MXPA99009224A - A transurethral device - Google Patents

Abstract

A transurethral device (10;110) comprises a transurethral insertion element (1;101) having an elongate shaft (9;109) with a free forward end (11;111) with at least a forward section of the elongate shaft which presents the forward end being insertable into the urethra of a human or animal body, for example into the urethra of an impotent male human or animal body for delivery of an impotence treatment drug. To facilitate insertion of the at least a forward section of the elongate shaft into the urethra the device further comprises lubricating means (29;130) for lubricating the outer surface of at least a part of the at least a forward section of the elongate shaft. The device may further comprise a sheath (7;107) for releasably sheathing the at least a forward section of the elongate shaft of the transurethral insertion element prior to insertion thereof into the urethra of the human or animal body.

Description

TRANSURETRAL DEVICE The present invention refers to a transurethral device comprising a transurethral insertion element having an elongated shaft with a free front end for insertion into the urethra of a human or animal body, alive and is particularly, though not exclusively related to a transurethral device of the aforementioned type for use in the treatment of erectile dysfunctions such as impotence, priapism and Peyronie's disease in human-male or living male animals. The invention further relates to a liner for lining a transurethral insert. Impotence in human, living male bodies is the condition in which a human, male body is unable to achieve or sustain an erect penis for the successful coupling of sexual intercourse. There are numerous documented causes for impotence, for example, impotence caused by vasculogenic disorders such as blood flow. insufficient to the arteries in the penis or a REF .: 31483 excessive venal secretion. Priapism is a condition characterized by a persistent and often painful erection of the penis, while Peyronie's disease is characterized by fibrosis of the cavernous tissue of the penis causing pain and a deformed erection. One aspect of the present invention is directed to erectile dysfunctions such as impotence, priapism and Peyronie's disease that can be treated by the distribution of erectile dysfunction treatment drugs, locally to the urethra. The international patent application publications, former W095 / 26158 and 096/28142 elaborate known transurethral devices for the treatment of erectile dysfunction such as impotence in a human, living male body by distributing an erectile dysfunction treatment drug in the urethra of the human body, masculine. These transurethral devices of the prior art comprise a transurethral insertion element having a part of the component that carries the drug and a part of the piston component that can move in the part that carries the drug and a liner to cover the insertable portion of the transurethral insertion element. The part of the component that carries the drug comprises an elongated shaft portion for insertion into the urethra of the human, • male body having axially separated front and rear ends, and a handle portion which is connected to a rear end of the portion. 'n of tree. The part of the component that carries the drug is provided with an open-ended axial hole comprising a rear section of a first width passing through the handle portion and a front section of a second width smaller than the first width passing through the elongated tree. The front section of the axial hole is adapted in use to transport the treatment drug. erectile dysfunction. The part of the plunger component comprises an elongated head portion and an elongated shaft portion protruding. forward of the elongated head portion. The part of the plunger component is adapted to be inserted forward towards the hole in the part of the component that. transports the drug to a withdrawal position in which the elongated head portion is located partially in the posterior section of the hole, such that a posterior section of the elongated head portion protrudes rearwardly from the hole and the tree portion elongate protrudes forward towards the front section of the axial bore, such that the free forward end of the elongated shaft portion is pulled back from the erectile dysfunction treatment drug. The liner of the transurethral device comprises an elongated main body having axially spaced front and rear surfaces and that is provided with an elongated depression extending forward from an open end at. the rear surface towards an intermediate position between the rear and front surfaces. The elongated shaft portion of the part of the drug transporting component can be received releasably in the depression presented by the liner to protect the elongated shaft portion from structural damage and / or contamination prior to insertion thereof into the urethra of the human body, male. In use, the user holds the handle of the part of the component that carries the drug in his fingers - and removes the liner to reveal the elongated tree portion of the part of the component that carries the drug. The elongated shaft portion of the component that carries the drug is then inserted into the user's urethra and the part of the plunger component is pressed forward from the withdrawal position towards the part of the component that carries the drug, to cause the end forward, free of the elongated shaft of the part of the plunger component discharges the erectile dysfunction treatment drug forward from the axial hole in the part of the. component that transports the drug to the urethra. Whereas the above transurethral devices, mentioned above, successfully provide the local distribution of an erectile dysfunction treatment drug, for example, for the achievement and maintenance of a penile erection in the case of impotence. An area in which these devices can be improved has been identified. To facilitate the insertion of the elongated tree portion of the part of the component that transports the drug, of the previously proposed transurethral devices, it is recommended that before the insertion of the elongated tree portion of the part of the component that carries the drug in the urethra the user first pass urine to moisturize the urethra. Clearly, this is not always practical. However, if this step is avoided, it can obviously lead to pain in the insertion of the elongated shaft portion of the part of the component that transports the drug to the urethra. Alternatively, the user is provided with a separate supply of lubricant for application to the outer surface of the elongated shaft of the part of the component that transports the drug of the transurethral insert after stripping thereof. Again, this is hardly convenient or practical, and the lubricant tends to end up in the hands and clothes of the user. More importantly, this additional step introduces the possibility of contamination of the elongated shaft portion of the part of the component that transports the drug from the transurethral insert. The present invention proposes to face this disadvantage of the transurethral devices proposed up to now and according to a first aspect in the present invention a transurethral device is provided for treating erectile dysfunction in a male, male or live animal body comprising an element of transurethral insertion for transporting an erectile dysfunction treatment agent, the transurethral insertion element comprising an elongated shaft with a free leading end with at least a front section of the elongated shaft having the leading end which is adapted for insertion into the urethra of the human or animal body, male, a means for transferring the erectile dysfunction treatment agent from the transurethral insertion element to the urethra at the insertion of at least one forward section of the elongated shaft towards the urethra and a lubrication means for Lubricate the outer surface of at least a portion of at least one front section of the shaft, to facilitate the insertion of at least one front section of the elongate shaft of the transurethral insert into the urethra of the human or animal body. In the embodiments of the invention, which are described hereinafter, the transurethral device additionally comprises a liner for releasably lining the at least one front section of the elongated shaft of the transurethral insert with the lubricating means that forms part of the lining. According to a second aspect of the invention, there is provided a transurethral device comprising a transurethral insert having an elongated shaft with a free front extremity with at least one front section of the elongated shaft having the elongate front end for insertion in the urethra of a human or animal body, and a liner for releasably lining at least one front section of the elongated shaft of the transurethral insertion element prior to insertion thereof into the urethra of the human or animal body, the liner being provided with a lubricating means for lubricating the outer surface of at least a portion of at least one front section of the elongated shaft, to facilitate the insertion of at least one front section of the elongate shaft of the transurethral insert into the urethra of the human or animal body. In one embodiment of the invention, the lubricant means is adapted to lubricate all or substantially all of at least one front section of the elongated shaft.

