US20070178770A1 - Medical electrical lead connector assembly - Google Patents
Medical electrical lead connector assembly Download PDFInfo
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- US20070178770A1 US20070178770A1 US11/343,859 US34385906A US2007178770A1 US 20070178770 A1 US20070178770 A1 US 20070178770A1 US 34385906 A US34385906 A US 34385906A US 2007178770 A1 US2007178770 A1 US 2007178770A1
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- Prior art keywords
- connector
- conductors
- conductor
- connector body
- lead
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/375—Constructional arrangements, e.g. casings
- A61N1/3752—Details of casing-lead connections
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S439/00—Electrical connectors
- Y10S439/909—Medical use or attached to human body
Definitions
- the present invention relates generally to implantable medical device (IMD) leads for delivering active electrodes to various places in a human body, such as the heart.
- IMD implantable medical device
- the present invention relates to connectors for connecting a lead with an IMD.
- HV high voltage
- quadripolar leads having four conductors have been introduced for tachyarrythmia management and other applications.
- These leads include an industry standard IS-1 connector pin for connecting the IMD with a typical coil conductor and a sensing electrode conductor for performing Brady-type pacing.
- the present invention is directed to a connector for a medical electrical lead in which a single connector delivers three or more conductors to an implantable medical device (IMD).
- IMD implantable medical device
- the invention includes a connector having multiple integrated electrode rings and conductors, and having a modular system of connector and spacer blocks for routing the conductors to a lead body.
- FIGS. 1A and 1B show partially cut-away views of a lead connector of the present invention.
- FIG. 2 shows the distal end of a connector body having three wire conductors.
- FIG. 3A shows a cross sectional view of a connector assembly having single layer polytetrafuoroethylene (PTFE) insulated wire conductors.
- PTFE polytetrafuoroethylene
- FIG. 3B shows a cross sectional view of a connector assembly having double layer PTFE insulated wire conductors.
- FIG. 4 shows an electrode ring having a wisdom tooth connector.
- FIG. 5 shows a locking mechanism for a connector assembly.
- FIG. 6 shows a transition assembly of the lead connector of the present invention.
- FIG. 7 shows a connector block having wisdom tooth connectors.
- FIG. 8 shows a spacer block for use in a transition assembly.
- FIG. 9 shows a transition assembly comprised of connector blocks and spacer blocks.
- FIG. 10 shows a transition assembly rigged in a bypass configuration.
- FIGS. 1A and 1B show a partially cut-away views of lead connector 10 , which is used to connect multi-conductor lead 11 with an implantable medical device (IMD), such as a cardiac pacing pulse generator or implantable cardioverter defibrillator, through a single connector.
- IMD implantable medical device
- Lead connector 10 is positioned at a proximal end of lead 11 , and is comprised of connector assembly 12 and transition assembly 13 .
- lead 11 comprises a quadripolar construction in which three wire conductors (conductors 14 A, 16 A, and 18 A) and one coil conductor (conductor 20 ) are delivered to or near the distal end of lead 11 .
- Transition assembly 13 includes connector blocks 22 A, 22 B and 22 C, which are used to coordinate the interconnection of the conductors from lead 11 to connector assembly 12 .
- Lead 11 also includes sheathing 24 , which comprises a flexible, protective barrier between the conductors and the body in which lead 11 is implanted.
- Sheathing 24 can be formed of silicone, polyurethane, or a non-porous or dense PTFE.
- Lead connector 10 delivers each of the conductors to a single uni-axial connector body, such that a single connector links all four conductors with the IMD.
- Transition assembly 13 is used to deliver conductors 14 A, 16 A, 18 A and 20 to connector assembly 12 , which can be fitted with a connector socket of an IMD.
- Connector assembly 12 comprises a universal connection to a variety of IMDs in which up to four conductors can be linked with the IMD.
- Connector assembly 12 is a modular assembly that can be separately manufactured, assembled and distributed for use with a variety of leads.
- transition assembly 13 is a modular, adaptable system that can be configured for linking various leads having up to four conductors to connector assembly 12 .
- Transition assembly 13 connects wire conductors 14 A, 16 A and 18 A of lead 11 with conductors 14 B, 16 B and 18 B of connector assembly 12 , while also allowing coil conductor 20 to travel uninterrupted from the proximal end to the distal end of lead 11 .
- Connector block 22 B connects wire conductor 14 A with wire conductor 14 B and electrode ring 26 , thus forming a circuit with an electrode positioned at the distal end of lead 11 for performing sensing functions within a heart.
- Connector block 22 C connects conductor 16 A with wire conductor 16 B and electrode ring 28 , thus forming a circuit with, for example, a right ventricle defibrillation coil electrode (RV defib coil).
- RV defib coil right ventricle defibrillation coil electrode
- Connector block 22 A connects wire conductor 18 A with wire conductor 18 B and electrode ring 30 , thus forming a circuit with, for example, a superior vena cava defibrillation coil electrode (SVC defib coil).
- Coil conductor 20 which runs concurrently through lead connector assembly 10 , is connected with connector pin 38 and is used in conjunction with electrode ring 26 and wire conductors 14 A and 14 B in performing heart pacing functions.
- FIG. 2 illustrates the distal end of connector assembly 12 , showing the distal end of wire conductors 14 B, 16 B and 18 B.
- Connector assembly 12 includes connector body 34 and retainer 36 .
- Wire conductors 14 B, 16 B and 18 B are spaced one hundred twenty degrees apart around the circumference of connector body 34 .
- Conductors 14 B, 16 B and 18 B are integrally formed with connector body 34 , such as in a molding process.
- Wire conductors 14 B, 16 B and 18 B can be selectively cut off of connector body 34 when being connected with leads having fewer than three wire conductors.
- Retainer 36 is inserted into connector body 34 and is used to join connector assembly 12 with transition assembly 13 .
- FIG. 3A shows a cross section of connector assembly 12 of lead body connector 10 taken along section 3 - 3 of FIG. 2 .
- FIG. 3A shows lead connector assembly 12 having a single coating of PTFE insulation on wire conductors 14 B, 16 B and 18 B.
