ABSTRACT
Abstract
Herein described is an osseointegrated interface device for engagement with an amputated limb including the skin comprising: a cap portion engageable with an osseointegrated device; wherein the cap portion comprises a surrounding flange; and wherein in use the surrounding flange receives the skin of the amputated limb at a distance spaced from the osseointegrated device.
Description
This application is a continuation of U.S. patent application Ser. No. 15/764,307, filed on Mar. 28, 2018 and claims benefit under 35 U.S.C. 120 to International Patent Application No. PCT/GB2016/053010, filed on Sep. 28, 2016, entitled âMODULAR DEVICE & INTERFACE DESIGNâ, which claims priority to United Kingdom Application No. GB 1517135.8, filed on Sep. 28, 2015 and United Kingdom Application No. GB 1517134.1, filed on Sep. 28, 2015, the disclosures of which are hereby incorporated by reference in their entireties.
TECHNICAL FIELD
The present invention relates to a prosthetic interface device. In particular, the present invention provides for an osseointegrated prosthetic interface device for permanent or semi-permanent fitting to the end of a patient's limb to enable attachment to any future prosthesis.
BACKGROUND
Amputations are commonly performed to save the remainder of limbs where damage or disease threatens the viability of the limb itself. It is believed that the rates of amputation is likely to increase as a result of the general increases in the rates of diabetes and obesity.
Traditionally with amputees, prosthetics are offered to address some of a patient's functional and/or aesthetic concerns. These prosthetics are often connectable to the amputated limbs by means of a cup/socket arrangement. Although often addressing the aesthetic concerns of a patient, as the coupling interface tends to be weak, functionally, these systems/devices tend to fail in providing patients with the strength needed for adequate functional use. Additionally, the interaction between the socket and stump is often a significant source of discomfort for the patient.
To address these deficiencies, the development of percutaneous osseointegrated interface devices has been developed to couple with the prosthesis. Although addressing the patient's need for improved functionality, these systems are prone to infection at the transcutaneous site.
To reduce this risk, some of these percutaneous osseointegrated prostheses systems have focused on forming a seal between the skin of the limb and the implant. Although reducing the risk of infection, these systems have often failed to show long term skin-implant viability or demonstrable mechanical robustness.
Additionally, these systems have the major disadvantage of often requiring a patient to undergo multiple surgeries; for example, a patient will normally require a first surgery to create the stump; once this has healed, the patient will be fitted with a threaded bar into the bone; again, its only after this surgery has healed that a further surgery will be scheduled to fit a further bar, mateable with already implanted bar, which protrudes through the skin. It is not uncommon for multiple further corrective surgeries to also be required.
Therefore, there is a need for an improved prosthetic osseointegrated interface device which addresses the deficiencies in the current state of technology.
SUMMARY
In one embodiment, there is described an osseointegrated interface device for engagement with an amputated limb including the skin comprising: a cap portion engageable with an osseointegrated device; wherein the cap portion comprises a surrounding flange; wherein in use the surrounding flange receives the skin of the amputated limb at a distance spaced from the osseointegrated device.
Preferably, the device further comprises a stem portion engageable with the cap portion. The stem portion may comprise any one or more of a threaded section, a compression fitting, a bayonet or other suitable means for engaging with the cap portion. When in use, the stem portion may be osseointegrated. When in use the stem portion may be engageable with the osseointegrated device.
Preferably, the stem portion further comprises a prosthesis connector. The means for prosthesis connector may include female and male connection portions. The prosthesis connector may have a substantially triangular configuration. The prosthesis connector may comprise any one or more of a threaded section, a compression fitting, a bayonet or other suitable means for facilitating fixing of the connector to the means for prosthesis connection.
Preferably, the device further comprises one or more ports. The one or more ports may facilitate for one or more of the following: passage of biosensors; passage of cables carrying electrical data for control of a prosthesis when in use; access through which fluids or gasses can be passed either continuously, periodically or in a single instance; access for surgical procedures including keyhole surgery; and access for other medical procedures including but not limited to administering of medicines, draining of edema fluid in the stump or care of internal tissues.
Preferably, the device further comprises one or more cables or wires carrying electrical data for control of a prosthesis when in use. The one or more cables or wires may facilitate feedback from the prosthesis when in use. The one or more cables or wires may be connectable to nerve cuffs and/or muscle activation sensing electrodes and/or other electrical connections to or from the nervous system or other internal tissues comprising the data for control of the prosthesis. The electrical data may include neural and/or muscular data. The one or more cables or wires may comprise a shape, material and/or particular properties, mechanical or otherwise, which is biocompatible and preferably minimizes tissue reaction. The one or more cables or wires may be selected to minimize tissue damage caused from chemical reactions, toxicity or otherwise. The one or more cables or wires may comprise cuff, needle, sieve or micro array electrodes and/or implantable myoelectric sensors or similar. The one or more cables or wires in use may connect to the tissue of the limb without requiring passage through the bone. The one or more cables or wires in use may facilitate an electrical connection between the limb and prosthetic device connected thereto.
Preferably, the device further comprises an electronics unit to detect and/or process nerve signals. The processing may include neural processing for neural control and/or communication and/or patient health monitoring. The detection and/or processing may include any one or more of individual nerve and muscle activations; analysis of groups of muscles and nerves; dynamics of firing patterns of nerves or muscles including the timing of firing such as frequency, rate, interval, shape of firing signal and the distribution pattern across the population of neurons; and the overall changes in electrical potential of tissue at one or more sites anywhere within the amputee.
The distance between the surrounding flange and the osseointegrated device in use may be substantially the radius of the amputated limb. The distance between the surrounding flange and the osseointegrated device in use may be a portion of the radius of the amputated limb. The distance between the surrounding flange and the osseointegrated device may be such that in use the skin received by the flange is not in contact with the osseointegrated device.
Preferably, the surrounding flange may have dimensions which provide a homeostatic barrier about the amputated limb in use. The dimensions of the surrounding flange may be adaptable. The adaptable dimensions may include one or more of the angle that the flange protrudes in respect of the cap portion, the geometry of connection between the flange and the cap portion including but not limited to the curvature radii of the connection between the flange and the cap portion, the relative sizing of profile of the cross-section of the flange, the length of the flange and the thickness of the flange.
