WO2019155195A1 - Transcutaneous port and method for manufacture - Google Patents
Transcutaneous port and method for manufacture Download PDFInfo
- Publication number
- WO2019155195A1 WO2019155195A1 PCT/GB2019/050304 GB2019050304W WO2019155195A1 WO 2019155195 A1 WO2019155195 A1 WO 2019155195A1 GB 2019050304 W GB2019050304 W GB 2019050304W WO 2019155195 A1 WO2019155195 A1 WO 2019155195A1
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- WO
- WIPO (PCT)
- Prior art keywords
- mesh
- port
- transcutaneous
- port body
- impermeable portion
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
- A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
- A61F5/445—Colostomy, ileostomy or urethrostomy devices
- A61F2005/4455—Implantable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
- A61M2039/0261—Means for anchoring port to the body, or ports having a special shape or being made of a specific material to allow easy implantation/integration in the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
- A61M2039/0273—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body for introducing catheters into the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
- A61M2039/0279—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body for introducing medical instruments into the body, e.g. endoscope, surgical tools
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
- A61M2039/0285—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body with sterilisation means, e.g. antibacterial coatings, disinfecting pads, UV radiation LEDs or heating means in the port
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
- A61M2039/0291—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body method or device for implanting it in the body
Definitions
- the present invention relates to a transcutaneous port.
- the invention further relates to a method of manufacturing the transcutaneous port of the invention, and to a method of inserting the transcutaneous port into the human or animal body.
- Transcutaneous ports provide a point of access into a human or animal body from the outside. Transcutaneous ports can usefully provide sites for intermittent access to the body, for instance to allow administration of intravenous fluids or pharmaceutical products.
- Transcutaneous ports are also useful in providing long-term access, such as for a power supply cable to an implanted medical device. Transcutaneous ports may also be potentially used to support stoma for ileostomy, colostomy, neurostimulation or urostomy.
- a common problem arising with transcutaneous ports is the high risk of infection at the port site. It is thought that infections are caused because after the skin is broken to provide an entry site for the transcutaneous port, although the skin generally locally heals it does not form a secure and skin tight seal with the implanted port. Small gaps between skin and port provide sites for entry of foreign bodies which cause infection. Furthermore, during the healing process epidermal cells (cells forming the top layer of skin) have a tendency to migrate inwards along the side of the port, towards the soft tissue below the skin (also referred to as growth or migration of skin“downwards”). Epidermal cells also grow outwards along the port edge, forming a raised lip on the skin surface.
- the epidermal layer separates the vascularised tissue and dermis beneath from the transcutaneous port, preventing this tissue from bonding to the port.
- the migration of epidermal cells inwards or outwards along the sides of the port also creates folds within the skin, or pockets between the skin and the device, which cannot be easily cleaned and disinfected. These pockets can fill with bodily fluids and/or foreign bodies, and are thus highly susceptible to infection. Infection can lead to painful swellings, abscesses and even sepsis.
- US 2003/0120215 suggests a transcutaneous access device having a flat button portion which is implanted under the skin.
- the button has a neck which can receive a catheter.
- the neck is attached to a highly flexible sleeve or tube.
- the button and neck positioned beneath the skin are covered with a porous coating such as a Dacron velour.
- This coating is intended to promote the formation of subcutaneous tissue.
- skin cells migrate down the sleeve or tube towards the coating and it is hoped that a tight seal will form with the subcutaneous tissue at the covering.
- this device still suffers from the difficulty that epidermal cells migrating down the sleeve or tube form pockets which are difficult to clean, and the risk of infection remains.
- Transcutaneous devices can be subject to considerable torsional forces. The problem is particularly pronounced for transcutaneous devices which are attached to tubes outside a patient’s body, which can be easily pulled or twisted. Another common problem with transcutaneous devices is therefore that they are easily torn away from the skin, and in some cases ripped out entirely. Even in the absence of large or sudden torsional forces, frequent micro-motion of a transcutaneous device against the adjacent skin can lead to undesirable consequences such as abrasion, inflammatory response and infections.
- transcutaneous part which is screwed into the subcutaneous portion.
- this device has considerable disadvantages. Firstly, the subcutaneous portion must be implanted several months before the transcutaneous portion can be attached, meaning that the process is very slow. Secondly, in some cases epidermal downgrowth was found to occur, meaning that epidermal skin cells were growing down the sides of the transcutaneous portion and preventing connections forming between the device and connective tissue. Moreover, this downgrowth caused pockets which could harbour infection.
- the present invention aims to overcome the disadvantages of the above devices and to provide a transcutaneous port which reduces the likelihood of infection and which can effectively withstand torsional forces.
- the present inventors have surprisingly found that excellent integration of a transcutaneous port with the skin can be achieved by encouraging growth of the dermis into the port body while restricting the space available for epidermal cell growth.
- the mesh has a greater thickness below the epidermis, meaning that the volume available for dermal growth into the mesh is larger than the volume available for epidermal cell growth into the mesh.
- the transcutaneous port further comprises an impermeable surface portion which is found to discourage epidermal cells from growing up over the transcutaneous port and forming folds or pockets.
- the device of the invention therefore reduces the occurrence and size of folds formed within the skin or pockets formed between the skin and the device, and therefore reduces the instance of infection.
- the excellent integration of skin tissue with the transcutaneous port means that is it resistant to being tom out of the skin.
- the excellent resistance to torsional forces means that the transcutaneous port can be surprisingly small, and need not necessarily be separately anchored in subcutaneous soft tissue or bone. Small size is a particular advantage for a transcutaneous port as the implantation of a small device is less traumatic for a patient.
- the smaller the wound site the more quickly it can heal, which again reduces the likelihood of infection.
- the invention therefore provides a transcutaneous port comprising:
- a port body (1) having an external end (2a) and a subcutaneous end (2b);
- port body (1) comprises:
- a mesh portion (4) extending longitudinally from the subcutaneous end (2b) of the port body (1), which mesh portion (4) extends laterally from an inner mesh surface (4a) to an outer mesh surface (4b) by a thickness T; wherein T has a value Tl proximate to the first impermeable portion (3) and a value T2 proximate to the subcutaneous end (2b), and Tl is less than T2.
- the mesh portion (4) comprises pores, which may advantageously be of a suitable size to promote growth of tissue into the port body (1).
- the mesh portion (4) comprises pores with a diameter of 50 to 2000 microns.
- the mesh portion (4) comprises a stiff mesh.
- the stiff mesh is robust and advantageously assists in firmly attaching the transcutaneous port to the skin of a patient when implanted.
- the mesh portion (4) may comprise a plurality of ribs arranged in a diamond hexagonal lattice.
- a diamond hexagonal lattice is strong, leading to a robust device.
- a diamond hexagonal lattice of ribs can also be formed into a cylinder (which is one preferred shape of the mesh portion (4)) leaving few ribs protruding from the cylinder and thus reducing discomfort and tissue damage for the patient when the transcutaneous port is implanted.
- a diamond hexagonal lattice can conveniently be manufactured by an integral method such as 3D printing.
- the mesh portion (4) comprises a plurality of ribs arranged in a lattice, at least 90% of the ribs terminate (i) in a vertex with another rib or (ii) in an impermeable portion (3, 6).
- the first impermeable portion (3) may have a smooth surface located adjacent to the outer mesh surface (4b).
- the surface of the first impermeable portion (3) adjacent to the outer mesh surface (4b) typically protrudes from the skin when the transcutaneous port is implanted in a patient.
- the smooth surface discourages epidermal cells from growing up the side of the port body (1) (that is, away from the dermis). This prevents the device from becoming buried in the skin and reduces the occurrence of skin folds and pockets which may harbour infection.
- the transcutaneous port may comprise a coating or surface treatment on all or part of the port body (1) with properties that promote tissue integration or discourage infection when the transcutaneous port is implanted.
- the port body (1) may comprise a surface treatment or coating on all or part of its surface which comprises a biocidal metal such as silver. This discourages infection.
- the transcutaneous port of the invention can conveniently be obtained by integrally forming the port body (1). Integrally forming the port body (1) leads to a device which is strong and durable and will not come apart over time. Moreover, integral formation is a highly convenient method of forming a device having a complex internal structure, which may be the case for a transcutaneous port according to the invention.
- a transcutaneous port comprising a port body (1) according to the invention, wherein the method comprises integrally forming the port body (1).
- the transcutaneous port of the invention is suitable for implantation in the human or animal body.
- the invention therefore also provides a method of inserting a transcutaneous port according to the invention into the human or animal body, the method comprising:
- Figure 1 shows a longitudinal cross-section through the centre of an exemplary port body (1).
- Figure 2 is a view of the port body (1) corresponding to the device in Figure 1.
