FI104540B - Pre-filled disposable device for introducing a pharmacologically active substance into a body cavity of a patient, a process for making the device and a moulding apparatus for making the device - Google Patents

Description

104540

Pre-filled disposable device for delivering a pharmacologically active substance to a patient's body cavity, a method for making the device and a device for making a device - Förfylld anordning av engängstyp för att införa en pharmacologie Active substance and patient care 5 anordningen och en formapparat för

The present invention relates to a pre-filled disposable device for delivering a pharmacologically active substance, preferably in the form of a jelly, to the body cavity of a patient, for example a urethra comprising a reservoir for the substance and a tubular, tubular portion for insertion into the cavity. with a frangible cover, the interior of which is turned towards toward the inner side and outer side of the device the exterior side, the cover being arranged at a small distance from the opening and Pref-15 lisimmin form of a film, and the lid outer side being further provided with an integrally formed actuating arm, which protrudes from the opening device outside, with the operating arm disposed on the guide and prior to insertion of the tubular member into the body cavity to break and remove the lid, wherein the walls of the tubular member located outside the lid is further provided with rounded-crossed edges to avoid any discomfort to the patient when inserting the tubular portion into the body cavity.

The invention also relates to a method and a mold for making a device according to the invention; tamiseksi.

25 It is sometimes necessary to place pharmacologically active substances in the patient's body cavities, such as the urethra or rectum. An example of such is the application of a local anesthetic to the urethra prior to insertion of a catheter or similar urethra to avoid discomfort and pain experienced by the patient during such an operation. Local anesthesia can be given, for example, to the concerned ..:. with a tubular part inserted into the body cavity.

To prevent the patient from experiencing the same 11 "v discomfort when administering a local anesthetic as when inserting the actual catheter, very high requirements are set for the shape and smoothness of the tubular: '' ': 35 parts, especially at the tip.

These requirements are met if a reusable, durable, tubular part is made of durable material without an inner lid, 2 104540. However, such tubular part must be sterilized. before new use, which is one reason they are just not in use anymore.

In contrast, 5 pre-filled disposable devices are now widely used in hospitals and medical applications. These devices are normally delivered in a sterile state in the form of sealed containers, with a normally breakable lid in their dispensing opening. In a device of the kind mentioned above in the introduction, the dispensing opening may, of course, be the opening of the tubular part. When designing a puncture lid, account must be taken of the fact that there must be no sharp edges in the opening after removal of the puncture lid 10, since such sharp edges cause pain or other discomfort to the patient when inserted into a tubular portion of the body cavity.

One solution to this problem is disclosed in AT-B-386,123. This document discloses a device for inserting a lubricant into the urethra for the purpose of facilitating subsequent insertion of a catheter. The device consists of two parts, namely a bellows-shaped container and a funnel-shaped end ending in a tubular part. The free end of the tubular member is closed by a breakable lid. The container and the funnel-like part are welded together by ultrasound. The free end aperture of the tubular member has rounded edges and the breakable lid is located a short distance within the tubular member 20. The breakable cover is provided with a uniformly shaped drive rod protruding from the opening, and the breakable cover breaks when the rod is used.

iVt Publication CH-A-608 373 discloses another known device of the kind described above! device with a major difference in the area of use, which in this case is the administration of a pharmacologically active agent to the patient's rectum.

However, there are a few things to consider when designing and making a device like the one described above. When such a device is opened, the • • · · 'lid must always be clearly broken in a specified manner, leaving no protruding parts or loose fragments that may cause discomfort or injury to the patient. This means that it must meet very high uniformity requirements for the use of the arm, the breakable cover and the tubular portion, as well as the overall accuracy of these parts.

• The breakable lid must also break in the following clearly defined manner: '·'; regardless of how the operating arm is used.

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Depending on the quality of the body cavity where the tubular device is to be placed, high demands must be placed on the sterility of the tubular part, especially when the cavity in question is the urethra.

The present invention seeks to provide a device as described above that meets these high requirements. This is accomplished by providing the operating arm at its outer end with at least one support arm shaped as a single piece with the operating arm extending into the container, the support arm being connected to the container by a breakable joint, thereby providing a support bar to protect against damage to the cover for controlled movement, the operating arm is used to provide proper breakage of the breakable cover and acts as the operating arm of the operating arm, whereupon the operating arm together with the operating arm further defines and protects the tubular portion of the area considered sterile.