- FIG. 3B shows another embodiment of connector assembly 12 in which wire conductors 14 B, 16 B and 18 B include a double coating of PTFE insulation.
- the embodiments of lead body 10 shown in FIG. 3A and FIG. 3B are similarly constructed and include like element numbers. FIGS. 3A and 3B will be discussed concurrently.
- Connector assembly 12 is comprised of electrode rings 26 , 28 and 30 , connector body 34 , retainer 36 , connector pin 38 , locking mechanism 40 and wire conductors 14 B, 16 B and 18 B (of which only wire conductor 14 B and 18 B can be seen in FIGS. 3A and 3B ).
- Connector body 34 and retainer 36 are typically comprised of a urethane material.
- Wire conductors 14 B, 16 B and 18 B are typically comprised of silver core wires, but can be of any suitable construction and material.
- Wire conductors 14 B, 16 B and 18 B are pre-assembled with electrode rings 26 , 28 and 30 , respectively.
- FIG. 4 shows electrode ring 26 , which is also representative of electrode rings 28 and 30 .
- Electrode ring 26 is comprised of a conducting, non-reactive material, such as titanium, and typically includes a conductive, corrosion resistant coating.
- Electrode ring 26 includes wisdom tooth connecting mechanism 44 , which is comprised of spaced rails 46 A and 46 B that form channel 48 .
- One of the wire conductors (e.g. wire conductor 14 B) is laid flat into channel 48 . Any insulation around the wire conductor along the segment that interacts with electrode ring 26 is removed such that a conductive link is formed, as shown, for example, in FIG. 3B .
- Rails 46 A and 46 B are then crimped inward around the wire conductor, thus forming a mechanical bond having tensile strength suitable for withstanding tension imposed on lead connector assembly 10 during installation and operation of lead 11 .
- the crimping of rails 46 A and 46 B also improves the electrical connection between the wire conductor and electrode ring 26 .
- wire conductor and electrode ring assemblies are then integrally formed with connector body 34 , such as with a molding process.
- Wire conductors 14 B, 16 B and 18 B extend a length d beyond the distal face of connector body 34 in order that they can be joined with transition assembly 13 .
- length d is about three to four inches.
- the wire conductors can be selectively trimmed from connector body 34 . For example, if connector assembly 12 is to be used with a lead having only one wire conductor in addition to a coil conductor, two of wire conductors 14 B, 16 B and 18 B can be cut off at the distal face of connector body 34 .
- wire conductors 14 B, 16 B and 18 B of connector assembly 12 can be joined with other types of transition assemblies or directly with lead 11 .
- Electrode rings 26 , 28 and 30 and wire conductors 14 B, 16 B and 18 B are therefore assembled to form connector body 34 , which is manufactured as a separate part that can be customized for use in different applications.
- connector pin 38 is assembled with coil conductor 20 .
- Connector pin 38 which is comprised of a conducting material, such as titanium, includes post 50 , lumen 52 and circumferential groove 54 .
- Post 50 is inserted into coil conductor 20 , and bonded with a welding or soldering procedure.
- Lumen 52 accepts a stylet used to guide lead 11 into a body during implanting of an IMD.
- Connector pin 38 also includes circumferential groove 54 , which is used in conjunction with locking mechanism 40 to retain connector pin 38 with respect to connector body 34 .
- connector pin 38 is assembled with connector body 34 .
- Connector body 34 includes sheathing groove 55 , central channel 56 and locking channel 58 .
- Sheathing groove 55 is used to secure a protective sheathing around transition assembly 13 .
- Connector pin 38 is inserted into central channel 56 of connector body 34 , along with coil conductor 20 , until circumferential groove 54 aligns with locking channel 58 . Once they are aligned, locking mechanism 40 can be assembled with connector body 34 .
- locking mechanism 40 includes two interlocking pieces: collar 40 A and key 40 B.
- Collar 40 A prevents connector pin 38 from disengaging from connector body 34 .
- Key 40 B prevents collar 40 A from disengaging connector pin 38 .
- Collar 40 A is inserted into locking channel 58 and circumferential groove 54 from one side of connector assembly 13 , while key 40 B is inserted through the opposite side.
- the outer extent of collar 40 A and key 40 B mates with locking channel 58 and the inner extent of collar 40 A and key 40 B mates with circumferential groove 54 . Movement of connector pin 38 along the axis of connector body 34 is thereby prevented.
- Collar 40 A includes notches 62 A and 62 B, which receive teeth 64 A and 64 B of key 40 B.
- Teeth 64 A and 64 B allow key 40 B to be inserted into notches 62 A and 62 B of collar 40 A, but prevent key 40 B from disengaging from collar 40 A. Once assembled, collar 40 A and key 40 B form a circular yoke 60 , which allows connector pin 38 to rotate in central channel 56 .
- retainer 36 is placed around coil conductor 20 and inserted into central channel 56 until flange 66 engages the distal face of connector body 34 .
- retainer 36 could also be placed around coil conductor 20 before connector pin 38 is linked with connector body 34 .
- Retainer 36 provides an additional insulating layer between coil conductor 20 and electrode rings 26 , 28 and 30 .
- the diameter of retainer 36 is slightly smaller than the diameter of central channel 56 such that a press fit connection is formed.
- Retainer 36 includes connector post 68 , which includes flange 70 , for linking connector assembly 12 with transition assembly 13 .
- FIG. 6 shows a partial cross sectional view of transition assembly 13 connected with connector assembly 12 .
- Transition assembly 13 joins connector assembly 12 with lead 11 , and orchestrates the connection and arrangement of the conductors or each component.
- Transition assembly 13 includes first connector block 22 A, second connector block 22 B, third connector block 22 C and sheathing 72 .
- Lead 11 includes sheathing 24 , multilumen tube 80 , coil sheathing 82 , and wire conductors 14 A, 16 A and 18 A.
- Sheathing 72 and connector assembly 12 are shown in cross section, while the interior of transition assembly 13 is shown in full to show the inter-linking of the wire conductors.
