JP2012011237A

Implantable addressable segmented electrode

Abstract

Problem to be solved.To provide a segmented electrode device which is implantable and addressable. An implantable and addressable segmented electrode device, a method of manufacturing the same, and a method of using the same are provided. The subject device includes segmented electrodes made from integrated circuits that are electrically connected to two or more electrodes, each electrode can be actuated individually. Also provided are implantable devices and systems, as well as kits, or components thereof, that include such devices and systems, which include segmented electrode structures. [Selection diagram] Fig. 40

JP2012011237A, drawing sheet 1 — Sheet 1 of 63

Term

Projected expiry 17 October 2031.

1 claim: 1 independent, 0 dependent

1
明細書に記載の発明。

132 paragraphs, as filed

(Citation of related application) 35 U.S. Provisional Patent Application No. 60 / 638,692 (filed December 22, 2004), US Provisional Patent Application No. 60 / 655,609 (filed February 22, 2005), in accordance with U.SC Section 119 (e), "Fatigue Resistant IC Chip US Provisional Patent Application No. 60 / entitled "Connection"Issue (filed December 15, 2005), and US Provisional Patent Application No. 60 / entitled "Fatigue Resistant Coiled IC Chip Connection"The application claims priority to the filing date of issue (filed December 20, 2005), and the disclosures of the above application are incorporated herein by reference.

Pacing leads that are implanted in the vasculature of the body are flexible cylindrical devices for many applications. Pacing leads are columnar for three main reasons. Most anatomical devices are columnar. Medical sealing devices and access devices are sealed in a cylindrical shape. The columnar leads have a uniform bending moment of inertia around the longitudinal axis of the device. The cylindrical nature of the device requires a cylindrical design of the pacing electrode in the device body.

Due to the tortuous nature of the vasculature in the body, in many devices currently in use, the direction of rotation of one electrode, following the implant, cannot be determined. As such, many reed devices in use today use a columnar electrode design that is conductive to the tissue surrounding the entire diameter of the reed. This ensures that a portion of the columnar electrode is in contact with the stimulus-sensitive tissue when implanted. Despite the use of columnar continuous ring electrodes in many devices, such structures have disadvantages, including, but not limited to, undesired irritation of non-target tissue. Including, for example, it can result in unwanted side effects, additional power usage and the like.

Segmented electrode devices that are implantable and addressable, as well as methods of their manufacture and use thereof, are provided. The subject device includes a segmented electrode structure created from an integrated circuit that is electrically coupled to two or more electrodes, each electrode can be operated separately. Also provided are not only implantable devices and systems, but also kits, or components thereof, that include such devices and systems. They include segmented electrode structures Aspects of the invention include, for example, segments of electrodes in tissues / organs to provide better current distribution and stimulate tissues / organs. In such embodiments, for example, "Methods and" the content of the disclosure is incorporated herein by reference. PCT Application No. PCT / US2005 / entitled "PLC for Tissue Activation and Monitoring"Using integrated circuits (ICs), such as the composite circuits disclosed in issue (filed September 1, 2005), in leads, segmented electrodes can be paced and detected separately. Is. The IC allows each electrode to be addressed individually, and each electrode can be operated separately or in combination with other electrodes on a medical device. In addition, the electrodes can be used in new and new combinations with composite circuit aids on ICs for pacing. Aspects of the present invention include embodiments in which the components are constructed in a manner that minimizes mechanical stress between the components, such as integrated circuits, electrodes, and / or elongated conductive members. Stress minimization is achieved by a number of different methods, such as flexible connectors, flexible electrode designs, molded integrated circuits, coiled conductive connectors, etc., as described in more detail below. Can be done. Embodiments of IC chip configurations support a fatigue-resistant design for biomedical electrodes, such as that found in cardiac pacing leads, or other permanently implantable devices, or devices used in emergencies. To do. In certain embodiments of the invention, the IC chip is connected to a pacemaker having one or more, eg, two conductive members. The advantage of this design configuration is that it reduces the number of conductors required in medical devices. Until the present invention, a large number of electrodes in a permanently implantable lead required a large number of conductors. In a reed of about 9 French diameter with a small diameter medical device (eg 4-5 French) constrained by two conductors for size and reliability, the number of separate conductors possible is It is limited to 2 to 3 at the maximum. Aspects of the invention include a segmented electrode structure that is implantable and addressable, the electrode structure being an integrated circuit and two or more individually addressable electrodes coupled to the integrated circuit. including. In certain embodiments, the integrated circuit is electrically connected to, for example, at least one elongated conductive member present in the medical carrier, where the integrated circuit is conductive to one elongated conductive member. Connected or conductively connected to two or more elongated conductive members. In certain embodiments, the integrated circuit is closer than about 20 mm, eg, about 1 mm, from the electrode. In certain embodiments, the integrated circuit comprises electrodes. In certain embodiments, the electrodes are arranged so as to surround the integrated circuit. In certain embodiments, the electrodes are substantially aligned. In certain embodiments, the electrodes are twisted and arranged. In certain embodiments, the structure comprises electrodes that are fitted alternately. In certain embodiments, the structure comprises at least two different sized electrodes. In certain embodiments, the structure comprises electrodes of approximately the same size. In certain embodiments, the structure comprises four electrodes. In certain embodiments, the structure comprises three electrodes. In certain embodiments, the structure is sized to fit within the implant. In certain embodiments, the structure is sized to fit inside the leads. In certain embodiments, each electrode is about 0.1 mm.2~ About 15mm2, For example, about 0.5 mm2~ About 10mm2Take the range of, for example, about 1.3 mm2Has a surface area of. In certain embodiments, the integrated circuits, electrodes and at least one elongated conductive member are conductively connected to each other in a manner that imparts fatigue resistance to the lead assembly, and in certain embodiments, the integrated circuits, electrodes, And at least two of the elongated conductive members are electrically connected to each other in a way that minimizes structural mechanical stress. In certain embodiments, at least two of the integrated circuits, electrodes, and elongated conductive members are electrically connected to each other by flexible conductive members. In certain embodiments, at least two of the integrated circuits, electrodes, and elongated conductive members are electrically connected to each other by a liquid member. In certain embodiments, at least two of the integrated circuits, electrodes, and elongated conductive members are electrically connected to each other by a coiled conductive member. In certain embodiments, at least two of the integrated circuits, electrodes, and elongated conductive members are electrically connected to each other by spherical conductive members. In certain embodiments, the electrodes have a curved configuration. In certain embodiments, the electrodes are flexible. In certain embodiments, the electrodes include one or more hairpin curves. In certain embodiments, the electrodes have a helical configuration. In certain embodiments, the integrated circuit comprises at least one through hole. In certain embodiments, the integrated circuit comprises at least two through holes. In certain embodiments, the integrated circuit has a non-rectangular configuration, eg, a curved configuration such as a disk shape. In certain embodiments, the integrated circuit is a sealed integrated circuit, the integrated circuit being, for example, an in vivo corrosion resistant integrated circuit holder having at least one feedthrough, at least one integrated circuit present within the holder. Circuits, including closed layers, said closed layers and holders to define a closed capacitance such that at least one integrated circuit is present. It is composed of. In certain embodiments, the structure resides, for example, in an implant, or reed, having a circular, elliptical, planar, or other shaped cross section. In certain embodiments, the reed is a cardiac pacing reed. In certain embodiments, the elongated conductive member is electrically connected to, for example, at least one control unit present within the pacemaker vessel. Aspects of the invention further include implantable medical devices, which further include at least one implantable and addressable segmented electrode structure of the invention, said electrode structure. Is present on the implant, or lead, such as a cardiovascular lead, left ventricular lead, or epicardial lead. In certain embodiments, the device is a neural device, a muscular device, a gastrointestinal device, a skeletal device, a lung device, an eye device, or an auditory device. In certain embodiments, the structure is conductively connected to at least one elongated conductive member, which conductive member is conductively connected to a control unit, eg, the control unit is a pacemaker. Present in the container. In certain embodiments, the device is a cardiovascular pacing device. Aspects of the invention use, for example, the method of implanting an implantable medical device according to the invention and the addressable segmented electrode structure of the implanted medical device, eg, electrical energy. Further includes methods of delivering to the subject. In certain embodiments, at least the first electrode is connected to the first conductive member and the second electrode is connected to the second conductive member. In certain embodiments, the method comprises not actuating at least one of the electrodes as much as actuating only one of the electrodes. In certain embodiments, the method further comprises determining which electrode is actuated. In certain embodiments, the method further comprises operating the electrodes continuously. In certain embodiments, the method comprises minimizing power consumption. In certain embodiments, it comprises activating the electrodes in a manner sufficient to not stimulate the phrenic nerve. In certain embodiments, the method comprises activating at least one of the electrodes in the structure to sense an electric potential in the subject. In certain embodiments, the method senses a conductive velocity. Aspects of the invention further include systems and kits that include segmentable and addressable segmented electrode structures according to the invention.The present invention provides, for example,:(Item 1) A segmented electrode structure that is implantable and addressable, With integrated circuits An electrode and two or more electrodes coupled to the integrated circuit, each of which can be addressed separately. Structure with.(Item 2) The implantable and addressable segmented electrode structure of item 1, wherein the integrated circuit is electrically coupled to at least one of the conductive elongated members in the medical carrier.(Item 3) The implantable and addressable segmented electrode structure of item 2, wherein the integrated circuit is electrically coupled to one conductive elongated member.(Item 4) The implantable and addressable segmented electrode structure of item 2, wherein the integrated circuit is electrically coupled to two conductive elongated members.(Item 5) The implantable and addressable segmented electrode structure of item 1, wherein the integrated circuit is closer than about 1 mm from the electrode.(Item 6) The implantable and addressable segmented electrode structure of item 1, wherein the integrated circuit is closer than about 20 mm from the electrode.(Item 7) The implantable and addressable segmented electrode structure of item 1, wherein the integrated circuit comprises the electrodes.(Item 8) The implantable and addressable segmented electrode structure of item 1, wherein the electrodes are arranged so as to surround the integrated circuit.(Item 9) The implantable and addressable segmented electrode structure according to item 8, wherein the electrodes are substantially aligned.(Item 10) The electrode is a twisted, implantable, addressable segmented electrode structure according to item 8.(Item 11) The implantable and addressable segmented electrode structure of item 1, wherein the structure comprises alternating electrodes.(Item 12) The implantable and addressable segmented electrode structure according to item 1, wherein the structure comprises at least two different sized electrodes.(Item 13) The implantable and addressable segmented electrode structure of item 1, wherein the structure comprises electrodes of approximately the same size.(Item 14) The above-mentioned structure is an implantable and addressable segmented electrode structure according to item 1, comprising four electrodes.(Item 15) The above-mentioned structure is an implantable and addressable segmented electrode structure according to item 1, comprising three electrodes.(Item 15) The implantable and addressable segmented electrode structure of item 1, wherein the structure is sized to fit within the implant.(Item 16) The implantable and addressable segmented electrode structure of item 1, wherein the structure is dimensioned to fit within the lead.(Item 17) Each electrode is about 0.1 mm2~ About 15mm2The implantable and addressable segmented electrode structure according to item 1, which has a surface area ranging from.(Item 18) Each electrode is about 0.5 mm2~ About 10mm2The implantable and addressable segmented electrode structure according to item 1, which has a surface area ranging from.(Item 19) Each electrode is about 1.3 mm2The implantable and addressable segmented electrode structure of item 1, which has a surface area that is.(Item 20) The implantable and addressable item of item 2, wherein the integrated circuit, electrodes, and at least one conductive elongated member are electrically coupled to each other in a manner that imparts fatigue resistance to the lead assembly. A segmented electrode structure.(Item 21) 20. The implant of item 20, wherein at least two of the integrated circuits, electrodes, and conductive elongated members are electrically coupled to each other in a manner that minimizes structural mechanical stress. A segmented electrode structure that is possible and addressable.(Item 22) 20. Implantable and addressable, wherein at least two of the integrated circuits, electrodes, and conductive elongated members are electrically connected to each other by a conductive flexible member. A segmented electrode structure.(Item 23) 20. Implantable and addressable segmentation according to item 20, wherein at least two of the integrated circuits, electrodes, and conductive elongated members are electrically connected to each other by a liquid member. Electrode structure.(Item 24) 20. Implantable and addressable, wherein at least two of the integrated circuits, electrodes, and conductive elongated members are electrically connected to each other by a conductive coiled member. A segmented electrode structure that is possible.(Item 25) 20. The implantable and addressable member of item 20, wherein at least two of the integrated circuits, electrodes, and conductive elongated members are electrically connected to each other by a conductive spherical member. The segmented electrode structure that is.(Item 26) The implantable and addressable segmented electrode structure of item 1, wherein the electrode has a curved configuration.(Item 27) The electrode is a flexible, implantable and addressable segmented electrode structure according to item 1.(Item 28) The implantable and addressable segmented electrode structure of item 27, wherein the electrode comprises one or more hairpin curves.(Item 29) The implantable and addressable segmented electrode structure of item 1, wherein the electrode has a helical configuration.(Item 30) The implantable and addressable segmented electrode structure of item 1, wherein the integrated circuit comprises at least one through hole.(Item 31) The implantable and addressable segmented electrode structure of item 30, wherein the integrated circuit comprises at least two through holes.(Item 32) The implantable and addressable segmented electrode structure of item 30, wherein the integrated circuit has a non-rectangular configuration.(Item 33) The integrated circuit is a segmented electrode structure that has a curvilinear configuration and is implantable and addressable according to item 32.(Item 34) The integrated circuit is a disk-shaped, implantable and addressable segmented electrode structure according to item 33.(Item 35) The integrated circuit is a sealed integrated circuit, the implantable and addressable segmented electrode structure of item 1.(Item 36) The sealed integrated circuit is With an in vivo corrosion resistant integrated circuit holder with at least one feedthrough, With at least one integrated circuit present in the holder With a sealing layer With 35. The implantable and addressable segmented electrode structure of item 35, wherein the sealing layer and holder are configured to define the sealing capacitance in which the at least one integrated circuit resides.(Item 36) The above-mentioned structure is a segmented electrode structure that is present in the implant and is implantable and addressable according to item 1.(Item 37) The above-mentioned structure is a segmented electrode structure that is present in a lead and is implantable and addressable according to item 1.(Item 38) The implantable and addressable segmented electrode structure of item 37, wherein the lead has a circular cross section.(Item 39) The implantable and addressable segmented electrode structure of item 37, wherein the lead has an elliptical cross section.(Item 40) The implantable and addressable segmented electrode structure of item 37, wherein the lead has a flat cross section.(Item 41) The reed is a cardiac pacing lead, the implantable and addressable segmented electrode structure of item 37.(Item 42) The implantable and addressable segmented electrode structure of item 2, wherein the conductive elongated member is electrically coupled to at least one control unit.(Item 43) The implantable and addressable segmented electrode structure of item 42, wherein the control unit resides in a pacemaker container.(Item 44) The implantable medical device having at least one implantable and addressable segmented electrode structure according to item 1.(Item 44) The implantable medical device of item 44, wherein the device is present within the implant.(Item 45) The implantable medical device of item 44, wherein the device is present in a lead.(Item 46) The implantable medical device according to item 45, wherein the reed is a cardiovascular reed.(Item 47) The implantable medical device according to item 45, wherein the lead is a left ventricular lead.(Item 48) The implantable medical device according to item 45, wherein the lead is an epicardial lead.(Item 49) The implantable medical device according to item 44, wherein the device is a neural device.(Item 50) The implantable medical device according to item 44, wherein the device is a muscle device.(Item 51) The implantable medical device according to item 44, wherein the device is a gastrointestinal device.(Item 52) The implantable medical device according to item 44, wherein the device is a skeletal device.(Item 53) The implantable medical device according to item 44, wherein the device is a lung device.(Item 54) The implantable medical device according to item 44, wherein the device is an eye device.(Item 55) The implantable medical device according to item 44, wherein the device is an auditory device.(Item 56) 44. The implantable medical device of item 44, wherein the structure is conductively connected to at least one conductive elongated member.(Item 57) The implantable medical device of item 56, wherein the at least one conductive member is conductively connected to the control unit.(Item 58) The implantable medical device of item 57, wherein the control unit resides in a pacemaker container.(Item 59) The implantable medical device according to item 58, wherein the device is a cardiovascular pacing device.(Item 60) Implanting an implantable medical device, described in item 44, into a subject. Using the addressable segmented electrode structure of the implanted medical device Including, methods.(Item 61) The method of item 60, wherein the use comprises activating at least one of the electrodes of the structure to transfer electrical energy to the subject.(Item 62) At least the first electrode of the plurality of electrodes is connected to the first conductive member, and the second electrode of the plurality of electrodes is connected to the second conductive member. The method according to item 61.(Item 63) The method of item 61, wherein the method comprises not activating at least one of the plurality of electrodes.(Item 64) 63. The method of item 63, wherein the method comprises activating only one of the plurality of electrodes.(Item 65) The method of item 60, wherein the method further comprises determining which of the plurality of electrodes to operate.(Item 66) The method according to item 60, wherein the method further comprises operating the plurality of electrodes in succession.(Item 67) 65. The method of item 65, wherein the method comprises minimizing power consumption.(Item 68) The method of item 60, wherein the method comprises activating the electrodes in a manner sufficient to not stimulate the phrenic nerve.(Item 69) The method of item 60, wherein the use comprises activating at least one of the plurality of electrodes of the structure to detect the potential of the subject.(Item 70) The item, in which the first electrode of at least the plurality of electrodes is connected to the first conductive member, and the second electrode of the plurality of electrodes is connected to the second conductive member. The method described in 69.(Item 71) The method of item 70, wherein the method comprises detecting a conductive velocity.(Item 72) The implantable and addressable segmented electrode structure described in item 1 and With control unit The system.(Item 73) 72. The system of item 72, wherein the structure and control unit may be electrically coupled by at least one conductive elongated member.(Item 74) The system according to item 73, wherein the structure is present in the lead.(Item 75) The system according to item 74, wherein the reed is a cardiovascular reed.(Item 76) The system according to item 72, wherein the control unit is a pacemaker container.(Item 77) The implantable and addressable segmented electrode structure described in item 1 and With control unit A kit that includes.(Item 78) The kit according to item 77, wherein the kit further includes a conductive elongated member.(Item 79) The kit according to item 78, wherein the structure is present in the lead.(Item 80) The kit according to item 79, wherein the reed is a cardiovascular reed.(Item 81) The kit according to item 77, wherein the control unit is present in a pacemaker container.

