Implant connector enhanced seals for implantable medical devices

Abstract

An implantable medical device is described herein that includes a housing, a head coupled to the housing, and a stack of receptacle connectors disposed in the head. The receptacle connector stack includes a plurality of electrical contacts and a plurality of scratch seals. Each of the plurality of electrical contacts is separated by a corresponding scratch seal. A first sealing element is disposed at a proximal end of the receptacle connector stack and a second sealing element is disposed at a distal end of the receptacle connector stack. Sealing elements are mounted on respective sealing housings. A third sealing element is disposed proximate to the first sealing element and closer to the connector stack to limit a rebound effect caused by one or more of the plurality of scratch seals during insertion of the lead.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 348,416, filed on June 2, 2022, and U.S. Provisional Application No. 63 / 391,897, filed on July 25, 2022, the disclosures of which are incorporated herein in their entireties for all purposes. Technical Field

[0002] The present disclosure relates generally to implantable medical devices and related components. More particularly, the present disclosure relates to sealing elements used in implantable medical devices, such as ventricular assist device controllers. Background Art

[0003] A ventricular assist device (known as a VAD) is an implantable blood pump used for both short-term (i.e., days, months) and long-term applications (i.e., years or a lifetime) when a patient's heart is unable to provide adequate circulation (commonly known as heart failure or congestive heart failure). According to the American Heart Association, more than five million Americans have heart failure, and approximately 670,000 new cases are diagnosed each year. People with heart failure often experience shortness of breath and fatigue. Years of living with clogged arteries or high blood pressure can weaken the heart and make it unable to pump enough blood to the body. As symptoms worsen, advanced heart failure occurs.

[0004] Patients with heart failure (also known as congestive heart failure) can use a VAD while awaiting a heart transplant or use the VAD as a long-term destination therapy. In another example, a patient can use a VAD while their native heart recovers. Thus, the VAD can assist a weakened heart (i.e., partially support) or can effectively replace the function of the native heart. The VAD system of the present invention can be fully implanted in the patient and powered by an implantable electrical power source in the patient. Summary of the invention

[0005] The present disclosure relates to an implantable medical device, such as a VAD controller, including a connector assembly. The connector assembly includes a female socket (referred to as a socket connector stack) configured to receive a male lead body to establish an electrical connection (e.g., power and / or communication) between electronic components disposed in the implantable controller and / or other components of the VAD system. The connector assembly should be properly sealed to prevent body fluids from entering the connector assembly and the interior of the associated head. In addition, the connector assembly should provide electrical isolation between the contacts. Traditional scraper seals or blades disposed between the contacts typically provide a degree of electrical isolation and liquid leakage suppression while facilitating low lead insertion force. Some implantable medical devices, such as VAD controllers (or high-power devices with four or more conductors), have a strict power profile that requires these devices to be in an on state all or most of the time because continuous power is required to operate the VAD system. For example, a VAD system is a relatively high-power system in which the VAD controller supplies an average of about 3W to about 6W of power and a peak power of about 8W to about 15W to operate the VAD. Therefore, the electrical contacts at the proximal and distal ends of such high-power medical devices should be additionally isolated to further minimize stray currents and fluid leakage from the external environment, thereby improving device and patient safety, durability, and performance considerations.

[0006] The present disclosure provides an enhanced sealing element, which can be arranged in an implantable medical device and is configured to inhibit liquid from entering from the distal and proximal ends of a socket connector stack. For example, the sealing element can be an O-ring. The O-ring can be installed on an O-ring housing arranged at the distal end of the socket connector stack. Another O-ring can be installed on another O-ring housing arranged at the proximal end of the socket connector stack. The sealing element provides an additional contact isolation layer beyond traditional scraping blades. The sealing element also inhibits any stray current that may enter or leak into the electrical contact. In addition, the sealing element can be configured to easily receive a lead without increasing the significant insertion force of the connector assembly. Therefore, the sealing element advantageously provides an increase in isolation between contacts from stray currents and reduces liquid from entering the external environment of the implantable medical device without significantly increasing the lead insertion force.

