Abstract
Provided is an enema nozzle for an enema device. Said enema nozzle includes an insertion body with a flexible insertion tip. The flexible insertion tip is located at the insertion end of the insertion body, and said tip will flex when it abuts intestinal tissue. This will provide a smoother insertion, which effectively will alleviate the physical discomfort and pain that a patient may expire during insertion of an enema nozzle.
Claims
1-28. (canceled)
29. An enema nozzle for an enema device and wherein said enema nozzle comprises an insertion and a flexible insertion tip; and wherein the flexible insertion tip has a shore A hardness from 30 to 80 and the insertion body has a shore A hardness above 100.
30. The enema nozzle according to claim 29, wherein the flexibility of the flexible insertion tip is different from the flexibility of the insertion body.
31. The enema nozzle according to claim 29, wherein the flexible insertion tip has a shore A hardness from 40 to 70, and even more preferred about 60.
32. The enema nozzle according to claim 29, wherein the insertion body has a shore A hardness above 150 and even more preferred above 250.
33. The enema nozzle according to claim 29, wherein the flexibility of the insertion tip is constant over the longitudinal length of said flexible insertion tip.
34. The enema nozzle according to claim 29, wherein the flexibility of the insertion tip is different along the longitudinal length (X) of said tip.
35. The enema nozzle according to claim 29, wherein the enema nozzle comprises at least one flow channel having a delivery opening for delivering/expelling the enema, and wherein said at least one delivery opening is placed at the distal end of the insertion body, below the flexible insertion tip.
36. The enema nozzle according to claim 29, wherein the enema nozzle comprises at least one flow channel having a delivery opening for delivering/expelling the enema, and wherein said at least one delivery opening is placed at the distal end of the flexible insertion tip.
37. The enema nozzle according to claim 29, wherein the flexibility of the insertion tip is provided by mechanically and/or chemically altering at least a part of said insertion tip.
38. The enema nozzle according to claim 29, wherein the flexible insertion tip is a hollow construction.
39. The enema nozzle according to claim 37, wherein the chemical treatment comprises adding one or more plasticizers to the insertion tip.
40. The enema nozzle according to claim 29, wherein the flexibly insertion tip comprises a number of elongated grooves in an exterior wall of said insertion tip.
41. The enema nozzle according to claim 40, wherein the grooves are spaced equidistant from each other along a longitudinal length (X) of the flexible insertion tip.
42. The enema nozzle according to claim 40, wherein the grooves are concentrated at one or more areas of said flexible insertion tip.
43. The enema nozzle according to claim 29, wherein the flexible insertion tip comprises a head portion and a stem portion, and wherein said stem portion has a smaller diameter than the insertion body and/or the head portion.
44. The enema nozzle according to claim 43, wherein the stem portion has a diameter which is between 0.20 and 0.5 times the diameter of the head portion and/or the insertion body.
45. The enema nozzle according to claim 29, wherein the flexible insertion tip comprises a rounded head region, the diameter (D) of which is substantially the same or at least slightly greater than the diameter (d) of the insertion body.
46. The enema nozzle according to claim 29, wherein the flexible insertion tip and insertion body are made of the same material.
47. The enema nozzle according to claim 46, wherein the flexible insertion tip and insertion body are provided as an integrated unit.
48. The enema nozzle according to claim 29, wherein the flexible insertion tip is made of a material which is different from the material of the insertion body.
49. The enema nozzle according to claim 48, wherein the flexible insertion tip is a separate part connected to the insertion body by an attachment means.
50. The enema nozzle according to claim 29, the flexible insertion tip is divided into a dome and a lower section connected by an elastic attachment unit.
51. The enema nozzle according to claim 50, wherein the elastic attachment unit comprise an elastic string that at one end is integrated with a top section of the dome, and at the other end a grid that is connected to the lower section.
52. An enema device comprising an enema nozzle according to claim 29.
53. A process for manufacturing an enema nozzle according to claim 29 wherein said enema nozzle is manufactured in a single injection molding procedure by 2K injection molding or 3K injection molding.
54. A process according to claim 53, wherein the 2K or 3K single injection molding procedure combines a polymer having intrinsic hydrophilic properties with one or two elastomeric polymer(s), respectively.