<figref num="1">FIG. 1 shows the configuration of a segmented electrode structure including four electrodes (eg, quadrant electrodes) arranged around an arranged IC according to an embodiment of the present invention.</figref><figref num="2">FIG. 2 provides a flexible shape depiction of the electrodes according to embodiments of the present invention.</figref><figref num="3">FIG. 3 provides a schematic diagram of electrode connection to an integrated circuit composed of thin and flexible members according to an embodiment of the present invention.</figref><figref num="4">FIG. 4 provides a view of a medical device according to an embodiment of the present invention, which has a non-circular cross section.</figref><figref num="5A">FIG. 5A provides a variation of the design according to an embodiment of the present invention in which two conductive members contact two electrodes.</figref><figref num="5B">FIG. 5B provides a variation of the design according to an embodiment of the present invention in which two conductive members contact two electrodes.</figref><figref num="5C">FIG. 5C provides a variation of the design according to an embodiment of the present invention in which two conductive members contact two electrodes.</figref><figref num="6">FIG. 6 provides a diagram of a flexible connection between the backside of an integrated circuit and a kind of conductive member according to an embodiment of the present invention.</figref><figref num="7">FIG. 7 shows a diagram of the completed assembly prior to being molded into the cross-sectional shape of a medical device according to an embodiment of the present invention.</figref><figref num="8">FIG. 8 shows a diagram of an integrated circuit adhered to the inner diameters of one electrode or a plurality of electrodes according to an embodiment of the present invention.</figref><figref num="9A">FIG. 9A shows various diagrams of an assembly according to an embodiment of the invention that provides details of a flexible connection from an integrated circuit to a small diameter conductive cable according to an embodiment of the invention.</figref><figref num="9B">FIG. 9B shows various diagrams of an assembly according to an embodiment of the invention that provides details of a flexible connection from an integrated circuit to a small diameter conductive cable according to an embodiment of the invention.</figref><figref num="10">FIG. 10 provides a cross-sectional view of a non-circular medical device according to an embodiment of the present invention.</figref><figref num="11">FIG. 11 provides a configuration similar to FIG. 10 with a circular cross section.</figref><figref num="12A">FIG. 12A provides various diagrams of medical device structures according to embodiments of the present invention.</figref><figref num="12B">FIG. 12B provides various diagrams of medical device structures according to embodiments of the present invention.</figref><figref num="13">FIG. 13 provides an alternative configuration for connecting flexible members according to an embodiment of the present invention.</figref><figref num="14A">FIG. 14A provides details of the connection of integrated circuits to flexible electrodes according to various embodiments of the invention.</figref><figref num="14B">FIG. 14B provides details of the connection of integrated circuits to flexible electrodes according to various embodiments of the invention.</figref><figref num="14C">FIG. 14C provides details of the connection of integrated circuits to flexible electrodes according to various embodiments of the invention.</figref><figref num="14D">FIG. 14D provides details of the connection of integrated circuits to flexible electrodes according to various embodiments of the invention.</figref><figref num="14E">FIG. 14E provides details of the connection of integrated circuits to flexible electrodes according to various embodiments of the invention.</figref><figref num="14F">FIG. 14F provides details of the connection of integrated circuits to flexible electrodes according to various embodiments of the present invention.</figref><figref num="15">FIG. 15 provides an alternative arrangement of integrated circuits within a medical device assembly according to an embodiment of the present invention.</figref><figref num="16">FIG. 16 provides a diagram of a flexible electrode assembly having a porous flexible polymeric material containing a steroid according to an embodiment of the present invention.</figref><figref num="17">FIG. 17 provides a diagram of the final assembly further including a stress sensor according to an embodiment of the present invention.</figref><figref num="18">FIG. 18 provides a cross-sectional view of the assembly of FIG.</figref><figref num="19">FIG. 19 provides a diagram of an obliquely located electrode pattern according to an embodiment of the present invention.</figref><figref num="20">FIG. 20 provides a diagram of an assembly comprising two integrated circuits according to an embodiment of the invention, in a medical device, one integrated circuit handles a high power requirement and a second circuit is a low power. Handle the request of.</figref><figref num="21">FIG. 21 provides a diagram of the shape of a flexible electrode according to an embodiment of the invention, which allows the electrode to bend on two axes.</figref><figref num="22A">FIG. 22A provides a diagram of a lead frame that supports an integrated circuit within a quadrant electrode assembly according to an embodiment of the present invention.</figref><figref num="22B">FIG. 22B provides a diagram of a lead frame that supports an integrated circuit within a quadrant electrode assembly according to an embodiment of the present invention.</figref><figref num="23A">FIG. 23A provides a simplified version of the device shown in FIG. 22, where the leads and electrodes are combined into one.</figref><figref num="23B">FIG. 23B provides a simplified version of the device shown in FIG. 22, where the leads and electrodes are combined into one.</figref><figref num="23C">FIG. 23C provides a simplified version of the device shown in FIG. 22, where the leads and electrodes are combined into one.</figref><figref num="24">FIG. 24 provides a diagram of an approach to structural assembly according to an embodiment of the present invention.</figref><figref num="25">FIG. 25 provides a diagram of an approach to structural assembly according to an embodiment of the present invention.</figref><figref num="26">FIG. 26 is a book containing a liquid conductor that makes a conductive connection between two electrical components, such as a chip, and a flexible connection between an electrode and / or a chip and one or more elongated conductors. The figure of the embodiment of the invention is shown.</figref><figref num="27A">FIG. 27A shows an IC formed in a circular shape for incorporation into a medical device according to an embodiment of the present invention.</figref><figref num="27B">FIG. 27B shows a cross-sectional view of an IC connected to an electrode according to an embodiment of the present invention.</figref><figref num="28">FIG. 28 shows an IC connected to a plurality of electrodes according to an embodiment of the present invention, for example, in a quadrant electrode configuration.</figref><figref num="29">FIG. 29 shows a coiled configuration for electrodes with electrodes connected to an IC according to an embodiment of the present invention.</figref><figref num="30">FIG. 30 describes an IC mounted on an electrode in a helical configuration supported by a polymer according to an embodiment of the present invention.</figref><figref num="31">FIG. 31 describes an IC connected to electrodes dispersed and arranged along the longitudinal direction of a medical device according to an embodiment of the present invention.</figref><figref num="32A">FIG. 32A describes an embodiment of the present invention in which the IC is connected to a metal coil by a flange on the opposite side of the chip.</figref><figref num="32B">FIG. 32B describes an embodiment of the invention in which two flanges on each side of the IC are conductively connected to a conductive coil.</figref><figref num="32C">FIG. 32C describes an embodiment of the invention in which two flanges on each side of the IC are conductively connected to a conductive coil.</figref><figref num="32D">FIG. 32D describes the metal bands underneath the flanges and coils that are present in certain embodiments of the invention.</figref><figref num="33">FIG. 33 describes a flange mounted on an IC according to an embodiment of the present invention.</figref><figref num="34">FIG. 34 describes an IC mounted on an electrode having an electrical cable passing through the IC according to an embodiment of the present invention.</figref><figref num="35">FIG. 35 describes a polymer or ceramic molded structure having Pt or Pt or other suitable material molded within the structure according to an embodiment of the invention.</figref><figref num="36A">FIG. 36A describes a flexible connection from a conductor to an IC according to an embodiment of the present invention.</figref><figref num="36B">FIG. 36B describes a flexible connection from a conductor to an IC according to an embodiment of the present invention.</figref><figref num="37">FIG. 37 provides a diagram of a mesh electrode mounted on an IC according to an embodiment of the present invention.</figref><figref num="38">FIG. 38 provides a diagram of a fiber reinforced medical device with fibers fastened along a device portion having an IC according to an embodiment of the present invention.</figref><figref num="39">FIG. 39 provides a diagram of an embodiment of the invention characterized by a tension relaxation connection between the IC chip and one or more conductors.</figref><figref num="40">FIG. 40 illustrates an overall view of a complete assembly, including spring connections, according to an embodiment of the invention.</figref><figref num="41">FIG. 41 illustrates a first subassembly of the embodiment shown in FIG. 40 having a flexible connector fitted and fitted to a conductor.</figref><figref num="42">FIG. 42 illustrates a second subassembly of the embodiment shown in FIG. 40 having a quadrant electrode molded with PEEK.</figref><figref num="43">FIG. 43 illustrates a third subassembly that introduces an integrated circuit into the assembly of FIG.</figref><figref num="44">FIG. 44 illustrates a fourth subassembly of the embodiment of FIG. 40, in which the subassembly shown in FIG. 41 is introduced into the subassembly shown in FIG. 43.</figref><figref num="45">FIG. 45 provides a description of a cardiac resynchronization treatment system, which includes one or more sealed integrated circuits coupled to lead electrodes according to embodiments of the present invention.</figref>

As summarized above, aspects of the invention include not only implantable and addressable segmented electrode devices, but also methods of manufacture and use thereof. Embodiments of the device include a segmented electrode structure consisting of integrated circuits conductively connected to two or more electrodes, each electrode being individually actuated. Also provided are devices and systems that are implantable, including segmented electrode structures, as well as devices and systems that include those devices and systems, or components. Embodiments of the present invention are particularly suitable for use in multiple reed devices. Because these embodiments may have ancillary electrodes with IC chips of various suitable dimensions and their internal connections, the conductive connections with the structure are firm and fatigue resistant. Give to the structure.

Before the invention is described in detail, it should be understood that the invention is not limited to the particular embodiments described and may be modified. It should also be understood that the terms used herein are for the sole purpose of describing a particular embodiment and are not intended to be limiting. This is because the scope of the present invention can be limited only by the claims.