[0007] It can also be appreciated that the implantable medical device has an overall size that is small enough to be implanted in the patient's body. Therefore, the size of the components in the implantable medical device should also be designed to be small enough. However, if the size of the sealing element is too small, the manufacture and assembly of such components may be difficult. For example, during the assembly process, the fingers of the technician may become fatigued over time. The present disclosure provides a sealing housing that helps the size of the sealing element to be properly designed and easy to assemble. In addition, the sealing element can be an O-ring having an inner diameter in the range of 0.115 inches to 0.375 inches and an outer diameter in the range of 0.145 inches to 0.515 inches, so as to facilitate assembly and provide improved sealing performance. The most effective O-ring material is a long-term implant grade rubber material with a Shore A hardness in the range of 30-90. Silicone is a widely used and common implant grade rubber.

[0008] In the process of inserting the lead into the socket connector stack, the conventional scraping blade may apply force to the lead in some instances, thereby causing the lead to be over-inserted or misaligned with the contact. This undesirable axial displacement or misalignment of the lead relative to its original insertion position is called the rebound effect. In order to solve this rebound effect problem, the present disclosure provides an implantable medical device that also includes a rebound reducer (such as a sealing element arranged at the proximal end of the socket stack). The rebound reducer advantageously reduces the rebound effect that may cause the lead in the socket connector stack to be axially displaced, thereby improving the alignment between the electrical contact of the lead and the connector stack. For example, the axial offset is in the range of 0.01 inch to 0.15 inch. And the axial offset can be minimized by the rebound reducer. In addition, the rebound reducer can be retrofitted into other implant connector designs. The rebound reducer can be in the form of an inclined or cantilever spring, an O-ring, a synchronization feature, or any other elastic (complaint) member.

[0009] Thus, in one aspect, an implantable medical device is described that includes an implant connector having a reinforced sealing element for improving sealing performance. The implantable medical device includes a housing, a head coupled to the housing, and at least one socket connector stack disposed in the head. The at least one socket connector stack includes a plurality of electrical contacts and a plurality of wiper seals. Each of the plurality of electrical contacts is separated by a corresponding wiper seal. A first sealing element is disposed at a proximal end of the at least one socket connector stack, and a second sealing element is disposed at a distal end of the at least one socket connector stack.

[0010] In many embodiments, the first sealing element is configured to inhibit liquid ingress and stray current from the external environment at the proximal end of at least one socket connector stack, and the second sealing element is configured to inhibit liquid ingress and stray current from the external environment at the distal end of at least one socket connector stack. The first sealing element and the second sealing element may include O-rings. The inner diameter of each O-ring is in the range of 0.115 inches to 0.375 inches, and the outer diameter of each O-ring is in the range of 0.145 inches to 0.515 inches.

[0011] In many embodiments, the implantable medical device further comprises a proximal seal housing, which is configured to receive a first seal element. Similarly, the distal seal housing is configured to receive a second seal element. In many embodiments, the proximal seal housing and the distal seal housing are separate components assembled together with at least one socket connector stack. In some embodiments, the proximal seal housing and the distal seal housing are formed integrally with at least one socket connector stack. The proximal seal housing comprises a retaining mechanism, which is configured to engage with at least one socket connector stack and the head.

[0012] In many embodiments, retaining mechanism comprises at least one of press fit, extrusion rib fit, snap fit, retaining ring or thread fit.For press fit, the size of the periphery of proximal seal housing is designed to be closely matched with the inner periphery of the proximal end of head.For extrusion rib fit, the periphery of proximal seal housing comprises one or more ribs, and one or more ribs are configured to embed in the inner periphery of the proximal end of head.For snap fit, the periphery of proximal seal housing comprises one or more snap elements, and one or more snap elements are configured to engage with the inner periphery of the proximal end of head.For retaining ring, retaining ring is attached on the periphery of proximal seal housing, to fix proximal housing on housing, and limit axial movement at proximal end.For thread fit, the periphery of proximal seal housing comprises thread, and thread is configured to engage with the thread on the inner periphery of the proximal end of housing.

[0013] In many embodiments, the implantable medical device further comprises a third sealing element disposed proximate the first sealing element and more proximal to at least one socket connector stack to limit a rebound effect caused by one or more of the plurality of scraper seals. In many embodiments, the implantable medical device is a ventricular assist device (VAD) implantable controller, the VAD implantable controller being configured to generate control signals to control blood flow and provide power to the VAD. In many embodiments, the head comprises two socket connector stacks spaced apart from each other, each connector stack comprising six contacts for supplying power to and communicating with the VAD and the TETS. At least one socket connector comprises a first socket connector stack, the first socket connector stack being spaced apart from and electrically isolated from a second socket connector stack.

