Software Technology for “Method for producing a bushing containing cermet for an implantable medical devices”

Medical Device – Jens Troetzschel, Heiko Specht, Heraeus Deutschland GmbH and Co KG

Abstract for “Method for producing a bushing containing cermet for an implantable medical devices”

“One aspect concerns a method of producing an electrical bushing to be used in an implantable medical device. This method involves forming a holding component for the electrical bushing within the implantable medical device. The holding element includes a through-opening. The through-opening is used to form an aluminum oxide insulation element. An elongated conduction elements is formed that extends beyond the insulation element. An aluminum oxide is embedded in a metallic matrix. The joint firing of the insulation element and at least one elongated coneduct element creates a hermetic seal between them without welding or soldering.

Background for “Method for producing a bushing containing cermet for an implantable medical devices”

One aspect is an electrical bushing for an implantable device that has an annulus-like holding component for holding the implantable medical devices, which includes a through opening, at least one conduction element, and an insulation element to form a hermetic seal. One aspect is a method of producing an electrical bushing to be used in an implantable medical device.

An electrical bushing is used to implant an electrical therapeutic device. These electrical bushings are used to create an electrical connection between the hermetically sealed exterior and interior of the therapeutic device. Implantable therapeutic devices such as cardiac pacemakers and defibrillators are known to include a hermetically sealed housing made of metal. This housing is usually equipped with a header on one side. The connection socket is used to connect electrode leads. The connection socket contains electrical contacts, which are used to connect the electrode leads to control electronics within the housing of the implantable therapy device. Also known as implantable device. Hermetic sealing is a prerequisite for this type of electrical bushing.

It is important to ensure that conducting wires are properly inserted into insulation elements. This will allow for the transmission of electrical signals. It has been shown to be a disadvantage that conducting wires are generally made of metal and must be introduced into ceramic insulation elements. To ensure a strong connection between the elements, the bore hole of the insulation element must have a metallized interior to allow for the soldering of the conducting wires. It is difficult to apply said metallization within the bore hole of the insulation element. Only expensive methods can ensure homogeneous metallization on the bore hole of the insulation element’s internal surface.

“Patent specification U.S. Pat. No. No. 5,769,874 is an implantable electric therapeutic device. The therapeutic device described herein includes a sealed area that houses a battery. This area is coated with a coating. The coating is used to capture chemicals that leak from the battery. The coating can be made from a cermet.

“These and other reasons are the reason there is a need to invent.”

“One aspect is an electric bushing for an implantable device. It has an annulus-like holding component to hold the electrical bushing inside the implantable device. The holding element has a through-opening. Through the through-opening, at least one conduction element is extended. The through-opening houses an insulation element that forms a hermetic seal between conduction and holding elements. Components made of cermet are included in at least one conduction component.

“The following Detailed Description refers to the accompanying drawings. These form a part of the description and illustrate specific embodiments where the invention can be used. This section uses directional terminology such as “top”,? ?bottom,? ?front,? ?back,? ?leading,? ?trailing,? etc. are used to refer to the orientation of the Figure(s). Components of embodiments may be placed in many different orientations. The directional terminology is only used to illustrate and is not intended to limit. Other embodiments can be used and structural or logic changes may be made to the invention without departing from its scope. This detailed description is not intended to be taken as a limitation and the appended claims define the scope of the invention.

“It is to understood that the features described in the various exemplary embodiments may be combined, except where otherwise noted.”

One aspect is an electrical bushing that can be used to implant a medical device. This eliminates the disadvantages and provides a reliable sealing connection between conduction and insulation elements. One aspect refers to an electrical bushing that can be used in implantable medical devices. The other aspect describes a method of making an electrical bushing. All features and details described in this context with respect to the implantable medical devices or the electrical bushing shall also be applicable to the method and vice versa.

“The electrical bushing according one embodiment is distinguished in that at least one insulation component includes a cemet.”

According to prior art, the conduction elements are a metallic wire. Contrary to this, one embodiment of the conduction element is a “cermet”, which is a composite material consisting of ceramic materials and a metallic matrix. Because it is a ceramic material, a conduction element as described can be connected to the insulation element easily. It is possible to create green compacts from both the conduction and insulation elements. These are then subject to a sintering procedure. The resultant electrical bushing is biocompatible, resistant, and has good hermetic sealing. There are no connecting points or fissures between the conduction and insulation elements. Sintering is used to connect the conduction and insulation elements. An embodiment development provides at least one conduction component that is made of cermet. One development’s conduction element includes both components made from cermet and is entirely made of cermet.

“In the context for one embodiment, the terms?cermet? or?cermet-containing? shall refer to all composite materials made of ceramic materials in a metallic matrix (binding agent). “cermet-containing?” or “cermet” shall be used to refer to composite materials that are made from ceramic materials in a metallic matrix. These materials are distinguished by their high hardness and wear resistance. These are also known as?cermets? and/or ?cermet-containing? Substances are cutting materials that are related or contain tungsten carbide but are not made from powder metallurgical methods. The sintering of cermets or the cermet-containing bearing elements proceeds exactly as with homogeneous particles, except that the metal is compressed more strongly at the same pressure force than the ceramic material. The cermet-containing bearing elements have a greater resistance to thermal shock and oxidation than sintered metals. The ceramic components of the Cermet are usually aluminum oxide (Al2O3) or zirconium dioxide, while niobium and molybdenum as well as titanium, cobalt, zinc, chromium and cobalt are possible metallic components.

