bioe 3

4 kinds of intellectual property

trademarks copyrights trade secrets patents

what is a trademark

any word, name, symbol, or device or any combo thereof and used to identify goods and distinguish them from those manufactured and sold by others ex: google, apple

what is a copyright?

an exclusive legal right to print, publish, perform, film, or record material

what is a trade secret?

secret device or technique used especially in a trade

what is a patent?

a patent is a claim(s) of invention. it permits its owner to exclude others from making, using, or selling an invention

types of patents

utility patent design patent plant patent provisional patent

utility patent

a utility patent is obtained for processes (chemical, mechanical, or electrical procedures), machines, articles of manufacturing, and compositions of matter.

design patent

is obtained for an invention of a new, original and ornamental design for an article of manufacture. Design patent protection extends only to an item’s appearance, not its functional aspects

plant patent

is granted for a distinct and new variety of a cultivated asexually reproduced plant.

provisional patent

contains a specification sufficient detail to allow one skilled in the art to practice the invention. A provisional is a preliminary action to provide the inventor 12 months to develop the full patent claims

process for patents (4 steps)

1. it must fall into one of the statutory classes: processes, machines, manufactures (objects made by humans or machines), compositions of matter

2. it must be useful

3. it must be novel

4. it must not be obvious to a person w/ ordinary skill in the art to which the subject matter pertains

what goes into a patent?

claims (from uspto.gov)

two types of claims for patents

independent claims and dependent claims

independent claims

is a standalone claim that contains all the limitations necessary to define an invention.

dependent claims

must refer to a claim previously set forth and must further limit that claim.

who can file a patent application?

must be filed in the name of the inventor(s). However, patents can be assigned to others. ~ assignee

assignee

the legal owner of a patent (unless you’re an entrepreneur, usually your employer

who is an inventor

an inventor must take creative contributions to the invention

if you want to patent... (do's)

~ maintain a lab notebook ~ make progress on "completing" the invention ~ seek professional assistance

if you want to patent... (dont)

~ publish an article that would enable others to practice the invention; you have 1 yr to file an application after an article has been published ~ sell or offer for sell anything based upon the invention or accept a purchase order ~ explain your invention to anyone without a confidentiality agreement ( Non-disclosure agreement)

how long do you have protection?

20 years from the earliest filing to which the patent claims 'priority'

'priority'

sometimes one files ‘follow-on’ or derivative patents, these usually expand or specialize the originals claims, therefore, they usually link back to the original patent in terms of their protection and lifespan

filing rules

~ US patent rights have historically been granted on the basis of ‘first to invent’ ~ The US patent law has recently been updated and will be on a ‘first to file’ basis going forward, generally consistent with international practice

what is the value of intellectual property?

depends on how you utilize your patent protection ~ exclusion of others ~ give your business exclusivity ~ licensing rights to others for consideration

license

a legal document granting rights to intellectual property and/or material in exchange for good and valuable consideration

rights to the invention

rights can be restricted to: ~ type of license ~ field of use ~ a period of time ~ a territory

what goes into a license?

a royalty and a grant of the right to prohibit others from practicing the technology

how does IP impact me as a researcher in a large company

researcher in a large company ~ May be called upon to build a better mouse trap. (i.e. find a way around a competitors patent) ~ Named as inventor but all rights assigned to the company as a condition of employment

how does IP impact me as a product manager/ marketing

~ may work with all types of Intellectual Property in the marketing of a product ~ need to be aware of competitor's products that may infringe

how does IP impact me as a an entrepreneur

~ excludes others ~ creates value ~ can be costly to protect

used for wound closure

sutures, tissue adhesives/ sealants

goals of wound closure (5)

• Accelerate healing and reduce scarring • Reduce the opportunity for infection • Restore mechanical strength to wounded tissue during healing • Reduce blood loss-hemostasis • Minimize the formation of adhesions -internal wound closure

general procedures (dermal)

• General wound cleaning – PVP-iodine (betadine) • Local anesthesia (sutures / staples-not required for most adhesives) • Irrigation-sterile water or saline • Debridement if necessary – Remove foreign material – Create sharp wound edges – Can accelerate healing and improve cosmetic outcome • Approximate wound edges and close via selected method

suture applications

• Closure of surgical incisions (dermal / internal) • Securing medical devices to patient tissue (permanent implant) • Re-connection of tissues separated by injury (permanent implant) – tendon – peripheral nerve

