DEVICE FOR VASCULAR AND PERITONEAL ACCESS AND A DEVICE FOR HEMODIALYSIS

Abstract

An implantable device for venous or peritoneal access including a housing including a void having distal a proximal openings; an insert for insertion through the proximal opening comprising a venous or peritoneal catheter; a valve element mounted in a cylindrical recess of the insert; an extracorporeal coupling member of which a terminal portion can be inserted into a proximal recess of the valve element; one or two conduits extending from the catheter to the proximal end of the coupling member via the valve element and the insert for providing fluid communication, which can be interrupted by rotating the coupling member. The coupling member can be extracted from the recess only in a state of interrupted communication.

Claims

1. Device for venous or peritoneal access, comprising: a housing comprising a void; an insert disposable in the void and removable from it, the insert comprising a first conduit extending from a first distal face thereof disposed intra-corporeally to a bottom face of a recess in a second proximal face thereof disposed extra-corporeally, the faces including an angle of about 90; a cylindrical valve member housed in the insert recess, the valve member comprising a first valve conduit extending between the distal end face of the valve member and the bottom face of an oblong radially extending recess in a proximal face of the valve member; a coupling member comprising a portion extending from its distal end of same but positive form as the valve member recess and capable of being inserted into the recess and of being withdrawn from it, the coupling member comprising a first coupling conduit communicating, in an inserted position, with the first valve member conduit; wherein the first valve member conduit is displaceable by rotation of the valve member about its cylinder axis from an open position in which it is in communication with the first insert conduit to a closed position in which it is not or vice versa by rotation of the coupling member.

2. The device of claim 1, the insert comprising a second conduit of about same extension as the first conduit disposed in parallel therewith; a second valve member conduit of same extension as the first valve member conduit and disposed in parallel therewith, wherein the second valve member conduit can be brought into communication with the second insert conduit by rotation of the valve member about its cylinder axis; the coupling member comprising a second coupling conduit being in communication with the second valve member conduit at an inserted position of the valve member.

3. The device of claim 1, wherein is from 80 or 85 or 88 to 100 or 95 or 92, respectively.

4. The device of claim 1, wherein the insert comprises coupling means disposed at its first distal face for coupling with a single lumen venous catheter so as to establish communication of its conduit with the first insert conduit.

5. The device of claim 1, wherein the insert comprises coupling means disposed at its first distal face for coupling with a double lumen venous catheter so as to establish communication of the conduits thereof with the insert conduits.

6. The device of claim 1, comprising a means for restricting the rotation of the coupling member, the means comprising a rotation restricting element.

7. The device of claim 5, wherein rotation is restricted to an angle of about 90, such as from 80 to 100.

8. The device of claim 6, wherein the rotation restricting element comprises one or more shoulders disposed in distal sections of the central bore of the rotation restricting element, the shoulders co-operating with one or more lugs disposed on a cylindrical portion of the coupling member.

9. The device of claim 1, comprising a means for controlling the insertion of the coupling member into the valve member recess so as to only permit insertion or withdrawal at a closed position of the valve member, wherein the insertion control means is comprised by the rotation restricting element.

10. The device of claim 9, wherein the insertion control means comprises one or more grove(s) extending axially in the wall of the central bore capable of co-operating with the lug(s) of the coupling member, and wherein full insertion of the coupling member is only possible when the valve member is in a closed position.

11. The device of claim 1, wherein the cylindrical section carrying the lugs extends from the distal terminal section in a proximal direction.

12. The device of claim 6, wherein the rotation restricting element is comprised by a cover mountable on and dismountable from a proximal extracorporeal face of the housing.

13. The device of claim 12, wherein said proximal face is coplanar with the second face of the insert.

14. The device of claim 12, wherein the cover comprises a shield and a mounting member into which the rotation restricting element is integrated.

15. The device of claim 14, wherein the shield is attachable to the mounting member upon mounting the mounting member on the housing.

16. An insert for the venous access device of claim 2 comprising a double lumen venous catheter.

17. An insert for the venous or peritoneal access device of claim 1, further comprising a single lumen venous or peritoneal catheter.

