Software Technology for “Multilayer medical balloon”

Medical Device – John Jianhua Chen, Daniel James Horn, Boston Scientific Scimed Inc

Abstract for “Multilayer medical balloon”

“An expandable medical ball, comprising an inner layer of poly (ether-blockamide) copolymer, and an outer layer of polyamide. The expandable medical ball has a burst strength greater than 50,000 PSI. Methods of making and using it.

Background for “Multilayer medical balloon”

“Expandable medical balls are used in a variety medical procedures, including plain old balloon angioplasty (POBA), as well as delivery of medical devices to treatment sites such as stent delivery.”

“Medical applications in which a balloon is used intraluminally, such as POBA or stent delivery, can be difficult because of the small vessels and the long distances that the catheter might travel to reach the treatment site. It is desirable for such applications that the balloon has a thin wall, but maintains high strength, as measured most often by hoop strength, pressure at burst, and be predictable in inflation properties.

Inelasticity is desirable because it allows for easy control over the balloon’s diameter. However, some flexibility is desirable so that the surgeon can adjust the balloon’s diameter to suit individual needs. Small variations in pressure shouldn’t cause large variations in the balloon’s diameter.

“It is difficult to get a good balance of properties using a single polymer material. Over the years, many polymer mixtures and multi-layered polymer balloons were developed.

“But, there is still a need for an expandable medical ball with excellent physical properties.”

Below is a summary of some of claimed embodiments of invention, without limiting their scope. The Detailed Description below contains additional details about the claimed embodiments and/or embodiments.

“In one aspect, this invention is a expandable medical balloon that has at least two layers. An inner layer made from a soft, elastic material and an outer layer made from a harder, more elastic material.

“In one aspect, this invention is a medical balloon that expands. The inner layer is made of a Polymer Material with Shore D hardness between 25 and 70. The outer layer is made of a Polymer Material with Rockwell hardness between 60 and 115. The expandable medical balloon has a burst strength greater than 45,000 psi, more suitable than 47,500 and most suitably above 50,000 psi.

“In one embodiment, this invention concerns an expandable medical ball that includes an inner layer of poly (ether-blockamide) copolymer and an outside layer of polyamide. The expandable medical ball has a burst strength greater than 45,000psi, more suitable than 47,500psi and most appropriate over 50,000psi.”

The dual-layer balloons have shown a synergistic increase of hoop strength according to the invention.

“These and other aspects, embodiments, and benefits of the present invention will become apparent to those with ordinary skill in art after reviewing the Detailed Description and Claims.

While this invention can be implemented in many different ways, the specific embodiments of it are detailed here. This description is intended to illustrate the principles of the invention but is not meant to limit the invention to those illustrated.

“All published documents, which include all US patent documents mentioned in this application, are hereby expressly included herein by reference. All copending patent applications mentioned in this application are also expressly incorporated by reference herein in their entirety.

“The invention concerns an expandable medical ball with at least two layers. An inner, more elastic, layer is softer than the outer layer. The outer layer is harder and less elastic. The inner layer that is softer and more elastic is made from a material with a lower tensile setting (see ASTM D412). The inner layer is made from a lower tensile material, which allows for easier refolding after the procedure is completed.

“Suitably the shore D hardness (or inner layer) is less than 75D, less suitable than 70D, and a range of 25D to 75D, or more appropriately about 25D-to-about 70D. Some embodiments have a range of 50D to 75D, 50D to 70D in some cases.

The outer layer is more difficult than the inner layer. The Rockwell hardness of the outer layer can range from 60 to about 115 to more suitable about 70 to about 120, to most appropriately about 80 to around 115 to to suitably, but this range could vary. The Shore D hardness (ASTM D2240), of the outer layer is suitable for greater than 70D, more suitable than 75D and most suitable than 80D. FIG. 1. FIG. 1 is reproduced from http://www.calce.umd.edu/general/Facilities/Hardness_ad_.htm. The scale shows that nylon has a Shore D harness score of 80 or higher and a Rockwell hardness rating of at least 95. These numbers can be approximated using the scale.