“In the context for one embodiment, the term “comprising the cermet?” refers to a mixture in which a portion of the material of a conduction element or another element is connected to the cermet. This is understood to indicate that the element corresponding is cermet-containing. It can be made from a powder or cermet-containing material. This includes a development in which the element is made of cermet. This variant’s corresponding elements, such as the conduction element and the holding element that will be illustrated below, are entirely made of a cemet.

The holding element is necessary to allow the electrical bushing to be integrated into the housing for a cardiac pacemaker. The holding element is placed around the insulation element in an annulus-like arrangement. The housing is connected to the holding element in either a positive or negative type of fit. A media-tight connection between the housing and the holding element is required for this purpose. One development is that the electrical bushing contains a holding element with a cermet. The holding element containing cermet can be attached to the housing of an implantable medical device in a quick, secure, and long-lasting way.

“Another embodiment of the holding element does not include a ceramic but consists of a ceramic. It is possible that both the conduction element as well as the holding element could be made from the same material. This variant uses the same materials for both the conduction and holding elements. This is a biocompatible, resistant, conductive cermet. Both the conduction and holding elements must be connected to metal components. Therefore, they must both include the prerequisites for welding and soldering. A cermet that meets these prerequisites can be used for both the conduction and holding elements. This will allow you to make a very inexpensive electrical bushing.

“One embodiment contains an insulation element made of an insulating mixture of materials. The insulation element protects the conducting wire from contact with the holding element or any other objects in the implantable medical device. Contacting the housing of an implantable device will not reduce or stop the electrical signals that are passing through the conductor. To be medically implanted, the insulation must contain a biocompatible material. It is preferable in one embodiment that the insulation element be made of glass-ceramic, or glass-like materials. In one embodiment, it has been found to be preferable for the insulation composition of the materials of the insulation element at least one of the following: aluminum oxide (Al2O3) (MgO), magnesium oxide (MgO), Zirconium oxide [ZrO2], aluminum-titanate (?Al2TiO5)), and piezoceramics. Aluminum oxide ceramic material exhibits high electrical resistance and low losses. These properties are further enhanced by their high thermal resistance and good biocompatibility.

“Another variation of the bushing according one embodiment is that the holding element has at least one flange. In particular, the flange acts as a metal-conductive flange. The flange seals the electrical bushing to the housing of the implantable devices. The holding element is used to hold the implantable device’s electrical bushing. The holding element in the present invention has at least one flange at one exterior surface. These flanges can form a bearing that can be engaged by the lids on the implantable medical device. In one embodiment, the lids can also be used to seal the element. The cross-section of the holding element can be U- or H-shaped if it has flanges attached. The implantable device can be made safe and durable by incorporating at least one flange in the holding element. The flanges may be designed so that the lids of an implantable device can be connected clip-like with the holding element in either a positive or negative fit-like fashion.

“Another variation of the electrical bushing according one embodiment is that at least one flange contains a cermet. This development includes both the holding element as well as the flange. The flange and the holding element can be made from the same material in one embodiment. The cermet flange can be easily and cheaply sintered as part of the holding elements and together with the insulation element or conduction element as described below.

“One embodiment includes at least one conduction element that is cermet-containing in an electrical bushing to support an implantable medical device. Any features and details described in relation the the method and/or electrical bushing shall be applicable to the use a cermet bearing element.

“Another embodiment of an implantable medical device is a cardiac pacemaker, defibrillator or other similar device that has an electrical bushing in accordance with any one of these embodiments. Any features and details described in relation the the electrical bushing or the method will also be applicable to the implantable device.

“One embodiment also refers to a method of producing an electrical bushing that can be used in implantable medical devices. We have already discussed some disadvantages that can arise during the manufacture of electrical bushings. It has been also described what the objective is. One embodiment of the method to produce an electrical bushing for an implantable device medical device involves the following steps:

“All features and details described in this context with respect to the electrical bushing shall also be applicable to the method according the embodiment and vice versa.”

“One feature of the method according one embodiment is that both the conduction element and the insulation element comprise ceramic components, which are then processed using a sintering process. An insulating mixture of materials is used to create an insulation element called green compact. You can do this by pressing the materials together in a mold. The insulating mixture of materials is a powder mass with a minimum amount of cohesion. This is usually achieved by ensuring that the grain size of powder particles is not greater than 0.5mm. This is because the green compact can be made by either pressing powder masses or drying them. These are the same steps that are used to create the green compact containing conduction elements.

