EP2178594A2 - Diagnostic et traitement de la varicocèle et des troubles de la prostate - Google Patents

Diagnostic et traitement de la varicocèle et des troubles de la prostate

Info

Publication number
EP2178594A2
EP2178594A2 EP08776606A EP08776606A EP2178594A2 EP 2178594 A2 EP2178594 A2 EP 2178594A2 EP 08776606 A EP08776606 A EP 08776606A EP 08776606 A EP08776606 A EP 08776606A EP 2178594 A2 EP2178594 A2 EP 2178594A2
Authority
EP
European Patent Office
Prior art keywords
vein
catheter
wire
prostate
reflux
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP08776606A
Other languages
German (de)
English (en)
Other versions
EP2178594A4 (fr
Inventor
Yigal Gat
Menachem Goren
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US11/826,283 external-priority patent/US20090018486A1/en
Application filed by Individual filed Critical Individual
Publication of EP2178594A2 publication Critical patent/EP2178594A2/fr
Publication of EP2178594A4 publication Critical patent/EP2178594A4/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M25/007—Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1011—Multiple balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
    • A61M29/02—Dilators made of swellable material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B18/24—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor with a catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09175—Guide wires having specific characteristics at the distal tip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09175—Guide wires having specific characteristics at the distal tip
    • A61M2025/09183—Guide wires having specific characteristics at the distal tip having tools at the distal tip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1052—Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1095—Balloon catheters with special features or adapted for special applications with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft

Definitions

  • the invention in some embodiments thereof, relates to diagnosis and/or treatment of varicocele, benign prostate hyperplasia (BPH), prostate cancer and/or disorders of testosterone hormone. Some embodiments relate to the diagnosis and treatment to impaired testicular venous drainage.
  • the left internal spermatic vein enters the left renal vein at a right angle near a potential site of compression by the superior mesenteric artery, while the right spermatic vein drains at an acute angle into the inferior vena cava.
  • varicocele of the right internal spermatic vein was recognized to play a similar role in male infertility. See, for example, Gat Y, Bachar GN, Zukerman Z and Gornish M (2004) Varicocele: a bilateral Disease, Fertil Steril 81,424-42. Studies over the past years demonstrated a correspondence between varicocele and serum testosterone level, though the findings did not converge to a consistent and plausible correlation. See, for example, Gat Y, Gornish M, Belenky A and Bachar G N, Elevation of serum testosterone and free testosterone after embolization of the internal spermatic vein or the treatment of varicocele in infertile men, Human Reproduction Vol.19, No.10 pp. 2303-2306, 2004.
  • FIG. 1 Part of the relevant anatomy is schematically illustrated in Fig. 1 and Fig. 2.
  • Fig. 1 schematically illustrates a typical testicular and prostate venous drainage system of a human male.
  • One drainage path from a testes 104 comprises the pampiniform plexus 118 to the internal spermatic vein 102 that leads towards the inferior vena cava 106 through one-way valves 108.
  • the valves 108 facilitate venous blood flow upwards towards the vena cava 106, and inhibit back flow down to the testes 106.
  • Another drainage path comprises a sequence of pampiniform plexus 1 18 to the deferential vein 1 10, the vesicular vein 1 12, the internal iliac vein 114, the common iliac vein 116 towards the inferior vena cava 106.
  • the latter path is shared by the prostate 120 drainage path from the vesicular plexus 128 towards the vesicular vein 112 and onwards.
  • FIG. 2 schematically illustrates typical testicular and prostate venous drainage paths in a normal left side of a human male where the arrows directions illustrate the venous blood flow as described above.
  • the one-way valves 108 in the internal spermatic vein 102 block back flow down to the testes 104, they isolate hydrostatic pressure from the sections between them, so that a typical pressure at the entry 142 to the left internal spermatic vein 102 is about 5-6 mmHg and may be somewhat lower at entry 144 to the right spermatic vein 130.
  • the following articles relate in general to the subject of varicocele, male infertility and treatment and/or venous embolism.
  • a broad aspect of some embodiments of the invention relates to the innovative recognition that impaired valves in the spermatic veins play a causative role in prostate and testosterone disorders, such as BPH, cancer and/or aging, possibly as outlined below.
  • free testosterone secreted by the testes drains to the general blood circulation where it is diluted and binds (about 98%) to proteins such as SHBG (serum hormone binding globulin) and albumin.
  • SHBG serum hormone binding globulin
  • albumin proteins
  • the reverse flow diverts free testosterone from its production site in the testis directly to the prostate, greatly increasing the concentration of testosterone in the gland, and particularly free testosterone, to an excessive level far above normal levels (typically beyond the normal level of about 17nmol/l and 1 Onmol/1 of free testosterone) It is theorized that the excessive level of free testosterone in the prostate stimulates cell proliferation (such as in BPH) and/ or cancer.
  • An aspect of exemplary embodiments of the invention relates to a method for forestalling and therapy of BPH and prostate cancer by preventing or impeding the reflux of venous blood (rich in free testosterone) to the prostate.
  • the reflux is prevented or impeded by occlusion, of the internal spermatic vein, or veins, that have effected the hydrostatic pressures and back flow (e.g. by embolization, sclerosis, or occlusion).
  • some or all veins through which the reflux flows to the prostate are occluded.
  • bypass veins 136 that might have developed (for example, as a result of the hydrostatic pressure) are occluded if they carry blood from the testis to the prostate.
  • the veins carrying blood to the prostate are occluded initially in order to prevent testicular venous blood rich in testosterone (relative to normal circulation) from reaching the prostate, allowing recovery from the venous congestion and shrink the swelling and/or tumor.
  • a spermatic vein which affected the excessive hydrostatic pressure is occluded, optionally after treatment of veins leading blood to the prostate, to allow drainage of testosterone rich blood to the body via vessels such as the scrotal veins or other bypass veins 136.