Preferably, the flange comprises a bio-compatible material. Additionally or alternatively, the cap portion may comprise a bio-compatible material. Additionally or alternatively, the device comprises a bio-compatible material. The bio-compatible material may comprise titanium, medically relevant titanium alloys including but not limited to Ti6A14V, stainless steel, 316 stainless steel, high-density polyethylene (HDPE), polylactic acid (PLA), polypropylene (PP) or other medically relevant polymer or metal, and/or combinations or mixtures thereof. The bio-compatible material may comprise a biomimetic surface microstructure. The bio-compatible material may comprise porosity at surface.
The bio-compatible material may be an open-celled foam. The pore size may be in the range of 50 pm to 800 pm. The pore size may range from 100 pm to 750 pm, 150 pm to 700 pm, 200 pm to 650 um, 250 pm to 600 pm, 300 pm to 550 pm, 350 pm to 500 pm, 400 pm to 450 pm or any combined or intermediate range thereof. The pore size may range from 200 pm to 300 p.m. The pore size may or may not be uniform and/or the porosity may extend any part or substantially all of the flange, the cap portion and/or the device. The density of the pores may be no less than 1/mm 3 , and/or optionally, wherein density of the pores is inferred from and/or dependent on the size of the pores.
The pores may penetrate less than 1 mm into the surface of the flange, cap portion and/or device, less than 2 mm into the surface, less than 3 mm into the surface, less than 4 mm into the surface, less than 5 mm into the surface or any intermediate thereof. The pores may extend through substantially the full thickness of the flange. The pores penetrate 2 mm into the surface of the flange, cap portion and/or device.
Preferably, the flange further comprises one or more conduits for providing nutrient flow between the skin and the tissue of the amputated limb, for example the muscle. The conduits may extend through substantially the entire thickness of the flange. The conduits may be 850 pm, 900 pm, 950 pm, 1.05 mm, 1.1 mm, 1.15 mm, 1.2 mm, 1.25 mm or any dimension in between. The conduits may range from 800 pm to 1 mm.
Preferably, the angle that the flange protrudes in respect of the cap portion is at or less than 90 deg, at or less than 80 deg, at or less than 70 deg, at or less than 60 deg, at or less than 50 deg, at or less than 40 deg, at or less than 30 deg, at or less than 20 deg, at or less than 10 deg or any intermediate thereof. The angle that the flange protrudes in respect of the cap portion may be at 45 degrees.
Preferably, the length of the flange is 5 mm, 10 mm, 20 mm, 25 mm, 30 mm to 35 mm or any intermediate thereof. The length of the flange may be 15 mm.
Preferably, the thickness of the flange is less than 1 mm, less than 2 mm, less than 3 mm, less than 4 mm to less than 5 mm or any intermediate thereof. The thickness of the flange may be 3 mm.
Preferably, the geometry of the connection where the flange meets the cap portion is substantially concave, and optionally, substantially curved, circular or parabola-like. The geometry may comprise a radius of curvature where the flange meets the cap portion at 1 mm, 2 mm, 3 mm, 4 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm or any intermediate thereof. The radius of the curvature where the flange meets the cap portion may be 5 mm.
Preferably, the flange further comprises hydroxyapatite and/or any other material which promotes growth and/or integration of tissue groups. The flange may be constructed by wire sintering or similar. The flange may be constructed by bead sintering. The flange may be constructed by 3D printing. The flange may be constructed by chemical etching. The flange may be constructed by metal casting with void creating materials.
In a further aspect of the invention, there is described a method of manufacturing and/or fitting the device of any preceding claim, the method comprising: adapting any one or more of the dimensions of the surrounding flange in view of the amputated limb.
Preferably the method further comprises selecting one or more of the following parameters of the flange: surface properties including stiffness and surface tension, the mean asperity sizes, overall density and solid and/or fluid permeabilities.
In an additional or alternative aspect of the invention, there is described a method of fitting the osseointegrated interface device of any preceding claim to an osseointegrated device.
In a further embodiment, there is described a device for engagement with an amputated limb including the skin comprising: a cap portion comprising a surrounding flange for engagement with the skin of the amputated limb; wherein the dimensions of the surrounding flange provide a homeostatic barrier about the amputated limb in use.
Preferably, the dimensions of the surrounding flange are adaptable. The adaptable dimensions may include one or more of the angle that the flange protrudes in respect of the cap portion, the geometry of connection between the flange and the cap portion including but not limited to the curvature radii of the connection between the flange and the cap portion, the relative sizing of profile of the cross-section of the flange, the length of the flange and the thickness of the flange.
Preferably, the flange comprises a bio-compatible material. The cap portion may comprise a bio-compatible material. The device may comprise a bio-compatible material. The bio-compatible material may comprise titanium, medically relevant titanium alloys including but not limited to Ti6A14V, stainless steel, 316 stainless steel, high-density polyethylene (HDPE), polylactic acid (PLA), polypropylene (PP) or other medically relevant polymer or metal, and/or combinations or mixtures thereof. The bio-compatible material may comprise a biomimetic surface microstructure. The bio-compatible material may comprise porosity at surface.
Preferably, the bio-compatible material is a open-celled foam. The pore size may be in the range of 50 p.m to 800 p.m. The pore size ranges may be from 100 p.m to 750 p.m, 150 p.m to 700 p.m, 200 p.m to 650 p.m, 250 p.m to 600 p.m, 300 p.m to 550 p.m, 350 p.m to 500 p.m, 400 p.m to 450 p.m or any combined or intermediate range thereof. The pore size may range from 200 p.m to 300 p.m. The pore size may or may not be uniform and/or the porosity may extend any part or substantially all of the flange, the cap portion and/or the device. The density of the pores may be no less than 1/mm 3 , and/or optionally, wherein density of the pores is inferred from and/or dependent on the size of the pores.
The pores may penetrate less than 1 mm into the surface of the flange, cap portion and/or device, less than 2 mm into the surface, less than 3 mm into the surface, less than 4 mm into the surface, less than 5 mm into the surface or any intermediate thereof. The pores may extend through substantially the full thickness of the flange. The pores may penetrate 2 mm into the surface of the flange, cap portion and/or device.
