Home

Report

1. RX Sphincterotome is as safe and as effective as the predicate device 21 14 FMEA Item Function Failure Mode Potential S a Causes Actions Responsibility Figure 1 Effects of S S z Deliverable Label Failure S EJF 3 3 Z Cutting je Cauterize je Increase heat le The wire can e Improper e Have a relay that R Attardo Wire A the papilla production and severe and current setting trips when too January 20 melting dislodge in the by doctor much current is 2014 e Doesn t patient e Improper detected perform proper je Too much insulation from cauterization current can 9 2 8 other pieces of 144 lead to burns the Hydratome e Too little current will not properly cauterize Cannula je Holds the je Cracking e Loses sterility e Mishandling of e Design caps that T Gunnels B cutting wire Bending when cracks the device will cover the February 2 contrast and le Obstruction occur e Foreign contrast agent and 2014 guidewire in e Kinks inhibit 1 2 1 materials enter 2 cutting wire one lumen proper use through contrast injection sites e Cutting wire and cutting wire and contrast injection sites can t reach correct location Cutting je Provides an le Obstruction e Cutting wire e Foreign material e Develop a cap for A Ravilla Wire opening for je Doesn t will need to be enters into the the cutting wire February 2 Injection insertion properly hold removed and injection site injection site 2014 S
2. guide wire becomes displaced and it will need to be redirected through the body ducts which is a very difficult procedure and increases the time of the operation The proposed solutions will allow for a faster procedure with fewer components reducing patient trauma and overall time and cost The final product will address the need of reducing the time spent during the procedure reducing the amount of time the patient is under anesthesia This is done by including the contrast dye cutting wire and guide wire into one cannula and removing the need to switch between cannulas In addition the proposed final product will give the physician control over the cannula tip allowing for more precise cutting and cannulation The single cannula inserted will cause lower incidents of pancreatitis caused by accidental perforations of the duodenum or bile duct which occurs during multiple insertions of cannula Also once the distal end is properly located it can remain in place throughout the procedure and other surgical devices can be placed onto the guide wire increasing precision and reducing the occurrences of accidental perforations The handle has the ability to control the distal end and orientate the cutting wire The proposed design will eliminate the step of requiring a precut in order to place the cutting wire into place where it will then cut a larger hole The cutting wire is the necessary component that the rest of the procedure is dependen
3. Contrast Agent Injection Site 8 7 s 4 3 2 All Units are in mm KO SolidWorks Student Edition For Academic Use Only 8 7 6 5 t 4 3 2 28 D Connector All Units are in mm SolidWorks Student Edition For Academic Use Only 8 7 29 E Cutting Wire Injection Site 0 80 2 All Units are in mm 30 F Cannula 8 7 All Units are in mm SolidWorks Student Edition For Academic Use Only 8 7 O 31 References David Kaminstein The Gale Group Endoscopic Sphincterotomy 2002 http health yahoo net galecontent endoscopic sphincterotomy Web 13 Oct 2013 Digestive Disease Center MUSC Health Diseases of the Pancreas and Biliary Tree http www ddc musc edu public symptomsDiseases diseases pancreas cfm Web 13 Oct 2013 gt Jamidar et al Endoscopic Spincterotomy http emedicine medscape com article 1891681 overview Kalid et al Bile Duct Obstruction http www healthline com health bile duct obstruction SignsandS ymptoms gt Bonheur et al Biliary Obstruction http emedicine medscape com article 187001 overview a0199 Chemmanur et al Biliary Disease http emedicine medscape com article 171386 overview a0199 7 Vitellas Kenneth et al MR Chol MR Cholangiopancreatography of Bile and Pancreatic Duct Abnormalities with Emphasis on th
4. biliary ducts are often difficult to diagnose The bile duct is on average 4 1 mm wide and 7 mm long As such it is difficult to image the area and even more difficult to conclude whether the duct is functioning correctly To diagnose the disease there are three main options The first is magnetic resonance imaging MRI which noninvasively observes the duct This approach enables physicians to structurally examine the duct in a process known as magnetic resonance cholangiopancreatography MRCP This technique is particularly useful in observing cysts or tumors that do not absorb contrast needed to make clear X ray images Ultrasound is another noninvasive technique but the low spatial resolution of the technology makes it difficult to diagnose small problems Finally x ray technigues using contrast injected into the ducts through an endoscope are collectively known as endoscopic retrograde cholangiopancreatography ERCP This approach provides excellent clarity and is useful in detecting sphincter dysfunction While invasive this technique allows for treatment and diagnosis to be administered in the same procedure If this treatment involves the cutting of the sphincter of Oddi it is referred to as an endoscopic retrograde spincterotomy ERS With ERCP and ERS the procedure begins by the patient being anesthetized A local anesthetic is applied to the throat to suppress the gag reflex The patient is placed on an x ray table to allow
