DE102012010901A1 - Head part assembly for implantable pulse generator, for heart rhythm management, has locating pins inserted into head part and coupled with electrical contact rings to hold rings and seals in hole of head part - Google Patents

Abstract

The assembly (20) has electrical contact rings (26) and annular seals (28), which are arranged in a hole (24) of a plastic head part (22). Locating pins (44) are inserted into the head part through a set of holes (42) and coupled with the rings to hold the rings and the seals in the hole. The set of holes is formed in the head part at distance from an intake port of the head part. The rings comprise annular outer grooves (40), which are in contact with the pins. Springs (30) e.g. radial or axial canted coil springs, are positioned in annular inner grooves (32) of the rings. An independent claim is also included for a method for manufacturing a head part assembly for an implantable device.

Description

Cross reference to related application

This is a utility model application of provisional application No. 61 / 495,259, filed on Jun. 9, 2011, the contents of which are hereby expressly incorporated herein by reference.

Field of the invention

The present disclosure relates to methods, devices, and systems for positioning and holding electrical contacts, gaskets, and related components within a housing. For example, electrical contacts, gaskets, and related components may be positioned in a head portion of an implantable medical device, including implantable pulse generators (IPGs) used for cardiac rhythm management and neurostimulation devices.

General state of the art

Conventional methods of fabricating an implantable pulser (IPG) header assembly used for cardiac rhythm management and neurostimulation devices include attaching electrical contacts coupled to the stimulation lead with a tooling pin and elastomeric release seals between the contacts by overmolding the assembly with a liquid plastic resin. The resin solidifies to encapsulate the contact and seal assembly, which holds the components in place, thus forming the header assembly. In this process, the liquid resin can leak into the electrical contacts and the seals. If the resin leaks into the electrical contacts and seals or the header spray process does not work properly for some reason, the whole IPG must be rejected.

Brief description of the invention

A header assembly and method for incorporating electrical contacts and seals into a header include properly positioning a block of electrical contact housings and seals or seal assemblies in the header and maintaining the electrical contact enclosures and seals in the header with pins extending from outside the header Head part are inserted through axially disposed holes in the head part in the head part, to be coupled to corresponding grooves of the electrical contact housing. The head part may be a preformed plastic head part.

One aspect of the present disclosure includes a head part assembly for an implantable device, the head part assembly including a head part having a bore; at least one electrical contact ring located in the bore; at least one seal located in the bore; and at least one fixing pin inserted in the head part through an opening in the head part, which is spaced from an inlet opening of the head part. In one example, the pin is configured to be coupled to the electrical contact ring to retain the electrical contact ring and seal in the bore of the head portion.

In some embodiments, the head part is made of a plastic material.

In some embodiments, the at least one electrical contact ring includes an outer groove in contact with the pin.

In some embodiments, the at least one electrical contact ring includes an annular inner groove and a spring positioned in the groove.

In some embodiments, the spring is a canted coil spring.

In some embodiments, the annular groove includes two sidewalls and a bottom wall.

In some embodiments, the at least one contact ring mechanically engages the at least one seal.

In some embodiments, the at least one seal includes at least one inner rib for sealing against a lead.

Another aspect of the present disclosure is a method of manufacturing a headpiece assembly for an implantable device. The method may include forming a head portion, the head portion having an outlet and a bore; installing at least one electrical contact ring and at least one seal in the bore of the head portion; and retaining the electrical contact ring and seal in the bore of the head portion with a pin inserted into the head portion through a corresponding opening in the head portion spaced from the inlet to be coupled to the electrical contact ring.

In certain embodiments of the method, the head part is made of plastic.

In certain embodiments, the method may further comprise the step of forming an outer groove in the at least one electrical contact ring to receive the pin.

In certain embodiments of the method, the at least one electrical contact ring comprises an annular inner groove and a spring positioned in the groove.

In certain embodiments of the method, the spring is a canted coil spring.

In certain embodiments of the method, the annular groove comprises two side walls and a bottom wall therebetween.

In certain embodiments of the method, the head part has a parting line and consists of at least two housing sections.

