EAR CATHETER AND INSERTION AID FOR A CATHETER

Abstract

The invention relates to an ear catheter for insertion into the eustachian tube with a first tube as catheter tube (3) provided with at least one first lumen as injection duct (3A) for the application of a liquid/fluid, at least one second lumen as pressure relief lumen (3B) for pressure relief and a self-expandable sealing element (2) for the occlusion of the eustachian tube, as well as an insertion aid comprising a headpiece, a middle piece and an end piece, wherein the insertion aid consists of a biocompatible polymer, and with at least one separator line extending at least through each of the middle piece and the end piece, along which the insertion aid can be unfolded or split open. The insertion aid proposed by the invention can thus be removed from a catheter even if the catheter ends are blocked.

Claims

1. Ear catheter for insertion into the eustachian tube, including a first tube as catheter tube (3) with at least one first lumen as injection lumen (3A) for application of a liquid, at least one second lumen as pressure relief lumen (3B) for pressure relief, and a self-expandable sealing element (2) for the occlusion of the eustachian tube.

2. Ear catheter according to claim 1, characterized in that the sealing element (2) is provided in the form of a shield at the distal end of the catheter tube (3) and an expansion device (6) is provided for controlling the expansion of the shield (2).

3. Ear catheter according to claim 2, characterized in that the shield (2) comprises self-expandable support elements and/or a self-expandable framework and a membrane secured thereto.

4. Ear catheter according to claim 3, characterized in that the self-expandable support elements and/or the self-expandable framework are made of a shape memory material.

5. Ear catheter according to claim 3, characterized in that the membrane is made of PTFE or ePTFE.

6. Ear catheter according to claim 2, characterized in that the expansion device (6) is provided as a second tube having a distal and a proximal end, said tube being provided in a form-closed manner externally around the catheter tube (3) and longitudinally displaceable relative to the catheter tube (3), and wherein a displacement of the expansion device (6) in proximal direction causes the shield (2) to be released for expansion and a distal displacement results in a compression of the shield (2).

7. Ear catheter according to claim 6, characterized in that the expansion device (6) comprises an operating aid (7) arranged at its proximal end.

8. Ear catheter according to claim 1, characterized in that the sealing element (2) is provided as a balloon at the distal end of the catheter tube (3) and the catheter tube (3) comprises a further lumen as inflation lumen (3E).

9. Ear catheter according to claim 1, characterized in that the catheter tube (3) is provided with at least one connection device (5), in particular a Luer-Lock system (5), which is located at its proximal end.

10. Ear catheter according to claim 1, characterized in that the injection lumen (3A) and the pressure relief lumen (3B) extend proximally from the connection device to distally of the sealing element (2).

11. Ear catheter according to claim 1, characterized in that the distal end (12) of the ear catheter (1) is designed so as to be atraumatic.

12. Ear catheter according to claim 1, characterized in that at least one one-way valve (4) is provided in at least one of the lumens of the catheter tube (3), in particular in the injection lumen (3A) or in the pressure relief lumen (3B).

13. Ear catheter according to claim 1 provided with an insertion aid, characterized in that the insertion aid (101) comprises a headpiece (102, 102), a middle piece (103, 103) and an end piece (104, 104), wherein the insertion aid (101) consists of a biocompatible polymer, and at least one separator line (105) extends at least through the middle piece (103, 103) and the end piece (104, 104) each, which enables the insertion aid (101) to be unfolded or split open along said line.

14. Insertion aid in particular for an ear catheter according to claim 1 provided with a headpiece (102, 102), a middle piece (103, 103) and an end piece (104, 104), wherein the insertion aid (101) consists of a biocompatible polymer, characterized in that at least one separator line (105) extends at least through the middle piece (103, 103) and the end piece (104, 104) each, which enables the insertion aid (101) to be unfolded or split open along said line.

15. Insertion aid according to claim 14, characterized in that at least the middle piece (103, 103) and the end piece (104, 104) of the insertion aid (101) are provided divided into two longitudinal parts (A, B) as a result of two oppositely located separator lines (105).

