the invention. 5C-5D are illustrations of a guiding catheter with a balloon tip for fast access on the left and right sides, according to an illustrative embodiment of the invention. 6A-6B are illustrations of an in vivo guidance catheter for fast access on the left and right sides, according to an illustrative embodiment of the invention. FIG. 7 is a flowchart illustrating a rapid venous access procedure according to one illustrative embodiment of the invention. FIG. 8A schematically illustrates a therapeutic catheter including an optional distal balloon and multiple input / output ports, according to one illustrative embodiment of the invention. 8B is a cross-sectional view of the treatment catheter of FIG. 8A, according to one illustrative embodiment of the invention. FIG. 8C is a perspective view of the distal tip of the treatment catheter of FIG. 8A with any distal balloon attached, according to one illustrative embodiment of the invention. FIG. 8D schematically illustrates a therapeutic catheter according to one illustrative embodiment of the invention. FIG. 8E is a cross-sectional view of the catheter of FIG. 8D, according to one illustrative embodiment of the invention. FIG. 9A schematically illustrates a treatment catheter with a tandem balloon, according to one illustrative embodiment of the invention. 9B is a cross-sectional view of a treatment catheter with the tandem balloon of FIG. 9A in a segment without a balloon, according to one illustrative embodiment of the invention. FIG. 9C is a cross-sectional view of a treatment catheter with the tandem balloon of FIG. 9A in a segment of the balloon, according to one illustrative embodiment of the invention. FIG. 10A is a side view of a brush stimulator, according to one illustrative embodiment of the invention. 10B is a side view of the brush stimulator of FIG. 10A within a delivery catheter, according to one illustrative embodiment of the invention. 10C is a side view of the brush stimulator of FIG. 10A deployed from the delivery catheter, according to one illustrative embodiment of the invention. 10D is a cross-sectional view of the brush stimulator of FIG. 10A across a section of the brush structure and including a delivery catheter, according to one illustrative embodiment of the invention. FIG. 11A is a side view of an arm assembly type stimulator according to one illustrative embodiment of the invention. FIG. 11B is a cross-sectional view of an arm assembly according to one illustrative embodiment of the invention. FIG. 11C is a side view of the arm assembly stimulator of FIG. 11A in a delivery catheter, according to one illustrative embodiment of the invention. FIG. 11D is a side view of the delivery catheter and arm assembly stimulator of FIG. 11A inserted into a vessel to be treated, according to one illustrative embodiment of the invention. FIG. 11E is a side view of the arm assembly type stimulator of FIG. 11A deployed from a delivery catheter, according to one illustrative embodiment of the invention.

  The terms “left side” and “right side” in this description and in the claims follow normal anatomical terminology (eg, the heart, stomach and spleen are on the left side in most humans) ). The term “drain” in the present description and claims refers to the flow of venous blood towards and into the vena cava via the venous blood vessels, and “return” and “backflow”. Is used as a synonym for the flow in the opposite direction of the “drain”. It should be noted that anatomical features may vary from individual to individual, and the methods and / or devices described herein are intended for use in a wide variety of anatomical configurations. It should also be noted.

  In some exemplary embodiments of the invention, one or more of the above undesirable conditions and effects may be avoided, delayed, mitigated and / or at least to some extent by reducing or eliminating excessive pressure. Or it can be repaired. By reducing the pressure, varicocele, BPH, infertility, some forms of cancer and / or testosterone from the testes to the prostate (compared to normal levels in the blood circulation) Backflow (reflux) can be reduced or eliminated.

  The headings herein are not limiting and are intended to be clear only.

Single shot sclerotherapy procedure As shown in US patent application Ser. No. 11 / 826,283 and US patent application Ser. No. 61/064511, refluxing of left and right ISVs 102 and / or right ISVs 130 that had affected excessive hydrostatic pressure ( Can be prevented or inhibited by occlusion (eg using embolization or curing). Occasionally and / or additionally, some or all veins in which reflux occurs, such as the vas deferens 110 and the venous plexus 118 are occluded. In some cases or in addition, the bypass vein 136 that may have occurred is also occluded. In one embodiment of the invention, left ISV 102 is treated before right ISV 130. However, it should be noted that the right ISV 130 may be treated first instead.

  Referring to FIG. 4A, a flowchart 400 illustrating a single shot sclerotherapy procedure is shown, according to one illustrative embodiment of the invention. In one illustrative embodiment of the present invention, the term “single shot” conventionally required multiple discrete injections of sclerosant and associated multiple discrete movements of the therapeutic catheter. The venous length occlusion, which was otherwise accompanied by a single continuous movement of the treatment catheter (or no movement of the treatment catheter as described in connection with FIG. 4B) Without) means to perform by using a single injection step.

  One advantage of using the single shot method is that it usually reduces the time required to treat sclerotherapy for diseases such as varicocele, BPH, and blood return to the prostate. is there. In one embodiment of the invention, the single shot procedure is performed in 20-30 minutes. In some embodiments of the invention, the single shot procedure is performed in 30-45 minutes. In some cases, the single shot procedure is performed in less than one hour. Note that each patient has different needs, and the level of time required for the involvement of his / her health care professional varies with their needs and / or anatomy and / or medical condition. Should. In some embodiments of the present invention, the single shot procedure is combined with the fast venous access procedure described below to reduce the overall length of time it takes to perform sclerotherapy.

  The amount of sclerosant injected is matched to the rate of movement of the infusion catheter to maximize the effectiveness of the occlusion in some embodiments of the invention. Assuming a diameter range of 1 mm to 4 mm, the treated blood vessel is 0.3 ml for a 1 cm long segment of a 2 mm diameter vein according to some illustrative embodiments of the invention. Volume of sclerosing agent may be injected, and 0.7 ml of sclerosing agent may be injected for a 1 cm long segment of a 3 mm diameter vein, and a 1 cm long vein of 4 mm diameter. For the segment, 1.3 ml of sclerosing agent may be injected. When treating varicocele, the diameter of the vessel being treated can be greater than 1 mm to 4 mm, in which case the methods and / or devices described herein are larger than these It can be adapted for use in a space of diameter. Some or all of the operations described herein (eg, device insertion / retraction, balloon inflation / deflation, material infusion / suction, etc.) are performed in accordance with operator commands using the controller and It should be understood that it may be implemented by the controller in any of the manners that are automatically performed using the controller.

  In one embodiment of the present invention, preparatory measures are taken to prepare the patient to enter the treatment device into the target ISV 102, 130 (402). In one embodiment of the present invention, it is desirable to obtain percutaneous access to the femoral vein. In some embodiments of the present invention, the right femoral vein is used. In some cases, the left femoral vein is used. The localization of the femoral vein puncture site is ascertained in some cases: at or below the line from the superior anterior iliac spine to the pubic bone; In some cases, local anesthesia is performed around the puncture site and, in some cases, a Valsalva maneuver is performed to dilate the femoral vein while puncturing the vein with an optionally sheathed femoral puncture needle. In some cases, the femoral puncture needle is at least 18 gauge.

  In some embodiments of the invention, a coaxial system with a femoral vein sheath and at least one of two preformed guide catheters 500, 550 is used, which guide catheters are shown in FIGS. As shown in FIGS. 7 and 7 and described in more detail in connection with those drawings, one catheter 500 is configured to be suitable for entry into the left ISV 102 and one catheter 550 is the right The shape is suitable for entering the ISV 130. In some cases, this procedure is performed using a 6 French sheath and a 6 French pre-shaped guide catheter 500, 550, through which the guide catheters 500, 550 are shown in FIGS. A therapeutic catheter 850 is disposed as described in more detail in connection with the figure. In some cases, the therapeutic catheter 850 is 3 French. In some embodiments of the invention, smaller or larger sheaths and / or guide catheters may be used provided that they allow the treatment catheter 850 to pass therethrough. In some cases, such therapeutic catheters are suitable for passing through any sheath and / or guide catheter used and / or suitable for treating the patient's anatomical features and / or Or, smaller or larger therapeutic catheters may be used, provided that they are sized to travel through the patient's anatomical features.

  Venous puncture is sometimes performed as a two-wall puncture to allow additional local anesthesia applied deep into the vein. In one embodiment of the invention, a guide wire is inserted into the vein through the needle and advanced into the renal pelvis. In some cases, the guidewire is a 0.014-0.018 inch guidewire. In some embodiments of the present invention, the guidewire is variably curved and / or soft and / or flexible adapted to be used to directly engage an ISV orifice. The tip part for engagement is provided. Additionally, optionally and / or alternatively, the therapeutic catheter is variably curved and / or soft and / or adapted to be used for direct engagement with an ISV orifice. Alternatively, a flexible engaging tip is provided. In one embodiment of the invention, the engagement tip is manipulated and introduced into the orifice by a responsible medical professional using skill and / or feel and / or imaging. The needle or sheath is pulled back around the guide wire while compressing the puncture site. In one embodiment of the present invention, the sheath is temporarily placed on the guide wire with its external port positioned at the groin while washing the side port of the sheath with heparinized saline. In some cases, this operation is repeated throughout the procedure at regular intervals. In some cases, the interval is 5 to 10 minutes.