  • the occlusion is applied in the opening of a vein or at a spot or region along the vein so that blood cannot flow in the vessel.
  • the occlusion is carried out by injecting, for example, by a catheter, a sclerosant into the vein.
  • a catheter a sclerosant
  • other methods and/or elements are used, such as placement of coils or silk that block the vein passage and/or induce thrombosis.
  • hot liquid or contrast medium is injected that effect shrinkage and occlusion of the vessel.
  • other methods are used such as ablation.
  • An aspect of some embodiments of the invention relates to using sclerosants and/or blocking elements and/or sclerotic medication for forestalling and/or treating BPH and/or prostate cancer.
  • persons diagnosed for varicocele by standard procedures are selected for prostate hypertrophy diagnosis.
  • the person is treated as described, taking into account that the treatment such as occlusion may affect fertility, optionally positively, as the hydrostatic pressure is reduced and testosterone may flow pass normally from the testis.
  • the treatment has anti-aging and/or fertility effects as the hypoxia in the testicular tissue is eliminated and normal testosterone production is restored, raising testosterone concentration in the blood when the hydrostatic pressure is reduced.
  • the invention allows to treat patients in a priority to the significance of the prostate malfunction.
  • the treatment is potentially applicable in forestalling by either (a) treating varicocele as described above, preventing the development of cancer, and hence, metastases, or (b) if cancer is already present, occlusion of at least the deferential vein or other vessels that drain from the prostate to the blood stream, trying to prevent cancerous cells from leaking from the prostate to the blood stream.
  • a sclerosant is used for the manufacture of a medicament for forestalling and/or treating BPH or prostate cancer in a subject.
  • the sclerosant is adapted to treating backflow that effects BPH and/or prostate cancer.
  • the adaptation comprises the composition of materials and/or their proportions.
  • a medication such as an antigen bound guided molecular therapy, optionally as a medication, may be used as part of the treatment.
  • An aspect of some embodiments of the invention relates to a method for diagnosis, or estimation, of the degree of valves degradation and/or venous reflux to the prostate and/or varicocele by a palpation, or any other way of estimating prostate situation, of the prostate for hypertrophy.
  • the diagnosis relates to effects from either a unilateral (left or right side) malfunction or bilateral (left and right side), or a combination of malfunction levels of each side.
  • the malfunctioning side may be identified by methods such as radiology or ultrasonography.
  • reflux may be diagnosed by injecting contrast medium or the appropriate diagnostic radionuclide agent into suspected regions and following its dispersion, or motion, by x-ray or gamma camera.
  • other diagnostic methods for blood flow analysis may be used ultrasonography.
  • An aspect of some embodiments of the invention relates to a method for diagnosis of varicocele and/or venous reflux by measuring venous testosterone levels between testes and the prostate where reflux is expected, or a region before testicular venous blood enters the vena cava.
  • the level of free and/or bound (serum) testosterone is measured.
  • testosterone may be tested in the arterial blood.
  • the tests are made when the patient is standing, and then when he is lying down (reducing the hydrostatic pressure), checking if the testosterone level reduced, which may indicate the presence of varicocele or malfunction of the spermatic vein valves and consequent prostate malfunction.
  • the diagnosis is related to or based on the measurement location and/or proximity to the testes and/or the prostate.
  • An aspect of some exemplary embodiments of the invention relates to a method for reducing the expression or symptoms of male aging due to deficient serum testosterone due to backflow to the prostate, by increasing testosterone supply to the blood stream.
  • aging symptoms or expressions are reduced, to some extent, by preventing reflux in the internal spermatic veins, resulting in restoration of normal blood circulation in the testes.
  • the testosterone level is increased due to changing blood circulation pathways.
  • aging expressions or symptoms are reduced due to one or both of (a) at least a partial restoration of adequate drainage of the testis venous blood to the systemic blood circulation, possibly allowing testosterone to drain to the bloodstream and increase the testosterone bound and unbound concentration, and (b) at least partial allowance of fresh arterial blood to the testis, healing, at least partially, the congested testis and/or allowing increased production of androgens.
  • the fresh arterial supply and restoration of drainage may increase testosterone production due to either of both of (a) supply of oxygen and removal of carbon dioxide and waste material, and (b) reducing an effect of a local feed back cycle that might have signaled the testes to reduce testosterone production when it was present in high concentrations.
  • the reflux is prevented or impeded by occlusion, for example, as described above (with respect to BPH and cancer).
  • testosterone as an injection, patch or orally administered, may given to the patient to test if beneficial effects are expected to achieved before occlusion by elevating the blood testosterone levels therapeutically.
  • the vessels leading venous blood to the prostate may be occluded and the resultant effects evaluated.
  • the spermatic veins which may effected the reflux, are occluded.
  • one side left or right is treated (in order to preserve functioning valves), and the results are evaluated if further treatment is required.
  • the mechanism is a guide-wire for an intravascular catheter.
  • the mechanism comprises a catheter.
  • the guide-wire is used to guide a catheter though a valve.
  • the catheter is intended for sclerotherapy.
  • the guide-wire comprises, near the distal end, an expandable element which may be retracted back. By expanding the element near a valve the vein is widened, opening the valve orifice, consequently, the expanded elements is contracted and the guide-wire is inserted through the valve orifice before the valve closes.
  • the element comprises a wire mesh.
  • it comprises other expandable and contractible mechanisms, such as an inflatable balloon.
  • An aspect of some exemplary embodiments of the invention relates to an intravascular catheter for sclerotherapy, designed to apply the sclerosing agent into an intended region of a blood vessel limiting, at least to some extent, the agent flow or drainage to another region (which flow may be detrimental).
  • the catheter comprises two (or more) inflatable balloons and one or more apertures defined in the catheter between the balloons.