- Transition assembly 13 is first linked with connector assembly 12 with coil conductor 20 and coil sheathing 82 .
- Coil conductor 20 is inserted into sheathing 82 up to the distal face of connector body 34 .
- Sheathing 82 fits around post 50 of retainer 36 and is retained by tension in sheathing 82 . This connection also avoids the necessity of adhesive bonding, which has the same benefits as described above.
- Coil sheathing 82 runs the length of transition assembly 13 .
- FIG. 7 shows connector block 22 , which is representative of connector blocks 22 A- 22 C.
- Connector block 22 includes center bore 86 , first wisdom tooth connector 88 A and second wisdom tooth connector 88 B.
- Connectors 88 A and 88 B link wire conductors 14 A, 16 A and 18 A of lead 11 with wire conductors 14 B, 16 B and 18 B of connector assembly 12 , respectively.
- Connectors 88 A and 88 B are similar in construction to wisdom tooth connector 44 of electrode ring 42 , in that they are comprised of opposing rails to form a channel in which a conductor is laid. The opposing rails are then crimped to form a mechanical bond having adequate tensile strength. The crimp also improves the electrical contact between connector block 22 and the conductor.
- Wisdom tooth connectors 88 A and 88 B are placed one hundred eighty degrees apart on the outer periphery of connector block 22 ; one at the top and one at the bottom. Connector block 22 can be used, however, in any orientation.
- Connector block 22 is comprised of a conductive body having a diameter approximating the diameter of connector body 34 .
- the sides of connector block 22 are trimmed down to allow other conductors, not attached to connector block 22 , to travel past connector block 22 within transition assembly 13 .
- connector block 22 is comprised of titanium, but any acceptable conductive, non-reactive metal can be used.
- wire conductors 14 B, 16 B and 18 B extend from the distal face of connector body 34 and conductors 14 A, 16 A and 18 A extend from the proximal end of lead 11 .
- the wire conductors are joined with connector blocks 22 A, 22 B and 22 C.
- Connector blocks 22 A, 22 B and 22 C are spaced equally apart on coil sheathing 82 and orientated along its axis one hundred twenty degrees apart, such that each wisdom tooth connector has clear access to the proximal end of lead 11 and the distal face of connector body 34 .
- wisdom tooth connectors are positioned at 12, 2, 4, 6, 8 and 10 o'clock with respect to the distal face of connector body 34 . Any insulating layers surrounding conductors 14 A, 16 A, 18 A, 14 B, 16 B and 18 B are removed where the conductors are to be joined with the wisdom tooth connectors so that conductive connections can be made.
- Connector block 22 B is positioned near the center of transition assembly 13 , with its wisdom tooth connectors positioned at 12 and 6 o'clock.
- Wire conductor 18 B extends from the top of connector body 34 to the wisdom tooth connector of connector block 22 B at 12 o'clock.
- Wire conductor 18 B is positioned within the channel of the wisdom tooth connector and the rails are crimped around conductor 18 B to form an electrically conductive connection. Any excess length of conductor 18 B, beyond what is necessary to completely join with connector block 22 B, is cut away.
- wire conductor 18 A extends from near the bottom of lead 11 to the wisdom tooth connector of connector block 22 B at 6 o'clock.
- Wire conductor 18 A is positioned within the channel of the wisdom tooth connector and the rails are crimped around conductor 18 A to form an electrically conductive connection. Any excess length of conductor 18 A, beyond what is necessary to completely join with connector block 22 B, is cut away. Thus, wire conductor 18 A is conductively linked with wire conductor 18 B.
- Connector block 22 C is positioned near the proximal end of transition assembly 13 , with its wisdom tooth connectors positioned at 4 and 10 o'clock.
- Wire conductor 16 B extends from the 4 o'clock position of connector body 34 to the wisdom tooth connector of connector block 22 C at 4 o'clock.
- Wire conductor 16 B is positioned within the channel of the wisdom tooth connector and the rails are crimped around conductor 16 B to form an electrically conductive connection. Any excess length of conductor 16 B, beyond what is necessary to completely join with connector block 22 C, is cut away.
- wire conductor 16 A extends from near the bottom of lead 11 and runs past connector blocks 22 A and 22 B to the wisdom tooth connector of connector block 22 C at 10 o'clock.
- Wire conductor 16 A is positioned within the channel of the wisdom tooth connector and the rails are crimped around conductor 16 A to form an electrically conductive connection. Any excess length of conductor 16 A, beyond what is necessary to completely join with connector block 22 C, is cut away. Thus, wire conductor 16 A is conductively linked with wire conductor 16 B.
- Connector block 22 A is positioned near the distal end of transition assembly 13 , with its wisdom tooth connectors positioned at 2 and 8 o'clock.
- Wire conductor 14 B extends from the 8 o'clock position of connector body 34 to the wisdom tooth connector of connector block 22 A at 8 o'clock.
- Wire conductor 14 B is positioned within the channel of the wisdom tooth connector and the rails are crimped around conductor 14 B to form an electrically conductive connection. Any excess length of conductor 14 B, beyond what is necessary to completely join with connector block 22 A, is cut away.
- wire conductor 14 A extends from near the bottom of lead 11 to the wisdom tooth connector of connector block 22 A at 2 o'clock.
- Wire conductor 14 A is positioned within the channel of the wisdom tooth connector and the rails are crimped around conductor 14 A to form an electrically conductive connection. Any excess length of conductor 14 A, beyond what is necessary to completely join with connector block 22 A, is cut away. Thus, wire conductor 14 A is conductively linked with wire conductor 14 B.
- transition assembly sheathing 72 is positioned around transition assembly 13 .
- the distal end of sheathing 72 is fitted around sheathing 24 at the proximal end of lead 11 .
- the proximal end of sheathing 72 is connected with the distal end of connector body 34 , and is fitted around sheathing groove 55 .
- Transition assembly 13 achieves the electrical connection of the wire conductors of lead 11 with the wire conductors of connector assembly 12 , while maintaining electrical isolation of each conductor circuit.