In embodiments of the invention, which will be described later herein, the lubrication means is adapted to lubricate the outer surface of at least a portion of. at least one 'front section of the elongated shaft when it is lined in the lining. In embodiments of the invention to be described later herein, the liner has a body in which a hole having an open end on an exterior surface of the body is provided to releasably receive the at least one front section of the elongated shaft of the transurethral insertion element. According to a third aspect of the invention, there is provided a liner for a transurethral insert having an elongated shaft with a front end, free with at least one front section of the elongated shaft having the front end adapted for insertion in the urethra of a. human or animal body, the liner having a body in which a hole having an open end on an outer surface of the body is provided to releasably receive the at least one front section of the elongated shaft - of the transurethral insertion and provided with a lubricating means for lubricating the outer surface of at least a portion of the at least one front section of the elongate shaft of the transurethral insert, to facilitate the insertion of at least one front section of the elongated element in the urethra of the human or animal body. In embodiments of the invention to be described later herein, the lubricant means comprises a lubricant container in the liner which under a predetermined condition allows the transfer of the lubricant into the lubricant container on the outer surface of at least one lubricant. a portion of at least one front section of the elongated body of the transurethral insert. In one embodiment of the invention which will be described later herein, the lubricant container is a lubricant compartment in the body of the liner having a boundary wall that is common with at least one. portion of the boundary wall in the hole in the body of the liner and the common boundary wall is able to be put in - an open arrangement by the application of the predetermined condition, whereby the lubricant in the lubricant compartment is capable of being discharged towards the hole in the body of the liner and on the outer surface of at least a portion of at least one front section of the elongated body of the transurethral insert when it is received therein. pierce In one embodiment of the invention which is to be described later herein, the common boundary wall is constructed as such. to be breakable by the application of a predetermined pressure to the outer surface of the body of the liner for the discharge of the lubricant from the compartment of the. lubricant towards the hole and on the outer surface of at least a portion of at least one front section of the elongate shaft of the transurethral insert when it is received in the hole. The lubricant compartment can thus be sized and arranged in the body of the liner so that the common boundary wall circumvents at least a portion of at least one front section of the elongate shaft of the transurethral insertion element when it is received in the bore. In addition, the lubricant can be dimensioned and arranged, in fact, in the body of the lining so that the common limit wall surrounds at least one front section of the elongated shaft of the element. transurethral insertion when received in the hole so that the entire insertable portion of the elongated shaft is lubricated. In another embodiment of the invention, which is to be described later herein, the lubricant container is an open-ended tube having annular front and rear ends for placement in the hole in the body of the liner., for at least one front part of at least one front section of the elongated shaft to pass through or be received in, the tube having an inner surface for receiving lubricant and which is additionally of such dimensions that the lubricant is capable of to be coated on the outer surface of at least one front part of at least one front section of the shaft elongated by the movement of at least one front section of the shaft elongate relative to the tube. In one embodiment of the invention, at least one front part of at least one front section of the elongated shaft is a front portion of at least one front section of the elongate shaft and the front portion is capable of passing through the tube with the rest of at least one front section of the elongated shaft that can be discarded in the tube. In this way, all or substantially all of the outer surface of at least one front section is capable of being lubricated. In one embodiment of the invention to be described hereinafter, the tube can be placed in the hole in the body of the liner so that at least one front portion of at least one front section of the elongated shaft passes through. This and the annular forward end of the tube is provided with an annular flange directed radially inwardly to form a sealing ring around the elongated shaft of the transurethral insertion element, when it is received in the hole in the body of the liner to substantially prevent or prevent it. the transfer of the lubricant from the inner surface of the tube to the outer surface of at least one front part of the at least one front section of the elongated shaft in the passage through the tube. In this manner, the lubricant is essentially restricted to being transferred from the inner surface of the tube to the outer surface of at least one leading part of at least one front section of the elongated shaft in the withdrawal of the elongated shaft from the hole. Preferably, at least one front portion of at least one front section of the elongate shaft is a front portion of at least one front section of the elongated shaft with the remainder of at least one front section of the elongated shaft that can be discarding in the tube, whereby removal of the elongate shaft from the hole results in the entire or substantially all of the outer surface of the insertable portion being lubricated. In an embodiment of the invention according to its first and second aspects, which will be described later herein, the transurethral insert comprises a collar having a leading end connected to a rear or rear end of the elongated shaft with a front section of the collar having the front end thereof which can be received in the hole in the body of the liner in the insertion of the elongated shaft towards the 'hole. The front section of the collar has a width that is greater than the width of the elongated shaft and is selected so that the peripheral outer surface thereof adapts to form a tight fit with the adjacent boundary wall of the hole when it is received in the shaft. Additionally, the front end of the collar is adapted to butt-lock with the annular, rear end of the tube when the elongated shaft is • inserted in the hole, thereby allowing an additional sealing ring to be formed by The collar In one embodiment of the invention to be described later herein, the tube is made of a compressible material and has an outer surface profile that is dimensioned relative to the hole so that the tube can be moved from a non-compressed state to a compressed state in the placement of the tube in the hole for a tube expansion fit into the hole As an example, the tube may have an external surface profile erior frus to-conical. In one embodiment of the invention according to its third aspect, which is to be described later herein, the transurethral insert comprises a collar having a front end which is connected to a rear end of the elongated shaft and which is presented by a front section of the collar having a width which is greater than the width of the elongated shaft, the hole is adapted to receive the front section of the collar when the elongated shaft is received in the hole with the outer, peripheral surface of the front section of the collar forming a narrow fit with the wall The adjacent boundary of the bore and the tube is sized to be locatable in the bore so that the leading end of the collar abuts the annular rear end of the tube to form an additional sealing ring. By way of example, the embodiments of the present invention will now be described with reference to the accompanying drawings, in which: Figure 1 is a view with separation of parts of a transurethral device for the treatment of erectile dysfunction such as impotence in a human, male, living body according to a first embodiment of the invention, comprising a transurethral insertion element for insertion into the urethra of the human, male body having a drug transporting part, a plunger part and a liner for lining the insertable portion of the transurethral insertion element; Figure 2 is a cross-sectional view of the transurethral device of Figure 1 in an assembled state; Figure 3 is a side view of the transurethral device of Figure 1 in an assembled state; Figure 4 is a bottom plan view of the transurethral device of Figure 1 in the assembled state; Figure 5 is a top plan view of the transurethral device of Figure 1 in the assembled state; Figure 6 is a view with separation of transurethral device parts for the treatment of erectile dysfunction such as impotence in a human, male body, alive according to a second embodiment of the invention comprising a transurethral insert for the insertion into the urethra of the human body, which has a part of drug transport and a part of the plunger and a liner to cover the insertable portion of the transurethral insert comprising a transparent body part and a tubular part of the transurethral insert. open end; Figure 7 is a cross-sectional view of the transurethral device of Figure ß in an assembled state; Fig. 8 is a side view of the transurethral device of Fig. 6 in an assembled state; Figure 9 is a bottom plan view of the transurethral device of Figure 6 in the assembled state; Figure 10 is a top plan view of the transurethral device of Figure 6 in the assembled state.