“One embodiment contains the powder that is pressed into a conduction element green compact to contain cermet or consist of cermet. The conduction element and insulation element green compacts are then combined. The two green compacts are then fired. This is also known as sintering. The green compacts undergo heat treatment that lowers the melting point of the green powder particles. The volume and porosity of the green compacts is significantly reduced during this process. The conduction and insulation elements are then fired together. The two elements are no longer required to be connected. The firing process effects connection of the conduction element to the insulation element that is of the non-positive fit- and/or positive fit- and/or substance-to-substance-type. This seals the conduction element to the insulation element. The conduction element is not required to be soldered or welded into the insulation element. Instead, the insulation element and conduction element are sealed by joint firing and using a green compact containing cermet.

“One embodiment of the method is described in step a), which includes partial sintering the insulation element green compact. The insulation element’s green compact is heat-treated as part of this partial sintering. This process is already associated to some shrinkage in the volume of insulation element green compact. The volume of the green compact doesn’t reach its final stage. Instead, another heat treatment is needed as part of step D), in which the insulation and conduction elements green compact are reduced to their final sizes. The green compact is only partially heat-treated in this process to make it easier to handle the insulation element. This is especially useful for insulating materials that can be compressed into a green compact with minimal difficulty.

“Another important development is that the conduction element green comp is already partially sintered in step B. The conduction element green comp can be sintered in some cases, as described for the insulation element. This allows it to achieve a certain level of surface stability. In this context, it is important to note that the final, complete and final sintering of this development does not occur until step. The conduction element green compact, therefore, can only be reached at step d).

“Another variation of the method is that it includes the steps preceding step (d):

“whereby step (d)” includes:

“d. Fire the insulation element green compact, the at least 1 bearing element green compact, and the holding component green compact to obtain an insulation layer with at least 1 bearing element and a hold element.

The special feature of this step is that the bearing element and insulation elements green compact are also generated. The three green compacts are first generated and then joined and fired or sintered together. Partial sintering is possible in one production. To achieve higher surface stability, the fringe compact can be partially sintered.

“FIG. “FIG. The implantable device 100’s housing 110 is connected to the electrical bushing 10, by welding, in a hermetically sealed fashion. It is advantageous, for example, to have a holding element 20 in the electrical bushing 10, which includes a metal that can easily be welded to housing 110. The electrical bushing 10 is used to create an electrical connection between exterior and hermetically sealed internal of the medical device 100.

The conducting coil 120 can be connected to the stimulation electrode. These stimulation electrodes are used to stimulate heart muscles to permit signals from the cardiac pacemaker (or other stimulators) to be transmitted to them. The conducting wire 30 is embedded in an insulation element 40 to achieve hermetic sealing. The insulation element 40 forms a hermetic seal between holding element 20, the conducting wire 30, and at least one conductor 30 through a through-opening 22, which is formed by the annulus-like hold element 20. The insulation element 40 is electrically insulating and prevents short-circuiting between an electrically conductive elongated conductor 30 and a metallic housing 110 or the metallic holding element 20.

According to the prior art, an electrical bushing is made from a metallic wire that acts as a conduction element. It must be soldered to an insulation element. The insulation element contains a cylindrical-shaped bushing that serves as the conduction element. This bushing is coated with a metallic coating. Soldering is costly and error-prone. FIG. FIG. 2 shows an example of an electrical bushing 10, according to one embodiment, which overcomes the disadvantages described above.

“In one embodiment, an annulus-shaped holding element 20 is included in the electrical bushing 10. The holding element 20 holds the electrical bushing 10 within the implantable medical device 100. A through-opening 22 is part of the holding element 20, which is designed to look annulus-like. FIG. 3 shows this clearly. FIG. 3 shows a top view of the electrical bushing 10, as illustrated in FIG. 2. The holding element 20, which is rectangular and annulus-like in design, contains the through-opening 22 on its interior. This is a rectangular shape. Through said through-opening 22, at least one conduction element 30 is elongated. The exemplary embodiment shows six conduction elements 30 extending through the holding layer 20. The through-opening 22 houses an insulation element 40. This allows for hermetic sealing between the conduction elements 30 and 20. According to one embodiment of the electrical bushing 10, the special feature of the 10th illustrated result from the conduction elements 30 consisting of a or comprising a cemet.

A cermet is a composite material that is made up of ceramic materials and a metallic matrix. This conduction element 30, which is cermet-containing, can be sintered together with the 40-containing insulation element in one step. Conduction element 30 and 40 are therefore not affected by any imperfections, through-openings, or fissures. Instead, the media-tight connection between elements 40, 30, is established. These are the steps that can be used to produce an electrical bushing 10, according to one embodiment:

“a. Creating an insulation element green compact from an insulating mixture of materials;

“b. Forming at least one conduction element green compact for conduction elements (30);

“c. inserting at least one conduction component green compact into an insulation element green compact;

“d. firing an insulation element green compact with at least one of the conduction elements green compact to obtain an insulate element (40), with at least one conduction element (30).

The embodiment’s special feature is that both the insulation element and conduction element green comp are pressed from powders, and then fired. In a few steps, it is possible to create a green compact with both the conduction and insulation elements green compacts and then fire the total compact. One development is that not only the insulation elements 40 and 30 but also the holding element 20 are made from powders and then sintered.