  In one embodiment of the present invention, at least one of the pre-shaped guide catheters 500, 550 is advanced along the guide wire into the IVC 106. In order to guide the guiding catheters 500, 550 to the appropriate ISV 102, 130, depending on which ISV 102, 130 is targeted and / or the patient's specific anatomy, in some cases, slightly Different procedures are used. In one embodiment of the present invention, the treatment catheter 850 optionally includes a guidewire lumen 864 as shown in FIG. 8E, where the treatment catheter 850 is advanced by following the guidewire. The guide wire is passed through the guide wire lumen 864. In one embodiment of the invention, the guide wire is routed into the treatment catheter 850 using the inlet port 854.

  In one embodiment of the present invention, guide catheter 500 is manipulated into orifice 154 of left renal vein 150 (when treating ISV 102) under fluoroscopic control as shown in more detail in FIG. 6A. Introduced (404). In about 5% of those cases, the junction of the left renal vein and IVC 106 is an obtuse angle that points from the kidney to the caudal or head direction. In such a case, the orifice 158 of the ISV 102 is joined to the left renal vein 150 at an acute angle, which makes it difficult to enter from the upwardly tilted renal vein 150 and / or the upwardly tilted renal vein. It is difficult to find from 150. In another 2% to 3% of those cases, the ISV 102 joins the renal vein 150 with or just below the para-aortic vein. In these cases, the guiding catheter 500 needs to be manipulated so that the tip 502 overlaps the orifice 158, and according to one illustrative embodiment of the invention, a temporary The ISV 102 orifice 158 is engaged using a combination of respiratory arrest, fluoroscopy table tilt, and gentle but firm rotation of the catheter 500. In some embodiments of the invention, the orifice 158 is just engaged by the soft tip of the treatment catheter 850 or its flexible guidewire. In some cases, a guiding catheter with an alternative tip (eg, a tip used in the context of the adrenal vein or spinal artery) to engage the orifice 158 of ISV 102 and / or the orifice 132 of ISV 130 500 is used. In one embodiment of the invention, the tip is an engaging tip 584 described below.

  Within ISV 102 (and / or ISV 130) are typically a series of one-way valves that prevent the return of blood down ISV 102 and toward testis 104 under normal operation. The valve can be passed through a combination of patient / table positioning, breathing technique, and suction force applied through the guiding catheter (406). If the valve can be easily passed, in some cases, the therapeutic catheter 850 is introduced with or without a guidewire placed in place. The therapeutic catheter 850 is guided by manipulation to the lowest desired point for sclerotherapy (ie occlusion), which is usually just above the inguinal ligament, according to one embodiment of the present invention. In one embodiment of the present invention, the lowest point desired for sclerotherapy is the risk of return to the scrotum and / or the availability of secondary veins as an appropriate alternative route for venous flow, etc. It is selected by factor analysis of many factors including In some cases, the lowest desired point is higher than just above the inguinal ligament.

  In one embodiment of the present invention, the fluoroscopic tilt table is appropriately manipulated to ensure that the ISV 102 and its communicating and collateral tributary anatomy are properly manipulated to provide a distal and proximal side. In order to obtain venograms of both ISVs 102, an intravenous contrast agent is injected into the therapeutic catheter 850 under the control of fluoroscopy. In one embodiment of the present invention, the contrast agent and / or sclerosant passes through the therapeutic catheter 850 via the contrast agent and / or sclerosant lumen 866. In one embodiment of the present invention, this is optionally used to map (408) both collateral ISV tributaries and even interconnectivity between ISV 102 and other retroperitoneal veins. Is done.

  In some embodiments of the present invention, these vessels and their vessels if there is obvious interconnectivity to other important veins such as renal capsule veins, ureteral veins and paravertebral retroperitoneal veins. Whether or not these interconnected veins should be occluded by ISV therapy, or localized sclerotherapy, before attention is paid to the interconnection of ISVs and moving to occlusion treatment with ISV general sclerotherapy And / or by using other occlusion techniques, it is determined whether it is necessary to occlude separately and / or separate from the ISV.

  In some embodiments of the present invention, the chemical sclerosant flows at least partially down from the ISV to the branch and / or branch vein when the vein may otherwise function as a bypass conduit. The chemical sclerosing agent is selected because it has a tendency to occlude the vein. Therefore, the method of using a chemical sclerosing agent is that the chemical sclerosing agent flows at least some distance into the branch vein and / or the branch vein and / or the connecting vein and in particular closes the vein Since it is anticipated that the vein will be occluded by stimulating the vein to a sufficient extent to allow it to be securely clamped, the need to occlude the vein separately can be eliminated. In some embodiments of the invention, none of the branch veins are occluded. In some embodiments of the invention, up to several branch veins are occluded simultaneously with ISV. In some cases, several or more branch veins are occluded simultaneously with the ISV. In some embodiments of the invention, mechanical plugs and / or cement are used to occlude branch veins.

  When it is necessary to occlude interconnecting blood vessels separately (for example, when it is thought that the use of a chemical sclerosing agent for ISV cannot effectively occlude interconnecting blood vessels) In one embodiment of the invention, this procedure is optionally performed prior to working on the main ISV 102 and its branch veins. The distal end 852 of the therapeutic catheter is placed in the occluding blood vessel and a very small amount of sclerosant mixture (possibly less than 0.5 ml) is applied into the blood vessel. The therapeutic catheter tip 852 is held in place for a time determined to be sufficient to provide the desired therapeutic effect; in one embodiment of the invention, the time is 2-4. For minutes. After sufficient time has passed to provide the desired therapeutic effect, the catheter can be removed and, in some cases, according to one embodiment of the invention, to confirm occlusion of the branch vein A small amount of iodine contrast agent can also be injected into the ISV. In one embodiment of the invention, the patient is monitored to ensure that no contrast agent is flowing into the prostate when the patient is upright or standing.

  Alternatively, when the interconnecting veins are larger than 2-3 mm, in some cases, an intravascular microcoil or other occlusive device known in the art is used to occlude the interconnecting veins Is done. Other techniques for occluding blood vessels can also be used, including but not limited to biologically compatible adhesives, local heating using a radio frequency driven catheter, heating using a coil. , Cryoablation, focused ultrasound and / or any vascular closure method known in the art.

  In one embodiment of the invention, upon completion of the patient's associated anatomy mapping step (408), the therapy begins an occlusion procedure for at least a portion of the ISV. Treatment of ISV 102 with sclerotherapy includes occluding a length of ISV 102 that extends from just above the inguinal ligament to within a few centimeters of ISV orifice 158 where ISV 102 leads to the left renal vein 150; In some embodiments of the invention, a treatment catheter 850 is placed just above the inguinal ligament at the start of treatment. It should be understood that shorter or longer regions of ISV 102 may be occluded depending on the opinion of the healthcare professional in charge and / or the needs of the patient. Further, as described elsewhere herein, according to some embodiments of the present invention, other vessel structures besides ISV 102 may be occluded in order to successfully terminate treatment. May be needed.

  In one embodiment of the present invention, the occlusion of at least a portion of the ISV 102 is inguinal to prevent the sclerosing agent from refluxing downward and / or to prevent the sclerosing agent from being pushed upward in the venous blood flow. This is done by intravenous application of a sclerosing agent in the ISV 102 performed while pressing (410) the ISV 102 in the part. In one embodiment of the invention, an automatic external compression device is placed at the appropriate location on the patient and is activated by the operator using the control device or automatically by the control device itself.

  In some embodiments of the invention, the physical compression step (410) may be performed on the therapeutic catheter by using other techniques, for example, during the injection step (414) (the injection step (414) described below). It is enhanced and / or replaced, such as by applying a suction force. In one embodiment of the invention, aspiration and infusion are performed through separate ports provided on the treatment catheter. In some embodiments of the invention, the compression step (410) injects a harmless fluid, such as saline, upstream from the treatment site where the sclerosing agent is being injected (414), thereby It is augmented and / or replaced by creating a pressure gradient across the vein with the direction of flow away from the scrotum. In some cases, the pressure exerted by the innocuous fluid is sufficient to prevent reflux but not so strong as to drive the sclerosing drug out of the treatment site. In some embodiments of the invention, the patient is placed in the Trendelenburg position using gravity to help avoid reflux. In some embodiments of the invention, manual compression and / or external tourniquets are used to direct sclerosant flow.

  In one embodiment of the invention, the contrast agent is treated with a therapeutic catheter after the groin has been compressed to test the effectiveness of the compression and to confirm that the flow toward the scrotum is suppressed. Injected into 850. In one embodiment of the invention, groin pressure is adjusted until it is clear that flow towards the scrotum is largely prevented.

