METHOD AND APPARATUS FOR TREATMENT OF ERECTILE DYSFUNCTION WITH EXTRACORPOREAL SHOCKWAVES

Abstract

A method and device producing extracorporeal shockwaves for the treatment of erectile dysfunction

Claims

1-42. (canceled)

43. A method for the treatment of Erectile Dysfunction the method comprising: a) associating a penis with an electrohydraulic or/and electromagnetic shockwave generating device within an aqueous environment; and b) applying a shockwave regimen to a penis wherein the shockwave generating device produces shockwave directed to a focal zone comprising at least a portion of the penis.

44. The method of claim 43 wherein the shockwaves are directed at a focal zone which includes at least a portion of the corpus cavernosa of the penis.

45. The method of claim 44 wherein the shockwaves are directed at a focal zone which comprises most of the length of the penis.

46. The method of claim 43 wherein the shockwaves are directed at a focal zone which includes most of the corpus cavernosa of the penis.

47. The method of claim 43 wherein the shockwave treatment regimen is determined based on at least one parameter chosen from the group consisting of shockwave parameters, treatment protocol parameters, and anatomical parameters.

48. The method of claim 47 wherein the shockwave parameters comprise number of shockwaves, frequency of shockwaves and intensity of the shockwave.

49. The method of claim 48 wherein the parameters are selected from at least one of: shockwave intensity in a range between 50 bar to 200 bar; shockwave frequency in a range between 60 to 300 shockwaves per min; and the number of shockwaves is below 3500 per session.

50. The method of claim 47 wherein the anatomical parameters comprise a selection of at least one treatment zones selected from at least seven treatment zones including the glans to the penis root, corpora cavernosa, corpus spongiosum, root of the penis, bulbos and glans, ischiocavernosus and bulbospongiosus.

51. The method of claim 47 wherein the anatomical parameters comprise a single focal zone including up to 90% of the corpus cavernosa of the penis.

52. The method of claim 43 further comprising administering the shock wave regimen in combination with a drug or medicament.

53. The method of claim 52 0wherein the medicament or drug is chosen from a group consisting of stem cells, growth factors, hormones, peptides, biologics, DNA, RNA, animal extract, plant extract, oil, gel, balm, cream, angiogenic drugs, PDES and vasodilating drugs.

54. The method of claim 53 wherein the shockwave and drug combination treatment promotes at least one of: vasodilatation, vasoconstriction, angiogenesis, endothelial function, neural regeneration, decalcification, increased cytoplasmic calcium concentration, reduced cytoplasmic calcium concentration, inhibition of PDES, enzymatic inhibition, enzymatic excitation, or any combination thereof.

55. The method of claim 43 wherein at least one of the shockwaves targets at least one or more of the penis vasculature chosen from the group consisting of: cavernosal artery, dorsal artery, bulbar artery, cavernosal vein, dorsal vein and bulbar vein.

56. The method of claim 43 wherein the shockwave treatment is applied at least during one phase of an erectile cycle chosen from the group consisting of initiation, generation, maintenance, and detumescence.

57. The method of claim 43 wherein the treatment protocols targets at least one erectile function chosen from the group consisting of arterial inflow, sufficient corpora cavernosal expansion, and competent venous sinusoidal outflow occlusion.

58. The method of claim 43 wherein at least one of the shockwaves is directed towards at least one or more penile anatomy member chosen from the group consisting of corpora cavernosa, corpus spongiosum, and glans.

59. The method of claim 43 wherein the shockwave treatment regime is implemented over a period of up to 18 weeks including periods of active shockwave treatment sessions and periods of rest.

60. The method of claim 59 wherein the treatment regimen comprises up to 18 active shockwave treatment sessions.

61. The method of claim 59 wherein the active treatment session treatment are implemented at least once a week.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0060] The invention is herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only, and are presented in order to provide what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice.

[0061] In the drawings:

[0062] FIG. 1A-B are schematic illustrative diagrams of optional device configurations according to an optional embodiment of the present invention;

[0063] FIG. 2 is a schematic illustrative diagram of an exemplary device according to an optional embodiment of the present invention.;

[0064] FIG. 3 is a flowchart of an exemplary method according to the present invention for ESWT for ED.

[0065] FIG. 4 is a schematic Gantt chart of an ESWT treatment protocol according to an optional embodiment of the present invention.