5. for the duration of the procedure The endoscopist controls the endoscope insertion and positioning for surgeon The surgeon performs cutting of sphincters cannulation stent placement etc Nurses assist in feeding endoscope and sphincterotome wires into the endoscope as well as monitoring patient vitals Current studies have found the cost of the ERCP procedure ranges from 1 952 to 2 790 uspe The effectiveness of ERCP in confirming a patient s diagnosis cannot be understated In one study covering 1341 procedures the accuracy of diagnosis greatly increased after performing this technigue Prior to the procedure the physician s diagnosis was correct only 64 of the time for bile duct stones 86 89 for other biliary dysfunctions 77 for chronic pancreatitis and 74 for pancreatic cancer based on observed symptoms of first time cases 849 in all In 35 of the cases studied the diagnostic confidence improved significantly after ERCP was performed Using these more accurate diagnoses additional invasive surgical procedures were reevaluated and the course of action changed in 82 of cases that required it For example percutaneous biliary studies and open surgical procedures were suggested less often in favor of laparoscopic techniques This can be attributed to more precise diagnosis and identification of the patient s issue prior to any invasive surgeries By improving diagnosis accuracy through the use of ERCP physicians were able to determ
6. juices can cause many secondary problems including gallstones and pancreatitis To repair this dysfunction a technique called endoscopic retrograde sphincterotomy ERS is used to cut the diseased valve to provide access to the ducts in order to remove gallstones insert a stent in the duct or otherwise treat the underlying cause of the disease The tools necessary for ERS are threaded through an endoscope to reach the ducts of the pancreas and gallbladder The endoscope is inserted in the mouth down the pharynx and esophagus through the stomach and pylorum and into the duodenum The ampulla of Vater is the opening of the common bile duct and pancreatic duct which controls release of bile for fat digestion and pancreatic juice for the breakdown of carbohydrates lipids nucleic acids and protein respectively The release of these solutions is controlled by the sphincter of Oddi a smooth muscular valve When the end of the endoscope has reached the sphincter of Oddi a cannula is threaded through the scope and releases fluorescent dye used to detect blockages and lesions in the area After releasing the dye the cannula is removed and a cutting tool is inserted Using the camera on the endoscope as a guide the cutting device the spincterotome cuts through the sphincter of Oddi for access into the ducts Repair of the ducts or removal of lesions can then be performed ERS is performed in over 150 000 patients per year to treat these dis
7. predicate devices in terms of safety and efficacy Therefore human clinical trials will not be required for this device 16 Standards and Guidelines To insure an expedited approval process improved patient safety and general good manufacturing practices several standards will be adhered to The International Electrotechincal Commission IEC has a set of standards for Medical Electrical Equipment specifically Particular Requirements for the Safety of High Frequency Surgical Equipment The Hydratome depends on the delivery of high current through its cutting wire thus adhering to these standards reduces potential harm Moreover as our device is an accessory to an endoscope standards detailed by the American Society for Testing and Materials ASTM Standard Practice For Reprocessing Of Reusable Heat Stable Endoscopic Accessory Instruments Eai Used With Flexible Endoscopes ObGyn Gastroenterology Due to the high chance of infection if our device were to be reused the Hydratome is designed as a single use device Together these two standards should ensure maximum patient safety 25 Appendix A Handle All Units are in mm SolidWorks Student Edition For Academic Use Only 8 7 26 B Slider 8 7 All Units are in mm SolidWorks Student Edition For Academic Use Only 8 7 27 C
8. Hydratome RX 44 Sphincterotome Boston Scientific Group December 9 2013 Ross Attardo Matt Elam gt Fe Ryan Grubbs Z A 20 Taylor Gunnels LE A 20 Anoop Ravilla esp 4 dd 20 ASSIGNMENT 1 NO REGRADE 3 1 STATEMENT OF CLINICAL PROBLEM 3 2 DESCRIPTION OF CURRENT PRACTICES 4 3 PROBLEM STATEMENT 7 4 NEED STATEMENT 8 5 PRELIMINARY DESIGN CONCEPTS 9 ASSIGNMENT 2 NO REGRADE 13 6 STATEMENT OF INTENDED USE 13 7 STATEMENT OF INDICATION OF USE 13 8 FUNCTIONAL amp PERFORMANCE SPECIFICATIONS 13 9 TEST PLAN 14 10 PRODUCT DESIGN CONCEPT 15 ASSIGNMENT 30 11 INTELLECTUAL PROPERTY REVIEW 18 12 REGULATORY CLASSIFICATION 19 13 REGULATORY NOTIFICATION APPROVAL 19 14 FMEA 22 15 PRECLINICAL AND HUMAN STUDY PLAN 24 16 STANDARDS AND GUIDELINES 24 APPENDIX 26 A HANDLE 26 B SLIDER 27 C CONTRAST AGENT INJECTION SITE 28 D CONNECTOR 29 E CUTTING WIRE INJECTION SITE 30 F CANNULA 31 REFERENCES 32 Assignment 1 No Regrade 1 Statement of Clinical Problem Normal functioning of the bile ducts pancreas and gallbladder promotes healthy digestion through the release of hydrolytic enzymes and bile to breakdown organic materials Malfunction of this system often begins with improper flow of the powerful digestive solutions through the ducts that lead to the intestines Often this is a result of narrowing ducts or stenosis of the valve leading to the lumen of the digestive tract This improper flow of bile and pancreatic