- Figure 3a shows the port body (1) of Figure 2 and indicates the internal impermeable portion (6) and an end of the channel (5). Also shown by a solid line is plane X, which is the position of the lateral slice through the port body (1) at which the cross-section in Figure 3b is taken.
- Figure 3b is a cross-section of the port body (1) taken through the plane X indicated in Figure 3 a.
- the area of the cross-section through the internal impermeable portion (6) is labelled A and the thickness of the mesh portion (4) in plane X is labelled T.
- Figure 3c is a cross-section of the port body (1) taken through a lateral plane.
- An internal impermeable portion (6) laterally surrounded by a mesh portion (4) is shown.
- the internal impermeable portion (6) comprises a plurality of channels (5).
- the cross-sectional area A of impermeable portion (6) is shaded in grey, and includes all area contained within that portion including the channels (5).
- Figure 4 is a cross-section of the exemplary transcutaneous port according to Figures 1 to 3b implanted in the skin of a patient.
- Figure 5 shows a section of the exemplary transcutaneous port according to Figures 1 to 3b with the front half cut away. Thicknesses Tl and T2 are labelled on the Figure.
- transcutaneous port of the invention and suitable methods for manufacturing and implanting the device of the invention, are described in more detail below.
- the transcutaneous port of the invention comprises at least a first impermeable portion (3), a mesh portion (4) and a channel (5). These structural elements are arranged to form a port body (1) which can be firmly anchored in skin and which resists infection.
- transcutaneous port of the invention is described herebelow with reference to Figures 1 to 5.
- Figures 1 to 5 are merely exemplary and that the present invention encompasses variations of these embodiments.
- Figure 1 shows a longitudinal cross-section through the centre of an exemplary port body (1) comprised in the transcutaneous port of the invention.
- the transcutaneous port preferably has a rounded profile at all points of the transcutaneous port which are suitable for implantation within the skin .
- the rounded profile avoids the growth of dermal tissue around comers or points, as corners or points would lead to regions of particularly high torsional stress in the skin with a high risk of tissue damage or ripping.
- a convenient shape for the port body (1) which avoids comers is a cylindrical (annular) shape.
- the port body (1) has an approximately circular cross-section in all planes perpendicular to the longitudinal axis.
- the port body (1) comprises an external end (2a), shown at the top of the cross-section, and a subcutaneous end (2b), shown at the bottom of the cross-section.
- a first impermeable portion (3) extends longitudinally from the external end (2a).
- An internal impermeable portion (6) is typically present, abutting the first impermeable portion and extending longitudinally from the first impermeable portion (3), towards the subcutaneous end (2b) of the port body (1).
- a mesh portion (4) Arranged laterally around internal impermeable portion (6) and extending longitudinally from the subcutaneous end (2b) of the port body (1) is a mesh portion (4).
- the mesh portion (4) has a thickness T (shown in Fig.
- the port body (1) further comprises at least one channel (5) which extends longitudinally through the port body (1) from the external end (2a) to the subcutaneous end (2b) of the port body (1). In this instance the channel passes through the first impermeable portion (3) and the internal impermeable portion (6).
- exital end (2a) is meant the end of the device from which the first impermeable portion (3) extends.
- subcutaneous end (2b) is meant the end of the device which is located distally to the first impermeable portion, i.e. distally to the external end.
- the distance in a lateral direction between the inner mesh surface (4a) and the outer mesh surface (4b) may have multiple values in any lateral plane.
- the thickness T in that plane may be defined as the minimum or shortest distance in a lateral direction between the inner mesh surface (4a) and the outer mesh surface (4b).
- Figure 2 is a diagrammatic view of the outside of the port body (1) shown in Figure 1. An end of the channel (5) is visible extending through the first impermeable portion (3) at the external end (2a) of the port body (1).
- the mesh portion (4) at the subcutaneous end (2b) of the port body (1) is also visible.
- the outer mesh surface (4b) of the mesh portion (4) is visible.
- the inner mesh surface (4a) and the internal impermeable portion (6) are present but not visible.
- Figure 3a corresponds to Figure 2, except that the location of the internal impermeable portion (6) and the end of a channel (5) at the subcutaneous end (2b) of the port body (1) are indicated. Also shown by a solid line is plane X; plane X is the position of the lateral slice through the port body (1) at which the cross-section in Figure 3b is taken.
- Figure 3b is a cross-section of the port body (1) of Figures 1, 2 and 3a taken through the plane X indicated in Figure 3a.
- the port body (1) has a circular cross-section in plane X. Visible in the cross-section are: a lateral slice through a channel (5), which channel (5) passes longitudinally through the internal impermeable portion (6); the internal mesh surface (4a) at the interface between the mesh portion (4) and the internal impermeable portion (6); the mesh portion (4) and the outer mesh surface (4b). Also indicated is the thickness T in plane X.
- Thickness T in plane X is the shortest distance between the inner mesh surface (4a) and the outer mesh surface (4b), as measured along the direction of a straight line in plane X originating at a longitudinal axis through the port body (1).
- the longitudinal axis lies along a channel (5).
- FIG 4 shows a longitudinal cross-section of an exemplary transcutaneous port of the invention (corresponding to the port body (1) of Figures 1 to 3b) implanted in the skin of a patient.
- the port body (1) comprises a first impermeable portion (3) standing proud of the skin, a cone-shaped internal impermeable portion (6) and a mesh portion (4) surrounding the cone-shaped internal impermeable portion (6).
- the thickest part of the mesh portion (4) at the subcutaneous end (2b) of the port body (1) is placed in contact with the innermost part of the dermis.
- the thinnest part of the mesh portion (4) proximate to the first impermeable portion (3) of the port body (1) is placed adjacent to or in contact with the epidermis.
- the first impermeable portion is typically exposed to the environment when the transcutaneous port is implanted in a patient, as shown in Fig. 4.
- the first impermeable portion (3) may alternatively be covered entirely or partly by a coating or surface treatment, or a further structural moiety.
- the first impermeable portion (3) extends across the entire external end (2a) of the port body (1) (excepting the opening to a channel (5)). As is seen in Fig.
- the first impermeable portion (3) is configured to cover the entire external end (2a) of the port body (1) except the opening of the channel, (5), the first impermeable portion (3) covers the whole incision site when the device is implanted (except the opening of a channel, (5)).
- the first impermeable portion (3) can thereby prevent environmental contaminants from entering the body at the implant site.
- the first impermeable portion (3) is configured to stand proud of the skin when the transcutaneous port is implanted into a body.
- Figure 4 shows the entire longitudinal height of the first impermeable portion (3) protruding from the skin when the port is implanted;
- first impermeable portion (3) may be positioned partly beneath the plane of the skin. This arrangement prevents growth of skin over the top of the port body (1) when it is implanted in a body.
- the first impermeable portion (3) and if present the second impermeable portion - also referred to as the internal impermeable portion - (6) typically comprise an impermeable material.
- impermeable means“impermeable to tissue growth”.
- Suitable impermeable materials include inert metals such as surgical steel or titanium, and biologically compatible plastics such as Dacron; however, other materials may be used if they are coated with a biologically compatible, impermeable material.
- the first impermeable portion typically comprises a layer of impermeable material that is sufficiently high (in the longitudinal direction) to impart strength to the port body (1) and to stand proud of the skin when implanted.
- the height of the first impermeable portion in a longitudinal direction is at least 0.5 mm, preferably at least 1 mm and more preferably at least 2 mm.
- the height of the first impermeable portion in a longitudinal direction is typically 2 cm or less; preferably 1 cm or less.
- the height of the first impermeable portion in a longitudinal direction is from 1 mm to 1 cm.
- the first impermeable portion has a rounded profile in a lateral direction, which shape avoids sharp comers and hence regions of particularly high torsional stress in the skin.
- This is exemplified in Figures 1, 2 and 3a where the first impermeable portion (3) has a circular profile in the lateral plane.
- the first impermeable portion comprises a rounded disc such as a circular or oval disc, approximately 1 mm to 10 mm high in the longitudinal direction, and comprises an opening for a channel.
- the first impermeable portion comprises an opening to allow a channel to extend through the first impermeable portion.
- the port body(l) comprises two or more channels
- the first impermeable portion typically comprises one opening per channel, to allow each channel to extend through the first impermeable portion.
- an opening is located approximately in the middle of the first impermeable portion.
- the first impermeable portion may comprise an opening located away from the middle of the first impermeable portion.
- the first impermeable portion comprises a smooth surface.
- a typical smooth surface is a polished surface.
- Other examples of typical smooth surfaces include grit blasted surfaces, machine finished surfaces and shot peened surfaces.
- a surface of the first impermeable portion which is suitable for exposure to the environment when the
- transcutaneous port is implanted (which may be referred to as the upper surface) is typically smooth; for example it may be a smooth polished surface. This prevents catching of the device on clothing and makes it easy to clean. Moreover it discourages bacterial attachment and allows for easier removal of bacteria.