- the wire conductors are covered by a single layer of polytetrafluoroethylene (PTFE) insulation. It is advantageous to include insulation on each wire conductor in order to avoid electrical interference with the signal carried by each conductor within transition assembly 13 .
- PTFE polytetrafluoroethylene
- a second PTFE coating is added to the conductors to ensure that the signal carried by each conductor does not produce noise or interference in nearby conductors, especially in transition assembly 13 .
- the insulating layers can be added to the conductors during manufacture, such as during extruding of the wires.
- Transition assembly 13 also provides a flexible junction that maintains strong tensile strength due to the crimping mechanism of the wisdom tooth connectors.
- the connector blocks are discussed as being set at positions relative to the distal face of connector body 34 , this is only intended to describe their approximate position. Once the connector blocks are assembled, they are free to rotate around coil sheathing 82 , which also aids in tension dissipation in the conductors and flexibility of transition section 13 .
- transition assembly 13 is fitted with spacer blocks to dissipate some of the tension produced in the conductors during handling of lead 11 .
- FIG. 8 shows spacer block 90 , which comprises a circular disk having central bore 92 and peripheral channels 94 A- 94 F. Central bore 92 allows spacer block 90 to be fitted around coil sheathing 82 , in between connector blocks 22 A- 22 C.
- Peripheral channels 94 A- 94 F allow wire conductors travelling between connector blocks 22 A- 22 C to be laid across spacer block 90 .
- Peripheral channels 94 A- 94 F have diameters large enough to accept insulated wire conductors.
- Peripheral channels 94 A- 94 F are spaced around the circumference of spacer block 90 sixty degrees apart (i.e. at 12, 2, 4, 6, 8 and 10 o'clock with respect to the distal face of connector body 34 ).
- Spacer block 90 provides tension relief of the wire conductors by preventing wire conductors 14 A, 16 A, 18 A, 14 B, 16 B and 18 B from bending or kinking.
- Spacer block 90 is preferably composed of silicone rubber, but can be made of any suitable insulating and dampening material.
- FIG. 9 shows an embodiment of transition assembly 13 provided with spacer blocks 96 and 98 .
- Conductors 14 A, 16 A, 18 A, 14 B, 16 B and 18 B are shown as connected with connector blocks 22 A- 22 C in FIG. 9 .
- Connector blocks 22 A, 22 B and 22 C are co-axially aligned on coil sheathing 82 of coil conductor 20 , which has been omitted for clarity.
- Spacer block 96 is disposed on coil sheathing 82 between connector blocks 22 A and 22 B
- spacer block 98 is disposed on coil sheathing 82 between connector blocks 22 B and 22 C.
- Wire conductor 14 B extends distally in the 12 o'clock position, past connector block 22 C and through a channel in spacer block 98 in the 12 o'clock position and into a wisdom tooth connecting mechanism of connector block 22 B.
- Wire conductor 14 A extends proximally in the 6 o'clock position, past connector block 22 A and through a channel in spacer block 96 in the 6 o'clock position and into a wisdom tooth connecting mechanism of connector block 22 B. Thereby, conductors 14 B and 14 A are conductively joined at connector block 22 B.
- Wire conductor 16 B extends distally in the 4 o'clock position and into a wisdom tooth connecting mechanism of connector block 22 C.
- Wire conductor 16 A extends proximally in the 10 o'clock position past connector block 22 A, through a channel in spacer block 96 in the 10 o'clock position, past connector block 22 B, through a channel in spacer block 98 in the 10 o'clock position and into a wisdom tooth connecting mechanism of connector block 22 C in the 10 o'clock position.
- conductors 16 B and 16 A are conductively joined at connector block 22 C.
- Wire conductor 18 B extends distally in the 8 o'clock position, past connector block 22 C, through a channel in spacer block 98 in the 8 o'clock position, past connector block 22 B, through a channel in spacer block 96 in the 8 o'clock position and into a wisdom tooth connecting mechanism of connector block 22 A in the 8 o'clock position.
- Wire conductor 18 A extends proximally in the 2 o'clock position and into a wisdom tooth connecting mechanism of connector block 22 A in the 2 o'clock position. Thereby, conductors 18 B and 18 A are conductively joined at connector block 22 A.
- Spacer blocks 96 and 98 maintain a general linear shape to the conductors. Spacer blocks 96 and 98 are also comprised of a flexible or compressible material that allows transition assembly 13 to flex during handling of lead 11 . These features assist in dissipating stress created in the conductors by preventing the formation of stress points, such as bends or kinks.
- FIG. 10 shows an alternative embodiment of transition assembly 13 in which the connector blocks are used to create a bypass configuration for conductors 100 , 102 and 104 .
- the bypass configuration allows a single conductor lead to be connected with a connector body having two conductors.
- Conductor 104 extends from a lead at its distal end to transition assembly 13 at its proximal end.
- Conductor 104 is conductively linked to conductor 102 at conductor block 106 , and conductively linked to conductor 100 at connector block 108 .
- Conductor 104 extends past connector block 106 and is then joined with a connection mechanism of connector block 108 .
- Conductor 104 curves back around to extend past connector block 108 and into a connecting mechanism of connector block 106 .
- Conductor 102 extends past connector block 108 and into a connecting mechanism of connector block 106 , while conductor 100 is joined with a connecting mechanism of connector block 108 .
- Conductors 102 and 100 are ultimately connected at their proximal ends with circuitry of an IMD, and each is responsible for carrying a distinct signal to or from the circuitry, such as a sense signal and RV defibrillation pulse.
- Conductor 104 is ultimately connected with one or more electrodes positioned within body tissue at the distal end of conductor 104 .
- the electrode(s) connected to conductor 104 may perform both sensing/pacing and defibrillation functions, depending on whether conductor 100 or 102 is active.
Abstract
Description
- The present invention relates generally to implantable medical device (IMD) leads for delivering active electrodes to various places in a human body, such as the heart. In particular, the present invention relates to connectors for connecting a lead with an IMD.