Brief description of the drawings

These and other features and advantages of the present devices, systems and methods will become apparent as they become better understood by reference to the specification, claims and appended drawings. Show it:

1 a sectional perspective view of a head part assembly for an implantable pulse generator (IPG) according to one embodiment.

2 another perspective view of the header assembly from 1 ,

3 a cross-sectional view of the header assembly from 1 ,

4 FIG. 3 is a process flow diagram illustrating an exemplary method of fabricating a header assembly for an implantable device. FIG.

Detailed description

The detailed description set forth below in conjunction with the accompanying drawings is intended as a description of the presently preferred embodiments of row plug blocks and headers and related methods provided in accordance with aspects of the present apparatus, systems and methods and is not intended to do so to represent the only forms in which the present devices, systems and methods can be constructed or used. The description sets forth the features and steps for constructing and using the embodiments of the present apparatuses, systems, and methods in conjunction with the illustrated embodiments. It should be understood, however, that the same or equivalent features and structures can be achieved by other embodiments that: are also intended to be included within the spirit and scope of the present disclosure. As noted elsewhere herein, like element numbers are intended to designate the same or similar elements or features.

Regarding 1 is a sectional view of a header assembly 20 shown according to an embodiment. The headboard assembly 20 can be used in many different applications. The embodiments described herein utilize the implantable pulser (IPG) header assembly used in cardiac rhythm management and neurostimulation. The headboard assembly 20 includes a headboard 22 having a bore 24 in which a supply cap 25 , one or more generally annular electrical contact rings 26 and one or more generally annular seals 28 are mounted. Because the headboard assembly 20 configured to implant into a living body, prevent the seals 28 that body fluids are the electrical contacts 26 to reach. For example, the seals seal 28 outside the headboard 22 from and seal against a feed cable inside when in the inlet hole of the common hole 24 is inserted. Every electrical contact ring 26 may include at least one spring, such as a radial or axial canted coil spring 30 in at least one annular groove 32 record, which includes two side walls and a bottom wall located therebetween. In another example, at least one of the sidewalls is defined by a wall portion of an adjacent annular seal 28 formed, defined or provided. A lead or feeder cable (not shown), which may be generally in the form of a pin, rod or the like, may enter the bore 24 be introduced to the springs 30 to contact an electrical current flow between the supply line and the electrical contact rings 26 provide. In practice, the contact rings 26 with an encapsulated circuit located inside a sealed housing, also referred to as a shielding cup, which has control circuitry and power to send signals to the infeed cable, cords or is in electrical communication therewith. The feathers 30 Make a holding connection between the supply line and the electrical contact ring 26 ready. Details of the electrical contacts, gaskets, canted coil springs, and / or holding, locking, or Blocking of pins, rods or the like with canted coil springs are disclosed in US patents US 2008/0254670 . US 2008/0255631 . US2009 / 0258519 . US 2010/0123291 . US 2010/0267265 , the entire disclosures of which are hereby expressly incorporated by reference.

The headboard 20 is a preformed plastic part according to the embodiment described herein, but may be made of any type of biocompatible material. For example, the head part could be made of an elastomer or a thermoplastic elastomer (TPE). The head portion may comprise a one-piece housing or may be formed of two or more housing portions having a horizontal parting line, a vertical parting line, or both, at which or which the two or more housing portions are joined together. An outer surface of each electrical contact ring 26 includes outer grooves, channels, recesses or slots 40 , in the 1 and 3 as annular outer grooves 40 to be shown. The headboard 22 includes axially arranged holes 42 which are aligned or positionally the position of the grooves 40 correspond when the electrical contact rings 26 and the seals 28 in the hole 24 are installed. The holes may be during the molding of the head part 20 can be formed or subsequently formed after the molding process, such as drilled, be. The headboard assembly 20 includes fixing pins 44 that are sized to fit in the holes 42 pressed in and with the grooves 40 to be coupled. The fixing pins 44 can be rigid and made of steel, titanium or other rigid, biocompatible metals or plastics. The holes 42 have slightly smaller inner diameter than the outer diameter of the pins 44 to provide a suitable seal. In one example, the pins and the axially disposed holes are press fit. In another embodiment, the holes are about as large as the pins or slightly larger than the pins and are sealed after placing the pins in the holes. In yet another example, the grooves become 40 to engage the pins on the seals 28 or formed on both the contact rings and on the seals.