Accordingly, the holding elements 20 can also be made from cermet-containing powders in one production step. The three green compacts, holding element 20, conduction elements 30 and insulation element 40?are then combined. The result is the green compact stage with the electrical bushing 10. The three green compacts are then fired together. The resulting electrical bushing 10, on one hand, meets all electrical requirements. On the other, it is made in one step without the need to solder or weld individual elements. The metal-containing, a-cermet-comprising holding elements 20 allows for a simple and long-lasting connection with the housing of the implantable device 100.

“FIG. 4. Again, the components of the electrical busting 10, in magnification. This is a magnification of FIG. 3 denoted I. The conduction element 30 is enclosed by an insulation element 40. It is made from an electrically insulating mixture of materials. Conductors can be attached to the conduction element 30, for example, for a cardiac pacemaker. An annulus-like holding element 20 surrounds the insulation element 40. The development shown includes cermet-containing holding element 20.

“The holding element 20 may include a flange to allow integration of the electrical bushing 10, in the implantable device 100. Figures do not show a flange. The housing 110 can be pressed against the flange to create a hermetically sealed connection. One embodiment of the device 100’s holding element 20 and flange is made from the same material or in one piece.

“Even though specific embodiments have been described and illustrated herein, it will be apparent to those with ordinary skill in art that many alternative and/or equivalent implementations can be substituted without departing from scope of invention. This application covers any modifications or variations to the particular embodiments described herein. This invention is to be limited by the claims and equivalents.

Summary for “Method for producing a bushing containing cermet for an implantable medical devices”

One aspect is an electrical bushing for an implantable device that has an annulus-like holding component for holding the implantable medical devices, which includes a through opening, at least one conduction element, and an insulation element to form a hermetic seal. One aspect is a method of producing an electrical bushing to be used in an implantable medical device.

An electrical bushing is used to implant an electrical therapeutic device. These electrical bushings are used to create an electrical connection between the hermetically sealed exterior and interior of the therapeutic device. Implantable therapeutic devices such as cardiac pacemakers and defibrillators are known to include a hermetically sealed housing made of metal. This housing is usually equipped with a header on one side. The connection socket is used to connect electrode leads. The connection socket contains electrical contacts, which are used to connect the electrode leads to control electronics within the housing of the implantable therapy device. Also known as implantable device. Hermetic sealing is a prerequisite for this type of electrical bushing.

It is important to ensure that conducting wires are properly inserted into insulation elements. This will allow for the transmission of electrical signals. It has been shown to be a disadvantage that conducting wires are generally made of metal and must be introduced into ceramic insulation elements. To ensure a strong connection between the elements, the bore hole of the insulation element must have a metallized interior to allow for the soldering of the conducting wires. It is difficult to apply said metallization within the bore hole of the insulation element. Only expensive methods can ensure homogeneous metallization on the bore hole of the insulation element’s internal surface.

“Patent specification U.S. Pat. No. No. 5,769,874 is an implantable electric therapeutic device. The therapeutic device described herein includes a sealed area that houses a battery. This area is coated with a coating. The coating is used to capture chemicals that leak from the battery. The coating can be made from a cermet.

“These and other reasons are the reason there is a need to invent.”

“One aspect is an electric bushing for an implantable device. It has an annulus-like holding component to hold the electrical bushing inside the implantable device. The holding element has a through-opening. Through the through-opening, at least one conduction element is extended. The through-opening houses an insulation element that forms a hermetic seal between conduction and holding elements. Components made of cermet are included in at least one conduction component.

“The following Detailed Description refers to the accompanying drawings. These form a part of the description and illustrate specific embodiments where the invention can be used. This section uses directional terminology such as “top”,? ?bottom,? ?front,? ?back,? ?leading,? ?trailing,? etc. are used to refer to the orientation of the Figure(s). Components of embodiments may be placed in many different orientations. The directional terminology is only used to illustrate and is not intended to limit. Other embodiments can be used and structural or logic changes may be made to the invention without departing from its scope. This detailed description is not intended to be taken as a limitation and the appended claims define the scope of the invention.

“It is to understood that the features described in the various exemplary embodiments may be combined, except where otherwise noted.”

One aspect is an electrical bushing that can be used to implant a medical device. This eliminates the disadvantages and provides a reliable sealing connection between conduction and insulation elements. One aspect refers to an electrical bushing that can be used in implantable medical devices. The other aspect describes a method of making an electrical bushing. All features and details described in this context with respect to the implantable medical devices or the electrical bushing shall also be applicable to the method and vice versa.

“The electrical bushing according one embodiment is distinguished in that at least one insulation component includes a cemet.”

According to prior art, the conduction elements are a metallic wire. Contrary to this, one embodiment of the conduction element is a “cermet”, which is a composite material consisting of ceramic materials and a metallic matrix. Because it is a ceramic material, a conduction element as described can be connected to the insulation element easily. It is possible to create green compacts from both the conduction and insulation elements. These are then subject to a sintering procedure. The resultant electrical bushing is biocompatible, resistant, and has good hermetic sealing. There are no connecting points or fissures between the conduction and insulation elements. Sintering is used to connect the conduction and insulation elements. An embodiment development provides at least one conduction component that is made of cermet. One development’s conduction element includes both components made from cermet and is entirely made of cermet.