18. A coupling member for use with the device of claim 2.

19. A coupling member for use with the device of claim 1.

20. Access device for hemodialysis, comprising: a housing comprising a void having a distal opening and a proximal opening; a venous double lumen catheter attached to an insert at its proximal end; a cylindrical valve element mountable in a cylindrical recess of the insert; wherein, upon implantation of the housing, the distal opening is disposed so as to face soft tissue of the patient whereas the proximal opening is disposed exteriorly of the patient, and wherein the insert of the double lumen catheter is mountable in the housing by inserting the double lumen catheter foremost into the proximal opening, and making the catheter pass through the distal opening.

21. The device of claim 20, wherein the cylindrical recess in the insert for mounting the valve element is disposed in a distal face thereof exteriorly of the patient's body.

22. The device of claim 21, wherein the valve element comprises a non-cylindrical, preferably oblong, recess disposed in a proximal face thereof.

23. The device of claim 20, wherein the device comprises an extracorporeal coupling member, the coupling member comprising a distal terminal portion mountable in the recess of the valve element, the coupling member comprising first and second conduits designed to be brought, in a coupled position, into fluid communication with the respective conduits of the valve element at their distal openings.

24. The device of claim 23, wherein the coupling member is mountable and dismountable in a closed valve position only.

25. The device of claim 20, wherein the insert housed in the void of the housing does not extend through the proximal opening thereof.

26. The device of claim 25, wherein the insert housed in the void of the housing does not extend through the distal opening thereof.

27. Device for venous or peritoneal access, comprising: a housing for implantation into soft tissue, comprising a void having a distal opening and a proximal opening; an insert for insertion into the housing through the proximal opening; a venous or peritoneal catheter mounted at a distal portion of the insert; a cylindrical valve member mounted in a cylindrical recess of a proximal portion of the insert; an extracorporeal coupling member of which a distal terminal portion is insertable into a recess disposed at a proximal face of the valve member; one or two conduits extending from the catheter to the proximal end of the coupling member via the valve member and the insert so as to provide fluid communication between the catheter and the coupling member; wherein said communication can be interrupted by rotation of the coupling member.

28. The device of claim 27, wherein the coupling member cannot be withdrawn from the recess in state of fluid communication between the catheter and the coupling member via said conduits.

29. The device of claim 28, wherein withdrawal and insertion of the coupling member is controlled by insertion control means comprised by a rotation restricting element of the device.

30. The device of claim 29, wherein the rotation restricting element comprises one or more shoulders disposed in distal sections of a central bore of the rotation restricting element, the shoulders co-operating with one or more lugs disposed on a cylindrical portion of the coupling member.

31. The device of claim 30, wherein the insertion control means comprises one or more groves extending axially in the wall of the central bore capable of co-operating with the one or more lugs of the coupling member.

Description

SHORT DESCRIPTION OF THE FIGURES

[0051] FIGS. 1b, 2a-2f, 4c, 5a-5c, and 6 relate to a first embodiment of the device of the invention. FIGS. 1c, 4d, 9a-9f, 10a-10c, and 11 relate to a second embodiment of the device of invention. FIGS. 1a, 1d, 3a, 3b, 4a, 4b, 5d are shared by the first and second embodiments of the device of the invention. FIGS. 7 and 8 pertain to a variety of the housing of the first and second embodiments. In particular:

[0052] FIGS. 1a-1c illustrate a housing, in section C-C (FIG. 1a), in a front view (FIGS. 1b and 1c) and in a top view (FIG. 1d);

[0053] FIGS. 2a-2e and 9a-9e illustrate alternative inserts: [0054] Section B-B (FIGS. 2a, 9a); [0055] Section B-B, with a valve member mounted in a closed condition (FIGS. 2b, 9b); [0056] Section B-B, with a valve member mounted in an open condition (FIGS. 2c, 9c); [0057] Section A-A, with a valve member mounted in a closed condition (FIGS. 2d, 9d); [0058] Section A-A, with a valve member mounted in an open condition (FIGS. 2e, 9e);

[0059] FIGS. 2f and 9f illustrate alternative valve members, in the same axial section as in FIGS. 2b, 9b;

[0060] FIGS. 3a and 3b illustrate a locking element, in section L-L (FIG. 3a) and in section K-K (FIG. 3b);