  • the catheter By placing the catheter so that the balloons are about the ends of a vessel section to be occluded and inflating the balloons into the vein walls, the section is blocked and a sclerosing agent may be injected through the holes while the balloons impede, or block, a drain or flow beyond the section.
  • the catheter is designed for use with the guide- wire described above.
  • An exemplary embodiment of the invention comprises a method for forestalling and/or therapy, at least partially, of BPH and/or prostate cancer comprising:
  • effecting and/or conveying comprises having incompetent valves resulting in hydrostatic pressure that prevents upstream venous drainage.
  • treating comprises occlusion one or more veins.
  • occlusion comprises one of utilizing a sclerosant, or an element that blocks the vein passage and/or induce thrombosis, or radiation or thermal ablation or ultrasonic or cryogenic ablation, or a combination thereof.
  • a vein comprises at least one of an internal spermatic vein or a deferential vein or a by-pass vein.
  • the venous blood is rich in testosterone relative to a normal concentration range in the blood circulation.
  • assessing the degree of the reflux comprises assessing a degree of a malfunction of a spermatic vein valves.
  • the testosterone comprises at least one of free or bound testosterone.
  • assessing the degree of the reflux is responsive to the anatomical location of the measurement.
  • assessing the degree of the reflux comprises assessing a degree of a malfunction of a spermatic vein valves.
  • the measurement comprises a measurement of at least one of a venous blood or arterial blood.
  • the measurement comprises a measurement in a blood vessel at an anatomical location near the prostate before the blood drain to the vena cava.
  • An exemplary embodiment of the invention comprises a method for reducing aging symptoms comprising effecting a cause that decreased testosterone supply to the blood stream.
  • effecting comprises impeding a reflux of venous blood.
  • impeding the reflux comprises treating veins effecting and/or conveying the reflux.
  • treating comprises occlusion.
  • occlusion comprises utilizing at least one of a sclerosant, an element that blocks the vein passage, an element that induces thrombosis, a material that induces thrombosis, ablation or medication.
  • the vein comprises an internal spermatic vein and/or a deferential vein and/or a by-pass vein.
  • An exemplary embodiment of the invention comprises a method of passing a wire or a catheter through a venous valve, comprising (a) expanding a vein such that a valve orifice is opened;
  • the vein comprises one of an internal spermatic vein, a deferential vein or a by-pass vein.
  • expanding comprises utilizing an expandable element
  • the expandable element is retractable.
  • the expandable element comprises a wire mesh.
  • the expandable element comprises an inflatable balloon.
  • the expandable element comprises an elastic element.
  • the expandable element is contractible.
  • the guide-wire comprises a lumen.
  • a control wire passes through the lumen.
  • control wire effects at least one of expanding or contracting the element.
  • the expandable element is contractible.
  • the expandable element comprises a wire mesh.
  • the expandable element comprises an inflatable balloon.
  • the expandable element comprises an elastic element.
  • the expandable element comprises a shape memory material (SMA) expanding or retracting responsive to temperature.
  • the expandable element comprises a piezoelectric element expanding or retracting responsive to voltage.
  • An exemplary embodiment of the invention comprises a vascular catheter for occluding a region of a blood vessel comprising: (a) one or more inflatable elements; and
  • the material is a glue or a sclerosant injected into the catheter or a mechanical element removably attached to the catheter.
  • the length of an interval between the inflatable elements is modifiable.
  • the catheter applies electric field to induce sclerosis.
  • at least some of the perforations are closable.
  • An exemplary embodiment of the invention comprises a kit for forestalling or therapy, at least partially, of BPH and/or prostate cancer, comprising:
  • the material comprises at least one of a glue, a sclerosant, or an embolization material.
  • the element is a coil or an elastic element.
  • the element is adapted in size for drainage veins, for example, in a range of about 0.2 mm to 5 mm.
  • several different sizes are provided, for example, for allowing treatment of various situations.
  • the kit comprises a plurality of the guide-wire or a plurality of the vascular catheters.
  • the material or elements are sufficient for at least one treatment.
  • the kit comprising an auxiliary device.
  • the auxiliary device comprises one of a catheter port, a syringe, or other devices used with the guide-wire or the catheter or the occlusion material or the occlusion element.
  • An exemplary embodiment of the invention comprises using a sclerosant for the manufacture of medicament for treating BPH or prostate cancer in a subject.
  • the subject age is about 40 or over, 50 or over or 60 or older.
  • the subject was not diagnosed as infertile and/or not diagnosed for varicocele.
  • Fig. 1 schematically illustrates a typical testicular and prostate venous drainage system of a human male
  • Fig. 2 schematically illustrates typical testicular and prostate venous drainage paths in a normal left side of a human male
  • Fig. 3 schematically illustrates typical testicular and prostate venous drainage paths in a left side of a human male when the one-way valves in the internal spermatic vein do not function.
  • Fig. 4A schematically illustrates a guide-wire designed to move through venous valves and corners, having an expandable and contractible element in a collapsed state, in accordance with exemplary embodiments of the invention
  • Fig. 4B schematically illustrates a guide-wire designed to move through venous valves and corners, having an expandable element in an expanded state, in accordance with exemplary embodiments of the invention
  • Fig. 4C schematically illustrates a side view of a distal end of a guide-wire (similar to that of Fig. 4A and 4B) with expandable and contractible elements, connected to elastic members, in a collapsed state, in accordance with exemplary embodiments of the invention
  • Fig. 4D schematically illustrates a side view of a distal end of a guide-wire (similar to that of Fig. 4A and 4B) with expandable and contractible elements, connected to elastic members, in an expanded state, in accordance with exemplary embodiments of the invention
  • Fig. 5A schematically illustrates a catheter for blocking a region and injection within the blocked region, in accordance with exemplary embodiments of the invention
  • Fig. 5B schematically illustrates a cross section of the catheter of Fig. 5A perpendicular to the length, in accordance with exemplary embodiments of the invention
  • Fig. 5 C schematically illustrates a section of the perforated interval between balloons of the catheter of Fig. 5A, in accordance with exemplary embodiments of the invention
  • Fig. 5D schematically illustrates a catheter for blocking a region in a vein and injection within the blocked region where the catheter is inside a vein, expanding its walls and blocking the region, in accordance with exemplary embodiments of the invention.