9. assembly distal tip 23 15 Preclinical and Human Study Plan Preclinical testing will be used to validate the device s functional specifications in vivo We will use a pig analog to confirm that the device can reliably cut the Sphincter of Oddi and cannulate the biliary ducts for the treatment of biliary diseases A pig model will be used because of the similarity in digestive anatomy and relative size of the digestive tract The device will be tested by feeding the sphincterotome down the pig s digestive tract into the Papilla of Vater Here the rotation of the guide wire will be tested as detailed in the test plan checking for degree of rotation The Sphincter of Oddi will be cut to ensure the cutting wire functions in the aqueous environment of the body Finally the biliary duct will be cannulated to confirm that capability of the device to treat a variety of biliary diseases including those that require cannulation These animal trials will confirm our device is safe and effective for our indications for use All regulations in the following documents will be followed IEC 60601 1 ISO 14971 2007 ISO 10993 ISO 11135 1 2003 and ASTM FI 980 07 2007 Furthermore an IRB approval will be required before these preclinical studies are conducted Human clinical trials will not be necessary as detailed in our premarket notification We believe that there is not a significant difference between our device and
10. cess to the average biliary duct The device must withstand 15 Nm of torque to assure the device can easily be operated by hand without failure The rotation will not be limited however such that the device can be rotated continuously if need be Finally the Hydratome must be able to inject x ray imaging contrast agent into an area of interest during surgery To accomplish this a third lumen in addition to the guidewire and cutting wire lumens must be used to isolate the dye from the other wires This lumen must also run the length of the catheter to allow injection of contrast agent from an external source This lumen will be connected to an injection port on the handle The device will need to be able to dispense 4 mL of contrast agent With regards to control the device must dispense no more or less than 0 1 mL than what the surgeon intended 9 Test Plan 1 The device must treat conditions caused by inflammation or constriction of the biliary duct To verify the performance specifications under this functional specification quantitative measurements of the device must be taken After manufacturing the guidewire and catheter will be measured In particular the catheter must be 200cm long the guidewire must be 260cm long and the width of the cutting wire must be 20cm or 30cm Finally a voltmeter will be used to ensure the voltage output of the cutting wire meets specifications This output must be 1 5 k Volts to allow for adequate c
11. e Single Shot Fast Spin Echo Technique RadioGraphics http radiographics rsna org content 20 4 939 abstract Parulekar Suhas Ultrasound Evaluation of the Common Bile Duct Radiology http radiology rsna org content 133 3 703 abstract NIH ERCP http digestive niddk nih gov ddiseases pubs ercp 10 American Society for Gastrointestinal Endoscopy ASGE Technology Status Evaluation Report radiographic contrast used in ERCP Gastrointestinal Endoscopy http www asge org assets 0 71312 71314 4a061d86479a49f3983 1c54cad4be0b9 pdf 1l American Society for Gastrointestinal Endoscopy GI Endoscopes Gastrointestinal Endoscopy http www asge org uploadedFiles Publications and Products Technology Reviews GI 20End oscopes 1 pdf American Society for Gastrointestinal Endoscopy ERCP cannulation and sphincterotomy devices Gastrointestinal Endoscopy http www asge org uploadedFiles Publications and Products Technology Reviews ERCP 20 Cannulation 20and 20Sphincterotomy 20Devices pdf 5 American Society for Gastrointestinal Endoscopy Electrosurgical Generators Gastrointestinal Endoscopy http www asge org assets 0 713 12 713 14 a287d885 e2ad 4c3b ae7c 12e035d3061f pdf 14 http medicalphysicsweb org cws products category 185 gt Arguedas MR et al Suspected Sphincter of Oddi Dysfunction Type II Empirical Biliary Sphincterotomy or Manometry Guided Therapy Thieme https www thieme co
12. ed in 21CFR876 4300 these devices must adhere to specified performance standards in their 510 k Premarket review of this 510 k is expected to be performed by the Office of Device Evaluation the Division of Reproductive Gastro renal and Urological Devices and the Urology and Lithotripsy Devices Branch 13 Regulatory Notification Approval Section 5 510 k SUMMARY 510 k SUMMARY 1 Submitter Boston Scientific Corporation 100 Boston Scientific Way Marlborough MA 01752 Telephone 508 683 4793 Fax 508 683 5939 Contact Ryan Grubbs Regulatory Affairs Specialist Date Prepared September 10 2009 19 2 Proposed Device Trade Name Hydratome RX Sphincterotome Classification Name Endoscopic Electrosurgical Unit and Accessories Regulation Number 876 4300 Product Code KNS Classification Class II 3 Predicate Devices Trade Name Autotome RX Sphincterotome Manufacturer and Clearance Number Boston Scientific Corporation K013153 Classification Name Endoscopic Electrosurgical Unit and Accessories Regulation Number 876 4300 Product Code KNS Classification Class II Trade Name Ultratome XL Sphincterotome Manufacturer and Clearance Number Boston Scientific Corporation K930022 Classification Name Endoscopic Electrosurgical Unit and Accessories Regulation Number 876 4300 Product Code FDI Classification Class II 4 Proposed Device Description The proposed Hydratome RX is a triple lumen sphincte