  Once it has been confirmed that flow prevention towards the scrotum has been achieved (412), the therapeutic catheter tip 852 is pulled back along the predetermined length of the ISV 102 to be occluded (416). The sclerosant mixture is slowly injected into the ISV 102 via the therapeutic catheter 850 (414). In this manner, a single injection of sclerosing agent, accompanied by a smooth continuous pullback of the therapeutic catheter 850 along the section of ISV 102 to be occluded, provides a “single shot” procedure for performing sclerotherapy. To do. In some embodiments of the present invention, at least one port is for the distal tip of the therapeutic catheter for sclerosant injection (414) and / or for the aspiration (420) of flowable material described below. Is provided.

  In some embodiments of the present invention, the therapeutic catheter 850 is withdrawn a total of about 20-25 cm within the ISV 102. In some embodiments of the invention, depending on the size of the ISV, a mixture of up to 4 ml of sclerosing agent and 0.25 to 0.5 ml of 2% local anesthetic such as lidocaine is made. Stir in a 5 ml plastic syringe. In some embodiments of the present invention, the stopcock arrangement can be used to transfer the mixture from syringe to syringe to form foam prior to injecting the sclerosing agent into the patient.

  In some embodiments of the invention, the sclerosing agent is metered and / or withdrawn (416) during infusion (414) so that treatment can be performed according to a predetermined ratio of infusion volume to withdrawal rate. The speed is measured. In some cases, a position indicator is provided at the proximal end of the shaft of the treatment catheter so that the controller and / or medical professional can monitor the indicator when pulling back the treatment catheter. It becomes possible. In some embodiments of the invention, the amount of sclerosing agent per unit length or transverse diameter of the vein used during treatment is predetermined. In some embodiments of the invention, the therapeutic catheter 850 is preloaded with a pre-metered dose of sclerosant and / or a sclerosant mixture such as those described above for the infusion step (414). Yes.

  In one embodiment of the present invention, the pull back step (416) and / or the infusion step (414) may provide movement and / or other manipulation (eg, sclerosis) for the catheter used in the sclerotherapy procedure. Automatically performed by a device adapted to perform the injection). In some cases, the device is automatically activated by the controller. In some cases, the medical professional in charge controls the device. In one embodiment of the present invention, the controller is programmed with various sclerosing agent dosages and / or types, and the corresponding rate of movement of the sclerosing agent required to effect treatment with effective sclerotherapy. ing.

  The injected sclerosing agent is sometimes left in the treatment area for a period of time (418) so that the maximum stimulation effect can be obtained. In some cases, 5-10 minutes are allowed to elapse to allow the sclerosing agent to exert its effect. In one embodiment of the invention, the fluoroscopy table on which the patient is placed is tilted slightly. In some cases, the platform is positioned in a “foot down” state. In some cases, the platform is rotated from a horizontal state to 10 degrees. In one embodiment of the invention, the platform is maintained in a horizontal position for up to 5-10 minutes after injection. In one embodiment of the invention, the time that the platform is maintained in a horizontal position corresponds to the length of any pause step (418).

  According to one embodiment of the present invention, after the sclerosing agent injection step (412) and the optional resting step (418) to allow the sclerosing agent to take effect, the contents of the vein to be treated are By applying a suction force, it is aspirated (420) through the contrast agent and / or sclerosant lumen 866 of the therapeutic catheter 850 and possibly discarded. In one embodiment of the invention, compression of ISV 102 in the groin is released (422) and therapeutic catheter 850 is flushed with a small amount of saline and / or intravenous contrast. In one embodiment of the invention, occlusion of the ISV 102 is confirmed (424) by injecting contrast agent above the occlusion site and observing the treated area. In some embodiments of the invention, the confirmation step (424) is optional. In some cases, the patient is placed in a semi-upright position (20-50 degrees) during the confirmation step (424).

  In one embodiment of the present invention, if the ISV 102 is not successfully occluded, a second pass of the treatment catheter 850 is performed and the tip of the catheter 850 in the segment of the ISV 102 that requires additional treatment. Part 852 is moved. Some or all actions performed in the first infusion step are repeated until it becomes clear that the ISV 102 is occluded. In some embodiments of the invention, the confirmation step (424) is not performed, and after a while if the ISV is not successfully occluded and / or the branch vein is dilated, The procedure is performed again. In some cases, this “for a while” period is a period of about several days, weeks or months.

  In one embodiment of the invention, once the ISV 102 is successfully occluded, the guide catheter 500 is flushed with sterile saline solution. In some cases, the left renal vein 150 may be used to obtain a diagnostic venogram to look for collateral veins that may have been poured into the ISV 102 that may not have been visible before the ISV 102 was occluded. The contrast medium is injected into the inside. In some embodiments of the present invention, any collateral vein that appears after occlusion of ISV 102 is noted for the possibility of occlusion. In one embodiment of the invention, the noted vein in the abdominal region is treated and / or occluded (the vein in the scrotum is not occluded).

  In some embodiments of the invention, the right ISV 130 is also occluded to treat the patient's condition. In one embodiment of the present invention, diagnostic venograms of the right renal vein 152 and its associated region are obtained. In some cases, the catheter 500 is introduced from the left renal vein 150 to the right renal vein 152 and a contrast medium is injected through the catheter 500, whereby the guiding catheter 500 is used. In one embodiment of the present invention, the guiding catheter 500 located on the left side is suitable for entry into the right renal vein 152 for the purpose of venography and is already present inside the patient. In order to collect diagnostic venograms. In some embodiments of the present invention, a preliminary study for the right ISV 130 is performed using the guiding catheter 500 to see if the right ISV 130 is located in a normal anatomical location. When the guiding catheter 500 is used to obtain a venogram, the catheter is replaced with a right guiding catheter 550 that is connected to the right renal vein 152 and / or the right ISV 130. Adapted for use in the context of A right guide catheter 550 is shown in FIG. 5B and described in more detail in connection with FIG. 5B.

  Due to the specificity on the right, it may be difficult to identify the junction between ISV 130 and IVC 106. In fact, there may be multiple junctions between the ISV 130 and the IVC 106, and in some cases, the ISV 130 may intersect the right renal vein 152 rather than the IVC 106. In addition, a valve may be present at the inlet orifice 132 to the ISV 130, which makes it more difficult to enter the ISV 130 with a catheter. In one embodiment of the present invention, it may be helpful to use pedestal positioning (e.g., Trendelenburg position "with feet up") and / or breathing techniques. As shown in more detail in FIG. 6B, once the right ISV 130 is advanced by the guide catheter 550, the treatment catheter 850 is advanced into the ISV 130 in a manner similar to that performed with the ISV 102. In one embodiment of the invention, the remainder of this treatment performed on ISV 130 is performed in the same manner as performed on left ISV 102. A right guide catheter 550 is provided at its distal end 552 to facilitate entry of the right ISV 130 into the orifice 132 when there is a properly functioning valve near or at the position of the orifice 132. It has a valve.

  At the end of treatment, when the right ISV 130 appears to be occluded and no collateral pour ("bypass") of the right ISV 130 is seen, the treatment catheter 850 is pulled back to guide the catheter. 550 is pushed upward to remove it from the orifice 132 of the right ISV. In some embodiments of the present invention, guidance is provided by either manipulating to introduce the tip 552 into the left renal vein 150 or lowering it into the orifice of the left internal iliac vein. Catheter 550 is bent and straightened. The guide catheter 550 and femoral vein sheath are removed, and in some embodiments of the invention, the puncture site is compressed to reduce bleeding and initiate patient recovery.

  As discussed elsewhere in this specification, single shot methods using a therapeutic catheter 850 may include varicocele, BPH, some forms of cancer, and / or testosterone from the testis to the prostate. Applicable to treat abundant venous blood reflux (perfusion) (compared to normal levels in blood circulation). Further, some actions may be performed more than once and / or are optional depending on the needs of the individual patient and / or the opinion of the medical professional in charge.

Single shot sclerotherapy using alternative catheters and techniques FIG. 4B alone or in combination with other devices treats a region in the vein by occluding two opposing ends of the region. FIG. 46 shows a flow chart 450 of a single shot sclerotherapy procedure using at least one device as defined. In some embodiments of the invention, a tandem balloon arrangement is provided to define the treatment area. The tandem balloon arrangement may be provided by a single device or a combination of devices, at least at the proximal balloon (ie, at the intersection of the ISV and IVC / renal vein). Closely placed balloons) and distal balloons (ie, balloons located away from the IVC / renal vein and closer to the groin) are treated with the lumen between them It should be understood that it is given to prescribe.

  In some embodiments of the present invention, a therapeutic catheter 900 with a tandem balloon is used to deliver a sclerosing agent to the occluded vasculature. A therapeutic catheter 900 with a tandem balloon is shown in more detail in FIGS. In some cases, the tandem catheter 900 is a 3F catheter. In one embodiment of the invention, the left ISV 102 is treated before the right ISV 130. However, it should be noted that the right ISV 130 may be treated first instead.