- Advances in technology have led to IMDs having increased capabilities for performing therapeutic, diagnostic and other functions. Such advances can require the use of leads carrying additional electrodes, which require additional conductors that run from the IMD to a distal end of the lead. Recently, high voltage (HV), quadripolar leads having four conductors have been introduced for tachyarrythmia management and other applications. These leads include an industry standard IS-1 connector pin for connecting the IMD with a typical coil conductor and a sensing electrode conductor for performing Brady-type pacing.
- In addition, for performing other pacing, sensing, defibrillation therapy and diagnostic functions, for example, in the superior vena cava (SVC) or right ventricle (RV), additional conductors are connected to the IMD with standard DF-1 connector pins. Thus, these leads require up to three connector pins for inserting into the IMD. Because an additional connector port is necessary for each connector pin, the increased number of pins can result in an increased size of the IMD, which requires a larger space-volume and may pose hermiticity and patient comfort issues. Therefore, there is a need for a lead connector capable of connecting multiple conductors with a single connector pin.
- The present invention is directed to a connector for a medical electrical lead in which a single connector delivers three or more conductors to an implantable medical device (IMD). The invention includes a connector having multiple integrated electrode rings and conductors, and having a modular system of connector and spacer blocks for routing the conductors to a lead body.
-
FIGS. 1A and 1B show partially cut-away views of a lead connector of the present invention. -
FIG. 2 shows the distal end of a connector body having three wire conductors. -
FIG. 3A shows a cross sectional view of a connector assembly having single layer polytetrafuoroethylene (PTFE) insulated wire conductors. -
FIG. 3B shows a cross sectional view of a connector assembly having double layer PTFE insulated wire conductors. -
FIG. 4 shows an electrode ring having a wisdom tooth connector. -
FIG. 5 shows a locking mechanism for a connector assembly. -
FIG. 6 shows a transition assembly of the lead connector of the present invention. -
FIG. 7 shows a connector block having wisdom tooth connectors. -
FIG. 8 shows a spacer block for use in a transition assembly. -
FIG. 9 shows a transition assembly comprised of connector blocks and spacer blocks. -
FIG. 10 shows a transition assembly rigged in a bypass configuration. -
FIGS. 1A and 1B show a partially cut-away views oflead connector 10, which is used to connectmulti-conductor lead 11 with an implantable medical device (IMD), such as a cardiac pacing pulse generator or implantable cardioverter defibrillator, through a single connector.Lead connector 10 is positioned at a proximal end oflead 11, and is comprised ofconnector assembly 12 andtransition assembly 13. In the embodiment shown,lead 11 comprises a quadripolar construction in which three wire conductors (conductors lead 11.Transition assembly 13 includesconnector blocks lead 11 toconnector assembly 12. - In the embodiment described, three wire conductors are used, however it is contemplated that the lead connector of the present invention can be adapted for leads having two, four or more wire conductors.
Lead 11 also includessheathing 24, which comprises a flexible, protective barrier between the conductors and the body in whichlead 11 is implanted.Sheathing 24 can be formed of silicone, polyurethane, or a non-porous or dense PTFE. -
Lead connector 10 delivers each of the conductors to a single uni-axial connector body, such that a single connector links all four conductors with the IMD.Transition assembly 13 is used to deliverconductors connector assembly 12, which can be fitted with a connector socket of an IMD. -
Connector assembly 12 comprises a universal connection to a variety of IMDs in which up to four conductors can be linked with the IMD.Connector assembly 12 is a modular assembly that can be separately manufactured, assembled and distributed for use with a variety of leads. Likewise,transition assembly 13 is a modular, adaptable system that can be configured for linking various leads having up to four conductors toconnector assembly 12. -
Transition assembly 13 connectswire conductors lead 11 withconductors connector assembly 12, while also allowingcoil conductor 20 to travel uninterrupted from the proximal end to the distal end oflead 11.Connector block 22B connectswire conductor 14A withwire conductor 14B andelectrode ring 26, thus forming a circuit with an electrode positioned at the distal end oflead 11 for performing sensing functions within a heart.Connector block 22C connectsconductor 16A withwire conductor 16B andelectrode ring 28, thus forming a circuit with, for example, a right ventricle defibrillation coil electrode (RV defib coil).Connector block 22A connectswire conductor 18A withwire conductor 18B andelectrode ring 30, thus forming a circuit with, for example, a superior vena cava defibrillation coil electrode (SVC defib coil).Coil conductor 20, which runs concurrently throughlead connector assembly 10, is connected withconnector pin 38 and is used in conjunction withelectrode ring 26 andwire conductors -
FIG. 2 illustrates the distal end ofconnector assembly 12, showing the distal end ofwire conductors Connector assembly 12 includesconnector body 34 andretainer 36.Wire conductors connector body 34.Conductors connector body 34, such as in a molding process.Wire conductors connector body 34 when being connected with leads having fewer than three wire conductors.Retainer 36 is inserted intoconnector body 34 and is used to joinconnector assembly 12 withtransition assembly 13. -
FIG. 3A shows a cross section ofconnector assembly 12 oflead body connector 10 taken along section 3-3 ofFIG. 2 .FIG. 3A showslead connector assembly 12 having a single coating of PTFE insulation onwire conductors FIG. 3B shows another embodiment ofconnector assembly 12 in whichwire conductors lead body 10 shown inFIG. 3A andFIG. 3B are similarly constructed and include like element numbers.FIGS. 3A and 3B will be discussed concurrently. -
Connector assembly 12 is comprised of electrode rings 26, 28 and 30,connector body 34,retainer 36,connector pin 38,locking mechanism 40 andwire conductors wire conductor FIGS. 3A and 3B ).Connector body 34 andretainer 36 are typically comprised of a urethane material.Wire conductors -
