[[Image:Patent Search Strategy.jpg|700px]]
==Dolcera Patent Analysis==
{|border "1" style="border-spacing:0;"
| rowspan="2" style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''S.No. '''</font></center>
| rowspan="2" style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Patent/Publication No.'''</font></center>
| rowspan="2" style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Publication Date''' (mm/dd/yyyy)</font></center>
| rowspan="2" style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Assignee/Applicant'''</font></center>
| rowspan="2" style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Title'''</font></center>
| colspan="2" style="background-color:#4f81bd;padding:0.079cm;"| <center><font color="#FFFFFF">'''Dolcera Analysis'''</font></center>
|-
| style="background-color:#4f81bd;padding:0.079cm;"| <center>'''Problem'''</center>
| style="background-color:#4f81bd;padding:0.079cm;"| <center>'''Solution'''</center>
|-
| style="background-color:#dce6f1;padding:0.079cm;"| 1
| style="background-color:#dce6f1;padding:0.079cm;"| [http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220090187254%22.PGNR.&OS=DN/20090187254&RS=DN/20090187254 US20090187254A1]
| style="background-color:#dce6f1;padding:0.079cm;"| 07/23/2009
| style="background-color:#dce6f1;padding:0.079cm;"| BOSTON SCIENTIFIC SCIMED, INC.
| style="background-color:#dce6f1;padding:0.079cm;"| UROLOGICAL MEDICAL DEVICES FOR RELEASE OF UROLOGICALLY BENEFICIAL AGENTS
| style="background-color:#dce6f1;padding:0.079cm;"| In previous attempts to develope a uerteral stent, encrustation was the problem associated with the stent. Along with this pain and discomfort by stent implantaion was there.
| style="background-color:#dce6f1;padding:0.079cm;"| This invention provides a ueteral stent which release one or more urologically beneficial agents in effective amounts to reduce the problem of encrustation and pain related to stent.
|-
| style="padding:0.079cm;"| 2
| style="padding:0.079cm;"| [http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220090171465%22.PGNR.&OS=DN/20090171465&RS=DN/20090171465 US20090171465A1]
| style="padding:0.079cm;"| 07/02/2009
| style="padding:0.079cm;"| Boston Scientific Scimed, Inc.
| style="padding:0.079cm;"| Polymeric Regions For Implantable Or Insertable Medical Devices
| style="padding:0.079cm;"| In previous attempts to develope a uerteral stent, encrustation was the problem associated with the stent. Along with this pain and discomfort by stent implantaion was there.
| style="padding:0.079cm;"| This invention provides a ureteral stent with a coating of a material(EVA) that reduces the discomfort caused by the stent during implantation.
|-
| style="background-color:#dce6f1;padding:0.079cm;"| 3
| style="background-color:#dce6f1;padding:0.079cm;"| [http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220080097349%22.PGNR.&OS=DN/20080097349&RS=DN/20080097349 US20080097349A1]
| style="background-color:#dce6f1;padding:0.079cm;"| 04/24/2008
| style="background-color:#dce6f1;padding:0.079cm;"| Boston Scientific Scimed, Inc.
| style="background-color:#dce6f1;padding:0.079cm;"| Partially soluble implantable or insertable medical devices
| style="background-color:#dce6f1;padding:0.079cm;"| In previous attempts to develope a uerteral stent, encrustation was the problem associated with the stent. Along with this pain and discomfort by stent implantaion was there.
| style="background-color:#dce6f1;padding:0.079cm;"| Here the device (Stent) is provided with at least one surface that contains one or more depressions, which are at least partially filled with a soluble material. This makes stent more flexible and soft after implantation hence minimizing pain and discomfort after implantation or insertion.
|-
| style="padding:0.079cm;"| 4
| style="padding:0.079cm;"| [http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=5554147.PN.&OS=PN/5554147&RS=PN/5554147 US5554147A]
| style="padding:0.079cm;"| 09/10/1996
| style="padding:0.079cm;"| CApHCO, Inc.