  In one embodiment of the present invention, the proximal balloon 908 and the distal balloon 910 are inflated / deflated lumens 912, 914 of the respective balloons provided in the treatment catheter 900, as shown in FIG. 9C. Can be selectively inflated and deflated by using a side hole in the presence of a fluid connection between the balloon and the inside of the balloons 908, 910. In one embodiment of the invention, the balloons 908, 910 are adapted to be inflated to a degree sufficient to substantially impede fluid flow through the vascular structure having a therapeutic catheter disposed therein. Is done. In some cases, the vasculature is ISV 102,130. In one embodiment of the present invention, distal balloon 910 and proximal balloon 908 define a lumen or space therebetween when inflated. In one embodiment of the invention, the therapeutic catheter 900 is adapted to inject a sclerosing agent between the distal balloon 910 and the proximal balloon 908 via the injecting side hole 916. .

  In one embodiment of the present invention, the tandem therapeutic catheter 900 is provided with a contrast and / or sclerosant delivery lumen. In some cases, the space present between the balloons is aspirated or evacuated through the side holes 916 using a contrast and / or sclerosant delivery lumen by applying a suction force. In some embodiments of the present invention, each balloon 908, 910 is provided with its own inflation / deflation lumen 912, 914, as shown in FIG. , 910 can be individually expanded and / or deflated. In some cases, the tandem treatment catheter 900 includes a guidewire lumen so that the guidewire can be passed through the guidewire lumen when the treatment catheter is moved to the treatment site. In some cases, the guidewire is withdrawn from the lumen when the tandem treatment catheter 900 reaches the proper position for treatment.

  In some embodiments of the present invention where the treatment catheter comprises a distal balloon, eg, a distal balloon 910, the sclerotherapy procedure proceeds from the preparation step (402) to the passage step (406) depicted in the flowchart 400. ) Starting in a substantially similar manner. In one embodiment of the invention, at the beginning of the optional mapping step (460), the distal balloon 910 is gently inflated (458) to approach the wall of the ISV. In some embodiments of the present invention, the distal balloon 910 occludes the vasculature being treated below the treatment area and prevents material from flowing back toward the scrotum. Used to do. In some cases, the distal balloon 910 is inflated under fluoroscopic observation after injecting an iodine contrast agent to make the ISV 102 opaque. In some cases, the distal balloon 910 is inflated with dilute iodine contrast agent (ratio of 1 ml contrast agent to 3-5 ml sterile saline). In some embodiments of the present invention, at least one side hole 914 is provided in the therapeutic catheter 900 for injecting material into the distal balloon 910 (eg, for inflating the distal balloon 910). And at least one side hole 916 is provided for injecting contrast and / or sclerosant into the vasculature to be occluded.

  In one embodiment of the invention, a compression step (462) is applied to an occluded vasculature, such as an ISV, and the distal balloon 910 is inflated before extending distally (towards the renal vein). Blood remaining in the ISV above the side balloon 910 is aspirated at the best reasonably possible. In one embodiment of the invention, the inflated distal balloon 910 can fully occlude the ISV. In some cases, manual compression (462) is maintained to prevent the sclerosing agent from flowing back into the scrotum. In order to test the effectiveness of the occlusion provided by the distal balloon 910, in some cases, a small amount of contrast agent is passed through the at least one side hole 916 into the lumen of the ISV above the occlusion site. Injected. Intravenous contrast agent injection is used to confirm (464) that there is no reflux of contrast agent (to the scrotum) into the vein below the groin, thereby allowing the distal balloon It is confirmed that the ISV below the site where 910 is present is completely isolated.

  If it is determined that the ISV is satisfactorily occluded by the distal balloon 910, in one embodiment of the invention, the distal balloon 910 until no contrast agent passes through the groin. Repositioning and / or reinflating and / or digital compression at the base of the leg is adjusted.

  In one embodiment of the invention, the proximal balloon 908 of the treatment catheter 900 is inflated (466) to occlude the vasculature to be treated, thereby allowing the two inflated balloons 910, 908 to In the middle, a lumen in the vein is created, which is substantially, if not completely, isolated from the fluid flow. In one embodiment of the invention, it represents a segment of a vein in which the lumen defined by two inflated balloons 910, 908 is occluded. In one embodiment of the invention, after confirming the inflation of the proximal balloon 908 and the distal balloon 910, the side holes 916 of the tandem balloon catheter 900 are used to make the lumen as rational as possible. The lumen of the blood vessel is aspirated until empty (468). In one embodiment of the invention, a sclerosing agent is injected 470 into the lumen to be treated via at least one side hole 916. In one embodiment of the invention, the amount of sclerosing agent injected into the lumen is tailored to the needs of the patient and / or the individual characteristics of the sclerosing agent and / or sclerosing agent mixture used. In some cases, 3-4 ml of sclerosant mixture is injected into the lumen.

  In one embodiment of the present invention, after an optional pause step (472) to allow the sclerosing agent to take effect, balloons 910, 908 are deflated (474) and the treated vein contents. Is aspirated through the catheter 900 (476). The optional pause step lasts 5 to 10 minutes after application of the sclerosing agent mixture; however, the quiescence time can be tailored to the characteristics of the particular sclerosing agent used. In one embodiment of the invention, groin pressure is removed and / or deactivated (478).

  In one embodiment of the invention, the therapeutic catheter 900 is flushed with a small amount of saline and / or intravenous contrast. In one embodiment of the present invention, in some cases, a vein is occluded by injecting contrast agent over the occlusion site and observing the treated area (480). In some cases, the patient is placed in a semi-upright position (20-50 degrees) during the confirmation step (480). Of course, if the treated vein is occluded, the contrast agent will not traverse directly beyond the occluded area (however, the occluded area via the branch vein). It is possible that there is a flow that indirectly exceeds

  In one embodiment of the invention, if the vein is not occluded, a second manipulation through the therapeutic catheter 900 is performed and the tip of the catheter is placed in the distal renal pelvis portion of the ISV 102 under fluoroscopy. Again, after the vein contents are aspirated through the treatment catheter 900, the distal balloon 910 and the proximal balloon 908 of the treatment catheter 900 are inflated again as described above. The infusion step is repeated to achieve ISV occlusion.

  However, in one embodiment of the present invention, the ISV 102 is partially occluded after the first procedure or subsequent procedure, and the therapeutic catheter 900 can only be partially re-extended. Causes one or both of the balloons 910, 908 to deflate and the treatment catheter 900 is manipulated similarly to the treatment catheter 850 for the positioning step and / or the infusion step. This procedure is continued until it is determined that the vein to be treated has been successfully occluded.

  In some embodiments of the invention, the confirmation step (480) is not performed and the ISV is not successfully occluded and / or partially occluded and / or the branch vein is dilated. If this is the case, after a while, this procedure is performed again. In some cases, this “for a while” period is a period of about several days, weeks or months.

  Once the occlusion of the vein to be treated is achieved, in one embodiment of the invention, the treatment catheter 900 is removed. The left kidney in a semi-upright position to look for collateral veins poured into the ISV 102 that may have been washed before the guiding catheter 500 was washed with sterile saline solution and the main ISV 102 was occluded A contrast medium is injected into the vein 150. When it is determined that there is no direct or indirect pouring into the left ISV 102, the right ISV 130 is essentially the same technique as described in the context of the left ISV 130 elsewhere (however, , Taking into account that a therapeutic catheter 900 with a tandem balloon is used).

  In one embodiment of the invention, a therapeutic catheter 800 with a single distal balloon 810 is used to perform a single shot treatment of a vein. One illustrative therapeutic catheter 800 is shown in FIGS. The difference between using the therapeutic catheter 900 and using the therapeutic catheter 800 is that in the case of the therapeutic catheter 900, the sclerosing agent was poured into a closed lumen, whereas the therapeutic catheter 800 was used. Instead, as in the case of the therapeutic catheter 850, it is to release the sclerosant into the vein to be treated when it is being pulled back towards the renal vein. In some cases, the distal balloon 810 is positioned 1-2 cm from the distal end 820 of the catheter 800. In one embodiment of the invention, the distal balloon 810 is used to open and push the valve 108 present in the ISV laterally when the catheter 850 is retracted. In some embodiments of the invention, some or all of these valves 108 are closed by this sclerotherapy. In some embodiments of the invention, some or all of these valves 108 are not damaged.

  In one embodiment of the invention, the distal balloon 810 uses a side hole 818 with fluid connection between the balloon inflation / deflation lumen 812 provided in the treatment catheter 800 and the interior region of the balloon. Thus, it can be selectively expanded and contracted. In one embodiment of the invention, inflation and / or deflation air passes through the air input / output port 802. In one embodiment of the invention, the distal balloon 810 can be inflated to a degree sufficient to substantially prevent fluid flow through the vasculature in which the therapeutic catheter 800 is disposed. Be adapted. In some cases, the vasculature is an ISV. In some embodiments of the present invention, the therapeutic catheter 800 is adapted for use in a single shot sclerotherapy procedure, the therapeutic catheter 800 with a 810 infused and inflated balloon 810. Pull back can be performed simultaneously.