13. eft and right as well as a lever to pull on in order to bend the cutting wire up and down The handle will have a locking mechanism to keep the cutting wire in the correct position as the physician s discretion An alternative proposed sphincterotome would have a steerable sphincterotome that allows the physician to have control over the distal tip to adjust for any inconsistencies in anatomy or endoscope positioning similar to the previous proposed design In addition the proposed sphincterotome will be an improvement over the current art in that the guide wire cutting wire and contrast agent can all be used within one lumen removing the extra step of inserting multiple cannulas and needing to position them multiple times This is an added feature over the previous proposed solution in that all the proximal lumens will converge into one distal lumen reducing the size of the cannula Through the proximal lumens a guide wire contrast dye and a cutting wire can each be inserted into the cannula The ergonomic handle will allow for physician comfort and the independent control over the position of the distal end and cutting wire The locking mechanism of the handle will secure the position of the distal end ensuring proper placement throughout the entire procedure The main risk of the proposed solution is in regards to the cutting wire If the cutting wire is not properly placed through the distal end of the sphincterotome there is a possibil
14. ers the cutting wire and contrast agent requires two lumens embedded within a rapid exchange catheter as described in patents US6007522 US6606515 and US6879854 filed in 1997 1999 2003 respectively The two lumens within the catheter are complimented by a third U shaped lumen which houses the guidewire and allows for rapid catheter exchange along its length This platform allows for a single operator two if available to quickly exchange devices along the length of the guidewire These patents also describe a design and method for inserting the guidewire through an external funnel shaped port which connects directly to the catheter s guidewire lumen this port gives ease of insertion as well as a specialized notch where the clinician can place the guidewire to fix it in place when the target is reached These patents are central to the general design of the device and allow for a single device to complete a surgery instead of several These patents were used in predicate devices to the Hydratome RX44 but several were filed for this device For example patent US7706861 describes a more modern version of this technology with an improved notch to hold the guidewire as well as a reshaped funnel Additionally several more recent patents were filed for the specialized handle used in our device The handle consists of a rotatable portion which can be turned to articulate the tip of the cutting wire without rotating the catheter as well as multiple ports for
15. f clear plastic Figure 1 Exploded view of the proposed Hydratome RX 44 device showing each individual component A Hydra Jagwire Guidewire cutting wire B Cannula C Cutting Wire Injection Site D Connector E Contrast Agent Injection Site F Slider G Handle 16 The packaging of the device will be in a sterile bag because of the fact that this device will be entering the body The surgeon will be able to open the packaging and remove the device in an easy to open manner The labeling on the device will contain the manufacturer of the device as well as the name of the device in large letters to ensure the correct choice of the device while in the operating room There will also be a contents list that will contain the components of the device that is inside the packaging and a clearly labeled diagram of guide wire and cutting wire There will be the manufacturers address and contact information also on the front of the packaging with the lot number and reference numbers of each component that is present in the packaging On the reverse side of the packaging will be the user manual that contains warnings device description indications for use adverse events precautions preparation instructions and directions for use 17 Assignment 3 11 Intellectual Property Review Our product has several key patents which make it both highly functional and unique for endoscopic procedures First the method with which the device deliv
16. for continuous imaging of the patients GI tract An endoscope is placed down the throat through the stomach and into the small intestines Air is pumped into the GI tract to allow for easy maneuvering and imaging with the endoscope Once the endoscope has reached the duodenum the surgeon must locate the sphincter of Oddi A catheter is run down the length of the endoscope and this catheter is placed through the sphincter and into the bile duct Dye is injected through this catheter to allow for high contrast x ray imaging Once the dye is released that catheter is removed and a new tool is placed in the endoscope This new tool is either a sphincterotome for incision of the sphincter of Oddi or forceps for the removal of gallstones Either mechanical or electrical mechanisms are used to incise the sphincter If more contrast agent is needed the catheters must be reinserted s Currently the procedure reguires use of an endoscope a cannula for dye injection a sphincterotome an electrosurgical generator a fluoroscopy machine and radiographic contrast Currently Olympus Fujinon and Pentax produce endoscopes Boston Scientific Cook Conmed and Olympus make cannulas and cutting wires Olympus Conmed and Boston scientific produce generators Philips and Siemens produce Fluoroscopy machines E Multiple personnel are required for the procedure The anesthesiologist ensures patient s gag reflex has been disabled and that they are unconscious