[0061] FIGS. 4a, 4b illustrate a cover with integrated locking element, in section E-E (FIG. 4a) and in section M-M (FIG. 4b); FIGS. 4c and 4d are top views of the cover mounted on the housing comprising the insert with the valve element of FIGS. 2f and 9f, respectively;

[0062] FIGS. 5a-5c, 9a-9c illustrate a coupling member, in axial sections Q-Q (FIGS. 5a, 10a) and P-P (FIGS. 5b, 10b), and in a bottom view (FIGS. 5c, 10c);

[0063] FIG. 5d illustrates a rotationally symmetric protection cap in axial section, for which the coupling member is exchanged during non-use of the device;

[0064] FIGS. 6, 11 illustrate the device of the invention, complete with a double lumen and single lumen venous catheter, respectively and inlet/outlet tubes for connection with a dialysis apparatus, peritoneal dialysis solution reservoir or similar, in a closed condition and in a proximal/distal section corresponding to section F-F in FIGS. 4c, 4d;

[0065] FIGS. 7, 8 are perspective views of a variety of a housing of the invention.

DESCRIPTION OF PREFERRED EMBODIMENTS

EXAMPLE 1

First Embodiment of the Device of the Invention

[0066] A first embodiment 1 of the venous access device of the invention relates to a device for hemodialysis (FIG. 6). The device 1 comprises a housing 2, an insert 3 disposed in a void 11 of the housing 2, and a cylindrical valve member 4 disposed in a cylindrical recess 16 of the insert. The housing 2 has about the form of a skirt 2, which is about elliptical in radial section or a top view (FIG. 1d). The housing 2 extends between about elliptical upper 10 (proximal) and lower 10 (distal) circumferential rims disposed in parallel planes (FIG. 1b). Broken line D-D indicates roughly the extra-corporeal/intra-corporeal border. The interior of the housing 2 defined by the skirt 2 and said planes is divided by an insert holding wall 2 which, together with sections of the skirt 2 (inner face of 2), defines the void 11 in which the insert 3 is disposed. The wall thickness of an elliptic upper/proximal portion 2 of the skirt 2 extending downwards from the upper rim 10 over about a fourth to a third of the proximal/distal height h of the skirt 2 is substantially greater than the thickness of the major part of the skirt 2. The increased wall thickness allows the provision of threaded bores (not shown) in a proximal face 35 of the housing 2 which extends inwardly from the upper rim 10 for the rugged mounting of a cover 7.

[0067] In an inserted position the insert 3 is substantially symmetric in respect of a plane (C-C, FIG. 1d) defined by the long axes of the upper and lower skirt rim 10, 10 ellipsis. In a side view the insert 3 has the general form of a circular segment of about 90. The insert holding wall 2 extends from one end of the long axis of the elliptical proximal (upper) skirt rim 10 to near the opposite end of the long axis of the elliptical distal (lower) skirt rim 10. The insert wall 2 is about U-formed in a transverse vertical (proximal/distal) section, viz. in a distal/proximal section coinciding with or parallel with the short axes of the upper and lower skirts 10, 10. The form of the void 11 corresponds closely to the form of the side and bottom walls of the insert 3. Upon insertion into the void 11 the side/bottom walls of the insert 3 abut snugly corresponding wall sections of the housing 2. The void 11 has a proximal (upper) opening 11 defined by a proximal inner circumferential edge 10 of the housing 2 and distal (lower) opening 11 centered in respect of the long axis of the lower skirt rim 10. The distal opening 11 is disposed near the end of the elliptic lower skirt axis opposite to the end of the long axis of the elliptical proximal inner circumferential rim 10 from which the insert holding wall 2 extends in a skew downward direction. The housing 2 is shown in FIGS. 1a, 1c in a longitudinal distal/proximal section (FIG. 1a) and in a top view (FIG. 1c). In FIG. 1b the housing 2 with the insert 3 disposed in the void 11 is shown in a frontal view displaying the first opening 11, in which a distal face 14 of the insert 3 and the distal openings of its conduits 12, 13 are seen. The broken line D-D indicates the level of the intra-corporeal (distal)/extracorporeal (proximal) border. The portion of the housing 2 located downwards (distally) of D-D (skin level) thus is disposed in soft tissue.