Preferably, the flange may further comprise one or more conduits for providing nutrient flow between the skin and the tissue of the amputated limb, for example the muscle. The conduits may extend through substantially the entire thickness of the flange. The conduits may be 850 p.m, 900 p.m, 950 p.m, 1.05 mm, 1.1 mm, 1.15 mm, 1.2 mm, 1.25 mm or any dimension in between. The conduits may range from 800 um to 1 mm.
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This application is a continuation of U.S. patent application Ser. No. 15/764,307, filed on Mar. 28, 2018 and claims benefit under 35 U.S.C. 120 to International Patent Application No. PCT/GB2016/053010, filed on Sep. 28, 2016, entitled âMODULAR DEVICE & INTERFACE DESIGNâ, which claims priority to United Kingdom Application No. GB 1517135.8, filed on Sep. 28, 2015 and United Kingdom Application No. GB 1517134.1, filed on Sep. 28, 2015, the disclosures of which are hereby incorporated by reference in their entireties.
TECHNICAL FIELD
The present invention relates to a prosthetic interface device. In particular, the present invention provides for an osseointegrated prosthetic interface device for permanent or semi-permanent fitting to the end of a patient's limb to enable attachment to any future prosthesis.
BACKGROUND
Amputations are commonly performed to save the remainder of limbs where damage or disease threatens the viability of the limb itself. It is believed that the rates of amputation is likely to increase as a result of the general increases in the rates of diabetes and obesity.
Traditionally with amputees, prosthetics are offered to address some of a patient's functional and/or aesthetic concerns. These prosthetics are often connectable to the amputated limbs by means of a cup/socket arrangement. Although often addressing the aesthetic concerns of a patient, as the coupling interface tends to be weak, functionally, these systems/devices tend to fail in providing patients with the strength needed for adequate functional use. Additionally, the interaction between the socket and stump is often a significant source of discomfort for the patient.
To address these deficiencies, the development of percutaneous osseointegrated interface devices has been developed to couple with the prosthesis. Although addressing the patient's need for improved functionality, these systems are prone to infection at the transcutaneous site.
To reduce this risk, some of these percutaneous osseointegrated prostheses systems have focused on forming a seal between the skin of the limb and the implant. Although reducing the risk of infection, these systems have often failed to show long term skin-implant viability or demonstrable mechanical robustness.
Additionally, these systems have the major disadvantage of often requiring a patient to undergo multiple surgeries; for example, a patient will normally require a first surgery to create the stump; once this has healed, the patient will be fitted with a threaded bar into the bone; again, its only after this surgery has healed that a further surgery will be scheduled to fit a further bar, mateable with already implanted bar, which protrudes through the skin. It is not uncommon for multiple further corrective surgeries to also be required.
Therefore, there is a need for an improved prosthetic osseointegrated interface device which addresses the deficiencies in the current state of technology.
SUMMARY
In one embodiment, there is described an osseointegrated interface device for engagement with an amputated limb including the skin comprising: a cap portion engageable with an osseointegrated device; wherein the cap portion comprises a surrounding flange; wherein in use the surrounding flange receives the skin of the amputated limb at a distance spaced from the osseointegrated device.
Preferably, the device further comprises a stem portion engageable with the cap portion. The stem portion may comprise any one or more of a threaded section, a compression fitting, a bayonet or other suitable means for engaging with the cap portion. When in use, the stem portion may be osseointegrated. When in use the stem portion may be engageable with the osseointegrated device.
Preferably, the stem portion further comprises a prosthesis connector. The means for prosthesis connector may include female and male connection portions. The prosthesis connector may have a substantially triangular configuration. The prosthesis connector may comprise any one or more of a threaded section, a compression fitting, a bayonet or other suitable means for facilitating fixing of the connector to the means for prosthesis connection.
Preferably, the device further comprises one or more ports. The one or more ports may facilitate for one or more of the following: passage of biosensors; passage of cables carrying electrical data for control of a prosthesis when in use; access through which fluids or gasses can be passed either continuously, periodically or in a single instance; access for surgical procedures including keyhole surgery; and access for other medical procedures including but not limited to administering of medicines, draining of edema fluid in the stump or care of internal tissues.
Preferably, the device further comprises one or more cables or wires carrying electrical data for control of a prosthesis when in use. The one or more cables or wires may facilitate feedback from the prosthesis when in use. The one or more cables or wires may be connectable to nerve cuffs and/or muscle activation sensing electrodes and/or other electrical connections to or from the nervous system or other internal tissues comprising the data for control of the prosthesis. The electrical data may include neural and/or muscular data. The one or more cables or wires may comprise a shape, material and/or particular properties, mechanical or otherwise, which is biocompatible and preferably minimizes tissue reaction. The one or more cables or wires may be selected to minimize tissue damage caused from chemical reactions, toxicity or otherwise. The one or more cables or wires may comprise cuff, needle, sieve or micro array electrodes and/or implantable myoelectric sensors or similar. The one or more cables or wires in use may connect to the tissue of the limb without requiring passage through the bone. The one or more cables or wires in use may facilitate an electrical connection between the limb and prosthetic device connected thereto.
Preferably, the device further comprises an electronics unit to detect and/or process nerve signals. The processing may include neural processing for neural control and/or communication and/or patient health monitoring. The detection and/or processing may include any one or more of individual nerve and muscle activations; analysis of groups of muscles and nerves; dynamics of firing patterns of nerves or muscles including the timing of firing such as frequency, rate, interval, shape of firing signal and the distribution pattern across the population of neurons; and the overall changes in electrical potential of tissue at one or more sites anywhere within the amputee.
The distance between the surrounding flange and the osseointegrated device in use may be substantially the radius of the amputated limb. The distance between the surrounding flange and the osseointegrated device in use may be a portion of the radius of the amputated limb. The distance between the surrounding flange and the osseointegrated device may be such that in use the skin received by the flange is not in contact with the osseointegrated device.