2 types of suture materials

absorbable and non-absorbable

absorbable

for wounds, 2-3 months ~ cagut: (isolated from sheep or bovine intestine) commonly treated with chromium trioxide-reduces absorption rate 40 to 75 days, reduces tissue reaction ~ polyglycolic acid (PGA) and poly lactic-co-glycolic acid (PLGA)

Non-absorbable

implants and wounds ~ cotton, silk, PET, polypropylene

hydrogel

~ cross-linked network of water soluble polymers ~ once cross-linked MW essentially goes to infinity ~ due to cross-linking the hydrogel is insoluble fun fact <3 : jello is a hydrogel :)

why are hydrogels good?

the human body is 70% water and the high water content of hydrogels provides mech properties similar to many soft tissues

primary applications of hydrogels

contact lens, intraocular lens, tissue sealants, tissue engineering

making hydrogels

cross-linking mechanisms ~ physical, ionic, covalent ~ step growth ~ free radical polymerization

adhesives

A substance capable of holding materials together in a functional manner

sealant

A material applied to a joint in paste or liquid form that hardens or cures in place, forming a barrier against gas or liquid entry-particularly blood leakage

purpose of surgical adhesives/ sealants

• Rapid wound closure • Improved prevention of blood loss • Minimizing deformation of tissue (reduce scarring) • Closure of mechanically weak tissues that are difficult to suture (liver, kidney, spleen)

in situ forming

liquid to solid transformation occurs during application (in situ polymerization of liquid monomers)

cure time

how long liquid-solid transformation requires

shelf life

how long can it be stably stored as a monomer without premature polymerization

key characteristics of surgical adhesives/ sealants (6)

~ in situ forming ~ cure time ~ shelf life ~ tissue bond strength ~ flexible - minimize irritation ~ easily sterilized

failure mechanisms

adhesive failure, cohesive failure, substrate failure

adhesive failure

failure occurs at the tissue/material interface

cohesive failure

failure occurs within the substance of the adhesive

substrate failure

failure of the tissue substrate

type of adhesive

cyanoacrylate

cyanoacrylate

~ superglue and other chem variations ~ degradation is proportional to length of chain ~ rapid degradation is toxic ~ octyl cyanoacrylates are approved for topical use in humans

cyanoacrylate polymerization

initiated by water and amine groups present on proteins in the tissue ~ bc the tissue initiates the polymerization, it is chemically bonded to the adhesive, providing exceptional bond strength

application of dermal cyanoacrylate adhesive

• Use proper good wound care practices • Appose wound edges tightly • DO NOT GET ADHESIVE IN THE WOUND!!!

5 types of sealants (all hydrogels)

– Fibrin glue – BioGlue – ProGel – DuraSeal – FocalSeal

clinical considerations

• Source of proteins-human • Possible disease transmission (viruses) • Such risk is considered minuscule • Proteins are purified from pooled batches of human blood • Two commercial products – Hemaseel-Hemacure – Tisseel-Baxter Healthcare

bioglue

• Composed of two solutions-bovine serum albumin (BSA) and glutaraldehyde ** challenge with using BSA clinically is that it is xenogenic intended use: sealing suture lines in vascular implants

challenge of crosslinking chemistry for bioglue

cures too fast, glutaraldehyde is toxic

double barrel syringe

allows two highly reactive solutions to be stored separately and stably in one device

static mixer

the coiled piece of metal in the syringe tip-allows mixing of two solutions without agitation

xeno-free

does not contain any animal-derived products

in the US, total cardiovascular disease mortality is what rank in leading cause of death

#1

how many americans die each day from cardiovascular disease (on average)