15 of the above-mentioned objects of the invention are further achieved by a method of making a device from a thermoplastic material by injection-molding in a mold, which comprises, the core having the general shape of the container interior and the tubular member, wherein the KEEMA is placed in a mold having the general appearance according to the operating rod and the support rod including wherein the thermoplastic material injecting the molten material into the mold from the portion of the mold that delimits the support bar and / or operating rod, whereby the molten material is forced to pass through the annular space which limits the breakable lid prior to forming the container and tubular member.

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The object of the invention is further achieved by making the device in an injection molding machine, characterized in that the boil comprises an adjusting rod located in a longitudinal I * V central hole of the boil, which extends through the tip of the boil, is fixed, and the adjusting rod is movable by means of micrometer threads, whereby · · · ·: the tip of the adjusting rod forms the surface which forms the inner surface of the breakable lid, and the micrometer threads are positioned outside the adjusting rod and twist the rod to adjust accurately.

• · * • · · • r t .:. The accompanying drawings illustrate the preferred embodiment of the invention and should be explored in the detailed description given below. It should be noted, 'y' 35 that the expressions included in this description, such as "upper", "lower", "down",: T: "horizontal", "vertical", etc., are only used to facilitate expressions in the mold * · «•« «· «4 104540 for making a device illustrated in a particular vertical direction and should not be construed as limiting.

For the sake of clarity, not all figures are reproduced by reference numeral.

5

Figure 1 is a longitudinal view of the device, Figure 2 illustrates the device rotated 90 degrees relative to Figure 1, Figure 3 is an enlarged, partially sectioned partial view of a tubular member illustrating a breakable lid and operating arm (detail B of Figure 1); Figure 3b is an enlarged view of detail A of Figure 1, Figure 3c illustrates zone II of Figure 3b, Figure 4 is a semi-sectional view of an injection press in a closed position with a mold for manufacturing a device according to the invention, Figure 5 is a vertical sectional view of Fig. 6 is a vertical sectional view similar to Fig. 4, but here the mold begins to open, Fig. 7 is an enlarged detail A of Fig. 6, illustrating portions of the mold forming a proximal breakable lid in the first step 20 of Fig. 7 Figure 8 is a vertical sectional view similar to Figure 6 but illustrating the next step of the mold opening,. . -. Fig. 9 is an enlarged detail B of Fig. 8 illustrating the lower arm I 'of the adjusting arm; heads, Fig. 10 is a vertical sectional view similar to Fig. 8 illustrating a mold opening • · ·: Next step, Fig. 11 is a vertical sectional view similar to Fig. 10 illustrating a mold opening * * \ * ·: Final step and ejecting the finished product , and Fig. 12 is a vertical section along the line ΧΠ-ΧΠ in Fig. 11.

30

As can be seen from Figures 1-3c, the device, in its primary embodiment, has the shape of an injection syringe having a cylindrical container 1. Cylinder 1 is open at one end and closed at one end by an integral tubular '/ part 2 with a breakable lid 3. The open end of cylinder 1 can be closed by a plunger'. '35 (not shown) and the contents of the cylinder can be injected by means of a plunger through a tubular member:' - ': 2 when the lid 3 has been broken, for which purpose the cylinder is fitted, such as · * 5 104540 with two handles -sheet 18 ', 18 ".

The bearing end of the cylindrical conical portion 2 has an inwardly directed flange or shoulder 5 which may be obliquely oriented with respect to the longitudinal axis of the cylinder so as to form a blunt angle with a narrow end away from the cylinder; said narrow end defining an annular opening concentric with The conical part 2 consists of a relatively short cylindrical part 5 which is connected to the shoulder 6 in said opening and which sinks into the tapered tapered part 7 of the tube 4 10. The free end of this tube 4 ends in an aperture 8 with a uniformly rounded shape. In this particular case, a portion of the edge 9 could be curved in approximately a semicircular shape, vert. Figure 3, wherein the semicircular shape is connected continuously to the inside and outside of the tube 4, respectively. The breakable lid 3 is disposed at the junction of the curved portion or edge 15 9 on the inside of the tube 4 or slightly inside this junction and has a relatively thin film shape. The drive arm 10 made integral with the diaphragm extends concentricly past the edge 9 with the tube 4 from the center of the diaphragm. The non-supporting side of the diaphragm may be provided with a hemispherical portion 17 concentric with the operating arm. The main function of this hemispherical portion 17 is to collect the air bubbles provided with the plastic raw material when injected to prevent such air bubbles from remaining in the membrane. or the handle near the membrane, which. . ·, Could cause cracking of the shaft rather than the film.