55. A process according to claim 54, wherein the polymer having intrinsic hydrophilic properties is used to form at least the flexible insertion tip and optionally at least the part of the insertion body intended for being inserted into the body opening.
56. A process according to claim 53, wherein a hydrophilic coating is applied to the flexible insertion tip, and optionally at least the part of the insertion body intended for being inserted into the body opening, during the single injection molding procedure.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0065] FIG. 1 shows a perspective view of a first embodiment of an enema nozzle according to the present invention,
[0066] FIG. 2 shows a perspective view of a second embodiment of an enema nozzle according to the present invention,
[0067] FIG. 3 shows a perspective view of a third embodiment of an enema nozzle according to the present invention,
[0068] FIG. 4 shows a perspective view of a fourth embodiment of an enema nozzle according to the present invention,
[0069] FIG. 5 shows a perspective view of a fifth embodiment of an enema nozzle according to the present invention,
[0070] FIG. 6 shows a perspective view of a sixth embodiment of an enema nozzle according to the present invention,
[0071] FIG. 7 shows a perspective view of a seventh embodiment of an enema nozzle according to the present invention,
[0072] FIG. 8 shows a perspective view of an eight embodiment of an enema nozzle according to the present invention,
[0073] FIG. 8a shows a cross sectional view of the distal end of the enema nozzle shown in FIG. 9,
[0074] FIG. 9 shows a perspective view of a ninth embodiment of an enema nozzle according to the present invention,
[0075] FIG. 9a shows a cross sectional view of the distal end of the enema nozzle shown in FIG. 9,
[0076] FIG. 10a-c show different perspectives of a tenth embodiment of an enema nozzle according to the present invention, and
[0077] FIG. 11 shows a perspective view of an enema device comprising the enema nozzle shown in FIG. 7.
DETAILED DESCRIPTION OF THE INVENTION
[0078] The invention is described below with the assumption that the enema nozzle is provided as an integrated unit, preferably made of the same material. This assumption is not to be construed as limiting, as the flexible insertion tip and insertion body in the embodiments described below also could be made as separate units/parts, e.g., of different materials, and wherein the separate units/parts are connected to each other by conventional means, e.g., welding, heat etc.
[0079] FIG. 1 is a schematic view of a first embodiment of the enema nozzle la according to the invention. Said nozzle la consists basically of an insertion body 2 and a flexible insertion tip 3a arranged at the distal end 4 of the insertion body 2. The insertion body 2 is a substantially elongate tubular part 5 having a proximal end 6 that extends into a flared funnel-shaped part 7 via a smooth transition.
[0080] The enema nozzle 1 comprises a flow channel 8 for the enema. Said flow channel is a first tube 9 which in the embodiment shown is a tube extending in the longitudinal direction at the inside of the insertion body 2. The tube's proximal end 10 is arranged for being connected to an enema reservoir and/or enema pump (not shown) via a coupling means and the tube's distal end is ending in one or more delivery opening(s) 11 for delivering/expelling the enema. Said delivery opening 11 is placed at the distal end 4 of the insertion body 2, just below the flexible insertion tip 3a. Thereby the flexible insertion tip 3a will operate independently of the enema flow.
[0081] In the embodiment shown the enema nozzle also comprises an expandable fixation member in form of a balloon 12, shown in dotted line, for retaining the enema nozzle 1 in the rectum during the enema injection. Said balloon 12 can be inflated with air or a liquid via a second tube 13 ending in an outlet 14. In the embodiment shown said second tube 13 is placed parallel with the first tube 9 for the enema flow, but these tubes 9,13 could also be placed in another mutual relationship, e.g., the first tube inside the second tube.
[0082] In FIG. 1 the flexible insertion tip 3a comprises a head portion 15 and a stem portion 16 having a smaller diameter than both the insertion body 2 and the head portion 15. The smaller cross sectional geometry of the stem portion 16 relative to the insertion body 2 and head portion 15, changes the flexible insertion tip 3's bending moment of inertia, providing the desired flexibly to the insertion tip 3a. In this way the flexible insertion tip 3a can easily conform to differences, obstructions, bends etc. when the enema nozzle 1 is introduced in a body opening, e.g., the rectum.