The headboard assembly 20 is achieved by inserting and correctly positioning the supply cap 25 , the electrical contact rings 26 and the seals 28 in the hole 24 of the headboard 22 assembled. Once the electrical contact rings 26 and seal assemblies 28 axially correctly positioned so that the grooves 40 on the holes 42 are aligned, the fixing pins 44 in the holes 42 inserted to the grooves 40 to be coupled. The fixing pins 44 can any electrical contact ring 26 Position and hold in a correct axial position relative to the headboard. In addition, the positioning of the electrical contact rings receives 26 the right sealing function between the electrical contact rings 26 and the seals 28 to prevent the leakage of body fluids that would affect the IPG's electrical circuits. Furthermore, the coupling of the pins prevents 44 with the grooves 32 an axial displacement of the electrical contact rings 26 and the seals 28 or compressing these parts when the lead is for engagement with the springs 30 into the hole 24 is introduced. In other words, the interventions are between the pens 44 and the grooves 32 configured to prevent or limit axial displacement of the various components in the insertion direction of the feeder cable when the feeder cable enters the bore 24 is inserted. If offset, it is typically on the inner or inwardly extending ribs 37 the annular seals 28 which grips the outer surface of the feeder cable (not shown) while the feeder cable enters the bore 24 is inserted. Thus, the aspects of the present apparatus, apparatus and present assembly include a row plug block located in a head portion, and wherein the row plug block prevents axial movement relative to the head portion by at least one pin engaging in a groove the row connector block is formed, is secured. In specific embodiments, a plurality of pins engage a plurality of corresponding grooves on the row connector block to secure the row connector block against axial movement relative to the head portion. In one example, each contact ring has a groove to engage a pin, which may alternatively be referred to as an anchor pin.

In one embodiment, in 1 and 2 will be shown, the pins are 44 from the bottom of the headboard 22 from in the preformed headboard 22 pressed, there the head part 22 can be glued to the top of the IPG, the battery and control circuits for convenient connection with the pins 44 may contain. The pencils 44 can be anywhere on the headboard 22 are located. In still other embodiments, the pins are located at different portions of the header 22 along. For example, two pins may be on the underside of the header, while two other pins are on the top of the header. Because the pins 44 in the holes 42 are press-fit, the pins are 44 by the elastic properties of the head part 22 retained. In a particular embodiment, the head part is made of a plastic material. If the headboard is made of plastic, there may not be a large retention force or none firm press fit, since the plastic material has relatively greater structural integrity than other prior art header materials. In addition to positioning and holding the components within the plastic head part 20 prevent the pins 44 also an axial rotation of the electrical contact rings 26 and seals 28 when the supply line in the headboard 20 is inserted. The block passing through the supply cap 25 , the electrical contact rings 26 and the seals 28 is formed by an end cap 46 completed. The end cap 46 may also include a groove, a recess or a slot for engagement with a fixing pin. The groove on the end cap 46 is in 1 and 3 as an annular groove 48 shown. The supply line can also have a safety or safe section to the supply line with a locking screw either with the supply cap 25 or the end cap 46 in the hole 24 to secure. Both the lead fuse section and the cap 46 can with pins 44 at the headboard 22 be pinned (in 1 to 3 is only shown as the cap 46 is pinned).

4 FIG. 10 shows an exemplary method of manufacturing a headpiece assembly for an implantable device. FIG 60 provided in accordance with the aspects of the present disclosure. In an example, the method includes 60 the steps of forming a header in step 62 , In a particular embodiment, this may involve molding a head part, such as in FIG 1 is shown comprising with a plastic material. In another example, the header is molded using different materials, such as an elastomer or a TPE. The header may include an inlet and a bore for receiving a feeder cable.

at 64 the method comprises the step of installing at least one electrical contact ring and at least one seal in the bore of the head part. In other examples, multiple contact rings and multiple seals are installed in the header. at 66 the method comprises the step of retaining the electrical contact ring (s) and the gasket (s) in the bore of the header having a corresponding number of pins formed by a corresponding number of apertures formed in the header in the header be inserted. The openings are spaced from the inlet to be coupled to the electrical contact ring.

