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Procurement Capacity Development Process Danish Assistance to Bangladesh Agricultural Sector Programme Support, Phase II (ASPS II) Water and Sanitation Sector Programme Support, Phase II (WSSPS II) Scoping Mission to Bangladesh, November 2 – 11, 2008 Mission Report (Draft of November 21, 2008) Rita Roos, Senior Procurement Consultant 1 Table of Contents Page 1. Introduction 3 2. Terms of Reference 3 3. Mission Activities 3 4. Mission Findings 4.1 Danida Context 4 4.2 Public Procurement Context in Bangladesh 5 4.3 Procurement Portfolio in Danidas Sector Programmes 6 4.4 Perceived Procurement Capacity Assets and Gaps 8 4.5 Stakeholder Engagement 9 5. Mission Recommendations 5.1 Adapting the UNDP Procurement Capacity Assessment to 11 the needs of the two sectors 5.2 Design of the Procurement Capacity Assessment and 13 Development Process 5.3 Team composition, duration and estimated costs 15 5.4 Further Recommendations for immediate consideration in Transition Phase 16 Annexes Annex 1: Terms of Reference Scoping mission Annex 2 : List of People met Annex 3: List of Documents reviewed Annex 4: Debriefing presentation Annex 5: Terms of Reference Procurement Capacity Assessment and Design of a Procurement Development Plan (Draft) 2 1. Introduction In line with the principles of the Paris Declaration, the Danish assistance to Bangladesh through the Agricultural Sector Programme Support, Phase II (ASPS II, approx. USD 110 mill.) and the Water and Sanitation Sector Programme Support, Phase II (WSSPS II, approx. USD 70 mill.) are following a gradual alignment with the Government of Bangladesh (GoB) set-up and procedures in terms of programme and component management, financial flows, auditing, procurement and reporting. By 2008 the two sector programmes generally follow the GoB Public Procurement Act 2006 (PPA 2006) and the Public Procurement Rules 2008 (PPR 2008). This report presents an overview of findings from a scoping mission to Bangladesh from November 2 to 11, 2008. It comprises recommendations for conducting a procurement capacity assessment with a view to designing a procurement capacity development plan for the two sector programmes. The report is based on interviews and discussions with various representatives from key governance institutions (GoB), development partners, the two sector programmes, private sector, non-government organizations and the Royal Embassy of Denmark in Dhaka. 2. Terms of Reference The primary objective of the mission was to undertake the scoping of the procurement capacity development process for the two sectors. The scoping exercise was to include the aspects covered under "Mobilize and Design" of the UNDP Procurement Capacity Development Framework e.g. 1. Clarify objectives and expectations 2. Identify and engage national and local stakeholders 3. Adapt the default Procurement Capacity Framework to the needs of the two sectors 4. Determine how the process will be conducted. Expected outputs from the mission were: An approx. 10 page mission report including the Terms of Reference for the capacity development process, which identifies the approach (including entry points and core issues), the resources (team/costs) and the timing. Before departure from Bangladesh, presentation of a debriefing note as well as an outline of the mission report. For complete Terms of Reference for the mission, see Annex 1: Terms of Reference Scoping Mission. 3. Mission Activities 3 The mission conducted 19 interviews with representatives of the Embassy of Denmark, Project Directors and staff of ASPII and WSSPS II, international and national advisors of ASPS II and WSSPS II, key governance institutions of GoB (Central Procurement Technical Unit, the Auditor's General Office, Economic Relations Division of the Ministry of Finance, Anti-Corruption Commission), Transparency International Bangladesh, Federation of Bangladesh Chambers of Commerce and Industry, Bangladesh Employer's Federation, Crown Agents and a number of development partners (World Bank, ADB, EU, UNDP, DFID). A list of people met is attached in Annex 2. In addition, the mission reviewed a number of key documents related to the assignment. A list of these documents is included in Annex 3. 4. Mission Findings 4.1 Danida Context in Bangladesh The Danish country programme in Bangladesh mainly consists of three sector programs in agriculture, water and sanitation, and human rights and good governance. According to the Bangladesh Country Programme Review, Final report of May 2007, the two sector programmes relevant to the procurement assessment have several components as follows. The ASPS II as a whole is anchored in the Planning Commission and has three components: 1. The Agricultural Extension Component (AEC) hosted by the Ministry of Agriculture 2. The Regional Fisheries and Livestock Development Component (RFLDC), with two sub-components (for fisheries and livestock, respectively), hosted by two different departments of the Ministry of Fisheries and Livestock 3. The Rural Roads and Market Access Component (RRMAC) hosted by the Local Government Engineering Department (LGED) in the Ministry of Local Government, Rural Development and Cooperatives (MLGRDC). The WSSPS II is anchored in the MLGRDC and features the following components relevant to the procurement assessment: 1. Sector Policy Component (SSC) hosted by the MLGDC 2. The Water Supply and Sanitation Component (WSSC) with two sub-components: The Coastal Belt Project hosted by the Department of Public Health Engineering (DPHE) and the HYSAWA Fund which is established as a publicly owned company 3. The Capacity Building Component (CBC) with three sub-components: the Local Government Institutions Capacity Development Project hosted by the National Institute of Local Government (NILG); the NGO and Civil Society Networking Project hosted by the NGO Forum; and the Knowledge Development and Training Networking Project hosted by the International Training Network Centre (ITN). As stated in the a.m. Bangladesh Country Programme Review, the conditions for taking the aid effectiveness agenda forward in Bangladesh are difficult. In 2006, the "Bangladesh Harmonization Action Plan" was drafted. Although in principle committed to the agenda, the Government does not in practice take the lead in donor coordination and harmonization, and 4 development partners themselves used to be configured in two groupings, one comprising the four biggest donors and the other the rest. In August 2008 a Statement of Intent on Developing a Joint Cooperation Strategy for Bangladesh was agreed upon with the PRS- Harmonization Action Plan Cell of the Economic Relations Division of the Ministry of Finance (GoB) and signed by 15 development partners. This agreement is considered a big step forward towards increased ownership and harmonization. The Final Joint Cooperation Strategy is scheduled to be prepared and signed by the end of May, 2010. According to the Bangladesh Country Programme Review, both harmonization and alignment are hampered by the character and quality of the public sector, which is highly centralized, very bureaucratic, and focused on compliance with rules and on resources spent rather than on results to be achieved. Many civil servants are insufficiently qualified, and they are lowly paid. The quality of PFM is stated to be generally poor, with a low level of accountability. Corruption is widespread. With reference to the new legal framework for procurement, the Review Team agreed with the Embassy on a concrete way forward at the level of the programmes, i.e. that the Embassy should seek to have more of the procurement done under the Government regulations, accompanying this with relevant safeguards such as procurement audits. 4.2 Public Procurement Context in Bangladesh The World Bank Country Procurement Assessment Report of 2002 identified deficiencies in public sector procurement practices of that time as the most serious issue affecting activities of the entire public sector. Outdated procurement rules and procedures, inadequate capacity to manage public procurement, lack of accountability, and corruption seriously impacted the country's aid utilization capacity and aid effectiveness. It was estimated that economic losses due to overall corruption were costing the country about 2,5 % in GDP growth each year. With the assistance of the World Bank, a comprehensive Public Procurement Reform Project was implemented (PPRP, Phase I: 2002 – 2007, USD 4,5 mill.) that successfully addressed key deficiencies in the legal and policy framework. The Government established a procurement policy unit (Central Procurement Technical Unit or CPTU) within the Implementation Monitoring and Evaluation Division (IMED) of the Ministry of Planning. The Government issued the Public Procurement Act 2006 through a Gazette notification in July 2006. It published the Public Procurement Rules 2008 in January 2008, on the basis of which it made the Public Procurement Act 2006 effective from January 31, 2008. Standard Bidding Documents for goods, works and services were published. Transparency was improved by increased publishing of invitations for bids and contract award information. Accountability was improved by specifying processing and approving entities/authorities with respective time-lines for different types and magnitude of procurement. Review and appeals mechanisms were incorporated in the new legislation. With regard to improved procurement management capacity, a critical mass of 25 national procurement trainers was developed, training courses were provided to more than 1700 public officials and a centralized procurement performance tracking system (MIS) was piloted. 