- the first impermeable portion may alternatively or additionally comprise a coating to improve its smoothness, and/or to reduce attachment of external species.
- This coating may for instance be provided on a polished, grit blasted, machine finished or shot peened surface, or to a roughened surface. Suitable coatings include diamond-like carbon coating (DLC coating).
- the first impermeable portion may comprise a smooth surface at any point which may contact the epidermis when the port body (1) is implanted.
- the first impermeable portion (3) may comprise a smooth surface located adjacent to the outer mesh surface (4b). This advantageously discourages or even prevents epidermal growth up the sides of the port body (1) in a direction towards the external end (2a) of the port body (1).
- a smooth surface typically has an average surface roughness (RA) of 0.2 microns or less, typically 0.1 microns or less.
- the average surface roughness (RA) as used herein refers to the arithmetic mean surface roughness, which is defined as the arithmetic average of the absolute values of the profile height deviations from the mean surface plane. Average surface roughness is typically measured by stylus, interferometry or SEM.
- the surface(s) of the port body that are for contacting tissue when the device is implanted may be rough.
- the surface(s) of the internal impermeable portion that are for contacting tissue e.g. epithelial tissue, particularly the dermis
- all or part of the mesh portion may comprise a rough surface(s).
- such surfaces may have an average roughness of at least 0.2 microns, or at least 0.5 microns. For instance, they may have an average roughness of up to 5 microns or up to 10 microns.
- the roughened surface is advantageous in that it promotes tissue growth onto the roughened surface and thus promotes the formation of a tight seal between the port and the skin. It is additionally of assistance during the implantation process as it grips the skin and reduces sliding, which is convenient for the surgeon.
- the ability of the port body of the invention to grip the skin is also promoted by the porous structure of the mesh portion, which allows partial infilling of the dermis into the mesh portion (i.e. the porous body) upon implantation of the transcutaneous port.
- the mesh portion (4) is located at the subcutaneous side of the first impermeable portion (3). As can be seen in each of Figures 1, 2, 3a and 4, the mesh portion (4) is located underneath the first impermeable portion when the device is implanted. Thus, when the transcutaneous port of the invention is implanted into a body, all or part of the mesh portion (4) is placed within or below the skin (Fig. 4); typically, the mesh portion (4) is not exposed to the environment once the transcutaneous port is implanted and the wound has healed.
- the mesh portion (4) is configured to allow the ingrowth of skin cells, causing the
- the mesh portion (4) has a thickness, T, which has a value Tl proximate to the first impermeable portion (3) and a larger value T2 proximate to the subcutaneous end (2b) of the port body (1).
- T is illustrated in Figure 3b. T varies longitudinally through the mesh portion (4). The exact value of T will therefore depend on the lateral plane in which it is measured.
- T may also vary depending on which part of the mesh portion (4) is measured in that plane if the mesh portion (4) is not symmetrical. T may therefore be defined as being equal to the shortest distance between the inner mesh surface (4a) and the outer mesh surface (4b) measured along the direction of a straight line in a plane perpendicular to a longitudinal axis of the port body and originating at the longitudinal axis.
- inner mesh surface (4a) is meant the surface of the mesh portion (4) nearest to the centre of the port body (1), illustrated in Figures 1, 3a and 3b.
- the inner mesh surface (4a) is typically the surface abutting the channel (5) or the internal impermeable portion (6).
- outer mesh surface (4b) is meant the surface of the mesh portion (4) furthest from the centre of the port body (1) in a lateral direction.
- the outer mesh surface extends laterally around the outside of the mesh portion (4) and also often along the subcutaneous end (2b) of the port body (1).
- the thickness of the mesh portion T has a value Tl proximate to the first impermeable portion (3) and a value T2 proximate to the subcutaneous end (2b).
- Tl is smaller than T2.
- T varies from Tl to T2 in a longitudinal direction away from the first impermeable portion (3). It may equally be said that T varies from Tl to T2 in a longitudinal direction towards the subcutaneous end (2b) of the port body (1).
- a longitudinal axis of the port body (1) is an axis that passes in a straight line between the external end (2a) and the subcutaneous end (2b) of the port body (1).
- a longitudinal axis of the port body (1) is an axis that passes in a straight line between the external end (2a) and the subcutaneous end (2b) of the port body (1).
- longitudinal axis lies along the straight line which connects the centre of the external end (2a) and the subcutaneous end (2b) of the port body (1).
- a longitudinal axis lies along a channel (5).
- the longitudinal axis may not coincide with a channel, for instance where a channel (5) is off-set or lies at an angle to a straight line connecting the external end (2a) to the subcutaneous end (2b).
- the port body (1) may not be symmetrical about a longitudinal axis.
- one or more of the first impermeable portion (3), the mesh portion (4), the channel (5) and the internal impermeable portion (6) may not be symmetrical about the longitudinal axis.
- the port body is substantially symmetrical about the longitudinal axis.
- the port body (1) has a longitudinal axis joining the centre of the external end (2a) to the centre of the subcutaneous end (2b) of the port body (1) and the channel (5) lies along that longitudinal axis.
- the part of the mesh portion (4) which has a thickness Tl extends longitudinally from the first impermeable portion (3) of the port body (1).
- the mesh portion (4) typically extends from the subcutaneous end (2b) of the implant to the first impermeable portion (3), as in Figures 1 to 4.
- the part of the mesh portion (4) having a thickness Tl typically contacts the epidermis (Fig. 4). It is desirable to encourage the epidermis to grow closely against the port body (1) or even into the port body (1) to a limited extent, to promote healing and create a barrier against foreign bodies entering the mesh portion (4). However, it is desirable to prevent excessive ingrowth of the epidermis to prevent downgrowth and hence Tl is typically small, as will be discussed in more detail below.
- the part of the mesh portion (4) having thickness Tl may contact the upper layers of the dermis.
- the first impermeable portion (3) is typically situated at least partly within the skin ( i.e . below the skin surface, for instance in contact with the epidermis).
- the thickness T of the mesh portion (4) may fall to zero at the end of the mesh portion (4) nearest to the external end (2a) of the port body (1).
- the end of the mesh portion (4) which is nearest to the external end (2a) of the port body (1) is located at the interface between the mesh portion (4) and the first impermeable portion (3) and is very small or even zero.
- Tl is zero.
- the mesh portion (4) may have a non-zero thickness T at the end of the mesh portion (4) nearest to the external end (2a) of the port body (1).
- the subcutaneous end (2b) of the port body (1) contacts the dermis when implanted (see Figure 4). It is desirable to encourage dermal growth and even vascularisation into the port body (1) to ensure that the port body (1) is well secured and that the tissue within, underneath and around it is healthy. Thus the greater thickness T2 of the mesh portion (4) at or proximate to the subcutaneous end (2b) encourages maximal ingrowth of the dermis to the port body (1) (the dermis being the portion of the skin under the epidermis). The subcutaneous end may also contact the hypodermis, beneath the dermis (Fig. 4).
- the subcutaneous end (2b) may protrude through the hypodermis to contact the soft tissue or even bone underneath the skin.
- the mesh portion (4) at the subcutaneous end (2b) of the port body (1) is typically configured to promote ingrowth of the said soft tissue or bone into the port body (1).
- the transcutaneous port of the invention may comprise a coating, surface treatment or further structural moiety at the subcutaneous end (2b) of the port body (1) such that the mesh portion (4) does not extend longitudinally to the extreme subcutaneous end (2b) of the port body (1).
- the smaller thickness Tl of the mesh portion (4) proximate to the first impermeable portion (3) of the port body (1) in comparison to the larger thickness T2 of the mesh portion (4) proximate to the subcutaneous end (2a) discourages migration of the epidermal cells in a direction towards the subcutaneous end (2b) of the port body, i.e. discourages downgrowth of epidermal cells.
- the first impermeable portion (3) may or may not contact the mesh portion (4).
- the mesh portion (4) is directly attached to the first impermeable portion (3).
- the mesh portion (4) is directly attached to the internal impermeable portion (6), where present. In further embodiments (such as are shown in Figures 1, 2 and 3a) the mesh portion (4) is attached to the first impermeable portion (3) and to the internal impermeable portion. In Figures 1, 2 and 3a the mesh portion (4) is attached to the first impermeable portion (3) at the point where the outer mesh surface (4b) meets the first impermeable portion (3). In other embodiments the mesh portion (4) may contact a larger area of the first impermeable portion (3).
- an internal impermeable portion (6) is present ( Figures 1, 3a, 3b, 4).
- the internal impermeable portion (6) can define a part of a channel (5) through the port body (1) and can advantageously anchor any conduit such as a tube, hose, needle, cable, electrode, wire, catheter, gas line or drain passing through the port body (1).