  • the terms 'left side' and 'right side' refer to the conventional anatomical terminology (e.g. the heart, stomach and spleen are on the left side of most human beings).
  • 'drainage' refers to a flow of venous blood via venous vessels towards and into the vena cava, and the terms 'reflux' and 'backflow' are used synonymously. In some cases, it is possible that at least some of the hormones reach the prostate by diffusion along the venous pathway.
  • Fig. 3 schematically illustrates typical testicular and prostate venous drainage paths in a left side of a human male when the one-way valves in the internal spermatic vein do not function normally, for example, due to mechanical deterioration such as weakening of valves materials, operational grinding or aging effects.
  • the internal spermatic veins 102 or 130 form continuous columns of blood in which hydrostatic pressure develops up to approximately 31 mmHg at entry 142 to the left internal spermatic vein 102 approximately 27 mmHg at entry 144 to the right internal spermatic vein 130 (typically about 4-6 fold the typical pressure in ordinary conditions) when the patient is in an upright position such as standing.
  • This excessive hydrostatic pressure may exist in vessels connecting to internal spermatic vein 102, such as deferential vein 110 or pampiniform plexus 118, since, according to the law of connecting vessels, the pressure propagates from the testicular to the prostate venous drainage systems and hydro-dynamically equilibrates between both drainage systems.
  • the pressure may diminish as vessels are further away from entry 142 or 144, but may be still more than the normal range of about 5 mmHg.
  • the excessive pressure at 142 or 144 and nearby vessels will be denoted as 'EP'.
  • This excessive high pressure EP inhibits the drainage of the venous blood from the testes 106 and the pampiniform plexus 118 up the internal spermatic vein 102. Rather, the pressure pushes the testicular venous blood, rich in free testosterone (about 130 fold above serum level), towards the vesicular plexus 128 and onwards to the prostate 120, limiting drainage of venous blood from the prostate.
  • venous blood from the testis is drained, at least partly, via other paths, such as the deferential vein 1 10, scrotal vein 128 or by-pass veins 136 that might have developed, possibly due to the excessive pressure.
  • the excessive pressure EP may produce at least some of the following effects: (a) The venous blood that is diverted towards prostate 120 and congests and enlarges (dilates) prostate 120. The dilation of prostate 120 may be manifested, at least partially, as BPH or other prostate problems.
  • the excessive pressure EP and congestion of the prostate inhibits or reduces arterial blood from entering microcirculation 124 of the prostate and disrupts the biological balance and/or causes hypoxia, which misbalance and/or hypoxia may encourage formation and/or growth of cancerous and/or pre-cancerous cells.
  • the excessive amounts of testosterone and DHT present in the prostate may induce an accelerated proliferation of prostate cells, and promote the development of cancer. It should be noted that the extreme concentration of free testosterone (about or over 100 fold relative to normal) in the prostate may overload the DNA hormonal feed back system, and increase the probability of mutations in the accelerated cells divisions.
  • the excessive venous pressure EP inhibits or reduces arterial blood from entering the microcirculation 126 of the testes. The blood stagnates to at least some extent, and oxygenated arteriolar blood cannot flow normally into the testis, resulting in degenerative processes in the testes tissues which diminish its testosterone production.
  • the impaired testosterone production, resulting in reduced testosterone in the blood serum, may effect aging expressions or symptoms.
  • one or more of the adverse states and effects described above may be avoided, delayed, alleviated and/or repaired, at least to some degree, by reducing or eliminating the excessive pressure EP. Reducing the pressure reduces or eliminates the back flow (reflux) of venous blood, rich in testosterone (relative to normal levels in the blood circulation), from the testes to the prostate.
  • the reflux is prevented or impeded by occlusion (e.g. embolization or sclerosis), of the left internal spermatic vein 102 and/or the right internal spermatic vein 130 that has effected the excessive hydrostatic pressures EP.
  • occlusion e.g. embolization or sclerosis
  • some or all veins through which the reflux flows such as the deferential vein 110 and the pampiniform plexus 118, are occluded.
  • bypass veins 136 that might have developed are occluded too.
  • deferential vein 110 is occluded to block the backflow of testicular venous blood into the prostate, relieving it of the excessive pressure and high testosterone, and allowing it to recover.
  • other veins are not treated for backflow and/or varicocele, at least for a certain time duration.
  • occluding only deferential vein 110 may be beneficial in case of metastases or suspicion for metastases, since testosterone drainage to the bloodstream via the internal spermatic veins 102/130 is inhibited by the excessive pressure EP, and blocking also the passage via deferential vein 110 results in reduced testosterone supply to the bloodstream, and possibly reduced risk for metastases proliferation.
  • deferential vein is occluded using microsurgery, and optionally be exposing the vein.
  • the surgery is conducted under ultrasound or other imaging guidance.
  • other veins are treated during the operation.
  • venous blood from the testes may drain to the according to the negative pressure gradient to the inferior vena cava via the vesicular vein without diverting to the prostate and/or through a scrotal vein 128.
  • Arterial blood may now enter the testes microcirculation unimpeded 126, and restoring, at least partially, testosterone production and allow recovery of damaged tissues.
  • the prostate is relieved of the back flow and swelling, and it can drain the excessive blood congestion with testosterone via the vesicular plexus 128.
  • the excessive venous pressure relieved arterial blood can more easily enter the prostate microcirculation 124.
  • the recovering prostatic tissue, with arterial blood with approximately normal testosterone levels (and bound serum testosterone) could reduce the stimulus to growth of cancer tissues in the prostate.