When a range of values is provided, it should be understood that each value between the upper and lower bounds of the range and any other constant value or value in between. , Up to one tenth of the lower limit unit, is within the scope of the invention, unless the context explicitly states otherwise. The upper and lower limits of these smaller ranges may be individually contained within the smaller range and are within the scope of the present invention and cover any limits explicitly excluded within a certain range. If a range includes one or both of the limits, then a range that excludes either or both of the limits is also included in the invention.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art in the context of the present invention. Any method or material similar to or equivalent to that described herein may also be used in the practice or testing of the present invention, but representative and exemplary methods and materials are described herein. ..

All publications and patents cited herein are by reference herein, as if each of the individual publications or patents is expressly and individually incorporated by reference. Disclose and describe the materials and / or methods associated with the cited publications, which are incorporated and incorporated herein by reference. Any publication citation is for disclosure prior to the filing date and should not be considered as an admission that the invention loses its right to supersede such publication due to the effects of the preceding invention. In addition, the published dates provided may differ from the actual published dates and may need to be confirmed individually.

It should be noted that, as used in the specification and the appended claims, the singular "one", "one" unless the context explicitly states otherwise. And "that" is to include multiple referents. It should be further noted that the claims can be drafted to exclude any optional elements. Therefore, this statement is a pre-established criterion for the use of such restrictive terms in connection with the description of the claim element, such as "alone", "only", or the use of "negative" limitations. Intended to be used as.

Each of the individual embodiments described and illustrated herein has separate components and features, as will be apparent to those skilled in the art upon reading the present disclosure. It can be immediately separated or combined with the features of any of several other embodiments without departing from scope or spirit. Any enumerated method can be performed in the enumerated order, or any other logically conceivable order.

In the further aspects described of the present invention, implantable and addressable segmented electrodes are initially more detailed, schematic, and both with respect to the figures of a particular embodiment of the invention. Outlined. Next, embodiments of devices and systems, such as implantable medical devices and systems that include segmented electrode structures of the invention, are disclosed along with methods of using the devices and systems in different applications. Also provided is a description of a kit that incorporates aspects of the invention.

(Implantable and addressable segmented electrode structure) As summarized above, aspects of the invention include segmentable and addressable segmented electrode structures. Embodiments of the structure include integrated circuits (ICs) that are conductively connected to two or more electrodes (to provide a conductive connection). The term "integrated circuit (IC)" is used herein to refer to conductive components and tiny compounds for their connections. The tiny composites are produced in or on small slices of material, such as chips such as silicon chips. In certain embodiments, the IC is a composite circuit, eg, PCT application No. PCT / US2005 / entitled "Methods and MFP for Tissue Activation and Monitoring," whose disclosure is incorporated herein by reference.Disclosure in issue (filed September 1, 2005). In a segmented electrode structure, the number of electrodes conductively connected to the IC can be varied, and in certain embodiments, there may be more than one number, such as three or more, four or more, and so on. In the embodiment of the above, the range is 2 to about 20, for example, about 3 to about 8, for example, about 4 to about 6. Electrodes that are conductively connected to the IC but have different structures are electrically isolated from each other so that current cannot flow directly from one electrode to another. Since the structure is implantable, it can be placed in a physiological location and maintained for a period of time without substantial functional defects (even if there are functional defects). Thus, once implanted in or on the body, the structure will be at least about 2 days or more, eg at least about 1 week, at least about 4 weeks, at least about 6 months, at least about 1 year or more, at least about 5 For a period of more than a year, it does not deteriorate in terms of function as determined by the ability of the structure to actuate the electrodes. Since the electrodes of the subject segmented electrode structure are addressable, the electrodes can be actuated individually. Thus, for example, a particular structure specific without activating the other electrodes in such a way that electrical stimulation can be delivered from one or more of the electrodes in the structure, but not from all electrodes in the structure. Electrodes can be actuated, but in certain embodiments, only one electrode of the structure is actuated at any given time. As another example, the electrodes can be actuated in one way, in which the electrodes transfer the potential from nearby tissue to the electrical circuit. In some embodiments, the operation may further comprise connecting the electrodes conductively to a conductor, eg, a bus conductor, for stimulation, voltage sampling, or other purposes. In certain embodiments, the elongated conductive member is as described in International Application Publication No. 2004/052182 and U.S. Patent Application No. 10 / 734,490, the disclosure of which is incorporated herein by reference. , Is part of a composite lead.

In certain embodiments, the electrodes of the segmented electrode structure are electrically isolated from each other, may be arranged so as to surround the IC, and are conductively connected to the IC. An example of such an embodiment is shown in FIG. 1, where four separate electrodes are conductively connected to one IC and are referred to herein as quadrant electrode configurations. As can be seen in the figure, the electrodes are arranged so as to surround the central IC. In the embodiment depicted in FIG. 1, the segmented electrodes are placed around the IC to form a columnar structure, which is a number of different medical uses, as shown below. Suitable for use in devices. However, the structure may optionally have any suitable shape, such as a biased columnar, elliptical, or other shape. In certain embodiments, the electrodes of the segmented electrodes are aligned with, for example, one edge, eg, the proximal end, and the proximal ends of the electrodes are common surfaces as shown in FIG. Share. In yet another embodiment, different electrodes may be present in an offset configuration, eg, a twisted configuration as shown in FIG. What is meant by "twisted" is that at least one of the electrodes' edges does not share a common surface. In yet another embodiment, the electrodes have an arrangement in which they are fitted alternately.

In embodiments of the invention, the structure is sized to be placed within a lead, such as a cardiovascular lead, epicardial lead, left ventricular lead, or implant. By "dimming to be placed in the lead or implant", the structure has a sufficiently small size (ie, form factor) and, as a result, is placed in the lead or implant. It can be done. In certain embodiments, the sealed structure has the longest dimensions. For example, the length, width, or height ranges from about 0.05 mm to about 20 mm, for example about 0.2 mm to about 5 mm including a range of about 0.5 mm to about 2 mm. Thus, structural embodiments make it possible to actually develop miniaturized implantable medical devices for practical and reliable use over days, months and years.

In certain embodiments, the segmented electrode structure is conductively connected to at least one elongated conductor, which may or may not be present in the leads. Then it can or cannot be electrically connected to the control unit. This control unit exists, for example, in a pacemaker container. In such embodiments, the combination of segmented electrodes and elongated conductors can be referred to as lead assemblies.

Embodiments of the present invention include implantable fatigue resistant structures. In such embodiments, at least the segmented structure of the IC and electrode components, such as the IC, electrode, and conductor components of the lead assembly, impart fatigue resistance to the structure and / or the lead assembly containing the structure. By the method, they are electrically connected to each other. This fatigue tolerance can remain intact in a physiological environment, such as a biological environment in which the structure contacts blood and / or tissue (ie, damage to the connection between the structure's integrated circuits and the electrode components. , If any, practically not). Since the structure is implantable, the implantable structure, if any, will last for a long time without substantial deterioration (eg, damage to the connections as determined by the function of the segmented electrode structure). It can be placed in or on the body and function over and over. Thus, once implanted, the structure will span a period of at least about 2 days or more, eg, at least about 1 week, at least about 4 weeks, at least about 6 months, at least about 1 year or more, at least about 5 years or more, eg. The function as determined by the function of the integrated circuit in the structure and the electrodes coupled to it does not deteriorate.

Aspects of the present invention include one or more properties that impart fatigue resistance to the subject segmented electrode structure. Characteristic fatigue resistance includes, but is not limited to, conductive connections between components, such as electrodes, ICs, elongated conductive members, which connections are mechanical between connected components. Minimize stress. For example, conductive and flexible connections of a variety of different materials and / or configurations are used in certain embodiments of the invention, as described in detail below. In yet other embodiments, conductive liquid connectors of a variety of different materials and / or configurations are used to allow flexible movement between connected components, as described in detail below. provide. In yet other embodiments, unconnected conductive connectors of a variety of different materials and / or configurations, such as rigid spheres, coils / springs, etc., are used and are described in detail below. Provides a high degree of freedom of movement between connected components. In these embodiments, "untied" means that the connector is not physically inoperable in the area of the connected component, but instead maintains a conductive connection. At least in one plane, it is possible to move across the surface of the connected components.

In certain embodiments, the IC components of the structure are sealed. For example, the IC component resides in a sealed structure that includes a sealed capacity that accommodates one or more ICs. Aspects of the invention include a sealed IC, the sealed IC comprising an in vivo corrosion resistant holder having at least one conductive feedthrough and a sealed layer, the sealed layer and the holder. For example, it is configured to define a sealed capacitance in which one or more ICs are present. Such sealed structures are described in PCT Simultaneous Application No. PCT / US2005 / entitled "Implantable Hermetically Sealed Structures", the disclosure of which is incorporated herein by reference.It will be described in more detail in the issue (filed on the same day as this application).

There are many advantages of this innovation for segmented electrodes that can be addressed separately, such as quadrant electrodes. Because the distribution of electric potentials (eg, cardiac pacing pulses) can be guided, significant flexibility is provided in clinical applications. For example, by selectively activating one or more of the electrodes of the segmented structure, the current can be directed only to the tissue that needs to be stimulated, thereby being stimulated. Avoid unwanted tissue irritation. This feature brings multiple benefits. For example, in prior art methods, if the capture of the phrenic nerve by the electrodes causes diaphragmatic spasm in the patient with each discharge, the left ventricular pacing electrode is generally disabled and resynchronized in the heart. Treatment (CRT) intervention must be terminated. Careful electrode selection to control the direction of the current provided by the present invention can often avoid phrenic nerve capture, but maintain adequate levels of cardiac stimulation.

In addition, any given electrode has a small surface area and can adequately stimulate the tissue that needs to be stimulated. About 0.1mm2~ About 4.0mm2, For example, about 0.5 mm2~ About 3.0mm2Electrodes having a surface area in the range of can be used. Although the surface area is small, stimulation of the tissue that needs to be stimulated is achieved. When the segments are distributed so as to surround the pacing reed, the stimulateable tissue can be contacted regardless of the direction of rotation of the device within the vessel. When the surface area of the electrode segment is reduced, the impedance exceeds the impedance of the ring electrode of the same axis length, thereby reducing the current drain on the pacemaker, which can improve the life of the device. Experimental data from epicardial left ventricular pacing with a four-segment electrode structure show that the difference in capture threshold between the segment in contact with heart tissue and the segment not in contact with heart tissue is eight-fold. Therefore, with proper configuration of segmented electrodes, a capture threshold difference of 10-fold or greater can be achieved. The capture threshold, defined as the minimum voltage that initiates stimulation of the heart tissue, is directly proportional to the power consumption of the pacemaker.

The use of quarterly electrodes, which can be addressed separately on multiple electrode leads, in the present invention provides a number of other clinical benefits. In many cases, the invention allows patients who cannot respond using prior art devices to respond to the procedure. For example, multiple potential stimulation positions along the reed allow the selection of the most advantageous pacing in real time without requiring reed rearrangement. Synergistic use of stimuli at multiple locations is also possible (simultaneously or consecutively) without further reed relocation. Currently available techniques are difficult and often fail to relocate leads when effective stimulus placement cannot be achieved. Due to the difficulty of various structural features and the time constraints available for relocation, the results are often suboptimal and of poor quality. Further advantages include the ability to achieve good measurements of conductive velocities on different axes.

Further, in an embodiment of electrical tomography as described in US Provisional Patent Application No. 60 / 705,900 (filed August 5, 2005) entitled "Electrical Tomography", the structure of the subject is local. Tomographic measurements allow for quantification of synchrony and improved accuracy in absolute measurements where possible (eg, cardiac output, ejection fraction, etc.). In electrical tomography applications, the applied electric field is distributed in a curved line within the body. Knowing the local electric field gradient in the region of interest (eg, the cardiovascular overlap with the LV) allows the absolute determination of the local relationship between electrical and physical distances. To do.

Embodiments of segmented electrode structures may include one or more of the above or other features. Further describing the present invention, embodiments of the structure are outlined in more detail by way of drawing.

As mentioned above, FIG. 1 provides a depiction of a segmented electrode structure according to an embodiment of the present invention. The cardiac pacing electrodes of the present invention can be modified, and in certain embodiments, the area is from about 0.1 to about 4 mm.2For example, the area is 1.5mm2Can be in the range. The electrodes can be arranged to be associated with the IC in a variety of different formats, eg, surrounding the IC and / or the lead body, or the electrodes are longitudinally along the longitudinal direction of the lead body. It can be distributed and can be arranged in a pattern that extends from the connection of the IC or improves tissue contact or facilitates the measurement of local electric field gradients.

The electrode configuration around the IC according to an embodiment of the present invention is an electrode referred to herein as an embodiment of a quadrant electrode and is shown in FIG. The four electrodes 1 are distributed in a pattern that surrounds the IC. Electrode 1 is shown as a solid surface, but may have a formed tiny scaly pattern that improves the flexibility of the electrode. The IC chip 2 is hermetically sealed and provides multiple connections to the conductors in the leads (not shown). If necessary, the top cap 3 is glued to the integrated circuit. Cap 3 is a component that helps support the connection of electrodes to integrated circuits. Cap 3 may include additional circuits or sensors. In certain embodiments, the assembly is incorporated into a flexible member, eg, a polymeric material, to form the device body. The device can be circular or some other shape that is most suitable for a particular location within the body where it is intended to be deployed.

The conductive components used with the ICs just described, for example, the constituent materials of the electrodes, are mainly platinum, or platinum alloys containing 5% platinum iridium, 10% platinum iridium, or 20% platinum iridium. Can be. Additional suitable platinum alloys include, but are not limited to, 8% platinum tungsten, platinum nickel, and platinum rhodium. The alloy can also be gold tin with a tin alloy of 20% gold. An additional material for the electrodes of the present invention can be titanium. Titanium can be plated with platinum or the plastic alloys mentioned above. Corrosion resistant alloys can also be deposited by high frequency sputtering, electron beam vapor deposition, cathode arc deposition, or chemical vapor phase deposition. In addition to titanium, the base electrode material may include stainless steel, such as 316SS, or a cobalt-based superalloy, such as MP35N, or tantalum. The electrodes can also be electroplated.

Electrodes can be made from cold-worked bulk alloys. In addition, the electrodes can be largely formed from a thin film deposition process. Electrodes formed from bulk metals or bulk alloys can take advantage of the thin microstructure formed by cold working to a final thickness. The refined microstructure generally increases the yield point of the material and the useful life of the material.