2,500

what does the heart do

~ pump using transport medium (blood) ~ propels substances to body cells (oxygen, nutrients, wastes, etc)

circulatory system is made up of these 2 sub circuits

systemic circuit and pulmonary circuit

systemic circuit

– Blood vessels that carry the functional blood supply to and from all body tissues – Left side of the heart

pulmonary circuit

• Blood vessels carry blood to and from lungs

• Right side of the heart

capillaries

-microscopically small blood vessels between arteries and veins where oxygen diffuses to surrounding tissue

blood-oxygen transport

~ red blood cells transport hemoglobin • Hemoglobin reversibly binds oxygen • Lungs-high levels of oxygen, oxygen binds to hemoglobin • Capillaries-low levels of oxygen, oxygen dissociates from hemoglobin and diffuses into surrounding tissue

structure of the heart wall

epicardium, myocardium, endocardium (together they make up the heart wall)

endocardium-endothelial cells

provide a “perfect” blood contacting surface that does not initiate coagulation

myocardium

composed of cardiac myoblasts (cardiomyocytes)

cardiomyocytes

• contraction and relaxation

chambers of the heart

4 chambers ~ 2 atriums ~ 2 ventricles

atriums

– Receiving chambers – Relatively small, thin-walled chambers – Blood only pushed to ventricles

ventricles

• Discharging chambers

• Make up most volume of the heart

the 4 chambers and their functions

• Right atrium (Blood from body)

• Right ventricle (Blood to lungs via the pulmonary artery)

• Left atrium (Blood from lungs via the pulmonary vein)

• Left ventricle (Blood to body via the aorta) – walls 3X’s as thick as right ventricle

cardiac cycle (long answer)

~ pumping action in a rhythmic sequence ~ atrial diastole - the atrium is relaxed, allowing blood from the body/lungs to fill the atrium ~ as the atria fill with blood, the pressure rises, forcing the tricuspid and mitral valves to open -> this allows blood to fill diastole ventricles ~ then the atria contracts (systole), filling the ventricles to capacity ** the atrial kick accounts for 30% of cardiac output ~ pressure in the atria and ventricles equalize and the tricuspid and mitral valves begin to close ~ then the ventricles contract (systole) causing ventricular pressure to rise and the aortic and pulmonic valves to open

blood pressure

systolic blood pressure over diastolic bp ex: bp is 120 over 80

systolic pressure

Maximum pressure achieved during ventricular contraction

diastolic pressure

Lowest pressure that remains in the arteries before the next ventricular contraction

heart valves - function

~ blood flow only occurs in 1 direction ~ valves direct blood flow and prevent back flow

valve locations

• Atrioventricular valves • Semilunar valves

2 Atrioventricular valves

tricuspid and mitral

2 semilunar valves

aortic and pulmonary

electrical regulation of the heart

• A. Autorhythmicity • B. Pathway of stimulation – 1. Sinoatrial node – 2. Atrioventricular node – 3. Bundle of His – 4. Purkinje fibers

SA node

signal generator ~ Basal heart rate is influenced by the nervous and endocrine systems

resting membrane potential

Voltage across the cell membrane due to asymmetrical distribution of cations produced by Na/K pump

depolarization

transient reversal of resting membrane potential due to opening of membrane ion channels ** depolarization of muscle triggers contraction **

cardiac action potential

a brief change in voltage (membrane potential) across the cell membrane of heart cells

cardiac conduction

• SA nodes generates a periodic, automatic electrical impulse (action potential) • Travels down the atrial intranodal and intraatrial pathways • Slows at the AV node allowing the atria to contract and empty • Travels through common AV bundle to Purkinje fibers causing ventricular contraction

monitoring cardiac conduction

~ ECG or EKG - electrocardiogram • Heart is in fluid • Fluid transmits electrical activity from the source to the surface of body • Electrodes placed on skin surface measure direction and magnitude of current flow • EKG-2-dimensional representation of this electrical activity

normal EKG (w/ pic)

P: atrial depolarization P-R: SA to AV QRS: ventricular depolarization T: ventricular repolarization

what causes heart failure #sad

~ insufficient oxygen & nutrients are supplied (usually from a blockage/ occlusion) ~ hypoxia leads to cardiomyocyte death ~ repaired by fibroblasts and scar tissue ~ lack contractile properties of cardiomyocytes ~ decrease the mechanical function of the heart as a pump

heart failure (cause, symptoms, consequence)

~ root cause is vascular pathology ~ symptoms: heart attack (AKA myocardial infarction) ~ consequence: permanent damage to the cardiac muscle

Cardiomyocytes

the muscle cells of the heart-are considered post-mitotic (incapable of cell division)

heart failure solutions for a partially damaged heart

prosthetic ventricles such as ventricular assist devices (VADs)

heart failure solutions for a severely damaged heart

~ transplant ~ prosthetic heart (temporary)