  • anti-androgenic agent may be administered, locally or systemic, to further the healing effect.
  • the additional medication may lower even more the testosterone levels without affecting the patient health.
  • the occlusion is carried out by applying sclerosants (sclerosing agents) into a vein.
  • the sclerosant may be, for example, Sodium tetradecyl sulfate (Sutra-Decol), alcohol or its derivatives, Cyanoacrylate, N-butyl- 2-cyanoacrylate (NBCA) ('glue'), Onyx, PVA particles, acrylic microspheres or any blocking agent of the art.
  • the sclerosant is applied via intravenous catheter or catheters.
  • the sclerosant is applied subcutaneously, such as by a syringe.
  • other methods of blood vessels blocking are used, such as placement of coils, or other elements such as silk (optionally coated with sclerosant or other materials) that block the vein lumen and/or induce thrombosis that blocks the vein and typically induces degeneration and permanent occlusion.
  • endovascular ablation such as radiofrequency radiation that heats up the vein, or application of direct heating, is used to damage the vein and/or induce its walls to shrink and/or develop a thrombosis, optionally a complete blocking of the vessel.
  • a friction with the vessel endothelium may be used to shrink and occlude the vessel.
  • electrocautery such as by electric wire in a catheter, or laser heating by an optic fiber in the catheter may be used to heat and shrink the vessel or effect sclerosis.
  • these methods are applied by minimally invasive methods such as by laparoscopy.
  • the methods are applied externally such as by or radiation, for example, a plurality of laser beams is used to focus at the sclerosis region, while each beam does not damage, or negligibly damage, the other tissues whereas the convergent beams at the focus have sufficient power to shrink and/or effect sclerosis of the vein.
  • electromagnetic radiation e.g. x-ray or by MRI
  • ultrasound radiation or cryogenic methods may be used to shrink the blood vessel.
  • a temporary embolization such as by Gelfoam (gelatin powder) which clots the vessel and later on dissolves may be used, at least partially.
  • a sclerosant is used for the manufacture of a medicament for forestalling and/or treating BPH or prostate cancer in a subject.
  • the sclerosant is adapted to treating backflow that effects BPH and/or prostate cancer.
  • the adaptation comprises the composition of materials and/or their proportions, for example, mixing two or more occlusion materials, optionally comprising temporary occlusion material such as Gelfoam.
  • the medicament may comprise materials with affinity to testosterone and/or adapted to bind to and occlude vessels containing high concentration of bound and/or free testosterone.
  • the high concentration comprises 5 to 10 fold, or higher (e.g. 50 to 100 fold), than the normal range of bound and/or free testosterone.
  • the medicament is administered systemically or locally.
  • an antiandrogen medication such as an antigen bound guided molecular therapy may be used as part of the treatment.
  • the antigen reduces testosterone production by affecting regions in the brain (e.g. hypophyse or hypothalamus) that regulate testosterone production.
  • the antiandrogen comprises materials such as is LHRH analogs (luteinizing hormone-releasing hormone), administered systemically or as subcutaneous patch.
  • such antiandrogen material may be a part of the medicament described above.
  • the occlusion treatments are useful in forestalling prostate cancer metastases by either (a) occlusion as described above, preventing the development of cancer, and hence, metastases, or (b) if cancer is already present, occlusion (e.g. by microsurgery) of at least the deferential vein or other vessels that drain from the prostate to the blood stream.
  • occlusion e.g. by microsurgery
  • the occlusion blocks at least some of the venous passage from the prostate and consequently reduces possible leakage of cancerous cells from the prostate that my settle at certain organs.
  • deferential vein 110 may be reached by a catheter or other methods via the femoral vein to the common iliac vein to internal iliac vein to internal spermatic vein and to the deferential vein.
  • the path is from the vena cava to the renal vein to the internal spermatic vein and to the deferential vein.
  • an antegrade approach may be used.
  • the deferential vein may by separated and exposed, allowing direct treatment thereof.
  • the level of varicocele, or the degree of valve degradation or malfunction, or the degree of the clinical significance of the valves degradation in a spermatic vein and/or the degree of venous blood reflux to the prostate may be assessed or diagnosed responsive to the degree of prostate hyperplasia.
  • prostatic hyperplasia may be diagnosed or assessed by palpation or other methods such as diagnostic imaging.
  • diagnosis is responsive to a unilateral (left or right side) malfunction of valves 108 or bilateral (left and right side) malfunction, or a combination of the malfunction levels of each side.
  • the malfunctioning side may be identified by methods such as radiology or ultrasonography.
  • the degree of varicocele, and/or the degree of valve degradation in the spermatic veins and/or the degree of venous blood reflux to the prostate may be assessed or diagnosed based on the testosterone concentration measured near a testes or the prostate or between them.
  • the serum testosterone is measured at the lower part of the internal spermatic vein, or at or above pampiniform plexus 118, or the deferential vein 110, or vesicular plexus 128.
  • the testosterone level is measured using a syringe or a catheter or by non-invasive methods such as radiation (e.g. laser or infrared).
  • varicocele is diagnosed visually or by palpation, and if present to a certain extent, which may indicate a potential increased risk of cancer, testosterone concentration is consequently measured.
  • free testosterone concentration is measured for varicocele diagnosis.
  • total testosterone is measured. The relation between the varicocele and testosterone concentration is based on the location where the measurement was made. For example, the measurement at the vesicular plexus 128 may be more indicative or credible than at a pampiniform plexus 118 because elevated testosterone concentration at the vesicular plexus is due to reflux whereas high concentration at the pampiniform plexus may be, at least partially, due to testosterone that did not yet enter the systemic circulation.
  • the measurement is repeated, or a plurality of measurements are taken at a plurality of anatomical locations. Consequently, an average, or other estimation or statistical derivation, may yield a more stable and/or reliable relation.