17. formed In particular a volumetric analysis of the contrast agent will be determined to verify that 4 mL of contrasting agent can be delivery through the lumen of the device The lumen will need to be tested for pressure tolerances so that 0 1 mL delivered over 5 seconds will not cause failure in the tubing 10 Product Design Concept There are several major components that all come together to make the entire handle of the Hydratome RX 44 The first is the center handle itself which can be seen in appendix 15 A This handle holds the slider appendix B and allows for the control of the rotation of the distal tip The slider contains the electrical connection to draw electricity through to the cutting wire as well as a connection to the distal tip that allows for the angulation of the cutting wire The handle then connects to the contrast injection site appendix C which tapers the size of the handle into the connection appendix D with the cutting wire injection site appendix E Finally the cannula appendix F that will hold the cutting wire and guide wire comes out of the cutting wire injection site The configuration of the Hydratome RX 44 can be seen in the exploded view of figure 1 The entire proximal handle shown in green in figure 1 is made from plastic except for the electrical connection site and guide wire connection piece of the slider The black connection piece shown in figure 1 is rubber while the distal tube is made o
18. ine the best course of action for the patient Despite the current ERCP procedure being considered a safe that does not preclude it from complications Common complications due to surgery include bleeding duodenal perforation pancreatitis or cholangitis among other infections and side effects In a study performed by doctors at National University Hospital in Singapore of the 336 ERCP procedures 33 complications were reported 9 8 of total The group observed pancreatitis in eighteen patients bleeding in three cholangitis in eight duodenal tearing in one a choledocho duodenal fistula in one subcapsular liver perforation in one and one case of developed bradycardia There were also six fatalities in the month following the procedure but only one is attributed to the ERCP Another larger study of 2 347 patients undergoing a biliary sphincterotomy including ERCP procedure there were 229 complications 9 8 Of these patients 127 developed pancreatitis ranging from mild to severe 48 had notable bleeding 24 developed cholangitis eleven developed cholecystits eight had duodenal or other perforations and the remaining 25 complications varied in cause 6 or less cases of each Within this subset of patients 10 died either directly or indirectly within 30 days of the procedure According to the authors of the study many of the injuries sustained by the pancreas were a result of cannulation of the bile ducts rather than the sphinctero
19. inserting 1 the guidewire 2 the cutting wire and 3 and the contrast agent The patents which describe this as well as the mode of operation for the device are US6676659 US6827718 and US7371237 Thusly they describe that the handle will have a locking mechanism to hold the tip in the prescribed orientation to allow a single operator to perform the procedure needed that the handle will be inhibited from rotating past a certain point 18 that there are visual markings which delineate the rotation of the tip and handle and that the device will use an electrosurgical tool cutting wire to perform any enlargement surgeries cutting These innovations are important for the proper positioning and control which is needed to complete sphincterotomy and other biliary related procedures Finally patent US7645254 describes the actual method of using the device to inject contrast agent into the desired area to facilitate more precise imaging This is vital for the reduction of difficulty and increasing the success of surgery 12 Regulatory Classification Given the use of electrosurgical equipment in in the GI tract the Hydratome RX 44 is a KNS product as described by the FDA Such products are Endoscopic Electrosurgical unit and accessories Devices in this category are classified as Class II devices requiring a 510 k for approval Boston Scientific s own Autotome exists as predicate device In accordance with FDA regulations stat
20. ion papillotomy and sphincterotomy Current practices use multiple cannulas to first inject the contrast dye then cut using a conductive wire and finally remove the obstruction In addition current practices involve moving the endoscope to get correct placement of the cutting wire and guide wire to the desired location There are many variations in patients with respect to the physical anatomy which results in difficulty to accurately and consistently place the contrast agent and cutting wires The clinical requirements of the proposed sphincterotome are that the distal end and cutting wire be controllable without the need to move the entire endoscope This will allow for proper placement without moving the endoscope reducing the possibility of displacement forces on the guide wire or catheters The other requirement is that there be one cannula in place containing the contrast agent guide wire and cutting wire instead of needing to insert multiple cannulas that each contain either the contrast dye guide wire or cutting wire A possible design to satisfy the clinical requirements is to have a multi lumen system within a single catheter that can be controlled by the handle One lumen will then be used to carry the contrast dye to the correct location another lumen will carry the guide wire and a third lumen will contain the cutting wire that is connected to the handle The handle will have the ability to rotate in order to move the cutting wire l