Figures 1 to 5 of the drawings "show a transurethral device" 10 for treating erectile dysfunction such as impotence in a male patient or human body, according to a first embodiment of the present invention. of Figure 1 showing the transurethral device 10 in an unmounted state, the transurethral device 10 comprises a transurethral insertion element 1 for insertion into the urethra of the male human body having a drug transport part 3 and a part 5 of plunger and a liner 7 for the storage of the transurethral insertion element 1 before use thereof Preferably, the aforementioned separable parts of the transurethral device 10 are molded as one-piece bodies from plastic material. 3 of drug transport presents an elongated shaft 9 having a front end 11, free adapted to be insertable into the urethra of the male human rpo, a digital handle 13 for the human, male body to retain the transurethral insertion element 1 and a collar 14 that connects the forward end of the digital handle 13 to the "rear end of the elongated shaft" 9. As shown in FIG. 2, an axial hole 15 extends through the drug transport part 3 between a front open end 17 at the front end 11 of the elongated shaft 9 and a rear open end 19 at the rear end of the digital handle 13. The hole 15 is staggered in a front section 16 of a first width extending backward from the front open end 17 through the elongate shaft -9 and a rear section 18 of a second width which is greater than the first width that extends forward from the open, rear end 19 through the digital handle 13. The front section 16 of the hole 15 is adapted in use to carry an erectile dysfunction treatment drug (not shown) that is going to be transferred to the urethra of the human body, male by the plunger part 5 as will be described later in the present. With reference to Figures 1 and 2, the plunger part 5 of the transurethral insertion element 1 has an elongated shaft 21 having a free end 23 and an elongated head 25 connected to the rear end of the elongated shaft 21. When the - Transurethral insertion element 1 is mounted, the elongated shaft 21 and the elongate head 25 of the plunger part 5 are respectively received in the front section 16 and the rear section 18 of the hole 15 in the drug transport part 3. Referring now specifically to Figure 2, the liner 7 is provided with a hole 27 made of a size to releasably receive the elongated shaft 9 and collar 14 of the drug transport portion 3 until such time as the transurethral insertion element 1 will not be used. The elongated shaft 9 is thus kept free from damage and / or contamination. As will be described hereinafter in more detail, the liner 7 is further provided with a compartment 29 containing lubricant adapted in use to coat the outer surface of the elongated shaft 9 of the drug transport part 3 with lubricant before the insertion of the same in the urethra of the human body, male. The transurethral device assembly 10 preparatory to the use thereof will now be described with reference to Figures 2 to 5.