5 The "Bangladesh Harmonization Action Plan" of 2006 refers to the PPRP I in Chapter 2.5 "Strengthening the Procurement Procedure". As part of the local Consultative Committee (LCG) activities, the World Bank has been leading the sub-group in procurement. The Project Appraisal Document (PAD) for the second phase of the Public Procurement Reform Project (PPRP II, USD 23,6 mill., 2007 – 2012) emphasizes that although the landscape of procurement has been reshaped during the course of the last several years and awareness among all stakeholders has been increased, application of the national procurement rules has proven to be relatively inconsistent across government and within individual agencies, and actual implementation of the regulations is slow with less progress in improving tangible outcomes on the ground. Reportedly, in practice there has been significant non- compliance to the rules and regulations in particular delays in contract award, ineffective contract administration, and inappropriate bidding practices favoring collusion. According to the PAD, the achievement of better procurement outcomes is further constrained by crosscutting governance, institutional, and implementation issues including inadequate enforcement of regulations, incidence of fraud and corruption, and political influence. PPRP II will shift focus to address generic procurement issues in the operational, implementation, and monitoring functions encountered at the sector level, in particular in the infrastructure, power, urban, and water sectors, in order to ensure sustainability of the reform efforts. On the political economy front, a wind of change is noted. The new Caretaker Government that came to power on January 11, 2007, has started to address governance problems. It is acting to minimize the impact of black money and corruption on the political process including procurement, and has reconstituted the Anti-Corruption Commission. PPRP II is designed to improve performance of the public procurement system progressively in Bangladesh. Four components will address the implementation challenges in target agencies (RHD, LGED, REB, BWDB), with cost estimates as follows: i. Policy Reform and Capacity Development (USD 8,9 mill.) ii. Sector and Central Procurement Management (USD 8,4 mill.) iii. E-GP (USD 4,2 mill.) iv. Communication, Behavioral Change, and Social Accountability (USD 3,4 mill.) A number of activities conducted under this project could be of particular interest when designing the procurement capacity development plan for ASPS II and WSSPS II, such as training courses offered, procurement monitoring and in-house guidance, incentive mechanisms, building of social awareness, engagement of beneficiary groups, etc. 4.3 Procurement Portfolio in Danidas Sector Programmes Procurement statistics covering all procurements carried out under ASPS II and WSSPS II were not readily available during the scoping missing. Since in the past, major procurement transactions were on request handled by Crown Agents Bangladesh, the mission initiated the compilation of some basic statistics. Based on information received from Crown Agents, in total 407 contracts were concluded between January 2006 and June 2008 amounting to approx. USD 6,2 mill. resulting in an average value per contract of approximately USD 15.000. In more detail: 6 7 Procurement handled by Crown Agents Jan 2006 – June 2008 Year 2006 2007 Jan – Jun 2008 No. Value USD No. Value USD No. Value USD Printing & Stationery 32 131.655 16 40.636 13 66.830 Training Materials 13 157.457 15 112.702 20 113.691 Works Contract 13 79.079 4 1.858 IT Equipment 41 280.096 27 118.602 16 71.542 Lab. Materials/chemicals 26 273.354 4 22.679 4 25.562 Furniture & Office Equipment 26 258.834 41 157.483 12 51.913 Vehicles, Motor cycles, Bicycles 7 145.087 16 347.683 11 434.073 Water & Sanitation Equipment 19 1.774.963 3 84.056 14 313.589 Road Construction Equipment 6 951.155 Others 2 55.825 5 12.375 1 86.896 TOTAL 179 3.156.350 131 898.074 97 2.115.251 Procurement Forecasts During the scoping mission, it was not feasible to estimate the total number and value of procurement per category (goods, works, services) for the remaining programme duration. Based on a sample of procurement plans submitted and according to information received during the interviews, the following programme components/projects are expected to account for the bulk of procurement in Fiscal Year 2008/2009 (July – June): ASPS II Rural Road and Market Access Component (RRMAC): Construction works for rural roads approx. 80 mill Tk (equivalent to USD 1,1 mill.) Regional Fisheries and Livestock Development, Barisal Component: Mainly goods, approx. 56 mill Tk (equivalent to USD 800.000) Ministry of Fisheries and Livestock, Strengthening Institutional Capacity of DoF Project: Mainly services and training, approx. 37 mill. Tk (equivalent to USD 500.000) Agricultural Extension Component (AEC): Goods, approx. 26 mill. Tk (equivalent to USD 370.000) WSSPS II HYSAWA Fund Company: Contracts with NGO's (approx. USD 5 mill.), construction works (approx. USD 15 mill.) 8 Policy Support Unit: Services (approx. USD 3 mill.) HYSAWA Project: Consultancy services, contracts with NGO's (approx. USD 1 mill.) 4.4 Perceived Procurement Capacity Assets and Gaps One purpose of interviewing key stakeholders was to collect sample perceptions on current key capacity assets and gaps. The findings are outlined below following the structure of the OECD Methodology for Assessment of National Procurement Systems and its 4 pillars: (I) Legislative and regulatory framework; (II) Institutional & Management Capacity; (III) Procurement operations and market practices; (IV) Integrity and Transparency. Pillar I Legislative and regulatory framework Procurement Law (PPA 2006) and Regulations (PPR 2008) in force since 31.1. 2008 Development of legislation and Standard Tender Documents assisted by Public Procurement Reform Project I (World Bank) English translation of Procurement Regulations pending Standard Tender Documents for ICB missing PPR very complex/complicated Lack of understanding of procurement law/rules at all levels Delegation of financial powers highly centralized Pillar II Institutional & Management Capacity Central Procurement Technical Unit (CPTU) in place Public Procurement Reform Project II ongoing (World Bank, 24 mill. USD, 2007 - 2011) •Focused on Roads & Highway Dept., Local Government Engineering Dept., Rural Electrification Board, Water Board •Comprising policy reform and capacity development (training of 11.000 government officials, 9 mill. USD); strengthening CPTU and sector agencies; development of electronic government procurement system; communication, behavioral change, mindset No Assessment of National Procurement System (OECD Methodology, although Bangladesh had volunteered to be a pilot country) Very bureaucratic culture in the public service 9 Pillar III Procurement operations and market practices Private sector included in upcoming PPRP II training program Level of procurement competence among government officials not consistent with their procurement responsibilities, no procurement cadre Frequent transfer of staff Delegation of authority (financial powers) and responsibility create inefficiencies and unclear accountability (many persons/committees involved, decision making highly centralized) Slow procurement process: inefficient packaging of total procurement, delays in decision making, frequent re-tendering Low salaries, no incentives, lack of leadership Pillar IV Integrity and Transparency Procurement appeals system established (PPA 2008) Anti-Corruption Commission reactivated Largest Transparency International Chapter worldwide, addressing public procurement issues Integrity Building/Awareness programs started Independent Judiciary since 2007 Inefficient checks and balances throughout procurement process Procurement audit framework weak TI CPI: Ranked 147 out of 180 countries (2008) Interference, manipulations, collusive practices, corruption in procurement frankly and broadly addressed in interviews Involvement of citizens, Law enforcement weak 4.5 Stakeholder Engagement Another important objective of the interviews was to start the process of engaging the support of key stakeholders. All meetings were supported by a very open and friendly atmosphere, and provided good opportunities for information sharing. Danidas policy of gradual alignment with the Government of Bangladesh (GoB) set-up and procedures in terms of programme/ project management including procurement was elaborated. The interview partners took the chance to reflect their views on the GoB Public Procurement Act 2006 (PPA 2006) and the Public Procurement Rules 2008 (PPR 2008) and shared their experiences and strategies towards further alignment. Moreover, the mission engaged the stakeholders in an initial screening of ideas on potential areas of cooperation related to procurement capacity development. The outcome can be summarized as follows: Representatives from the GoB (CPTU, Auditor General's Office, ERD and ACC) appreciate Danidas alignment strategy and the intention to strengthen procurement capacity at the sector level. 