Although the thickness of the operating arm, as depicted in Fig. 3, is chosen to be smaller than the inside diameter of the tube, which results in a more pronounced dimension of the membrane 3, the operating arm can, of course, be extended from the joint to the diaphragm by tapering * V · or otherwise. Fig. 3a illustrates how the stem 10 terminates in a conical portion 21 · · · · 'attached to diaphragm 3. A suitable base angle α for the conical portion 21 may be 42 degrees.

This arm extension can also be made such that the extended arm portion is in direct contact with the inside of the tube 4 along its circumferentially shaped portion, wherein said strip-like portion has a width equal to r i '*; · 35 substantially the thickness of the film. This widened portion may have a hemispherical shape and be complementary to the semicircular portion 17, thereby substantially forming a spherical joint at the end of the tube 4, which is connected to the inside of the tube in a strip-like, keystone region through the opening in the head. However, for the manufacture of the device, the mold device described below preferably has the film having a width approximately the same as the film thickness, whether the expanded portion is spherical or not.

5 The end 10 of the operating arm is provided with a transverse piece 15 from which the two support arms 1Γ, 11 "protrude rearwardly towards the container 1. The center lines of the two support arms 1Γ, 11" and the operating arm 10 are disposed in a common plane. Each arm is fixed to the cylindrical portion of the tubular member May 2 frangible joints 12 'and 10, 12'. Breakable joints size is selected so that the support arms, the outer half of the Samal la alignment with the cylinder 1 to the outside. Brittle joint 12 ', 12' each comprise a portion 13 'and respectively 13 "formed by a substantially frustoconical cone made integral with the respective support arm such that the bottom of the truncated cone is connected to the support arm. The tip of the truncated cone is connected to a cylindrical portion 15 5 by a narrow bridge 22', 22" in the shape of a truncated pyramid. The parts 13 ', 13 "may, of course, have a hemispherical shape or some other tapered shape.

It is preferred that the arms (1Γ, 11 ″) have a width greater than the outer diameter of the tube 4 at least at the point adjacent the tube 4.

The transverse member 15 is provided with a strip 14 for operating the operating arm. The outer end of the operating arm is provided with a protective, preferably circular plate 16 which is' perpendicular to the operating arm. This optional shield is marked with dashed lines in Figure 2.

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In one preferred embodiment, the support arms 1, 11 "are provided with edges" or cut-out portions 19 ', 19 ", 20', 20" which are disposed on the ends of the strip 14 and the tube 4. Between the circumferential plane of the ribs and at the outermost end of tip 9. These ridges act as hinges when the lid to be broken is bent by bending the tab 14: T sideways in the same direction as the axis of the transverse piece 15. This results in the membrane 3 breaks in a particularly controlled manner. The membrane begins to rupture from that portion of the membrane which is furthest in the direction opposite to the bending direction of the strip, and the rupture proceeds uninterruptedly around both sides of the rod 10.

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'·; · '35 heirs. In the final step, the rod 10 rotates over the rounded edge 9 of the opening 8, which results in that the edge of the rod 10 is still attached to the membrane 3, whereby the membrane moves more or less perpendicular to the wall of the opening 8, thus reducing the risk of pulling out of the skin through opening 8.

The devices are usually shipped in sterile condition. in "film packages" which protect 5 devices to some extent during transport and storage. However, the user must handle the device before use when unpacking the device and between actual use of the device. During this time, there is a high risk that the tip of the drive arm will be exposed to some force that can easily lead to the fracture of the lid, even with a small force, because the lever lever force is relatively high and the lid 10 needs to be relatively thin way. However, the arms act against all such forces and thus protect the cover from unintentional fracture during handling or operation.

15 The fact that the support arms, the outer sides are aligned with the cylinder portion of the outer side means that said bars and said cylinder brittle joints between are to some extent protected against accidental breakage, as this design minimizes the risk that the joints are exposed to unwanted, they break down to sufficient forces. Such forces may occur, for example, when the bars positioned adjacent the connections 20 are gripped during removal from the film package. The device according to the invention can be opened in a number of different ways, all of which guarantee the correct opening of the brittle lid. Thus, the device can be opened by gently hitting. ·. ·. the tip of the arm, i.e.. actually a transverse bar, more or less perpendicular to a surface in the longitudinal direction of the device. Even if the direction of motion is different '. "I 25 perpendicular, the fact that the tip is laterally stabilized by the support rods gives the drive arm a movement which is essentially longitudinal, with the result that forces of approximately the same magnitude are transmitted simultaneously. around the drive arm to the joint between the cover and the rod, which means that the v · * cover breaks in a clear, well-defined manner around its entire circumference.