- the port body (1) of the transcutaneous port of the invention further comprises an internal impermeable portion (6); the internal impermeable portion (6) being located between the first impermeable portion (3) and the subcutaneous end (2b) of the port body (1) (in a longitudinal direction) and located at least partly within the mesh portion (4); and a channel (5) extends longitudinally through the internal impermeable portion (6).
- the internal impermeable portion is clearly shown in Figure 1 and indicated in Figure 3 a.
- the internal impermeable portion (6) extends longitudinally from the first impermeable portion (3).
- the internal impermeable portion (6) extends from the first impermeable portion (3) in a direction towards the subcutaneous end (2b) of the port body (1) .
- the internal impermeable portion (6) is located at least partly within the mesh portion (4)
- the mesh portion (4) is disposed around at least a part of the internal impermeable portion (6).
- the first impermeable portion is laterally surrounded by the mesh portion in at least one lateral plane.
- the internal impermeable portion (6) extends
- the internal impermeable portion (6) may not extend as far as the subcutaneous end (2b) of the port body (1).
- the mesh portion (4) may extend further in the direction of the subcutaneous end (2b) than the internal impermeable portion (6).
- the internal impermeable portion (6) may extend further towards or more proximally to the subcutaneous end (2b) of the port body (1), such that at least a part of the internal impermeable portion (6) extends beyond the mesh portion (4) in the direction of the subcutaneous end (2b).
- the internal impermeable portion may therefore have a height in a longitudinal direction which is greater than, equal to or less than the height of the mesh portion in a longitudinal direction.
- the height of the internal impermeable portion is up to 50 mm, for instance up to 20 mm. More typically, the height of the internal impermeable portion is up to 10 mm, for instance up to 5 mm or preferably up to 2500 microns.
- the height of the internal impermeable portion is at least 100 microns, for example at least 200 microns or at least 500 microns.
- the height of the internal impermeable portion is from 100 to 5000 microns, particularly preferably from 200 to 2500 microns.
- the port body (1) is intended for implantation in the skin specifically.
- the internal impermeable portion (6) contacts the mesh portion (4).
- the mesh portion (4) can contact the internal impermeable portion (6) at the inner mesh surface (4a).
- a gap, a coating or a further structural element may intervene between the inner mesh surface (4a) and the internal impermeable portion (6).
- the mesh portion (4) is fused to the internal impermeable portion (6), as occurs for example when the port body (1) is integrally formed.
- the internal impermeable portion (6) contacts the first impermeable portion (3), as in Figure 1.
- the first impermeable portion (3) and the internal impermeable portion (6) are in direct contact, for example they may be fused together or provided as a single integral part.
- a gap, a coating or a further structural element may intervene between the first impermeable portion (3) and the internal impermeable portion (6).
- the internal impermeable portion defines a region into which skin cannot grow.
- the internal impermeable portion can therefore advantageously be shaped so as to restrict the area available for growth of epidermal cells through the port body and hence to discourage downgrowth of epidermal cells and promote dermal integration.
- the internal impermeable portion has a larger cross-section (measured in a plane perpendicular to a longitudinal axis, as in Figure 3b) proximate to the first impermeable portion (3) and a smaller cross-section (measured in a plane perpendicular to a longitudinal axis) proximate to the subcutaneous end (2b) of the port body (1). This shape allows more space inside the port body for ingrowth of the dermis and correspondingly restricts space for growth of epidermis.
- the invention provides a transcutaneous port wherein: the internal impermeable portion (6) has a cross-section of area A in a plane perpendicular to the longitudinal axis which has a value Al proximate to the first impermeable portion (3) of the port body (1), and a value A2 proximate to the subcutaneous end (2b) of the port body (1), and Al is larger than A2.
- Cross-sectional area A varies from Al to A2 in a direction away from the first impermeable portion. It may equally be said that A varies from Al to A2 in a direction towards the subcutaneous end of the port body.
- Cross-sectional area A includes not only the area of the internal impermeable portion (6) in a plane perpendicular to a longitudinal axis, but also includes the area of any channels within the internal impermeable portion (6) in that plane. Area A is shown as the shaded area in Figure 3C.
- the change in cross-section from Al to A2 may be achieved in a stepped manner.
- the internal impermeable portion comprises steps of differing cross-section.
- the internal impermeable portion may comprise from two to twenty steps, each step being a sub-portion of a particular cross-section.
- the step which is proximate to the first impermeable portion of the port body has cross-section Al, while the step which is proximate to the subcutaneous end of the port body has cross-section A2.
- the internal impermeable portion can have a tapering shape, meaning that cross-sectional area A of the internal impermeable portion (6) decreases in a graduated manner from the part of this portion nearest to the external end (2a) to the part of this portion nearest to the subcutaneous end (2b).
- the decrease of the cross-sectional area may occur in a non-linear manner from Al to A2.
- the cross-sectional area may decrease exponentially moving in a longitudinal direction along all or part of the length of the internal impermeable portion.
- the internal impermeable portion is approximately symmetrical about the longitudinal axis, this may lead to a curved conical (e.g. concave conical) or frustoconical shape of the internal impermeable portion.
- the decrease of the cross-sectional area may occur in a linear manner.
- the internal impermeable portion is approximately symmetrical about the longitudinal axis, this may lead to a conical or frustoconical shape of the internal impermeable portion.
- the decrease of the cross-sectional area of the internal impermeable portion in a longitudinal direction from Al to A2 may occur partly in a linear manner and partly in a non-linear manner.
- the internal impermeable portion is frustoconical ( Figures 1, 3a).
- internal impermeable portion (6) is frustoconical and the base (the larger of the two circular faces) of the frustocone is located adjacent to the first impermeable portion (3).
- the channel (5) typically passes approximately between the centres of the two circular faces of the frustoconical shape.
- a channel (5) passes approximately through the centre of the cross-section of the internal impermeable portion (6) in all planes perpendicular to the longitudinal axis.
- no channel passes through the centre of the said cross- section, or a channel (5) does not pass through the centre of the said cross-section in all planes.
- the port body (1) comprises two or more channels (5)
- one or more, e.g. all, of said channels are located in a non-central position.
- said channels may for instance extend longitudinally through the port body (1), arranged in a ring.
- Al is at least 10 mm 2 .
- Al may be at least 25 mm 2 or at least 50 mm 2 .
- Al is up to 1500 mm 2 .
- Al may be up to 1000 mm 2 , or up to 500 mm 2 , or up to 100 mm 2 .
- A2 is at least 0.15 mm 2 .
- A2 may be at least 0.5 mm 2 , or at least 1 mm 2 , or at least 5 mm 2 .
- A2 is up to 60 mm 2 .
- A2 may be up to 25 mm 2 or up to 10 mm 2 .
- Al may be equal to the cross-sectional area of the base of the frustoconical shape and A2 may be equal to the cross-sectional area of the other circular face of the frustoconical shape.
- A2 may be equal to the cross-sectional area of said non-circular face.
- the entire cross-sectional area A2 may be taken up with an opening to a channel (5).
- the internal impermeable portion (6) may have a face located adjacent to or in contact with the first impermeable portion (3), wherein said face has a shape that is identical to the shape of the facing part of the first impermeable portion (3).
- the first and the internal impermeable portions are in contact and are fused at their interface, or provided as a single integral part.
- the shape of the internal impermeable portion (6) complements the shape of the mesh portion (4).
- the port body (1) as a whole has an approximately identical cross-section in all planes perpendicular to the longitudinal axis.
- the port body (1) may be substantially cylindrical.
- the thickness T of the mesh portion (4) correspondingly increases to maintain the contact between the inner mesh surface (4a) and the internal impermeable portion (6).
- the mesh portion (4) may have a thickness which varies in a complementary stepped manner along the length of the port body.
- the mesh portion may comprise from two to twenty steps, each step being a sub-portion of a particular thickness.
- the step nearest to the external end of the port body has thickness Tl, while the step proximate to the subcutaneous end of the port body has thickness T2.
- the mesh portion (4) may have a thickness which varies in a complementary graduated manner along the length of the port body.
- the thickness of the mesh portion (4) may remain in contact with the internal impermeable portion (6) along the inner edge of the mesh portion (4a) along the length of the internal impermeable portion (6) in a longitudinal direction.
- the cross-sectional area changes in a non-linear manner (e.g. exponentially in a longitudinal direction along the internal impermeable portion)
- the thickness of the mesh portion may increase in a complementary non-linear (e.g. exponential) manner.
- the mesh portion may have a complementary convex shape.
- a tapering (e.g. frustoconical) internal impermeable portion (6) is not necessarily required in combination with a mesh portion (4) having a graduated thickness T.
- the thickness T of the mesh portion (4) may increase in a graduated (e.g. linear) manner from Tl to T2 and thus form a cavity between the first impermeable portion (3) and the mesh portion (4). This cavity may optionally be filled wholly or partly with the internal impermeable portion (6).