The electrodes formed by the thin film treatment can be formed using the same class of materials as those described above. The electrodes can also be manufactured as a layered structure, which removes different material properties in order to optimize performance conditions. High strength metals or alloys can be deposited for optimum strength as a base layer. An additional corrosion resistant layer can be formed on top of the base layer. The final coating can be a material that enhances the electrode's ability to charge the tissue or sense electrical signals. In addition, other coatings on the electrodes may allow chemical sensing, pH measurement, stress measurement, or ultrasonic detection.

The manufacturing process from bulk metals or bulk alloys can be performed by any suitable method, eg, the method used for the manufacture of cardiovascular stents and other passive mechanical devices. Electrodes can be manufactured by laser cutting, discharge machining (EDM), photochemical etching, or by stamping, forming, or a combination of their manufacturing processes. In addition, the electrodes can be chemically etched or electropolished, thereby producing a smooth surface. A smooth surface reduces the number of potential crack initiation points and is therefore desired for fatigue resistant devices.

In addition, the electrodes can be formed by vacuum deposition of a suitable metal or alloy onto a cloth or polymer film, which cloth or polymer film can cover the outer surface of the medical device. The sputtered area can be plated with additional layers as needed. This allows the fabric to perform two functions, firstly to reinforce the leads from the applied mechanical influence, and secondly to provide a flexible substrate for the conductive electrodes. Allows you to. This configuration reduces sudden changes in flexural stiffness resulting from changes in material along the longitudinal direction. This conductive area is connected to the IC chip using a conductive and flexible member.

In the present invention, the surface of a conductive member, eg, an electrode, may differ from the bulk material. Surfaces exposed to blood flow must withstand corrosion and electrolyte corrosion that occurs in such environments. In addition, the surface must maximize charge transfer to the tissue for pacing. In certain embodiments, the surface can optimize the detection of electrical signals. The surface may also provide the ability to detect changes in species or pH.

The surface coating may contain noble metal groups, including alloys, oxides, and elements of nitrides (platinum, platinum iridium, titanium nitride, and iridium oxide). In addition, these materials can increase the minimal irregularities of the electrodes, increasing the microscopic surface area. This improves the capacitive charge transfer capability of the electrode.

In addition, the coating can be applied to the structures of the present invention to reduce electrolyte corrosion of the electrodes when pacing the outside of the water window. Electrodes in saline can experience various degradation mechanisms when electrically driven at voltages below about -0.6V or above about 0.8V. These voltages define a window of water, and outside these ranges, water is decomposed into H + or OH-. When these ions are produced, the ions either raise or lower the pH. Changes in pH can also result in deterioration of the electrode material, or material very close to the electrode.

When used for electrical pacing, changes in pH can also result in tissue deterioration. At a sufficiently high voltage, Cl-ions are produced in saline solution. These ions can form corrosive species. Another degradation mechanism is provided by the generation of H + as the current application changes. H + can be moved back and forth through thin film electrodes, resulting in mechanical destruction of the electrodes. This is observed on the Pt electrode of the thin film. For electrodes formed from Pt and Group Pt metals, the formation of destructive ionic groups is increased by the electrolyte properties of Pt. This reduces the usefulness of the material, which is very stable in saline solution by being a noble metal.

It is known that S, Ca and other selected elements and compounds can "dope" Group Pt metals used in electrolyte converters. This is usually considered a detrimental effect. In order to use Group Pt materials as electrodes, doping to develop changes in Group Pt function can be innovatively useful. Doped electrodes may continue to retain the properties of the noble metal with respect to chemical resistance, but the addition of small amounts of S or selectively other elements may reduce the electrolyte properties of Pt.

This innovation, which provides doping to the surface or body of the electrode in this way, reduces the production of H +, OH-, and Cl- ions in saline solution. The reduction of these ionic groups reduces the destructive effect of changes in the pH of saline solutions near the electrodes and their pH deviations.

S, Ca, or other doped elements are introduced at the ppm level during the deposition of thin film Pt electrodes. These elements can also be incorporated into the base alloy during melting for the production of thicker electrodes. These elements can also be deposited on the surface by their appearance in fluids.

Embodiments of the present invention include the use of flexible connectors that are conductive between different components. The conductive connectors of these embodiments are flexible and allow some degree of movement on at least one axis of rotation without breaking. Therefore, one of the components moves with respect to another component without stress being transmitted to the other component, thereby not moving the other component. Moreover, the movement of one component does not result in damage to the conductive connection with the other component. Conductive and flexible connections may be provided with a number of different connection configurations, such as, but not limited to, adhesive solid connections, non-adhesive solid connections made of flexible materials. For example, it includes ball bearing connections, spring connections, fluid connections and the like.

As mentioned above, embodiments of the present invention further include the use of electrode configurations, for example, the use of electrode configurations provides flexibility to the electrodes and minimizes mechanical stress between the electrodes and integrated circuits. To do. The electrode design configuration of interest includes, but is not limited to, curved electrodes, bent electrodes, segmented electrodes, spiral electrodes, and the like.

Embodiments of the present invention further include the use of molded ICs, these molded chips having a non-rectangular configuration, eg, a curved configuration, eg, a disc-shaped configuration. Aspects of these embodiments include the presence of one or more holes in the center of the chip, for example, the chip provides a throughway to a conductive member. Aspects of these embodiments further include electrodes that are directly adhered to the edges of the chip.

One depiction of the flexible shape for the electrodes is shown in FIG. 2, where the electrodes 21 have, for example, a bent configuration consisting of multiple hairpin curves. Such flexible hairpin curves containing electrodes can be manufactured in a number of different ways. For example, the electrodes of these embodiments can be produced by having a slot cut at the parent electrode, either via laser cutting, EMD, or chemical etching into the shape. In addition, thin film electrodes can have this shape as defined by photolithography, and the electrodes are formed by plating or vapor deposition. One advantage of electrodes of this shape is that they reduce the flexion stress (EI) of this rigid member. Second, the greater flexibility of the electrodes reduces the stress applied to the IC inside the medical device. It also allows the entire device to be more flexible by reducing the tissue damage caused by repeated contact with the rigid device.

An additional advantage of the design of the invention over the preceding design is that the flexible electrode can provide a path through the electrode, thereby allowing the drug (ie, drug) to, for example, a delivery medium under the electrode, eg. , Can be placed in the depot, for example, thereby allowing the drug to seep out.

A drug delivery medium, eg, a drug that can be present in a depot integrated with an electrode, can be, for example, a therapeutic agent that can be non-ionic, essentially anionic, and / or cation. Including, but not limited to them. Exemplary non-genetic therapeutic agents for use in connection with the present invention are: (a) antithrombotic agents such as heparin, heparin derivatives, urokinases, and PPacks (dextrophenylalanine-proline-arginine). -Chloromethylketone), (b) Anti-inflammatory agents such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine, (c) antitumor / antiproliferative / anti-constrictor pupil agents, such as paclitaxel, 5-Fluorofracil, cisplatin, vinblastin, vincristin, epotiron, endostatin, angirostatin, angiopeptin, monoclonal antibodies capable of interfering with smooth muscle cell growth, and thymidine kinase inhibitors, (d) Anesthetics such as lidocaine, buvivacaine, ropivakine, (e) anti-blood clotting agents such as D-Phe-Pro-Arg chloromethylketone, RGD peptide-containing compounds, heparin, hirudin, antitrobin compounds, platelet receptors Antagonists, antithrombin antibodies, antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and tick antiplatelet peptides, (f) vascular cell growth reaction promoters such as growth factors, transcriptional activators , And translational promoters, (g) vascular cell growth inhibitors, such as growth factor inhibitors, growth factor receptor antagonists, transcriptional inhibitors, translational inhibitors, replication inhibitors, inhibitors, antibodies to growth factors, Bifunctional molecules consisting of growth factors and cytotoxins, bifunctional molecules consisting of antibodies and cytotoxins, (h) protein kinases and tyrosine kinase inhibitors (eg, tyrphostin, genistein, quinoxalin), (i) prostacycline analogs, (i) j) cholesterol inhibitors, (k) angiopoetins, (l) antibacterial agents such as triclosan, cephalosporin, a Minoglycosides and nitrofrantoins, (m) cytotoxins, cell growth inhibitors, and cell growth influencing factors, (n) vasodilators, (o) agents that interfere with internal vasoactive mechanisms, (p) Includes leukocyte growth inhibitors such as monoclonal antibodies, (q) cytokines, and (r) hormones. In certain embodiments, the agent of interest is an anti-inflammatory agent, such as a co-sugar corticosteroid, such as dexamethasone.

In certain embodiments, the agent is present in a polymer matrix near the electrodes. For example, the drug is placed below the electrodes in the polymer matrix or overlying the electrodes in the polymer matrix. In certain cases of these embodiments, the agents of interest are antithrombotic agents such as heparin, heparin derivatives, urokinase, and PPack (dextrophenylalanine-proline-arginine-chloromethylketone). In certain embodiments, the agents of interest are anti-inflammatory agents such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine. In certain embodiments, the agent of interest is an antitumor / antiproliferative / anti-constrictor pupil agent such as paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, eposylone, endostatin, anguillotatin, angiopeptin, smooth. Monoclonal antibodies and thymidine kinase inhibitors that are capable of interfering with the proliferation of various muscle cells. In certain embodiments, the agent of interest is an anesthetic, such as lidocaine, buvivacaine, ropivacaine. In certain embodiments, the agent of interest is an anticoagulant, such as D-Phe-Pro-Arg chloromethylketone, RGD peptide-containing compound, heparin, hirudin, antithrombin compound, platelet receptor antagonist, Antithrombin antibody, antiplatelet receptor antibody, aspirin, prostaglandin inhibitor, platelet inhibitor, and tick antiplatelet peptide. In certain embodiments, the agents of interest are vascular cell growth reaction promoters, such as growth factors, transcriptional activators, and translational promoters. In certain embodiments, the agents of interest are against vascular cell growth inhibitors, such as growth factor inhibitors, growth factor receptor antagonists, transcriptional inhibitors, translational inhibitors, replication inhibitors, inhibitory antibodies, growth factors. It is a bifunctional molecule consisting of an antibody, a growth factor and a cytotoxin, and a bifunctional molecule consisting of an antibody and a cytotoxin. In certain embodiments, the drug of interest is a professional TEIN kinase and tyrosine kinase inhibitors (eg, tylhostin, genistein, quinoxaline). In certain embodiments, the agent of interest is a prostacyclin analog. In certain embodiments, the agent of interest is a cholesterol-lowering agent. In certain embodiments, the drug of interest is anciopoetin. In certain embodiments, the agents of interest are antibacterial agents such as triclosan, cephalosporins, aminoglycosides, and nitrofurantoins. In certain embodiments, the agents of interest are cytotoxic agents, cell growth inhibitors, and cell growth influencing factors. In certain embodiments, the agent of interest is a vasodilator. In certain embodiments, the agent of interest is an agent that interferes with the internal vasoactive mechanism. In certain embodiments, the agent of interest is a leukocyte proliferation inhibitor, eg, a monoclonal antibody. In certain embodiments, the agent of interest is a cytokine. In certain embodiments, the drug of interest is a hormone. In certain embodiments, the agent of interest is a co-sugar corticosteroid, such as dexamethasone. Is. In certain embodiments, the agent of interest is a cytokine. In certain embodiments, the drug of interest is a hormone. In certain embodiments, the agent of interest is a co-sugar corticosteroid, such as dexamethasone. Is. In certain embodiments, the agent of interest is a cytokine. In certain embodiments, the drug of interest is a hormone. In certain embodiments, the agent of interest is a co-sugar corticosteroid, such as dexamethasone.

The agent can be present in any suitable delivery medium, eg, in a structure, eg, in a delivery medium that can be placed in the vicinity of one or more electrodes. Structures of interest include, but are not limited to, the drug delivery structure disclosed in US Pat. No. 4,506,680, the disclosure of which is incorporated herein by reference.

Steroids are used to lower the pacing threshold. The electrode configuration provided in FIG. 2 provides the ability to place the steroid exactly where the electrode is located. This is not possible with solid electrodes. Steroids can be present in any suitable depot composition. In FIG. 2, the molded (eg, including hairpin curve) electrode 21 is glued to the IC 22 via the connection 24. A flexible connection 23 is also shown to provide a conductive and flexible connection to an elongated conductive member.

FIG. 3 shows a twisted arrangement of electrodes 21 surrounding the IC 22 and a flexible connection 23 for making a conductive connection to an elongated conductor. Figure 3 shows four electrodes, but can be any number of electrodes, either one to four or more, and is limited only to the number of connections available on the chip or appendage. Will be done. The size of the electrodes can be varied and, in certain embodiments, is approximately 1.5 mm.2The range is 0.1 mm2~ About 4mm2Can be in the range. This sizing is generally based on the expected clinical use of a particular electrode and the position of the electrode in a medical device. As shown in FIG. 3, the connection of the electrode to the chip is a thin, flexible member that reduces the amount of stress applied to the chip. In certain embodiments, the thin connector has the longest cross-sectional dimension, which ranges from about 0.025 mm to about 2.5 mm, eg, about 0.075 mm to about 0.25 mm. What is meant by flexibility is that the connector can be bent around a rod with a diameter of 4 mm without breaking at least a quarter. The figure shows a linear element, but the shape of the element may include bending, and bending to avoid conductors in the medical device. Bending and bending can also improve the useful life of the device by increasing the deformations that can be applied and reducing the stress on the member without resulting in plastic deformation or crack growth. The figure shows a device assembly that has been molded into a cylinder or other shape and has not been adapted to the cross section of the medical device in which the structure is placed.

The flexible connecting member may have a number of configurations, and the connecting member may be molded to extend out of the IC. These designs can be both bulk electrode designs with electrodes having a material thickness of about 75 μm and thin film electrode designs with conductor thicknesses from about 10 μm to about 300 μm. Electrodes can also have polymer support of poirmid (thin film treatment) or PEEK (thermoforming). Polymeric materials can also be cut or molded into openings, increasing the flexibility of medical devices. The two main invention designs for electrodes are either bulk materials or thin film materials. Bulk material versions typically have a material thickness of about 75 μm, which can range from about 10 μm to about 300 μm, depending on special needs. The thin film version of the electrode can have a thickness of about 0.1 μm to about 100 μm, depending on the particular manufacturing method and design requirements.