30: T: Other ways to open the device include, for example, rotating the operating arm about its longitudinal axis or tilting the operating arm sideways by means of a tab attached to the crosspiece. In either case, the support arms operate as described above.

· 35 · A: Although it is in principle possible to touch the tube and the adjacent conical portion, the support rods still define the area that remains sterile 104540 8, even though the rods together with the cross piece provide a clearly perceptible indication of the area considered sterile. . Naturally, accidental contact of the tube tip would be more difficult if the crosspiece is provided with a protective plate as mentioned earlier.

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Providing at least one portion of the support rods and / or the operating arm with a diameter larger than the diameter of the tube or providing a shielding plate protects the sterility of the tube 4 and its adjacent conical portion 7 even if the device is unintentionally placed on a table or the like.

10

The device is, as mentioned above, made of a thermoplastic material. The primary substances are polyolefins and in particular homopolymer of polypropylene.

Some of the above-mentioned features are important when the device is manufactured by an injection molding mold according to the invention, as claimed in the appended claims and illustrated in Figures 4-11. These figures also illustrate the method used primarily, but not exclusively, in the manufacture of the device with the above injection molding mold.

As shown in Figure 20, in particular from Figures 10 and 11 can be seen, the device comprises a mold for producing four main parts, namely a first block 101 which supports keemaa shaping the inside of the device, ulostyöntäjäosan 103, the second block. ·. ·. 104, which comprises a mold for molding the outside of the device including the operating · • '_ arm and the support arms, and a third block 105 through which the molten plastic material injected J'; 25 is molded. The main portions are arranged sequentially along this centerline · γ scale, represented by a dashed line · · * γ; 106, and the parts are movable relative to one another along this line. The horizontal section of the mold would be substantially square in shape and the main sections guided therein

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v; in movement relative to one another by four guides passing parallel to the center line 106 through holes located in the corners of the square. The figures show: T: only two of these guides are illustrated, a bar 107 attached to a first block 101 and extending through holes 108j and 109 in said ejector section 103, respectively, to said second section 104, each of which is: provided with sleeves 108 ' and 109 '. The second rod 110 is fixed to the third block 105 of the third block 'γ' 35 and passes through the hole 111 in the second block 104 containing the sleeve 111 '.

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The third block 105 comprises an upper portion 113 and a lower portion 114, wherein the injection nozzle 112 is concentric with the center line 106 passing through both of these portions and opens into the mold when the injection nozzle is in its closed state. As illustrated in Fig. 4, two guides 106 are disposed obliquely with respect to the centerline, each extending downwardly and outwardly through respective holes 115 in said lower portion 114, and engaging with said lower portion. The guide pins extend below the lower part 114. However, only one of these controls is illustrated in the figures.

The guide pins 116 cooperate with the holes 118 in the first opposed mold portion 117 slidably inwardly and outwardly on a horizontal surface perpendicular to said center line 106. These mold portions 117 are supported on the second block 104 and provided with mold surfaces, the shape of the tubular part of the apparatus two outer side 15, including a drive arm 10, the support arms 11 and the strip 14, with the exception of the pipe end of the rounded edges and immediately adjacent to the area.

Each mold portion 117 also comprises a second mold portion 119 slidably disposed in a corresponding hole or opening 20 120 defined in said mold portion 117. The hole 120 is inclined upwardly toward centerline 106. The mold portion 119 is further tensioned toward centerline 106 by a helical spring 122A surrounding said mold portion 119. a shaft portion 122 disposed in a hole, whereby on one hand it lies against the shoulder 123 on said portion 119 and on the other hand rests against the shoulder 123; flange 124. made in the bore 120. Arm 122 extends past said flange 124 and is provided with a stopper 121 located on the opposite side of the flange. When the mold • · *; ·· / is closed, there is a small clearance between the stopper and the flange.