10 CPTU as the key government agency for public procurement reform in Bangladesh signalized to support the PCD process, in particular by assuring that training courses offered under PPRP II will be accessible for the two sector programmes and could even be customized according to specific requirements (content, time schedule). The Auditor General's Office emphasized the importance of IT systems in increasing transparency and efficiency of procurement audits. The Auditor General's Office would be highly interested in participating in training courses related to procurement audits and expressed its willingness to conduct special audits (pilots) during the procurement capacity development process if requested. ACC highlighted as main areas for corruption in procurement the following issues: definition of demand and technical specifications, quality assurance in tender stage and contract execution, nepotism/favourism throughout the whole process, and long lead times ("the more time it takes, the more scope for corruption"). In the meetings with Project Directors, Advisers, and TA staff of the two sector programmes, some participants frankly addressed concerns and pointed to negative impacts of Danida's alignment strategy on project implementation and accountability. It was suggested to develop a transition plan, intensify communication and clarify the (new) roles and responsibilities with respect to programme/project implementation in general and procurement issues in particular. Project Director positions are mostly part-time, the assigned work is usually perceived as "additional work", with little incentives. Some Project Directors criticize PPA/PPR as complicated, delaying and burdensome; others do not see any problems in applying the new legislation. However, the request for training is unanimous. Civil society and private sector institutions such as Transparency International Bangladesh and FBCCI appreciate the fact that the new legislation provides for harmonized procurement procedures in Bangladesh. However, it is believed that certain formalities (ex: inefficient approval procedures) lengthen the process and create windows of opportunities for corruption. For example, it seems to be wide-spread practice to award a tender to the (pretended) lowest bidder, although he can not fully deliver all goods requested and then to ask unsuccessful bidders to step in at the lowest price offered creating scope for an array of "underhand deals". TIB considers transparency and integrity in public procurement as a vital, important area to build up and would be interested to be involved in the PCD process in the two sectors. Potential areas of cooperation could be issues related to conflict of interest, integrity pacts, social accountability, code of conduct for public procurement entities, and the participation of civil society. Among development partners interviewed, there is a level of understanding that the World Bank should keep its leading role in assisting the GoB to improve the quality and performance of the national procurement system as a whole. The Danida initiative to improve procurement capacities in the agriculture and water & sanitation sector, is very much welcomed and interest in the outcomes and successes is high. The development partners are committed to the principles of the Aid Effectiveness agenda, implementation decisions are however country specific. The World Bank, ADB and EU have approved the use of country procurement systems for national bidding procedures in Bangladesh up to certain thresholds, additional safeguards apply (ex: further conditions, approval mechanisms, ex-ante and ex-post controls, additional audits). For International Competitive Bidding (ICB), donor rules apply. The EU is looking for concrete areas to further align. For the increased use of the national procurement system, a comparative analysis between national legislation and EU Procurement Regulations would be needed. As mentioned by the World Bank, GoB has applied to be considered in the World Bank pilot "Use of country procurement systems" (one sector). 11 UNDP and DFID handle most of the procurement themselves or through procurement agents/managing agents. DFID was engaged in a Sector Budget Support Programme (Roads & Highway Department) but terminated it ahead of time after about 50 % of the funds had been disbursed because of fiduciary risks and mainly due to the lack of action on audit report findings. DFID will not pass on procurement in the future and perceives a potential for huge delays. UNDP works on the basis of partnership agreements with division of budget lines and procurement often done by UNDP using UNDP procurement guidelines. UNDP takes on an assurance role ("delivery function") and argues that by efficiently carrying out the procurement function, the Government's ownership is increased and clear accountability is established. The following chart illustrates the development partners' procurement alignment strategy: 1 Use of PPR up to thresholds y = yes 2 Donor Rules for ICB n = no 3 Additional safeguards p = partially 4 GoB management of procurement process DP 1 2 3 4 Future Plans WB y y y y GoB applied for WB pilot "Use of country systems" ADB y y y y Intention, but no specific project EU y y y p Looking for concrete areas. Comparative analysis needed. UNDP n y - n Continue with partnership agreements, procurement mostly done by UNDP DFID n y - n No intention to change ("We took a step back") 5. Mission Recommendations 5.1 Adapting the UNDP Procurement Capacity Assessment to the needs of the two sectors The UNDP Capacity Assessment Framework encompasses 3 dimensions: (a) point of entry, (b) core issues, (c) functional capacities. The mission recommends adapting it to the needs of the two sectors as outlined below. a) Point of entry UNDP Framework: UNDP recognizes hat a country's capacity resides on different levels – enabling environment, organization and individual – and thus need to be addressed across these levels. A capacity assessment team selects one level as its point of entry, and may "zoom in" or "zoom out" from that level as needed. Recommendation: For the Procurement Capacity Assessment in Bangladesh, it is advisable to choose the organizational level as point of entry. Based on consultations with senior advisers of ASPS II and WSSPS II, the assessment could focus on 6 – 7 programme components/projects (out of a total of 15). In particular: 12 ASPS II Agricultural Extension Component (AEC) Class A1 Rural Road and Market Access Component (RRMAC) Class A Support Unit, Dept. of Livestock (SU DLS) Class B Institutional Support Unit MoA (ISU MOA) Class C WSSPS II HYSAWA Fund Company Class A NGO and Civil Society Project Class B Sector Policy Support Component Class B b) Core issues UNDP Framework: Core issues represent the issues upon which UNDP is most often called to address: (1) institutional arrangements; (2) leadership; (3) knowledge; (4) accountability. Recommendation: The core issues identified during the scoping mission are listed below. The mission recommends assessing the selected programmes/projects along the following lines: 1) Institutional arrangements Processes Tools Code of Conduct, Integrity Pacts Unwritten rules of the game Benefits of compliance/performance, costs of non-compliance 2) Leadership Common goals/Importance of procurement Manage implementation (Organize, Plan, Control) Communication 3) Knowledge Training Knowledge sharing 4) Accountability Culture of accountability Value for money Internal and external scrutiny Open dialogue with civil society institutions and private sector to improve transparency and accountability 1 Delegation of Financial Powers for Development Projects A = Projects above Tk 50 Crore; B = above Tk 20 crore, up to Tk 50 crore; C = up to Tk 20 crore 13 c) Functional and technical capacities UNDP Framework: In the case of Procurement Capacity Assessments, functional and technical capacities are synonymous with "procurement capacities". Recommendation: The procurement activities to be assessed should encompass the entire procurement cycle: Procurement Planning, Requirement Definition, Requisitioning, Identifying the correct procurement method, Sourcing, Preparation and Issuance of Solicitation Documents, Receipt and Opening of Offers, Evaluation, Contract Review and Award, Contract Finalization and Issuance, Contract Management, Asset Disposal, Payment of Invoices. With this in mind, it can be summarized that the procurement capacity assessment of ASPS II and WSSPS II should have an organizational entry point focusing on 6 – 7 selected programme components/projects and it should be structured around