Implant containing rods

Abstract

An implant that has a tubular interior section for implantation into a patient, an exterior section connected to the interior section and an ingrowth member that includes a three-dimensional porous structure. The three-dimensional porous structure is typically located at the inner circumference of the interior section and has desirable properties to facilitate ingrowth of tissue.

Claims

1. A percutaneous ostomy implant comprising: a tubular interior section for implantation into a patient; and an exterior section connected to the interior section, the exterior section having an inner portion defining an interior circumference and an outer portion surrounding the inner portion and defining an outer circumference, a surface of the inner circumference of the exterior section comprising a rigid three-dimensional porous structure for ingrowth of serosal tissue; wherein the porous structure comprises at least three layers having openings, and wherein said layers are interconnected and arranged such that the openings of each layer is displaced with respect to the openings of neighboring layers; and wherein a thickness of any member forming the porous structure is less than or equal to 500 μm and wherein the maximum diameter of any of said openings is 500 μm.

2. The implant as claimed in claim 1, wherein the porous structure is integral with the rest of the exterior section.

3. The implant as claimed in claim 1, wherein the exterior section is ring-shaped, and/or the porous structure is arranged around the entire inner circumference of the exterior section, and/or the interior section extends radially outwardly at an inner end.

4. The implant as claimed in claim 1, further comprising an anchoring flange extending radially outwardly from the interior section, wherein the anchoring flange is formed from a mesh.

5. The implant as claimed in claim 1, wherein the porous structure has a thickness of at least 0.5 mm, and/or the porous structure is completely permeable and has no dead ends, and/or each passage entering the porous structure also has an exit.

6. The implant as claimed in claim 1, wherein the porous structure is made from titanium and/or the porous structure is formed from interconnecting members that are arranged in layers or concentrically arranged layers and when layers are present, the layers are connected by connecting members.

7. The implant as claimed in claim 1, wherein the porous structure has an irregular structure and/or the implant includes a mating lid, bag and/or evacuation device provided therewith.

8. The implant as claimed in claim 1, wherein the ingrowth means has a three-dimensional porous structure that has a thickness of at least 0.5 mm, and/or is completely permeable and has no dead ends, with each passage entering the porous structure also having an exit.

9. The implant as claimed in claim 8, wherein the ingrowth means is in the form of a three-dimensional porous structure, wherein at least 80%, at least 85%, at least 90%, at least 95%, or at least 97% of the openings into the porous structure have a corresponding exit.

10. The implant as claimed in claim 1, wherein the cross-sections of any members and/or openings forming the three-dimensional porous structure are circular, elliptical, super-elliptical, quadratic with rounded corners, hexagonal, octagonal, polygonal, polygonal with rounded corners, or rectangular with rounded corners.

11. The implant as claimed in claim 1, wherein the porous structure has an irregular structure and/or the implant includes a mating lid, bag and/or evacuation device provided therewith.

12. The implant as claimed in claim 6, wherein the interconnecting members form a regular, repeating pattern throughout the porous structure.

13. The implant as claimed in claim 1, wherein pores of the porous structure extend in multiple directions with respect to the surface of the inner circumference.

14. The implant as claimed in claim 1, wherein there is no gap between the porous structure and the rest of the exterior section.

15. The implant as claimed in claim 1, wherein the porous structure is connected to the rest of the exterior section at least at first and second end regions thereof.

16. The implant as claimed in claim 1, wherein the porous structure extends to within 1 mm, 2 mm or 3 mm of an exterior end of the exterior section.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) Preferred embodiments of the invention will now be described by way of example only and with reference to the accompanying drawings, in which:

(2) FIG. 1 is a perspective view of an embodiment of an implant;

(3) FIG. 2 is another perspective view of the implant of FIG. 1;

(4) FIG. 3 is a bottom view of the implant of FIG. 1;

(5) FIGS. 4(a)-(c) are side views of the implant of FIG. 1;

(6) FIG. 5 is a top view of the implant of FIG. 1;

(7) FIG. 6 is a perspective view of another embodiment of an implant;

(8) FIG. 7 is another perspective view of the implant of FIG. 6;