The mold section 119 is still provided with a semi-circular, horizontal, vertical

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: with a pointed tab 125 defining a downwardly opening semicircular groove 30. The groove is semi-circular in cross-section and forms the mold surface forming the edge 9 of the device. Lips 125 also define a vertically oriented cylindrical bore centrally disposed with respect to the semicircular grooves. The lip 125 still has a flat, horizontal mold surface that forms the brittle lid outer surface. Lip 125 has a concave central hole '; · '35 to define a skewed surface for forming an extended portion of the operating arm.

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The second block also includes a mold part in the form of a third cylindrical bore 126 which is concentric with center line 106 and which, when closed, fuses with other mold parts of the second block.

The first block 101 carries a strain 102 consisting of three main portions, namely an outer cylindrical sleeve 127 which forms the main body of the mold and is best connected fixedly to said first block, an adjustment rod 129 centrally disposed in a central longitudinal bore of said outer sleeve 127; wherein said adjusting rod extends through the tip of the molded annular sleeve 127 and forms the inner surface of the mold 4 and the brittle lid 3 of the tube 4, and finally the supporting and guiding sleeve 128. The adjusting rod is pivotally connected to the inner sleeve and outer sleeve 129 provided with micrometer threads 131 associated with corresponding inner micrometer threads 13Γ, which are disposed in the inner hole 15 of the outer sleeve 127 just adjacent the upper end of the inner sleeve 128. The inner sleeve and the adjusting rod extend all the way through the first block to its lower part.

As best seen in Figure 9, the lower end of the adjusting rod is provided with a fixedly mounted, gear wheel 132 which is in contact with a horizontally disposed and rotatably worm worm screw 133 whose arm 134 extends beyond the block 101 and allows rotation of the screws. and, as a result, the gear and adjusting rod. The gear and helical screw are disposed in a recess on the underside of the first block 101 and are covered by suitable screws 136 on the block 13/25 mounted on the block 135. The adjusting rod is secured to said plate 135 by a screw 137 and is Γν tensioned against the plate 135 with suitable springs, such as Belle Wille spring washers located between the screw head and the plate. In this way, the position of the upper end of the adjusting rod * · '· can be accurately positioned and the thickness of the breakable lid or film 3 is precisely adjusted between the end of the adjusting rod and the tongue 125 of the mold surface. Because the micrometer threads are positioned near the top of the adjusting rod, most of the thermal: T: expansion of the adjusting rod is received by Belleville spring washers and has only a negligible effect on the cover 3 thickness (due to the short length of the adjusting rod above the threads). In this way, the thickness of the lid 3 can be adjusted during casting so that all devices meet the same requirements in this respect. This is a particularly important feature if multiple molds are installed together: Y; into cohesive units or blocks as is customary in practice. If a single form f i t f «·

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u 104540 machines tend to deviate from the norm, this special mold can be individually adjusted without the need to disassemble the entire mold system.

The ejector section 103 consists essentially of a plate or plate having a hole or opening 5 139 through which the collar 102 extends. The portion of the hem which extends through the bore 139 has an upwardly tapered conical shape, the bore 139 having a corresponding shape. At the top, the diameter of the hole corresponds to the diameter of the core.

The underside of the second block rests against the ejector portion 102 and is provided with two recesses 14Γ141 ″ 141 "connected to the main cavity of the mold or a cylindrical bore 126. These recesses form the mold cavities of the retaining tabs 18 '18 ″ with the top surface of the ejector portion 103. The ejector portion 103 may be moved relative to the first block 101 by two ejector rods 142 ', 142 "projecting from two holes 143 (only one of which is illustrated) parallel to centerline 106 and projecting downwardly past the underside of first block 101 where they are interconnected by user block 144.

The mold main parts are also joined by two latches or hooks that adjust the movement of the main parts when the mold is opened.

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The first elongated hook portion 145 ', 145 "is fixedly secured to the outside of the third block 105 and extends downwardly past the second block 104 parallel to the center line 106 with the device in the closed position. The hook portion is guided and held together against the second block. the outside of block 104 by an elongate, horizontal plane 146 secured to the second block by suitable screws 147. having intermediate plates. The first hook portions are provided with cam surfaces 147. Their lower ends are also provided with stop means 150 on the plate 146. and a second block for engaging the downwardly facing surface.