| style="padding:0.079cm;"| Compositions and devices for controlled release of active ingredients
| style="padding:0.079cm;"| During implantation of ureteral stent,pain and discomfort are the problem with previous stents. Also microbial or bacterial infection at the site of implantation was the problem.
| style="padding:0.079cm;"| In this invention stent is povided with a pH sensitive coating that includes antimicrobial agent to stop the infection. This coating also has the hydrogel property which Upon swelling, the hydrogel's coefficient of friction is reduced, and the polymer becomes slippery, this mechanism reduces the discomfort.
|-
| style="background-color:#dce6f1;padding:0.079cm;"| 5
| style="background-color:#dce6f1;padding:0.079cm;"| [http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=6468649.PN.&OS=PN/6468649&RS=PN/6468649 US6468649B1]
| style="background-color:#dce6f1;padding:0.079cm;"| 10/22/2002
| style="background-color:#dce6f1;padding:0.079cm;"| Scimed Life Systems, Inc.
| style="background-color:#dce6f1;padding:0.079cm;"| Antimicrobial adhesion surface
| style="background-color:#dce6f1;padding:0.079cm;"| In prior art problem was the lack of the device which can remain in vivo for extended periods of time without losing its antimicrobial efficacy and which can provides protection against bacterial and fungal organisms for extended periods of time without leaching substances into a patient.
| style="background-color:#dce6f1;padding:0.079cm;"| This invention provides a medical device with a hydrophobic coating that inhibits the growth of microbes for extended period of time.
|-
| style="padding:0.079cm;"| 6
| style="padding:0.079cm;"| [http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220030153983%22.PGNR.&OS=DN/20030153983&RS=DN/20030153983 US20030153983A1]
| style="padding:0.079cm;"| 08/14/2003
| style="padding:0.079cm;"| Scimed Life Systems, Inc.
| style="padding:0.079cm;"| Implantable or insertable medical device resistant to microbial growth and biofilm formation
| style="padding:0.079cm;"| In previous attempts to develope a ureteral stent with coating the problem was the formation of biofilm and microbial growth.
| style="padding:0.079cm;"| The device of the present invention, therefore, overcomes the disadvantages associated with the use of coatings as discussed above, and provides a reduced risk of biofilm fouling that eventually results in encrustation, occlusion and failure of the device. In this invention medical device comprises at least one biocompatible matrix polymer region and bioactive agents comprising an antimicrobial agent and a microbial attachment/biofilm synthesis inhibitor.
|-
| style="background-color:#dce6f1;padding:0.079cm;"| 7
| style="background-color:#dce6f1;padding:0.079cm;"| [http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220030139800%22.PGNR.&OS=DN/20030139800&RS=DN/20030139800 US20030139800A1]
| style="background-color:#dce6f1;padding:0.079cm;"| 07/24/2003
| style="background-color:#dce6f1;padding:0.079cm;"| None
| style="background-color:#dce6f1;padding:0.079cm;"| Stent assembly with therapeutic agent exterior banding
| style="background-color:#dce6f1;padding:0.079cm;"| In earlier attempts for stent with a therapeutic property, the problem was the coating or the sheath (responsible for therapy) may covers side branch arteries, vessels, or other lumens extending from the main lumen in which the stent is installed. The sheath can reduce blood flow to or from the side branch and deliver medication into the side branch where it is unnecessary.
| style="background-color:#dce6f1;padding:0.079cm;"| This invention provides a stent assembly with exterior banding for delivery of therapeutic agents that would overcome the previous disadvantages. Also this stent assembly which avoids side branch vessel blockage by a sheath, with increased drug storage capacity and allowing delivery of different drugs at different axial and radial locations.
|-
| style="padding:0.079cm;"| 8
| style="padding:0.079cm;"| [http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220040117007%22.PGNR.&OS=DN/20040117007&RS=DN/20040117007 US20040117007A1]
| style="padding:0.079cm;"| 06/17/2004
| style="padding:0.079cm;"| STS Biopolymers, Inc.