Although limited embodiments of row plug assemblies and headers and their components have been specifically described and illustrated herein, numerous modifications and variations will be apparent to those skilled in the art. For example, the various sealing configurations may be different, the contact rings may be different, the end cap may be different, or the inlet cap may be different. For example, the seal may have only a single inward boss to seal against a feeder cable, the contact ring may form a simple ring with no sidewalls forming a groove, etc. For example, one embodiment of a row plug may include contact rings with external grooves to fit into corresponding locator pins however, the remaining features of the gaskets and contact rings, such as the manner in which the gaskets and contact rings mechanically interlock or seal against the header, may be other than shown. In some examples, the gaskets and contact rings may be similar to those described in references no. US2011 / 0059639 . US2008 / 0246231 and US2010 / 0123291 disclosed, but wherein an outer fixing groove is formed on at least one contact ring. Preferably, each contact ring of the alternative contact rings comprises an outer fixing groove for engagement in a fixing pin. In still another embodiment, a device for securing leads in row plug devices is disclosed in US Pat U.S. Patent No. 8,092,260 installed in place of a safety screw assembly.

Further, it should be understood and intended that features specifically discussed for one embodiment of the row plug and header may be adopted for inclusion with another row plug and header embodiment as far as the functions are compatible. Accordingly, it will be understood that the row plug assemblies and headers and their components may be configured differently than described herein in accordance with the principles of the disclosed apparatus, system, and method. The disclosure is also defined in the following claims.

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• US 2008/0254670 [0026]
• US 2008/0255631 [0026]
• US 2009/0258519 [0026]
• US 2010/0123291 [0026, 0032]
• US 2010/0267265 [0026]
• US 2011/0059639 [0032]
• US 2008/0246231 [0032]
• US8092260 [0032]

Claims (15)

An implantable device header assembly, the header assembly comprising: a head part having a bore; at least one electrical contact ring located in the bore; at least one seal located in the bore; at least one locating pin inserted into the head portion through an opening in the head portion spaced from an inlet opening of the head portion to be coupled to the electrical contact ring for retaining the electrical contact ring and the seal in the bore of the head portion. The header assembly of claim 1, wherein the header is made of a plastic material. The header assembly of claim 1, wherein the at least one electrical contact ring includes an outer groove in contact with the pin. The header assembly of claim 1, wherein the at least one electrical contact ring comprises an annular inner groove and a spring positioned in the groove. The header assembly of claim 4, wherein the spring is a canted coil spring. The header assembly of claim 4, wherein the annular groove comprises two side walls and a bottom wall. The headboard assembly of claim 1, wherein the at least one contact ring mechanically engages the at least one seal. The header assembly of claim 1, wherein the at least one seal comprises at least one inner rib for sealing against a lead. A method of manufacturing a headpiece assembly for an implantable device, the method comprising the steps of: Forming a head portion, the head portion having an inlet and a bore; Installing at least one electrical contact ring and at least one seal in the bore of the head portion; and Retaining the electrical contact ring and seal in the bore of the head portion with a pin inserted into the head portion through a corresponding opening in the head portion spaced from the outlet to be coupled to the electrical contact ring. The method of claim 9, wherein the head part is made of plastic. The method of claim 9, further comprising forming an outer groove in the at least one electrical contact ring. to pick up the pen. The method of claim 9, wherein the at least one electrical contact ring comprises an annular inner groove and a spring positioned in the groove. The method of claim 12, wherein the spring is a canted coil spring. The method of claim 12, wherein the annular groove comprises two side walls and a bottom wall therebetween. The method of claim 9, wherein the head part has a parting line and consists of at least two housing sections.

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