  • testosterone is tested at the blood circulation so that a difference may be assessed for diagnosis.
  • a range of normal and pathological concentrations are compiled for comparison and diagnosis.
  • a catheter In order to access the internal spermatic vein 102 or 130 and below, such as to the pampiniform plexus 1 18 or the deferential vein 1 10, a catheter should pass the one-way valves 108 which normally resist flow against the normal flow direction. Since some of the valves may still be functional in patients with this condition, at least partially, it takes a special skill and training to perform the maneuver without damaging the valves.
  • the right internal spermatic vein 130 frequently enters the inferior vena cava 106 at an angle 132, such that a catheter being advanced from below (e.g. from the femoral vein) needs to take a sharp turn while accessing a valve or valves 108.
  • Fig. 4A schematically illustrates a guide-wire 400 designed to move through venous valves and junctions such as 132, having an expandable and contractible element
  • FIG. 4B schematically illustrates the guide-wire 400 having an expandable element 406 in an expanded state, in accordance with exemplary embodiments of the invention.
  • the guide-wire 400 comprises:
  • guide wire 400 comprises an elongated duct 402 having a lumen 410.
  • a guide wire 400 comprises a control wire 408 that passes through lumen 410.
  • control wire 408 passes through the expandable element 406 for expanding and contracting element 406.
  • an operation of the guide-wire comprises:
  • an intravascular catheter (not shown) is maneuvered to the proximity of a valve such as 108, and the operator injects a contrast agent via the catheter to visualize the valve and the position of the catheter.
  • the guide-wire is inserted in the catheter and manipulated, aided by the tip 404, to reach near a valve 108.
  • the element is expanded, opening the vessel walls and the valve orifice.
  • the control wire is operated as describe above. Once the wire has passed the valve, a catheter can be pushed through the open valve, optionally over guide wire 400.
  • guide wire 400 with flexible tip 404 allows easy maneuvering in the blood vessels and element tip allows fast passage through venous valves, for easy insertion of catheters into the vein.
  • the element 406 comprises a collapsible wire mesh.
  • the mesh is twisted in the collapsed state and untwisted in the expanded state.
  • the mesh expansion is by unwinding the spiraled grid wires 408 as the mesh is pulled by control wire 408.
  • the collapsed mesh is elongated relative to the expanded state.
  • the expansion of element 406 by control wire 408 is carried out about 2-3 cm upstream of a valve 108.
  • the distance is different, optionally to fit the expansion of the vein and valve orifice.
  • the expansion is approximately by 5 mm diameter.
  • the expansion is by 4-6 mm.
  • it is more than 6 mm.
  • the expansion is less than 4 mm.
  • the expansion is according to the vessel diameter.
  • the expansion is adjustable for the intended vessel or valve, e.g. by twisting or untwisting the mesh before use.
  • element 406 width in its collapsed state is approximately the same as guide- wire 400 width 412.
  • width 412 is approximately 0.018 inch.
  • width 412 is adapted to the operation or the vessels diameter.
  • width 412 is adjustable e.g. by twisting or untwisting duct 402.
  • the mesh may be replaced, at least partially, by other mechanisms.
  • an inflatable balloon, or other extendable/contractible mechanism such as by elastic elements or elements which, optionally, operated by the control wire, for example, as describe with respect to Fig. 4C below.
  • Fig. 4C schematically illustrates a side view of a distal end of a guide-wire 420 (similar to guide-wire 400 of Fig. 4A and 4B) with expandable and contractible elements 422, connected to elastic members 426, in a collapsed state, and Fig. 4C schematically illustrates the side view in an expanded state, in accordance with exemplary embodiments of the invention.
  • element 422 comprises a plurality of elements around the distal end of walls 428 of duct 402.
  • Elements 422 are rotatable about pivot 428 on walls 418 of duct 402 and connected to elastic elements 426 which normally push inwards into lumen 410 in directions 426.
  • Elements 422 touch tip 404 firmly due to the pressure force of elastic elements 426.
  • Elements 422 and tip 404 are shaped such that when control wire 408 is pulled towards the proximal end of guide-wire 420, tip 404 moves towards lumen 410, while forcing and pushing elements 422 outwards in directions 430 against the pressure of elastic elements 426. Expanded elements 422 push against a vein's wall, stretching and widening the wall and compelling the orifice of a nearby valve 108 to open. Pushing control wire 408 towards the distal end, control wire 108 pushes tip 404 while elements 422 contract under the pressure force of elastic elements 426 in directions 426, letting guide-wire 420 pass through the open orifice.
  • tip 404 is flexible and manipulated by the distal end of guide wire 400 to enter left internal spermatic vein, optionally beginning with the femoral vein or otherwise.
  • tip 404 is manipulated to enter the right spermatic vein 132 via corner 108.
  • the guide- wire is used for valves in the internal spermatic veins.
  • valves 108 are near a junction where veins join such as that of the left renal vein and left spermatic vein, or the inferior vena cava and the right spermatic vein (132). These locations are typically difficult to enter due to the sharp angle of the bending.
  • guide-wire 400 is suitable for entering and passing through a sharply angled vascular turn.
  • Fig. 5A schematically illustrates a catheter 500 for blocking a region and injection within the blocked region
  • Fig. 5B schematically illustrates a cross section of the catheter of Fig. 5 A perpendicular to its length, in accordance with exemplary embodiments of the invention.
  • the catheter is intended for occluding a volume in a vascular region and injecting material into that region limiting drainage of the injected material out of the region.
  • the region comprises a venous intersection (e.g. 132).
  • the catheter comprises:
  • the inflatable elements 506 and 508 comprise balloons.
  • the catheter 500 comprises more than two balloons.
  • the catheter comprises one balloon.
  • a balloon inflates at its two ends or at a plurality of locations along its length and may occlude
  • catheter 500 comprises one or more lumens 514 between proximal 516 end of catheter 500 and the balloons, as shown, for example, in Fig. 5B.