[0014] In another aspect, a fully implantable left ventricular assist system (FILVAS) includes a heart pump, an implantable transcutaneous energy transfer system (TETS) receiver, a first implantable lead, a second implantable lead, and an implantable controller. The heart pump is configured to pump blood from the ventricle of the patient's heart to the artery to supplement or replace the blood pumped from the ventricle to the artery. The TETS receiver is configured to receive and transmit power to continuously operate the heart pump. The implantable controller is communicatively coupled to the heart pump via the first implantable lead and communicatively coupled to the TETS receiver via the second implantable lead.

[0015] In many embodiments, the implantable controller includes: a housing; a head coupled to the housing; a first socket connector stack disposed in the head and configured to receive a first implantable lead and establish an electrical coupling between the implantable controller and a heart pump; and a second socket connector stack disposed in the head and configured to receive a second implantable lead and establish an electrical coupling between the implantable controller and a TETS receiver. Each of the first socket connector stack and the second socket connector stack includes: a plurality of electrical contacts configured to couple with a corresponding implantable lead; a plurality of wiper seals, each electrical contact isolated by a corresponding wiper seal; a proximal sealing element disposed at a proximal end of the corresponding socket connector stack; and a distal sealing element disposed at a distal end of the corresponding socket connector stack. In many embodiments, the proximal sealing element and the distal sealing element are O-rings.

[0016] In many embodiments, the fully implantable left ventricular assist system further comprises a proximal seal housing for each of the first and second socket connector stacks, the proximal seal housing being configured to receive a proximal seal element and being coupleable to the proximal end of the corresponding socket connector stack. The distal seal housing being configured to receive a distal seal element and being coupleable to the distal end of the corresponding socket connector stack. Each proximal seal housing comprises a retaining mechanism configured to engage with the corresponding socket connector stack and the head.

[0017] In many embodiments, the head also includes a rebound reducer, which is disposed in the head and is located at the proximal end of the corresponding proximal sealing element. The rebound reducer is configured to engage with the corresponding implantable lead and limit the rebound effect caused by the force applied by one or more scraper seals in the plurality of scraper seals when the corresponding implantable lead is inserted into the corresponding socket connector stack. In many embodiments, the rebound reducer is a tilted spring, an O-ring, or an elastic member. In many embodiments, the head also includes a box with a groove for receiving the rebound reducer.

[0018] In many embodiments, the head also includes a vent or diaphragm, which is located distally of the distal sealing element of the corresponding socket connector stack to prevent hydrostatic locking between the corresponding implantable lead and the corresponding socket connector stack. The distal sealing element inhibits the entry of liquid from the vent or diaphragm. In many embodiments, the first implantable lead includes an electrical contact configured to couple with a corresponding electrical contact of the first socket connector stack, and a cable for facilitating communication and power supply between the implantable controller and the heart pump. The second implantable lead includes an electrical contact configured to couple with a corresponding electrical contact of the second socket connector stack, and a cable for facilitating communication and power supply between the implantable controller and the TETS receiver. The first socket connector stack is spaced apart and electrically isolated from the second socket connector stack by a corresponding proximal sealing element and a corresponding distal sealing element.

[0019] In another aspect, an implantable lead of an implantable medical device is described. The implantable lead includes an elongated shaft, a stem, a plurality of electrical contacts, a reinforcing member, and a plurality of wires. The elongated shaft has a proximal end and a distal end, the elongated shaft has a diameter of approximately 3.2 mm, and the stem is coupled to the proximal end of the elongated shaft. The plurality of electrical contacts are disposed on the outer surface of the elongated shaft and are axially spaced apart from each other. The plurality of electrical contacts include a first electrical contact and a second electrical contact for power transmission, a third electrical contact and a fourth electrical contact for communication, and a fifth electrical contact and a sixth electrical contact for grounding. The reinforcing member is axially disposed within the elongated shaft. The plurality of wires are electrically coupled to the plurality of electrical contacts and extend axially within the elongated shaft. The plurality of wires include: a first wire and a second wire, the first wire and the second wire are electrically coupled to the first electrical contact and the second electrical contact, respectively; a third wire and a fourth wire, the third wire and the fourth wire are electrically coupled to the third electrical contact and the fourth electrical contact, respectively; and a fifth wire and a sixth wire, the fifth wire and the sixth wire are electrically coupled to the fifth electrical contact and the sixth electrical contact, respectively. The reinforcing member and the plurality of wires electrically isolated from each other are configured to be constrained within the diameter of the elongated shaft.