First, the transurethral insertion element 1 is assembled by inserting the plunger leg 5 at the open, rear end 19 of the axial hole 15 of the drug transport portion 3 into a withdrawal position in which the elongated head 25 is partially positioned in the rear section 18 of the hole 15 to protrude rearwardly from the open, rear end 19 and the elongated shaft 21 protrudes forward toward the front-section 16 of the axial hole 15; but the forward end 23 of the elongate shaft 21 is positioned rearwardly of the erectile dysfunction treatment drug transported in the front section 16 of the hole 15 in the drug transport portion 3. Second, the liner 7 and the transurethral insertion element 1 are assembled by inserting the elongated shaft 9 and the collar 14 of the drug transport part 3 into the hole 27 presented by the liner 7 until the front end of the digital handle 13 is butted with the back end of the liner 7. In the present embodiment, the entire elongated shaft 9 of the drug transport part 3 is received in the hole 27 of the liner 7. It will be appreciated by aq versed in the technique, however, that if the length of the elongate shaft 9 is greater than that portion of the shaft to be inserted into the urethra then it will be sufficient that at least the insertable length of the elongate shaft 9 is received in the bore 27 of the liner 7. As noted hereinabove, the liner 7 is provided with a compartment 29 containing lubricant. As can be seen by reference in Figure 2, a boundary wall 31 of the lubricant-containing compartment 29 also serves as a portion of the boundary wall of the bore 27 in the liner 7. The boundary, common wall 31 is constructed to be breakable or otherwise open in the application of a predetermined condition thereto, in this case a predetermined pressure which is applied to the outer surface of the liner 7 which when transmitted to the boundary wall 31 causes the common boundary wall 31 to be placed in an open disposition. Placing the common boundary wall 31 in the open arrangement results in the lubricant being able to be discharged from the compartment 29 into the hole 27 in the liner 7 and on the adjacent outer surface of the elongated shaft 9 of the part 3 of drug transport.