the following functional capacities and core issues: Core Issues according to 5.1 b) Procurement Institutional Leadership Knowledge Accountability Capacities Arrangements Procurement Planning Requirement Definition Requisitioning Identifying the correct procurement method Sourcing Preparation and Issuance of Solicitation Documents Receipt and Opening of Offers Evaluation Contract Review and Award Contract Finalization and Issuance Contract Management Asset Disposal Payment of Invoices 14 5.2 Design of the Procurement Capacity Assessment and Development Process The following steps are suggested: a) Conduct Procurement Capacity Assessment in 6 - 7 programme components/projects • Define desired procurement capacities • Understand existing procurement capacity assets • Assess procurement capacity level (gaps) • Identify root causes for capacity gaps, interpret results Due to the current lack of comprehensive procurement statistics including compliance and performance data, a qualitative assessment approach should be followed. Interviews with representatives of the selected 6 – 7 programme components/projects and focus group discussions should be conducted as well as with key stakeholders. A sample of procurement files should be analysed (strategic sampling, approximately 3 – 5 samples per programme component/project). b) Design Procurement Capacity Development Plan • Define the capacity development response • Define progress indicators for the capacity development response (output indicators, outcome indicators, targets) • Cost the capacity development response • Develop coherent CD plan (priorities, timeframe, lead institution, monitoring) It is important for all participants to gain ownership of the process and for stakeholders to be engaged appropriately. In order to ignite confidence in the potential for improvements in procurement capacity, motivation for the necessary changes in behavior, as well as to engage leadership support, it is vitally important to focus on the potential for quick wins as well as on long-term procurement capacity development. The GoB is implementing a comprehensive Public Procurement Reform Project II assisted by the World Bank. Capacity Development responses developed under this project (for example: Training Courses, Procurement monitoring incl. Key Performance Indicators, e-government procurement, Building social awareness and Engagement of beneficiary groups) should be evaluated with a view to utilizing potential synergy effects. 15 5. 3 Team composition, duration and estimated costs Team Composition Given the scope of this procurement capacity assessment and development process as well as the intention to conduct the assignment within 2 weeks (field mission), a well-structured team will be required to manage and execute the work. The recommended structure and definition of this team is described below: Sponsor Group The Sponsor Group will be responsible for senior management oversight, guidance, and decision- making for the assignment. It is presumed that the Counselors for Agriculture and Water & Sanitation at the Royal Danish Embassy in Dhaka will be the members of this Sponsor Group, and in order to increase ownership possibly members of coordinating government units (e.g. PUT, Programmed Steering Committee Agriculture, and Water Supply/Sanitation). The Sponsor Group will advise and guide the Team Leader, and will be informed by the Team Leader regarding the status of the assessment and the design of the capacity development plan.Team Leader The Team Leader will be managing and leading the conduct of the assignment (International consultant). Two Assessment Specialists The Assessment Specialists will be supporting the Team Leader in conducting the assessment and capacity development assignment (International consultant experienced in the UN capacity assessment and development approach, National consultant experienced in applying PPA/PPR 2008) . Administrative Support Part-time resource providing administrative support, ex: scheduling interviews/invitations (Administrative Embassy staff). Resource persons at organizational level Part-time resources at the programme components/projects level to be assessed (Project Director, Advisor, TA staff responsible for procurement). Quality assurance Part-time resource providing overall quality assurance in the assessment and quality of the approach and outputs (UNDP procurement assessment and capacity development adviser). Duration and estimated costs It is estimated, that the assessment and the design of a procurement capacity development plan for the two sectors as outlined above could be implemented within a period of 2 weeks (in the field), plus preparation, travel and report writing. 16 Based on the recommended team composition, the number of days for the assignment and related costs can be roughly calculated as follows: Position No. of days No. of days No. of days Fees (preparation, (field) (travel) assessment rep. and CD plan) Sponsor Group 1 - 2 days per No fees member Team Leader 7 12 2 Approx. 250.000 – Intern. Consultant 5 12 2 300.000 DKK plus per National 4 12 diem/accom., air fares Consultant and local transport Adm. Support 3 No fees Resource Persons 1 – 2 days per No fees person Quality assurance 2 5 2 No fees 5.4 Further Recommendations for immediate consideration in Transition Phase Design and implementation of the procurement capacity development process as outlined above is expected to focus on potential for quick wins. However, the process needs to be considered as a long-term capacity development intervention to be sustainable and it will take some time to achieve the expected outcome. To avoid bottlenecks, which could potentially affect the successful implementation of the two sector programmes, and could possibly result in unsatisfactory compliance with the national procurement legislation, inefficient procurement or even misprocurement, Danida may want to consider some immediate actions to mitigate risks in the transition phase. In particular: 1. Provide procurement support (Procurement Specialist) Create a position for a dedicated procurement specialist who could serve as a focal point and coordinator for Interpretation and clarification of PPR 2008 with CPTU Help-desk for specifications, tendering, evaluations, award Knowledge sharing Training organization During the scoping mission, it was discussed which role CPTU could play in this context. Given the fact that CPTU has been established as a policy unit which should not interfere in individual procurement transactions, and considering that there might be time/resource constraints at CPTU, it 17 should be considered to establish such a function at programme level or in the Embassy. It should be discussed with CPTU if they could support the process by creating a "Fast Track" for questions arising in the two aligned sector programmes. If such a position would be established, it could also assist in the preparation and implementation of the procurement capacity assessment and could later take a leading role in coordinating and monitoring the implementation of the future procurement capacity development plan. 2. Keep the Crown Agent option open at least until the assessment has been completed In the first two quarters of 2008, Crown Agents was reportedly still handling 97 procurement cases. As indicated during the scoping mission, the amount of cases handed over to Crown Agents has substantially declined since then. Given the complaints regarding current delays in procurement and considering the urgent need for training as articulated by Advisers, Project Directors and TA staff, it may be considered to synchronize the phasing out of the Crown Agent contract with the PCD process, i.e. to keep this option open "as a last resort". 3. Make immediate use of training offered by CPTU CPTU has piloted its 3-weeks training course for procurement practitioners in November and has announced to publish its comprehensive training programme on its website by the end of November with courses starting in January 2009. According to the World Bank, participation in the training will be mandatory for the four PPRP II target agencies and should therefore include Danidas projects hosted by LGED anyway. It is recommended to follow-up on this issue with CPTU. It should be clarified if the training courses offered satisfy the needs of the two sector programmes, if they could be customized if deemed necessary and when the training could take place. 4. Continue policy dialogue with development partners The Danish Embassy has been very active in intensifying donor coordination (Local Consultative Groups, Statement of Intent on Developing a Joint Cooperation Strategy for Bangladesh). The mission recommends to institutionalize the dialogue on public procurement in Bangladesh among the donors and with the GoB in order to ensure Official English translation of PPR 2008 (on short notice) Assessment of the National Procurement System using WB/OECD-DAC Methodology Understanding of the importance of Public Sector Reform for efficient public procurement. 18
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The Vampire Diaries' People's Choice Awards Nominations.