[0021] In many embodiments, the implantable lead further comprises an insulating cover disposed on each of the plurality of wires. In many embodiments, the plurality of electrical contacts are separated by an injection molded insulating material for electrical isolation. In many embodiments, a first electrical contact and a second electrical contact for power transmission are disposed at the distal portion of the elongated shaft. A fifth electrical contact and a sixth electrical contact for grounding are disposed at the proximal portion of the elongated shaft. A third electrical contact and a fourth electrical contact for communication are disposed between the proximal portion and the distal portion of the elongated shaft.

[0022] In many embodiments, the stem includes a shoulder at a distal portion of the stem, the elongated shaft being configured at the shoulder to receive a sealing element of a head assembly, and a groove configured to receive a locking assembly for securely coupling the lead to a head assembly of a second implantable medical device. In many embodiments, the implantable lead includes a ventricular assist device (VAD) lead or a transcutaneous energy transfer system (TETS) receiver lead. The implantable lead is coupled to a socket connector stack of an implantable controller.

[0023] In another aspect, a fully implantable left ventricular assist system (FILVAS) is described. The system includes an implantable heart pump, an implantable transcutaneous energy transfer system (TETS) receiver, a first implantable lead, a second implantable lead, and an implantable controller. The implantable heart pump is configured to pump blood from the ventricle of the patient's heart to the artery to supplement or replace the pumping of blood from the ventricle to the artery. The implantable transcutaneous energy transfer system (TETS) receiver is configured to receive and transmit power to continuously operate the implantable heart pump. The first implantable lead is coupled to the implantable heart pump. The first lead includes: a first elongated shaft; a first group of six electrical contacts, the first group of six electrical contacts are coaxially mounted on the outer surface of the first elongated shaft; a first group of six wires, the first group of six wires are disposed in the first elongated shaft, each wire is coupled to a corresponding electrical contact in the first group of six electrical contacts at one end, and is coupled to the implantable heart pump at an opposite end; and a first reinforcing member, the first reinforcing member is disposed in the first elongated shaft and is electrically isolated from the first group of six wires. A second implantable lead is coupled to the TETS receiver. The second lead includes: a second elongated shaft; a second set of six electrical contacts, the second set of six electrical contacts being coaxially mounted on an outer surface of the second elongated shaft; a second set of six electrical wires, the second set of six electrical wires being disposed within the second elongated shaft, each of the electrical wires being coupled at one end to a corresponding electrical contact in the second set of six electrical contacts and coupled to the TETS receiver at an opposite end; and a second reinforcement member, the second reinforcement member being disposed within the second elongated shaft and electrically isolated from the second set of six electrical wires. The diameter of the second implantable lead is greater than the diameter of the first implantable lead. The implantable controller includes: a first socket connector stack, the first socket connector stack being configured to receive the first implantable lead to electrically couple the implantable heart pump to the implantable controller; and a second socket connector stack, the second socket connector stack being configured to receive the second implantable lead to electrically couple the TETS receiver to the implantable controller. The first socket connector stack is spaced apart from the second socket connector stack.

[0024] In many embodiments, the first group of six electrical contacts of the first implantable lead includes: a first electrical contact and a second electrical contact for power transmission, a third electrical contact and a fourth electrical contact for communication, and a fifth electrical contact and a sixth electrical contact for grounding. The second group of six electrical contacts of the second implantable lead includes: a first electrical contact and a second electrical contact for power transmission, a third electrical contact and a fourth electrical contact for communication, and a fifth electrical contact and a sixth electrical contact for grounding. In many embodiments, the first implantable lead includes: a first electrical contact and a second electrical contact for power transmission are disposed at a distal portion of the first implantable lead. A fifth electrical contact and a sixth electrical contact for grounding are disposed at a proximal portion of the first implantable lead. A third electrical contact and a fourth electrical contact for communication are disposed between the proximal portion and the distal portion of the first implantable lead.