16. Insertion aid for catheters according to claim 14, characterized in that the headpiece (102) of the insertion aid (101) is provided in a one-piece tubular form and can be connected at its proximal end to the distal end of the middle piece (103, 103) by means of a coupling element (109), wherein the middle piece (103, 103) and the end piece (104, 104) forming a basic element.

17. Insertion aid for catheters according to claim 14, characterized in that the end piece (104, 104) comprises a connecting element (111) by means of which the two longitudinal parts (A, B) are connected to each other.

18. Insertion aid for catheters according to claim 17, characterized in that the end piece (104, 104) comprises a further connecting element (110), which is preferably arranged on the opposite side of the connecting element (111) and detachably connects the two longitudinal parts (A, B) to each other.

19. Insertion aid for catheters according to claim 13, characterized in that two continuous separator lines extend through the headpiece (102, 102) and the middle piece (103, 103) along which the insertion aid (101) can be split up, and with the end piece (104, 104) being split in two in continuation of these separator lines (105).

20. Insertion aid according to claim 14, characterized in that a safeguard (108) is provided at the proximal end of the middle piece (103).

21. Insertion aid according to claim 13, characterized in that a tubular sheath (113) is provided around the middle piece (103) and/or the headpiece (102).

Description

[0107] CLARIFICATION OF THE INVENTION IS PROVIDED BY THE FOLLOWING FIGURES WHERE

[0108] FIG. 1 is a general view of a first preferred embodiment of the ear catheter according to the invention with a shield as sealing element,

[0109] FIG. 2 shows details of the proximal and distal sections of the preferred embodiment according to FIG. 1,

[0110] FIG. 3 illustrates further details of the distal section of another preferred embodiment,

[0111] FIG. 4 shows various outlines of possible shield configurations,

[0112] FIG. 5 shows various ways of connecting the proximal shield section to the catheter tube,

[0113] FIG. 6 is an overview of a preferred embodiment with a balloon as sealing element,

[0114] FIG. 7 illustrates details of the proximal end of the embodiment according to FIG. 6,

[0115] FIG. 8 includes further details of the proximal end of the embodiment according to FIG. 7,

[0116] FIG. 9 includes further details of the proximal end of the embodiment according to FIG. 7 as a variant,

[0117] FIG. 10 shows a first embodiment of the insertion aid proposed by the invention,

[0118] FIG. 11 depicts the principle of use and removal of the first embodiment of the insertion aid,

[0119] FIG. 12 shows the extension of a separator line of the first embodiment,

[0120] FIG. 13 shows a first embodiment of the inventive insertion aid provided with safeguard,

[0121] FIG. 14 is a second embodiment of the insertion aid according to the invention in the unfolded state,

[0122] FIG. 15 is a perspective view of an alternative design of the second embodiment of the insertion aid according to the invention,

[0123] FIG. 16 is a top view of the inside of one half of the insertion aid according to FIG. 14,

[0124] FIG. 17 shows detailed views of FIG. 16,

[0125] FIG. 18 is a perspective view according to FIG. 6 provided with sheath,

[0126] FIG. 19 illustrates a section detail of the perspective view according to FIG. 18.

[0127] The ear catheter 1 proposed by the invention as shown in FIG. 1 comprises a catheter tube 3, at the distal end d of which a self-expandable shield 2 is arranged. At the proximal end p of the catheter tube 3 there is a Luer-Lock connector 5 for a conventional syringe, by means of which the medication to be applied can be inserted through the injection lumen 3A. Moreover, an additional connection for the pressure relief lumen (not shown) can be arranged at the proximal end. In this embodiment, the only lumen of the catheter 3 is the injection lumen 3A; however, an embodiment is preferred in which the catheter comprises another lumen for pressure relief purposes in addition to the injection lumen 3A, as shown in FIG. 3 hereinbelow.

[0128] The ear catheter 1 has an overall length ranging between about 15 cm and 30 cm with an outer diameter of the catheter tube 3 of preferably 2 to 3 mm and an inner diameter of the injection lumen of about 1 mm.

[0129] A tubular expansion device 6, which is arranged in a form-fitting or frictionally engaged manner around the catheter tube 3, is used to expand or compress the shield 2, with said expansion device 6, same as the catheter tube, preferably being made of plastic.