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The second hook portions 151 are firmly secured to the first block 101 and extend

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the second hook members 151 are held:, · ': and also guided against the second block 194 by said plate 146. The second hook members

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is further provided with a horizontal shoulder 152 which may be connected to a latch 154 movable in its locking position by a spring 154 movable in its horizontal plane 35. The latch 153 is. · '··, further provided with an actuator 155 which can be operated on a cam surface 148 and

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Thus, the latch 153 moves the latch 153 out of contact with said shoulder 152 by the actuator of said spring 154 releasing the second hook portions 151.

Although only one pair of hooks is illustrated, this embodiment is provided with two pairs of hooks as shown in Figures 5 and 12.

The mold also includes cooling tubes or passages in blocks 101 and 104 as well as in chemistry 102 for maintaining the mold at a temperature below the solidification temperature of the thermoplastic material to allow the extruded device to cure rapidly but high enough to allow the molten material to fill all mold cavities without adverse effects on the final product.

Figures 4 and 5 illustrate a mold, as detailed above, in a closed state immediately after injection of molten thermoplastic material.

15

Figures 6 and 7 illustrate the first step of opening the mold after the device has cured. At this point, the third block 105 containing the injection nozzle is moved slightly upward relative to the other blocks. As a result, the mold sections 117 ', 117 "in the second block move slightly outwardly under the influence of the obliquely directed guide bars 116', 116" in the obliquely oriented bores 118 ', 118 ". However, the other mold sections 119', 119" do not move outwardly ', 117 "as they are pushed inward by the action of springs 122A', 122A".

Instead, the outward movement of the mold members 117 ', 117 "forces the other mold members 119', I, · 119" to move vertically upwards, resulting in the lips 125 ', 125 ": 25 moving vertically up until they release the edge of the device 9. The fact that the lips 125 ', 125 "are provided with oblique faces facilitates the removal of the device from the mold and minimizes the risk of damage to the edge of the lid and tube.

The free play between said stopper 121 and said flange 124 is dimensioned such that stopper 121 engages with flange 124 at the moment lips 125 are released from t · edge 9. This results in the opening of the mold shown in Fig. 8; in this step, the mold members 119 ', 119 "move horizontally outwardly together

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: ...:. The mold parts 117 'and with such release, 117' of the tube 4 and the adjacent external side «35 in a conically tapered portion 7..

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104540 This movement, and thus also the toer step of opening the mold, ends when the stop means 150 meet the respective plates 146 and the said underside of the second block 104. Prior to this, the cam surface 148 engages the actuator 155, thereby releasing the second hook portions 151. In the third step 5 of opening the mold, the second and third blocks 104 and 105 then move together away from the first block 101 and pushing means 103. In this third step, released from the mold.

In the final stages illustrated in Figures 11 and 12, the ejection means 103 are moved upwardly by the ejection pins 142 '142 "with respect to the first block 101. In this way, the finished device is pushed out of the chemical 102 and finally released from the mold.

The device differs from the extended part of the drive rod by two additional features of the device which are important when the device is made in the mold described above. Both are mainly related to the fact that the brew is protruding from the first block.

The first of these features is the provision of two symmetrically arranged support rods with breakable joints. The mold operates at relatively high pressures when the molten material is injected into the mold cavity. Although the bulk of the molten material is fed through the annular space defining the brittle lid, it is transmitted. , injection pressure also to the inner part of the mold cavity through relatively small channels, which define the brittle joint between the support bar and the container. This pressure exerts a relatively high force and thus causes it to bend, since these forces are near the free end of the protruding boil. Such deflection is not desirable, since the brittle lid or membrane thickness of the device which is · '. * ·: intended for use in the urethra is approximately one-tenth of a millimeter, and: T: attempting to break the lid with the operating rod would in this case result in the tube wall breaking instead of a brittle lid, resulting in just such sharp angles that are unacceptable ' Equipped with two symmetrically positioned with the opposite joint::: produces two opposing forces acting inside the mold cavity, which effectively:.

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There may still be minor deflections or deviations in the position of the boiler. Such deviations can be difficult to avoid, again due largely to the fact that the boil is long and freely supported. Another feature compensates for this and consists in that the tube has an inside dimension that is larger than the wall at the open end of the tube towards the inside of the cover device, i.e.. that the diameter formed by the bandage on this part of the tube is larger than the outer diameter of the lip. This 5 feature is best seen in Figure 7. As a result, small deviations of the tip position relative to the apex are compensated for in the aspect of providing a flawless brittle cover around the entire circumference of the drive rod.