[0025] In many embodiments, the second implantable lead includes: a first electrical contact, which serves as a first voltage source and is disposed at a distal portion of the second implantable lead; a second electrical contact, which serves as a ground and is disposed adjacent to the proximal end of the first electrical contact; a third electrical contact, which serves as a power terminal and is disposed adjacent to the proximal end of the second electrical contact; a fourth electrical contact, which serves as a communication line and is disposed adjacent to the proximal end of the third electrical contact; a fifth electrical contact, which serves as another ground and is disposed adjacent to the proximal end of the fourth electrical contact; and a sixth electrical contact, which serves as another power terminal and is disposed at the proximal portion of the second implantable lead.

[0026] In many embodiments, the diameter of the proximal portion of the second implantable lead is greater than the diameter of the proximal portion of the first implantable lead. In many embodiments, the first implantable lead includes a first stem portion, the first stem portion is disposed at the proximal portion of the first slender shaft, and the second implantable lead includes a second stem portion, the second stem portion is disposed at the proximal portion of the second slender shaft. The diameter of the second stem portion is greater than the diameter of the first stem portion. Each of the first stem portion and the second stem portion includes a shoulder and a groove, the shoulder is used to mount a seal, and the groove is used to lock the corresponding lead to the head assembly of the implantable controller. In many embodiments, the first socket connector stack and the second socket connector stack each include a proximal sealing element and a distal sealing element. In many embodiments, each of the first implantable lead and the second implantable lead does not require tightening a set screw to electrically activate one or more conductive lines.

[0027] In another aspect, an implantable lead for an implantable medical device is described. The lead includes a stepped diameter elongated shaft, a plurality of electrical contacts, and a plurality of wires. The stepped diameter elongated shaft has a proximal portion and a distal portion, the proximal portion having a larger diameter than the distal portion. A plurality of electrical contacts are disposed on an outer surface of the stepped diameter elongated shaft and are spaced apart from each other in the axial direction, the plurality of electrical contacts including a first electrical contact and a second electrical contact for power transmission, a third electrical contact and a fourth electrical contact for communication, and a fifth electrical contact and a sixth electrical contact for grounding, wherein one or more of the electrical contacts have different diameters. A plurality of wires are electrically coupled to the plurality of electrical contacts and extend axially within the stepped diameter elongated shaft. The plurality of wires include: a first wire and a second wire, the first wire and the second wire being electrically coupled to a first electrical contact and a second electrical contact, respectively; a third wire and a fourth wire, the third wire and the fourth wire being electrically coupled to a third electrical contact and a fourth electrical contact, respectively; and a fifth wire and a sixth wire, the fifth wire and the sixth wire being electrically coupled to a fifth electrical contact and a sixth electrical contact, respectively.

[0028] In many embodiments, the stepped diameter elongated shaft comprises: a first diameter portion, the first diameter portion is configured to receive a first electrical contact and a second electrical contact for power transmission at a distal portion of the elongated shaft; a second diameter portion, the second diameter portion is configured to receive a third electrical contact and a fourth electrical contact for communication between the distal portion and the proximal portion of the elongated shaft; and a third diameter portion, the third diameter portion is configured to receive a fifth electrical contact and a sixth electrical contact for grounding at the proximal portion of the elongated shaft. The second diameter portion has a larger diameter than the first diameter portion; and the third diameter portion has a larger diameter than the second diameter portion. In many embodiments, the stepped diameter elongated shaft comprises a tapered diameter that gradually increases from the distal portion to the proximal portion, wherein each of the six electrical contacts has a different diameter. Optionally, the implantable lead further comprises a tapered reinforcement member that is axially disposed within the stepped diameter.

[0029] The foregoing general description of illustrative implementations and the following detailed description are merely exemplary aspects of the teachings of the present disclosure and are not limiting. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] The accompanying drawings, which have been incorporated into and constitute a part of this specification, illustrate one or more embodiments and together with the specification explain these embodiments. The accompanying drawings are not necessarily drawn to scale. Any values ​​and dimensions shown in the accompanying tables and figures are for illustrative purposes only and may or may not represent actual or preferred values ​​or dimensions.

[0031] Figure 1The diagram illustrates a medical system that includes an implantable percutaneous energy transfer system receiver, an implantable controller, and a ventricular assist device (VAD), in accordance with many embodiments.

[0032] Figure 2 is an illustration of a circulatory support system including a VAD implanted in a patient, in accordance with many embodiments.

[0033] Figure 3 yes Figure 2 Exploded view of the implanted components of a circulatory support system.