(9) FIG. 8 is a bottom view of the implant of FIG. 6;

(10) FIGS. 9(a)-(c) are side views of the implant of FIG. 6;

(11) FIG. 10 is a top view of the implant of FIG. 6;

(12) FIG. 11 is a perspective view of a porous structure;

(13) FIG. 12 is a part cut-away perspective view of an implant with the porous structure of FIG. 11;

(14) FIG. 13 is a perspective view of an implant with the porous structure of FIG. 11;

(15) FIG. 14 is a bottom view of the implant of FIG. 13;

(16) FIG. 15 is a side view of the implant of FIG. 13;

(17) FIG. 16 is a cross-sectional view of an implant along the line B-B in FIG. 15;

(18) FIG. 17 is a cross-sectional view of an implant along the line A-A in FIG. 15;

(19) FIG. 18 is a top view of the implant of FIG. 14;

(20) FIG. 19 is shows the area labelled C in FIG. 17 in more detail;

(21) FIG. 20 is the area labelled D in FIG. 16 in more detail;

(22) FIG. 21 is another perspective view of the implant of FIG. 13;

(23) FIG. 22 is a perspective view of part of a porous structure;

(24) FIG. 23 is an exploded perspective view of the porous structure of FIG. 22;

(25) FIG. 24 shows a part of another porous structure;

(26) FIGS. 25(a)-(c) show parts of the porous structure of FIG. 24 in more detail;

(27) FIGS. 26(a)-(f) show top, bottom, bottom perspective, top perspective, front and side views, respectively, of an embodiment of an adaptor;

(28) FIG. 27 is a bottom perspective view of the adapter of FIGS. 26(a)-(f) attached to the implant of FIG. 6;

(29) FIG. 28 is a top perspective view of the adapter of FIGS. 26(a)-(f) attached to the implant of FIG. 6; and

(30) FIG. 29 is a perspective view of the adapter of FIGS. 26(a)-(f) and the implant of FIG. 6 before attachment.

DETAILED DESCRIPTION OF THE INVENTION

(31) FIGS. 1 to 5 show an embodiment of an implant 1.

(32) The implant 1 is formed of an interior section 2 and an exterior section 3. When implanted in a patient, the interior section 2 is located mostly or entirely inside the patient whereas the exterior section 3 is located mostly or entirely outside of the patient.

(33) The interior section 1 is formed of an inner interior section part 4 and an outer interior section part 8.

(34) The inner interior section part 4 is a substantially cylindrical structure formed of a hexagonal mesh. At its lower (as shown in the figures) or inner end, the cylinder flares radially outwardly in a radially extending part 4a and is terminated by a continuous solid ring 5.

(35) An anchoring flange 6 extends radially outwardly from the inner interior section part 4. This is also made of a hexagonal mesh. The anchoring flange 6 has at its radially outer edge a continuous solid ring 7. The inner interior section part 4 extends both above and below (i.e. outwardly and inwardly from) the anchoring flange 6.

(36) The anchoring flange 6 extends to a greater radius than the radially extending part 4a.

(37) The outer interior section part 8 connects the inner interior section part 4 to the exterior section 3. The outer interior section part 8 is formed from a number of rods 9 extending between the inner interior section part 4 and the exterior section 3. The rods 9 are arranged circumferentially around the implant 1.

(38) Some of the rods 9 are slanted with respect to the longitudinal axis of the implant 1 and others are parallel with it. The slanted rods are angled so that they can withstand rotational forces acting on the implant 1. The rods which are parallel with the longitudinal axis of the implant 1 are for withstanding loads acting on the implant 1 longitudinally.

(39) Some of the rods 9 have an exterior end which is located radially inwardly compared to the exterior ends of other rods 9. The interior ends of the rods 9 are all located at the same radius of the implant 1.

(40) The rods 9 have a maximum diameter of 300 μm and a length of around 4.8 mm. The slanting rods are slightly longer than the parallel rods.

(41) The exterior section 3 is ring-shaped and has an outer circumferential groove 11 to which part of a lid or a connector (e.g. to a bag or other device) or other device may be attached.