Wire conductors FIG. 4 showselectrode ring 26, which is also representative of electrode rings 28 and 30.Electrode ring 26 is comprised of a conducting, non-reactive material, such as titanium, and typically includes a conductive, corrosion resistant coating.Electrode ring 26 includes wisdomtooth connecting mechanism 44, which is comprised of spacedrails channel 48. One of the wire conductors (e.g. wire conductor 14B) is laid flat intochannel 48. Any insulation around the wire conductor along the segment that interacts withelectrode ring 26 is removed such that a conductive link is formed, as shown, for example, inFIG. 3B .Rails lead connector assembly 10 during installation and operation oflead 11. The crimping ofrails electrode ring 26. - Returning to
FIG. 3A , the wire conductor and electrode ring assemblies are then integrally formed withconnector body 34, such as with a molding process.Wire conductors connector body 34 in order that they can be joined withtransition assembly 13. Typically, length d is about three to four inches. Depending on the type of lead with whichconnector assembly 12 is intended to be used, the wire conductors can be selectively trimmed fromconnector body 34. For example, ifconnector assembly 12 is to be used with a lead having only one wire conductor in addition to a coil conductor, two ofwire conductors connector body 34. Alternatively,wire conductors connector assembly 12 can be joined with other types of transition assemblies or directly withlead 11. Electrode rings 26, 28 and 30 andwire conductors connector body 34, which is manufactured as a separate part that can be customized for use in different applications. - Once electrode rings 26, 28 and 30 and
wire conductors connector body 34,connector pin 38 is assembled withcoil conductor 20.Connector pin 38, which is comprised of a conducting material, such as titanium, includespost 50,lumen 52 andcircumferential groove 54.Post 50 is inserted intocoil conductor 20, and bonded with a welding or soldering procedure.Lumen 52 accepts a stylet used to guidelead 11 into a body during implanting of an IMD.Connector pin 38 also includescircumferential groove 54, which is used in conjunction with lockingmechanism 40 to retainconnector pin 38 with respect toconnector body 34. - After
coil conductor 20 has been assembled withconnector pin 38,connector pin 38 is assembled withconnector body 34.Connector body 34 includessheathing groove 55,central channel 56 and lockingchannel 58. Sheathinggroove 55 is used to secure a protective sheathing aroundtransition assembly 13.Connector pin 38 is inserted intocentral channel 56 ofconnector body 34, along withcoil conductor 20, untilcircumferential groove 54 aligns with lockingchannel 58. Once they are aligned, lockingmechanism 40 can be assembled withconnector body 34. - As shown in
FIG. 5 ,locking mechanism 40 includes two interlocking pieces:collar 40A and key 40B.Collar 40A preventsconnector pin 38 from disengaging fromconnector body 34.Key 40B preventscollar 40A from disengagingconnector pin 38.Collar 40A is inserted into lockingchannel 58 andcircumferential groove 54 from one side ofconnector assembly 13, while key 40B is inserted through the opposite side. The outer extent ofcollar 40A and key 40B mates with lockingchannel 58 and the inner extent ofcollar 40A and key 40B mates withcircumferential groove 54. Movement ofconnector pin 38 along the axis ofconnector body 34 is thereby prevented.Collar 40A includesnotches teeth Teeth notches collar 40A, but prevent key 40B from disengaging fromcollar 40A. Once assembled,collar 40A and key 40B form acircular yoke 60, which allowsconnector pin 38 to rotate incentral channel 56. - To complete the assembly of
connector assembly 12,retainer 36 is placed aroundcoil conductor 20 and inserted intocentral channel 56 untilflange 66 engages the distal face ofconnector body 34. Alternatively,retainer 36 could also be placed aroundcoil conductor 20 beforeconnector pin 38 is linked withconnector body 34.Retainer 36 provides an additional insulating layer betweencoil conductor 20 and electrode rings 26, 28 and 30. The diameter ofretainer 36 is slightly smaller than the diameter ofcentral channel 56 such that a press fit connection is formed. There are several advantages of a press fit type connection. Previously, urethane connector pieces have been joined together with adhesives that require time to dry and sometimes caused deformation of the urethane pieces due to melting. Thus, press-fittingretainer 36 intoconnector body 34 avoids the necessity of special equipment and knowledge typically required in adhesive bonding. The press fit connection also prevents fluid from seeping intoconnector body 34.Retainer 36 includesconnector post 68, which includesflange 70, for linkingconnector assembly 12 withtransition assembly 13. -
FIG. 6 shows a partial cross sectional view oftransition assembly 13 connected withconnector assembly 12.Transition assembly 13 joinsconnector assembly 12 withlead 11, and orchestrates the connection and arrangement of the conductors or each component.Transition assembly 13 includesfirst connector block 22A,second connector block 22B,third connector block 22C andsheathing 72.Lead 11 includessheathing 24,multilumen tube 80,coil sheathing 82, andwire conductors Sheathing 72 andconnector assembly 12 are shown in cross section, while the interior oftransition assembly 13 is shown in full to show the inter-linking of the wire conductors. -
Transition assembly 13 is first linked withconnector assembly 12 withcoil conductor 20 andcoil sheathing 82.Coil conductor 20 is inserted intosheathing 82 up to the distal face ofconnector body 34.Sheathing 82 fits around post 50 ofretainer 36 and is retained by tension insheathing 82. This connection also avoids the necessity of adhesive bonding, which has the same benefits as described above.Coil sheathing 82 runs the length oftransition assembly 13. -
FIG. 7 showsconnector block 22, which is representative of connector blocks 22A-22C.Connector block 22 includes center bore 86, firstwisdom tooth connector 88A and secondwisdom tooth connector 88B.Connectors link wire conductors lead 11 withwire conductors connector assembly 12, respectively.Connectors wisdom tooth connector 44 of electrode ring 42, in that they are comprised of opposing rails to form a channel in which a conductor is laid. The opposing rails are then crimped to form a mechanical bond having adequate tensile strength. The crimp also improves the electrical contact betweenconnector block 22 and the conductor.Wisdom tooth connectors connector block 22; one at the top and one at the bottom.Connector block 22 can be used, however, in any orientation. -