The connection between the electrodes of the present invention and the IC can be made using a conductive polymer material, the polymer material being added with a material that may be conductive, a conductive filler, or a doping agent. Can have a variety of different configurations, such as spheres, rods, ingots, or irregular shapes, and can be formed from a variety of different materials, such as both pure metals and alloys, carbon, and the like. Specific conductive materials of interest include, for example, nickel spheres having a size range of about 5 μm and coated with gold, silver, or platinum, carbon fiber, or carbon nanotubes, etc. Not limited.

The electrodes of the present invention can be connected to an IC using suitable solder, such as precious metal solder, Pt-Sn, Pt-Ge, or Au-Sn, 20% gold tin, and gold silicon are suitable. Two examples of common solder, which can provide a conductive connection between an electrode and a chip. This joining method covers a large surface area of the IC chip. Advantages of this design include helping the large surface area disperse stress across the chip, and additional sealant for electronics under the connection area. In certain embodiments, the solder and electrodes connected in the connection area have similar electrochemical properties and reduce corrosion, such as galvanic electrical induction corrosion. Further, the mounting method of the present invention may include wire bonding and riveting, and chip bonding, in which the electrodes and tips are confined to the assembly. These mounting methods can be performed in both the thin film design version and the bulk electrode design version. In certain embodiments, the chip interface connections are wide and distribute stress over a wide area, eg, at least about 0.25 mm wide, for example at least about 1.25 mm wide. A large number of conductors can be present for each electrode, providing redundancy.

An additional configuration of the flexible member 44 connecting the curved flat electrode 41 to the IC 42 is shown in FIG. The stress applied to the IC is reduced, for example, by using materials and / or configurations as described above to increase the amount of elastic twist that the member can withstand. In FIG. 4, the fatigue resistant IC / electrode structure resides within the lead body 45, with the outside of the curved surface of the electrode 41 conforming to the configuration of the lead body.

FIG. 5A shows a variation of the design with two electrodes of the IC chip / electrode structure 50 having two conductive members 54 in contact with each electrode 51. Also represented is a flexible connection 53 for conductively bonding the structure to, for example, an elongated conductor. The conductive and flexible member 54 connects the electrode 51 to the IC chip 52. FIG. 5B shows the design of two conductor 54 electrodes 51 having bends 55 formed in a conductive member 54, the bends 55 acting to increase the flexibility of the member. FIG. 5C shows a variation of the curved pattern or bend 56 that provides flexibility in one direction. Other variations of the curvature or shape of the conductive member 54 as used in the field of stent design can be used.

FIG. 6 shows a flexible connection between the back side of an IC chip and a foam that is soldered, welded, or crimped onto a conductive member. The metal foam 61 extends from only one side of the assembly, reducing the likelihood that tensile strength will be transmitted through the assembly. The foam is metallurgically glued onto the bottom of the IC62. FIG. 7 shows the completed assembly 70 before being molded into the cross-sectional shape of the medical device. A flexible electrode 71, a flexible connection 72 to a conductive member, and a conductive multifilament coil having a diameter of, for example, about 0.25 to 1.25 mm, for example, about 0.5 to about 1 mm, and a diameter. A flexible connection 73 to another conductive member, such as a filler, which is about 0.01 to about 0.1, eg, about 0.05 to about 0.1 mm, is shown. The IC74 allows multiple connections to the electrodes. Polymer material 75 is an insert that is molded or thermoformed from the IC across the electrode connection, PEEK, PEKK, Ultem, or FEP.

FIG. 8 shows an IC 81 bonded to the inner diameters of an electrode or a plurality of electrodes 82. The connection can be of any type, eg, gold tin solder bonding, or, for example, other methods as described above. The segmented electrode 82 is conductively connected to the IC. The flexible member 83 is connected, for example, to a multifilament coil 84 as described in FIG. 7, which provides a conductive connection to, for example, a control unit present in a pacemaker vessel. Includes elongated conductive members. Also shown, material 85 is a partially or completely confined IC chip 81, eg, a sealed IC chip, the material being a polymer or other type of confining material. obtain. The second conductive member 86 is joined to the IC chip.

9A and 9B show details of the flexible connection 94 from the IC chip 91 to, for example, a small diameter conductive cable 92 represented as a standard cable. Multifilament cable 93 is also shown. The connection to the IC chip is not shown in these two figures. FIG. 9B shows a cross-sectional view of a conductive flexible member connecting the IC to the conductive cable 92. These conductive and flexible members 94 can be manufactured by the same method as the electrode manufacturing method described above with respect to the electrodes. Electrodes are not shown in these figures.

FIG. 10 shows a cross section 100A of a medical device according to an embodiment of the present invention, which is not circular. The electrodes are distributed on one or more long shafts. The configurations of the present invention are designed to be guided and implanted in the space between the epicardium and the pericardium for more than one tissue, eg, a cardiac application. This configuration can also be used to pace and sense the stomach. The medical device body 101A can be made from any suitable material, such as extruded silicone, or urethane. The multifilament coil conductor 102A is as described above. The coil provides a guide wire, or stylet path, to guide the device when it is implanted. The conductive and flexible member 103A connects the coil 102A to the electrode 104A or the IC chip 105A. In this figure, the electrode 104A has a portion formed by a method of capturing the IC chip 105A. The second conductor 106A is generally, for example, a standard conductive cable as described above. This design can be used with multiple IC chips, or alternative, this design can be used with a hard wire configuration with one or more electrodes.

FIG. 11 is similar to FIG. 10, but shows a configuration in which the cross section is circular. The medical device body 111A can be made from any suitable material, such as extruded silicone, or urethane. The multifilament coil conductor 112A has been described earlier. Coil 112A provides a guide wire, or stylet path, to guide the device when it is implanted. The conductive and flexible member 113A connects the coil to the electrode 114A or the IC chip 115A. In this figure, the electrode 114A has a portion formed by a method of capturing the IC chip 115A. The second conductor 116A is generally, for example, a standard conductive cable as described above. This design can be used with multiple IC chips, or alternative, this design can be used with a hard wire configuration with one or more electrodes.

FIG. 12A shows a cross section of the medical device 120 according to an embodiment of the present invention. The IC chip 121 and the medical device body 122 described above are shown. The electrode 123 is formed into, for example, a flexible pattern as described above with reference to FIGS. 5A-5C. The multifilament cable conductor 124 is also represented. Item 125 is a confinement material, such as a polymeric material, such as PEEK, PEKK, or FEP, which is a molded or thermoformed insert from the electrode to the tip and the conductor connecting element. Is. The polymeric material 126 is, for example, PEEK, PEKK, or FEP molded onto a flexible electrode. In addition, the polymeric material 126 is molded to provide flexibility with cuts or holes. The holes and cuts in the polymer material 126 provide a position for the polymer body of the device to flow between the molds. This provides additional structural integration for medical devices. The electrodes are molded into the shape of the cross section of the medical device. The electrodes are further molded or molded so that the edges are inside the body of the medical device. This detailed design provides a reduction in the stress caused by flexion, among other benefits. This is because the diameters of these rigid elements 123 and 126 determine flexion stress. A further advantage of using a flexible design for the electrodes is that it disperses stress and relieves stress at the edges of the IC chip. The electrodes are arranged so that they overlap the edges of the IC chip inside the medical device. This configuration provides a smooth transition of flexion stress along the longitudinal direction of the design and, when implanted in the body, achieves a long service life. The configuration of embodiments of the present invention also aids in the removal of medical devices after implantation. These medical devices can be implanted for more than 10 years. Within 3-6 months after implant, hard tissue capsules form around the device Will be done. If the device fails to be removed or needs to be removed, the current practice is to tunnel down the device with a hollow cutting catheter. Sharp edges, or crevices, cause obstruction to the edges of the cutting catheter. The failure of the amputated catheter to extract the reed requires the patient to have the medical device removed in open surgery. FIG. 12B shows area 127 under the electrode, which contains a steroid, eg, dexamethasone, in a depot configuration with an initial dose of, eg, about 0.5-1.0 mg. When the medical device is assembled, the drug, eg, a steroid, is incorporated into a depot, eg, a flexible polymeric material. Alternatively, the steroid is infiltrated into a porous polymeric material, such as PTFE, or open cells. Steroids can leach out where the electrodes are, reducing the pacing threshold.

FIG. 13 shows an alternative configuration for connecting the flexible member 138 to the flexible electrode 131. The flexible member 138 is joined to the IC chip 133, for example, as described above. The member is shaped to aid in a metallurgical connection with the electrode. The members can be joined by welding, laser welding, or, for example, soldering with precious metal solder. The welding zone 139 is formed between the flexible member 138 and the flexible electrode 133. The main body of the medical device 132 is as described above. The conductive and flexible member 135 joins the IC chip item 133 to the conductive multifilament conductor coil 134. The conductive and flexible member 136 connects the twisted conductor cable 137 to the IC chip 133.

FIGS. 14A-14F provide depictions of various different types of connections that can be formed between the electrodes and the IC chip. FIG. 14A shows the details of the connection of the IC chip 141 to the flexible electrode 142. Precious metal solders 143, Pt-Sn, Pt-Ge can be 20% gold plated, gold silicon, or pure gold. The mounting is done at the melting temperature of the solder or at a lower temperature when sound energy and / or stress is further applied. Metallurgical adhesion is performed on a flat pattern of electrodes and the device is molded into the shape of a cross section of a medical device.

FIG. 14B shows the details of the connection of the IC chip 141 to the flexible electrode 142. The conductive polymer material 143 is generally silicone filled with a conductive material. The conductive material can be one described above, eg, a 5 μm diameter Ni sphere with a silver, gold, or Pt coating. In addition, silicon may include carbon fibers, or carbon nanotubes. The conductive material can also be a ferrofluid, or a conductive gel or fluid. The electrodes can provide pockets, or chemically etched spaces, and contain a conductive and flexible material. This configuration is a conductive connection between the IC chip and the electrodes, allowing a connection that does not transmit mechanical forces, such as tension, to the adhesive pads on the surface of the IC chip.

FIG. 14C shows the configuration described in FIG. 14A. In addition, the padding to the electrodes is supported by the polymeric material 144. This material functions to support the assembly and reduce the force transmitted to the adhesive pad / electrode connection. This item can be applied to a number of contact variations. The polymeric material can be PEEK, Ultem, or FEP. These particular polymers can be thermoformed or inserts molded to fill small gaps in the assembly. These materials have been shown to be biocompatible and suitable for implant applications.

FIG. 14D shows a flexible electrode 145 of a thin film bonded to the IC chip 141 with gold-plated solder 143 or a conductive polymer. FIG. 14E shows the contact between the IC chip 141 and the electrode 142 using the spherical conductive member 146. Spherical members can be made from any suitable material, such as platinum, or nickel, or glass with a platinum or gold coating. The spherical connection depicted in this figure represents an embodiment of a connector that is not bonded to at least one of the electrodes and the IC chip, in which way these elements move relative to each other with greater degrees of freedom. To do. The spherical contact member is housed using a micromachine feature formed on the electrode 142. The components can also be housed with features molded into the IC chip by methods commonly used in the manufacture of MEMS devices. The spherical contact member can also be a conductive, eg, gold bump, metallurgically bonded to the IC chip. The simplest configuration of this contact method is the configuration of a spherical contact surface with the electrode that contacts the IC chip adhesive pad. For all design variations, reactive forces can be applied to maintain contact between the IC chip and the electrodes. The assembly can also be overmolded using a polymeric material, as described in Figure 14C. FIG. 14F shows the contact variations described in FIG. 14E. The contacts are formed on both sides of the IC chip.

FIG. 15 shows an alternative array of IC 141 inside the medical device assembly 150. The connection between the IC and the electrode 153 is made using a conductive and flexible member 154. The structure of these members has already been described. The conductive multifilament coil 152 is shown sized. The entire assembly is an insert molded into the medical device with flexible polymeric material 155.

FIG. 16 shows an embodiment of a flexible electrode assembly 160, wherein the electrode assembly 160 comprises a porous flexible polymer material 161 covering the electrodes, the porous flexible material comprising a drug in the pores of the material. , For example, steroids, or other agents. After the implant, the steroid leaches out of the material by itself, reducing the pacing threshold. IC chip 162 is also shown. The polymer capsule 163 encloses the electrode in the IC chip junction. The conductive and flexible member 164 connects the IC chip to the electrode. A flexible electrode 165 is shown along with a polymeric material 166 that backs up the electrode 165.

An additional connection method between the electrodes used in a particular embodiment is a ply-like flexible high-strength wire or cable. With respect to the connection to the conductor between the appendage and the chip, one or more conductors may function with a ply-like wire that can be soldered to the chip in the manner described for the electrode. They can relieve stress and then be wrapped around the conductor, soldered, and / or molded to be metallurgically joined using a process similar to laser welding.

FIG. 17 shows the final assembly depicting the IC171, stress sensor 173, and electrode 172. The electrode 172 is connected to the IC 171 and the stress sensor 173. The connection between the electrode and the chip can be made by soldering, ACF (anisotropic conductive film), or TAB. The general size is about 1 mm to about 3 mm.

FIG. 18 shows a cross section of an assembly 180 including an IC181, a stress sensor 183, and an electrode 182 connected to the IC181 and the stress sensor 183. A stress sensor cavity 184 for sensing stress is also provided. Item 186 acts as a spacer (bottom) and adhesive material (top). Item 186 controls the final bond gap between the IC 181 and the stress sensor 183. This gap is larger than the thickness of the electrode in certain embodiments. Solder 187 can be an alternative, ACF, or thermoformed bond. The bottom filling material 185 secures the final assembly.

FIG. 19 shows an electrode pattern located at an angle according to an embodiment of the present invention. In FIG. 19, structure 190 includes a flexible electrode 191 containing a hairpin that is electrically connected to the integrated circuit 192 by a flexible connector 194. Flexible connector 193 is also shown. As can be seen in the figure, the electrodes 191 are configured to be positioned at an angle to each other.