  • catheter 500 comprises one or more ports 520 at the proximal end of the catheter.
  • a port 520 connects to lumen 518, and two ports 520 connect to each tubes 514 leading to a balloon.
  • one port 520 connects to both tubes 514.
  • ports 520 are used to inflate and deflate the balloons and/or to inject material into the vein and/or to aspirate the vein.
  • the perforations 512 are closable, for example by valves operated by a mechanism such as a control wire, or by insertion of a tube inside catheter 500 to cover some of the perforations (without disrupting the catheter mechanism and operation).
  • an operation of the catheter comprises:
  • distal balloon 508 is inflated via a port 520 and a tube 514 connected to the balloon, until the balloon contacts the vessel walls with sufficient force to prevent drainage of blood and/or injected material.
  • proximal 506 balloon is inflated via a port 520 and a tube 514 connected to the balloon, forming a closed region about the interval;
  • a material is injected (or installed) from port 520 via the catheter lumen 518 and out of the perforations 512;
  • step (e) deflating the balloon and removing the catheter from the region.
  • step (c) may precede step (b).
  • removing the catheter in step (e) takes into account the nature of the material. For example, if it is a liquid then the catheter is pulled while the material is wet, or if it is a mechanism or elements, it is pulled without detaching the mechanisms or elements.
  • one balloon may be inflated to block flow of material to an undesirable location while letting the material to flow towards the opposite direction.
  • Fig. 5D schematically illustrates catheter 500 for blocking a region 532 in a vein 534. Balloons 506 and 508 are inflated, expanding vein 534 walls 530 and blocking region 532, in accordance with exemplary embodiments of the invention.
  • the inflatable balloons are replaced, at least partially, by other blocking elements.
  • a removable coil or an elastic element or other elements for example, a removable coil or an elastic element or other elements.
  • perforations 512 are adapted in size and/or shape to install the blocking elements.
  • a welding element is opened towards the walls of a vessel and welds and occludes the vessel lumen.
  • the welding comprises electrically heating.
  • the material comprises mechanical elements such as a coil or other elements.
  • the catheter is intended, but not limited to, for sclerosis of an internal spermatic vein 102 or 130.
  • distal 504 end is either open or closed.
  • a closed distal end 504 is openable (e.g. by inflating a balloon), for example to allow a passage of a guide-wire or another catheter, or for injection or aspiration at the end.
  • the length of interval 510 is designed to fit certain anatomies or venous regions.
  • a deferential vein 108 is shorter than an internal spermatic vein so that a shorter interval 510 may be required.
  • interval 510 is modifiable, for example, by having a plurality of balloons that inflate according to the required interval, or having a telescopic structure operated by a control cord or a guide- wire in the catheter lumen.
  • the length of interval 510 is such as to contain sufficient amount of sclerosant to ensure proper occlusion, or to allow the deployment of mechanical elements such as coils.
  • the catheter uses the guide-wire 400 for moving through venous valves.
  • kits for use in forestalling and/or treatment of BPH and/or prostate cancer comprises:
  • the occlusion material comprises a glue or a sclerosant or an embolization material.
  • the element is a coil or an elastic element.
  • the kit comprises a selection of a glue and/or sclerosant and/or embolization material,
  • the material or elements are sufficient for one or for more than one typical treatments, for example, amounts suitable for treating two sides, in 80% to 95% of the cases.
  • the kit comprises a plurality of guide-wires and/or catheters.
  • the kit comprises auxiliary devices such as one or more catheter ports for injection or aspiration, and/or one or more syringes for injecting material to the catheter.
  • the kit comprises other devices that are typically required or used with the guide-wire or the catheter or the occlusion material or the occlusion element.
  • the kit includes instructions for use, for example in writing and/or drawings.
  • Exemplary screening patients for treatment comprises one or more of the following procedures, or a combination thereof.
  • I Selecting patients complaining of nocturia, at least for some time. Priority is given to age and/or frequency and/or urgency of urination. Alternatively, diagnosis or assessment for hypertrophy of the prostate is performed by palpation of the prostate.
  • thermography may be used for non-invasive diagnosis of prostate disease which may be related to varicocele.
  • the diagnosis or assessment of a malfunction or disorder of the prostate comprises measuring testosterone levels near the prostate.
  • the diagnosis results are compared and/or combined to achieve a more reliable judgment relative to one method.
  • the diagnosis is repeated at least twice to avoid uncertainties.
  • thermographs may be used to asses directly elevation of the temperature in the ISV indicating that venous backflow exists, suggesting that there is elevation of hydrostatic pressure in the testicular-prostatic drainage systems (e.g. by a contact thermography using a flexible liquid crystal thermostrip (FertiPro, Breemen, Belgium)).
  • the thermographs are taken at a testis wherein an elevated temperature (above a typically about 32°C, e.g. about 37°C) indicates a backflow of systemic blood into the testis.
  • III Selecting patients over a certain age such as about 40 or over 50 or over 60 or older.
  • V Selecting patients with prostate problems with no apparent and/or palpatable varicocele.
  • VI Selecting patients having right side varicocele or impaired right side venous drainage.
  • Screening for cancer may be achieved, for example, by biopsy of the prostate.
  • occlusion may be combined with ablation (e.g. thermal, radiation, ultrasound, cryogenic) of veins that allow backflow to the prostate, such as the deferential vein.
  • ablation e.g. thermal, radiation, ultrasound, cryogenic
  • the combination may serve as a preventive measure to forestall the development of prostate hypertrophy to BPH, or to forestall the development of BPH into cancer.
  • Another example is when prostate cancer is present and occlusion of the deferential vein, and/or other veins which allow backflow, is augmented with chemotherapy.
  • Chemotherapy may be administered systemically (e.g. by transfusion) or locally at the prostate or its surroundings (e.g. by a catheter or subcutaneously).