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What's New
Commission Members
Charlene Zettel
Charlene Zettel was appointed by the Board of Regents of the University of California on July 1, 2010 as the representative to the Commission and serves at the pleasure of the Board of Regents of the University of California. She was previously the alternate Commissioner on July 1, 2009. She was appointed by Governor Schwarzenegger in 2009 to the Board of Regents of the University of California.Ms. Zettel was former Director of the San Diego Office of Governor Arnold Schwarzenegger. She served as the Director of the Department of Consumer Affairs from 2004-2007 and elected to the Poway Unified School District Board of Education. She was twice elected to the California State Assembly. In the State Assembly, she served as chair of the Republican Caucus, vice chair of the Assembly Committee on Jobs, Economic Development and the Economy, and a member of the Appropriations, Education, Health, Rules, Transportation and Governmental Organization committees. She was appointed by President George Bush as public interest director of the Federal Home Loan Bank of San Francisco.
B.S. - University of Southern California School of Dentistry.
- Member, Board of Regents of the University of California
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12. The assembly of
13. A stent and valve assembly for use in a vascular lumen, comprising:
a. a flexible and resilient structure of a plurality of struts designed as a variably diametered tubular shape; and
b. a plurality of valve leaflets formed from either SIS or sclera material and attached along designated edge portions to a plurality of said struts to enable opening and closing of free edge portions to emulate the operation of a naturally occuring vascualr valve.
14. The assembly of
15. The assembly of
16. A method of making a replacement valve assembly for implantation into a vascular lumen and to function as a check valve, the valve assembly comprising a plurality of flexible members, each flexible member conformed to cooperate with the other at least one flexible member to unidirectionally admit vascular fluid through the valve assembly, the method comprising the steps of:
providing a flexible biocompatible material;
constructing a plurality of flexible members from the flexible material; and
disposing the flexible members in a tubular member having at least one stage so as to function as a unidirectional flow valve.
17. The method of
18. The method of
19. A method of treating chronic vascular insufficiency, the method comprising the steps of:
providing a replacement valve assembly shaped for implantation within a venous lumen, the valve assembly comprising a plurality of flexible members, each flexible member shaped to cooperate with the other at least one flexible member to unidirectionally admit vascular fluid through the valve assembly;
introducing at least one of said replacement valve assemblies into a venous lumen generally proximate an insufficient vascular valve; and
fixing said replacement valve assembly in said venous lumen by actuating a self-expanding portion of the valve assembly to engage the inner lumenal wall of the venous lumen.
20. The method of
21. The method of
22. The method of
23. A method of making a vascular valve member assembly from mammalian sclera or small intestine sub-mucosa (SIS), the method comprising the steps of:
providing a mammalian tissue source;
removing said tissue from the tissue source; and
fashioning the valve member from the sclera or SIS.
24. The method of
[0001] The present invention relates to venous valve replacement and, in particular, to replacement venous valves to lower extremities and a therapeutic method of treating venous circulatory disorders.
[0002] Chronic venous insufficiency (CVI) of the lower extremities is a common condition that is considered a serious public health and socioeconomic problem. In the United States, approximately two million workdays are lost each year, and over 2 million new cases of venous thrombosis are recorded each year. About 800,000 new cases of venous insufficiency syndrome will also be recorded annually. Ambulatory care costs of about $2,000, per patient, per month contribute to the estimated U.S. cost of $16,000,000 per month for the treatment of venous stasis ulcers related to CVI.
[0003] It is estimated that greater than 3% of the Medicare population is afflicted by a degree of CVI manifested as non-healing ulcers. Studies have indicated that about 40% of seriously affected individuals cannot work or even leave the house except to obtain medical care. It is estimated that 0.2% of the American work force is afflicted with CVI.
[0004] Chronic venous insufficiency arises from long duration venous hypertension caused by valvular insufficiency and/or venous obstruction secondary to venous thrombosis. Other primary causes of CVI include varicosities of long duration, venous hypoplasia and arteriovenous fistula. The signs and symptoms of CVI have been used to classify the degree of severity of the disease and reporting standards have been published. Studies demonstrate that deterioration of venous hemodynamic status correlates with disease severity. Venous reflux, measured by ultrasound studies, is the method of choice of initial evaluation of patients with pain and/or swelling in the lower extremities. In most serious cases of CVI, venous stasis ulcers are indicative of incompetent venous valves in all systems, including superficial, common, deep and communicating veins. This global involvement affects at least 30% of all cases. Standard principles of treatment are directed at elimination of venous reflux. Based on this observation, therapeutic intervention is best determined by evaluating the extent of valvula incompetence, and the anatomical distribution of reflux. Valvular incompetence, a major component of venous hypertension, is present in about 60% of patients with a clinical diagnosis of CVI.
[0005] Endovascular valve replacement refers to a new concept and new technology in the treatment of valvular reflux. The concept involves percutaneous insertion of the prosthetic device under fluoroscopic guidance. The device can be advanced to the desired intravascular location using guide wires and catheters. Deployment at a selected site can be accomplished to correct valvular incompetence. Percutaneous placement of a new valve apparatus provides a less invasive solution compared to surgical transposition or open repair of a valve.
[0006] The modern concept of a stent was introduced in the 1960s. Subsequently, it has been successfully incorporated in the treatment of arterioral aneurysms and occlusive disease. The use of endovascular stents represents one of the most significant changes in the field of vascular surgery since the introduction of surgical graft techniques in the early 1950s.
[0007] Initially, the dominant interest of vascular specialists was application of stents in the arterial system. The venous system and venous disease were not considered an arena for stent application. The utilization of endovascular treatment in venous disease was initially confined to the treatment of obstruction, in the pelvic veins [for CVI] as well as treatment of obstructed hemodialysis access grafts and decompression of portal hypertension (TIPS). Although these procedures enjoy widespread application, the actual number of patients involved is relatively low compared to the number afflicted with CVI and related syndrome. Thus, the necessity for therapy using endovascular technology for the treatment of venous disease arose. The prevalence of CVI and the magnitude of its impact demand development of an effective alternative therapy.
[0008]FIG. 1 is a schematic representation of a portion of a venous system.
[0009]FIG. 2 is a schematic representation of a section view of a portion of a venous system at a closed venous valve.
[0010]FIG. 3 is a schematic representation of a sectional view of a portion of a venous system.
[0011]FIG. 4 is a schematic representation of a portion of a venous system.
[0012]FIG. 5 is a schematic representation of a section view of a portion of a venous system at an open venous valve.
[0013]FIG. 6 is a schematic representation of a section view of a portion of a venous system showing a deployment system for a device of the invention.
[0014]FIG. 7 is a schematic representation of a section view of a portion of a venous system showing a deployed device of the invention.
[0015]FIG. 8 is a schematic view of one embodiment of the invention.
[0016]FIG. 9 is a schematic view of one embodiment of the invention.