FIG. 20 shows a cross section of an embodiment of assembly 200, where assembly 200 includes two ICs 201 and 202, one IC 201 handles a high power requirement for a medical device, and a second IC 202 is medical. Handles low power demands of devices for. The functions are separated due to the different processing requirements of each IC circuit. The conductor cable 203 is connected to the first IC using the flexible conductor 206. The plurality of twisted conductor coils 204 are connected to the second IC by using a conductive flexible member 207. FIG. 21 shows details regarding the shape of the flexible electrode 210 according to the embodiment of the present invention, and the shape of the electrode 210 can be characterized as a stacked serpentine shape. This shape allows the electrode to bend on two axes.

Additional embodiments of the present invention that provide a particular benefit are depicted in FIGS. 22-25. The embodiments disclosed in these figures can be manufactured using procedures that significantly reduce the amount of processing, thereby reducing the physical risk to the IC chip as compared to other manufacturing methods. As a result, the scrap rate also drops.

The fatigue resistant IC chip connections of these embodiments enjoy a number of unique advantages. All devices are simply and expected to be assembled, eliminating waste, reducing production costs and enabling mass production. The device is well suited for robotic automation rather than the laborious manual labor commonly required for such devices. Assembly time is reduced in both robotic and manual embodiments of the present invention. Also, since the final structure is a "piece", potential material fatigue failures are minimized or eliminated.

The curved, somewhat flexible and sturdy attachment of the tip to the electrode allows for long-lasting device implants, the properties of which are shared with other embodiments of the invention. In one embodiment of the invention, the mounting "wire" is diagonally mounted, easily bent, and a sturdy final assembly results as outlined below in more detail. In one embodiment shown in these figures, a very miniaturized IC chip is soldered together from a small piece. This assembly is then processed in an oven and soldered. After this process, the device is welded, the lead frame is attached to the electrodes, and the power supply is connected to the other side of the chip. The assembly features a lead frame, IC chip, and power wire and is inserted into an internal electrode pre-molded into the PEEK ring. The resulting intermediate assembly at the edges is then welded to the electrodes at the ends of the assembly. The outer ring comes off and the assembly is complete. See Figures 22A and 22B. In the second embodiment, the step of mounting the lead frame on the electrodes is omitted, as described in detail below and shown in FIGS. 23A-23C. In this embodiment, the structures are joined to eliminate many assembly and reliability difficulties inherent in the use of welding.

The bending operation of this further developed embodiment is easier and more reliable than the joining operation in terms of conductivity and arrangement. The results are more consistent and reliable in the final assembly. Low resistance for good current transfer, and basically good communication from the chip to the body, are also advantages of this embodiment. An aspect of the fatigue-tolerant IC chip connection assembly method of the present invention in these embodiments is that the connection accesses or connects the IC chip very quickly. The method also provides the output of the chip to the body, or the chip to access or connect to the package very quickly, or to access the circuit or other device very quickly before going to the body. , Or provide a connection. The present invention allows the means to reach the body from a short path and chip with a minimum of assembly steps.

22A and 22B provide schematics of an embodiment of the present invention. The lead frame 221 supports the IC chip 223 within the quadrant electrode assembly 224. The lead frame 221 is mounted on the four electrodes 224. Element 227 is a bent and flexible connection between electrode 224 and IC 223. The mounting point 225 between the lead frame 221 and the quadrant electrode assembly 224 is composed of two weldable materials, which allow the frame to fit into the notches provided in the four electrodes 224. After that, it is welded. In one embodiment of the invention, the method of welding materials together is laser welding, which provides a good level of accuracy and predictability. However, stitching, or resistance welding, and soldering, or ultrasonic welding are suitable methods of providing adhesion. The choice of the appropriate bonding method follows the characteristics of the structure of the invention, taking into account the stability by which the device can optimize the results. Whatever bonding method is selected, when power is applied, the outer ring substructure 222 falls off the main assembly. The purpose of the outer ring substructure 222 to this point is to maintain an array of various structures of the lead frame 221 and the four electrodes 224. When the outer ring structure 222 comes off and falls, the lead frame 221 and the four electrodes can be electrically connected.

23A-23C provide a simplified embodiment of the invention in comparison with that shown in FIG. In FIG. 23A, the lead frame of FIG. 22 and the four electrodes 224 are integrated into one piece via the leg 237. The manufacturing process for manufacturing the structure shown in FIG. 23A is simply accomplished by bending the electrodes with relief 239. The sacrifice bar 231 supports the IC chip before the assembly is fully assembled. The sacrifice bar 231 maintains assembly stability during the tip mounting step.

The assembly process of the embodiment of the invention in FIG. 23A allows all devices to be on one plane until the final stage of manufacturing as shown in FIG. 23B. The final manufacturing step is when all four electrodes 233 are first bent at the junction (ie, relief) 239. The junction 239 can be provided with a triangular relief cutout, providing a smooth, unbreakable connection to the four electrodes 233. The final stage of the mold is shown in FIG. 23C, where the four electrodes 233 are each bent around the longitudinal axis to match the curvature of the lead body.

24 and 25 show different approaches to assembly. In this model, the IC chip fits into a rectangular notch 247. A conductive via 249 extends out of the rectangular notch 247 and conveys a signal out of the IC chip. This embodiment of the present invention provides a method of sealing an IC chip and at the same time providing an attachment. The IC chip in the cylinder contacts the pad and forms a connection to the via 249. The structure includes the PEEK body 245. PEEK is a material with a high melting point that allows soldering and other manufacturing procedures. The rectangular notch 247 stabilizes the tip. Four conductive vias 249 are provided, the vias can be wires. In FIG. 24, four conductive vias 249 are provided. Embodiments of this design provide a method of sealing an IC chip and providing an attachment in one step. The contact pad is provided on an IC chip that is lined up in a semi-cylindrical piece. This assembly provides a simple way to manufacture the device of the invention. When PEEK is melted, PEEK has very good adhesive properties and is utilized in one embodiment of the present invention. During production, PEEK is melted into platinum electrode 243. The two halves of the assembly are each semi-cylindrical and are configured as subassemblies.

The IC chip 241 is arranged in the rectangular notch 247. Raised floss is provided for ultrasonic welding approaches. The sacrificial material 242 provides a good seal that does not allow fluid to enter when the two halves are lined up and sometimes welded. This approach is useful for accelerating the assembly process. This is because the subassembly can be molded to have vias and leads 249.

The IC chip is placed in a rectangular notch 247 in half of the columnar substructure that can be placed over the top of the complete assembly. Two side-by-side halves are held in a clamshell type facility to secure the two halves. Ultrasonic energy is applied to melt the plastic.

The sacrificial material 242 is designed to be sacrificed. That is, these pieces are designed to melt. Alternatively, the sacrificial material 242 may be placed so as to completely surround the rectangular notch 247, or it may be placed inside the rectangular notch 247. As a result, the edges of the entire structure are sealed to provide maximum airtightness.

Alternatively, an opening may be provided. In some parts of the structure, the advantage of having an opening is where it passes through the power reed to the chip, as can be described. In this case, it is possible to confine the entire final structure in order to provide stronger airtightness. In the final stage of assembly, the wires are passed through these vias 248 in FIG. 24. At this stage, the various components can be laser welded or resistance welded in place. The end of 249 falls. Guidewire cavity 246 is shown pointing towards the final device.

The fatigue-resistant IC chip connection and assembly methods of these and other embodiments described herein allow for practically reproducible production of IC chip packages and mounting designs. It makes the required dimensions uniquely measurable for a number of medical device applications, including, but not limited to, intracardiac and intraocular devices, such as those outlined below. The present invention provides an all-medical device having a dose to be measured relative to the size of currently available chip packages only. The unique miniaturization of this rugged quality device provides clinicians with unexpected applications of medical devices in diagnostic and therapeutic equipment.

The structure and assembly method of the present invention provides a means of reaching the body from the chip using the shortest possible path. An important aspect of the fatigue resistant IC connection assembly method of the present invention provides very quick access or connection to the IC chip. It also provides the output of the chip to access or connect to the body very quickly, or the chip to the package, or to access the circuit or other device very quickly before going to the body. Or provide to connect. Through these multiple improved segments of all devices, the present invention enables a means of reaching the body from the chip using the shortest possible path.

In certain embodiments, a conductive and flexible connection is provided by a liquid conductive connector that provides a liquid conductivity between the IC and the electrode component, eg, as shown in FIG. Provide a connection. In FIG. 26, the IC 261 is conductively connected to the flexible conductor 263 by a liquid conductor 262 present within the cap structure 264. This conductor can act to relieve mechanical tension between the two components, ensuring that a conductive connection is maintained regardless of the relative position of the components. Conductive connections stress during the relative movement of components during bending of surrounding package or electrical components, as conductors are liquids that cannot support shear loads. I can't. Embodiments of the liquid conductors of the present invention can be made in a number of different shapes. Another embodiment of the invention provides a conductive wax having a glass transition temperature just below body temperature, such that it can be used to bond two electrode components during assembly. After the implant, the conductive wax melts and becomes the electrical connection of the liquid. Similarly, a conductive liquid having a melting point below body temperature can be used. The wax can be a low melting point wax containing a shock absorber of conductive nanoparticles such as metal spheres or carbon nanotubes. In additional embodiments, low viscosity conductive hydrogels can be used. The gel can be trapped so that it does not dry during storage or use. In certain embodiments, brackets can be used to further secure the liquid conductor to the surface of the IC.

In certain embodiments, standard conductive adhesives are used, where the conductive adhesive is a conductive member with a high aspect ratio, such as a carbon nanotube, which member is a suitable flexible carrier. It is present in materials such as silicone rubber. Both components are biocompatible and carbon nanotubes can promote or interfere with the absorption of proteins on the carbon structure and alter the human body's response to carbon nanotubes. The importance of using carbon nanotubes is that the high aspect ratio structure ensures conductivity during elastic deformation of the material. Carbon nanotube "threads" can be twisted, but still provide a conductive connection. In addition, silicon can be mixed with carbon nanotubes, which have a very low specific gravity.

As summarized above, certain embodiments of the subject structure are characterized by having a molded IC chip that imparts fatigue resistance properties to the structure. Embodiments of such a structure are outlined in more detail by the figures.

FIG. 27A shows an embodiment of the shape of the IC chip of the present invention. In this embodiment, the integrated circuit (IC) chip 271 is formed into a non-rectangular shape, eg, a circular shape. Other shapes may include oval, elliptical, partially circular, eccentric squares with one or more angles, and the like. These and many other various shapes offer unexpected benefits for integration into medical devices. The IC chip 271 shown in FIG. 27 is provided with holes 272 and 273 through the structure. These orifices allow the connection of conductors 274 and 275, as well as the path of other medical devices and instruments, and may be custom designed to fit the appropriate shape. The fluid may also be able to pass through an IC chip when incorporated into a medical device. The IC chip 271 is mounted on the ring electrode 276. FIG. 27B shows a cross-sectional view of the IC chip 271 connected to the electrode 276, the structure being present on the medical reed 278. Two holes 272 and 273 are shown in the IC chip 271. However, the design may incorporate several holes into the chip in various arrangements as needed. The holes also do not need to be circular, but can be selected from a variety of shapes that best suit the needs, which will be readily appreciated by those skilled in the art.

FIG. 28 shows IC chips connected to multiple electrodes, namely 281, 282, 283, and 284, the electrodes arranged in a quadrant configuration. The electrodes are connected to the IC chip by solder 285 in this depiction. However, other conductive connection methods are useful within the scope of this design. Electrodes are sized and placed based on clinical needs. This configuration enables a unique mass production method for chips. The electrodes are elongated cylinders and are fitted. Then the surface is polished and the surface is cut.

FIG. 29 shows the coil configuration for the electrode 292 connected to the IC chip 291. This configuration provides a way to reduce stress concentration at the location of the IC chip within the device due to coil flexibility. The potential for failure due to material fatigue is substantially reduced by this configuration.

FIG. 30 (abbreviated FIG. 4) describes an IC chip 301 mounted on electrodes 302, 303, 304, and 305. The electrodes are supported by polymer 306. Polymer 306 can be PEEK, PEKK, polyamide, ETFE, urethane, or other suitable material. The material can also be a ceramic material, alumina, silicon carbide, or other suitable material. Fitting the electrodes in this way provides a number of advantages, such as keeping the electrodes in place, protecting the electrodes from possible biological fluid attacks, and flexible support for cushioning impact forces. Provide that. The electrodes were reconstructed spirally in this depiction, but other shapes can be taken as well.

FIG. 31 describes an IC chip 311 connected to electrodes 312, 313, 314, and 315, which are dispersed along the longitudinal direction of the medical device. In the configuration of the present invention, the two electrodes 312 and 315 are closest to the IC chip 311 and the two electrodes 313 and 314 are closest to the IC chip 311. The shape of this configuration provides the opportunity to house major features within the medical device. The shape of this configuration also disperses tension and provides greater flexibility than would otherwise be available. In addition, flexibility can be customized along the longitudinal direction of the device, providing optimal variability stiffness as may be required when accessing the coronary sinus, for example.

FIG. 32A describes an IC chip 321 connected to electrode 323. The conductive connection from the IC chip 321 to the device is via the metal coil 322, which is welded or glued to the metal flange 324. The metal coil 322 may have many configurations, eg, one conductor wound as a coil. The coil can be insulated using ETFE, polyimide, or other suitable material. The insulator is stripped where the conductive connection is made using the flange 324. The coil can also be a multifilament conductor and the conductive connection can be made of only a portion of the insulated filler conductor. For example, two of the six plyings can be connected. The coil of conductor may provide a central lumen in the path of the guidewire or fluid through the medical device. The coil can have a PTFE or urethane liner to provide insulation from the coil to the fluid in the device or lumen. Figure 32A also shows the flange 326 on the opposite side of the chip 321 that allows the connection of additional conductors. The conductor can be a coil, cable, or other suitable shape as described above. The conductive material can be MP35N, stainless steel, platinum, titanium, tantalum, or other suitable material. The conductor can have a conductive core material made of silver, copper, or gold.