| style="padding:0.079cm;"| Medicated stent having multi-layer polymer coating
| style="padding:0.079cm;"| The problem associated with previous stent and their implantation was thrombus formation in vicinity of stent.
| style="padding:0.079cm;"| The stent assembly developed in this invention consistently provide therapeutic activity from the surfaces of stents in order to reduce the incidence of restenosis and thrombus formation after coronary stenting procedures in the clinic.
|-
| style="background-color:#dce6f1;padding:0.079cm;"| 9
| style="background-color:#dce6f1;padding:0.079cm;"| [http://www.wipo.int/pctdb/en/wo.jsp?WO=1990013332 WO1990013332A1]
| style="background-color:#dce6f1;padding:0.079cm;"| 11/15/1990
| style="background-color:#dce6f1;padding:0.079cm;"| CEDARS-SINAI MEDICAL CENTER
| style="background-color:#dce6f1;padding:0.079cm;"| STENT WITH SUSTAINED DRUG DELIVERY
| style="background-color:#dce6f1;padding:0.079cm;"| Problem was to provide an intravascular stent that preserves vessel patency, inhibits luminal narrowing and at the same time stent can deliver a pharmaceutical agent to a specific body site or organ.
| style="background-color:#dce6f1;padding:0.079cm;"| The stent assembly provided by this invention will release anticoagulants, antiplatelet drugs or drugs that inhibit excessive endothelial cell growth at the placement site, thereby preserving the vessels patency and inhibiting luminal narrowing.
|-
| style="padding:0.079cm;"| 10
| style="padding:0.079cm;"| [http://www.wipo.int/pctdb/en/wo.jsp?WO=2001036008 WO2001036008A2]
| style="padding:0.079cm;"| 05/25/2001
| style="padding:0.079cm;"| STS BIOPOLYMERS, INC.
| style="padding:0.079cm;"| MEDICAL DEVICES COATED WITH ELASTIC POLYMERIC MATERIAL
| style="padding:0.079cm;"| The lack of flexibility, expandability and lubricity of coating surface was the problem with previous insertable medical device.
| style="padding:0.079cm;"| This invention provides a medical device with a polymeric coating adherent to the covering, such that the coating and covering possess desirable surface characteristics such as lubricity, or lack thereof, as well as flexibility, expandability and elasticity.
|}
== Dolcera Dashboard ==
=Insights=
{|border="2" cellspacing="0" cellpadding="4" width="100%"
|bgcolor = "#538ED5"|<font size = "4">''' '''</font>
|bgcolor = "#538ED5"|<font size = "4">''' '''</font>
|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font>
|bgcolor = "#538ED5"|<font size = "4">'''C R BARD'''</font>
|-
|align = "center" bgcolor = "#538ED5" rowspan = "4"|'''Products'''
|'''Portfolio'''
|8 Products
|6 Products
|-
|'''Material'''
|Percuflex - Biocompatible Polymer
|Silicone
|-
|'''Coating'''
|Hydroplus
|Licensed from pHreecoat
|-
|'''Shape'''
|Pigtailed and More
|Figure 4 and more
|-
|align = "center" bgcolor = "#538ED5"|'''Clinical <br>Trials'''
|'''Current Trials'''
|Truimph Ureteral stent - Loaded with Triclosan <br>Currently in Phase II (Canada)
|None
|-
|align = "center" bgcolor = "#538ED5" rowspan = "3"|'''Patents'''
|'''Coating'''
|Therapeutic / Medicinal coatings <br>Magnetic nano particles for MRI Imaging <br>Lubricious coatings helping easy insertion
|Therapeutic coatings
|-
|'''Structure'''
|Multiple channels filled with therapeutic agent<br>Multiple collapsible segments preventing fluid passing<br>Renal coil with wick to prevent reflux <br>Stent with beads on its surface <br>Stent with reservoir indicating its release <br>with change in color of urine<br>Expandable and collapsible stent<br>Stents with degradable barbs
|Expandable stents for reducing discomfort
|-
|'''Material'''
|Elastically deformable stents<br>Biodegradable polymer based stents<br>Porous polymer for long term implantation<br>Stent with variable hardness
|Biodegradable polymers<br>Shape memory alloys<br>General polymer based
|-
|}