[0034] Figure 4 yes Figure 1 Illustration of a VAD attached to a patient's heart to augment blood pumping by the patient's left ventricle.

[0035] Figure 5 yes Figure 4 Cross-sectional view of a VAD.

[0036] Figure 6 yes Figure 1 A schematic diagram of an embodiment of an implant controller.

[0037] Figure 7 yes Figure 1 A cross-sectional view of a header and socket connector stack of an implantable controller with a sealing element disposed therein.

[0038] Figure 8 The figure shows a header with a stack of female socket connectors disposed therein.

[0039] Fig. 9 The figure shows a configuration to receive Figure 8 The male leads in the socket connector stack.

[0040] Fig.10 The diagram shows Figure 8 and Fig. 9 Assembly of leads within the socket connector stack.

[0041] Fig.11A The diagram illustrates a snap-fit ​​arrangement for attaching a receptacle connector stack to a header, in accordance with many embodiments.

[0042] Fig. 11B Shows Fig.11A An enlarged portion of a snap-in element of a snap-in device.

[0043] Fig. 12A The diagram illustrates a threaded attachment arrangement for coupling a receptacle connector stack to a header, in accordance with many embodiments.

[0044] Fig. 12BThe figure shows being inserted into the head and via Fig. 12A The threaded means for coupling the receptacle connectors is stacked.

[0045] Fig.13A An illustration of a retention ring for coupling a receptacle connector stack to a header, in accordance with many embodiments.

[0046] Fig. 13B Figure 1 shows a stack of socket connectors coupled to the Fig.13A An enlarged portion of the retaining ring.

[0047] Fig.14A The diagram illustrates a press fit for coupling a receptacle connector stack to a header, in accordance with many embodiments.

[0048] Fig. 14B The diagram shows Fig.14A Cross section of a press-fit socket connector stack.

[0049] Fig.15A The diagram illustrates a compression rib mating for coupling a receptacle connector stack to a header, in accordance with many embodiments.

[0050] Fig. 15B The diagram shows Fig.15A Cross section of an extruded rib mating receptacle connector stack.

[0051] Fig.16 An illustration of a perspective view of an implantable lead is shown in accordance with many embodiments.

[0052] Fig.17 The figure illustrates a front view of an implantable lead that can be coupled to an implantable medical device (eg, a ventricular assist device), in accordance with many embodiments.

[0053] Fig.18 An illustration of a front view of another implantable lead that can be coupled to another implantable medical device (eg, a TETS receiver), in accordance with many embodiments.

[0054] Fig.19 The diagram shows Figure 16-Figure 18 The cross-section of any implantable lead.

[0055] Fig. 20 The diagram shows Figure 16-Figure 18 A cross-section of the stem of any implantable lead.

[0056] Fig.21 An illustration shows an implantable controller coupled to a head, in accordance with many embodiments.

[0057] Fig. 22 A stepped diameter implantable lead and corresponding socket connector stack is shown according to another embodiment.

[0058] Fig.23 yes Fig. 22 Perspective view of the elongated shaft of a stepped diameter implantable lead.

[0059] Fig.24 yes Fig. 22 Frontal cross-sectional view of the elongated shaft of a stepped diameter implantable lead.

[0060] Fig.25 An implantable lead of an implantable medical device having four electrical contacts according to another embodiment is shown.

[0061] Fig.26 Another implantable lead of another implantable medical device having four electrical contacts according to another embodiment is shown.

[0062] Fig. 27 An implantable lead having three electrical contacts is shown according to another embodiment. DETAILED DESCRIPTION

[0063] The following description in conjunction with the accompanying drawings is intended to describe various embodiments of the disclosed subject matter and is not intended to represent a unique embodiment. In some cases, in order to provide an understanding of (multiple) disclosed embodiments, the description includes specific details. However, it will be apparent to those skilled in the art that (multiple) disclosed embodiments may be practiced without these specific details. In some instances, well-known structures and components may be shown in block diagram form to avoid blurring the concept of the disclosed subject matter. In the accompanying drawings, the same reference numerals represent the same components throughout multiple views.