“In a preferred embodiment, only the inner and outer layers are used to form the balloon. The inner layer should provide at least 10% and, in some cases, at least 20% of the balloon’s burst strength. An optional lubricious coating can be placed on the outer layer. The coating is not structurally strong.

The resultant balloons should have a burst force of more than 45,000 psi. Sometimes, burst strength can be referred to as radial tensile force or hoop strength in the art.

The balloon can be made using any method that is suitable for the art. The method may include forming a tube parison, stretching it, placing the balloon in a mold and then forming the balloon by radially expanding that tubular paraison into a mold. Heat sets the balloon. U.S. Pat. reveals the balloon forming process with stretching and radial expansion. Nos. Nos. Nos. Nos. 6,946,092 & 7,1010,597 are incorporated herein in their entirety.”

The coextrusion technique may be used to form the tubular parison. Two layers may be used to form the tubular parison. One layer may include a soft layer and one layer that is harder. Other layers may alternate between hard and soft layers. Layers 1, 3, and 5, with 1 being the balloon’s innermost layer, are made from the flexible, softer material, while layers 2, 4, and 6 are made of the stronger, more durable polymer material.

The softer, flexible inner layer can also be applied to the balloon after it has been inflated from the balloon parason. You can coat the balloon with a solvent or a solvent mixture. For example, the coating can be injected directly into the balloon or tubular parison.

“In some embodiments it may be desirable that the waist portion is made of only one layer. You can mask the waist with an insert tube or clean after coating has been applied.

Suitably, the tubular paraison is stretched axially (longitudinally), using a ratio less than 4.0X, where X is its starting length. One specific embodiment of the method involves stretching the balloon paraison at a rate of 3.50X, where X is the tubular length.

“A balloon burst pressure decrease of over 20% at stretch ratios significantly higher than 4.25 was observed. The corresponding decrease of calculated burst strength was more than 10%.”

The tubular parison can then be used to form the balloon using any technique, including molding. The tubular parison can then be molded and radially expanded by using molding techniques. Molding pressures can range from 500 psi to 600 psi.

“The balloons that result, such as those used in cardiovascular procedures, have a wall thickness between 10 and 30 microns. More suitable, about 10 to 20 microns.

“Now let’s move on to the figures. FIG. 2. is a cross-sectional longitudinal representation of a balloon 10, according to the invention. Balloon 10 has two layers, one inner and one outer. This is in accordance to the invention. FIG. FIG. 2.”

The balloon may also have a lubricious coating (not illustrated). The lubricious coating can be applied to the balloon waists 16, 18, and cones 17, 19, or 21. Suitably, the thickness of lubricious coatings is between 0.1 and 5.0 microns. More suitable, about 0.5 to 2.0 microns.

“Any suitable lubricious substance may be used in the lubricious coat. These lubricious coatings have been described in the art. Thermoplastic and thermoset materials are two examples of materials that could be used as lubricious coatings. Hydrophilic or hydrophobic lubricious polymers are available. Because they are more biocompatible, hydrophilic materials are preferred. Commonly assigned U.S. Patents disclose lubricious coatings. No. No.

Interpenetrating polymer network can also be used. These materials can be described in U.S. Patents that are commonly assigned. No. No.

“Coatings to control the delivery of therapeutic agents can also be added optionally.”

“FIG. “FIG. Catheter assembly 20 has an inner shaft 22 as well as an outer shaft 24. Inner shaft 22 is characterized by an inner surface 23 that defines a guide wire lumen 26, while outer shaft 24 has an interior surface 23. The lumen 26 is shown with guide wire 28.

“Proximal waist 16 is located around the distal tip of outer shaft 24, and distal waist 18, about the distal tip of inner shaft 22.

“The assembly could also include a stent 30, which is positioned around balloon 10, as shown in FIG. 5. It may be beneficial to apply a lubricious coating to the only waist portions 16, 17, cone portions 17, 19, 18, or combination of both the waist and cone portions in the case of stent delivery.