[0083] FIGS. 2 and 3 show a second and third embodiment of the enema nozzle according to the invention, lb and lc, respectively. Said embodiments correspond to the embodiment of FIG. 1, except for the construction of the flexile insertion tip 3, and for like parts the same reference numbers are used. In FIGS. 2 and 3 the flexible insertion tips, 3b and 3c are respectively obtained by providing a number of elongated grooves 17.
[0084] In both FIGS. 2 and 3 the enema nozzle 1b,1c is made as an integrated unit, and the grooves 17 are made in an exterior wall 18 of the distal end 4 of said integrated unit, thereby providing the flexible insertion tip 3b,3c. However, if the flexible insertion tip and insertion body were separate units, said grooves could also be made in an exterior wall of the flexible insertion tip e.g., the proximal end. The grooves 17 define areas of decreased wall thickness which are structurally weaker and less rigid than areas of the wall 18 where the grooves are not present, thereby imparting the desired flexible properties to the flexible insertion tip 3b,3c.
[0085] In FIG. 2 the grooves 17 are spaced equidistant from each other along a longitudinal length X of the flexible insertion tip 3b, and in FIG. 3 the grooves 17 are concentrated in a transition section 19 at the proximal end of the flexible insertion tip, such that said section 19 provides the required flexibility to the flexible insertion tip 3c.
[0086] In the embodiments shown in FIGS. 2 and 3 the grooves 17 extend generally parallel to one another, and each groove 17 extends in a plane that is generally perpendicular to a longitudinal axis of the flexible insertion tip. However, other designs and locations of the grooves 17 are also contemplated within the scope of the present invention.
[0087] FIG. 4 shows a fourth embodiment 1d of an enema nozzle according to the present invention. Said embodiment corresponds to the embodiment of FIG. 3, with the difference that flexible insertion tip 3d comprises a rounded spherical head region 20, which may have a diameter D which is substantially the same or slightly greater than the diameter d of the insertion body 2. Such an embodiment is especially relevant if the body tissue is inflamed or otherwise damaged, as the contact pressure from the flexible insertion 3d will be distributed over a larger area. Such a spherical head region 20 could of course also be placed on the embodiments shown in the other figures.
[0088] FIGS. 5 and 6 show a fifth and sixth embodiment 1e,1f, of an enema nozzle according to the present invention, having a delivery opening 11 placed in a side wall 21 of the flexible insertion tip 3e,3f. In said embodiments the distal end 4 of the integrated unit is subjected to a chemical treatment, which may be addition of a plasticiser. The properties of the material will be changed by the chemical treatment, thereby providing the flexible insertion tip.
[0089] In FIG. 5 the chemical treatment is applied in such a way that the flexibility of the insertion tip 3e either increases or decreases in steps, toward the distal end of the flexible insertion tip 3e, depending on where the flexibility of the insertion tip is desired to be largest. This is illustrated by the dotted lines 22 in FIG. 5.
[0090] In the embodiment of FIG. 6 the chemical treatment is the same over the entire flexible insertion tip 3f, such that the flexibility of the insertion tip 3f is constant in the longitudinal length x of the flexible insertion tip 3f.
[0091] FIGS. 7 and 8 show a seventh and eight embodiment of the enema nozzle 1g,1h according to the invention. Said two embodiments are basically identical, i.e., they both comprise a flexible insertion tip 3f,3h having a stem portion 16 and a head region 15, as in FIG. 1, the main difference between said embodiments being the location of the delivering opening 11, which in FIG. 7 is placed below (adjacent) the flexible insertion tip 3f, and in FIG. 8 at the end of said tip 3g.
[0092] The enema nozzles of FIGS. 7 and 8 do not comprise a fixation member, and may accordingly e.g., be used for a fast and efficient enema procedure, or an enema administration in which the user can maintain the enema device 1 in place during the procedure. Even thought the flexible insertion tip 3g,3h in these embodiments corresponds to the embodiments of FIG. 1, the flexible insertion tips shown in the other figures, FIGS. 1-6, could also be used in an enema nozzle without a fixation member.