[0130] An operating aid 7 is provided at the proximal end p of the expansion device 6, which simplifies the handling of the expansion device 6 in that it enables the expansion device 6 to be safely gripped and thus safely controlled.

[0131] By means of expansion device 6 the expansion or compression of the shield 2 is brought about. With the expansion device 6 being pushed in distal direction d over the shield and left there, this results in the shield 2 to be compressed; if the expansion device 6 is pushed in proximal direction p off the shield 2 and left there, this causes shield 2 to be in the expanded state.

[0132] To prevent an inadvertent expansion of the shield 2 caused by a slipping of the expansion device 6 during placement of the ear catheter 1 through the nose and nasopharynx, a spacer element may be provided between Luer-Lock 5 at the proximal end p of the ear catheter 1 and the operating aid 7 of the expansion device 6, said spacer element being expediently provided in the form of a slotted tube, so that it can be pulled off and put back on (not shown).

[0133] FIG. 2 shows the details of the distal end d and the proximal end p of the ear catheter 1. The self-expanding shield 2 is provided at the distal end d of the ear catheter 1, said shield being preferably composed of three sections 2 A, B, C, i.e. a distal section 2 A of large diameter which has a cylindrical shape over a certain length without appreciable tapering and which essentially represents that part of the shield 2 which makes fluid-tight contact with the wall of the eustachian tube. An optional tubular proximal section 2 C is provided for safely securing the shield 2 within the distal lumen of the catheter tube 3.

[0134] However, it should be made sure that the open diameter of the catheter tube 3, which includes the injection lumen 3A and the pressure relief lumen (not shown) is reduced only insignificantly so as not to interfere with fluid application and pressure equalization. Between the proximal section 2 C and the distal section 2 A, a middle section 2 B is arranged, which is of funnel or cone shape and widens from the smaller diameter of section 2 C toward the larger diameter of section 2 A.

[0135] The configuration of shield 2, which means the proportions of the self-expanding support elements or framework on the one hand and of the membrane on the other, can vary within the sections 2 A to C. Preferably, to ensure the most effective seal possible, the membrane is of one-piece design and extends over all sections 2 A to C.

[0136] To make sure the tightest possible seal is brought about between the shield 2 and the wall of the eustachian tube, a cylindrical section 2 A may be provided distally over a certain length. Aside from the membrane, this section also comprises a multitude of self-expanding support elements, which are preferably arranged as meandering ring segments and may be provided in the form of an interconnected framework or exist as separate support elements. However, a distal section 2 A is optional, and embodiments are also conceivable in which the distal end of the tapered section 2 B already constitutes the distal end of the shield 2.

[0137] Sections 2 A to C can be supported in whole or in part by self-expanding support elements or by means of an interconnected framework. The structure and design may vary in each of the sections 2 A to C. It is, however, of importance at the distal end d of the shield 2 that an adequate but not too high radial force is exerted there, which ensures an as tight a seal as possible between the shield 2 and the eustachian tube, but at the same time does not lead to pressure points and necrosis. In this respect, the distal end of section 2 B and/or the optional section 2 A are to be designed accordingly. Otherwise, the tapered section 2 B does not need to be subjected to higher radial forces, since its main purpose is to prevent the drug from flowing back from the eustachian tube into the nasopharynx. Accordingly and in case a distal section 2 A has been provided, section 2 B would in principle be conceivable without a framework structure or relevant support elements. The same holds true for section 2 C, which ultimately serves solely to secure the shield 2 in the catheter tube 3, which is also conceivable solely by appropriately connecting the membrane to the catheter tube 3.

[0138] Conceivable are embodiments in which the complete shield 2 is formed by an inner framework and/or suitable support elements, with a membrane being connected thereto. Without any inventive effort, relevant combinations of sections 2 A to C of the shield, which besides the membrane also comprise a framework and/or support elements, can be devised by skilled persons to satisfy the respective requirements.

[0139] The expansion device 6, which is provided in a tubular form around the catheter tube 3, optionally comprises an operating aid 7 at its proximal end, which facilitates sliding the expansion device 6 forward and backward. In a preferred embodiment, a latching device 8 may be provided to releasably connect the operating aid 7 to the Luer-Lock system 5 to prevent a displacement of the operating aid 7 when the shield 2 is expanded and, in particular, to prevent the shield 2 from being compressed.