- a channel (5) is a passage through which matter can pass between the external end (2a) and the subcutaneous end (2b) of the port body (1).
- a single channel (5) is shown in Figure 1, but two or more, for example 2, 3, 4, 5 or 10 channels, may be present.
- An opening to a channel (5) is shown in Figures 2 and 3a.
- the or each channel (5) passes longitudinally through the first impermeable portion (3) and the mesh portion (4).
- the port body (1) comprises an internal subcutaneous portion (6)
- the internal impermeable portion (6) one or more, typically each channel (5) passes through the first impermeable portion (3) and the internal impermeable portion (6).
- the internal impermeable portion (6) is located at least partly within the mesh portion (4) and hence, in this latter embodiment, one or more, e.g. each channel (5) necessarily also passes through the mesh portion (4).
- a channel (5) comprises a cavity suitable for receiving a linear conduit such as a tube, hose, cable, electrode, wire, catheter, gas line, drain or needle.
- a channel (5) comprises an approximately cylindrical cavity having an approximately circular opening at each end; one opening located in the external end (2a) and the other being located in the subcutaneous end (2b) of the port body (1).
- a channel (5) is typically perpendicular to the skin, and therefore allows matter to cross the skin via the shortest possible route.
- the diameter of a channel (5) is generally sufficiently large to receive conduit such as a tube, hose, cable, electrode, wire, catheter, gas line, drain or needle.
- diameter of the channel is at least 0.1 mm, preferably at least 0.5 mm, for example at least 1 mm.
- the diameter of the channel is 2 cm or less, preferably 1 cm or less, for example 8 mm or less.
- the diameter of the channel is typically from 0.1 mm to 1 cm, preferably 0.5mm to 8 mm.
- the channel (5) may be suitably dimensioned to prevent any conduit (such as a needle, tube, cable, electrode, wire, catheter, gas line, drain or hose) therein from falling out of the port body (1).
- the maximum diameter of the channel is 4 cm or less.
- said maximum diameter of the channel is 2 cm or less, for example 1 cm or less.
- one or more of the channels (5) may comprise a means suitable for anchoring the conduit in the channel.
- a channel may comprise a part having a shape that is complementary to the shape of part of the conduit.
- a channel itself may have a shape suitable for anchoring the conduit.
- a channel may for instance be threaded, and consequently may anchor a threaded conduit.
- a channel may comprise a separate anchoring means, for instance a bayonet fitting, a snap fitting, a click fitting, a bulkhead or a crimp.
- a channel may be shaped to receive such an anchoring means, or the anchoring means may be an integral part of a channel.
- the transcutaneous port of the invention further comprises a conduit within a channel (5) of the port body (1).
- a conduit is a needle, tube, cable, electrode, wire, catheter, gas line, drain or hose.
- transcutaneous port does not comprise a conduit within a channel.
- the invention relates to a kit comprising a transcutaneous port of the invention and a needle, tube, cable, electrode, wire, catheter, gas line, drain or hose suitable for insertion into a channel (5) of the port body (1).
- the port body (1) is typically arranged in as compact a manner as possible.
- the transcutaneous port comprises:
- a port body (1) having an external end (2a) and a subcutaneous end (2b); and at least one channel (5) which extends longitudinally through the port body (1) from the external end (2a) to the subcutaneous end (2b);
- port body (1) comprises:
- a first impermeable portion (3) extending longitudinally from the external end (2a) of the port body (1);
- a mesh portion (4) extending longitudinally from the subcutaneous end (2b) of the port body (1), which mesh portion (4) extends laterally from an inner mesh surface (4a) to an outer mesh surface (4b) by a thickness T, the inner mesh surface (4a) being in contact with the internal impermeable portion (6);
- T has a value Tl proximate to the first impermeable portion (3) of the port body (1) and a value T2 proximate to the subcutaneous end (2b) of the port body (1), and Tl is less than T2.
- the lateral extent of the first impermeable portion is the distance across the first impermeable portion in a lateral direction, i.e. the diameter for a cylindrical (or annular) first impermeable portion.
- the minimum lateral extent of the first impermeable portion is typically at least 5 mm.
- the maximum lateral extent of the first impermeable portion (3) is usually 5 cm or less.
- the maximum lateral extent of the first impermeable portion is 3 cm or less.
- the diameter of the first impermeable portion is preferably from 8 mm to 3 cm, for instance from 1 cm to 2 cm.
- the transcutaneous port of the invention can take a conveniently small and compact shape.
- a small and compact shape reduces impact on the patient.
- the maximum extent of the port body (1) in a lateral direction is 5 cm or less, and the maximum height of the port body (1) in a longitudinal direction is 5 cm or less.
- the maximum extent of the port body (1) in a lateral direction is 2 cm or less, and the maximum height of the port body (1) in a longitudinal direction is 2 cm or less.
- pores is taken to mean a structure comprising pores, i.e. a porous body.
- the mesh may be regular or irregular, as discussed in more detail below.
- the pores are interconnected, i.e. each pore is typically in communication with one or more other pores within the mesh.
- a porous body comprising interconnected pores can suitably be formed of a series of ribs or strands, arranged in a regular or irregular lattice; however, other materials comprising a plurality of interconnected pores are also suitable for forming the mesh.
- the pores are required to allow ingrowth of skin, particularly the dermis but also possibly the epidermis, into the port body (1). In some cases, the pores also allow soft tissue and/or bone to grow into the transcutaneous port. Preferably, therefore, the size of the pores is selected to promote ingrowth of skin cells, particularly dermal cells. Further, the porous structure is suitable for receiving a gel containing a biologically active agent to encourage tissue ingrowth into the device.
- the size of a pore may be defined in terms of a diameter.
- the diameter of a pore is the diameter of the largest sphere that can fit inside that pore.
- the shape of a pore is approximately spherical. However, other pore shapes are envisaged.
- the mesh portion (4) comprises pores with a diameter of 50 to 2000 microns. This size range is found to be particularly useful in promoting vascularisation.
- the mesh portion comprises pores with a diameter from 50 to 1500 microns.
- the pore size of the mesh portion may be from 100 to 1250 microns, e.g. from 200 to 1000 or 400 to 800 microns.
- the mesh portion may comprise pores of only one specific size or of a limited number of specific sizes falling within the above ranges.
- the mesh portion has an irregular structure the pore size will vary. If the pore size varies, the average pore size preferably therefore falls within the above ranges, more preferably all pores or substantially all pores (e.g. at least 90%, preferably at least 95% of pores) have sizes falling within the above ranges.
- the mesh portion may comprise pores of a suitable diameter to encourage ingrowth of the epidermis.
- the mesh portion may comprise pores of a suitable size to encourage ingrowth of dermal tissue, which may preferably be 500 pm in diameter or larger, for instance from 500 pm to 1250 pm in diameter.
- the mesh may comprise pores of differing sizes.
- the size of the pores may vary in a lateral direction through the mesh portion, and/or in a longitudinal direction through the mesh portion.
- the mesh portion may comprise larger pores (e.g. at least 400 pm) located proximately to the outer mesh surface (4b) and smaller mesh pores (e.g. no more than 200 pm) located proximate to the inner mesh surface (4a). That is, the pore size may increase in a direction from the inner mesh surface (4a) to the other mesh surface (4b). This may allow the outer pores to be less rigid (i.e. more flexible), increasing patient comfort.
- larger pores e.g. at least 400 pm
- smaller mesh pores e.g. no more than 200 pm
- the mesh portion (4) comprises pores of a size to promote epidermal growth therein located proximate to the external end (2a) of the port body (1) and pores of a size to promote dermal growth therein located proximate to the subcutaneous end (2b) of the port body (1).
- the pores may contain a gel.
- the mesh portion may be coated in a gel.
- said gel is a biologically compatible gel, such as a hydrogel.
- the gel typically further comprises a biologically active agent, such as an antibiotic or a tissue-promoting agent. This gel may advantageously therefore, by the action of said biologically active agent, reduce infection and promote tissue ingrowth. Moreover, the gel can be resorbed into the tissue as the tissue grows, and so does not prevent tissue ingrowth by restricting the space available.
- the mesh portion may preferably have a rough surface to promote tissue integration.
- the surface of the material making up the mesh portion may have an average roughness of at least 0.2 microns, or at least 0.5 microns.
- said surface may have an average roughness of up to 5 microns, or up to 10 microns or up to 50 microns.
- the roughness of the mesh may be adjusted by varying the 3D printing conditions, e.g. by varying the size of the particles from which the mesh is printed.
- the mesh portion may typically have a smooth or rounded outer mesh surface (4b).
- the mesh portion may have a circular cross-section in all planes perpendicular to the longitudinal axis, e.g. the external profile of the mesh portion may be in the form of a cylinder.
- the smooth or rounded outer mesh surface avoid comers and other such locations of high torsional stress which can lead to abrasions, skin damage and significant discomfort for the patient.