[0068] In FIGS. 2a-2c the insert 3 is shown in a vertical sectional view B-B. In a horizontal section A-A (FIGS. 2d, 2e) the insert 3 is of about elliptic form. FIGS. 2b-2e illustrate the insert 3 with a valve member 4 mounted in a proximal recess 16 thereof. The insert 3 is substantially symmetric in respect of a plane B-B dissecting it in a proximal/distal direction, which plane is identical with the plane C-C (FIG. 1d) of the housing 2. The insert 3 comprises two faces, said distal face 14 and a proximal face 15. In a mounted position of the insert 3 the proximal face 15 is coplanar with an upper, proximal face 35 of the housing 2, that is, is disposed in the second opening 15 of the housing 2, whereas its distal face 14 is disposed at the inner end of the first opening 11 of the housing 2. The generally flat faces 14, 15 are disposed in planes or defined by planes dissecting each other by an axis perpendicular to the plane B-B. The first and second faces 14, 15 include an angle of about 90.

[0069] The insert recess 16 is of cylindrical form. Parallel conduits 12, 13 of equal length extend from the distal face 14 of the insert to the bottom face 16 of the insert recess 16. The valve member 4 mounted in the insert recess 16 is also of cylindrical form and of same size as the recess 16. The valve member 4 has flat lower 19 (distal) and upper 20 (proximal) faces. The upper (proximal) face 19 of the valve member 4 comprises an oblong recess 21. Two parallel conduits 17, 18 extend between the distal face 19 and the bottom face 21 of the valve member recess 21. The openings of conduits 12, 13 at the bottom face 16 of the insert recess 16 and the distal face 19 openings of the valve member conduits 17, 18 are equally spaced. When the valve member 4 is inserted in the insert recess 16 the proximal face 20 of the valve member 4 is coplanar with the proximal face 15 of the insert 3.

[0070] The insert 3 is held in place by the mounting frame 8 of a cover 7 shown in sectional side (E-E) and bottom (M-M) views in FIGS. 4a, 4b. The cover 7 is mounted on the upper (proximal) face 15 of the housing 2 by means of screws (not shown), and is supported by a circumferential shoulder 35 of the housing 2. In a top view (FIG. 4c) the cover 7 is shown mounted on the housing 2, its circumference being of substantially same form and size as the upper rim 10 of the housing 2. The cover 7 comprises a rotation restricting element 6 of cylindrical form with central bore 34. The cover 7 with the rotation restricting element 6 is mounted on the housing 2 so that the common axis of the rotation restricting element 6 and its central bore 34 coincide with the cylinder axis of the valve member 4. By the diameter of the central bore 34 being somewhat smaller than the diameter of the valve member 4 the latter is locked in the insert recess 16.

[0071] A venous double lumen catheter 43, 44 is mounted at the distal face 14 of the insert 2. The catheter 43, 44 protrudes through the distal opening 11 of the housing 2 and extends from the housing 2 in a direction about parallel with the lower rim 10 of the skirt 2. At its proximal end, which abuts the distal face 14 of the insert 3, the catheter 43, 44 comprises a cylindrical base 43, the proximal face of which is mounted on the distal face 14 of the insert 3. The base 43 comprises first and second conduits, which are in fluid communication with the conduits 12, 13 of the insert 3. From the other face of the base 43 protrudes a flexible double conduit catheter tube 44 comprising outer 45 and inner 47 conduits. Near its distal end the outer conduit 45 is provided with a number of radial inlet orifices 46. The inner conduit 47 extends for a further distance and comprises a single orifice 48 at its distal end. The venous catheter 43, 44 is inserted into a major vein (not shown) in a manner that the orifices 46 of its outer conduit 45 are disposed upstream of the orifice 48 of its inner conduit 47. The insert 3 with the venous catheter 43, 44 can be inserted into the void 11 of the housing 2 through the proximal opening 11, the catheter 43, 44 passing during insertion through the distal opening 11 of the housing 2 from where it is inserted into soft tissue and, finally, into a vein (not shown). In a corresponding manner the catheter 43, 44 and the insert 3 can be removed from the vein/soft tissue/void 11.