Connector block 22 is comprised of a conductive body having a diameter approximating the diameter ofconnector body 34. The sides ofconnector block 22 are trimmed down to allow other conductors, not attached toconnector block 22, to travelpast connector block 22 withintransition assembly 13. Typically,connector block 22 is comprised of titanium, but any acceptable conductive, non-reactive metal can be used. - Returning to
FIG. 6 ,wire conductors connector body 34 andconductors lead 11. The wire conductors are joined withconnector blocks coil sheathing 82 and orientated along its axis one hundred twenty degrees apart, such that each wisdom tooth connector has clear access to the proximal end oflead 11 and the distal face ofconnector body 34. In other words, wisdom tooth connectors are positioned at 12, 2, 4, 6, 8 and 10 o'clock with respect to the distal face ofconnector body 34. Any insulatinglayers surrounding conductors -
Connector block 22B is positioned near the center oftransition assembly 13, with its wisdom tooth connectors positioned at 12 and 6 o'clock.Wire conductor 18B extends from the top ofconnector body 34 to the wisdom tooth connector ofconnector block 22B at 12 o'clock.Wire conductor 18B is positioned within the channel of the wisdom tooth connector and the rails are crimped aroundconductor 18B to form an electrically conductive connection. Any excess length ofconductor 18B, beyond what is necessary to completely join withconnector block 22B, is cut away. Similarly,wire conductor 18A extends from near the bottom oflead 11 to the wisdom tooth connector ofconnector block 22B at 6 o'clock.Wire conductor 18A is positioned within the channel of the wisdom tooth connector and the rails are crimped aroundconductor 18A to form an electrically conductive connection. Any excess length ofconductor 18A, beyond what is necessary to completely join withconnector block 22B, is cut away. Thus,wire conductor 18A is conductively linked withwire conductor 18B. -
Connector block 22C is positioned near the proximal end oftransition assembly 13, with its wisdom tooth connectors positioned at 4 and 10 o'clock.Wire conductor 16B extends from the 4 o'clock position ofconnector body 34 to the wisdom tooth connector ofconnector block 22C at 4 o'clock.Wire conductor 16B is positioned within the channel of the wisdom tooth connector and the rails are crimped aroundconductor 16B to form an electrically conductive connection. Any excess length ofconductor 16B, beyond what is necessary to completely join withconnector block 22C, is cut away. Similarly,wire conductor 16A extends from near the bottom oflead 11 and runspast connector blocks connector block 22C at 10 o'clock.Wire conductor 16A is positioned within the channel of the wisdom tooth connector and the rails are crimped aroundconductor 16A to form an electrically conductive connection. Any excess length ofconductor 16A, beyond what is necessary to completely join withconnector block 22C, is cut away. Thus,wire conductor 16A is conductively linked withwire conductor 16B. -
Connector block 22A is positioned near the distal end oftransition assembly 13, with its wisdom tooth connectors positioned at 2 and 8 o'clock.Wire conductor 14B extends from the 8 o'clock position ofconnector body 34 to the wisdom tooth connector ofconnector block 22A at 8 o'clock.Wire conductor 14B is positioned within the channel of the wisdom tooth connector and the rails are crimped aroundconductor 14B to form an electrically conductive connection. Any excess length ofconductor 14B, beyond what is necessary to completely join withconnector block 22A, is cut away. Similarly,wire conductor 14A extends from near the bottom oflead 11 to the wisdom tooth connector ofconnector block 22A at 2 o'clock.Wire conductor 14A is positioned within the channel of the wisdom tooth connector and the rails are crimped aroundconductor 14A to form an electrically conductive connection. Any excess length ofconductor 14A, beyond what is necessary to completely join withconnector block 22A, is cut away. Thus,wire conductor 14A is conductively linked withwire conductor 14B. - Once all the conductors have been joined with
connector blocks transition assembly sheathing 72 is positioned aroundtransition assembly 13. The distal end ofsheathing 72 is fitted around sheathing 24 at the proximal end oflead 11. The proximal end ofsheathing 72 is connected with the distal end ofconnector body 34, and is fitted aroundsheathing groove 55. -
Transition assembly 13 achieves the electrical connection of the wire conductors oflead 11 with the wire conductors ofconnector assembly 12, while maintaining electrical isolation of each conductor circuit. In the embodiment shown inFIG. 6 , the wire conductors are covered by a single layer of polytetrafluoroethylene (PTFE) insulation. It is advantageous to include insulation on each wire conductor in order to avoid electrical interference with the signal carried by each conductor withintransition assembly 13. In another, such as shown inFIG. 3B , a second PTFE coating is added to the conductors to ensure that the signal carried by each conductor does not produce noise or interference in nearby conductors, especially intransition assembly 13. The insulating layers can be added to the conductors during manufacture, such as during extruding of the wires. -
Transition assembly 13 also provides a flexible junction that maintains strong tensile strength due to the crimping mechanism of the wisdom tooth connectors. Although the connector blocks are discussed as being set at positions relative to the distal face ofconnector body 34, this is only intended to describe their approximate position. Once the connector blocks are assembled, they are free to rotate aroundcoil sheathing 82, which also aids in tension dissipation in the conductors and flexibility oftransition section 13. - In another embodiment of the invention, illustrated in
FIGS. 8 and 9 ,transition assembly 13 is fitted with spacer blocks to dissipate some of the tension produced in the conductors during handling oflead 11.FIG. 8 showsspacer block 90, which comprises a circular disk havingcentral bore 92 andperipheral channels 94A-94F. Central bore 92 allowsspacer block 90 to be fitted aroundcoil sheathing 82, in between connector blocks 22A-22C. -
Peripheral channels 94A-94F allow wire conductors travelling between connector blocks 22A-22C to be laid acrossspacer block 90.Peripheral channels 94A-94F have diameters large enough to accept insulated wire conductors.Peripheral channels 94A-94F are spaced around the circumference ofspacer block 90 sixty degrees apart (i.e. at 12, 2, 4, 6, 8 and 10 o'clock with respect to the distal face of connector body 34).Spacer block 90 provides tension relief of the wire conductors by preventingwire conductors Spacer block 90 is preferably composed of silicone rubber, but can be made of any suitable insulating and dampening material. -