[0017]FIG. 10 is a schematic view of one embodiment of the invention illustrating angular relationships of components.
[0018]FIG. 11 is a top plan view taken along line 11-11 of FIG. 9.
[0019]FIG. 12 is a schematic elevation view of one embodiment of the invention.
[0020]FIG. 13 is a schematic view of various valve material placement embodiments of the invention.
[0021]FIG. 14 is a schematic view of a multiple stage embodiment of the invention.
[0022]FIG. 15 is a side elevation view of a six strut dual stage embodiment of the invention.
[0023]FIG. 16 is a side elevation view of a six strut dual stage truncated cone embodiment of the invention.
[0024]FIG. 17 is a photo image of an embodiment of the invention in vivo.
[0025]FIG. 18 is a photo image of an embodiment of the invention in vivo.
[0026]FIG. 19 is a photo image of an embodiment of the invention in vivo.
[0027]FIG. 20 is a photo image of an embodiment of the invention in vivo.
[0028]FIG. 21 is a photo image of an embodiment of the invention in vivo.
[0029]FIG. 22 is a photo image of an embodiment of the invention in vivo.
[0030]FIG. 23 is a photo image of an embodiment of the invention in vivo.
[0031]FIG. 24 is a perspective view of one embodiment of the invention.
[0032]FIG. 25 is a flow diagram depicting one embodiment of the invention.
[0033]FIG. 26 is a flow diagram depicting one embodiment of the invention.
[0034] A replacement valve assembly is provided that is configured for implantation within a vascular lumen. The valve assembly comprises a plurality of flexible members, with each flexible member arranged to cooperate with at least one other flexible member to unidirectionally admit vascular fluid through the valve assembly. In one embodiment, at least a portion of one of the flexible members includes natural sclera tissue. In other embodiments, the flexible members include at least a portion of either SIS or other known biocompatible material. Methods of manufacturing the flexible members and of assembling and delivering the assembly to the patient's venous system are also provided.
[0035] Within the field of endovascular treatment, no previous technology has effectively combined a replacement valve and a stent in a percutaneously located assembly. Indeed, recognition of the need for such a device, system and method of employment has been lacking. Attempts at venous valve repair are not common. Indeed, minimally invasive repair or replacement procedures are quite uncommon. This is due, in part, to the poor availability of properly sized and properly designed prosthetic venous valves. U.S. Pat. No. 5,500,014 has an excellent discussion of the different attempts to provide prosthetic venous valves, and such discussion is incorporated by reference herein. For the anatomy of venous valves, an excellent reference includes Venous Valves, by R. Gottlub and R. May, published by Springer-Verlag, Austria, 1986.
[0036] The inventors have devised a device, system and method of deployment for a stent and valve assembly utilizing various materials having excellent cost, biocompatibility, and ease of use. In one embodiment, a stent is assembled having excellent length and stability characteristics, as well as an improved profile for ease of placement and automatic deployment at a deployment site. The assembly does not rely on placement at a previous valvular site but may be utilized either proximate or distal to the incompetent valve site due to the self-expanding features and improved anti-migration characteristics of the assembly.
[0037] The use of the material chosen for endovascular valve replacement in this assembly represents a unique application of a biocompatible substance. Whether the material is formed of elastomer, sclera, small intestine sub-mucosa (SIS), other mammalian tissue, or other suitable material, the venous stent device of this invention will serve as a substitute for deteriorated venous valves which have been altered by thrombosis or congenital hypoplasia. The valve prosthesis within the self-expanding stent will be percutaneously introduced with a small sized catheter delivery system. Justification for development of this invention is based on the incidence of venous disorders that lack adequate endovascular therapy. Patients who are treated surgically undergo a more invasive method that involves greater costs and more numerous potential complications. The minimally invasive technique of this invention will decrease length of hospital stay, lower over-all costs and permit an almost immediate return to normal activity. Indeed, it is believed that the availability of this treatment will dramatically alter the lives of many people, including those who might not have been able to undergo previous surgical techniques for the repair or replacement of damaged venous valves.
[0038]FIG. 1 is a schematic representation of an exemplary portion 10 of a human venous system. In venous system portion 10, a representative venous valve 15 is illustrated and shown in a closed position. As is well understood, the flow of blood through venous system 10 is in the direction of arrows 17, with the dominant pressure illustrated by a symbol P1. Although the venous system is designed to ensure flow of blood from extremities back to the heart, FIG. 1 also illustrates the phenomenon of retrograde flow and retrograde pressure which exists in the venous system and which is illustrated by symbol P2. The design of competent human venous valves takes into account this retrograde pressure. Accordingly, the configuration of bicuspid venous valve 15 accommodates the pooling of the blood at a plurality of sites each known as a valvular sinus 22. The temporal pooling of blood in each sinus or pocket creates retrograde pressure against the valve leaflets and facilitates closure of the free borders 27 of the valve cusp. Although the clear majority of human venous valves are of the bicuspid variety, it is noted that certain venous valve formations in humans may also include other than bicuspid configurations.
[0039]FIG. 2 is a sectional view taken along line 2-2 of FIG. 1. In FIG. 2 it may be seen that the free borders 27 of cusp 29 of valve 15 are essentially closed, and are facilitated in maintaining that closure by the pressure of blood pooling in the valvular sinus areas 22. It is recognized that the free borders 27 of the valve cusp may actually present as an undulating shape rather than merely a substantially straight shape across the diameter of the valve when viewed from section 2-2.
[0040] As shown in the healthy venous valve schematically represented in FIG. 3, the vertical length L of valve 15 cusp 29 is often at least about twice the diameter d of the respective blood vessel. This relationship, though not absolute, is quite common. Also, the free borders 27 of the valvular cusps of bicuspid valve 15, when closed, may contact each other over a length corresponding to approximately ⅕ to ˝ of the venous diameter d at the site of the particular valve. Thus, the natural human bicuspid venous valve, in a competent state, utilizes both the axial and retrograde pressure of the blood in the valvular sinus, as well as the contact of the lengthy free ends of the valve cusps to maintain closure. In other words, the contact of the free ends is further enhanced by the axial pressure created by the weight and volume of the pooled blood in the sinus areas.
[0041] Replication of this phenomenon has generally been beyond the technical ability of known devices or prostheses. The challenge is particularly formidable in view of the anatomy of the venous valve system and in particular the nature of veins themselves. One example of the challenge attendant to venous valve replacement relates to the shape of the veins in the venous system. Indeed, inside the body, veins will have cross-sections of elliptic shape, particularly at the venous valve locations. This is due to the interaction of the skin, the subcutaneous fascia, and other tissue that presses the veins toward the muscles, or the muscles pressing the veins toward the bone. This results in the free ends of the valvular cusps being generally aligned along the longitudinal axis of the above-described ellipse. Therefore, proper insertion of or repair to venous valves involves precise orientation within the vessel. As appreciated from the above description, the optimum apposition of the free ends of venous valve cusps is achieved when the valvular cusps are aligned with the longest diameter of the ellipse. The venous system also includes, as shown in FIG. 3, a slight thickening of the vessel wall proximate each venous valve. FIG. 4 illustrates venous system portion 10, corresponding to that shown in FIG. 1, but with venous valve 15 in an open configuration and normal blood flow proceeding through the valve. FIG. 5 illustrates, similar to FIG. 2, the action of the free ends 27 of valve 15 cusps.