As discussed above, an important feature of the device manufacturing process is that the bulk of the molten material is pushed into the mold through the relatively narrow slot which defines the brittle cap. In the above-described mold device, the mold cavities are first filled to form the drive rod and support rods, and a small amount of molten material is pressed through the narrow passages defining the brittle joints in those parts of the mold cavities that mold the cylinder and tubular members. Because the molten material then flows continuously past the fragile lid of the device and the locations of adjacent portions, the final product ensures uniformity of the substance in these portions and eliminates the risk of encountering two streams with a lower surface heat and forming an incomplete bond therein. leads to breakage or breakage of the device at a location other than a brittle cover.

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•; ' The molten material then flows through the portions of the mold cavity defining the tube

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; - · · and tapered portion and insulates the material bulge that protrudes from the narrow channels defining the brittle joints. Thus, the bulges are attached «·: firmly to the main body of the device and the brittle joints become smooth and of the same good quality as mentioned in the preceding paragraph in the case of a brittle: lid.

30 As discussed above, the mold has been cooled to allow the size of the shaped device. · *: ·. watering within a reasonable time. If polypropylene is used, the molten material will preferably have a temperature of about 230 ° C to about 250 ° C, maintaining the mold temperature at 35 to 40 ° C. Naturally, this large temperature difference will have some effect on the flow properties of the molten material, which is undesirable in the narrow molded parts around the brittle lid, as it may affect the desired uniformity of these parts. Therefore, the process according to the invention advantageously contributes to the fact that it is very difficult to cool the tip of the boil and other parts of the mold cavity as effectively as the other parts of the mold and consequently allow these parts to heat up from the hot molten flow. As a result, the material flows more readily into these portions, and in particular through a particularly narrow space defining the brittle lid, by which means the mold cavities in the vicinity thereof are particularly well filled and the uniformity of the material is further improved. Relatively high temperatures will re-defrost so-called "cold joints", if any.

Because of the low mass of the relevant parts, these parts rapidly cool to the temperature of the main body of the mold 10 as soon as the flow of molten hot material is stopped.

In this way, the method of the invention eliminates the need for a complicated and expensive cooling arrangement at and around the tip of the boil.

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Claims (15)