“In the context for one embodiment, the terms?cermet? or?cermet-containing? shall refer to all composite materials made of ceramic materials in a metallic matrix (binding agent). “cermet-containing?” or “cermet” shall be used to refer to composite materials that are made from ceramic materials in a metallic matrix. These materials are distinguished by their high hardness and wear resistance. These are also known as?cermets? and/or ?cermet-containing? Substances are cutting materials that are related or contain tungsten carbide but are not made from powder metallurgical methods. The sintering of cermets or the cermet-containing bearing elements proceeds exactly as with homogeneous particles, except that the metal is compressed more strongly at the same pressure force than the ceramic material. The cermet-containing bearing elements have a greater resistance to thermal shock and oxidation than sintered metals. The ceramic components of the Cermet are usually aluminum oxide (Al2O3) or zirconium dioxide, while niobium and molybdenum as well as titanium, cobalt, zinc, chromium and cobalt are possible metallic components.

“In the context for one embodiment, the term “comprising the cermet?” refers to a mixture in which a portion of the material of a conduction element or another element is connected to the cermet. This is understood to indicate that the element corresponding is cermet-containing. It can be made from a powder or cermet-containing material. This includes a development in which the element is made of cermet. This variant’s corresponding elements, such as the conduction element and the holding element that will be illustrated below, are entirely made of a cemet.

The holding element is necessary to allow the electrical bushing to be integrated into the housing for a cardiac pacemaker. The holding element is placed around the insulation element in an annulus-like arrangement. The housing is connected to the holding element in either a positive or negative type of fit. A media-tight connection between the housing and the holding element is required for this purpose. One development is that the electrical bushing contains a holding element with a cermet. The holding element containing cermet can be attached to the housing of an implantable medical device in a quick, secure, and long-lasting way.

“Another embodiment of the holding element does not include a ceramic but consists of a ceramic. It is possible that both the conduction element as well as the holding element could be made from the same material. This variant uses the same materials for both the conduction and holding elements. This is a biocompatible, resistant, conductive cermet. Both the conduction and holding elements must be connected to metal components. Therefore, they must both include the prerequisites for welding and soldering. A cermet that meets these prerequisites can be used for both the conduction and holding elements. This will allow you to make a very inexpensive electrical bushing.

“One embodiment contains an insulation element made of an insulating mixture of materials. The insulation element protects the conducting wire from contact with the holding element or any other objects in the implantable medical device. Contacting the housing of an implantable device will not reduce or stop the electrical signals that are passing through the conductor. To be medically implanted, the insulation must contain a biocompatible material. It is preferable in one embodiment that the insulation element be made of glass-ceramic, or glass-like materials. In one embodiment, it has been found to be preferable for the insulation composition of the materials of the insulation element at least one of the following: aluminum oxide (Al2O3) (MgO), magnesium oxide (MgO), Zirconium oxide [ZrO2], aluminum-titanate (?Al2TiO5)), and piezoceramics. Aluminum oxide ceramic material exhibits high electrical resistance and low losses. These properties are further enhanced by their high thermal resistance and good biocompatibility.

“Another variation of the bushing according one embodiment is that the holding element has at least one flange. In particular, the flange acts as a metal-conductive flange. The flange seals the electrical bushing to the housing of the implantable devices. The holding element is used to hold the implantable device’s electrical bushing. The holding element in the present invention has at least one flange at one exterior surface. These flanges can form a bearing that can be engaged by the lids on the implantable medical device. In one embodiment, the lids can also be used to seal the element. The cross-section of the holding element can be U- or H-shaped if it has flanges attached. The implantable device can be made safe and durable by incorporating at least one flange in the holding element. The flanges may be designed so that the lids of an implantable device can be connected clip-like with the holding element in either a positive or negative fit-like fashion.

“Another variation of the electrical bushing according one embodiment is that at least one flange contains a cermet. This development includes both the holding element as well as the flange. The flange and the holding element can be made from the same material in one embodiment. The cermet flange can be easily and cheaply sintered as part of the holding elements and together with the insulation element or conduction element as described below.

“One embodiment includes at least one conduction element that is cermet-containing in an electrical bushing to support an implantable medical device. Any features and details described in relation the the method and/or electrical bushing shall be applicable to the use a cermet bearing element.

“Another embodiment of an implantable medical device is a cardiac pacemaker, defibrillator or other similar device that has an electrical bushing in accordance with any one of these embodiments. Any features and details described in relation the the electrical bushing or the method will also be applicable to the implantable device.

“One embodiment also refers to a method of producing an electrical bushing that can be used in implantable medical devices. We have already discussed some disadvantages that can arise during the manufacture of electrical bushings. It has been also described what the objective is. One embodiment of the method to produce an electrical bushing for an implantable device medical device involves the following steps:

“All features and details described in this context with respect to the electrical bushing shall also be applicable to the method according the embodiment and vice versa.”