  As shown in FIG. 8B, in some embodiments of the present invention, the therapeutic catheter 800 also includes a contrast and / or sclerosing agent lumen 816 through which the contrast and / or sclerosing agent is pulsed. It is routed through a treatment catheter 800 to a treatment site within the tube structure. In one embodiment of the invention, the contrast agent and / or sclerosing agent passes through an input / output port 804 for the contrast agent and / or sclerosing agent. In one embodiment of the invention, the therapeutic catheter 800 is adapted to inject contrast and / or sclerosant into the proximal side of the distal balloon 810 (ie, downstream from the balloon 810). The In some cases, the suction and evacuation of the treatment site is performed using the contrast and / or sclerosis lumen 816 by applying a suction force to the lumen.

  In one embodiment of the present invention, the treatment catheter includes a guidewire lumen 814 through which the guidewire is passed when the treatment catheter 800 is moved to the treatment site. In some cases, the guidewire is withdrawn from the lumen 814 when the treatment catheter 800 reaches the proper location for treatment. In one embodiment of the invention, the guidewire enters and exits through an input / output port 806 for the guidewire.

  In some embodiments of the present invention, the therapeutic catheter 800 with a distal balloon inflates the balloon 810 immediately downstream of the valve 108 to create a vacuum effect and opens the valve 108, thereby creating its interior. Adapted to perform a valve breach procedure by allowing movement of the therapeutic catheter 800 through. In one embodiment of the invention, the balloon 810 is deflated after the catheter has passed the valve 108.

  In some cases, guide catheters 570 and 580 with a balloon at the tip are used together with treatment catheter 800 or treatment catheter 850, and examples of such left and right side catheters, respectively, Shown in FIGS. 5C and 5D. As an example, a description will be given using one embodiment of the present invention in which a left guide catheter 570 and a treatment catheter 800 having a balloon at the tip are used. The balloon 572 of the catheter 570 is inflated (466) and used to perform a function similar to the function of the proximal balloon 908 of the therapeutic catheter 900 while treating the vein.

  In one embodiment of the present invention, the balloon 572 of the guide catheter 570 with a balloon at the tip is positioned approximately 4-8 mm from the tip 574 of the guide catheter 570. In some embodiments of the present invention, the balloon 572 has a diameter of 3-5 mm when inflated, but in some cases, various different sizes are used depending on the condition of the treatment site. In some cases, the balloon 572 is 3-5 mm in “length” and extends 3-5 mm along the catheter 570 near its distal end 574. In some embodiments of the present invention, the overall length and angle of curvature of the guiding catheter 570 with a balloon at the tip is similar to that of the guiding catheter 500 without a balloon at the tip. is there.

  In one embodiment of the present invention in which a guide catheter 570 with a balloon at the tip is used with a conventional treatment catheter 850, the balloon receives an ISV while the treatment catheter 850 is retracted toward the balloon. Used to occlude. When the sclerosing agent injection step ends, the treatment catheter 850 performs the remaining blood and sclerosing agent aspiration step (420). In some embodiments of the present invention, the left guide catheter 500 is adapted to include a balloon at the tip. In some embodiments of the present invention, the right guide catheter 550 is adapted to include a balloon at the tip. In some embodiments of the invention, the guiding catheter 570 is 4-6 French. In some embodiments of the invention, the balloon 572 is inflated to a diameter of 3-6 mm and extends 1-3 cm along the guide catheter 570 from the tip 574 of the guide catheter 570 to 1-2 cm.

  It should be noted that in some embodiments of the present invention, similar methods for the use and / or function of the right guide catheter 580 with a balloon at the tip and the associated balloon 582 are also envisioned. It is. The main difference between the left guide catheter 570 and the right guide catheter 580 is the shape of the catheters (each catheter is pre-shaped to match the anatomy on each side of each catheter. Also, in some embodiments of the present invention, the right guide catheter 580 (and possibly the right guide catheter 550) is a guide catheter at the orifice 132 of the right ISV. It is adapted to include an engagement tip 584 for “latching” the 580 to the right ISV 130. In one embodiment of the present invention, the engagement tip 584 is asymmetric because in some embodiments of the present invention a ridge is required above the tip to engage the IVC wall. . In some cases, the engagement tip 584 has a valve-like shape, an oval shape, or a ball-like shape. In some cases, the engagement tip 584 includes protrusions such as hooks and / or barbs. In some embodiments of the present invention, the length of the engagement tip 584 is from 1 mm to several mm. In some embodiments of the invention, the engagement tip 584 has a diameter of 0.5 mm to 2 mm. In some cases, the engagement tip 584 is rigid. In some cases, the engagement tip 584 is flexible. In some embodiments of the invention, the overall length and angle of curvature of the guiding catheter 580 with a balloon at the tip is provided with a balloon at the tip, as described elsewhere herein. This is the same as the case of the guiding catheter 550 that is not provided.

  In one embodiment of the invention, the engagement tip 584 includes a balloon 582. In one embodiment of the invention where a balloon 582 is used for engagement, the balloon is inflated to about 3 mm to 4 mm near the orifice 132. In use, the guiding catheter 580 is gently pushed upward (with the balloon inflated) for engagement with the wall above the orifice 132, thus opening the opening. And the valve 108 is also opened at the orifice 132, allowing the treatment catheter to be inserted into the ISV. After this, the balloon is deflated and the guiding catheter 580 is advanced into the orifice 132 to stabilize the devices and allow control of blood flow proximally.

  In some embodiments of the invention, a telescopic treatment catheter is used to perform sclerotherapy. In one embodiment of the invention, the telescopic catheter is not advanced toward the treatment site by pushing the catheter down the ISV as in catheters 800, 850, 900. Instead, the telescopic catheter does not reach the treatment site, but is placed in the ISV with the distal portion of the catheter folded. For example, when fluid is used to apply internal pressure to the catheter, the folded distal portion is deployed within the vessel to be treated and deploys far down the vessel to at least as much as the treatment site. . In some cases, the fluid used to deploy the distal fold is the sclerosing agent used to treat the blood vessel. In some cases, the fluid is saline. In one embodiment of the invention, the folded portion has a length of up to 25 cm when unfolded. In some cases, the folded portion has a length of up to 10 cm when unfolded. In one embodiment of the invention, the folded portion has a diameter of up to 6 mm when unfolded. In one embodiment of the invention, the telescoping channel is provided with at least one channel for flowing fluid. In some cases, the channel is provided in the folded material of the distal folded portion so that when the fluid is applied through a telescope-type catheter, the fluid is disengaged from the distal folded portion. It works to spread.

  As discussed elsewhere herein, single-shot methods using therapeutic catheters 800, 900 may include testicular varices, BPH, some forms of cancer, and / or testosterone from the testis to the prostate. Applicable to the treatment of abundant venous blood reflux (perfusion) (compared to normal levels in blood circulation). Further, some actions may be performed more than once and / or are optional depending on the needs of the individual patient and / or depending on the opinion of the responsible medical professional.

Single shot sclerotherapy using alternative access points In some embodiments of the present invention, access to ISVs 102, 130 is achieved by entering the vasculature without using the femoral vein. For example, as with PICC line insertion, access can be obtained by entering the arm vein. Alternatively, the right internal jugular vein can be used to gain vascular access.

  In some embodiments of the present invention, performing sclerotherapy with access to the neck or arm can be performed with a therapeutic catheter, regardless of which ISV (ie, left ISV or right ISV) is being treated. In combination, this is accomplished using a single guide catheter. Additionally, alternatively and / or optionally, sclerotherapy is performed using a guide wire to direct the treatment catheter into the treatment area and / or ISV. In some embodiments of the invention, the therapeutic catheter is adapted for use without the use of a guide wire or guide catheter. In one embodiment of the invention, the treatment catheter is 4F. In some cases, the therapeutic catheter is a “headhunter” type catheter. In some cases, the length of the therapeutic catheter is 100-120 cm. In some embodiments of the present invention, the therapeutic catheter includes a hydrophilic tip.

  In one embodiment of the present invention in which a guide catheter is used in combination with a therapeutic catheter, the guide catheter may optionally inject an upper ISV orifice while injecting a sclerosing agent through the therapeutic catheter into the area to be treated. An inflatable balloon (similar to the balloon 572 provided on the guide catheter 570 having a balloon at the tip). In some cases, the treatment catheter comprises a distal balloon (ie, a balloon provided near the tip of the catheter in a direction away from the renal vein), and the treatment catheter 900 comprises a tandem balloon. The side hole located between the distal balloon and the guide catheter is used in combination with a guide catheter having a balloon at the tip so that the distal balloon and the guide catheter are provided. A sclerosing agent is injected into the lumen formed by the balloon provided on the catheter.