21. ite C and removal the cutting wire reinserted e Open slit causes e Removal of slit in of the in place during the cutting wire device design 4 1 1 tomoveinside 4 je Add locking cutting wire the procedure the cannula mechanism for cutting wire to hold in place Connector je Connects e Cracking and je Contrast won t e Improper e None Found D contrast and general reach correct manufacturing during guidewire damage location or handling manufacturing and lumens to 1 inspection one lumen in the cannula Contrast le Location for e Contrast e Contrast won t e Incorrect choice 1 e Use a different Doctor During Agent contrast syringe isn t reach correct of syringe size syringe with procedure Injection agent to be correct size for location correct size Site E inserted injection site Slider F je Electrical je Loses control e Procedure must e Guidewire 135 jp Add an additional R Grubbs connection of distal end be stopped becomes guidewire January 20 for cutting because the severed attachment incase 2014 wire cutting wire of failure of the e Controls can t be first distal tip properly placed location Handle e Guides the je Cracks or e Procedure must Improper 1 le None Found G slider fatigue be stopped manufacturing during e Controls e Detaches from e Lose the fixed or handling manufacturing and rotation of rest of position of inspection distal tip
22. itions caused by inflammation or constriction of the biliary duct To accomplish this the sphincterotome must be able to reach the papilla of Vater and the sphincter of Oddi which are located in the duodenum Thus the catheter used to perform exploratory or therapeutic surgery must be 200cm to reach the biliary duct Additionally the guidewire must be at longer than the catheter a length of 260cm would suffice The guidewire will come preloaded into the device to prevent contamination or human error The device must also be able to perform a sphincterotomy if necessary and must therefore have a cutting tip The cutting wire is 20mm or 30mm depending on the patient and surgery needs it also uses an electric current to cut the tissue while also cauterizing it which is powered through the handle The maximum voltage to be run through the wire will be 1 5kV to ensure that the device cuts but does not produce excessive risk to the patient 13 Second the device must be able to cannulate the biliary duct The guidewire must be able to carry the cannula to the proper location and release it This includes the device fitting into the biliary duct and the sphincter about 6mm in diameter 77 The cannula must then be expelled from the lumen using the guidewire to slide it into position Additionally the device tip must articulate to properly place the cannula which can be achieved by rotating the handle It will need to rotate at least 40 to gain ac
23. ity of short circuiting and excessive heat generation In this scenario the cutting wire can contact the endoscope if it is not properly placed This will cause a short circuit and an increase in heat through the distal end of the cutting wire The cutting wire can become hot enough to sever itself and become dislodged within the patient as well as get hot enough to cause burning in the patient However having a properly coated guide wire in place during the procedure can alleviate the possibility of patient burning The benefits of the proposed solutions are numerous The first is that the distal end of the sphincterotome is controllable by the physician without having to move the endoscope The proposed handle is ergonomic and comfortable for the operator In addition it can be used to rotate the distal end as well as bend it into the proper location The handle will have a locking mechanism that will keep it securely in place There is a problem in previous procedures in which during unattended periods the cutting instrument will begin to relax and bow moving to 10 an unwanted orientation that will then need to be corrected for once again The locking handle removes this problem because it will be maintained in the proper orientation regardless of the unattended time duration An additional benefit is that the proposed sphincterotome is multi lumen and will require less cannula exchanges Often times during the catheter exchanges the
24. lly stimulated by continued irritation to the area caused by the extended surgical time In addition these continuous adjustments increase the chance of accidental perforations of the duodenum or bile duct Studies have found that these types of complications are strongly related to skill of the endoscopist Fewer complications arose in hospitals that performed more endoscopic procedures and those with more qualified endscopists The overall decrease in complications in skilled medical centers was 8 4 percent versus 11 1 percent is unskilled centers 4 Need Statement The goal of a new sphincterotome device is to remove the time spent switching tools during an ERCP procedure in order to reduce stress on the patient and the incidence of surgical complications In addition the apparatus should give the physician greater control over the tip of the cannula allowing for more precise cutting and cannulation The quantitative results of this change would be a reduced surgical time and reduced incidences of accidental damage to the surrounding area This would manifest as a reduction of the overall incidences of complications after surgery falling below 8 4 percent In addition the increased control over the cannula should result in a reduction in the divide between skilled and unskilled endoscopists 5 Preliminary Design Concepts There are several clinical requirements that are necessary to improve the current art in performing endoscopic cannulat