(42) The exterior section 3 also has three indentations 12 into which an adaptor (such as the turnbull adaptor described below) or other device may be attached. The indentations 12 are arranged at equally spaced intervals around the outer circumference of the exterior section 3.

(43) The interior surface of the exterior section 3 is formed from a three-dimensional porous structure 13 (not shown in detail here), such as porous structure 213 or 313 described below.

(44) All elements of the implant 1 are integral with each other and made from the same material. The implant 1 is formed entirely of titanium.

(45) The implant 1 is manufactured using a laser 3D printing process. After the implants 1 have been printed using the laser 3D printing process, the outer surface of the exterior section 3 is polished to give a smooth finish.

(46) Alternatively, the implant 1 may be moulded and/or made in parts which are subsequently joined together.

(47) FIGS. 6 to 10 show an embodiment of an implant 101 with a larger inner diameter than the implant 1 of FIGS. 1 to 5.

(48) However, like the implant 1 of FIGS. 1 to 5, the implant 101 is also formed of an interior section 102 and an exterior section 103. The interior section 102 is formed of an inner interior section part 104 and an outer interior section part 108.

(49) The inner interior section part 104 has a radially extending part 104a which is terminated by a continuous solid ring 105.

(50) An anchoring flange 106 extends radially outwardly from the inner interior section part 104 and has at its radially outer edge a continuous solid ring 107.

(51) The outer interior section part 108 is formed of a number of rods 109 extending between the inner interior section part 104 and the exterior section 103.

(52) The exterior section 103 has an outer circumferential groove 111 and three indentations 112. The interior surface of the exterior section 103 is formed from a three-dimensional porous structure 113.

(53) Other features of the implant 1 described above apply equally to the implant 101.

(54) FIG. 11 shows a porous structure 213. As shown in FIGS. 12 to 21, the porous structure 213 is in the form of a hollow cylinder or tube located at an inner surface of the exterior section 203.

(55) The implant 201 shown in FIGS. 12 to 21 is generally similar to the implants 1 and 101 described above so its structure will not be described in detail. The only difference to implant 1 is that there are no indentations on the exterior section 203.

(56) The implant 201 is formed of an interior section 202 and an exterior section 203. The interior section 201 is formed of an inner interior section part 204 and an outer interior section part 208.

(57) The inner interior section part 204 has a radially extending part 204a which is terminated by a continuous solid ring 205.

(58) An anchoring flange 206 extends radially outwardly from the inner interior section part 204 and has at its radially outer edge a continuous solid ring 207.

(59) The outer interior section part 208 is formed of a number of rods 209 extending between the inner interior section part 204 and the exterior section 203.

(60) The exterior section 203 has an outer circumferential groove 211 but no indentations. The interior surface of the exterior section 203 is formed from the three-dimensional porous structure 213.

(61) The porous structure 213 is completely permeable; there are no dead ends. Every passage entering the porous structure also has an exit. The maximum thickness of any member forming the porous structure is 300 μm and the maximum diameter of any opening is also 300 μm.

(62) FIGS. 22 and 23 show a part of the porous structure 213 in more detail. It is formed from interconnecting members 215. The members 215 are arranged in layers 216 which are connected by connecting members 217.

(63) In the embodiment shown, the members 215 and 217 form a regular, repeating pattern throughout the porous structure 213. However, in other embodiments, the porous structure has an irregular structure. The apertures in the porous structure have substantially square, rectangular or cross-shaped cross-sections. However, in alternative embodiments, some or all of the apertures are circular or oval.

(64) FIGS. 24 and 25(a)-(c) show an example of another porous structure 313. This porous structure 313 is made up of a number of repeating sub-units 314. Each of the sub-units 314 is formed of four members 315 joined together at a central point of the sub-unit 314 at ends thereof. Six sub-units 314 are joined together to form a generally hexagonal ring or unit 316. The units 316 are then joined together in a regular repeating fashion to form the porous structure 313.

(65) FIGS. 26(a)-(f) show an adaptor 500 for securing a bowel segment outside a patient's body after an ostomy has been performed.