[0066] FIG. 5A-B are schematic diagrams of optional treatment zones for Erectile Dysfunction. FIG. 5B provides a schematic depiction of the preferred focal zone according to an optional embodiment of the present invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0067] The principles and operation of the present invention may be better understood with reference to the drawings and the accompanying description.

[0068] The following figure reference labels are used throughout the description to refer to similarly functioning parts. [0069] 1-7 optional treatment zones along the penis; [0070] 10 penis; [0071] 100 ESWT applicator; [0072] 101 ESWT apparatus; [0073] 102 handle; [0074] 104 shockwave applicator housing; [0075] 106 flexible ESWT cushion treatment head; [0076] 108 seal; [0077] 110 shock wave generator ensemble; [0078] 112 spark plug; [0079] 114 shockwave reflector; [0080] 115 ESWT focal treatment zone and/or therapeutic area; [0081] 116 shockwave transmission and/or propagation aqueous medium filled lumen; [0082] 120 penis positioning treatment neck; [0083] 122 proximal opening to penis positioning treatment neck; [0084] 126 connector; [0085] 130 pressure/vacuum inlet and outlet; [0086] 140 shockwave treatment applicator; [0087] 150 penis treatment coupling assembly; [0088] 152 penis treatment assembly housing; [0089] 154 shockwave coupling and transmission and/or propagation lumen; [0090] 156d distal opening to penis treatment assembly; [0091] 156p proximal opening to penis treatment assembly; [0092] 158 penis treatment assembly seal; [0093] 160 penis treatment neck; [0094] 162d distal opening; [0095] 162p proximal opening; [0096] 164 shockwave coupling and transmission/propagation lumen;

[0097] FIG. 1A provides a schematic illustration of an optional embodiment of ESWT apparatus 101 according to the present invention. Apparatus 101 comprises a shockwave treatment applicator 140 and penis treatment coupling assembly 150. Optionally and preferably shockwave treatment device 140 is a commercial off the shelf (COTS) ESWT generator as is known in the art. Treatment applicator 140 is optionally provided as electrohydraulic, electromagnetic, piezoelectric or the like shockwave generator as is known and accepted in the art. Optionally and preferably treatment applicator 140 is provided as a spark gap generator.

[0098] Most preferably penis treatment coupling assembly 150 is provided as an attachment element that may be coupled to shockwave treatment applicator 140. Optionally and preferably penis treatment coupling assembly 150 is a single use disposable applicator. Optionally penis treatment coupling assembly 150 may be provided as a multiuse personalized treatment applicator.

[0099] Treatment coupling assembly 150 preferably comprises a penis treatment housing 152 comprising at least two openings 156: a first, proximal, opening 156p and a second, distal, opening 156d. Optionally penis treatment housing 152 may be provided in optional shapes preferably amenable to accept the treated portion of the body, most preferably penis 10, and to be associated and/or coupled with treatment applicator 140. Optionally housing 152 may be provided in the form of a cone, cylinder or the like shape. Optionally housing 152 may be provided in customized form.

[0100] Most preferably proximal opening 156p is provided to accept penis 10. Optionally proximal opening 156p is provided with a seal 158.

[0101] Most preferably distal opening 156d is provided for associating and/or coupling penis treatment coupling assembly 150 with shockwave therapy device 140. Optionally and preferably shockwave therapy applicator 140 is placed over opening 156d and helped into place by a user. Optionally distal to opening 156d may be coupled with shockwave therapy applicator 140, for example with threading on the inner surface housing 152 over opening 156d corresponding to threading on the external applicator 140. Optionally distal opening 156d may be associated with flexible ESWT cushion treatment head 106 with suction, pressure, or the like means for coupling. Optionally distal opening 156d may be associated with treatment head 106 with connectors for example alligator clips, snaps, hook and loop or the like as is known in the art.