“The balloons described in this article may be used in any number of medical procedures, including angioplasty (PTCA), for delivery of medical device such as stents or stents (SDS), genitourinary, neurological, peripheral vascular, renal, and other procedures.”

“The following examples are not limited to the invention.”

“EXAMPLES”

“Example 1”

“The average balloon burst at 465 PSI (31.6 atm) (burst Pressure) with an average double wall thickness 0.00114 inches. At 6/16 atm, the average balloon distention was 5.8%. The average diameter of the balloon was 3.3024mm.”

“The calculated burst force was 53,033 PSI.”

“For example, the hoop ratio for 1 is 4.758.”

“Comparative Example A”.

“For comparison, the exact same material ratio was used in the previous example, but with an opposite material arrangement, i.e. the softer material outside. Vestamid L2101F was used as the inner layer (70% of the material ratio) while Pebax 733 was used as an outer layer (30% of this ratio). Per the balloon-forming process, the same dimensions of tubing were extruded as the balloon.

“The balloon burst with 386 psi (26.3 atm on average) (burst pressure), with an average double wall thickness 0.00108 inches. At 6/16 atm, the balloon distended 6.7%. The average diameter of the balloon was 3.360mm.

“The calculated burst force was 47,280 PSI.”

“Comparative Example A”

“The inner and outer layers were the same as in Example 1, but with a different tubing ratio.”

“An average balloon burst at 366 PSI (24.9 atm), with an average double wall thickness 0.00103 inches. At 6/16 atm, the average balloon distention was 6.0%. The average diameter of the balloon was 3.3505mm.

“The calculated burst force was 46,872 PSI.”

“Comparative Example C”.

“The inner and outer layers of the same material were used as in Example 1, but with a different heat setting temperature.”

“An average balloon burst at 391 PSI (26.6 atm) (burst Pressure) with an average double wall thickness 0.00113 inches. At 6/16 atm, the average balloon distention was 6.8%. The average diameter of the balloon was 3.362mm.

“The calculated burst force was 45,802 PSI.”

“The disclosures above are intended to be illustrative, not exhaustive. This description will show many alternatives and variations to the one of ordinary skill in the art. You can combine or modify the elements in the figures to create your own combinations.

Summary for “Multilayer medical balloon”

“Expandable medical balls are used in a variety medical procedures, including plain old balloon angioplasty (POBA), as well as delivery of medical devices to treatment sites such as stent delivery.”

“Medical applications in which a balloon is used intraluminally, such as POBA or stent delivery, can be difficult because of the small vessels and the long distances that the catheter might travel to reach the treatment site. It is desirable for such applications that the balloon has a thin wall, but maintains high strength, as measured most often by hoop strength, pressure at burst, and be predictable in inflation properties.

Inelasticity is desirable because it allows for easy control over the balloon’s diameter. However, some flexibility is desirable so that the surgeon can adjust the balloon’s diameter to suit individual needs. Small variations in pressure shouldn’t cause large variations in the balloon’s diameter.

“It is difficult to get a good balance of properties using a single polymer material. Over the years, many polymer mixtures and multi-layered polymer balloons were developed.

“But, there is still a need for an expandable medical ball with excellent physical properties.”

Below is a summary of some of claimed embodiments of invention, without limiting their scope. The Detailed Description below contains additional details about the claimed embodiments and/or embodiments.

“In one aspect, this invention is a expandable medical balloon that has at least two layers. An inner layer made from a soft, elastic material and an outer layer made from a harder, more elastic material.

“In one aspect, this invention is a medical balloon that expands. The inner layer is made of a Polymer Material with Shore D hardness between 25 and 70. The outer layer is made of a Polymer Material with Rockwell hardness between 60 and 115. The expandable medical balloon has a burst strength greater than 45,000 psi, more suitable than 47,500 and most suitably above 50,000 psi.

“In one embodiment, this invention concerns an expandable medical ball that includes an inner layer of poly (ether-blockamide) copolymer and an outside layer of polyamide. The expandable medical ball has a burst strength greater than 45,000psi, more suitable than 47,500psi and most appropriate over 50,000psi.”