[0042]FIG. 6 illustrates one embodiment of a deployment technique for deploying a valve and stent into a venous system according to the invention. In this figure, catheter means 38 comprises a portion of an interventional system facilitating, through various guiding technologies, placement and deployment of a stent and valve device 43 at an optimum location within representative venous system 10. It is understood that the optimum location for placement of stent and valve device 43 is generally proximate to existing sites of venous valves in the patient receiving the stent and valve device. However, it is recognized that by using the teachings of this invention it is possible to further optimize and possibly customize a stent and valve device 43 suitable for placement at various locations according to the anatomy of the patient's vein at the specific locations. Further discussion of this feature of the invention is included below. FIG. 6 illustrates the stent and valve device 43, with the stent portion partially deployed from the catheter means 38.
[0043]FIG. 7 is a representative, schematic, illustration of a venous portion 10, as shown in FIG. 6, with a fully deployed stent and valve device 43 therein. In this embodiment, the stent portion 51 of stent and valve device 43 comprises a functionally unitary mesh-type construction. As is understood in the art, stent material may vary according to the lumen or other tissue structure for which it is designed to provide support. In this instance, stent portion 51 accommodates the inner lumen of venous portion 10 sufficient to allow valve portion 55 sufficient diameter to properly function as an artificial venous valve. In FIG. 7, valve portion 55 is shown in a closed position. However, the inventors have discovered certain optimal features and properties for stent and valve device 43, which although they may vary according to design and patient need, may represent further improvements over the embodiment illustrated in FIG. 7.
[0044] The size of a preferred stent and valve device 43 is determined primarily by the diameter of the vessel lumen (preferably for a healthy valve/lumen combination) at the intended implant site, as well as the desired length of the overall stent and valve device. This latter feature is for optimum placement by achieving the best stability during the employment. Thus, an initial assessment of the location of the natural venous valves in the patient is determinative of several aspects of the prosthetic design. For example, the location will determine the number of support struts, the type of valve material selected, the size of deployment vehicle (French size of catheter or other deployment means) and the characteristics of the valvular sinus-like pockets. These and other factors must be considered according to the patient need. In one embodiment, the inventors have utilized algorithmic means for determining proper fit and customization of valves suitable for replacement of incompetent or insufficient valves in the patient. Once again, further discussion of this method is discussed herein below.
[0045] Another representative stent and valve device is shown in FIG. 8. In this embodiment, the stent and valve device 61 is simplified to demonstrate the 4-point connection of the selected valve material 73 at connection sites 80 on stent frame 84. Once again, stent frame 84 is shown in very simplified form but is adequate to demonstrate the challenge of having only a very minimum number of connection sites 80. This is challenging because it is important that the valvular sinuses retain the blood above the valve when the valve is in the closed position. Otherwise, a condition known as reflux exists. Obviously, a single point connection to the stent frame portion adjacent the lumenal wall probably will not provide adequate sealing of the valve material to the wall to prevent retrograde flow of blood past the valve. Indeed, what has been determined is the need for multiple point connection of the valve material to the stent structure to properly emulate the natural competent valve.
[0046] Referring to FIGS. 9 and 10, an exemplary single-stage stent and valve device, referred to in this embodiment as device 86, comprises multiple connection points 91 for the selected valve material 89 along various struts 93 of stent frame structure 95. The number of struts may vary between merely several struts to upwards of eight to ten struts or even more, as appropriate, according to the lumen size of the vein. For example, in the embodiment of FIG. 9, using valve material comprising either naturally occurring sclera tissue or naturally occurring small intestine sub-mucosa (SIS) or other comparable materials, or a combination thereof, it is possible to utilize between about six to twelve struts and deploy the stent and valve device 86 utilizing an approximately ten to fourteen French deployment catheter system.
[0047] Another consideration in the design and construction of stent and valve device 86 relates to the angle at which the valve material extends from the circumferential wall, i.e., the inner venous wall. In FIG. 10, a partial stent frame structure is shown as a vertical wall strut 101 corresponding to the elastic membrane and endothelial cells of the inner wall of a venous blood vessel. Valve material 105 is shown extending from a portion of strut 101 with a first side 107 corresponding to the lumenal part facing the lumen of the vessel and a parietal part 109 facing the wall of the vessel. Thus, the angle formed between strut 101 (corresponding to the venous wall) and valve material 105 is defined as angle V as shown in FIG. 10. The normal flow of blood through the stent and valve device 86 in the embodiment depicted in FIG. 10 is in the direction of arrow F. Thus the angle V corresponds to the angle at which the venous valve structure extends from the lumenal wall of a natural venous valve. Although various connection angles occur, it is believed that in the region of the natural valvular agger connection area (corresponding to area 113 of FIG. 10) angle V is in a range of between about 35° to 70°. It should also be recognized that the lumenal part of a natural venous valve in a human patient comprises a plurality of crypt-like crevices that further provide means for capturing and collecting the blood pooling in the valvular sinus areas. These crypts do not occur on the parietal side of the valve. Thus, in addition to whatever angle is selected for an artificially manufactured venous valve, it is important to note that there is no disclosure in any known prior artificial valve system to accommodate the angle V and the crypt structure. However, to the extent that a naturally occurring and non-thrombolytic substance may be used for valve material, it is possible that the structure may include substructures that act similar to the collection features of the naturally occurring crypts. For example, if valve material 105 is manufactured utilizing natural tissue such as the above-referenced SIS or sclera tissue, rather than a plastic or elastomer material, then the increased benefits of the tissue structure acting as pseudo-crypts may in fact provide unrealized advantages in a venous valve structure. It should also be appreciated that such advantage may be more accurately emulated subject to the cost limitations and manufacturing techniques attendant to manufacture of inventions disclosed herein. It is worth noting that this and other features of the invention may also be appropriate for placement into a non-venous valve device. FIG. 11 illustrates a top plan view of FIG. 9, in which the points of attachment are indicated and the free ends 27 of the valve material cusps are shown in apposition.
[0048]FIGS. 12 and 13 illustrate the optional radius R which may be formed at the free ends 27 of the valve material 89. A certain amount of radius allows improved functionality for a valve and stent device, subject to the size of the device and the location of use. FIG. 13 also indicates several options for attachment locations for free ends 27 on stent frame members. Any of these options may be selected, although a preferred embodiment may also be selected from other figures herein. It is noted that for certain uses valvular sinuses may be either deep or shallow, and the free ends of the valve material may be either centered or offset from a diameter when attached to the stent frame struts or other structure.
[0049]FIG. 14 illustrates another embodiment of stent and valve device 133 of the invention. The inventors realized that during deployment, under certain conditions, the self-expanding frame structure 137 and marginal retaining members 140 are inadequate to prevent momentary lack of control. As shown, frame structure 137 will expand and contract according to the pressure applied to the frame in axial directions, as shown by symbols E and C in FIG. 14. In particular, when a single stack device is allowed to exit or otherwise be liberated from a deployment means, the device may expand at an undesired rate. This may result in lack of stability during and after deployment. In order to overcome this concern, a double stacked device 133 is provided. As shown, device 133 is configured with valve material 146 arranged so that free ends 153 are proximate an end 149 of the device, rather than lower within the volume of the device. As noted in relation to FIG. 13, it is possible within the scope of this invention to alter the location of the valve material, as appropriate. The double stack feature of this device allows for deployment of one stack, and engagement and stability of the deployed stack to occur prior to liberating the second stack. However, the second stack is held is place pre-liberation by the deployment means, e.g. a catheter deployment means.