25. m ID 1845 http www accessdata fda gov cdrh docs pdf K013153 pdf http www accessdata fda gov scripts cdrh cfdocs cfcfr cfrsearch cfm fr 876 4300 33 34 http www accessdata fda gov scripts cdrh cfdocs cfstandards detail cfm standard identificatio n noz21971 35 http www accessdata fda gov scripts cdrh cfdocs cfstandards detail cfm standard__identificatio n no 29857 36 http www fda gov medicaldevices deviceregulationandguidance guidancedocuments ucm07375 8 htm 33
26. nnect com DOI DOI 10 1055 s 2004 8 14186 DaVee Thomas et al Precut sphincterotomy for selective biliary duct cannulation during endoscopic retrograde cholangiopancreatography Annals of Gastroenterology http www annalsgastro gr files journals 1 earlyview 2012 ev 06 2012 07 1551 pdf VTopazian Mark et al Clinical utility of endoscopic retrograde cholangiopancreatography Gastrointestinal Endoscopy Volume 46 Issue 5 November 1997 Pages 393 399 ISSN 0016 5107 http www sciencedirect com science article pii S00165 10797700300 i Ong TZ et al Complications of endoscopic retrograde cholangiography in the post MRCP era a tertiary center experience World Journal Gastroenterol 2005 Sep 7 11 33 5209 12 32 1 Freeman Martin L et al Complications of Endoscopic Biliary Sphincterotomy The New England Journal of Medicine 1996 335 909 919 September 26 1996 DOI 10 1056 NEJM199609263351301 Stapfer Maria et al Management of Duodenal Perforation After Endoscopic Retrograde Cholangiopancreatography and Sphincterotomy Annals of Surgery 2000 August 232 2 191 198 PMCID PMC1421129 Richard B Sisken et al Electrosurgical safety of guide wires during endoscopic sphinterotomy Gastrointestinal Endoscopy Volume 39 Issue 6 1993 Pages 770 773 2 D F Martin The Safety Sphincterotome The Device The Technique and Preliminary Results http www olympusamerica com m
27. orders Upwards of 1 55 million patients have some form of biliary tract obstruction which may cause many resounding effects through the biliary system General obstruction of the common bile duct and pancreas causes buildup of bile and pancreatic juices in the ducts Reported associated effects of this include jaundice itching pain in the upper right side of abdomen nausea vomiting weight loss and fever Obstruction of the biliary ducts may be secondary to gallstones malignancy infection pancreatitis and biliary cirrhosis while the disease itself may in turn cause the formation of gallstones As the duct is obstructed bilirubin present in the bile accumulates in the tissues of the body and causes the jaundice experienced by patients Cause of the biliary obstruction dictates the specific demographics of the disease Gallstones are the most common cause of biliary duct obstruction and thus are most pertinent in the discussion of the epidemiology of the disease Persons of Hispanic Northern European and Native American descent are at a particularly higher risk for developing biliary obstruction Women are much more likely to develop biliary disease than men particularly due to the much higher risk of developing gallstones over the course of a lifetime 35 for women VS 20 for men Risks of biliary disease increases with age especially when an individual is past age 40 2 Description of Current Practices Malfunctions in the
28. rotome with controlled orientation and rotation features It is compatible with the Boston Scientific Microinvasive Endoscopes Rapid Exchange platform and can accommodate a 0 035 guidewire while allowing simultaneous injection through a separate lumen 5 Indication for Use The Hydratome RX Sphincterotome is a multi cannula system that can be used during transendoscopic sphincterotomies in the biliary duct and pancreatic ducts specifically the Papilla of Vader and or the Sphincter of Oddi This device allows for a guiding wire a contrast agent lumen and a cutting wire to all be guided simultaneously down an endoscope tube to the biliary ducts Once there the device can assist with imaging cannulation and cutting of the sphincters of the biliary duct 6 Technological Characteristics The proposed Hydratome Sphincterotomes are similar in design materials and manufacturing processes to the predicate Autotome RX Sphincterotome K013153 and Ultratome XL Sphincterotome K930022 7 Performance Data The proposed device is substantially equivalent to the currently marketed Rapid Exchange Cannulating Sphincterotome in terms of performance characteristics tested and biocompatibility 20 8 Conclusion Boston Scientific Corporation has demonstrated that the Hydratome RX Sphincterotome is substantially equivalent to the predicate device Autotome RX Sphincterotome K013153 Therefore the proposed Hydratome