FIG. 9 shows an embodiment oftransition assembly 13 provided with spacer blocks 96 and 98.Conductors connector blocks 22A-22C inFIG. 9 . Connector blocks 22A, 22B and 22C are co-axially aligned oncoil sheathing 82 ofcoil conductor 20, which has been omitted for clarity.Spacer block 96 is disposed oncoil sheathing 82 betweenconnector blocks spacer block 98 is disposed oncoil sheathing 82 betweenconnector blocks -
Wire conductor 14B extends distally in the 12 o'clock position,past connector block 22C and through a channel inspacer block 98 in the 12 o'clock position and into a wisdom tooth connecting mechanism ofconnector block 22B. -
Wire conductor 14A extends proximally in the 6 o'clock position,past connector block 22A and through a channel inspacer block 96 in the 6 o'clock position and into a wisdom tooth connecting mechanism ofconnector block 22B. Thereby,conductors connector block 22B. -
Wire conductor 16B extends distally in the 4 o'clock position and into a wisdom tooth connecting mechanism ofconnector block 22C.Wire conductor 16A extends proximally in the 10 o'clock position pastconnector block 22A, through a channel inspacer block 96 in the 10 o'clock position,past connector block 22B, through a channel inspacer block 98 in the 10 o'clock position and into a wisdom tooth connecting mechanism ofconnector block 22C in the 10 o'clock position. Thereby,conductors connector block 22C. -
Wire conductor 18B extends distally in the 8 o'clock position,past connector block 22C, through a channel inspacer block 98 in the 8 o'clock position,past connector block 22B, through a channel inspacer block 96 in the 8 o'clock position and into a wisdom tooth connecting mechanism ofconnector block 22A in the 8 o'clock position.Wire conductor 18A extends proximally in the 2 o'clock position and into a wisdom tooth connecting mechanism ofconnector block 22A in the 2 o'clock position. Thereby,conductors connector block 22A. - Spacer blocks 96 and 98 maintain a general linear shape to the conductors. Spacer blocks 96 and 98 are also comprised of a flexible or compressible material that allows
transition assembly 13 to flex during handling oflead 11. These features assist in dissipating stress created in the conductors by preventing the formation of stress points, such as bends or kinks. -
FIG. 10 shows an alternative embodiment oftransition assembly 13 in which the connector blocks are used to create a bypass configuration forconductors assembly 13 at its proximal end. Conductor 104 is conductively linked toconductor 102 atconductor block 106, and conductively linked toconductor 100 atconnector block 108. Conductor 104 extendspast connector block 106 and is then joined with a connection mechanism ofconnector block 108. Conductor 104 curves back around to extendpast connector block 108 and into a connecting mechanism ofconnector block 106.Conductor 102 extendspast connector block 108 and into a connecting mechanism ofconnector block 106, whileconductor 100 is joined with a connecting mechanism ofconnector block 108. -
Conductors conductor - Although the present invention has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention.
Claims (47)
Priority Applications (2)
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US11/343,859 US7241180B1 (en) | 2006-01-31 | 2006-01-31 | Medical electrical lead connector assembly |
PCT/US2007/060566 WO2007089974A2 (en) | 2006-01-31 | 2007-01-16 | Medical electrical lead connector assembly |
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US11/343,859 US7241180B1 (en) | 2006-01-31 | 2006-01-31 | Medical electrical lead connector assembly |
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US7241180B1 US7241180B1 (en) | 2007-07-10 |
US20070178770A1 true US20070178770A1 (en) | 2007-08-02 |
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US11/343,859 Active US7241180B1 (en) | 2006-01-31 | 2006-01-31 | Medical electrical lead connector assembly |
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WO (1) | WO2007089974A2 (en) |
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US8849415B2 (en) | 2006-07-31 | 2014-09-30 | Boston Scientific Neuromodulation Corporation | Multi-channel connector for brain stimulation system |
US8504157B2 (en) | 2008-08-12 | 2013-08-06 | Boston Scientific Neuromodulation Corporation | Retention assemblies for implantable electric stimulation systems and methods of making and using |
US8301255B2 (en) | 2008-08-12 | 2012-10-30 | Boston Scientific Neuromodulation Corporation | Retention assemblies for implantable electric stimulation systems and methods of making and using |
US20100042169A1 (en) * | 2008-08-12 | 2010-02-18 | Boston Scientific Neuromodulation Corporation | Retention assemblies for implantable electric stimulation systems and methods of making and using |
US8075346B2 (en) * | 2009-10-30 | 2011-12-13 | Medtronic, Inc. | Implantable medical device headers that facilitate device and lead configuration variants |
US20120058688A1 (en) * | 2009-10-30 | 2012-03-08 | Seeley Dale F | Implantable medical device headers that facilitate device and lead configuration variants |
US8262418B2 (en) * | 2009-10-30 | 2012-09-11 | Medtronic, Inc. | Implantable medical device headers that facilitate device and lead configuration variants |
US8523617B2 (en) * | 2009-10-30 | 2013-09-03 | Medtronic, Inc. | Implantable medical device headers that facilitate device and lead configuration variants |
US20140099833A1 (en) * | 2009-10-30 | 2014-04-10 | Medtronic, Inc. | Implantable medical device headers that facilitate device and lead configuration variants |
US20110104955A1 (en) * | 2009-10-30 | 2011-05-05 | Seeley Dale F | Implantable medical device headers that facilitate device and lead configuration variants |
US9172192B2 (en) * | 2009-10-30 | 2015-10-27 | Medtronic, Inc. | Implantable medical device headers that facilitate device and lead configuration variants |
US20170128715A1 (en) * | 2010-03-31 | 2017-05-11 | Medtronic, Inc. | Medical leads and related systems that include a lumen body that is joined to a lead body and that has multiple filar lumens |
US9808615B2 (en) * | 2010-03-31 | 2017-11-07 | Medtronic, Inc. | Medical leads and related systems that include a lumen body that is joined to a lead body and that has multiple filar lumens |
Also Published As
Publication number | Publication date |
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WO2007089974A2 (en) | 2007-08-09 |
US7241180B1 (en) | 2007-07-10 |
WO2007089974A3 (en) | 2007-11-01 |
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