[0102] Most preferably housing 152 forms a shockwave propagation lumen 154 that is most preferably provided with an aqueous solution for example including but not limited to water, treated water, ionized water, gel, medicated solution, oil, or the like solution. Most preferably seal 158 is provided to maintain an aqueous solution within shockwave propagation lumen 154. Most preferably shockwave treatment applicator 140 generates a shockwave, for example with spark plug 112 and reflector 114 that propagates through an aqueous shockwave propagation medium filled lumen 116 and through to shockwave propagation lumen 154 most preferably providing a treatment focal zone 115 comprising penis 10 and most preferably at least a portion of the corpus cavernosa. Optionally a focal zone may be directed to at least one and up to about seven areas 1-7 (FIG. 5A) along the penis, optionally and preferably two treatment zones 1-7 along the penis and most preferably one treatment zone 115 along the penis. Most preferably focal zone 115 comprises the full length of penis 10, providing for a single ED treatment zone. Focal zone 115 optionally comprises at least a portion of the corpus cavernosa, for example at least about 50%, more preferably at least about 70%, more preferably at least about 80%, more preferably at least about 90%, most preferably about 100%.

[0103] FIG. 1B provides an optional embodiment of the penis treatment coupling assembly 150 described FIG. 1A. Penis treatment coupling assembly 150 further comprises a penis treatment neck 160 for accepting and retaining penis 10 during shockwave treatment with ESWT applicator 140. Optionally penis treatment neck 160 comprises a distal opening 162d and proximal opening 162p. Optionally and preferably the proximal end of penis treatment neck 160 comprises seal 158 about proximal opening 162p for sealing and maintaining an aqueous environment within treatment neck lumen 164. Most preferably treatment neck 160 comprises an aqueous environment within lumen 164.

[0104] Optionally treatment neck 160 may further comprise at least one or more opening along its posterior and/or anterior sides. Optionally such anterior and/or posterior opening provides for localized targeted treatment area with focal zone 115.

[0105] Most preferably shockwave treatment device 140 generates a shockwave that propagates through shockwave propagation lumen 154 as described above and treatment neck 160 preferably in an aqueous solution adapted to form treatment focal zone 115 comprising penis 10 and most preferably the corpus cavernosa.

[0106] FIG. 2 shows a schematic illustrative diagram of an exemplary ESWT applicator 100 according to an optional embodiment of the present invention for the delivery ESWT for the treatment of ED. ESWT applicator 100 preferably comprises a handle 102, shockwave applicator housing 104 and treatment head 106. Most preferably shockwave applicator housing 104 comprises shockwave generator apparatus 110 for generating and propagating shockwave treatment. Shockwave generator apparatus 110 may be provided as electrohydraulic (also referred to as spark gap), electromagnetic (also referred to as EMSEA), or piezoelectric generators as is known and accepted in the art. Optionally shockwave generator apparatus 110 is provides in the form of a spark gap comprising spark plug 112 shockwave reflector 114 that are preferably immersed in an transmission and/or propagation medium 116 most preferably an aqueous solution confined by treatment head 106. Most preferably medium 116 comprises an aqueous environment for transmitting/propagating the generated shockwave, optionally water, treated water, gel, ionized water, oil or the like aqueous solution as is know in the art.

[0107] Most preferably treatment head 106 is coupled to shockwave applicator housing 104 and shockwave generator ensemble 110 via connectors 126. Optionally and preferably connectors 126 are provided in the form of hermetic seal. Treatment head 106 forms a shockwave propagation lumen 116 wherein most preferably a shockwave generated by shockwave generator 110 is propagated through aqueous environment 116 optionally in the form of water, treated water, gel, ionized water, oil or the like aqueous solution as is know in the art. Most preferably shockwave generator 110 provides a shockwave that propagates through the aqueous solution to form treatment focal zone 115 comprising penis 10 and most preferably the corpus cavernosa.

[0108] Most preferably lumen 116 is provided with a penis positioning treatment neck 120 comprising a proximal opening 122 provided to accept a penis 10 into treatment neck 120 where optionally and preferably most of the ESWT for ED is provided.

[0109] Most preferably shockwaves according to a treatment protocol according to an optional embodiment of the present invention for ED is generated by shockwave generator 110 propagating through lumen 116 comprising aqueous solution and onto treatment neck 120. Most preferably treatment neck 120 is filled with an aqueous solution for example including but not limited to water, oil, treated water, gel, ionized water or the like aqueous solution as is know in the art. Preferably aqueous solution is maintained within treatment neck 120 with seal 108. Most preferably the aqueous solution within treatment neck 120 provides a medium to propagate shockwaves onto penis 10.

[0110] Optionally and preferably shockwave applicator 100 further comprises vacuum inlet and outlet 130 associated with and/or connected to treatment neck 120. Most preferably vacuum inlet and outlet 130 provides for vacuum within treatment neck 120, providing vacuum of about 0.3-0.4 atm. Optionally seal 108 provided at the base of treatment neck 120 maintains vacuum within treatment neck 120, providing for drawing penis 10 into treatment neck 120.