The type of lubricant contained in the compartment 29 will depend on the material having the outer surface of the insertable length of the elongate shaft 9 of part 3 of the drug transport component. Typically, the lubricant will be in the form of a gel, for example, cellulose gels. Where the outer surface of the insertable length of the elongate shaft 9 of the drug transport portion 3 is hydrophilic, however, water or saline could be used as a lubricant. If any lubricant is used, there should not be a destructive effect on the. effectiveness of erectile dysfunction treatment drug. The lubricant can be coated on the entire surface. outside of the elongated shaft 9 of the drug transport portion 3 by manipulation of the transurethral insertion element 1 relative to the liner 7. For this purpose, the collar 14 of the drug transport part 3 acts as a ring sealing to prevent leakage of the lubricant from the hole 27 of the liner 7. Alternatively, the compartment 29 containing the lubricant can be sized and juxtaposed in this way to the hole 27 in the liner 7, of. so that the discharge of the lubricant from the compartment 29 automatically covers the elongate shaft 9 of the drug transport part 3 attached by the hole 27. For example, the lubricant-containing compartment 29 could be formed to substantially join all the hole adjacent to the elongated tree 9 of drug transport part 3. While it is preferable that substantially the entire insertable length of the elongated shaft 9 of the drug transport part 3 is lubricated, the insertion of the elongated shaft 9 into the urethra of the male human body will still be more comfortable even if only a part of the insertable length is lubricated, for example, a front section of the elongated shaft 9. In use, the elongated shaft 9 of Part 3 of drug transport is first lubricated in the manner summarized in the preceding paragraphs. Then, the transurethral device 1 is held by the digital handle 13 and the removal of the liner 7 to reveal the elongated, lubricated shaft 9 of the drug transport part 3. The elongate shaft 9 of the drug transport part 3 is inserted into the male human body urethra and the plunger part 5 is pressed forward to a lowered position in which the leading end of the elongated head 25 is joins butt with the passage between the front and rear sections 16, 18 of the hole 15 in the drug transport part 3. The depression of the plunger portion 5 to the depressed position results in the free forward end 23 of the elongate shaft 21 of the plunger portion 5 pushing the erectile dysfunction treatment drug out of the forward open end 17 of the hole 15 in part 3 of drug transport in the urethra of the male human body, whereby in the case of impotence, it will give a sustainable penile erection. In Figures 6 to 10 of the drawings, a transurethral device 110 is shown to treat erectile dysfunction such as. impotence in a human, male body, alive according to a second embodiment of the present invention. Referring first to Figure 6, which shows the transurethral device 110 in an unmounted state, the transurethral device 110 corresponds to the transurethral device 10 described hereinabove with reference to Figures 1 to 5, since the transurethral device 110 comprises In addition, the transurethral insertion element 101 corresponds to the transurethral insertion element 1 of the transurethral device 10 described above with reference to FIGS. 1 to 5. The transurethral insertion element 101 of the transurethral device 110, therefore comprises first a drug transport part 103 having an elongated shaft 109 defining a free front end 111 for insertion into the urethra of the human male body, a digital handle 113 for maintaining the element 101-transurethral insert and a collar 114 that connects the front end of the handle di gland 113 to the rear end of the elongate handle 109. Additionally, as shown in Fig. 7; an axial bore 115 extends through the drug transport portion 103 between an open, forward end 117 at the front end 111 of the elongated shaft 109 and a rear open end 119 at the rear end of the digital handle 113, the bore 115 which is staggered in a front section 116 of a first width extending rearwardly a. through the elongate shaft 109 of the front open end 117 and a rear or rear section of a second width greater than the first width extending forwardly through the digital handle 113 from the open, rear end 119. The front section 116 of hole 115 is adapted in use to transport an erectile dysfunction treatment drug (not shown) to be transferred from hole 115 to the male human body urethra as will be described hereinafter. The transurethral insertion element 101 comprises secondly a plunger portion 105 for discharging the erectile dysfunction treatment drug from the transport portion 103. drug towards the urethra of the human, male body, the piston part 105 having an elongated shaft 121 having a free leading end 123 made of a size to be received in the front section 116 of the axial hole 115 in the part 103 of drug transport and an elongate head 125 connected to the rear end of the elongated shaft 121 and made of a size to be received in the rear section 118 of the axial hole 115 in the drug transport portion 103. Referring now to Figures 6 to 8, the liner 107 comprises a body portion 120 in which an axial bore 127 having an open end at the rear end of the body part 120 and an end tubular portion 130 is provided. open that has an outer, slightly conical surface profile that can be inserted into the hole 127 in the body part.120 of the liner 107. As can be seen in particular with reference to Figure 7, the front end of the part tubular 130 has an annular flange 140 directed radially inwardly, for the purpose of which it will become apparent later. The tubular part 130 is made of a compressible material and is made in dimensions relative to the hole 127 in the body part 120 of the liner 107 so that in the insertion of the tubular part 130 in the hole 127 in the part 120 of the body of the lining. 