The dual-layer balloons have shown a synergistic increase of hoop strength according to the invention.

“These and other aspects, embodiments, and benefits of the present invention will become apparent to those with ordinary skill in art after reviewing the Detailed Description and Claims.

While this invention can be implemented in many different ways, the specific embodiments of it are detailed here. This description is intended to illustrate the principles of the invention but is not meant to limit the invention to those illustrated.

“All published documents, which include all US patent documents mentioned in this application, are hereby expressly included herein by reference. All copending patent applications mentioned in this application are also expressly incorporated by reference herein in their entirety.

“The invention concerns an expandable medical ball with at least two layers. An inner, more elastic, layer is softer than the outer layer. The outer layer is harder and less elastic. The inner layer that is softer and more elastic is made from a material with a lower tensile setting (see ASTM D412). The inner layer is made from a lower tensile material, which allows for easier refolding after the procedure is completed.

“Suitably the shore D hardness (or inner layer) is less than 75D, less suitable than 70D, and a range of 25D to 75D, or more appropriately about 25D-to-about 70D. Some embodiments have a range of 50D to 75D, 50D to 70D in some cases.

The outer layer is more difficult than the inner layer. The Rockwell hardness of the outer layer can range from 60 to about 115 to more suitable about 70 to about 120, to most appropriately about 80 to around 115 to to suitably, but this range could vary. The Shore D hardness (ASTM D2240), of the outer layer is suitable for greater than 70D, more suitable than 75D and most suitable than 80D. FIG. 1. FIG. 1 is reproduced from http://www.calce.umd.edu/general/Facilities/Hardness_ad_.htm. The scale shows that nylon has a Shore D harness score of 80 or higher and a Rockwell hardness rating of at least 95. These numbers can be approximated using the scale.

“In a preferred embodiment, only the inner and outer layers are used to form the balloon. The inner layer should provide at least 10% and, in some cases, at least 20% of the balloon’s burst strength. An optional lubricious coating can be placed on the outer layer. The coating is not structurally strong.

The resultant balloons should have a burst force of more than 45,000 psi. Sometimes, burst strength can be referred to as radial tensile force or hoop strength in the art.

The balloon can be made using any method that is suitable for the art. The method may include forming a tube parison, stretching it, placing the balloon in a mold and then forming the balloon by radially expanding that tubular paraison into a mold. Heat sets the balloon. U.S. Pat. reveals the balloon forming process with stretching and radial expansion. Nos. Nos. Nos. Nos. 6,946,092 & 7,1010,597 are incorporated herein in their entirety.”

The coextrusion technique may be used to form the tubular parison. Two layers may be used to form the tubular parison. One layer may include a soft layer and one layer that is harder. Other layers may alternate between hard and soft layers. Layers 1, 3, and 5, with 1 being the balloon’s innermost layer, are made from the flexible, softer material, while layers 2, 4, and 6 are made of the stronger, more durable polymer material.

The softer, flexible inner layer can also be applied to the balloon after it has been inflated from the balloon parason. You can coat the balloon with a solvent or a solvent mixture. For example, the coating can be injected directly into the balloon or tubular parison.

“In some embodiments it may be desirable that the waist portion is made of only one layer. You can mask the waist with an insert tube or clean after coating has been applied.

Suitably, the tubular paraison is stretched axially (longitudinally), using a ratio less than 4.0X, where X is its starting length. One specific embodiment of the method involves stretching the balloon paraison at a rate of 3.50X, where X is the tubular length.

“A balloon burst pressure decrease of over 20% at stretch ratios significantly higher than 4.25 was observed. The corresponding decrease of calculated burst strength was more than 10%.”

The tubular parison can then be used to form the balloon using any technique, including molding. The tubular parison can then be molded and radially expanded by using molding techniques. Molding pressures can range from 500 psi to 600 psi.

“The balloons that result, such as those used in cardiovascular procedures, have a wall thickness between 10 and 30 microns. More suitable, about 10 to 20 microns.