FIG. 32B describes two flanges 324A, 324B on each side of an IC chip 321 that is electrically connected to a conductive coil 322 having a conductive flexible polymer 325. This configuration allows for stability with considerable flexibility. The conductive polymer can be formed conductively with additional carbon in the form of flakes, or nanotubes. Silver or platinum flakes can also be added to increase conductivity. The polymer can be silicone, urethane, or epoxy, or any other suitable material. If desired, conductive connections can be increased by adding laser welding, or spot welding, in addition to the conductive material. Connections with flanges are suitable solders, such as Pt-Sn, Pt-Ge, Au-20Sn, Au-19.5Si, Au-Ge, or Sn-5Ag, or are relatively biocompatible and corrosion resistant. Can be achieved using some other material. FIG. 32C provides another description of the structure shown in FIG. 32B and also shows the electrode 323. Figure 32D describes the metal band 329 under the flange and coil 322. The flange is mounted on the IC chip 321 as described in the previous drawing. Both the coil flange and the band are welded.

FIG. 33 describes the flange 332, which is mounted on the IC chip 331 as described above. The flanges are laser cut, EMD, or electrochemically machined to form a flexible structure that reduces the bending stress applied to the IC chip. The coiled conductor 333 is also shown.

FIG. 34 describes the IC chip 341 mounted on the electrode 342 together with the electric cable 343 penetrating the IC chip. Elastomer boots 344A, 344B are molded on either edge of the insert 341 to reduce flexion stress applied to the insert. Boot, or tension release, is overmolded with highly stretchable elastromas 345A, 345B to balance the device body.

FIG. 35 describes a molded structure 352 made of platinum, or a polymer or ceramic containing other suitable materials to be molded into the structure. The assembly is sawn or laser cut to a thickness of 0.05-0.1 mm. The metal portion 353 of assembly 352 is aligned with the adhesive pad on the IC chip 351 above. The assembly is glued to the IC chip using a conductive material at the location of the glue pad. The above electrodes are welded or glued to this assembly, which protects the IC chip from the stress applied to the medical device.

Figures 36A and 36B describe flexible connections from conductors 362, 363 to IC chip 361. The conductive connections 363, 364 are formed using a conductive polymer, such as a silicone, epoxy, or thermoplastic material filled with carbon nanotubes, such as PEEK. The conductive material can also be a conductive gel, or an assembly of a conductive structure, eg, a ball, as shown as element 365 in FIG. 36B. Alternatively, nanofibers suspended in a conductive fluid or a ferromagnetic fluid with a magnetic material can be used as described above.

FIG. 37A provides a diagram of an embodiment of an electrode mounted on the IC chip 371. Electrode 372 is Pt or other mesh. The electrode mesh can be aligned with the IC chip or, alternative, can be mounted on the IC chip at an angle.

FIG. 38 shows an embodiment of a device according to the invention, in which the fiber reinforced medical device 380 has a fiber 381 fastened along a portion of the device having IC chips 382, 383. In this case, the device may be capable of varying diameters. This diameter may also provide an important size that is optimal for device placement and fixation. In an alternative configuration, the fiber is wound directly onto the medical device. Alternatively, the fiber can be provided from debris cut from the cloth and can be wrapped directly onto the medical device. In embodiments of the invention, the fiber follows the contour shape of the device. The device may have the same diameter, or the device may have a larger diameter portion at the position of the electrode. The large diameter of the device at the position of the electrodes helps ensure conductive contact with the tissue. The large diameter portion of the embodiment of the invention helps secure the device within a small flexible conduit. The device is inserted into a vein or artery with a conduit extending at the position of the electrode. The tip of the device can also have a large diameter portion that varies from a small diameter to a large diameter, such as a cone. The shape can then quickly return to a smaller diameter that descends towards the proximal direction of the lead. The cone may also have a soft filament that is applied to the cone. The cone at the tip of the device can also be an arrangement of a set of IC chips and electrodes.

FIG. 39 provides a diagram of a plurality of electrode / IC devices according to another embodiment of the present invention. The structure 390 mechanically supports the IC chip 394, conductively connects the chip 394 to the conductor coil 396, and provides a means of providing tension relief between the chip 394 and the conductor coil 396. Flange 392A , And 392B, as well as a set of spiral cut sleeves 391A and 391B. The figure shows an embodiment having only one conductor coil, but other embodiments of the device of the present invention include a plurality of conductor coils. For example, each coil has its own pair of spiral cut sleeves. The spiral cut sleeve 391A and the flange 392A are one piece and are formed from a medical implantable quality metal such as platinum iridium. The outer rims 393A, 393B of the flange are made of non-conductive medical implantable quality material, eg PEEK, the conductive material of the flange 392A and the electrode 395A on the surface of the lead body 397. Insulate with, 395B. Hard flanges 392A, 392B are glued to both sides of the tip 394 and then to electrodes 395A, 395B to provide mechanical support to the tip 394. The flanges 392A, 392B function as the main structural elements, holding the electrodes 395A, 395B properly against the conductive coil 396 and the lead body, while the sandwiched tip 394 is from mechanical load. Substantially insulated. To form a reliable conductive contact between the tip 394 and the conductor coil 396, the metal flanges 392A, 392B are made using any suitable technique, such as soldering or laser welding. , Conductively connected to chip 394. The metal spiral cut sleeves 391A, 391B are then soldered or laser welded to the conductive coil 396. Multiple surplus laser welds or soldering points can be used, tip 394 and flange 392A, 3 Increases the reliability of conductive contact between the 92B and between the spiral cut sleeves 391A, 391B and the conductor coil 396. Cut sleeves 391A, 391B are used to provide tension relief between the tip 394 and the conductive coil 396. The spiral cut sleeves 391A, 391B can be manufactured using standard laser cutting techniques. The spiral cut adds flexibility to the sleeve, allowing the sleeve to bend with the conductive coil 396, thereby occurring at the interface between the bending conductor coil 396 and the hard solid sleeve. Relieve the concentration of stress you get. Optimizing tension relief using the spiral cut sleeves 391A, 391B is achieved by varying the pitch and width of the spiral cut, and if desired, is very flexible with coil 396 and stiff. Achieved by tapering the distal end of the sleeve with the aim of forming a seamless stiffness transfer through the sleeve between the flanges 392A, 392B.

40-44 provide a description of yet another embodiment of the subject segmented electrode structure, in which the conductive connection is provided by a coil. In the embodiments described in these figures, a coiled spring is provided that provides a conductive connection between the IC and one or more conductive elongated members. Longitudinal compression and extension forces of the conductive elongated member of the chip electrode assembly can result in tension with respect to mounting on the chip. The use of springs provides a release source for this tension and reduces tension in the connection. In some cases, the spring can be taper off, providing a gradual transition of tension. This reduces the impact of wearing tension in that aspect.

In one embodiment of the invention, flexible springs are used to reduce stress on conductive connections. For springs, select other suitable materials such as Platinum, Platinum Iridium, Platinum Nickel, Platinum Tungsten, MP35N, Elgiloy, L605, 316 Stainless Steel, Titanium, Nickel Titanium, Nitinol, Cobalt Chromium, Cobalt, NiTi, Tantal, etc. It can be formed from a number of suitable materials, including but not limited to them.

The flexible springs of the present invention are provided in the length most suitable for a particular miniaturized device and its application. The spring can potentially be as long as the device of which the spring itself is a part. As an example, the length of the spring can be from about 0.080 to about 0.200 inches, for example from about 0.030 to about 0.100 inches, including from about 0.015 to about 0.250 inches. The diameter of the wire of the spring can be selected according to the needs of the material and the needs of the particular application. The range of wire diameters for some embodiments of the invention is from about 0.0005 to about 0.250 inches, eg, about 0.002 to about 0.010 inches, and includes about 0.003 inches.

Stress can occur on the device. This is because the conductive elongated member is curved away from or toward the electrode, for example, the quadrant electrode assembly, either laterally or vertically. Will be done. These compression and extension forces can also be released by using the flexible mounting structure of the invention and allowing other stress release functions to act synergistically with the rigid structure of the device.

FIG. 40 shows an assembly 400 with a flexible connection, in this case a tiny spring used as part of the assembly. A variety of other flexible connectors can be used as desired. As shown in FIG. 40, a flexible connection 401 is provided between the IC 403 and the conductive elongated members 405 and 407. This design creates a flexible connection between the IC and the elongated conductive member. In an embodiment of this design, the conductive elongated members 405 and 407 are placed in the lumen 402 inside the flexible connection 401, as shown in the assembly.

The IC403 is attached to the quadrant electrodes 409A, 409B, 409C, and 409D by a junction 411. The quadrant electrodes 409A, 409B, 409C, and 409D are joined using PEEK material 413. The guidewire cavity 415 extends under and / or between the conductive elongated members 405 and 407 under the IC403 and passes through all of the quadrant electrodes 409A, 409B, 409C, and 409D. Or wrapped in everything.

FIG. 41 provides a diagram of the first subassembly of the final assembly shown in FIG. 40. In this subassembly, conductive elongated members 405 and 407 are placed within the cavity 402 inside the flexible connection 401. The spring finger 404 is provided for physical and conductive mounting after the flexible connection 401 to the IC 403. At this point in assembly, the flexible connection 401 is suitable for mounting on the conductive elongated members 405 and 407. This can be achieved by a number of methods. For example, the spring can be crimped into conductive elongated members 405 and 407, as shown herein as the crimped area 416. The flexible connection 401 may be designed to have a tight fit with conductive elongated members 405 and 407 (not shown). Any suitable mounting approach can be used, and as a result, close conductive contact with the cable is preferred.

In certain embodiments of the invention, the tightly wound portion is taper off in the coil starting area of the flexible connection 401. This design feature facilitates the assembly process. This design feature also provides a portion of the spring that can extend and contract axially. Physical problems of axial extension and contraction can occur in the presence of motion between the conductive elongated members 405 and 407 and the IC 403. In addition, axial stretching and contraction can occur with overall stress throughout the device.

FIG. 42 illustrates a second subassembly with quadrant electrodes 409A, 409B, 409C, and 409D molded using PEEK material 413. This second subassembly provides an intermediate structure in which the quadrant electrodes 409A, 409B, 409C, and 409D are completely joined to a single but fatigue resistant structure. The junction 411 also facilitates and stabilizes the post-mounting of the quadrant electrodes 409A, 409B, 409C, and 409D to the IC403, as shown.

FIG. 43 illustrates a third subassembly that introduces IC413 into the assembly. In this case, the IC 413 is provided with a mounting tab 417 to facilitate the bonding of the IC 413 to the quadrant electrodes 409A, 409B, 409C, and 409D. IC413 is introduced into the lumen of the quadrant electrodes 409A, 409B, 409C, and 409D. The mounting tab 417 of the quadrant electrode 419 is located at the junction 411 of the IC 413. Generally, the mounting tab 417 and the joint 411 are welded to provide additional stability. In this way, a direct connection between the IC413 and the quadrant electrodes 409A, 409B, 409C, and 409D is achieved.

FIG. 44 illustrates a fourth subassembly. In this figure, the subassembly shown in FIG. 41 is introduced into the subassembly shown in FIG. 43. Conductive elongated members 405 and 407 reside in the lumen 402 inside the flexible connection 401. This subassembly is placed in a semi-cylinder between the IC403 mounted on the quadrant electrodes 409A, 409B, 409C, and 409D. The finger 404 of the flexible connection 401 allows the flexible connection 401 to be attached directly to the IC 403. Similar to the mounting of some of the above components, mounting of the flexible connection 401 to IC403 is generally welded to increase stability.

The device assembled as a final result shown in FIG. 40 enjoys the numerous benefits provided by the various parts or features. As an example, the flexible connection 401 provides a fault-tolerant connection even in very difficult environments, such as the heart. The PEEK material 413 joining the quadrant electrodes 409 provides structural stability, especially during the joining of the subassemblies. These design innovations ensure device fatigue tolerance and stress reduction without compromising structural integrity.

By acting synergistically with the additional fatigue resistant members of the structure, the joined area, eg, the joint 411, which may include welding, provides the device with essentially strong and structural integrity. To do. Properties such as the mounting tab 417 ensure that these joints of the device are neatly aligned, reducing tension in the welded joints while also providing additional structural stability.

(Devices and systems) Aspects of the invention include devices and systems including implantable medical devices and systems, the devices and systems comprising a hermetically sealed structure according to an embodiment of the invention. Devices and systems can perform a number of different functions, including, but not limited to, electrical stimulation applications, such as specimens, such as glucose detection, for medical purposes.

Implantable medical devices and systems can have a number of different components or elements in addition to electrodes, such elements being detectors (eg, cardiac wall motion detectors, eg, cardiac wall motion timing). A detector) and, for example, a processing element that controls the timing of cardiac stimulation in response to signals from one or more detectors, for example, between an implantable medical device and an extracorporeal position. It may include, but is not limited to, remote transmission devices for exchanging information remotely, drug distribution elements, and the like. Thus, the subject's hermetic structure can be operably coupled with a number of different types of implantable medical device and system components, eg, conductively communicated, such devices and systems. Includes, but is not limited to, physiological parameter detection devices, electrical (eg, heart) stimulation devices, and the like.

In certain embodiments of the system and device of interest, one or more of the segmented electrode structures of the present invention are at least one conductive elongated member, eg, a conductive elongated member present in a lead. For example, it is electrically connected to a cardiovascular lead. In certain embodiments, conductive elongated members are described, for example, in International Application Publication No. 2004/052182 and US Patent Application No. 10 / 734,490, the disclosure of which is incorporated herein by reference. Is part of multiple leads such as. In some embodiments of the invention, the device and system may include, for example, a central control unit, eg, an onboard logic circuit or processor located within a pacemaker vessel. In these embodiments, the central control unit may be electrically connected to one or more sealed structures via one or more conductive members.