[0140] The expansion device 6 is preferably provided in the form of a hose or tube. Moreover, conceivable are also embodiments in which the expansion device 6 is provided, at least partially, with slots, for example to enhance the flexibility of ear catheter 1.

[0141] The operating aid 7 can be provided in the form of a ring, although slotted embodiments or retaining elements arranged at only certain points on the expansion device 6 are conceivable as well.

[0142] To prevent backflow of the applied liquid through the injection lumen 3A, a one-way valve 4 is preferably located in its distal end. A corresponding valve is provided for the pressure relief lumen (not shown).

[0143] After the placement of the catheter and expansion of the shield, the treatment proceeds by filling the medication into the middle ear via a syringe and with the drug remaining there for the required time. Filling of medication into the middle ear is monitored by ear microscopy. Preferably, the procedure is performed under local anesthesia, but in special cases general anesthesia may be recommendable. After the medication has been administered, the proximal part of the application catheter is stuck to the cheek with a medical strip. The sealing element remains in place in the eustachian tube and prevents the injected solution from draining off. At the end of the treatment, the sealing element is compressed and the catheter is withdrawn.

[0144] FIG. 3 shows another preferred embodiment of the ear catheter 1 identifying the injection lumen 3A and the pressure relief lumen 3B. At the distal end, the catheter tube 3 terminates in an atraumatically formed tip 12, wherein the injection lumen 3A terminates in opening 3C distally of the atraumatically formed tip 12, with the pressure relief lumen 3B terminating proximally of the atraumatic tip 12 with an opening 3D. Other than the embodiment illustrated in FIG. 2, at least part of the catheter tube 3 with injection lumen 3A and pressure relief lumen 3B extends through the shield 2 and terminates distally of the shield 2.

[0145] In the illustrations A to H in FIG. 4 various possible configurations of the shield 2 are depicted in outline representations, with in said illustrations the distal end being located on the left and the proximal end on the right in each case. The outlines respectively reflect the combination of framework and membrane, i.e. the configuration of the shield 2 in each individual case will essentially be determined by the framework, the membrane or the combination thereof.

[0146] FIG. 5 shows details of various connectors 9 by means of which the proximal shield section 2C and the catheter tube 3 can be interconnected. FIG. 5A shows a connector 9 including latching elements 9A, said connector being preferably be bonded by injection molding. In FIG. 5B an adhesive connector 9 is shown, and in this case the catheter tube 3 extends into and is adhesively bonded to the proximal end of the shield 2C. To further stabilize the adhesive connector 9, the proximal shield end 2C may include punched-out holes 9B. Alternatively, this connection can also be made as a straightforward form fit. FIG. 5C shows a form-fit connector 9 with optionally arranged additional retaining elements 9C, which increase the frictional resistance and thus additionally prevent the shield from sliding out. The catheter tube 3 in this embodiment surrounds the distal shield end 2C, and this connector may also be provided as an adhesive connection. FIG. 5D shows a connector 9 provided with a threaded connection 9D, with the male thread to be part of the distal shield end 2C and the female thread to be part of the catheter tube 3, or vice versa.

[0147] FIG. 6 is a complete view of the preferred embodiment of the ear catheter 1 including a balloon as sealing element 2. Three connections are located at the proximal end of the catheter 3, i.e. connection 10C for inflation of the balloon, connection 10A accommodating a syringe for the injection lumen, and connection 10B for pressure balancing via the pressure relief lumen. An atraumatic tip 12 is provided at the distal end of the catheter 1.

[0148] In FIG. 7 a detailed view of the distal catheter section is illustrated including atraumatic tip 12, the balloon 2 located proximal to it and three markers arranged proximal to the balloon, said markers serving to endoscopically determine the position of the ear catheter during placement.

[0149] FIG. 8 is a detailed view of a first preferred embodiment of the distal section of the catheter tube 3, wherein the injection lumen 3A terminates in opening 3C at the distal tip of the atraumatic tip 12, and the pressure relief lumen 3B terminating in an opening 3D laterally offset at the atraumatic tip 12. The inflation lumen 3E terminates in the opening 3F in the area of the balloon 2.