107, the tubular part 130 moves inwardly from an uncompressed state to a compressed state. The transurethral device assembly 110 will now be described with reference to Figures 7 to 10 of the drawings. First, the plunger portion 105 of the transurethral insertion element 101 is inserted forwardly into the axial bore 115 in the drug transport portion 103 into a withdrawal position in which the enlarged head 125 is partially positioned in the posterior section 118. of the hole 105 such that the rear end of the head 125 protrudes rearwardly from the rear open end 119 of the hole 115 and the elongated shaft 121 protrudes forward towards the front section 116 of the hole 115 such that the forward end 123 of the elongated shaft 121 it is placed backward of the erectile dysfunction treatment drug transported in the front section 116 of the hole 115. Secondly, the tubular part 130 of the liner 107 is inserted into the hole 127 in the body portion 120 of the liner 107. In third and finally, the transurethral insert element 101 is mounted to the liner 107 when the elongated shaft 109 and a front section of the collar 11 are inserted. 4 of the transport part 103 of drug 103 in the axial hole 127 in the part 120 of the lining body 107 with the elongated shaft 109 passing through the tubular part 130. Before the assembly of the transurethral insert element 101 and the lining 107 As mentioned above, the inner surface of the tubular part 130 is covered with lubricant. As shown in figure 7When the transurethral device 110 is mounted a lubricating layer 150 is interposed between the inner surface of the tubular part 130 of the liner 107 and the adjacent outer surface of the elongated shaft 109 of the drug transport part 103 of the transurethral insert element 101. The annular flange 140 directed radially inwardly presented at the front 'end of the tubular part 13Q makes contact with the outer surface of the elongate shaft 109 of the drug transport part 103 in the insertion thereof in the hole 127' in the part 120 of the body of the liner 107. The flange thus acts to inhibit the transfer of lubricant from the inner surface of the tubular portion 130 to the outer surface of that portion of the elongated shaft 109 of the drug transport portion 103 which passes to in front of the flange 140 in the insertion of the elongated shaft 109 of the drug transport part 103 in the hole 127 in the part 120 of the body of the liner 107. In effect, the inner surface and the flange 140 of the tubular part 130 define "end walls" of a lubricant container surrounding the exterior, adjacent surface of the elongate shaft '109 of the drug transport part 103 when the product is mounted; transurethral device 110. With this in mind, the circumferential, outer surface of the front section of the collar 114 of the drug transport portion 103 protruding into the hole 127 in the body part 120 of the liner 107 when the transurethral device 110 it mounts a closed fit with the adjacent boundary wall of the bore 127 and the forward end of the collar 114 and abuts a rear end of the tubular part 130. Therefore, the collar 114. also acts to contain the lubricant in the "lubricant container". When the transurethral device 110 is required to be worn by the human, male body, the human, male body removes the transurethral insertion element 101 from the liner 107 by holding the digital handle 113 and pulling the transurethral insert 101 back towards the liner. 107. Removal of the transurethral insertion element 101 from the liner 107 results in the lubricant being transferred from the inner surface of the tubular portion 130 of the liner 107 onto the outer surface of the elongated shaft 109 of the removed drug transport part 103. through the tubular part 130. Although the illustrated embodiment is to be constructed and arranged so that the entire outer surface of the elongate shaft 109 of the drug transport component 103 is removed through the tubular portion 130 that goes away to coat with the lubricant, it will be appreciated by those skilled in the art that it is not strictly necessary that the entire The exterior surface of the elongated shaft 109 of the drug transport portion 103 is coated with lubricant to facilitate its insertion into the urethra of the human, male body. For example, if the total length of the elongate shaft 109 of the drug transport part 103 is not required to be inserted into the urethra, then only the insertable length could be coated with the lubricant. Even then, the insertion will be facilitated provided that at least a portion of the insertable length of the elongate shaft 109 of the drug transport portion 103 is lubricated, for example, a front section of the shaft 109. Once the elongated shaft 109 of the drug transport part 103 has been inserted into the urethra of the human, male body, the plunger part 105 is pressed forwardly from the retracted position to a lowered position in which the leading end of the Elongate head 125 is butted with the step defining the transition between the front and rear sections 116, 118 of the hole 115 in the drug transport portion 103. The forward depression of the plunger portion 105 to the depressed position causes the forward end 123 of the elongated shaft 121 of the plunger portion 105 to discharge the erectile dysfunction treatment drug from the front section 116 of the hole 115 in the portion 103 of transport of drug in the urethra of the human body, male, so in the case of impotence will give a sustainable penile erection. Therefore, it can be seen that according to the present invention, there is provided a transurethral device for the treatment of erectile dysfunction in a human, male or male animal body, which has the advantage of including a means that facilitates the insertion of the insertable portion of the insertion element tra? suretral thereof into the urethra of the human, male or male animal body, without the need for (1) the human or animal body passing urine first, or (ii) introducing a step additional to lubricate the insertable portion of the transurethral insert that has a possible possibility of contamination of the insertable portion. It is to be understood, however, that the present invention is not limited to the transurethral devices used for drug delivery, but has broad application in the general field of transurethral devices.