Preferably, the surrounding flange may have dimensions which provide a homeostatic barrier about the amputated limb in use. The dimensions of the surrounding flange may be adaptable. The adaptable dimensions may include one or more of the angle that the flange protrudes in respect of the cap portion, the geometry of connection between the flange and the cap portion including but not limited to the curvature radii of the connection between the flange and the cap portion, the relative sizing of profile of the cross-section of the flange, the length of the flange and the thickness of the flange.
Preferably, the flange comprises a bio-compatible material. Additionally or alternatively, the cap portion may comprise a bio-compatible material. Additionally or alternatively, the device comprises a bio-compatible material. The bio-compatible material may comprise titanium, medically relevant titanium alloys including but not limited to Ti6A14V, stainless steel, 316 stainless steel, high-density polyethylene (HDPE), polylactic acid (PLA), polypropylene (PP) or other medically relevant polymer or metal, and/or combinations or mixtures thereof. The bio-compatible material may comprise a biomimetic surface microstructure. The bio-compatible material may comprise porosity at surface.
The bio-compatible material may be an open-celled foam. The pore size may be in the range of 50 pm to 800 pm. The pore size may range from 100 pm to 750 pm, 150 pm to 700 pm, 200 pm to 650 um, 250 pm to 600 pm, 300 pm to 550 pm, 350 pm to 500 pm, 400 pm to 450 pm or any combined or intermediate range thereof. The pore size may range from 200 pm to 300 p.m. The pore size may or may not be uniform and/or the porosity may extend any part or substantially all of the flange, the cap portion and/or the device. The density of the pores may be no less than 1/mm 3 , and/or optionally, wherein density of the pores is inferred from and/or dependent on the size of the pores.
The pores may penetrate less than 1 mm into the surface of the flange, cap portion and/or device, less than 2 mm into the surface, less than 3 mm into the surface, less than 4 mm into the surface, less than 5 mm into the surface or any intermediate thereof. The pores may extend through substantially the full thickness of the flange. The pores penetrate 2 mm into the surface of the flange, cap portion and/or device.
Preferably, the flange further comprises one or more conduits for providing nutrient flow between the skin and the tissue of the amputated limb, for example the muscle. The conduits may extend through substantially the entire thickness of the flange. The conduits may be 850 pm, 900 pm, 950 pm, 1.05 mm, 1.1 mm, 1.15 mm, 1.2 mm, 1.25 mm or any dimension in between. The conduits may range from 800 pm to 1 mm.
Preferably, the angle that the flange protrudes in respect of the cap portion is at or less than 90 deg, at or less than 80 deg, at or less than 70 deg, at or less than 60 deg, at or less than 50 deg, at or less than 40 deg, at or less than 30 deg, at or less than 20 deg, at or less than 10 deg or any intermediate thereof. The angle that the flange protrudes in respect of the cap portion may be at 45 degrees.
Preferably, the length of the flange is 5 mm, 10 mm, 20 mm, 25 mm, 30 mm to 35 mm or any intermediate thereof. The length of the flange may be 15 mm.
Preferably, the thickness of the flange is less than 1 mm, less than 2 mm, less than 3 mm, less than 4 mm to less than 5 mm or any intermediate thereof. The thickness of the flange may be 3 mm.
Preferably, the geometry of the connection where the flange meets the cap portion is substantially concave, and optionally, substantially curved, circular or parabola-like. The geometry may comprise a radius of curvature where the flange meets the cap portion at 1 mm, 2 mm, 3 mm, 4 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm or any intermediate thereof. The radius of the curvature where the flange meets the cap portion may be 5 mm.
Preferably, the flange further comprises hydroxyapatite and/or any other material which promotes growth and/or integration of tissue groups. The flange may be constructed by wire sintering or similar. The flange may be constructed by bead sintering. The flange may be constructed by 3D printing. The flange may be constructed by chemical etching. The flange may be constructed by metal casting with void creating materials.
In a further aspect of the invention, there is described a method of manufacturing and/or fitting the device of any preceding claim, the method comprising: adapting any one or more of the dimensions of the surrounding flange in view of the amputated limb.
Preferably the method further comprises selecting one or more of the following parameters of the flange: surface properties including stiffness and surface tension, the mean asperity sizes, overall density and solid and/or fluid permeabilities.
In an additional or alternative aspect of the invention, there is described a method of fitting the osseointegrated interface device of any preceding claim to an osseointegrated device.
In a further embodiment, there is described a device for engagement with an amputated limb including the skin comprising: a cap portion comprising a surrounding flange for engagement with the skin of the amputated limb; wherein the dimensions of the surrounding flange provide a homeostatic barrier about the amputated limb in use.
Preferably, the dimensions of the surrounding flange are adaptable. The adaptable dimensions may include one or more of the angle that the flange protrudes in respect of the cap portion, the geometry of connection between the flange and the cap portion including but not limited to the curvature radii of the connection between the flange and the cap portion, the relative sizing of profile of the cross-section of the flange, the length of the flange and the thickness of the flange.
Preferably, the flange comprises a bio-compatible material. The cap portion may comprise a bio-compatible material. The device may comprise a bio-compatible material. The bio-compatible material may comprise titanium, medically relevant titanium alloys including but not limited to Ti6A14V, stainless steel, 316 stainless steel, high-density polyethylene (HDPE), polylactic acid (PLA), polypropylene (PP) or other medically relevant polymer or metal, and/or combinations or mixtures thereof. The bio-compatible material may comprise a biomimetic surface microstructure. The bio-compatible material may comprise porosity at surface.
Preferably, the bio-compatible material is a open-celled foam. The pore size may be in the range of 50 p.m to 800 p.m. The pore size ranges may be from 100 p.m to 750 p.m, 150 p.m to 700 p.m, 200 p.m to 650 p.m, 250 p.m to 600 p.m, 300 p.m to 550 p.m, 350 p.m to 500 p.m, 400 p.m to 450 p.m or any combined or intermediate range thereof. The pore size may range from 200 p.m to 300 p.m. The pore size may or may not be uniform and/or the porosity may extend any part or substantially all of the flange, the cap portion and/or the device. The density of the pores may be no less than 1/mm 3 , and/or optionally, wherein density of the pores is inferred from and/or dependent on the size of the pores.