Devices and systems for which the subject's segmented electrode structure finds applications include, but are not limited to: Methods and Systems. International Application Publication No. 2004/066817 entitled "For Measuring Cardiac Parameters"; International Application Publication No. 2004/066814 entitled "Method And System For Remote Hemodynamic Monitoring"; International Titled "Implantable Pressure Sensors" Publication No. 2005/058133; International Application Publication No. 2004/052182 entitled "Monitoring And Treating Hemodynamic Parameters"; International Application Publication No. 2004/067081 entitled "Methods And MFP For Enhancing Cardiac Pacing"; "Methods and Systems for Programming and US Provisional Patent Application No. 60 / 638,928 entitled "Controling a Cardiac Pacing Device" (filed December 23, 2004); US Provisional Patent Application No. 60 / 658,445 entitled "Fiberoptic Cardiac Wall Motion Timer" Filed March 3, 2005); US Provisional Patent Application No. 60 / 667,759 entitled "Cardiac Motion Detection Using Fiberoptic Strain Gauges" (filed March 31, 2005); "de Minimus" US Provisional Patent Application No. 60 / 679,625 entitled "Control Circuit for Cardiac pacing and Signal Collection" (filed May 9, 2005); US Provisional Patent Application No. 60 entitled "Deployable Epicardial Electrode and Sensor Array" / 706,641 (filed August 8, 2005); "Electrical" US Provisional Patent Application No. 60 / 705,900 entitled "Tomography" (filed August 5, 2005); US Provisional Patent Application No. 60 / entitled "Methods and MFP for Tissue Activation and Monitoring"Issue (filed on August 12, 2005, Agent Reference No. PRO-P37); "Measuring Conduction Velocity Using One" US Provisional Patent Application No. 60 / 707,913 entitled "or More Satellite Devices" (filed August 12, 2005). These applications are incorporated herein by reference in their entirety.

Some, such as the present inventors, have developed Doppler stress detectors, additional cardiac wall motions, and other cardiac parameter detection devices, the devices, or at least their components, as desired. May be present in a medical device according to an embodiment of. Some of these devices are embodied in the provisional application currently filed: US Provisional Patent Application No. 60/607280 entitled "One Wire Medical Monitoring and Treating Devices" (September 2, 2004). Filing); US Patent Application No. 11 / 025,876 entitled "Pressure Sensors having Stable Gauge Transducers", US Patent Application No. 11 / 025,366 entitled "Pressure Sensor Circuits"; "Pressure Sensors Having Transducers" US Patent Application No. 11 / 025,879 entitled "Positioned to Provide for Low Drift"; "Pressure" US Patent Application No. 11 / 025,795 entitled "Sensors Having Neutral Plane Positioned Transducers"; US Patent Application No. 11 / 025,657 entitled "Implantable Pressure Sensors"; "Pressure Sensors Having Spacer Mounted" US Patent Application No. 11 / 02,793 entitled "Transducers"; US Provisional Patent Application No. 60/615117 entitled "Stable Micromachined Sensors" (filed September 30, 2004); "Amplified Complaint Force Pressure Sensors" US Provisional Patent Application No. 60/616706 (filed October 6, 2004); US Provisional Patent Application entitled "Cardiac Motion characterization by Strain Measurement" (filed December 20, 2004); and " Implantable Pressure PCT application entitled "Sensors" (December 10, 2004); US provisional patent application entitled "Shaped Computer Chips with Electrodes for Medical Devices" (February 22, 2005); "Fiberoptic Cardiac Wall Motion" US Provisional Patent Application No. 60/658445 entitled "Timer" (filed March 3, 2005); US Provisional Patent Application No. 60 / 667,749 entitled "Cardiac Motion Detection Using Fiberoptic Strain Gauges" (2005) Filed on March 31). These applications are incorporated herein by reference in their entirety.

In certain embodiments, implantable medical devices and systems include subject segmented electrode structures and are used in cardiovascular applications such as pacing applications, cardiac resynchronization therapy applications, and the like. is there.

A representative system in which a sealed complete structure finds use is depicted in FIG. 45, along with an embodiment of a cardiac resynchronization therapy (CRT) system comprising a sealed integrated circuit according to an embodiment of the present invention. A cross-sectional view of is provided. The system includes a pacemaker vessel 106, a right ventricular electrode lead 109, a right atrial electrode lead 108, and a left ventricular ventricular vein lead 107. Also shown are the cardiovascular veins of the right ventricular septum 102, the ventricular septum 103, the apex 105, and the left ventricular sidewall 104.

The left ventricular electrode lead 107 includes a lead body and one or more electrode assemblies 110, 111, and 112. Each electrode contains a sealed integrated circuit. Having a large number of distal electrode assemblies allows selection of the optimal electrode position for the CRT. In a typical embodiment, the electrode lead 107 is a standard material for cardiac leads, eg silicon or polyurethane on the lead body, and Pt-Ir (90% platinum, 10% iridium) electrode assembly 110, MP35N is used for the coiled or standard conductors connected to 111 and 112. Alternatively, these device components are (eg, published US patent application publications whose disclosures are incorporated herein by reference: US patent application publications entitled "Methods and systems for measuring cardiac parameters". No. 20040254483; "Method and apparatus for enhancing cardiac US Patent Application Publication No. 20040220637 entitled "pacing"; US Patent Application Publication No. 20040215049 entitled "Method and system for remote hemodynamic monitoring"; and "Method and system for monitoring and treating hemodynamic parameters" Can be connected to the proximal end of electrode lead 107 by a number of systems (as disclosed in US Patent Application Publication No. 20040193021). The proximal end of the electrode lead 107 may be connected to a pacemaker 106.

Electrode leads 107 are placed in the heart using standard cardiac lead placement devices, including introducers, guide catheters, guide wires, and / or stylets. Briefly, the introducer is located in the subclavian vein. A guide catheter is placed via an introducer and is used to find the coronary sinus in the right atrium. Guide wires are used to find the left atrial cardiovenous. The electrode lead 107 slides over the guide wire to the left ventricular ventricular vein 104 and is tested until an optimal location for the CRT is found. Once implanted, a large number of electrode leads 107 allow for continuous readjustment for optimal electrode position.

Electrode leads 109 are placed in the right ventricle of the heart, along with an active fixation helix, at the end 116 embedded in the cardiac septum. In this figure, the electrode lead 109 is provided with one or more electrodes 113, 114, 115.

The electrode lead 109 is placed in the heart in a procedure similar to the general procedure for placing the right ventricular lead. Electrode leads 109 are placed in the heart using standard cardiac lead devices, including introducers, guide catheters, guide wires, and / or stylets. The electrode lead 109 is inserted into the subclavian vein, through the superior vena cava, through the right atrium and into the right ventricle. The electrode leads 109 are placed under an X-ray fluoroscope at a location determined by the clinician to be clinically optimal and logically feasible for immobilizing the electrode leads 109. Under the X-ray fluoroscope, an active fixation helix 116 is inserted and screwed into the heart tissue to secure the electrode leads 109 to the septum. Electrode leads 108 are placed in the right atrium using an active fixation helix 118. The distal tip electrode 118 is used to provide both pacing and motion detection of the right atrium.

Yet another type of medical device and system, where the subject's segmented electrode structure finds use, is a vision recovery device and system, such as an implant that converts light detected to stimulate the optic nerve into an electrical signal. Devices and systems that include light sensing elements that are possible. For example, integrated circuits and photodetectors, such as photovoltaic cells, can be coupled to segmented electrode structures of embodiments of the present invention. Representative implantable vision recovery devices and systems to which segmented electrode structures can be incorporated include, but are not limited to, the devices and systems described below: U.S. Pat. No. 4,628,933; U.S.A. Patent No. 5,042,223; US Pat. No. 5,397,350; and US Pat. No. 6,230,057; and "Multi-Phasic Microphotodetector Retinal Implant With Variable Voltage And Current Capability And MFP For International Application Publication No. 01/74444 entitled "Insertion"; International Application Publication No. 01/83026 entitled "Artifical Retina Device With Stimulating And Ground Return Electrodes Disposed On Opposite Sides Of The Neuroretina And Method Of Attachment"; International Application Publication No. 03/002190 entitled "Methods For Improving Damaged Retinal Cell Function"; "Methods For Improving Damaged Retinal Cell Function Using Physical" International Application Publication No. 03/002070 entitled "And / Or Mechanical Stimulation"; "Implantable Device Using Diamond-like Carbon" International Application Publication No. 2004/071338 entitled "Coating", International Application Publication No. 2004/112893 entitled "Implant Instrument"; International entitled "Treatment Of Degenerative Retinal Disease Via Electrical Stimulation Of Surface Structure" Publication No. 2005/004985; International Application Publication No. 2005/004985; entitled "Device For Treatment Of Degenerative Retinal Disease Via Electrical Stimulation Of Surface Structures Of The Eyeball"; and "Mechanically Activated Objects For Treatment Of Degenerative Retinal Disease" International Application Publication No. 2005/110326 entitled ".

(kit) Kits containing segmented electrode structures of the subject are also provided as part of one or more components of implantable devices or systems, such as the devices and systems described above. In certain embodiments, the kit further comprises at least a control unit, for example in the form of a pacemaker container. In certain of these embodiments, the structure and control units may be electrically connected by conductive elongated members. In certain embodiments, segmented electrode sealing structures may be present on the reed, eg, cardiovascular reed.

In certain embodiments of the subject kit, the kit provides instructions for using the device of interest, or elements for obtaining the instructions (eg, the URL of a website that directs the user to the web page that provides the instructions). Further included, these instructions are generally printed on a substrate, which can be one or more of a package insert, packaging, reagent container, and the like. In the subject kit, one or more components are present in the same or different containers as may be appropriate or desired.

The above invention has been described in considerable detail by figures and examples for the purpose of clarifying understanding, but no particular modification or amendment to it without departing from the intent or scope of the appended claims. Is clear to those skilled in the art in light of the teachings of the present invention.

Therefore, the above-mentioned ones only exemplify the principle of the present invention. Those skilled in the art can embody the principles of the invention and devise various configurations within the intent and scope of the invention, although not explicitly described or illustrated herein. It is understood that there is. In addition, all examples, and the conditional terms cited herein, help the reader to understand, in principle, the principles of the invention and the concepts that the inventor can contribute to the advancement of the art. It is understood that it is intended to be construed as not limited to the particular examples and circumstances cited as such. Moreover, all statements herein that cite the principles, aspects, and embodiments of the invention, as well as specific embodiments thereof, are intended to include structural and functional equivalents. Moreover, such equivalents are intended to include both currently known equivalents and future developed equivalents, i.e., any element that performs the same function, regardless of structure. Therefore, the scope of the invention is not intended to be limited to the exemplary embodiments illustrated and described herein. Rather, the scope and intent of the invention is embodied by the appended claims.

47 members in 4 offices

This recordMember, by publication datePriority claim

Priority claims20

Priority claims
Document	Office	Kind	Date
60638692	United States of America	–	2004-12-22
63869204	United States of America	P	2004-12-22
63869204	United States of America	P	2004-12-22
60655609	United States of America	–	2005-02-22
65560905	United States of America	P	2005-02-22
65560905	United States of America	P	2005-02-22
60751111	United States of America	–	2005-12-15
75111105	United States of America	P	2005-12-15
75111105	United States of America	P	2005-12-15
60752733	United States of America	–	2005-12-20
75273305	United States of America	P	2005-12-20
75273305	United States of America	P	2005-12-20
2004638692	–	–	–
2005655609	–	–	–
2005751111	–	–	–
2005752733	–	–	–
US20040638692P	–	–	–
US20050655609P	–	–	–
US20050751111P	–	–	–
US20050752733P	–	–	–

Members47

Family members, oldest first
Document	Office	Kind
US2006058588A1	United States of America	A1	2006-03-16
WO2006029090A2	World Intellectual Property Organization (WIPO)	A2	2006-03-16
WO2006069322A2	World Intellectual Property Organization (WIPO)	A2	2006-06-29
WO2006069323A1	World Intellectual Property Organization (WIPO)	A1	2006-06-29
WO2006029090A3	World Intellectual Property Organization (WIPO)	A3	2006-12-21
US7214189B2	United States of America	B2	2007-05-08
US2007123944A1	United States of America	A1	2007-05-31
EP1799101A2	European Patent Office (EPO)	A2	2007-06-27
US2007173896A1	United States of America	A1	2007-07-26
US2007173897A1	United States of America	A1	2007-07-26
US2007179569A1	United States of America	A1	2007-08-02
US2007185537A1	United States of America	A1	2007-08-09
US2007185548A1	United States of America	A1	2007-08-09
US2007185549A1	United States of America	A1	2007-08-09
EP1827583A1	European Patent Office (EPO)	A1	2007-09-05
EP1833551A2	European Patent Office (EPO)	A2	2007-09-19
US2008027289A1	United States of America	A1	2008-01-31
US2008077186A1	United States of America	A1	2008-03-27
US2008097566A1	United States of America	A1	2008-04-24
JP2008525120A	Japan	A	2008-07-17
JP2008525121A	Japan	A	2008-07-17
US2008255647A1	United States of America	A1	2008-10-16
EP1799101A4	European Patent Office (EPO)	A4	2008-11-19
US2008312726A1	United States of America	A1	2008-12-18
WO2006069322A3	World Intellectual Property Organization (WIPO)	A3	2009-06-18
US7637867B2	United States of America	B2	2009-12-29
US7640060B2	United States of America	B2	2009-12-29
EP1827583A4	European Patent Office (EPO)	A4	2010-04-21
US2010114234A1	United States of America	A1	2010-05-06
US2010114250A1	United States of America	A1	2010-05-06
US7713194B2	United States of America	B2	2010-05-11
US7713195B2	United States of America	B2	2010-05-11
US2010249883A1	United States of America	A1	2010-09-30
EP1833551A4	European Patent Office (EPO)	A4	2010-12-08
US7877149B2	United States of America	B2	2011-01-25
US2011066057A1	United States of America	A1	2011-03-17
US7935056B2	United States of America	B2	2011-05-03
JP2012011237AThis record	Japan	A	2012-01-19
US8123684B2	United States of America	B2	2012-02-28
JP2012050849A	Japan	A	2012-03-15
US8195308B2	United States of America	B2	2012-06-05
JP5112879B2	Japan	B2	2013-01-09
EP1827583B1	European Patent Office (EPO)	B1	2013-01-23
US2013046356A1	United States of America	A1	2013-02-21
EP1833551B1	European Patent Office (EPO)	B1	2013-02-27
JP5254622B2	Japan	B2	2013-08-07
US8700148B2	United States of America	B2	2014-04-15

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	Event	Code
2013-06-13	Decision of refusalJAPANESE INTERMEDIATE CODE: A02A02	A02
2012-10-11	Written amendmentJAPANESE INTERMEDIATE CODE: A523A521	A521
2011-10-19	Written request for application examinationJAPANESE INTERMEDIATE CODE: A621A621	A621