Claims (29)

1. A transurethral device for treating erectile dysfunction in a human, male or living animal body comprising a transurethral insert for transporting an erectile dysfunction treatment agent, the transurethral insert comprising an elongated shaft with an end free front with at least one front section of the elongated shaft having the front end that is adapted for insertion into the urethra of a human, male or male animal body, and a means for transferring the erectile dysfunction treatment agent from the element of transurethral insertion to the urethra in the insertion of at least one front section of the elongated shaft in the urethra, characterized in that the transurethral device further comprises a lubricating means for lubricating the outer surface of at least a part of at least one front section of the elongated shaft to facilitate the insertion of at least a front section of the elongate shaft of the transurethral insertion element - in the urethra of the human or animal body.

2. A transurethral device according to claim 1, characterized in that it additionally comprises a liner for releasably lining at least one front section of the elongated shaft of the transurethral insert, characterized in that the lubricant means forms part of the liner.

3. A transurethral device according to claim 2, characterized in that the lubricating means is adapted to lubricate the outer surface of at least a portion of at least one front section of the elongated shaft when it is lined in the liner.

4. A transurethral device comprising a transurethral insert having an elongated shaft with a free front end with at least one front section of the elongated shaft having the front end adapted for insertion of the urethra of a human or animal body, and a liner for releasably lining at least one front section of the elongate shaft of the transurethral insert prior to insertion thereof into the urethra of the human or animal body, characterized in that the liner contains a lubricating means for lubricating the outer surface of the less a part of at least one front section of the elongate shaft, to facilitate the insertion of at least one front section of the elongate shaft of the transurethral insert into the urethra of the human or animal body.

5. A transurethral device according to claim 4, characterized in that the lubricating means is for lubricating the outer surface of at least a portion of at least one front section of the elongated shaft when it is lined in the liner.

6. A transurethral device according to any of claims 2 to 5, characterized in that the lubricating means comprises a lubricant container in the liner which under a predetermined condition is capable of transferring lubricant in the lubricant container on the outer surface of at least a portion of at least one front section of the elongate shaft of the transurethral insert.

7. A transurethral device according to claim 6, characterized in that the liner has a body in which a hole having an open end on an outer surface of the body is provided to releasably receive at least one front section of the elongated shaft of the body. transurethral insertion element, in which the lubricant container is a compartment of the lubricant in the "liner body having a boundary wall that is common with at least a portion of the boundary wall of the bore in the body of the liner, and The common boundary wall is capable of being placed in an open arrangement by applying a predetermined condition, whereby the lubricant in the lubricant compartment is capable of being discharged into the bore in the body of the liner and on the outer surface of the liner. at least a portion of at least one front section of the elongated shaft of the transurethral insertion element-when received in the hole.

8. A transurethral device according to claim 7, characterized in that the common, boundary wall is constructed to be breakable by applying a predetermined pressure to the outer surface of the liner body, to discharge the lubricant from the lubricant compartment into the hole and on the outer surface of at least a portion of at least one front section of the elongated shaft of the transurethral insert when it is received in the hole.

9. A transurethral device according to claim 7 or 8, characterized in that the lubricant compartment is dimensioned and arranged in this way in the body of the liner so that the common boundary wall encircles a part of at least one front section of the shaft elongate of the transurethral de-insertion element when received in the needle.

10. A transurethral device according to claim 9, characterized in that - the lubricant compartment is sized and arranged in the body of the liner so that the common boundary wall encircles at least one front section of the elongated shaft of the transurethral insert when the receives in the hole.

11. A transurethral device according to claim 6, characterized in that the liner has a body in which a hole having an open end on the outer surface of the body is provided to releasably receive at least one front section of the elongated shaft of the transurethral insert member, wherein the lubricant container is an open end tube having annular front and rear ends for placement in the hole in the body of the liner so that at least one front portion of at least one front section of the elongated shaft passes through or is received in, the tube having an inner surface for receiving lubricant and which is additionally of such dimensions that the lubricant is capable of being coated on the outer surface of at least one front part of the less a front section of the shaft elongated by the movement of at least one front section of the elongated shaft in the hole in relation to the tube.

12. A transurethral device according to claim 11, characterized in that the tube can be placed in the hole in the body of the liner so that at least one front part of at least one front section of the elongated shaft passes through and in which the annular forward end of the tube is provided with an annular flange, directed radially inwardly to form a sealing ring around the elongated shaft of the transurethral insertion element when it is received in the hole in the shaft of the shaft to prevent or substantially prevent the transfer of lubricant from the inner surface of the tube to the outer surface of at least one front part of at least one front section of the elongated shaft in the passage through the tube, whereby the lubricant can be transferred from the inner surface of the tube. tube to the outer surface of at least one front part of at least one front section of the shaft lengthens in the withdrawal - from at least one front section of the elongated tree from the hole.

13. A transurethral device according to claim 12, characterized in that at least one front part of at least one front section of the elongated shaft is a front portion of at least one front section of the elongated shaft, and that the rest of the less a front section of the elongated shaft can be discarded in the tube, whereby at least one front section is capable of being lubricated in the withdrawal of the elongated shaft from the hole.

14. A transurethral device according to claim 12 or 13, characterized in that the sealing ring • is a first sealing ring, in which the transurethral insertion element comprises a collar having a front end connected to a rear extremity of the shaft elongate, in which a front section of the collar prevents the front end of the collar from being received in the hole in the body of the liner in the insertion of the elongated shaft in the hole, in which the front section of the collar has a width that is greater than the width of the elongated shaft and is selected so that the outer, peripheral surface thereof is capable of forming a closed fit with the boundary wall adjacent to the bore when it is received therein and in that the end The front of the collar is able to join the stop with the annular end of the tube when the elongated shaft is inserted in the hole, to form a second sealing ring.