29. sg section ET files wp OAIETO509REP5181 pdf Web 13 Oct 2013 23 Gholson CF Needle knife papillotomy in a university referral practice Safety and efficacy of a modified technique Journal of Clinical Gastroenterology Volume 23 Issue 3 1996 Pages 177 180 ss Sphintromere 510k Boston Scientific http www accessdata fda gov cdrh_docs pdf K973826 pdf gt Autome 510k Boston Scientific http www accessdata fda gov cdrh_docs pdf K013153 pdf Ultratome 510k Boston Scientific http www accessdata fda gov cdrh_docs pdf K970053 pdf Majeed A W Ross B Johnson A G The preoperatively normal bile duct does not dilate after cholecystectomy results of a five year study Gut 1999 45 741 743 doi 10 1136 gut 45 5 741 S Liu Q Khay G Cotton PB Feasibility of stent placement above the sphincter of Oddi inside stent for patients with malignant biliary obstruction Endoscopy 1998 Oct 30 8 687 90 2 Dark J S Lee D H Jeong S Cho S G Determination of Diameter and Angulation of the Normal Common Bile Duct using Multidetector Computed Tomography Gut Liver 2009 December 3 4 306 310 doi 10 5009 gnl 2009 3 4 306 30 Parasher V Romain k Sukamar R Jordan J Can ERCP contrast agents cause pseudomicrolithiasis Their effect on the final outcome of bile analysis in patients with suspected microlithiasis Gastrointestinal Endoscopy 1999 401 404 k http www accessdata fda gov scripts cdrh cfdocs cfpcd classification cf
30. t on and a failure of the cutting wire will result in the failure of the procedure The demonstration of the cutting wire to withstand the tension and torsional forces imposed by the turning of the handle is required to show feasibility The 11 feasibility of the proposed device will be demonstrated by the tensile and torsional characterization of the material used in the cutting wire The proposed handle will therefore be restricted in the torsion and tensional forces imposed as to not exceed the strength of the cutting wire material 12 Assignment 2 No Regrade 6 Statement of Intended Use The Hydratome RX 44 Sphincterotome is a multi cannula system that can be used during transendoscopic sphincterotomies in the biliary duct and pancreatic ducts specifically the Papilla of Vater and or the Sphincter of Oddi This device allows for a guiding wire a contrast agent lumen and a cutting wire to be guided simultaneously down an endoscope tube to the biliary ducts Once there the device can assist with imaging cannulation and cutting of the sphincters 24 25 of the biliary duct 7 Statement of Indication of Use The Hydratome RX is indicated for the use of transendocopic cannulation dye injection and sphincterotomy of the Papilla of Vater and the Sphincter of Oddi s 8 Functional amp Performance Specifications The Hydratome RX44 must perform several functions to meet the needs of the device First the device must treat cond
31. tomy 1 A duodenal perforation study performed at the Los Angeles County University of Southern California Medical Center documented 1 413 ERCP procedures Of the 1 413 fourteen patients suffered from a duodenal perforation related to the ERCP with one case being fatal The injuries were suspected to have been caused by the sphincterotome 6 injuries and the endoscope guidewire apparatus remaining 8 inj uries These studies among others demonstrate the most common risks involved with the current procedure for diagnosing dysfunction of the bile ducts Overall between 5 and 10 of all ERCP procedures result in mild to severe complications with an overall mortality rate of 1 3 3 Problem Statement The main problem with current ERCP procedures is the time wasted by switching of cannulas Under current practices after each part of the protocol the cannula is switched to move on in the procedure For example after injecting contrast dye into the area the clinicians must remove the dye injection tube and insert the cutting tool extending the time of the procedure in the process The extended period in which the patient is under anesthesia is an unnecessary stress on that patient In addition to this physicians lack control over the cannula once it exits the distal end of the endoscope This means that the physician has to physically adjust the endoscope or reinsert the cannula The most common post surgery complication pancreatitis is partia
32. utting of the soft tissue 14 After verification the functional specification of the catheter guidewire and cutting wire must be validated This will be tested in animal models to insure that the length and width of each component can be reliably fed through the animal s digestive system to the Papilla of Vater At this point the cutting wire will be validated by ensuring that application of voltage will effectively cut through the Spincter of Oddi allowing for further treatment of biliary duct disease 2 The device must be able to cannulate the biliary duct To verify the performance specifications of this functional specification the rotation of the guidewire and ability to deliver cannulate the biliary ducts will be tested The guidewire will be put through rotation and force testing to ensure the design meets the expected 40 and 15 Nm to maneuver a cannula into the biliary duct The cannula must be measured to verify the 2 33mm diameter required for cannulation After verification the functional specification of the cannula and guide wire must be validated To achieve this an animal model will be tested to ensure the ability of the device components to reliably cannulate the biliary duct 3 Hydratome must be able to inject x ray imaging contrast agent into an area of interest during surgery To verify the performance specifications of this functional specification an analysis of the reliable delivery of contrasting agent will be per

Report

Contents

Download Pdf Manuals

Related Search

Related Contents