[0150] Another preferred embodiment of the distal portion of the catheter tube 3 is shown in FIG. 9, wherein the pressure relief lumen 3B terminating laterally in an opening 3D distal to the balloon 2 but proximally to the tip (not shown). The inflation lumen 3E ends in the area of balloon 2 (the injection lumen is shown here).

[0151] FIG. 10 shows an insertion aid 101 according to the invention with an angled headpiece 102, a straight middle piece 103 and the end piece 104 split into two arms. Headpiece 102 forms an angle relative to the middle piece 103, ideally by appr. 70 (shown differently), i.e. said angle of 70 arising as a result of the run of the middle piece 103.

[0152] The end piece 104 is split so that it forms two arms, which serve as a handle for the treating physician to tear the insertion aid 101 open lengthwise. In continuation of the split section, a separator line or seam 105 extends along the length of the middle piece 103 and the end section 102, said line forming a weakening zone, for example by creating a partially incised area.

[0153] The insertion aid 101 is composed of a biocompatible polymer that has adequate rigidity as is needed to guide the system properly. At the same time, the polymer must not exhibit too much resistance which might otherwise impair tearing the insertion aid open. Customary polymers such as polyamide, polypropylene or copolymers such as Pebax are suitable.

[0154] FIG. 11 is a sequence of actions showing in image A the ear catheter 106 inserted through the nose of a patient by means of insertion aid 101 with the pressurizer 107 connected, in image B, the removal of the insertion aid 101 from the nose of the patient along the catheter tube, in image C, the insertion aid 101 already removed completely out of the patient's nose, in image D, the insertion aid 101 torn open to a large extent, in image E, the insertion aid 101 torn open up to the distal headpiece 102, and in image F, the insertion aid 101 which has been torn open completely and can now be disposed of.

[0155] FIG. 12 shows an insertion aid 101 proposed by the invention with the distal headpiece 102, the middle piece 103 and the two arms of the end piece 104 as well as the separator line 105 shown in broken lines, with the separator line 105 extending along the entire length of the middle piece 103 and the end piece 104. Said line starts at the junction point of the two arms of the end piece 104. It is understood that a corresponding separator line 105 is arranged on the opposite side.

[0156] FIG. 13 shows the proximal region of an inventive insertion aid 101 with a safeguard 108 arranged at the proximal end of the middle piece 103. Safeguard 108 consists of an adhesive medical strip that surrounds the insertion aid 101 at the location indicated and prevents premature tearing along the separator line 105. Before tearing open the insertion aid 101, the adhesive strip 108 is torn off by the attending physician.

[0157] In FIG. 14 a second embodiment of the insertion aid according to the invention is illustrated in the unfolded state, with a first half A comprising a half of the headpiece 102, a half of the middle piece 103 and a half of the end piece 104 as well as a second half B comprising a half of the headpiece 102, a half of the middle piece 103 and a half of the end piece 104. In this example, the halves A, B of the insertion aid 101 are provided to form a mirror-inverted configuration identical to each other.

[0158] The headpiece 102, 102 forms an angle relative to the middle piece 103, 103, preferably by appr. 70 when used as an insertion aid for an ear catheter (shown differently here). The angle of 70 is formed based on the run/extension of the middle piece 103, 103. An angle of the headpiece 102, 102 relative to the middle piece 103, 103 of 0 would thus result in an overall straight run of the middle and headpieces 103, 103, 102, 102.

[0159] In a region of the end piece 104, 104, the halves A, B are connected to each other, preferably in a handle area 112, 112, by means of a connecting element 111. The two end pieces 104, 104, resp. the two parts of the handle area 112, 112 are connected to one another preferably permanently by means of the connecting element 111, which, preferably, is already provided when the insertion aid 101 is manufactured, but alternatively it may be used to assemble the components later, i.e. the parts 104, 104, respectively 112, 112, or both halves A, B which initially may be manufactured as unconnected items.

[0160] A further connecting element 110A, 110B in the form of a latching component is additionally provided on end piece 104, 104, with the interacting latching elements 110A, 110B each being arranged at the respective locations on the end piece 104, 104.