- mesh portion (4) comprises a stiff mesh.
- stiff mesh is meant a mesh that is resistant to deformation.
- a stiff mesh is a rigid (i.e. self-supporting) mesh.
- a stiff mesh has a compressive stiffness of 5 N or more, for example 10 N or more.
- a typical test to determine whether a mesh has compressive stiffness can be performed by placing a 10 mm x 10 mm x 10 mm cube of the mesh between an upper plate and an immoveable surface and applying a force to the upper plate.
- a stiff mesh is one which does not deform under a force of 5 N or less, preferably under a force of 10 N or less.
- a stiff mesh has a deformation stiffness of 5 N or more, for instance of 10 N or more.
- a typical test to determine the deformation stiffness of a sample can be performed by securing a 10 mm x 10 mm x 1 mm cuboid of the mesh at one end and applying a force to the other end.
- The“deformation stiffness” is the stiffness required to bend the mesh in this test. In one embodiment, therefore, a stiff mesh is one which does not bend under a force of 5 N or less, preferably under a force of 10 N or less.
- a stiff mesh is advantageous for the purpose of providing a robust transcutaneous port.
- flexible meshes also have advantages.
- flexible meshes often have excellent biological compatibility.
- By“flexible mesh” is meant a mesh which is readily deformed.
- a flexible mesh typically comprises flexible fibres. Typical flexible meshes may not satisfy the requirements of the above test for a stiff mesh.
- Typical flexible meshes include meshes made of less stiff materials, such as low modulus titanium alloys (e.g. Ti-29Nb-l lTa-5Zr). Typical flexible meshes also include those made of more flexible materials such as polymers, preferably biopolymers. For instance flexible meshes may comprise PEEK, polyethylene, polyurethane, PVC, polypropylene,
- Flexible meshes may comprise biological cells. Alternatively or additionally, flexible meshes may comprise traditionally stiff materials provided in a less stiff arrangement, for instance as thin ribs or entangled rather than joined ribs. Thus, typical flexible meshes also include meshes comprising titanium, beta phase titanium alloys, steel, tantalum, and so on.
- the mesh portion (4) comprises a flexible mesh.
- the mesh portion (4) comprises a stiff mesh and a flexible mesh.
- the mesh portion (4) may comprise a stiff mesh located along the inner mesh surface (4a), and a layer of flexible mesh around the outside of the stiff mesh (i.e. a region of stiff mesh and a region of flexible mesh). That is, the flexible mesh layer may be arranged along the outer mesh surface (4b). The region of flexible mesh may be integral with the region of stiff mesh.
- the invention provides a transcutaneous port as described herein wherein the mesh portion (4) comprises a region of stiff mesh located along all or part of the inner mesh surface (4a) and a region of flexible mesh located along all or part of the outer mesh surface (4b).
- the stiffness of the mesh may be graduated.
- a mesh portion may comprise a region of stiff mesh and a region of flexible mesh, and the stiffness of the mesh may vary in a graduated manner between the two regions.
- the invention provides a transcutaneous port as described herein wherein the stiffness of the mesh in the mesh portion (4) decreases or increases (preferably decreases) in a graduated manner from the inner mesh surface (4a) to the outer mesh surface (4b).
- the stiffness of the mesh may vary in a stepped manner.
- the stiffness of the mesh portion (4) may decrease or increase (preferably decrease) in a stepped manner from the inner mesh surface (4a) to the outer mesh surface (4b).
- Suitable porous materials with a graduated structure and hence graduated properties would be recognised by the skilled person.
- An example of a such a material is a functional graded material.
- Functional graded materials are materials whose composition and properties vary throughout the body of the material. Functional graded materials are therefore suitable for forming a mesh with varying properties, e.g. graduated stiffness. For instance, such materials may transition from a largely or entirely metallic composition to a largely or entirely ceramic composition throughout their structure; in another example, such materials may transition from a first metallic composition to a second metallic composition throughout their structure.
- An exemplary method of providing a functional graded material comprises providing the desired constituent materials in particulate form (for instance in the form of powder or granules) and distributing these powders within a mould in the desired spatial arrangement.
- the particulate species in the mould are then fused, for instance by the application of pressure and/or heat.
- Exemplary methods and materials are described in Godoy et al ., European Cells and Materials, Vol. 31, pp250-263 (2016).
- Exemplary materials for forming such functional graded materials include ceramics and metals, e.g. transition metals such as titanium, cobalt, chromium, manganese and niobium. Biologically compatible metals such as titanium are preferred.
- Functional graded materials provide variation throughout their structure in physical properties such as pore size, strength, compression stiffness, bending stiffness, roughness and so on. They may also vary throughout their structure in biological compatibility, susceptibility to coating, etc.
- the flexible mesh region may not be integral with the stiff mesh region but may be formed by the addition of an additional flexible mesh layer around the port body (1).
- the flexible mesh may be integral with the region of stiff mesh.
- the flexible mesh may differ from the stiff mesh in its composition (for instance, the stiff mesh may be made of a different and more rigid material).
- the flexible mesh may alternatively or additionally differ from the stiff mesh in the thickness of the strands (e.g. fibres or ribs, see below) from which the mesh is formed, the flexible mesh being formed of thinner strands.
- the flexible mesh may differ from the stiff mesh in its design, for instance having a larger pore size than the rigid mesh, or having tangled rather than joined ribs.
- the mesh portion (4) may comprise a regular mesh or an irregular mesh. Often, the mesh portion comprises a regular mesh. By a“regular mesh” is meant a mesh having a repeating pattern within its structure. It may be preferred that the mesh portion comprises a regular mesh as such meshes are strong and are simple to design and manufacture integrally, for instance by 3D printing.
- the mesh portion (4) comprises a plurality of ribs arranged in a lattice.
- the ribs can form an array of polyhedra, with each side of each polyhedron formed by all of part of a rib.
- the ribs are preferably approximately linear but may also be non-linear.
- the ribs may, for instance, be in the form of wires.
- the ribs have a first dimension (a“length”) that is considerably greater than its other dimensions.
- the length of a rib is at least as large as Tl.
- the length of a rib is up to T2, although it may be longer if the rib bends within the mesh portion.
- the length of a rib is at least 0.1 mm, for instance at least 0.5 mm.
- the length of a rib is up to 50 mm, for instance up to 20 mm.
- the length of a rib may be from 0.1 to 50 mm, more preferably from 0.5 mm to 20 mm, particularly preferably from 1 mm to 10 mm.
- the diameter of the rib is the diameter of the largest circle which can fit inside the rib in a plane perpendicular to a line along the length of the rib.
- the diameter of a rib is at least 1 micron or 5 microns, preferably at least 10 or at least 50 microns.
- the diameter of a rib is 1000 microns or less; more preferably, the diameter of a rib is 500 microns or less, or 300 microns or less.
- the diameter of a rib may be less than 200 or less than 100 microns. In some embodiments the diameter of a rib is from 5 to 500 microns, for instance from 50 to 200 microns.
- the diameter of a rib may vary along its length and/or the rib diameter may vary through the mesh.
- the diameter of a rib may be larger proximate to the inner mesh surface (4a) and smaller proximate the outer mesh surface (4b).
- the rib diameter may decrease in a graduated manner or in a stepped manner along its length or through the mesh.
- the rib diameter may for instance, decrease by at least 10 %, or at least 20 %, or at least 50%, and by up to 80%, 90% or even 95%, along the length of the rib; and/or the rib diameter may decrease by at least 10 %, or at least 20 %, or at least 50%, and by up to 80%, 90% or even 95% from the diameter at inner surface of the mesh to that at the outer surface of the mesh.
- a lattice comprises a regular arrangement of unit cells.
- a unit cell is a structural motif that is repeated throughout the whole lattice.
- the lattice comprises an arrangement of adjacent unit cells.
- each side of the unit cell may comprise a rib or a portion of a rib. This is typically the case where the lattice comprises plurality of ribs arranged in cubes.
- the unit cell does not necessarily comprise a rib along each side (as in, for instance, in a diamond hexagonal lattice).
- the pore size in a lattice formed by ribs is determined by the size of the spaces between the ribs.
- Each unit cell may comprise one, two, three or more pores, and/or may share pores with a neighbouring unit cell.
- the lattice, and the unit cell are dimensioned so as to provide pores of 50 to 2000 microns in diameter, more preferably pores of 50 to 1000 microns in diameter.
- the side of each side of each unit cell is from 50 to 2000 microns in length.
- the lattice is a diamond hexagonal lattice.
- the diamond hexagonal lattice is advantageously strong, leading to a robust transcutaneous port. Further, the diamond hexagonal lattice can conveniently be manufactured by integral manufacturing techniques such as 3D printing.
- the mesh portion (4) comprises a plurality of ribs arranged irregularly.
