bioe 3

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4 kinds of intellectual property
trademarks
copyrights
trade secrets
patents
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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
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what is a copyright?
an exclusive legal right to print, publish, perform, film, or record material
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what is a trade secret?
secret device or technique used especially in a trade
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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
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types of patents
utility patent
design patent
plant patent
provisional patent
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utility patent
a utility patent is obtained for processes
(chemical, mechanical, or electrical procedures), machines, articles of manufacturing, and compositions of matter.
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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
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plant patent
is granted for a distinct and new variety of a cultivated asexually reproduced plant.
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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
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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
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what goes into a patent?
claims (from uspto.gov)
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two types of claims for patents
independent claims and dependent claims
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independent claims
is a standalone claim that contains all the limitations necessary to define an invention.
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dependent claims
must refer to a claim previously set forth and must further limit that claim.
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who can file a patent application?
must be filed in the name of the inventor(s). However, patents can be assigned to others.
~ assignee
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assignee
the legal owner of a patent (unless you’re an entrepreneur, usually your employer
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who is an inventor
an inventor must take creative contributions to the invention
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if you want to patent... (do's)
~ maintain a lab notebook
~ make progress on "completing" the invention
~ seek professional assistance
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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)
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how long do you have protection?
20 years from the earliest filing to which the patent claims 'priority'
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'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
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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
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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
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license
a legal document granting rights to intellectual property and/or material in exchange for good and valuable consideration
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rights to the invention
rights can be restricted to:
~ type of license
~ field of use
~ a period of time
~ a territory
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what goes into a license?
a royalty and a grant of the right to prohibit others from practicing the technology
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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
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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
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how does IP impact me as a an entrepreneur
~ excludes others
~ creates value
~ can be costly to protect
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used for wound closure
sutures, tissue adhesives/ sealants
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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
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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
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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
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2 types of suture materials
absorbable and non-absorbable
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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)
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Non-absorbable
implants and wounds
~ cotton, silk, PET, polypropylene
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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
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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
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primary applications of hydrogels
contact lens, intraocular lens, tissue sealants, tissue engineering
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making hydrogels
cross-linking mechanisms
~ physical, ionic, covalent
~ step growth
~ free radical polymerization
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adhesives
A substance capable of holding materials together in a functional manner
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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
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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)
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in situ forming
liquid to solid transformation occurs during application (in situ
polymerization of liquid monomers)
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cure time
how long liquid-solid transformation requires
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shelf life
how long can it be stably stored as a
monomer without premature polymerization
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key characteristics of surgical adhesives/ sealants (6)
~ in situ forming
~ cure time
~ shelf life
~ tissue bond strength
~ flexible - minimize irritation
~ easily sterilized
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failure mechanisms
adhesive failure, cohesive failure, substrate failure
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adhesive failure
failure occurs at the tissue/material interface
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cohesive failure
failure occurs within the substance of the adhesive
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substrate failure
failure of the tissue substrate
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type of adhesive
cyanoacrylate
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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
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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
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application of dermal cyanoacrylate adhesive
• Use proper good wound care practices
• Appose wound edges tightly
• DO NOT GET ADHESIVE IN THE WOUND!!!
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5 types of sealants (all hydrogels)
– Fibrin glue
– BioGlue
– ProGel
– DuraSeal
– FocalSeal
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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
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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
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challenge of crosslinking chemistry for bioglue
cures too fast, glutaraldehyde is toxic
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double barrel syringe
allows two highly reactive solutions to be stored separately and stably in one device
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static mixer
the coiled piece of metal in the syringe tip-allows mixing of two solutions without agitation
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xeno-free
does not contain any animal-derived products
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in the US, total cardiovascular disease mortality is what rank in leading cause of death
#1
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how many americans die each day from cardiovascular disease (on average)
2,500
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what does the heart do
~ pump using transport medium (blood)
~ propels substances to body cells (oxygen, nutrients, wastes, etc)
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circulatory system is made up of these 2 sub circuits
systemic circuit and pulmonary circuit
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systemic circuit
– Blood vessels that carry the functional blood supply to and from all body tissues
– Left side of the heart
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pulmonary circuit
- Blood vessels carry blood to and from lungs
- Right side of the heart
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capillaries
-microscopically small blood vessels between arteries and veins where oxygen diffuses to surrounding tissue
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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
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structure of the heart wall
epicardium, myocardium, endocardium (together they make up the heart wall)
epicardium, myocardium, endocardium (together they make up the heart wall)
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endocardium-endothelial cells
provide a “perfect” blood contacting surface that does not initiate coagulation
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myocardium
composed of cardiac myoblasts (cardiomyocytes)
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cardiomyocytes
- contraction and relaxation
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chambers of the heart
4 chambers
~ 2 atriums
~ 2 ventricles
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atriums
– Receiving chambers
– Relatively small, thin-walled chambers
– Blood only pushed to ventricles
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ventricles
- Discharging chambers
- Make up most volume of the heart
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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
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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
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blood pressure
systolic blood pressure over diastolic bp
ex: bp is 120 over 80
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systolic pressure
Maximum pressure achieved during ventricular contraction
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diastolic pressure
Lowest pressure that remains in the arteries before the next ventricular contraction
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heart valves - function
~ blood flow only occurs in 1 direction
~ valves direct blood flow and prevent back flow
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valve locations
• Atrioventricular valves
• Semilunar valves
• Atrioventricular valves
• Semilunar valves
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2 Atrioventricular valves
tricuspid and mitral
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2 semilunar valves
aortic and pulmonary
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electrical regulation of the heart
• A. Autorhythmicity
• B. Pathway of stimulation
– 1. Sinoatrial node
– 2. Atrioventricular node
– 3. Bundle of His
– 4. Purkinje fibers
• A. Autorhythmicity
• B. Pathway of stimulation
– 1. Sinoatrial node
– 2. Atrioventricular node
– 3. Bundle of His
– 4. Purkinje fibers
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SA node
signal generator
~ Basal heart rate is influenced by the nervous and endocrine systems
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resting membrane potential
Voltage across the cell membrane due to asymmetrical distribution of cations produced by Na/K pump
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depolarization
transient reversal of resting membrane potential due to opening of membrane ion channels
** depolarization of muscle triggers contraction **
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cardiac action potential
a brief change in voltage (membrane potential) across the cell membrane of heart cells
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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
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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
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normal EKG (w/ pic)
P: atrial depolarization
P-R: SA to AV
QRS: ventricular depolarization
T: ventricular repolarization
P: atrial depolarization
P-R: SA to AV
QRS: ventricular depolarization
T: ventricular repolarization
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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
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heart failure (cause, symptoms, consequence)
~ root cause is vascular pathology
~ symptoms: heart attack (AKA myocardial infarction)
~ consequence: permanent damage to the cardiac muscle
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Cardiomyocytes
the muscle cells of the heart-are considered post-mitotic (incapable of cell division)
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heart failure solutions for a partially damaged heart
prosthetic ventricles such as ventricular assist devices (VADs)
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heart failure solutions for a severely damaged heart
~ transplant
~ prosthetic heart (temporary)