The pores may penetrate less than 1 mm into the surface of the flange, cap portion and/or device, less than 2 mm into the surface, less than 3 mm into the surface, less than 4 mm into the surface, less than 5 mm into the surface or any intermediate thereof. The pores may extend through substantially the full thickness of the flange. The pores may penetrate 2 mm into the surface of the flange, cap portion and/or device.
Preferably, the flange may further comprise one or more conduits for providing nutrient flow between the skin and the tissue of the amputated limb, for example the muscle. The conduits may extend through substantially the entire thickness of the flange. The conduits may be 850 p.m, 900 p.m, 950 p.m, 1.05 mm, 1.1 mm, 1.15 mm, 1.2 mm, 1.25 mm or any dimension in between. The conduits may range from 800 um to 1 mm.
Preferably, the angle that the flange protrudes in respect of the cap portion is at or less than 90 deg, at or less than 80 deg, at or less than 70 deg, at or less than 60 deg, at or less than 50 deg, at or less than 40 deg, at or less than 30 deg, at or less than 20 deg, at or less than 10 deg or any intermediate thereof. The angle that the flange protrudes in respect of the cap portion is at 45 degrees.
Preferably, the length of the flange is 5 mm, 10 mm, 20 mm, 25 mm, 30 mm to 35 mm or any intermediate thereof. The length of the flange may be 15 mm.
Preferably, the thickness of the flange is less than 1 mm, less than 2 mm, less than 3 mm, less than 4 mm to less than 5 mm or any intermediate thereof. The thickness of the flange may be 3 mm.
Preferably, the geometry of the connection where the flange meets the cap portion is substantially concave, and optionally, substantially curved, circular or parabola-like.
The geometry comprises a radius of curvature where the flange meets the cap portion may be at 1 mm, 2 mm, 3 mm, 4 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm or any intermediate thereof. The radius of the curvature where the flange meets the cap portion may be 5 mm.
Preferably, the flange further comprises hydroxyapatite and/or any other material which promotes growth and/or integration of tissue groups.
Preferably, the flange is constructed by wire sintering or similar. Additionally or alternatively, the flange may be constructed by bead sintering. Additionally or alternatively, the flange may be constructed by 3D printing. Additionally or alternatively, the flange may be constructed by chemical etching. Additionally or alternatively, the flange may be constructed by metal casting with void creating materials.
Preferably, the device is engageable with the amputated limb via an osseointegrated device.
Preferably, the device further comprises a stem portion engageable with the cap portion. The stem portion may comprise any one or more of a threaded section, a compression fitting, a bayonet or other suitable means for engaging with the cap portion. When in use the stem portion may be osseointegrated. When in use the stem portion may be engageable with an osseointegrated device.
Preferably, the stem portion further comprising a prosthesis connector. The means for prosthesis connector may include female and male connection portions. The prosthesis connector may have a substantially triangular configuration. The prosthesis connector may comprise any one or more of a threaded section, a compression fitting, a bayonet or other suitable means for facilitating fixing of the connector to the means for prosthesis connection.
Preferably, the device further comprises one or more ports. The one or more ports may facilitate for one or more of the following: passage of biosensors; passage of cables carrying electrical data for control of a prosthesis when in use; access through which fluids or gasses can be passed either continuously, periodically or in a single instance; access for surgical procedures including keyhole surgery; and access for other medical procedures including but not limited to administering of medicines, draining of edema fluid in the stump or care of internal tissues.
Preferably, the device further comprises one or more cables or wires carrying electrical data for control of a prosthesis when in use. The one or more cables or wires may facilitate feedback from the prosthesis when in use. The one or more cables or wires may be connectable to nerve cuffs and/or muscle activation sensing electrodes and/or other electrical connections to or from the nervous system or other internal tissues comprising the data for control of the prosthesis. The electrical data may include neural and/or muscular data. The one or more cables or wires may comprise a shape, material and/or particular properties, mechanical or otherwise, which may be biocompatible and preferably may minimize tissue reaction. The one or more cables or wires may be selected to minimize tissue damage caused from chemical reactions, toxicity or otherwise. The one or more cables or wires may comprise cuff, needle, sieve or micro array electrodes and/or implantable myoelectric sensors or similar.
The one or more cables or wires in use may connect to the tissue of the limb without requiring passage through the bone. The one or more cables or wires in use may facilitate an electrical connection between the limb and prosthetic device connected thereto.
Preferably, the device further comprises an electronics unit to detect and/or process nerve signals. The processing may include neural processing for neural control and/or communication and/or patient health monitoring. The detection and/or processing may include any one or more of individual nerve and muscle activations; analysis of groups of muscles and nerves; dynamics of firing patterns of nerves or muscles including the timing of firing such as frequency, rate, interval, shape of firing signal and the distribution pattern across the population of neurons; and the overall changes in electrical potential of tissue at one or more sites anywhere within the amputee.
In a further embodiment, there is described an interface device for engagement with skin, the device comprising: a cap portion; wherein the cap portion comprises a surrounding flange engageable with the skin; and wherein the cap portion comprises one or more ports for transcutaneous access.
In a further embodiment, there is an osseointegrated interface device for engagement with an amputated limb comprising: a cap portion engageable with an osseointegrated device via a stem portion; wherein the stem portion is further engageable with a prosthesis connector.
In a further embodiment, there is described a device for engagement with the skin, the device comprising: a cap portion for engagement with the skin; and an electronics unit to detect and/or process nerve signals.
Preferably, the device further comprises a stem portion engageable with the cap portion. The stem portion may comprise any one or more of a threaded section, a compression fitting, a bayonet or other suitable means for engaging with the cap portion. When in use, the stem portion may be osseointegrated. When in use the stem portion may be engageable with the osseointegrated device.
Preferably, the stem portion further comprises a prosthesis connector. The means for prosthesis connector may include female and male connection portions. The prosthesis connector may have a substantially triangular configuration. The prosthesis connector may comprise any one or more of a threaded section, a compression fitting, a bayonet or other suitable means for facilitating fixing of the connector to the means for prosthesis connection.