[0093] FIG. 8a shows a cross section of the distal end of the enema nozzle 1h where the first tube 9 for the enema extends into a delivery opening 11 placed at the end of the flexible tip, i.e., the tube 9 extends through both the head region 15 and stem portion 16.
[0094] FIG. 9 shows a ninth embodiment 1i, of the enema nozzle according to the invention in which the first tube 9 also extends into a delivery opening 11 placed at the end of the flexible tip, as in the embodiment shown in FIG. 8 and FIG. 8a. As best shown in FIG. 9a, which is a cross-sectional view of the distal end of enema nozzle 1i, the desired flexibility of the flexible insertion top 3i is provided by gradually reducing the wall thickness y at the flexible tip towards the distal end, and in such a way that the wall thickness y of the flexible insertion tip is smaller than the wall thickness Y of the insertion body 2.
[0095] A person skilled in the art will understand that the insertion body 2 of the embodiments shown in the figures can have any desired shape, length and dimension, and that the flared funnel shaped part 7 shown in the embodiments in the figures is optional. Furthermore, even though the delivery opening is shown as a round hole in the figures, said opening may have any other relevant shape, e.g., be in the form of one or more elongated slots or slits.
[0096] FIG. 10 shows a tenth embodiment of a flexible insertion tip 3j according to the invention, in which the flexible insertion tip is, divided into a dome 23 and a lower section 24, connected by an elastic attachment unit 25.
[0097] FIG. 10a is a cross-sectional view taken in the longitudinal direction of the enema nozzle and shows the insertion tip 3j in an insertion position, where the lower circumferical edge 26 of the dome 23 abuts the top circumferical edge 27 of the lower section 24, i.e., no sharp edges that may cause harm or irritation to the colon tissue during insertion is provided.
[0098] The elastic attachment unit 25 comprise an elastic string 28 which at one end 29 it integrated with a top section 30 of the dome 23, and at the other end 31 a grid 32. Said grid is best seen in FIG. 10b, which is an upper view showing the inside of the flexible insertion unit 3j, but with the dome 23 and elastic string 28 removed. The grid consists of three connecting members 33, with little or no elasticity. Said connecting members 33 is evenly distributed along the inner circumference 34 of the lower section 24 and intersects in a centre point 35 where the other end of the 31 of the string 28 is attached/integrated. The elastic string 25 and grid 32 will in combination substantially prevent relative movements, especially lateral movements, of the dome and firmly combine the dome and the lower section.
[0099] As is best seen in FIGS. 10b and 10c, when the user initiate an enema flow through the enema flow channel 8, said enema will which upon contact with the dome 23, force the lower circumferical edge 26 of the dome 23 to separate from the top circumferical edge 27 of the lower section 24, thereby proving a gap (delivery opening) 36, extending along the entire circumference of the insertion body 3j, through which the enema can be expelled into the body opening.
[0100] The flexibility of the insertion tip 3j is provided by chemical treatment but could be provided as disclosed in any of the other embodiments.
[0101] FIG. 11 shows an enema device 37 according to the invention, wherein the enema nozzle 1g shown in FIG. 7 is connected to a substantially bulb-formed enema delivery container 38, arranged for containing the enema. The enema is administered by squeezing the delivery container 38 one or more times, depending on the desired dosage. The enema device 38 may comprises a one-way valve (not shown) that effectively will prevent backflow of liquid and faeces from the colon and/or rectum into the device 37 and said one-way valve will therefore preclude any contamination of the delivery container 38 and its remaining content, which may occur after administration of the enema to a patient. Furthermore, since backflow efficiently is prevented, the delivery container 38 can easily be used for several applications, e.g., by refilling the container with a second dose of the same—or a different—enema (liquid).
[0102] The enema nozzle, 1g, may be removable connected to the delivery container 38 by means of a coupling 39. Thereby can the enema nozzle 1g be a disposable nozzle or the nozzle can be individually cleaned and/or sterilised, and the delivery container 38 may be reused several times.
[0103] The enema nozzle 1 may also be used for larger irrigations systems wherein the enema nozzle 1 is connected to the enema reservoir via a relatively long delivery tube, and wherein the irrigation system e.g., comprises pumping means, control means, collection means for the stool, etc.
[0104] Modifications and combinations of the above principles and designs are foreseen within the scope of the present invention.