“One feature of the method according one embodiment is that both the conduction element and the insulation element comprise ceramic components, which are then processed using a sintering process. An insulating mixture of materials is used to create an insulation element called green compact. You can do this by pressing the materials together in a mold. The insulating mixture of materials is a powder mass with a minimum amount of cohesion. This is usually achieved by ensuring that the grain size of powder particles is not greater than 0.5mm. This is because the green compact can be made by either pressing powder masses or drying them. These are the same steps that are used to create the green compact containing conduction elements.

“One embodiment contains the powder that is pressed into a conduction element green compact to contain cermet or consist of cermet. The conduction element and insulation element green compacts are then combined. The two green compacts are then fired. This is also known as sintering. The green compacts undergo heat treatment that lowers the melting point of the green powder particles. The volume and porosity of the green compacts is significantly reduced during this process. The conduction and insulation elements are then fired together. The two elements are no longer required to be connected. The firing process effects connection of the conduction element to the insulation element that is of the non-positive fit- and/or positive fit- and/or substance-to-substance-type. This seals the conduction element to the insulation element. The conduction element is not required to be soldered or welded into the insulation element. Instead, the insulation element and conduction element are sealed by joint firing and using a green compact containing cermet.

“One embodiment of the method is described in step a), which includes partial sintering the insulation element green compact. The insulation element’s green compact is heat-treated as part of this partial sintering. This process is already associated to some shrinkage in the volume of insulation element green compact. The volume of the green compact doesn’t reach its final stage. Instead, another heat treatment is needed as part of step D), in which the insulation and conduction elements green compact are reduced to their final sizes. The green compact is only partially heat-treated in this process to make it easier to handle the insulation element. This is especially useful for insulating materials that can be compressed into a green compact with minimal difficulty.

“Another important development is that the conduction element green comp is already partially sintered in step B. The conduction element green comp can be sintered in some cases, as described for the insulation element. This allows it to achieve a certain level of surface stability. In this context, it is important to note that the final, complete and final sintering of this development does not occur until step. The conduction element green compact, therefore, can only be reached at step d).

“Another variation of the method is that it includes the steps preceding step (d):

“whereby step (d)” includes:

“d. Fire the insulation element green compact, the at least 1 bearing element green compact, and the holding component green compact to obtain an insulation layer with at least 1 bearing element and a hold element.

The special feature of this step is that the bearing element and insulation elements green compact are also generated. The three green compacts are first generated and then joined and fired or sintered together. Partial sintering is possible in one production. To achieve higher surface stability, the fringe compact can be partially sintered.

“FIG. “FIG. The implantable device 100’s housing 110 is connected to the electrical bushing 10, by welding, in a hermetically sealed fashion. It is advantageous, for example, to have a holding element 20 in the electrical bushing 10, which includes a metal that can easily be welded to housing 110. The electrical bushing 10 is used to create an electrical connection between exterior and hermetically sealed internal of the medical device 100.

The conducting coil 120 can be connected to the stimulation electrode. These stimulation electrodes are used to stimulate heart muscles to permit signals from the cardiac pacemaker (or other stimulators) to be transmitted to them. The conducting wire 30 is embedded in an insulation element 40 to achieve hermetic sealing. The insulation element 40 forms a hermetic seal between holding element 20, the conducting wire 30, and at least one conductor 30 through a through-opening 22, which is formed by the annulus-like hold element 20. The insulation element 40 is electrically insulating and prevents short-circuiting between an electrically conductive elongated conductor 30 and a metallic housing 110 or the metallic holding element 20.

According to the prior art, an electrical bushing is made from a metallic wire that acts as a conduction element. It must be soldered to an insulation element. The insulation element contains a cylindrical-shaped bushing that serves as the conduction element. This bushing is coated with a metallic coating. Soldering is costly and error-prone. FIG. FIG. 2 shows an example of an electrical bushing 10, according to one embodiment, which overcomes the disadvantages described above.

“In one embodiment, an annulus-shaped holding element 20 is included in the electrical bushing 10. The holding element 20 holds the electrical bushing 10 within the implantable medical device 100. A through-opening 22 is part of the holding element 20, which is designed to look annulus-like. FIG. 3 shows this clearly. FIG. 3 shows a top view of the electrical bushing 10, as illustrated in FIG. 2. The holding element 20, which is rectangular and annulus-like in design, contains the through-opening 22 on its interior. This is a rectangular shape. Through said through-opening 22, at least one conduction element 30 is elongated. The exemplary embodiment shows six conduction elements 30 extending through the holding layer 20. The through-opening 22 houses an insulation element 40. This allows for hermetic sealing between the conduction elements 30 and 20. According to one embodiment of the electrical bushing 10, the special feature of the 10th illustrated result from the conduction elements 30 consisting of a or comprising a cemet.