“Now let’s move on to the figures. FIG. 2. is a cross-sectional longitudinal representation of a balloon 10, according to the invention. Balloon 10 has two layers, one inner and one outer. This is in accordance to the invention. FIG. FIG. 2.”

The balloon may also have a lubricious coating (not illustrated). The lubricious coating can be applied to the balloon waists 16, 18, and cones 17, 19, or 21. Suitably, the thickness of lubricious coatings is between 0.1 and 5.0 microns. More suitable, about 0.5 to 2.0 microns.

“Any suitable lubricious substance may be used in the lubricious coat. These lubricious coatings have been described in the art. Thermoplastic and thermoset materials are two examples of materials that could be used as lubricious coatings. Hydrophilic or hydrophobic lubricious polymers are available. Because they are more biocompatible, hydrophilic materials are preferred. Commonly assigned U.S. Patents disclose lubricious coatings. No. No.

Interpenetrating polymer network can also be used. These materials can be described in U.S. Patents that are commonly assigned. No. No.

“Coatings to control the delivery of therapeutic agents can also be added optionally.”

“FIG. “FIG. Catheter assembly 20 has an inner shaft 22 as well as an outer shaft 24. Inner shaft 22 is characterized by an inner surface 23 that defines a guide wire lumen 26, while outer shaft 24 has an interior surface 23. The lumen 26 is shown with guide wire 28.

“Proximal waist 16 is located around the distal tip of outer shaft 24, and distal waist 18, about the distal tip of inner shaft 22.

“The assembly could also include a stent 30, which is positioned around balloon 10, as shown in FIG. 5. It may be beneficial to apply a lubricious coating to the only waist portions 16, 17, cone portions 17, 19, 18, or combination of both the waist and cone portions in the case of stent delivery.

“The balloons described in this article may be used in any number of medical procedures, including angioplasty (PTCA), for delivery of medical device such as stents or stents (SDS), genitourinary, neurological, peripheral vascular, renal, and other procedures.”

“The following examples are not limited to the invention.”

“EXAMPLES”

“Example 1”

“The average balloon burst at 465 PSI (31.6 atm) (burst Pressure) with an average double wall thickness 0.00114 inches. At 6/16 atm, the average balloon distention was 5.8%. The average diameter of the balloon was 3.3024mm.”

“The calculated burst force was 53,033 PSI.”

“For example, the hoop ratio for 1 is 4.758.”

“Comparative Example A”.

“For comparison, the exact same material ratio was used in the previous example, but with an opposite material arrangement, i.e. the softer material outside. Vestamid L2101F was used as the inner layer (70% of the material ratio) while Pebax 733 was used as an outer layer (30% of this ratio). Per the balloon-forming process, the same dimensions of tubing were extruded as the balloon.

“The balloon burst with 386 psi (26.3 atm on average) (burst pressure), with an average double wall thickness 0.00108 inches. At 6/16 atm, the balloon distended 6.7%. The average diameter of the balloon was 3.360mm.

“The calculated burst force was 47,280 PSI.”

“Comparative Example A”

“The inner and outer layers were the same as in Example 1, but with a different tubing ratio.”

“An average balloon burst at 366 PSI (24.9 atm), with an average double wall thickness 0.00103 inches. At 6/16 atm, the average balloon distention was 6.0%. The average diameter of the balloon was 3.3505mm.

“The calculated burst force was 46,872 PSI.”

“Comparative Example C”.

“The inner and outer layers of the same material were used as in Example 1, but with a different heat setting temperature.”

“An average balloon burst at 391 PSI (26.6 atm) (burst Pressure) with an average double wall thickness 0.00113 inches. At 6/16 atm, the average balloon distention was 6.8%. The average diameter of the balloon was 3.362mm.

“The calculated burst force was 45,802 PSI.”

“The disclosures above are intended to be illustrative, not exhaustive. This description will show many alternatives and variations to the one of ordinary skill in the art. You can combine or modify the elements in the figures to create your own combinations.

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.