  • the augmentation by chemotherapy may also prevent and/or treat metastases.
  • radiation therapy e.g. brachitherapy or external radiation from a Linac or gamma radiation
  • Ill Augmenting, or combining, the occlusion with anti-androgenic agent administration, optionally with reduced dosage relative to conventional androgenic treatments.
  • typical quantities of sclerosant comprise a range of about 0.2 cc to 10 cc.
  • about 5 cc may be used, and for the right spermatic vein about 4 cc may be used, and for the deferential vain about 0.5cc to 1 cc may be used.
  • a "One stick" trocar type venous access sheath 6 French (2 mm) inner diameter flushable sheath placed with ultrasound guidance for rapid access.
  • vasodilatory agents such as sublingual nitrates, Cordil, or Viagra to induce venous dilatation and facilitate entry into the internal spermatic vein.
  • Exemplary non-catheter applications Direct access of the deferential vein using ultrasound guidance to allow selective percutaneous occlusion of the connection between the internal spermatic vein and the prostatic venous plexus. 1) Direct access to the internal spermatic vein at the base of the scrotum to allow visualization of otherwise occult collateral veins which have caused recurrence of varicocele in previously treated cases.
  • Exemplary Study 1 Before treatment all 9 patients (in ages 36-67) reported nocturia (ranging from one to eight times a night), with a prostate volume (measured by ultrasonography) in the range of 21-52 ml. Three to six weeks after occlusion treatment the prostate volume decreased to 12-30 ml and nocturia decreased to a 0-2 time a night.
  • Exemplary Study 2 A 69 years old patient was diagnosed (11/05) with prostate cancer after a PSA screening test (14.5ng/ml). Digital rectal examination revealed an enlarged prostate but otherwise unremarkable physical examination with no suspicious nodules.
  • TRUS trans-rectal ultrasound
  • a hypoechogenic region was found (11mm) in his right lobe.
  • the patient was treated with one injection of goserelin (12/05) and then referred to an oncologist. After a long discussion on all possible treatment options for low risk prostate cancer the oncologist opted for an active surveillance.
  • Study 1 In some 250 cases, while performing venographies on patients with varicocele, the height of the vertical blood columns in the ISVs was measured in order to estimate the venous hydrostatic pressure. Study 2. In 12 infertile men with varicocele, during the above procedure, the concentration of total testosterone and FT in 21 blood samples taken from the lower part of the left and the right ISV was measured, along with peripheral blood testosterone and FT levels.
  • testicular drainage system penampiniform plexus
  • prostate drainage system was examined.
  • contrast material was injected into in the lower third of the impaired venous drainage system of the right side exerting gentle pressure to simulate the hydrostatic pressure on the testicular drainage system in the erect posture.
  • Results Study 1 The average distance between competent one-way valves in the ISVs is 6-8cm; the average vertical height of the blood column in the right ISV is ⁇ 35cm and in the left one is ⁇ 40cm and there are no competent valves in diseased patients.
  • the hydrostatic pressure in the vein is calculated from where p the density of the liquid (gr/cm 3 ), g the gravitational acceleration (981cm/s 2 ), and h the vertical height of the blood column (cm); leading to en estimation of some
  • Prostate volume (by transabdominal ultrasonography) measured an average of 55ml. Following the treatment (4-12 weeks later), the prostate volume decreased to an average of 37ml and nocturia decreased to an average of 1 (range 0-2) (see Table 1).
  • each of the verbs "comprise”, “include” and “have” as well as any conjugates thereof, are used to indicate that the object or objects of the verb are not necessarily a complete listing of members, components, elements or parts of the subject or subjects of the verb.
  • the term “treating” includes abrogating, substantially inhibiting, slowing and/or reversing the progression of a condition, substantially ameliorating clinical and/or aesthetical symptoms of a condition and/or substantially preventing and/or delaying the appearance of clinical and/or aesthetical symptoms of a condition.
  • the word “exemplary” is used herein to mean “serving as an example, instance or illustration”. Any embodiment described as “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments and/or to exclude the incorporation of features from other embodiments.
  • the word “optionally” is used herein to mean “is provided in some embodiments and not provided in other embodiments”. Any particular embodiment of the invention may include a plurality of "optional” features unless such features conflict.

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Abstract

L'invention concerne une méthode destinée à prévenir ou traiter, au moins partiellement, la HBP ou le cancer de la prostate, et consistant à identifier un reflux de sang veineux vers la prostate et à empêcher ce reflux par traitement des veines provoquant ou véhiculant ce reflux. L'invention concerne également un appareil et une trousse associés.
EP08776606A 2007-07-13 2008-07-13 Diagnostic et traitement de la varicocèle et des troubles de la prostate Withdrawn EP2178594A4 (fr)

Applications Claiming Priority (3)

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US11/826,283 US20090018486A1 (en) 2007-07-13 2007-07-13 Diagnosis and treatment of vericocele and prostate disorders
US6451108P 2008-03-10 2008-03-10
PCT/IL2008/000971 WO2009010962A2 (fr) 2007-07-13 2008-07-13 Diagnostic et traitement de la varicocèle et des troubles de la prostate

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AU2008277251A1 (en) 2009-01-22
WO2009010963A3 (fr) 2010-01-14
CN101801289A (zh) 2010-08-11
WO2009010962A2 (fr) 2009-01-22
EP2178594A4 (fr) 2011-02-23
WO2009010963A2 (fr) 2009-01-22
EP2170180A2 (fr) 2010-04-07
WO2009010964A3 (fr) 2010-02-25
CA2693227A1 (fr) 2009-01-22
WO2009010964A2 (fr) 2009-01-22
CA2693735A1 (fr) 2009-01-22
JP2010533052A (ja) 2010-10-21
WO2009010962A3 (fr) 2010-09-16

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