[0072] The valve formed by the combination of insert recess 16 and valve member 4 can be opened and closed by rotation of the valve member 4. In an open position the conduits 17, 18 of the valve member 4 are in communication with the conduits 12, 13 of the insert 2, that is, their facing openings are in a superimposed position. From this open position the valve 4, 16 is brought to a closed position by rotating the valve member 4 by about 90. Rotation is accomplished by inserting an oblong rotation means into the oblong valve member recess 21 and turning the rotation means over a desired angle. A suitable rotation means is provided by two alternatively used tools, a coupling member 5 and a protecting cap 39.

[0073] The coupling member 5 is used for providing fluid communication between the conduits 17, 18 of the valve member 4 and a dialysis apparatus or similar.

[0074] Fluid communication between a vein and a dialysis apparatus or similar device is so provided by means of the intermediate access device 1, specifically via the conduits of the venous catheter 43, 44, the insert 2, the valve member 4, the coupling member 5 and flexible tubes connecting the coupling member 5 with the apparatus. The coupling member 5 comprises conduits 23, 24 extending in an axial direction from its distal end to its proximal end. At their distal openings the coupling member conduits 23, 24 are equidistant with the valve conduits 17, 18. The coupling member 5 is rotationally symmetric by a two-fold symmetry in respect of a central axis R-R (FIGS. 5a, 5b) corresponding to the intersection of planes P-P and Q-Q in FIG. 5c. The coupling member 5 is provided with a valve operating portion 22 extending from its distal end and of same but positive form as the valve member recess 21. Upon insertion of the valve operating portion 22 into the valve member recess 21 (FIG. 6) the valve member 4 can be rotated by rotating the coupling member 5. For ease of rotation the coupling member 5 is provided with turning wings 30, 31. Radially opposite grooves 28, 29 in the bore 34 wall of the rotation restricting element 6 co-operate with radially opposite lugs 25, 25 disposed on a cylindrical portion 27 of the coupling member 5 so as to restrict insertion of the coupling member to one rotational position, in which the valve member 4 is disposed so that the terminal portion 22 of the coupling member 5 can be inserted in the oblong recess 21 of the valve member 4. The coupling member 5 is inserted until the distal face of its terminal portion 22 abuts the bottom face 21 of the valve member recess 21. To allow rotation of the coupling member 5 in a fully inserted position the bore 34 comprises diametrically opposite disposed widened portions 32, 33 extending for about 90 in one circumferential direction from grooves 28, 29. The widened portions 32, 33 allow the lugs 25, 25 to be rotationally displaced over an angle of about 90 until they abut shoulders 26, 26 radially narrowing and limiting the widened portions 32, 33 of the bore 34. The shoulders 26, 26 are disposed so as to stop rotation of the coupling member 5 at an open position of the valve 4, 16. In the open position of the valve 4, 16 the coupling member 5 cannot be withdrawn from the bore 34 since the lugs 25, 25 hinder withdrawal by abutting upper faces of the widened portions 32, 33 of the bore 34, said upper faces extending in a plane parallel with the proximal end face 20 of the valve member 4. The distal ends of the coupling member conduits 23, 24 are in communication with flexible tubes 37, 38 attached to them via a connector 36, which is only represented schematically in FIG. 6. At their proximal ends the tubes 37, 38 are connected to a dialysis apparatus or similar equipment (not shown).

[0075] The connection of a person's circulation to a dialysis apparatus is only temporary since the access device of the invention 1 is only used in intervals of a few days for a couple of hours. At the end of a dialysis session the coupling member 5 is exchanged for a protecting cap 39 reflecting the design of the distal portions 22, 27 of the coupling member 5 and comprising corresponding lugs 40, 40. Upon removal of the coupling member 5 with the valve 4, 16 in a closed position the protecting cap 39 is inserted into the bore 34 of the rotation restricting element 6 with the lugs 40, 40 disposed in the grooves 28, 29. In an inserted position the distal face 39 of the cap 39 abuts the bottom face 16 of the second recess 21 thereby closing the proximal openings of the insert conduits 12, 13. Rotation of the cap 39 by 90 is accomplished by turning a screw driver or similar gear inserted into a transverse slot 42 in the distal face of the cap 39. By this rotation the cap 39 is disposed in a position in which it cannot be withdrawn and in which the valve 4, 16 is closed. Additional sealing is provided by a circumferential radial flange 41 of the cap 39 abutting the proximal end face 20 of the valve member 4.