  In one embodiment of the invention that does not use a coaxial system (therapeutic catheter within the guide catheter), the therapeutic catheter is approximately about the top of the catheter tip to occlude the lumen of the ISV being treated. A proximal occlusion balloon is provided at a location of 20-25 cm (ie, near the location where the ISV and renal vein / IVC meet). In some cases, a second occlusion balloon is provided on the distal portion of the treatment catheter located at a location remote from the renal vein / IVC junction. The sclerosant is 3-5 cm from the side hole provided in a portion of the therapeutic catheter between the two balloons (if there are two) or from the distal end of the therapeutic catheter. It is injected through a side hole provided at the place. The sclerotherapy is performed at the treatment site depending on the device configuration as described elsewhere herein. In one embodiment of the invention, this process is repeated at the treatment site in the patient's other ISV.

  Also, alternative “stimulants” for achieving vascular occlusion can be used with the methods described herein or adapted variations thereof, and one technique can be overlaid with another. It should also be noted that applying is left to the professional judgment of the physician and / or the needs of the patient. Examples of mechanical stimulus devices are shown in FIGS. 10A-11E below and are described with reference to FIGS.

Rapid Venous Access Procedure FIG. 7 shows a flowchart 700 of a rapid venous access procedure, according to one illustrative embodiment of the invention. Usually, access to a specific vein using a treatment device, such as access to the left and right ISVs, especially the right ISV, is time consuming and requires high skill on the part of the medical professional in charge. . In one embodiment of the present invention, faster and simpler venous access is achieved by using the preformed devices and valve crossing methods described herein. These common device features (eg, distal balloons) are used in the valve crossing method and are also used in the single shot method described elsewhere herein, so that it is described herein. It should be noted that there is a synergistic effect between the particular method and device features.

  In one embodiment of the present invention, the left guide catheter 500 is adapted to be aligned with the left renal vein 150 and / or the left ISV 102 in a typical anatomical arrangement, as seen in FIG. 6A. The For example, the main shaft of the guiding catheter 500 makes a bend of approximately 90-130 degrees (ie, the first curve) close to the angle of entry into the IVC 106 by the renal vein 150 and then the left ISV 102 for the left renal vein 150. Are pre-shaped to form another bend (ie, a second curve) of about 100-125 degrees close to the incident angle of the guide catheter 500, and the two bends of the guide catheter 500 are the flexibility of the catheter. By using the guiding catheter 500, it is possible to provide relatively quick ISV access to the medical professional in charge. In one embodiment of the invention, the overall length of guide catheter 500 is about 600 mm to 700 mm. In some embodiments of the invention, the distance between the two turns is about 30 mm.

  In some embodiments of the present invention, for most patients, the right ISV 130 intersects the IVC 106 rather than the right renal vein 152, so the right guide catheter 550 is It is adapted to be able to align with the right ISV 130 directly (without passing through). The adaptation of the right guide catheter 550 to align with the right ISV 130 is the entry into the orifice 132 and / or the right ISV 130 when there is a properly functioning valve 108 near the orifice 132 or at the position of the orifice 132. Providing a valve at the distal end 552 of the catheter. In one embodiment of the present invention, the guiding catheter 550 is initially bent at least 170 degrees, as shown in FIG. 6B, and (close to the tip 552, close to the angle of incidence of the right ISV 130 on the IVC 106). Pre-shaped to be curved at an angle of up to 180 degrees (with a small second bend in the opposite direction at the tip). In one embodiment of the invention, the length of the guiding catheter 550 is between 600 mm and 700 mm. In some embodiments of the invention, the length of the catheter 550 after the first bend is about 6 cm. In one embodiment of the present invention, the engagement tip 552 can traverse the first valve 108 of the ISV 130 (which in many patients is located near the orifice 132), in addition to a small at the orifice 132. Used to provide a stable entry into ISV 130 by aligning or coupling with a groove or recess.

  It will be appreciated that the above lengths and angles are for illustrative purposes only, and the actual configuration may vary depending on many factors, including the individual needs of the patient and commercial considerations. Should.

  A pre-shaped guide catheter, such as the guide catheters 500, 550 described above, is inserted 702 into the patient's body at an access point, such as a femoral vein. In one embodiment of the invention, a flexible guide catheter is inserted (702) in a substantially straight shape, even if the preset shape of the catheter is not straight. Once the guide catheter has sufficient room to enter, for example, the IVC 130, it expands into a predetermined shape. In one embodiment of the present invention, the guide catheter is manipulated and directed (704) to the IVC 106 on its way to the ISVs 102, 130, where the guide catheter is expanded to a preset shape. In one embodiment of the present invention, once the catheter reaches the IVC 106, a medical professional aligns the guiding catheter with the pre-shaped anatomical features for coupling the guiding catheter (706). .

  In one embodiment of the present invention, a treatment catheter (eg, 800, 850, 900) is inserted (708) into the guide catheter and through the guide catheter, the first of the ISVs 102, 130 being targeted. Advance to the location of the valve 108. If the treatment catheter comprises a distal balloon, the balloon is inflated 710 just downstream of the traversed valve 108 (710). Balloon dilation and subsequent vessel occlusion creates a vacuum effect immediately downstream of the valve 108, thereby opening the valve. In one embodiment of the invention where the treatment catheter does not include a distal balloon, a balloon-attached guide catheter is optionally used to allow rapid traversal of the first valve 108. Is done. In one embodiment of the invention, when the valve 108 is still open, the therapeutic catheter is advanced 712 past the valve. In one embodiment of the invention, once the therapeutic catheter has crossed the valve 108, the balloon is deflated (714). In some embodiments of the invention, the balloon remains inflated when the treatment catheter reaches the treatment site. Assuming that the treatment catheter has not yet reached the treatment site after crossing, the treatment catheter is further advanced (716) until the next valve is reached, and the crossing process is repeated at the next valve position. (718). As described above, the above process continues until the treatment catheter reaches the treatment site and / or there are no more valves 108 to traverse.

Illustrative Mechanical Stimulator With reference to FIG. 10A, a side view of a brush stimulator 1000 is shown, according to one illustrative embodiment of the invention. The brush stimulator 1000 includes a flexible shaft similar to a flexible intravascular guidewire. In one embodiment of the invention, the shaft length is 140 cm. In some cases, the shaft has an outer diameter of 0.0534 cm (equivalent to 0.021 inches). At the working end of the stimulator 1000, a brush section 1002 welded onto the shaft is provided. In one embodiment of the invention, the stimulator 1000 is adapted to function in the venous plexus space and / or other small venous regions and / or inaccessible veins. In one embodiment of the present invention, the brush section 1002 consists of fine bristles fixed in the form of finely twisted wires and is thus shaped like a pipe cleaner. In some cases, the bristles are nylon. In one embodiment of the invention, the length of the brush section 1002 is about 1 cm. In one embodiment of the invention, the effective diameter of the brush can be varied to match the inner diameter of the vessel wall being treated. In some cases, since the bristles are flexible, the diameter can vary from about 0.3 cm to 0.5 cm.

  In one embodiment of the invention, the brush stimulator 1000 is incorporated into a delivery catheter 1004 for delivery to the treatment site, as shown in FIG. 10B. In one embodiment of the invention, the brush section 1002 does not protrude from the delivery catheter 1004 prior to deployment of the device 1000. A cross-sectional view of the stimulator 1000 across the brush section 1002 and also including the delivery catheter 1004 according to one illustrative embodiment of the invention is shown in FIG. 10D.

  In operation, the distal end of delivery catheter 1004 is positioned beyond the desired treatment site. When the delivery catheter 1004 is withdrawn, the brush stimulator 1000 is advanced relative to the delivery catheter 1004 such that the brush section 1002 is deployed from the delivery catheter 1004 as shown in FIG. 10C. It is done. Once deployed outside the delivery catheter 1004, the entire assembly 1000, 1002, 1004 is withdrawn along the length of the vein being treated by the stimulus. After this, the stimulator 1000 is withdrawn back into the delivery catheter 1004, possibly fully withdrawn, or the second segment can be treated with the stimulator 1000 in the same manner as described above.

  In one embodiment of the present invention, prior to the introduction of a sclerosing agent to treat a vein, a segment of the vein that has been treated with a stimulator to verify that there are no breaks in the vein wall. A diagnostic venogram is acquired in the usual manner, using an iodinated contrast agent injected under the control of fluoroscopy. If a break is detected, that segment of the vein is not treated with a sclerosing agent.