[0111] FIG. 3 shows a flowchart of an optional method of treatment of ED according to an optional embodiment of the present invention. First in stage 300 at least one suspect cause of ED is determined along with at least one treatment protocol for treating it. Next in stage 302, the ESWT treatment focal zone, for example 115 of FIGS. 1-2, 5A-B is determined most preferably for improving treatment results. Optionally, a localized and/or primary ESWT targeted zone with the focal zone, for example 115 of FIG. 1-2, 5A-B, is determined in stage 304. Most preferably focal zone 115 comprises the full length of penis 10, providing for a single ED treatment zone. Focal zone 115 optionally comprises at least a portion of the corpus cavernosa, for example at least about 50%, more preferably at least about 70%, more preferably at least about 80%, more preferably at least about 90%, most preferably about 100%. Next in stage 306, an appropriate treatment protocol is determined and ESWT device and applicator, for example applicator 140 of FIG. 1A-B, is configured to provide the treatment. Next in stage 308, the ESWT device according to any of the optional embodiments of the present invention is associated with a penis experiencing ED, as shown in FIGS. 1 and 2, and thereafter treatment is provided in stage 310 as determined in stage 306.

[0112] Next in stage 312, treatment, assessment and evaluation is provided for determining follow up treatment to undertake, optionally to provide further treatment with a focal treatment zone, as described in stage 300, or to continue with follow up treatments in stage 314.

[0113] Optionally stage 314 is provided for follow up treatments as an addition to the treatment protocol defined in 306. Optionally stage 314 may be used to provide for continued treatment, complimentary treatment, ongoing preventative treatment, regression prevention treatment, treatment for episodes of ED or the like treatment in continuation of the treatment protocol of stage 306. Optionally following stage 314 treatment is reevaluated in stage 312.

[0114] Optionally treatment protocol determined in stage 306 comprises at least one or more parameters, for example including shockwave parameters, treatment protocol parameters, anatomical parameters or the like parameters. For example protocol parameters may include but are not limited to the number of treatment sessions, treatment protocol duration, period of active/inactive treatment sessions, duration of interval periods without ESWT, number of treatment zones on the treated penis, number of shockwaves per zone, total number of shockwaves, treatment intensity, treatment frequency, or the like parameters. Table 1 below summaries the optional treatment parameters and their optional value ranges for treating ED with the ESWT device according to the present invention.

TABLE-US-00001 TABLE 1 Parameter S. N. Group Parameter Value Range 1 Protocol Number of treatment 12 (3-18) parameters sessions 2 Treatment Protocol 3-18 weeks Duration 3 Weeks of active Treatment Weeks 1, 2, 3, and sessions 7, 8, 9, - twice a week 4 Weeks of non-treatment Weeks 4, 5, 6, - Interval treatment recess 5 Anatomical Number of treatment zones 1-7 parameters on the treated penis 6 Shockwave Number of Shockwaves 300 (100-500) Parameters per zone 7 Total number of Shock- 300-3500 waves per session 8 Shockwave intensity 50-200 bar = 0.09 mJ/mm.sup.2 (0.02-0.18) 9 Shockwave Frequency 120/min (60-240)

[0115] Optionally the number of treatment sessions for ED treatment protocols may comprise from about 3 to about 18 active treatment session, optionally about 12 treatment session.

[0116] Optionally the duration of one treatment protocol for ED treatment may comprise from about 3 weeks to about 18 weeks. Optionally and preferably the protocol duration comprises periods of active ES WT treatment and period of inactive and/or rest periods without ESWT treatment. Optionally during weeks of active treatment session treatment may optionally be delivered at least once a week and more preferably at least twice a week, as shown in the schematic Gantt chart of FIG. 4.

[0117] Optional anatomical parameters are depicted in FIGS. 5A-B providing a schematic illustration of optionally treatment zones that may be utilized in the treatment protocol according to the present invention most preferably provided with the device according the present invention. FIG. 5A shows optional localized treatment zones 1-7 distributed along a penis 10 while FIG. 5B shows a central treatment zone 115, incorporating most of the length of penis 10. FIG. 5B provides a further depiction of the most preferred focal treatment zone according to the present invention as previously described in FIGS. 1-2.