[0076] For exchange of the venous catheter 43, 44 the cap 39 is brought back to the closed condition of the valve 4, 16 and withdrawn. Then the cover 7 is dismounted. Finally, the insert 3 with the valve member 4 and the venous catheter 43, 44 is withdrawn through the proximal opening 11 of the housing 2 and replaced by a new insert with valve member and catheter 3, 4, 43, 44. To protect the cover 7 from contamination and damage a shield (not shown) may be mounted on it.

EXAMPLE 2

Second Embodiment of the Device of the Invention

[0077] The second embodiment (FIG. 11) of the venous or peritoneal access device of the invention relates to a device for venous infusion or peritoneal infusion as well as peritoneal sequential infusion and drainage in peritoneal dialysis. The device 101 for venous infusion or peritoneal infusion or infusion/drainage shares all functional elements with the device for hemodialysis 1 of EXAMPLE 1 except for that its catheter is a single lumen venous or peritoneal catheter 147, 148 and that one 13, 18, 24 of the two fluid passages 12, 17, 23 and 13, 18, 24 extending between the hemodialysis catheter 47, 48 and the coupling member 5 has been omitted. In contrast to the double-channel embodiment of Example 1, the device of Example 3 is a single-channel venous access device. It can be used, for instance, for infusion of aqueous solutions or suspensions comprising pharmaceuticals and/or nutrients and/or salts. Elements of same function in the single fluid passage venous or peritoneal access device 101 of Example 3 as in the double fluid passage hemodialysis access device 1 of Example 1 retain the reference numbers of the latter 1 preceded by 10. In the device of Example 3 non-modified elements 2, 6, 7, 39 and their substructures are shared with the device of Example 1 and therefore retain their reference numbers. When used for peritoneal dialysis, the catheter of the device of the invention is one specifically designed for peritoneal access having a blunt tip (not shown) since it need not be inserted into a blood vessel.

[0078] Correspondence of FIGS. (first embodiment/second embodiment): 1a/1a; 1b/1d; 1c/1c; 2a/9a; 2b/9b; 2c/9c; 2d/9d; 2e/9e; 2f/9f; 3a/3a; 3b/3b; 4a/4a; 4b/4b; 4c/4d; 5a/10a; 5b/10b; 5c/10c; 5d/5d; 6/11.

EXAMPLE 3

Variety of the Housing of the Device According to the Invention

[0079] The third embodiment of the invention relates to a housing 102 variety, FIG. 7, which can be substituted for the housing 2, 102 of the first and second embodiment of the device of the invention. The lower portion of the housing 102 is provided with a number of slits 150 extending in a circumferential direction. Also provided are a number of through bores 151 arranged near the distal skirt of the housing 102. The bores 151 are provided to allow attachment of the housing 102 to surrounding tissue by means of suture. On a circumferential proximal flat face are disposed four threaded bores 152 for mounting of a cover 107 (FIG. 8) by means of screws. The cover 107 comprises an integral rotation restricting element 106 of a design corresponding to that of element 6, 106 of the first and third embodiments. Reference numbers indicate: 135, a central bore; 128, 129, diametrically opposite, axially extending grooves in the bore 135 wall; 126, a shoulder limiting the rotation of a coupling member (not shown) inserted into the bore 135. Also provided are four circumferentially disposed through bores 153 in a flat distal circumferential face of the cover 107 for insertion of mounting screws. The bores 153 are superimposable on the threaded bores 152 of the housing 102.

[0080] Materials. The housing 2; 102; 102 of the device 1, 101 of the invention is preferably made of a stiff material, in particular a metallic or ceramic biocompatible material, for instance titanium or zirconium oxide, suitable for tissue integration. The other components of the device 1, 101, except for the flexible tubing of the catheter and the tubes connecting the device (1, 101) with a dialysis apparatus, are preferably made of a stiff biocompatible material, such as polylactide or poly(lactide-co-glycolide) of high molecular weight or a polyurethane/polyurea material. Surfaces of the device (1, 101) in contact with blood are preferably made anticoagulant by chemical treatment, such as by heparinization.