A cermet is a composite material that is made up of ceramic materials and a metallic matrix. This conduction element 30, which is cermet-containing, can be sintered together with the 40-containing insulation element in one step. Conduction element 30 and 40 are therefore not affected by any imperfections, through-openings, or fissures. Instead, the media-tight connection between elements 40, 30, is established. These are the steps that can be used to produce an electrical bushing 10, according to one embodiment:

“a. Creating an insulation element green compact from an insulating mixture of materials;

“b. Forming at least one conduction element green compact for conduction elements (30);

“c. inserting at least one conduction component green compact into an insulation element green compact;

“d. firing an insulation element green compact with at least one of the conduction elements green compact to obtain an insulate element (40), with at least one conduction element (30).

The embodiment’s special feature is that both the insulation element and conduction element green comp are pressed from powders, and then fired. In a few steps, it is possible to create a green compact with both the conduction and insulation elements green compacts and then fire the total compact. One development is that not only the insulation elements 40 and 30 but also the holding element 20 are made from powders and then sintered.

Accordingly, the holding elements 20 can also be made from cermet-containing powders in one production step. The three green compacts, holding element 20, conduction elements 30 and insulation element 40?are then combined. The result is the green compact stage with the electrical bushing 10. The three green compacts are then fired together. The resulting electrical bushing 10, on one hand, meets all electrical requirements. On the other, it is made in one step without the need to solder or weld individual elements. The metal-containing, a-cermet-comprising holding elements 20 allows for a simple and long-lasting connection with the housing of the implantable device 100.

“FIG. 4. Again, the components of the electrical busting 10, in magnification. This is a magnification of FIG. 3 denoted I. The conduction element 30 is enclosed by an insulation element 40. It is made from an electrically insulating mixture of materials. Conductors can be attached to the conduction element 30, for example, for a cardiac pacemaker. An annulus-like holding element 20 surrounds the insulation element 40. The development shown includes cermet-containing holding element 20.

“The holding element 20 may include a flange to allow integration of the electrical bushing 10, in the implantable device 100. Figures do not show a flange. The housing 110 can be pressed against the flange to create a hermetically sealed connection. One embodiment of the device 100’s holding element 20 and flange is made from the same material or in one piece.

“Even though specific embodiments have been described and illustrated herein, it will be apparent to those with ordinary skill in art that many alternative and/or equivalent implementations can be substituted without departing from scope of invention. This application covers any modifications or variations to the particular embodiments described herein. This invention is to be limited by the claims and equivalents.

Click here to view the patent on Google Patents.

What is a software medical device?

The FDA can refer to software functions that include ” Software As a Medical Device” and “Software in a Medical Device(SiMD)”, which are software functions that are integral to (embedded in a) a medical device.

Section 201(h),?21 U.S.C. 321(h),(1) defines a medical device to be?an apparatus, implements, machine, contrivances, implant, in vitro regulator, or other similar or related articles, as well as a component or accessory. . . (b) is intended for diagnosis or treatment of disease or other conditions in humans or animals. (c) Is intended to alter the structure or function of human bodies or animals. To be considered a medical device, and thus subject to FDA regulation, the software must meet at least one of these criteria:

• It must be used in diagnosing and treating patients.
• It must not be designed to alter the structure or function of the body.

If your software is designed to be used by healthcare professionals to diagnose, treat, or manage patient information in hospitals, the FDA will likely consider such software to be medical devices that are subject to regulatory review.

Is Your Software a Medical Device?

FDA’s current oversight, which puts more emphasis on the functionality of the software than the platform, will ensure that FDA does not regulate medical devices with functionality that could be dangerous to patient safety. Examples of Device Software and Mobile Medical Apps FDA is focused on

• Software functions that aid patients with diagnosed mental disorders (e.g., depression, anxiety, and post-traumatic stress disorder (PTSD), etc.) by providing “Skill of the Day”, a behavioral technique, or audio messages, that the user can access when they are experiencing anxiety.
• Software functions that offer periodic reminders, motivational guidance, and educational information to patients who are recovering from addiction or smokers trying to quit;
• Software functions that use GPS location data to alert asthmatics when they are near high-risk locations (substance abusers), or to alert them of potential environmental conditions that could cause symptoms.
• Software that uses video and games to encourage patients to exercise at home.
• Software functions that prompt users to choose which herb or drug they wish to take simultaneously. They also provide information about interactions and give a summary of the type of interaction reported.
• Software functions that take into account patient characteristics, such as gender, age, and risk factors, to offer patient-specific counseling, screening, and prevention recommendations from established and well-respected authorities.
• Software functions that use a list of common symptoms and signs to give advice about when to see a doctor and what to do next.
• Software functions that help users to navigate through a questionnaire about symptoms and to make a recommendation on the best type of healthcare facility for them.
• These mobile apps allow users to make pre-specified nurse calls or emergency calls using broadband or cell phone technology.
• Apps that allow patients or caregivers to send emergency notifications to first responders via mobile phones
• Software that tracks medications and provides user-configured reminders to improve medication adherence.
• Software functions that give patients access to their health information. This includes historical trending and comparisons of vital signs (e.g. body temperature, heart rate or blood pressure).
• Software functions that display trends in personal healthcare incidents (e.g. hospitalization rates or alert notification rate)
• Software functions allow users to electronically or manually enter blood pressure data, and to share it via e-mail, track it and trend it, and upload it to an electronic or personal health record.
• Apps that offer mobile apps for tracking and reminders about oral health or tools to track users suffering from gum disease.
• Apps that offer mobile guidance and tools for prediabetes patients;
• Apps that allow users to display images and other messages on their mobile devices, which can be used by substance abusers who want to quit addictive behaviors.
• Software functions that provide drug interaction and safety information (side effects and drug interactions, active ingredient, active ingredient) in a report based upon demographic data (age and gender), current diagnosis (current medications), and clinical information (current treatment).
• Software functions that allow the surgeon to determine the best intraocular lens powers for the patient and the axis of implantation. This information is based on the surgeon’s inputs (e.g., expected surgically induced astigmatism and patient’s axial length, preoperative corneal astigmatism etc.).
• Software, usually mobile apps, converts a mobile platform into a regulated medical device.
• Software that connects with a mobile platform via a sensor or lead to measure and display electrical signals from the heart (electrocardiograph; ECG).
• Software that attaches a sensor or other tools to the mobile platform to view, record and analyze eye movements to diagnose balance disorders
• Software that collects information about potential donors and transmits it to a blood collection facility. This software determines if a donor is eligible to collect blood or other components.
• Software that connects to an existing device type in order to control its operation, function, or energy source.
• Software that alters or disables the functions of an infusion pump
• Software that controls the inflation or deflation of a blood pressure cuff
• Software that calibrates hearing aids and assesses sound intensity characteristics and electroacoustic frequency of hearing aids.