[0050]FIGS. 15 and 16 illustrate further embodiments of a stent and valve device 167, similar to that shown in FIG. 14, but having only six struts 174 per stack or stage. These devices are configured with marginal wires or other thin retaining means 181 providing connection through eye-loops 184 on each strut. The truncated cone arrangement of FIG. 16 may be particularly useful in certain geometries of vein locations. FIGS. 15 and 16 each disclose an excellent embodiment for employment as a modular design for controlled deployment. Indeed, such a design as shown in FIG. 15 has been tested in vivo, with excellent results for stability and valve operation.
[0051]FIG. 17 is an in vivo photo image taken of porcine subject #5020 with the Emitron Corporation DigiMed II™ imaging system of a venous system portion in which a device according to the invention is being deployed. Stent and valve device 202 is shown in its compressed configuration within the deployment catheter. Device 202 is approximately 2 cm in length, and is about 15 mm in fully extended diameter. In this example, valve material comprising SIS is used, although sclera was used successfully in similar trials. FIG. 18 shows device 202 having deployed first stage 205 to establish a stable platform, and second stage 208 (with the valve material therein) in the process of deployment. FIG. 19 shows the fully expanded device 202 which has accommodated the internal lumen of the venous site and has placed the valve material in position. FIG. 20 is a further view of device 202 during the systolic flow of blood through the device 202, and with the imaging system measuring gage 213 shown in a verification mode to ensure proper deployment. Verification of valve functionality is also shown in FIG. 21. In that Figure, the venous portion is shown in diastole, with the blood pooled in valvular sinus areas 220 and 221 (partially hidden due to orientation of image). FIG. 21 clearly illustrates the anti-retrograde feature of device 202 according to several of the teachings of the invention.
[0052]FIG. 22 is an in vivo photo image taken of porcine subject #5022 with the Emitron Corporation DigiMed II™ imaging system of a venous system portion in which a device according to the invention is being deployed. Stent and valve device 202 is shown in its partially deployed configuration within the deployment catheter. Device 202 is approximately 2 cm in length, and is about 15 mm in fully extended diameter. In this example, valve material comprising SIS is used, although sclera was used successfully in similar trials. FIG. 22 shows device 202 having deployed first stage 205 to establish a stable platform, and second stage 208 (with the valve material therein) in the process of deployment. FIG. 23 shows the fully expanded device 202 which has accommodated the internal lumen of the venous site and has placed the valve material in position. Verification of valve functionality was demonstrated in similar manner to that shown in FIGS. 20 and 21 of Example 1.
[0053] The feasibility of a stent-valve combination was studied in the laboratory and in a porcine model. A modified self-expanding stent was combined with a biocompatible material to assess the efficacy, thrombogenicity and histocompatibility of a new prosthesis. The material was configured in a spherical shape and fashioned into adjacent leaflets as a bi-valve design. Leaflets were secured to the stent with 7-0 nylon interrupted sutures. Hydrodynamic and barometric tests were conducted in clear tubular apparatus with variable pulsatile flow. Upon confirmation of valvular integrity, a pilot animal study was conducted. Under general anesthesia, prostheses having a tradename of Valvestent™ were implanted, from a jugular approach, in the distal IVC of 4 six-month old swine. Animals were maintained on warfarin anticoagulant to reduce the risk of embolism.
[0054] Following a 30-day observation, with no mortality or extremity edema, a second set of 14 swine underwent baseline phlebography and Valvestent™ prosthesis placement. Follow-up studies were performed at 30, 60 and 180 days consist of phlebography, perfusion retrieval of IVC and iliac veins for histological analysis, and autopsy examination for pulmonary embolus.
[0055] Initial hemodynamic testing revealed 10-20% reflux, which was corrected with design modifications. The valve opens with low pressure and maintains shape with elevated hydrostatic pressure above. All animals rapidly recovered from the implantation procedure with no ill effects. Thirty-day mortality is 78% (14/18). One animal died of malignant hyperthermia during surgery, and three animals died at 6-8 days due to internal bleeding related to prolonged prothrombine time. Primary patency of the prostheses at 30 days is 100%. One pilot stent migrated to the pulmonary artery, but remained patent.
[0056] The combination of a self-expanding stent and biocompatible material suitable for formation of durable, flexible and non-thrombogenic valve substitute, which does not reflux, appears feasible. Percutaneous delivery of such a Valvestent™ prosthesis assembly would permit a minimally invasive treatment for lower extremity valvular insufficiency.
[0057]FIG. 24 illustrates an alternate embodiment stent and valve device 234. Device 234 has a two stage stent 238 configuration, with valve material 241 arranged both inside the lumen and outside the structure of the generally tubular shaped device. This example is of a relatively shallow sinus variety, and may be one of several embodiments which have dual application to both venous and other vascular uses, including, e.g., an arterial-venous fistula treatment device.
[0058]FIG. 25 is a flow diagram of a method of configuring a sheet or other portion of valve material for use in stent and valve devices according to the various embodiments of this invention. Block 263 illustrates obtaining basic tissue or other suitable material for use as valve material and providing it in a generally planar form 266 for later processing. In block 272, the material is further shaped over convex/concave shaping means to provide optimum concavity for use in the appropriately sized and shaped valvular sinus configuration. The final shaping and cutting is performed in block 279 at which the precise shape for use in a valve material leaflet is accomplished, including a plurality of arcuate and possibly other edge portions. As disclosed herein, various forms of sclera may be used in the embodiments of this invention. It has excellent features in most respects and is readily harvested at very low cost. Also discussed herein is the use of the known material made of small intestine sub-mucosa, also referred to as SIS. Examples of this material, though not in this use and application, are found in U.S. Pat. Nos. 4,902,508, 4,956,178, 5,516,533 and 5,641,518, each of which is incorporated herein by reference for the teachings of SIS related manufacture and principles of use.
[0059]FIG. 26 illustrates an optional technique of manufacturing the proper stent and valve device of this invention according to its intended placement in a specific patient. In this technique, it is possible to utilize either some or all steps. In a full utilization of this methodology, a patient is designated 301 for sizing. The insufficient or incompetent valve site or sites are identified 305 using imaging means, such as that identified herein or other systems having highly accurate capabilities. Sizing values for optimum stent and valve configurations are obtained 308 using the imaging means, and the values are then either stored or otherwise transferred 311 to stent and valve device manufacturing means. Molds or other tools may be effectively utilized in this process. In order to further customize or render more effective in some manner the manufacture of the valve material, it is desired to either select or obtain 315 a tissue sample from the patient or an appropriate subject. The tissue sample may then be utilized in known manner to construct or grow 319 a customized valve portion or portions for later use by the designated patient. Teaching examples of this tissue engineering technology are found in U.S. Pat. Nos. 4,996,154, 5,326,357, 5,902,741, and 5,902,829, all of which are incorporated herein by reference for such teachings. Following proper growth of the valve material, the material is then assembled 323 with a properly sized stent, and then placed 327 in the patient at the specifically targeted site. A regimen of monitoring and follow up 331 continues as appropriate. It is believed that the teachings of this method of manufacture and use of the devices herein will greatly facilitate the treatment of many people for a medical problem of great severity and which little history of remedy.
[0060] Because numerous modifications may be made of this invention without departing from the spirit thereof, the scope of the invention is not to be limited to the embodiments illustrated and described. Rather, the scope of the invention is to be determined by appended claims and their equivalents.
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