Preferably, the device further comprises one or more ports. The one or more ports may facilitate for one or more of the following: passage of biosensors; passage of cables carrying electrical data for control of a prosthesis when in use; access through which fluids or gasses can be passed either continuously, periodically or in a single instance; access for surgical procedures including keyhole surgery; and access for other medical procedures including but not limited to administering of medicines, draining of edema fluid in the stump or care of internal tissues.
Preferably, the device further comprises one or more cables or wires carrying electrical data for control of a prosthesis when in use. The one or more cables or wires may facilitate feedback from the prosthesis when in use. The one or more cables or wires may be connectable to nerve cuffs and/or muscle activation sensing electrodes and/or other electrical connections to or from the nervous system or other internal tissues comprising the data for control of the prosthesis. The electrical data may include neural and/or muscular data. The one or more cables or wires may comprise a shape, material and/or particular properties, mechanical or otherwise, which is biocompatible and preferably minimizes tissue reaction. The one or more cables or wires may be selected to minimize tissue damage caused from chemical reactions, toxicity or otherwise. The one or more cables or wires may comprise cuff, needle, sieve or micro array electrodes and/or implantable myoelectric sensors or similar. The one or more cables or wires in use may connect to the tissue of the limb without requiring passage through the bone. The one or more cables or wires in use may facilitate an electrical connection between the limb and prosthetic device connected thereto.
Preferably, the device further comprises an electronics unit to detect and/or process nerve signals. The processing may include neural processing for neural control and/or communication and/or patient health monitoring. The detection and/or processing may include any one or more of individual nerve and muscle activations; analysis of groups of muscles and nerves; dynamics of firing patterns of nerves or muscles including the timing of firing such as frequency, rate, interval, shape of firing signal and the distribution pattern across the population of neurons; and the overall changes in electrical potential of tissue at one or more sites anywhere within the amputee.
The distance between the surrounding flange and the osseointegrated device in use may be substantially the radius of the amputated limb. The distance between the surrounding flange and the osseointegrated device in use may be a portion of the radius of the amputated limb. The distance between the surrounding flange and the osseointegrated device may be such that in use the skin received by the flange is not in contact with the osseointegrated device.
Preferably, the surrounding flange may have dimensions which provide a homeostatic barrier about the amputated limb in use. The dimensions of the surrounding flange may be adaptable. The adaptable dimensions may include one or more of the angle that the flange protrudes in respect of the cap portion, the geometry of connection between the flange and the cap portion including but not limited to the curvature radii of the connection between the flange and the cap portion, the relative sizing of profile of the cross-section of the flange, the length of the flange and the thickness of the flange.
Preferably, the flange comprises a bio-compatible material. Additionally or alternatively, the cap portion may comprise a bio-compatible material. Additionally or alternatively, the device comprises a bio-compatible material. The bio-compatible material may comprise titanium, medically relevant titanium alloys including but not limited to Ti6A14V, stainless steel, 316 stainless steel, high-density polyethylene (HDPE), polylactic acid (PLA), polypropylene (PP) or other medically relevant polymer or metal, and/or combinations or mixtures thereof. The bio-compatible material may comprise a biomimetic surface microstructure. The bio-compatible material may comprise porosity at surface.
The bio-compatible material may be an open-celled foam. The pore size may be in the range of 50 pm to 800 pm. The pore size may range from 100 pm to 750 pm, 150 pm to 700 pm, 200 pm to 650 um, 250 pm to 600 pm, 300 pm to 550 pm, 350 pm to 500 pm, 400 pm to 450 pm or any combined or intermediate range thereof. The pore size may range from 200 pm to 300 p.m. The pore size may or may not be uniform and/or the porosity may extend any part or substantially all of the flange, the cap portion and/or the device. The density of the pores may be no less than 1/mm 3 , and/or optionally, wherein density of the pores is inferred from and/or dependent on the size of the pores.
The pores may penetrate less than 1 mm into the surface of the flange, cap portion and/or device, less than 2 mm into the surface, less than 3 mm into the surface, less than 4 mm into the surface, less than 5 mm into the surface or any intermediate thereof. The pores may extend through substantially the full thickness of the flange. The pores penetrate 2 mm into the surface of the flange, cap portion and/or device.
Preferably, the flange further comprises one or more conduits for providing nutrient flow between the skin and the tissue of the amputated limb, for example the muscle. The conduits may extend through substantially the entire thickness of the flange. The conduits may be 850 pm, 900 pm, 950 pm, 1.05 mm, 1.1 mm, 1.15 mm, 1.2 mm, 1.25 mm or any dimension in between. The conduits may range from 800 pm to 1 mm.
Preferably, the angle that the flange protrudes in respect of the cap portion is at or less than 90 deg, at or less than 80 deg, at or less than 70 deg, at or less than 60 deg, at or less than 50 deg, at or less than 40 deg, at or less than 30 deg, at or less than 20 deg, at or less than 10 deg or any intermediate thereof. The angle that the flange protrudes in respect of the cap portion may be at 45 degrees.
Preferably, the length of the flange is 5 mm, 10 mm, 20 mm, 25 mm, 30 mm to 35 mm or any intermediate thereof. The length of the flange may be 15 mm.
Preferably, the thickness of the flange is less than 1 mm, less than 2 mm, less than 3 mm, less than 4 mm to less than 5 mm or any intermediate thereof. The thickness of the flange may be 3 mm.
Preferably, the geometry of the connection where the flange meets the cap portion is substantially concave, and optionally, substantially curved, circular or parabola-like. The geometry may comprise a radius of curvature where the flange meets the cap portion at 1 mm, 2 mm, 3 mm, 4 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm or any intermediate thereof. The radius of the curvature where the flange meets the cap portion may be 5 mm.
Preferably, the flange further comprises hydroxyapatite and/or any other material which promotes growth and/or integration of tissue groups. The flange may be constructed by wire sintering or similar. The flange may be constructed by bead sintering. The flange may be constructed by 3D printing. The flange may be constructed by chemical etching. The flange may be constructed by metal casting with void creating materials.