What does it mean if your software/SaaS is classified as a medical device?

SaaS founders need to be aware of the compliance risks that medical devices pose. Data breaches are one of the biggest risks. Medical devices often contain sensitive patient data, which is why they are subject to strict regulations. This data could lead to devastating consequences if it were to become unprotected. SaaS companies who develop medical devices need to take extra precautions to ensure their products are safe.

So who needs to apply for FDA clearance? The FDA defines a ?mobile medical app manufacturer? is any person or entity who initiates specifications, designs, labels, or creates a software system or application for a regulated medical device in whole or from multiple software components. This term does not include persons who exclusively distribute mobile medical apps without engaging in manufacturing functions; examples of such distributors may include the app stores.

Software As Medical Device Patenting Considerations

The good news is that investors like medical device companies which have double exclusivity obtained through FDA and US Patent and Trademark Office (USPTO) approvals. As such, the exit point for many medical device companies is an acquisition by cash rich medical public companies. This approach enables medical devices to skip the large and risky go-to-market (GTM) spend and work required to put products in the hands of consumers.

Now that we have discussed the FDA review process, we will discuss IP issues for software medical device companies. Typically, IP includes Patents, Trademarks, Copyrights, and Trade secrets. All of these topics matter and should be considered carefully. However, we will concentrate on patents to demonstrate how careless drafting and lack of planning can lead to problems, namely unplanned disclosures of your design that can then be used as prior art against your patent application.

In general, you should file patent application(s) as soon as practicable to get the earliest priority dates. This will help you when you talk to investors, FDA consultants, prototyping firms, and government agencies, among others. Compliance or other documents filed with any government agency may be considered disclosure to third parties and could make the document public. In general, disclosures to third parties or public availability of an invention trigger a one year statutory bar during which you must file your patent application. Failure to file your application within the required time frame could result in you losing your right to protect your invention.

The information from your FDA application may find its way into FDA databases, including DeNovo, PMA and 510k databases and FDA summaries of orders, decisions, and other documents on products and devices currently being evaluated by the FDA. Your detailed information may be gleaned from Freedom of Information Act requests on your application. This risk mandates that you patent your invention quickly.

When you patent your medical device invention, have a global picture of FDA regulatory framework when you draft your patent application. Be mindful of whether your software/SaaS application discusses the diagnosing and treating patients or affecting the structure or function of the body and add language to indicate that such description in the patent application relates to only one embodiment and not to other embodiments. That way you have flexibility in subsequent discussions with the FDA if you want to avoid classification of your software/SaaS/software as a medical device. In this way, if you wish to avoid FDA registration and oversight, you have the flexibility to do so.

An experienced attorney can assist you in navigating the regulatory landscape and ensure that you comply with all applicable laws. This area of law is complex and constantly changing. It is important that you seek legal advice if you have any questions about whether or not your software should be registered with FDA.

Patent PC is an intellectual property and business law firm that was built to speed startups. We have internally developed AI tools to assist our patent workflow and to guide us in navigating through government agencies. Our business and patent lawyers are experienced in software, SaaS, and medical device technology. For a flat fee, we offer legal services to startups, businesses, and intellectual property. Our lawyers do not have to track time as there is no hourly billing and no charges for calls or emails. We just focus on getting you the best legal work for your needs.

Our expertise ranges from advising established businesses on regulatory and intellectual property issues to helping startups in their early years. Our lawyers are familiar with helping entrepreneurs and fast-moving companies in need of legal advice regarding company formation, liability, equity issuing, venture financing, IP asset security, infringement resolution, litigation, and equity issuance. For a confidential consultation, contact us at 800-234-3032 or make an appointment here.