==Inferences =={|border="2" cellspacing="0" cellpadding="4" width="82%"|bgcolor = "#538ED5"|<font size = "4">'''Boston Scientific'''</font>|bgcolor ="#538ED5"|<font size ="4">'''C R BARD'''</font>|-|Relatively late entrant with patents filed post mid 90s|Early mover with patents filed in mid 80s|-|Increased patent activity since 2000|Patent activity never gained traction|-|Large number of patents yet to be "productized"|Few patents yet to be "productized"|-|Some products undergoing clinical trails|No products undergoing clinical trails|-|Diverse range of products with variation in material <br>and structure|Small product portfolio|-|Seem to be strengthening they market position|Seem to be moving focus away from Ureteral stents market|-|}
===Products===
* They have '''8 ureteral stents''' in their portfolio
* Boston's ureteral stent portfolio have some common features such as:
#Stent '''material''' consisting of '''Percuflex'''- a Biocompatible Polymer Material
#The '''coating''' on the stent may be a '''Hydroplus''' coating
#Most of the stents are designed to have an '''indwelling time''' of '''365 days'''
#Pigtailed shaped ureteral stent
===Regulatory data===
* Ureteral stents are class II medical devices and hence require a 510(k) approval to launch the product in the market. The '''time''' taken for Boston to get their stent '''approved''' ranged from '''21 days to 9 months
'''
===Clinical trials===*The clinical trials of new medical devices of Class II and Class III can be conducted only after clinical trial approval by the relevant authority in accordance with the rules of the drug regulatory authority under State Council. '''Currently''' Boston scientific is conducting clinical '''trials''' for '''Truimph Ureteral stent''' which is a ureteral '''stent''' loaded with '''Triclosan''' (used as an antimicrobial agent).The trials are currently in '''Phase II''' in '''canada'''(NCT00250406). *Other trials are related to comparison of various ureteral stent of different companies in terms of patient comfort and materials used in the stent.*The result of trials is that there is '''not much differenc'''e among the ureteral stents of different companies in terms of '''patient comfort''' and '''materials''' used in the stent ===Patents===*The '''mapped patents''' gives an insight in to patents which were '''successfully commercialized''' *The '''unmapped patents''' gives us a glimpse of '''future moves''' in terms of product development strategy.It may also '''signify''' those patents which '''failed to productize'''.*The unmapped patents are analysed based on the following parameters'''1.Coating on stents:''' Boston scientific has patents on Therapeutic/ medicinal coatings on stents which releases into the vascular region. Magnetic nanoparticles which helps in imaging the ureteral stent using MRI. Lubricious coatings which help in easy insertion of the stent '''2.Structure of stent:''' Boston scientific has patents on various structures of stent . For eg: Multiple channels(Depressions) along the length of stent filled with therapeutic agent,Multiple segments on the distal side of stent which is collapsible to prevent fluid from passing from the bladder to the kidney, Stent with a renal coil with wick portion to prevent reflux of urine,Stent with beads on its surface which is of figure 8 shape having therapeutic agents, Stent with reservoir indicating its release with change in color of urine,Stents with degradable barbs,Expandable and collapsible stent to reduce patient discomfort '''3.Materials used for stent:'''Boston scientific has patents on various materials used for stent. For eg.Elastically deformable stents(polysaccharide-based hydrogels), Biodegradable polymer based stents, Porous polymer for long term implantation( poly(styrene) blocks and polyisobutylene blocks),Stent with variable hardness (ethylene vinyl acetate and hydroxypropylcellulose) ==C.R.Bard== ===Products===* They have '''6 products''' in their ureteral stent portfolio* C.R Bard ureteral stent portfolio have some common features such as:#Most of the stent has '''Silicone''' as their '''main material'''#They