The features of each of the above aspects and/or embodiments may be combined as appropriate, as would be apparent to the skilled person, and may be combined with any of the aspects of the invention. Indeed, the order of the embodiments and the ordering and location of the preferable features is indicative only and has no bearing on the features themselves. It is intended for each of the preferable and/or optional features to be interchangeable and/or combinable with not only all of the aspect and embodiments, but also each of preferable features.
BRIEF DESCRIPTION OF DRAWINGS
For better understanding of the aspects and/or embodiments described herein and to show how the same may be carried into effect, reference will now be made, by way of example only, to the accompanying figures, in which:
FIG. 1A is a photograph of an amputated limb without and/or before a prosthetic interface device according to one embodiment is fitted thereto;
FIG. 1B is a photograph of the amputated limb of FIG. 1A with a prosthetic interface device according to one embodiment fitted thereto;
FIG. 2A depicts a top view of the cap portion of the prosthetic interface device according to one embodiment;
FIG. 2B depicts a bottom view of the cap portion of the prosthetic interface device of FIG. 2A ;
FIG. 3 illustrates a side view of the stem portion of the prosthetic interface device according to one embodiment, which is suitable for engagement firstly with the cap portion of FIGS. 2A and 2B and secondly with the prosthetic connector, for example the one depicted in FIG. 5 ;
FIG. 4 depicts a cross-sectional side view of the prosthetic interface device according to one embodiment;
FIG. 5A illustrates a top view of the prosthetic interface device according to one embodiment; FIG. 5B illustrates a bottom view of the prosthetic interface device of FIG. 4A ;
FIG. 6 depicts a side view of the prosthetic interface device according to one embodiment when in use and particularly when configured for connection with a prosthesis;
FIG. 7 depicts a top view of the cap portion of the prosthetic interface device comprising on board electronics suitable for neural processing and/or monitoring according to one embodiment;
FIGS. 8A to 8E depict cross-sectional side views of the prosthetic interface device and specifically the skin integration portion of the device according to various embodiments when in use; and
FIGS. 9A to 9D illustrate a cross-sectional side view of exemplary geometries of the prosthetic interface device according to various embodiments when in use.
It will be appreciated that although features from each of the embodiments may be identified by different reference numerals in the figures and throughout the description, similar features including the properties and functionality attributed thereto from one embodiment may be interchangeable with those of another embodiment.
DETAILED DESCRIPTION
References will now be made in detail to the various aspects and/or embodiments, examples of which are illustrated in the accompanying figures. In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the invention. However, it will be apparent to one of ordinary skill in the art that the invention may be practiced without these specific details and/or with any number of the specifics from one or more of the embodiments unless description to the contrary has been noted herein.
FIGS. 1A and 1B are photographs of an amputated limb without and/or before and after a prosthetic interface device has been fitted thereto, respectively. The terms âprosthesisâ and âprostheticâ are used throughout and should be broadly construed to include any device designed to replace a missing or damaged part of the body or to make a part of the body work better and includes, but is not limited to, bionic limbs and similar. Additionally, the terms âpatientâ and âamputeeâ should be broadly construed to include both human and animal subjects.
The prosthetic interface device 100 in this embodiment is a bone implanted (osseointegrated) prosthetic interface device. Although not required or essential, in a preferred embodiment, the patient will be fitted with prosthetic interface device 100 during amputation instead of having a stump formed. However, it is envisaged that retroactive fitting of prosthetic interface device 100 once a stump has formed can also occur, as depicted in FIG. 1A .
Advantageously, the prosthetic interface device 100 in this embodiment, provides mechanical, neural and soft tissue integration with the amputated limb. It will be appreciated that although the prosthetic interface device 100 in this embodiment provides neural integration, this feature is not essential but rather preferable in some embodiments.
Once the prosthetic interface device 100 has been fitted to the limb, a prosthesis can be connected thereto. Although in this embodiment the surface 110 of prosthetic interface device 100 is relatively flat and uniformly round, i.e. disc shaped, and covers substantially the entire area of the limb, it will be appreciated that prosthetic interface device 100 need not have this shape or configuration as will be discussed in more detail below.
Embodiments of the invention include the skin interface device at the full width or partial width of the amputated limb. It has been found that where the prosthetic interface device 100 is substantially the full surface area of the amputated limb, the surgery made easier. However, it has also been found that where the prosthetic interface device 100 has a surface area less than that of the amputated limb, there is less residing of the muscles and any cauterized vessels, for example caused from tissue swelling during/after surgery.
The prosthetic interface device 100 may be designed to cover any amount of the area of the amputated limb; for example, a particular percentage of the limb. Also, it will be appreciated that not all amputated limbs have the same dimensions and shapes. As such, in certain preferred embodiments, the dimensions of prosthetic interface device 100 may be configurable or adaptable to suit the particular type of limb (e.g. lower leg v. forearm etc.) and/or may be customizable depending on the specifications of the particular patient. For example, the surface 110 of the prosthetic interface device 100 may not comprise a disk shape, but instead may comprise a (substantially or semi) conical, (substantially or semi) oblong or any other desired configuration, more detail of which is described below, for example with respect to FIGS. 9A to 9D . Furthermore, the cap in FIGS. 9A to 9D may or may not be rotationally symmetric, particularly when engaging with limb locations featuring substantially off-center main bones.
Prosthetic interface device 100 may comprise a means 120 for facilitating connection (e.g. means adaptable for connection with a prosthesis connector), as will be described in more detail below, for example with respect to FIG. 5 ; wherein the prosthesis connector may be adaptable such that its shape and/or dimensions are engageable with specific prostheses. For example, a particular patient may have a desire for a particular prostheses type, the dimensions of prosthetic interface device 100 may be determined based on those ideal for maximum compatibility with the particular prosthesis. In some preferred embodiments, a connector is designed to be a universal connector and hence engage with all possible prostheses
FIGS. 2A and 2B depict a top and bottom view of a cap portion of the prosthetic interface device 100 according to one embodiment.
The cap portion 200 is the housing portion of the prosthetic interface device 100 which is configurable to house or cover a portion or all of the surface area of the end of the amputee's limb. In this embodiment, the cap portion 200 comprises a surface 205 , in this example having a circular disk shape, with a surrounding flange 210 .