  Referring to FIG. 11A, a side view of an arm assembly type stimulator 1100 according to one illustrative embodiment of the invention is shown. Arm assembly stimulator 1100 includes a flexible shaft similar to a flexible intravascular guidewire. In one embodiment of the invention, the shaft length is 140 cm. In some cases, the shaft has an outer diameter of 0.0534 cm (equivalent to 0.021 inches). A plurality of arms 1102 are attached to the distal end of the shaft. In one embodiment of the invention, the stimulator 1100 is adapted to function in the venous plexus space and / or other small venous regions and / or inaccessible veins. In one embodiment of the invention, five arms are used, but in some cases more or fewer arms are used. In one embodiment of the invention, the arm is slightly curved toward the central longitudinal axis of the device 1100. In some embodiments of the invention, the arms 1102 are symmetrically distributed over 360 degrees around the radial direction of the shaft, as shown in FIG. 11B. In one embodiment of the invention, the arm 1102 is 6 mm long. The maximum diameter of the arm 1102 is adapted to be near the diameter of the blood vessel to be treated so that the tip of the arm 1102 rubs against the inner wall of the blood vessel. In some cases, the diameter of arm 1102 is between 0.4 cm and 0.6 cm. In one embodiment of the invention, the tips of the arms 1102 are shaped so as not to puncture the walls of the blood vessel to be treated, for example, the tips are rounded.

  In one embodiment of the invention, the arm assembly stimulator 1100 is placed in a flexible delivery catheter 1104 as shown in FIG. 11C. In some cases, delivery catheter 1104 is made of plastic. Referring to FIG. 11D, in one embodiment of the present invention, a delivery catheter 1104 with a stimulator 1100 therein is advanced to a position slightly past the treatment site of the vein 1106. In some cases, the delivery catheter is advanced just distal to the treatment site, after which the stimulator 1100 is near the distal end of the delivery catheter 1104 but from the delivery catheter 1104. It can be advanced through the delivery catheter to a position where it does not protrude. In some embodiments of the invention, preliminary venography of the treated vein segment is performed to assess the approximate diameter of the vein. In one embodiment of the present invention, an iodine contrast agent is placed in the lumen of the vein segment to be treated to opacify the lumen. In some cases, movement of the stimulator 1100 within the delivery catheter 1104 is performed with guidance by fluoroscopy.

  In one embodiment of the invention, the delivery catheter 1104 is withdrawn to deploy the arm 1102 within the vessel 1106 to be treated, as shown in FIG. 11E. In one embodiment of the present invention, the delivery catheter 1104 is pulled back enough to deploy the arm 1102 to the approximate diameter of the vein to be treated (estimated by the above venogram). It is. In one embodiment of the invention, once the arm 1102 has been deployed to approximately the inner diameter of the blood vessel 1106, both the stimulator 1100 and the delivery catheter 1104 are withdrawn along the segment of the blood vessel to be treated. In traversing the segment to be treated, the delivery catheter 1104 is maintained without moving until the stimulator 1100 is fully within the delivery catheter 1104, and the stimulator 1100 is withdrawn. In one embodiment of the present invention, diagnostic venography of the treated segment is performed to confirm that there are no breaks in the wall of the blood vessel 1106. If there is a break in the wall, no sclerosing agent is injected into this segment of the vein. If no damage is detected, sclerotherapy is optionally performed by the method described so far.

Illustrative sclerotherapy kit In one embodiment of the present invention, a kit for performing the methods described herein is assembled and / or sold as a commercial unit. For example, the kit optionally includes at least one therapeutic catheter (eg, 800, 850, 900), at least one guide catheter (eg, 500, 550, 570, 580), at least one venous sheath, Instructions for the use of devices and / or materials included in a container for waste, materials necessary to make a sclerosing agent material and / or sclerosing agent mixture, tourniquet, at least one guidewire, contrast agent material and / or kit Includes some or all of the book. In one embodiment of the invention, the contents of the kit are sterilized.

  The terms “comprises, comprising, includings, including”, “having”, and their equivalents mean “including, but not limited to, including”. . This term encompasses the terms “consisting of” and “consisting essentially of”.

  The expression “consisting essentially of” means that a composition or method is further component and / or process only if the further component and / or process does not substantially change the basic and novel characteristics of the claimed composition or method. It means that a process may be included.

  As used herein, the singular forms (“a”, “an”, and “the”) include plural references unless the context clearly dictates otherwise. For example, the term “a compound” or the term “at least one compound” can encompass a plurality of compounds, including mixtures thereof.

  Throughout this disclosure, various aspects of this invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, descriptions of ranges such as 1-6 are specifically disclosed subranges (eg, 1-3, 1-4, 1-5, 2-4, 2-6, 3-6 etc.), and Should be considered as having individual numerical values (eg, 1, 2, 3, 4, 5 and 6) within the range. This applies regardless of the breadth of the range.

  Whenever a numerical range is indicated herein, it is meant to include any mentioned numerals (fractional or integer) included in the indicated range. The first indicated number and the second indicated number “the range is / between” and the first indicated number “from” to the second indicated number “to” The expression “range to / from” is used interchangeably and is meant to include the first indicated number, the second indicated number, and all fractions and integers in between.

  While the invention has been described in terms of specific embodiments thereof, it will be apparent to those skilled in the art that there are many alternatives, modifications, and variations. Accordingly, the present invention is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

  It will be appreciated that certain features of the invention described in the context of separate embodiments for clarity may also be provided in combination in a single embodiment. On the contrary, the various features of the invention described in a single embodiment for the sake of brevity are provided separately or in suitable subcombinations or as preferred in other described embodiments of the invention. You can also Certain features that are described in the context of various embodiments should not be considered essential features of those embodiments, unless that embodiment is inoperable without those elements. .

  As used herein, the term “method” means a mode, means, technique and procedure for accomplishing a given task, including but not limited to chemistry, pharmacology, biology, biochemistry, And includes methods, means, techniques and procedures that are known to or readily developed by those skilled in the medical arts from known formats, means, techniques and procedures.

  As used herein, the term “treat / treat” includes canceling, substantially inhibiting, slowing, and / or reversing the progression of a condition, It includes substantially improving clinical symptoms and / or aesthetic symptoms and / or substantially preventing the appearance of clinical symptoms and / or aesthetic symptoms of the condition.

  As used herein, the phrase “exemplary” means “exemplary, illustrative, or illustrative”. Any embodiment described as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments, and / or excludes the incorporation of features from other embodiments. is not.

  As used herein, the phrase “optionally” means “provided in some embodiments but not in other embodiments.” Any particular embodiment of the present invention may include a plurality of “optional” features as long as the features are not inconsistent.

  All publications, patents, and patent applications cited herein are hereby incorporated in their entirety as if each individual publication, patent and patent application was specifically and individually cited. It is intended to be used. Furthermore, citation or confirmation in this application should not be considered as a confession that it can be used as prior art to the present invention. To the extent that section headings are used, they should not necessarily be construed as limiting.

  During the lifetime of the patent that matures from this application, many related advances in sclerotherapy and / or treatment of varicocele, BPH, and related medical conditions are expected to become apparent, The range of terms used herein (eg, catheters, sclerosants, irritants) is intended to encompass all such new techniques a priori.

Claims (78)