(66) The adaptor 500 is formed of a flattened ring 501 with a short cylindrical part 502 protruding in a first direction from an inner diameter of the ring 501. Three resilient members 503 protrude from the ring 501 in an opposite direction to the cylindrical part 502.

(67) The resilient members 503 are arranged equally spaced around the ring 501 and each member 503 has a protruding part 505 located on a radially inward side of the resilient member 503 and towards an end of the resilient member 503 away from the ring 501.

(68) The ring 501 has a number of slot-shaped apertures 504 (in this case, twelve) arranged around it circumferentially.

(69) As shown in FIGS. 28 to 30, the adaptor 500 can be attached to the exterior section 103 of an implant 101. The protruding parts 505 of the resilient members 503 fit into the indentations 112, thereby attaching the adaptor 500 to the implant 101 and preventing it from moving both rotationally, transversally and longitudinally with respect to the implant 101.

(70) When attached, the adaptor 500 and the implant 101 have a common axis and the adaptor 500 is sized such that it can fit over and be attached to the implant 101. The inner diameter of the adaptor 500 and the exterior section 103 of the implant 101 are the same.

(71) The adaptor 500 is made entirely of plastic and is fabricated in a laser sintering process from medical quality polyamide powder (PA2200).

(72) The adaptor 500 is sterilised by means of autoclaving and is provided sterile. Alternatively, the adaptor 500 may be sterilised by radiation, gas such as ethylene oxide, plasma or other methods.

(73) The adaptor 500 is provided in different sizes, for example two sizes, to fit different sized implants (i.e. implants with different diameters).

(74) The adaptor 500 is intended to be used during the surgical procedure when implanting an implant such as one described above. When attached to the implant 101, the adaptor 500 can receive the bowel segment therethrough and allow the bowel segment to be reverted back over the adaptor 500.

(75) The adaptor 500 can be used to fix the efferent intestine for around 4 to 6 weeks after implantation, in order to provide best possible stress-free healing and in-growth conditions for the ileum during the integration process with the implant.

(76) The adaptor 500 is attached to the exterior section 103 of the implant 101 at the end of the implantation procedure. It is used to secure the efferent intestine with a few sutures, during the first four to six weeks after implantation. Thereafter, the efferent intestine is cut away and the adaptor 500 is removed.

(77) In order to use the adaptor 500, the following steps are performed: Clip the adaptor 500 onto the exterior section 103 of the implant 101. Turn it lightly to ensure it locks correctly in place. The efferent end of the intestine is reverted over the adaptor 500 above the implant 101 and secured using sutures through the apertures 504. Make sure that the groove 111 around the outside of the exterior section 130 is free from tissue so that it can be used for attachment of a stabiliser device (not shown). (A stabiliser device is a device used to secure the implant 101 in place during the healing period by providing support against tilting or vertical movement of the implant 101. It can be attached to the exterior section 103 of the implant 101, for example, and rests on the skin or a skin barrier.) Anchor the intestine to the peritoneum using sutures.

(78) After a few weeks the intestine should have grown enough into the implant 101 for the adaptor 500 to be removed. The part of the intestine protruding outside the implant 101 will now have started to wizen and is cut away. The adaptor 500 is removed and the intestine will reside permanently just at the top of the implant 101.

(79) In order to remove the adaptor 500, the following steps are performed: Remove any stoma bag and clean the orifice gently. Carefully remove the stabiliser device and the stoma skin barrier. Gently rinse around the implant 101 to remove any intestinal content or liquid. With a diathermy scalpel, incise the intestine inside of adaptor 500 three millimetres from the top through the entire thickness of the intestine. If needed, dissect the intestine down to the base of the adaptor 500 with a forceps. Do not to go beyond the base of the adaptor 500 as this could cause harm to the tissue in-growth into the implant cylinder, resulting in leakage. With a pointed object, carefully lift the resilient members 503 out of the indentations 112 in the exterior section 103 and remove the adaptor 500 slowly. With dissection scissors, trim any excess tissue that remains above the exterior section 103 of the implant 101. If catheterization is needed, do not to touch the inside (interior diameter) of the implant 101. Put a new skin barrier, stabiliser and stoma bag in place.