In some embodiments, the cap portion 200 comprises a flexible material, for example, but not limited to a polymer which may or may not be coated.
When in use, it is envisaged that the cap portion 200 will be secured to a stem portion (not shown, but described in respect of FIG. 3 ) which may be osseointegrated or connected to an osseointegrated device through an aperture 220 in the surface 205 of the cap 200 and that the edges of the surrounding flange 210 of the cap portion 200 will interface with the skin of the amputated limb. As mentioned above, the detailed shape and the dimensions of each of the component parts of the cap portion 200 are exemplary only. Indeed, any desired configuration may be provided, more detail of which is described below, for example with respect to FIGS. 9A to 9D . Indeed, alternative embodiments may include the flange 210 protruding downwards from the side of the surface 205 at any angle to the cap. The flange 210 may be integral with the surface 205 of the cap 200 or may be distinct from but fixable thereto.
In one exemplary embodiment of the prosthetic interface device 100 , the surface 205 of the cap portion 200 protrudes 2 cm from the circumference of the aperture 220 which may be configurable to receive a (osseointegrated) stem portion. In this exemplary embodiment, after the protrusion of the surface 205 for 2 cm, surrounding flange 210 may extend further (from the circumference of the aperture), for example, where the flange 210 is an angled flange. It will be appreciated that when in use, the flange 210 , angled or not, will be substantially provided within the interior of the stump or limb as it is intended to interface with the skin of the amputated limb.
Although in the above exemplary embodiment an aperture 220 is provided, no aperture 220 is required. Indeed, in additional or alternative embodiments, an integrated or distinct connection means can be provided to facilitate mechanical connection between cap portion 200 and the limb, and preferably via an osseointegrated stem portion.
Although in the above exemplary embodiment, the radius of the surface area of the surface 205 need can be any dimension which covered as large a radius as the amputated limb in question.
Not wishing to be bound by theory, it is believed that the larger the surface area of the cap portion 200 , the less chance of infection from the wound site, around the skin integration area where the flange 210 adjoins the skin of the amputated limb, spreading to the bone via the osseointegrated device; i.e. the more distance between these two features the less chance of infection spreading. Therefore, in one preferred embodiment, the radius of the cap portion 200 is not less than 1 cm and/or the surface area of the cap portion 200 is no less that 10% of the surface area of the amputated limb. However, it will be appreciated that the surface area of the cap portion 200 may be up to 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or 100% of the surface area of the amputated limb or any percentage therein between.
Again, not wishing to be bound by theory, it is believed that although there are adv
CLAIMS
Claims ( 23 )
1 . A device for engagement with an amputated limb including the skin comprising:
a cap portion, comprising a surrounding flange; wherein the surrounding flange receives the skin of the amputated limb at a distance spaced from the device.
2 .- 3 . (canceled)
4 . The device of claim 2 , wherein when the stem portion is osseointegrated.
5 . The device of claim 2 , wherein when the stem portion is engageable with the device.
6 . The device of any of claim 2 , the stem portion further comprising a prosthesis connector.
7 . The device of claim 6 , the stem portion further comprising a prosthesis connector.
8 . The device of claim 7 , wherein the prosthesis connector has a substantially triangular configuration.
9 . The device of any of claims 6 to 8 , wherein the prosthesis connector comprises any one or more of a threaded section, a compression fitting, a bayonet or other suitable means for facilitating fixing of the connector to the means for prosthesis connection.
10 . The device of claim 1 , further comprising one or more ports.
11 . The device of claim 10 , wherein the one or more ports facilitate for one or more of the following: passage of biosensors; passage of cables carrying electrical data for control of a prosthesis; access through which fluids or gasses can be passed either continuously, periodically or in a single instance; access for surgical procedures including keyhole surgery; and access for other medical procedures including but not limited to administering of medicines, draining of edema fluid in the stump or care of internal tissues.
12 . The device of claim 1 , further comprising one or more cables or wires carrying electrical data for control of a prosthesis.
13 .- 67 . (canceled)
68 . A device for engagement with an amputated limb including the skin comprising:
a cap portion comprising a surrounding flange for engagement with the skin of the amputated limb; wherein the dimensions of the surrounding flange provide a homeostatic barrier about the amputated limb in use.
69 . The device of claim 68 , wherein the dimensions of the surrounding flange are adaptable.
70 . The device of claim 69 , wherein the adaptable dimensions include one or more of the angle that the flange protrudes in respect of the cap portion, the geometry of connection between the flange and the cap portion including but not limited to the curvature radii of the connection between the flange and the cap portion, the relative sizing of profile of the cross-section of the flange, the length of the flange and the thickness of the flange.
71 . The device of claim 68 , wherein the flange comprises a bio-compatible material.
72 . The device of claim 68 , wherein the cap portion comprises a bio-compatible material.
73 . The device of claim 68 , wherein the device comprises a bio-compatible material.
74 . The device of claim 71 , wherein the bio-compatible material comprises titanium, medically relevant titanium alloys including but not limited to Ti6A14V, stainless steel, 316 stainless steel, high-density polyethylene (HDPE), polylactic acid (PLA), polypropylene (PP) or other medically relevant polymer or metal, and/or combinations or mixtures thereof.
75 . The device of claim 74 , wherein the bio-compatible material comprises a biomimetic surface microstructure.
76 . The device of claim 74 , wherein the bio-compatible material comprises porosity at surface.
77 . The device of claim 76 , wherein the bio-compatible material is a open-celled foam.
78 .- 130 . (canceled)
US17/686,085
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2022-03-03
Modular device & interface design
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GB1517134.1A
GB2542635B
( en )
2015-09-28
2015-09-28
Cap device for use with an osseointegrated implant
GB1517134.1
2015-09-28
GB1517135.8
2015-09-28
GB1517135.8A
GB2542636B
( en )
2015-09-28
2015-09-28
Interface device for use with osseointegrated implant
PCT/GB2016/053010
WO2017055836A1
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2015-09-28
2016-09-28
Modular device & interface design
US201815764307A
2018-03-28
2018-03-28
US17/686,085
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2015-09-28
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