[0161] A continuous duct extends through the insertion aid 101 through which a catheter can be passed. The duct gradually widens at the proximal end of the end piece 104, 104 to facilitate insertion of the catheter (not shown) into the insertion aid 101.

[0162] FIG. 15 shows a perspective view of an alternative design of the second embodiment of the insertion aid 101 according to the invention, with this alternative design differing only with respect to the arrangement of the headpiece 102, which in the present case is not split into two halves but designed as an undivided tube. The headpiece is connected to the two-part middle piece 103, 103 via a coupling element 109. The coupling element 109 is provided in the form of a sleeve that encompasses the proximal portion of the headpiece 102 and the distal portion of the middle piece 103, 103. For example, force-fit plug-in connections or threads can be provided to join the headpiece 102, coupling element 109 and middle piece 103, 103.

[0163] Thus, the coupling element 109 also serves as a further connecting element of the middle piece halves 103, 103.

[0164] The remaining elements of the insertion aid 101, particularly the design of the end piece 104, 104 with the further connecting element 110 corresponds to the second embodiment according to FIG. 14.

[0165] FIG. 16 is a top view of the inside of one half of the insertion aid 101 as per FIG. 15, as a longitudinal section. The individual elements correspond essentially to FIG. 14, to which reference is made as appropriate. This representation of the alternative design however differs in that in particular the arrangement of the coupling element 109 is shown, which is provided here as a sleeve embracing the adjoining ends of the headpiece and middle piece.

[0166] FIG. 17 shows in detail partial views of certain portions of the alternative second embodiment shown in FIGS. 15 and 16.

[0167] FIG. 17A shows a longitudinal section through the distal end of the headpiece.

[0168] FIG. 17B shows the coupling element 109 in longitudinal section with the respective ends of the headpiece 102 and the middle piece 103. These three elements are connected via threads, i.e. a female thread in coupling element 109 and male threads on the relevant areas of the headpiece 102 and the middle piece 103.

[0169] Finally, in FIG. 17C the proximally widening portion of the end piece 104 can be seen which is provided to facilitate introducing a catheter (not shown) into the insertion aid.

[0170] FIG. 18 illustrates a perspective view of the alternative design of the second embodiment of the insertion aid 101 according to the invention as shown in FIG. 15. Additionally, this embodiment includes a sheath 113 provided on and closely fitting the head and/or middle piece 102, 103. Sheath 113 provides additional support to the two-piece head and/or middle pieces 102, 103 by holding the two halves of these components together.

[0171] FIG. 19 shows a detail of a section of the sheath 113. A perforation line 114 may be provided to enable opening and removal of the sheath 113. However, such a perforation is mainly for operational convenience and may be omitted without any problems. Alternatively, the user may elect to remove the sheath by making a longitudinal cut or by tearing it open.

LIST OF REFERENCE NUMERALS

[0172] 1 Ear catheter [0173] 2 Shield (A: distal section; B: middle section; C: proximal section) [0174] 3 Catheter tube (A: injection lumen; B: pressure relief lumen; C: distal opening of the injection lumen; D: distal opening of the pressure relief lumen; E: inflation lumen; F: distal opening of the inflation lumen) [0175] 4 One-way valve [0176] 5 Connection device (Luer-Lock system) [0177] 6 Expansion device [0178] 7 Operating aid [0179] 8 Latching device [0180] 9 Connector [0181] 10 Proximal connections (A: injection lumen; B: pressure relief lumen; C: inflation lumen) [0182] 11 Marker (A: first marker; B: second marker; C: third marker) [0183] 12 Atraumatic tip [0184] 101 Insertion aid [0185] 102 Headpiece (102 first half, 102 second half) [0186] 103 Middle piece (103 first half, 103 second half) [0187] 104 End piece (104 first half, 104 second half) [0188] 105 Separator line [0189] 106 Catheter [0190] 107 Pressurizer [0191] 108 Safeguard [0192] 109 Coupling element [0193] 110 Further connecting element (110A, 110B sections of further connecting element) [0194] 111 Connecting element [0195] 112 Handle area (112 first part, 112 second part) [0196] 113 Sheath [0197] 114 Perforation line [0198] d distal [0199] p proximal