15. A transurethral device according to any of claims 11 to 14, characterized in that the tube is of a comprehensible material and has an outer surface profile that is not dimensioned relative to the hole so that the tube is displaceable from a Non-compressed state to a compressed state in the placement of the tube in the hole for an expansion fit of the tube in the hole.

16. A transurethral device according to claim 15, characterized in that the tube has a frustoconical surface-outer profile.

17. A liner for a transurethral insert having an elongated shaft with a free front end with at least one front section of the elongated shaft having the front end adapted for insertion into the urethra of a human or animal body, the liner having a body in which a hole having an open end on an outer surface of the body is provided to receive in shape. releasable at least one front section of the elongate shaft of the transurethral insert, characterized in that the liner is provided with a lubricant means for lubricating the outer surface of at least a portion of at least one. front section of the elongate shaft of the transurethral insertion element, to facilitate the insertion of at least one front section of the elongate shaft into the urethra of the human or animal body.

18. A liner according to claim 17, characterized in that the lubricating means is for lubricating the outer surface • of at least a portion of at least one front section of the elongated shaft of the transurethral insertion element when it is received - in the needle ero

19. A liner according to claim 17 or 18, characterized in that the lubricating means comprises a lubricant container in the liner which under a predetermined condition is capable of transferring lubricant in the lubricant container - on the outer surface of at least a portion of at least one front section of the elongate shaft of the transurethral insert when it is received in the hole in the body of the liner.

20. A liner according to claim 19, characterized in that the lubricant container is a lubricant compartment in the body of the liner having a boundary wall that is common with at least a portion of the boundary wall of the liner body bore. and in that the common boundary wall is capable of being placed in an open arrangement by the application of a predetermined condition, whereby the lubricant in the lubricant compartment is capable of being discharged into the bore in the body of the liner and on the surface of at least one part of at least one front section of the elongated shaft of the transurethral insert, when it is received in the hole.

21. A compliance liner with claim 20, characterized in that the common boundary wall is constructed to be breakable by the application of a predetermined pressure to the outer surface of the liner body to discharge the lubricant from the lubricant compartment into the bore and on the outer surface of at least a portion of at least one front section of the elongated shaft of the transurethral insertion element when it is received in the needle.

22. A liner according to claim 20 or 21, characterized in that the lubricant compartment is sized and arranged in the body of the liner so that the common boundary wall encircles at least a portion of at least one front section of the elongated shaft of the liner element. Transurethral insertion when the elongated tree is received in the hole.

23. A liner according to claim 22, characterized in that the lubricant compartment is sized and arranged in the body of the liner so that the common boundary wall encircles at least one front section of the elongated shaft of the transurethral insert when the shaft elongate is received in the hole.

24. A liner according to claim 19, characterized in that the lubricant container is. an open end tube having annular and front ends for placement in the hole in the body of the liner so that at least one front part of at least one front section of the elongated shaft passes through or is received in, the tube has an inner surface for receiving lubricant and is further of such dimensions that the lubricant is capable of being coated on the outer surface of at least one front part of at least one front section of the shaft elongated by the movement of the elongated shaft in the hole in relation to the tube.

25. A liner according to claim 24, characterized in that the tube can be placed in the hole in the body of the liner so that at least one front part of at least one front section of the elongated shaft passes through it and in that the annular forward end of the tube is provided with an annular flange directed radially inwardly to form a sealing ring around the elongate shaft of the transurethral insertion element when it is received in the hole in the body of the liner to substantially prevent or prevent the transfer of the lubricant from the inner surface of the tube to the outer surface of at least one front part of at least one front section of the elongated shaft in the passage through the tube, whereby the lubricant can be transferred from the inner surface of the tube to the outer surface of at least one front part of at least one front section of the elongated shaft in the ro of the elongated tree from the hole.

26. A liner according to claim 25, wherein at least one front part - of at least one front section of the elongated shaft is a front portion of at least one front section of the elongated shaft, characterized in that the dimensions of the bore and the The tube is selected so that the tube can be placed in the hole for the removal of the remainder of at least one front section in the tube, whereby at least one front section is capable of being lubricated in the removal of the elongated shaft from the pierce

27. A liner according to claim 25 or 26, wherein the transurethral insert comprises a collar having a front end which is connected to a rear end of the elongated shaft and which is provided by a front section of the collar having a width which is greater than the width of the elongated shaft, characterized in that the hole is adapted to receive the front section of the collar when the elongated shaft is received in the hole with the outer, peripheral surface of the front section of the collar forming a closed fit with the boundary wall, adjacent to the bore, and in which the tube is dimensioned to be placeable in the bore so that the front end of the collar abuts the annular rear or rear end of the tube to form an additional sealing ring .

28. A liner according to any of claims 24 to 27, characterized in that the tube is made of a compressible material and has an outer surface profile that is to be dimensioned relative to the hole so that the tube can be moved from a state not compressed to a compressed state in a location of the tube in the hole for the expansion fit of the tube in the hole.

29. A liner according to claim 28, characterized in that the tube has an outer surface profile, frustoconical.