have stent with '''various''' '''designs''' and shapes eg Figure 4 ureteral stent#Some of the stent have '''coatings''' which is '''liscensed''' from third party eg."'''pHreecoat'''" ===Regulatory data===The time taken for C.R. Bard to get their '''stent approved''' ranged from '''21 days to 9 months''' ===Clinical trials===There are '''no trials currently''' conducted by C.R.Bard. The other trials are related to comparison of various ureteral stent of different companies in terms of patient comfort and materials used in the stent. The result of trials is that there is not much difference in all the ureteral stent of different companies in terms of patient comfort and materials used in the stent ===Patents===C R Bard is '''not very active''' in filing patents with very '''few''' patents '''filed after 2000'''. *The unmapped patents are analysed based on the following parameters '''1.Coating on stent:'''They have a couple of patents related to therapeutic coatigs on stent surface '''2.Structure of stent:'''C R. Bard patents are related to expandable stents for reducing patent discomfort '''3.Material used on stent:''' Recent patents focuses on Biodegrable polymers, Shape memory alloys or general polymer based stent =Key Findings===Major Players==*Boston Scientific Limited, Abbott, Medtronic and Cook Inc. are the major players in ureteral stent research field. [[Image:Major playersnew.jpg|thumb|center|1000px|Major Players]] ==Key Patents==*The key patents in the field are held by Cook Incorporated, Interventional Thermodynamics, Abbott laboratories and Boston Scientific Corp.[[Image:Key patent2.png|thumb|center|1100px|Key Patents]] ==IP Activity==*Patenting activity has been high growth rate during the period 2001 to 2005 with a peak no. of patents in year 2005, followed by saturation during the period 2006 to 2008 and after that a gradual declination upto year 2010 in the ureteral stent research area.[[Image:IPactivity3.png|thumb|center|1000px|year wise IP activity]] ==Geographical Activity==*USA, Europe and Germany are very active in ureteral stent research. [[Image:Geodistribution5.png|thumb|center|600px|Geographical Activity]] =Competitor AnalysisCompetitive landscape=
Total Sales in 2010 - 4.04 Billion USD
==Academic Research ==
Research at University of Minnesota about symptoms and pain associated with ureteral stent
[[Research Team]]
'''Background and Purpose'''
*Ureteral stents are associated with significant pain and urinary symptoms.
*Manufacturers have altered stent designs and materials in an attempt to minimize this morbidity.
*This study evaluated the impact of these modifications.
'''Patients and Methods'''
*Stent manufacturers were asked to provide the 6F ureteral stent they believed would be associated with the least patient discomfort.
*Patients undergoing uncomplicated ureteroscopy were randomized to the Bard Inlay, Cook Endo-Sof, Microvasive Contour, Applied Medical Vertex, or Surgitek Classic Double-Pigtail stent.
*The Ureteric Stent Symptom Questionnaire (USSQ) was administered on days 1, 3, and 5, and the patients maintained a narcotic diary. The data were analyzed using ANOVA and nonparametric methods.
'''Results'''
*A total of 44 patients (73%) completed all USSQ questionnaires.
*Urinary symptom scores were significantly lower for the Inlay stent on day 3 than for the Vertex (P = 0.01), Contour (P = 0.05), Endo-Sof (P = 0.03), and Classic (P = 0.02) stents. No significant differences were noted in pain and general symptom scores or narcotic use.
'''Conclusion'''
*'''The Bard Inlay stent is associated with less-severe urinary symptoms than other ureteral stents.'''
*The USSQ is a sensitive tool to measure differences between stents.
The complete USSQ form is available at [http://www.bui.ac.uk/ BUI] and [http://www.endourology.org/ endourology].
Source [http://www.liebertonline.com/doi/abs/10.1089/end.2005.19.990?journalCode=end University of Minnesota]
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