- An example of an irregular arrangement is an entangled mesh of ribs.
- the port body (1) of the transcutaneous port of the invention typically has an approximately circular cross-section in all planes perpendicular to the longitudinal axis. This shape advantageously avoids comers which are subject to high torsional stress when the port is implanted. This means, therefore, that the mesh portion (4) is typically formed into an approximately cylindrical shape. However, where the mesh portion comprises a stiff mesh having a regular lattice, cutting a cylinder out of the mesh may leave incomplete unit cells with protruding fibres or ribs. By“protruding” is meant that the fibre or rib in question protrudes from the mesh portion.
- the transcutaneous port of the invention comprises substantially no protruding ribs.
- at least 90% of the ribs terminate in (i) a vertex with another rib, or (ii) an impermeable portion.
- the unit cells in the mesh are substantially all complete.
- complete is meant that no structural element required in the unit cell (for instance a rib or part of a rib) is missing.
- at least 90%, or at least 95% of the unit cells in the mesh are complete.
- all of the unit cells of the mesh are complete.
- the thickness Tl corresponds to the thickness of a single unit cell.
- thickness of a unit cell is meant the smallest lattice parameter, or the smallest length of a side of the unit cell.
- the thickness Tl is the smallest thickness of mesh which comprises a complete pore within that thickness.
- Tl may be approximately equal to the diameter of a single pore within the mesh.
- Tl may be equal to the smallest thickness permitting a complete pore to be formed by the arrangement of ribs.
- the thickness T2 is greater than Tl. Accordingly, in some embodiments the thickness T2 corresponds to the thickness of two or more unit cells, preferably 5 or more unit cells. For instance, T2 may correspond to the thickness of at least three or at least four unit cells. T2 may have a thickness corresponding to the thickness of up to 10 or 20 unit cells. In some embodiments, the thickness T2 is approximately equal to the thickness of five or more pores. For instance, T2 may correspond to the thickness which comprises at least three or four pores within that thickness, up to ten or twenty pores. In order to avoid protruding ribs, T2 may take a value which allows a whole number of complete pores to be formed by the
- T2 is generally at least 1 mm, for instance at least 5 mm.
- T2 is generally up to 20 mm, for instance up to 10 mm.
- T2 is from lmm to 20 mm, more preferably from 5 mm to 10 mm.
- Tl is generally at least 0.1 mm, for instance at least 0.5 mm.
- Tl is generally up to 10 mm, for instance up to 5 mm.
- Tl is from 0.1 mm to 10 mm, more preferably from 0.5 mm to 5 mm.
- the mesh portion (4) may have a thickness which varies from Tl to T2 in a stepped manner along the length of the port body.
- the mesh portion may comprise from two to twenty steps, each step being a sub-portion of a particular thickness.
- the step proximate to the first impermeable portion of the port body has thickness Tl, while the step proximate to the subcutaneous end of the port body has thickness T2.
- the mesh portion (4) may have a thickness which varies from Tl to T2 in a graduated manner along the length of the port body. For instance, the thickness of the mesh portion may increase from Tl to T2 in a linear manner or a non-linear (e.g. exponential) manner.
- the thickness T may increase from Tl to T2 partly in a linear manner and partly in a non linear manner.
- the height of the mesh portion in a longitudinal direction is generally approximately equal to the thickness of the skin of the body.
- the height of the mesh portion may therefore vary with the intended patient. Further, in some embodiments the mesh portion may be extended to allow ingrowth of soft tissue or bone when the transcutaneous port is implanted.
- the height of the mesh portion is at least 500 microns, for instance at least 1000 microns or at least 1500 microns.
- the height of the mesh portion may be up to 50 mm, for instance up to 20 mm. More typically, the height of the mesh portion is up to 10 mm, for instance up to 5 mm or up to 2500 microns.
- the height of the mesh portion is at least 2 mm, for instance at least 5 mm or at least 8 mm. In such embodiments, the height of the mesh portion is up to 50 mm, for instance up to 20 mm.
- the height of the mesh portion may be between 2 mm and 20 mm, preferably from 5 to 15 mm. However, in a preferred embodiment, the height of the mesh portion is from 1000 to 5000 microns, particularly preferably from 1500 to 2500 microns. In a preferred aspect of this embodiment, the port body (1) is intended for implantation in the skin specifically.
- the height of the mesh portion is large enough to contain at least one pore.
- the height of the mesh portion is greater than or equal to the diameter of a pore.
- the height of the mesh portion is greater than or equal to two pore diameters or three pore diameters.
- the height of the mesh portion is up to twenty pore diameters or ten pore diameters, for example eight pores.
- the height of the mesh portion is from 1 to 10 pore diameters, for example from 2 to 8 or 2 to 5 pore diameters.
- the pores may be regarded as being arranged in layers.
- the mesh height typically contains 1 to 10 layers of pores, for example 2 to 8 or preferably 2 to 5 layers of pores.
- the height of the mesh portion may contain 2, 3, 4 or 5 layers of pores.
- the layers of pores may be regarded as a regular arrangement of pores in a lateral plane.
- the height of the mesh portion is approximately equal to an integer number of pores.
- the height of the mesh portion may be approximately equal to the height of an integer number of layers of pores, such as 1 to 10, 2 to 8 or preferably 2 to 5 layers of pores.
- the height of the mesh portion is from 1000 to 5000 and the pore size (also referred to as pore diameter) is from 200 to 1000 microns.
- the diameter of a rib is from 5 to 500 microns.
- the height of the mesh portion is from 1 to 10 pore diameters.
- the height of the mesh portion is from 1500 to 2500 microns and the pore size (also referred to as pore diameter) is from 400 to 800 microns.
- the diameter of a rib is less than 300 microns, for instance from 50 to 200 microns.
- the height of the mesh portion is from 2 to 5 pore diameters.
- the transcutaneous port of the invention may be optimised in view of the dermal and epidermal skin layer thickness so as to encourage growth of the dermis into the port body while restricting the space available for epidermal cell growth into the port body or over the external port body.
- the mesh height, the pore size, and the height of the first impermeable portion may be optimised to achieve this.
- the transcutaneous port of the invention is preferably made of one or more biologically compatible materials.
- the material(s) are also preferably strong so that the port is robust and can withstand the stresses placed on it when implanted in a patient.
- Suitable materials include metals and/or polymeric materials such as plastics. Examples of these materials include titanium, titanium alloys, steel, surgical steel, biopolymers, PEEK, polyethylene, polyurethane, PVC, polypropylene, thermoplastics, nylon, ceramics, acrylates, hydrogels or nitinol. Preferred among these are titanium, surgical steel, and biologically acceptable plastics such as Dacron. Particularly preferred is titanium.
- the transcutaneous port may comprise a cells in a biologically acceptable carrier such as a gel, e.g. a hydrogel.
- a biologically acceptable carrier such as a gel, e.g. a hydrogel.
- the transcutaneous port may comprise biological cells, e.g. skin cells.
- At least one of the first impermeable portion, the internal impermeable portion and the mesh portion comprises titanium.
- each of the first impermeable portion, the mesh portion, and where present the internal impermeable portion comprise titanium.
- the port body of the transcutaneous port of the invention comprises at least 80% titanium by weight, for instance at least 90% or at least 95% titanium by weight. Titanium is especially strong and has good biological compatibility.
- the transcutaneous port of the invention comprises means for receiving sutures.
- Means for receiving sutures allow the device to be securely attached to the patient before tissue ingrowth has occurred.
- Suitable means for receiving sutures are cavities.
- the transcutaneous port comprises two or more cavities suitable for receiving sutures.
- the means for receiving sutures may be attached directly to the port body or to another part of the transcutaneous port.
- the means for receiving sutures may comprise one or more loops or rings of material externally attached to the first impermeable portion or the mesh portion.
- the mesh portion may comprise one or more pores that are sufficiently large to receive sutures. Such pores are typically at least 0.5 mm in diameter, for instance between 0.5 mm and 2 mm in diameter.
- the sutures which can be received in the means for receiving sutures may be resorbable or non-resorbable sutures.
- the transcutaneous port of the invention further comprises one or more additional means for anchoring the device in the human or animal body.
- the transcutaneous port comprises means for attaching the device to bone, and/or to soft tissue.
- the port may comprise a further mesh portion suitable for allowing the ingrowth of bone and/or soft tissue at the subcutaneous end (2b) of the port body.
- the transcutaneous port of the invention may comprise a coating and/or a surface treatment.
- the coating or surface treatment typically imparts an additional desirable property to the port body.
- the coating may provide improved biological compatibility, improved tissue integration, improved durability and resistance to corrosion, or anti-infective properties.
- the port body comprises a coating on at least part of its surface.
- the mesh portion may comprise a coating.
- the first impermeable portion and/or the internal impermeable portion may comprise a coating.