A method of closing a venous network that provides a drain to the testis:
(A) inserting a therapeutic catheter into the main vein of the network; and
(B) closing the vein over at least a length by a single application of a venous stimulator so that no forward movement of the therapeutic catheter is required.   The method of claim 1, wherein the single application includes retracting the catheter while applying a sclerosing agent.   The method according to claim 1 or 2, wherein a distal balloon provided on the catheter is inflated prior to application of the venous stimulus.   4. The method of claim 3, wherein the effectiveness of the venous stimulator is enhanced by a distal balloon that at least partially obstructs flow in the main vein.   The method of claim 1, wherein the single application includes injecting a curing agent into a lumen defining a length to be closed.   6. The method of claim 5, wherein a distal balloon and a proximal balloon, one at each end of the length, are inflated thereby defining a lumen.   The method of claim 6, wherein the distal balloon and the proximal balloon are inflated using a therapeutic catheter.   The method of claim 6, wherein the distal balloon is inflated using a therapeutic catheter and the proximal balloon is inflated using a guiding catheter.   9. The method of any of claims 1-8, wherein the catheter is used to map a venous network by injecting a contrast agent from the catheter into the network.   The method of claim 9, wherein the length is selected to be closed based on a map of the venous network.   11. The method of any of claims 1-10, wherein the network closure is performed to treat at least one of BPH, varicocele, cancer, and venous blood return from the testis to the prostate.   The method of claim 2, wherein the curing agent is a chemical agent. A therapeutic catheter adapted to perform sclerotherapy comprising:
A shaft defining the longitudinal axis of the catheter;
A selectively inflatable and deflatable distal balloon provided on the shaft;
A side hole in fluid communication with the distal balloon and in fluid communication with a balloon inflation / deflation lumen for selectively inflating and deflating the distal balloon;
A side hole in fluid communication with the lumen of the contrast and sclerosing agent and the lumen of the vein to be treated, the side adapted to inject contrast and sclerosing agent downstream from the distal balloon in the lumen Hole;
A therapeutic catheter comprising:   14. The therapeutic catheter of claim 13, wherein aspiration of the lumen of the vein to be treated is achieved by applying suction through the contrast agent and sclerosant lumens.   15. A therapeutic catheter according to claim 13 or 14, further comprising a guidewire lumen adapted to be moved within the guidewire.   16. A selectively inflatable and deflatable proximal balloon, further comprising a distal balloon and a proximal balloon defining a lumen of a vein to be treated therebetween. A therapeutic catheter according to claim 1.   The therapeutic catheter of claim 16, wherein the therapeutic catheter is adapted to inject a sclerosant into a lumen of a vein being treated between the proximal balloon and the distal balloon.   The treatment catheter according to any of claims 13 to 17, further comprising an engagement tip provided at the distal end of the shaft and adapted to engage an orifice of the ISV. A therapeutic catheter adapted to perform sclerotherapy comprising:
A selectively inflatable and deflatable proximal balloon; and a selectively inflatable and deflatable distal balloon;
A therapeutic catheter comprising a proximal balloon and a distal balloon defining a lumen between them to be treated by sclerotherapy.   The therapeutic catheter of claim 19, further comprising dedicated inflation / deflation lumens for the proximal balloon and the distal balloon.   21. The therapeutic catheter of claim 20, further comprising a side hole in fluid communication with each dedicated inflation / deflation lumen and proximal and distal balloons.   The therapeutic catheter according to any of claims 19-21, wherein the at least one balloon is adapted to substantially inhibit flow within the lumen.   The treatment catheter according to any one of claims 19 to 22, wherein the lumen is an ISV lumen.   24. A therapeutic catheter according to any of claims 19 to 23, wherein the therapeutic catheter is adapted to inject a sclerosant into the lumen between the proximal balloon and the distal balloon.   25. A treatment catheter according to any of claims 19 to 24, further comprising a guidewire lumen adapted to be moved within the guidewire.   26. The therapeutic catheter according to any of claims 19 to 25, further comprising a lumen for transport of contrast agent and sclerosing agent.   27. The therapeutic catheter of claim 26, wherein aspiration of the lumen of the vein being treated by sclerotherapy is accomplished by applying a suction force through the contrast agent and sclerosant lumens.   28. A treatment catheter according to any of claims 19 to 27, further comprising an engaging tip provided at a distal end of the shaft and adapted to engage an orifice of an ISV. A guiding catheter having a pre-set shape:
An elongate tube defining a lumen suitable for receiving a treatment catheter therethrough at the proximal end; and at least one protrusion at the distal end of the tube that engages a recess in the right ISV valve A guide catheter comprising a projection adapted to be adapted.   30. The guide catheter of claim 29, further comprising a selectively inflatable and deflatable balloon provided at the distal end of the guide catheter.   31. A guide catheter according to claim 30, wherein the balloon is at least one protrusion at the tip.   32. A guide catheter according to any of claims 29 to 31, wherein the tube defines a first bend of at least 170 degrees.   Including a second bend opposite the first bend, the second bend being adapted to approximate the angle at which the right ISV enters the IVC and provided on the distal side of the first bend The guiding catheter according to claim 32, wherein   The guiding catheter according to any one of claims 29 to 33, wherein the length of the catheter is 600 mm to 700 mm.   35. A guide catheter according to any of claims 29 to 34, wherein the distal balloon is adapted to substantially occlude the vascular structure in which the balloon is located, thereby impeding fluid flow. .   36. The guiding catheter according to claim 35, wherein the vascular structure is an ISV.   37. The guide catheter according to any of claims 29 to 36, wherein the guide catheter is provided with a lumen for at least one of a guide wire or air for selectively inflating and deflating the balloon. .   38. A guide catheter according to any of claims 29 to 37, further comprising an engagement tip provided at a distal end of the elongate tube and adapted to engage an orifice of an ISV.   39. A guide catheter according to claim 38, wherein the selectively inflatable and deflated balloon is at least a portion of the engagement tip.   40. The guide catheter according to any of claims 29 to 39, wherein the guide catheter is flexible. A guiding catheter having a pre-set shape:
An elongate tube defining a lumen suitable for receiving a treatment catheter therethrough at a proximal end, the shape of the elongate tube being adapted to be placed in the left renal vein and the left ISV Catheter.   The elongated tube has a first bend of 70-130 degrees close to the angle at which the left renal vein enters the IVC and a second bend of about 100-125 degrees close to the angle at which the left ISV enters the left renal vein. 41. The guiding catheter according to 41.   The guide catheter according to claim 41 or 42, wherein the guide catheter has a length of 650 mm.   44. The guide catheter according to any of claims 41 to 43, further comprising a selectively inflatable and deflatable balloon provided at a distal end of the guide catheter.   45. The guide catheter according to claim 44, wherein the balloon is at least one protrusion at the tip.   46. A guide catheter according to claim 44 or 45, wherein the distal balloon is adapted to substantially occlude the vascular structure in which the balloon is located, thereby impeding fluid flow.   The guiding catheter according to claim 46, wherein the vascular structure is an ISV.   The guide catheter according to any one of claims 41 to 47, wherein the guide catheter is provided with a lumen for at least one of a guide wire or air for selectively inflating and deflating the balloon. . A method for obtaining rapid venous access to a vein draining to the testis comprising:
Inserting a pre-shaped guide catheter into the access point;
Manipulating the guiding catheter to place it at a location opposite the anatomical feature of interest;
Aligning the guide catheter with anatomical features;
Inserting the treatment catheter into the guide catheter and advancing the treatment catheter to the first valve of the anatomical feature;
Inflating the distal balloon of the treatment catheter immediately downstream of the first valve, thereby creating a vacuum effect on the valve and opening the valve;
Advancing the therapeutic catheter past the valve; and
Deflating the balloon after traversing the valve.   50. The method of claim 49, further comprising advancing the treatment catheter toward the treatment site.   51. The method of claim 50, further comprising repeating an inflation step, advancing the treatment catheter past the valve, a deflation step, and advancing the treatment catheter toward the treatment site until the treatment site is reached. The method described. A stimulator comprising a shaft and a brush structure provided at a distal end of the shaft, the brush structure being adapted to stimulate an inner wall of a blood vessel.   53. The stimulator of claim 52, wherein the brush structure comprises a plurality of short bristles.   54. A stimulator according to claim 52 or 53, wherein the brush structure is made of nylon.   55. A stimulator according to any of claims 52 to 54, wherein the brush structure is flexible.   56. A stimulator according to any of claims 52 to 55, wherein the stimulator is adapted to be inserted into and deployed from a delivery catheter. A shaft; and
A stimulator comprising an arm assembly provided at the distal end of the shaft, the arm assembly being adapted to stimulate the inner wall of the blood vessel.   58. The stimulator of claim 57, wherein the arm assembly comprises a plurality of arms.   59. The stimulator of claim 58, wherein the plurality of arms extend from the distal end of the shaft in at least one of a radial direction and a longitudinal direction.   60. A stimulator according to claim 58 or 59, wherein the arm is gently curved.   61. A stimulator according to any one of claims 58 to 60, wherein the arms are arranged at equal intervals in the radial direction.   62. The stimulation device according to any one of claims 57 to 61, wherein the arm assembly is made of metal.   62. The stimulation device according to any one of claims 57 to 61, wherein the arm assembly is made of plastic.   64. A stimulator according to any of claims 58 to 63, wherein the arm is adapted to prevent puncturing the vessel wall.   65. A stimulator according to any of claims 57 to 64, wherein the stimulator is adapted to be inserted into and deployed from a delivery catheter. A method for treating varicocele:
(A) determining that the patient has a failure valve in the venous plexus;
(B) inserting a catheter into the venous plexus;
(C) closing the venous plexus by performing a single injection of a sclerosing agent that reduces venous pressure on the testis using a catheter.   67. The method of claim 66, further comprising (d) confirming that the venous plexus is closed by injecting a contrast agent into the venous plexus and observing fluid flow therein. Method.   68. The method of any of claims 1-12, 66, or 67, wherein the venous network is closed in 20-30 minutes.   68. The method of any of claims 1-12, 66, or 67, wherein the venous network is closed in 30-45 minutes.   68. The method of any of claims 1-12, 66, or 67, wherein the venous network is closed in less than one hour. A method of closing a venous network that provides a drain to the testis:
(A) inserting a therapeutic catheter into the main vein of the network; and (b) at least a length by applying the venous stimulation source multiple times without changing the direction of the withdrawal of the therapeutic catheter. Closing the vein over time.   72. The method of claim 71, further comprising stopping after the valve in the vein and immediately before at least one of the multiple applications.   75. The method of claim 72, wherein the retracting action causes flattening of the valve as the catheter passes through the valve. A kit for performing sclerotherapy:
At least one therapeutic catheter; and
A kit comprising at least one pre-shaped guide catheter adapted to pass a treatment catheter therethrough.   75. The kit of claim 74, further comprising a venous sheath.   76. A kit according to claim 74 or 75, further comprising a sclerosing agent for use with a therapeutic catheter.   77. The kit according to any one of claims 74 to 76, further comprising a contrast agent.   78. A kit according to any of claims 74 to 77, further comprising instructions for using at least one of a therapeutic catheter, a pre-shaped guide catheter, a venous sheath, a sclerosant or a contrast agent.

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