[0118] Optionally the ESWT apparatus, for example 100 and/or 101, according to the present invention previously described in FIGS. 1-2 may produce at least one of the optional focal treatment zones, shown in FIGS. 5A and 5B, for example including but not limited to treatment zones 1-7 and/or 115. Optionally and preferably the ESWT apparatus 100 and/or 101 may provide for a plurality of treatment zones for example including but not limited to zones 1-7 and/or 115. Preferably the focal treatment zone may comprise of at least two treatment zones for example including but not limited to zones 1-7. Most preferably, ESWT apparatus 100 and/or 101 provide for focal treatment zone 115 comprising most of penis 10.

[0119] Optionally focal treatment zones 1-7, 115 used with ESWT apparatus 100 and/or 101 may vary according to the symptoms and/or causes of the ED being treated, for example including but not limited to at least one or more of physiologic, neurogenic, vasculogenic, hormonal, or psychologic factors or the like.

[0120] Optionally and preferably a combination of any of focal treatment zones 1-7 may be utilized. Most preferably focal zone 115 of the ESWT device according to any of the optional embodiments previously described and illustrated in FIGS. 1-2, may be further fine tuned to treat a particular zone along the treated penis. Optionally the targeted treatment zone, for example 115 of FIGS. 1-2, 5B, may for example include but is not limited at least one or more of corpora cavernosa, corpus spongiosum, root of the penis, bulbos and glans.

[0121] Optionally targeted treatment zone 115 provides a single treatment zone spanning the length of the treated penis for example including from about 50% of the penis to about 100% of the penis.

[0122] Optionally the shockwave parameters for example comprise parameters including but not limited to shockwave frequency, shockwave intensity and number of shockwaves delivered. Optionally and preferably the shockwave parameters are controllable and may be set in accordance with a particular treatment protocol, for example in stage 306 of FIG. 3 and schematically shown in FIG. 4 as described above. Optionally, shockwave parameters may be determined and defined based on the, anatomical area being treated, as shown and described above in FIGS. 5A and 5B. Optionally shockwave parameters may be determined and defined according to at least one or more effective treatment sought for example including but not limited to vasodilatation, vasoconstriction, angiogenesis, endothelial function, neuronal, neural regeneration, decalcification, increase cytoplasmic calcium concentration, reduce cytoplasmic calcium concentration, inhibition of PDE5, enzymatic inhibition, enzymatic excitation, or the like taken alone or in any combination thereof.

[0123] Optionally the total number of shockwaves provided during a single active treatment session comprises up to about 5000 shockwaves, more preferably from about 300 to about 3500 shockwaves. Optionally and preferably the total number of shockwave may be determined by the number of targeted treatment zones, for example zones 1-7, 115 as shown in FIGS. 5A-B. Optionally when a plurality of zones are treated each targeted treatment zone is provided with up to about 700 shockwaves, more preferably from about 100 to about 500 shockwaves and most preferably up to about 300 shockwaves per targeted treatment zone. Most preferably the device and apparatus of the present invention provides for a single treatment zone, for example 115 of FIGS. 1, 2, 5B spanning the length of the treated penis optionally and preferably reducing the overall number of shockwaves needed for comprehensive treatment.

[0124] Optionally shockwave intensity provided during a single active treatment according to the present invention comprises shockwaves intensity of up to about 300 bar, more preferably from about 50 bar up to about 200 bar, more preferably about 100 bar, most preferably about 125 bar. Optionally the shockwave intensity provided during a single active treatment comprises shockwaves intensity of up to about 0.25 mJ/mm.sup.2, more preferably from about 0.02 mJ/mm.sup.2 up to about 0.18 mJ/mm.sup.2, and most preferably at about 0.09 mJ/mm.sup.2. Optionally shockwave intensity parameters measurement may for example be provided in the unit measurements of bar and/or mJ/mm.sup.2 or the like equivalent unit measurement for shockwave intensity as is known and accepted in the art.

[0125] Optionally shockwave frequency provided during a single active treatment according to the present invention comprises shockwaves frequency of up to about 300 shockwaves per minute, optionally from about 60 up to about 240 shockwaves per minute and optionally and preferably about 120 shockwaves per minute.

[0126] While the invention has been described with respect to a limited number of embodiments, it will be appreciated that many variations, modifications and other applications of the invention may be made.