- the entire port body is coated. This is particularly convenient as the entire port body may be coated without requiring masking and de-masking to protect parts of the port during coating.
- the first impermeable portion may comprise a coating which discourages tissue growth over its surface and reduces the likelihood of dirt or clothes sticking to it.
- Suitable coatings include diamond-like carbon.
- Such coatings may incorporate a biocidal agent.
- the mesh portion and/or the internal impermeable portion may comprise one or more coatings to promote dermal attachment.
- the mesh portion and/or the internal impermeable portion may comprise a rough coating such as a coating comprising hydroxyapatatite, e.g. electrodeposited hydroxyapatite.
- the mesh portion and/or the internal impermeable portion may alternatively or additionally comprise a coating to encourage tissue growth.
- a coating may comprise one or more growth-promoting agents such as growth factors, proteins (e.g. collagen, keratin, cadherin or fibronectin), growth hormones or biological cells (e.g. stem cells).
- growth-promoting agents such as growth factors, proteins (e.g. collagen, keratin, cadherin or fibronectin), growth hormones or biological cells (e.g. stem cells).
- Such a coating may alternatively or additionally comprise agents to promote the growth of healthy tissue such as antibiotics or biocidal agents.
- Suitable carriers for such growth promoting agents include gels such as hydrogels, or gels comprising hyaluronic acids.
- it is not necessary to provide a carrier as some species such as proteins can be derivatised and attached directly to the mesh portion and/or the internal impermeable portion.
- hydroxyapatite has an affinity for proteins and so proteins may be ads
- the coating on the port of the invention preferably comprises a biocidal agent typically a biocidal metal.
- Suitable biocidal metals include silver, copper, nickel, antimony, barium, bismuth, gold, thallium, tin and zinc. Among these, silver is preferred as it has good biocidal properties and is not particularly soluble in bodily fluids.
- the coating may comprise one or more proteins. Suitable proteins include cadherin and fibronectin. The coating may further comprise hydroxyapatite to improve tissue integration.
- the transcutaneous port comprises a coating wherein the coating comprises one or more of silver, hydroxyapatite, cadherin or fibronectin.
- a coating may be applied by any suitable method including electrochemical treatment or spray-coating.
- a hydroxyapatite coating may be applied to all or part of the surface of the port body (1) by depositing thereon a ceramic coating containing
- hydroxyapatite by thermal spraying using a plasma spray system. Further species may be applied to the hydroxyapatite coating.
- a biocidal metal such as silver
- a biocidal metal may be incorporated into the hydroxyapatite coating by contacting the coated or partially coated port body with a solution of a soluble salt of the biocidal metal (e.g. silver).
- the method of applying a coating to the port body is not particularly limited.
- a coating may conveniently be provided on all or part of the port body by spraying, by application as a sol gel, by dip coating, by physical vapour deposition or by chemical vapour deposition.
- the invention provides a transcutaneous port as described herein wherein the port body (1) comprises a surface treatment on at least part of its surface.
- the port body may comprise a surface treatment in addition to a coating.
- a surface treatment on the port body is the state of the surface resulting from treating the surface by a surface treatment method.
- An exemplary surface treatment method is a method of incorporating biocidal metals such as silver into the surface of the port body.
- the port body (1) comprises a surface treatment comprising a biocidal metal selected from silver, copper, nickel, antimony, barium, bismuth, gold, thallium, tin and zinc, preferably silver.
- the method for providing a surface treatment on a surface of the port body comprises anodising the port body at a voltage above 50 V for a period of at least 30 min, and then performing ion exchange with a solution of a soluble salt of the biocidal metal so as to incorporate ions of a biocidal metal into the anodised surface.
- the method may preferably comprise stepping down the voltage or cycling the voltage.
- a preferred method for providing a surface treatment comprising silver on the port body comprises:
- step (d) removing or separating the anodised port body resulting from step (c) from the anodising electrolyte, the electrolyte solution or chemical reducing agent, and contacting the anodised port body with a solution containing a biocidal material so as to incorporate said biocidal material into the surface layer.
- step (c) is carried out by either (i) or (ii).
- the device of the invention may be made by moulding or machining by usual techniques.
- the port body is integrally formed.
- integrally formed is meant that the port body is formed as one entity, rather than by forming the separate parts and joining them together.
- the port body does not comprise adhesives.
- the first impermeable portion is integrally formed with the mesh portion.
- the internal impermeable portion is integrally formed with the first impermeable portion and the mesh portion.
- the transcutaneous port is integrally formed.
- a suitable method of integrally forming the transcutaneous port comprises forming the port body by 3D printing.
- 3D printing involves fusing a powdered raw material according to a predetermined design. The fusing of the powder is typically effected by the localised application of heat.
- Suitable methods of 3D printing are selective laser sintering (SLS), direct metal laser sintering (DMLS), stereolithography (SLA), fused deposition modelling (FDM), multi-jet modelling or polyjet printing. Suitable methods are described in more detail in“Surgical applications of three-dimensional printing: a review of the current literature and how to get started”, Hoang et al. , Ann. Transl. Med., 2016 Dec, 4(23) 456.
- the integrally formed device may be subjected to further process steps.
- the method further comprises providing a coating on at least part of the surface of the transcutaneous port.
- the coating provided in the method comprises one or more of silver, hydroxyapatite, cadherin or fibronectin.
- the method further comprises applying a surface treatment to at least a part of the surface of the port body (1).
- the surface treatment comprises a biocidal metal, e.g. silver.
- An exemplary method of treating the port body to produce a surface treatment thereon comprising silver comprises method steps (a) to (d), described above.
- the method may comprise other additional process steps.
- the method may comprise applying an additional outer layer such as a portion of flexible mesh to the port body.
- the transcutaneous port of the invention is suitable for insertion into the human or animal body.
- the invention therefore provides a method of inserting a transcutaneous port into the human or animal body, wherein the transcutaneous port is as defined above, the method comprising:
- An exemplary method for forming an incision in the skin is to use a punch to make a hole for the implant.
- the body is preferably a human body.
- the incision made usually requires time to heal.
- the skin does not immediately grow into the transcutaneous port.
- the method further comprises attaching the transcutaneous port to the body with temporary attachment means.
- Exemplary temporary attachment means are sutures, for instance dissolvable sutures.
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- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Gastroenterology & Hepatology (AREA)
- Pulmonology (AREA)
- Biophysics (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
Description
Claims
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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GB2017441.3A GB2587550B (en) | 2018-02-06 | 2019-02-05 | Transcutaneous port and method for manufacture |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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GB1801916.6 | 2018-02-06 | ||
GBGB1801916.6A GB201801916D0 (en) | 2018-02-06 | 2018-02-06 | Transcutaneous port and method for manufacture |
Publications (1)
Publication Number | Publication Date |
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WO2019155195A1 true WO2019155195A1 (en) | 2019-08-15 |
Family
ID=61730970
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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PCT/GB2019/050304 WO2019155195A1 (en) | 2018-02-06 | 2019-02-05 | Transcutaneous port and method for manufacture |
Country Status (2)
Country | Link |
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GB (2) | GB201801916D0 (en) |
WO (1) | WO2019155195A1 (en) |
Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4578063A (en) * | 1984-09-14 | 1986-03-25 | W. L. Gore & Assoc., Inc. | Central venous catheter |
EP0343114A1 (en) * | 1988-05-20 | 1989-11-23 | Asahi Kogaku Kogyo Kabushiki Kaisha | Transcutaneous device |
US20070060891A1 (en) * | 2003-12-08 | 2007-03-15 | Richard Skiera | Implant with a skin penetration section |
WO2012007755A2 (en) * | 2010-07-13 | 2012-01-19 | Ostomycure As | Surgical implant |
-
2018
- 2018-02-06 GB GBGB1801916.6A patent/GB201801916D0/en not_active Ceased
-
2019
- 2019-02-05 GB GB2017441.3A patent/GB2587550B/en active Active
- 2019-02-05 WO PCT/GB2019/050304 patent/WO2019155195A1/en active Application Filing
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4578063A (en) * | 1984-09-14 | 1986-03-25 | W. L. Gore & Assoc., Inc. | Central venous catheter |
EP0343114A1 (en) * | 1988-05-20 | 1989-11-23 | Asahi Kogaku Kogyo Kabushiki Kaisha | Transcutaneous device |
US20070060891A1 (en) * | 2003-12-08 | 2007-03-15 | Richard Skiera | Implant with a skin penetration section |
WO2012007755A2 (en) * | 2010-07-13 | 2012-01-19 | Ostomycure As | Surgical implant |
Also Published As
Publication number | Publication date |
---|---|
GB201801916D0 (en) | 2018-03-21 |
GB202017441D0 (en) | 2020-12-16 |
GB2587550B (en) | 2022-03-30 |
GB2587550A (en) | 2021-03-31 |
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