A pre-filled disposable device for introducing a pharmacologically active substance, preferably in the form of a gel, into a body cavity of a patient, for example in the urethra, comprising a container (1) for the substance and a tubular portion (2) which stays in communication with the container (1) and is intended for insertion into said sanctity, the tubular member (2) terminating in an opening (8) having a breakable closure (3) having an inner face of the device and a the outside facing the environment, the closure (3) being arranged at a small distance inside the opening (8) and preferably in the form of a membrane, the exterior of the closure (3) being further provided with an integrally formed control rod (10) which protrudes through the opening (8) of the device environment, the actuating rod (10) being arranged to break and remove the closure after the actuation and prior to insertion of the tubular part (2) into the body cavity. further, the portions of the walls of the tubular portion (2) located on the outside of the closure are provided with rounded edges (9) to alleviate any discomfort the patient may experience upon insertion of the tubular portion (2). ) in the body cavity, characterized in that the actuating rod (10) is provided at its outer end with at least one supporting rod (1Γ, 11 ") which is integrally formed with the actuating rod (10) and which extends to the container (1), wherein the supporting bar (1Γ, 11 ") is connected to the container (1) by a breakable connection (12 '), whereby the supporting bar (1Γ, 11") acts as a safety device against unintentional breaking of the closure (3): V and as a guide for controlled movement of the actuating rod (10) during actuation in ti; i · to ensure correct breaking of the breakable closure (3) and to: act as a handle for actuating the actuating rod (1 0), wherein the supporting rod (1Γ, 11 ") in cooperation with the actuating rod (10) also delimits and • · · ·: protects an area of the tubular member (2) to be sterile poured . • * · • · «• i i · · 2. Device according to claim 1, characterized in that the actuating rod (10) is provided with two supporting rods (1Γ, 11 ") which are arranged on opposite sides if the rod (10) is inserted in a common pane through the longitudinal center line of the overhang (10) 9 9 9 9 9 Device according to any one of claims 1 or 2, characterized in that the tubular part (2) at the joint against the container (1) has a conical tapered part. (7) terminating in a tube (4) intended for insertion into the body cavity, the conical tapered portion (7) ensuring a fluid-tight fit between the tubular portion (2) and the body cavity opening, said opening (8) forming the outer end of the tube (4) has the breakable closure (3). Device according to any one of claims 1-3, characterized in that the tubular part (2) extends from a part offset from the container (1) defining a shoulder (6). Device according to claim 4, characterized in that the supporting rod (s) (1Γ, 11 ") are connected (respectively connected) to the container (1) on the annular shoulder (6). Apparatus according to claim 4, characterized in that a cylindrical part (5), which protrudes in the tapered part (7), is connected to the annular shoulder (6), the supporting rod (s) (1Γ, 11 "). ) are connected (respectively connected) to the cylindrical portion (5). Device according to any one of the preceding claims, characterized in that the container (1) is shaped as a cylinder, one end of which is closed by the tubular part (2) and the other end of which is open and closable by means of a piston 20 by means of of which the contents of the container (1) can be discharged through the opening (8) in the tubular part (2) after breaking and removing the breakable closure (3). * ·? 8. Device according to any of the preceding claims, characterized in that the actuating rod (10) is provided with a disc-shaped element (16), which is arranged perpendicular to the longitudinal extension of the actuating rod (10) in order that further Protect and demarcate the area to be sterilized. • · »« i * · · • I Device according to any of the preceding claims, characterized in that the connection between the supporting rod (1Γ, 11 ") and the cylinder (1) has a substantially semi-spherical, integral with the supporting rod (1Γ, 11"). · · · Shape (13 ', 13 "), the flat side of which is attached to the supporting bar, the real breakable connection being formed by a one-piece, short r · · v: bridge between it the crown of the spherical mold (13 ', 13 ") and the container (1). • 4 I I · »·,> ··. 35 Device according to any of the preceding claims, characterized in that the actuator (10) at the joint between the rod (10) and the closure (3) is extended to a width which is only slightly smaller than the tubular part (2). inner width at the position of the closure (3), the closure (3) thus only being in the form of a narrow circumferential band around the circumference of the extended portion of the supporting rod. Device according to any of the preceding claims, characterized in that the supporting rods (1Γ, 11 ") are provided with notches or recesses (19 ', 19"), which are arranged between the crosspiece (15) and a tab which touches the circumference of the the tip of the tube (4) at the outermost part of the edge (9), which constitute articulating means when the crosspiece (15) and the tongue (14) are bent laterally in a direction perpendicular to the tab of the tongue (14). 10 12. A method of manufacturing an apparatus according to any preceding claim starting from a thermoplastic material by injection molding the device into a forming apparatus comprising a core, the general configuration of which corresponds to the inside of the container and the tubular part, wherein the core is arranged in a shape, the general shape of which corresponds to the outside of the device including the actuating rod and the supporting rod, characterized in that the thermoplastic material is injected into the mold in the mold at the part of the mold defining the supporting rod and / or the operating rod, whereby the molten material is forced pass mainly through the annular space defining in the mold the breakable closure before the container and tubular part are formed. • · • · «« * 13. Forming apparatus for manufacturing a device according to any of the patent claims; ; ven 1-11, comprising a mold cavity containing a core (102), wherein the mold cavity defines the outside of the device and the core defines the inside of the container ··! ί (1) and the tubular member (7), wherein the cam (102) and the mold hollow are * longitudinally movable relative to each other for opening of the mold hollow and 14 for the ejection of the device, characterized in that the cam (102) or parts thereof also are longitudinally movable relative to the mold hollow by micrometer adjustment threads (131), whereby the thickness of the breakable closure (3) which is delimited between the tip of the core (102) and the mold hollow the tubular part,. end accurately adjustable before and during the manufacturing process. «*« • t «r 14. Forming apparatus according to claim 13, characterized in that the core (102): '' ': comprises a setting bar (129) which is located in a central, longitudinal heel of the core (102) and extends through the tip of the core (102), the core is fixed and the adjusting rod (129) is movable by the micrometer threads (131), the tip of the jetting rod (129) forms the inside (3) axis and the micrometer threads (131) are arranged 29) outside and on the inside of the heel. in the core (102), whereby the flushing of the tip of the adjusting rod (129) is made possible by the rotation of the calibration apparatus according to claim 14, characterized in that the micrometer thread (31) is arranged near the tip of the adjusting rod (129). * · R · i »* '· · f · · t I ··' · *« · * / · '= · / ·· * «« • · i * ·· / f * - r f • · t