[0064] Throughout this specification, references to "one embodiment" or "an embodiment" mean that a particular feature, structure, or characteristic described in conjunction with the embodiment is included in at least one embodiment of the disclosed subject matter. Thus, the appearance of the phrase "in one embodiment" or "in an embodiment" in various places throughout this specification does not necessarily refer to the same embodiment. Furthermore, in one or more embodiments, the particular features, structures, or characteristics may be combined in any suitable manner. Furthermore, the embodiments of the disclosed subject matter are intended to cover modifications and variations thereto.

[0065] It should be understood that terms such as "distal", "proximal", "top", "front", "side", "interior", etc. used herein may be used only to describe reference points and do not necessarily limit the embodiments of the present disclosure to any particular orientation or configuration. As used herein, "proximal" refers to the direction of the end of the socket connector stack near the clinician, and "distal" refers to the direction away from the clinician and (usually) toward the patient's body. In addition, terms such as "first", "second", "third", etc. are used only to identify one of the multiple parts, components, steps, operations, functions, and / or reference points disclosed herein, and likewise do not necessarily limit the embodiments of the present disclosure to any particular configuration or orientation.

[0066] As used herein, the terms "longitudinal," "axial," or "axially" generally refer to the longitudinal direction and are used to describe relative positions with respect to a receptacle connector stack or other components of the system herein. For example, "longitudinal" or "axial" refers to an axis along the center of a receptacle connector stack from the proximal end to the distal end. The term "radial" generally refers to a direction perpendicular to the "axial" direction.

[0067] Figure 1 The figure shows a medical system 100, which includes an implantable medical device 20 that can be coupled to one or more components of the medical system for treating a medical condition of a patient. The implantable medical device 20 can be a controller that is configured to control one or more components of the medical system and / or provide power to one or more components of the medical system. Therefore, the implantable medical device 20 can also be referred to as an implantable controller 20. The implantable controller 20 includes a housing 70 and a head 700 coupled to the housing 70. In many embodiments, the housing 70 can be made of titanium or a similar biocompatible material, and the head 700 can be formed of a resin (e.g., epoxy or other polymer) or plastic by injection molding on the housing 70. The housing 70 is hermetically sealed.

[0068] Figure 2A circulatory assist system 10 is shown that utilizes an implantable controller 20 and is combined with a ventricular assist device (VAD) 14 implanted in a patient 12. In many of the embodiments described herein, the circulatory assist system 10 includes: an implantable VAD 14 coupled to a patient's heart 30; an implantable controller 20 that controls the operation of the VAD 14 and provides power to the VAD 14; and an implantable transcutaneous energy transfer system (TETS) power receiver 22 that provides power to the implantable controller 20. The VAD 14, as shown, may be a centrifugal flow blood pump or an axial flow blood pump that may be operated in a pulsatile mode (by increasing the rotational speed of the VAD to generate blood pressure pulses) or in a constant speed mode (where the VAD rotation rate remains constant).

[0069] refer to Figures 1 to 3 , the circulatory assist system 10 also includes: an implantable ventricular cuff 16; an implantable outflow cannula 18; an external TETS power transmitter 24; an implantable controller to VAD connection cable 26; and an implantable TETS receiver to controller connection cable 28. The VAD 14 can be coupled to the apex of the left ventricle via the ventricular cuff 16, as shown, or the right ventricle, or separate VADs can be attached to each of the ventricles of the heart 30. Therefore, depending on the medical application, the system 10 can also be referred to as a fully implantable left ventricular assist system (FILVAS) 10. Examples of such FILVAS are further described in U.S. Pat. No. 8,562,508 and U.S. Pat. No. 9,079,043, all of which are incorporated herein by reference in their entirety for all purposes.

[0070] As described in more detail below, the VAD 14 may be capable of pumping the entire blood flow delivered from the pulmonary circulation to the left ventricle (i.e., up to 10 liters per minute). Related blood pumps suitable for use with the present disclosure are also disclosed in U.S. Pat. Nos. 5,695,471, 6,071,093, 6,116,862, 6,186,665, 6,234,772, 6,264,635, 6,688,861, 7,699,586, 7,976,271, 7,997,854, 8,007,254, 8,152, 493, 8,419,609, 8,652,024, 8,668,473, 8,852,072, 8,864,643, 8,882,744, 9,068,572, 9,091,271, 9,265,870, and 9,382,908, all of which are incorporated herein by reference in their entirety for all purposes. VAD 14 may be attached to heart 30 via ventricular cuff 16, which may be sutured to heart 30 and coupled to VAD 14. In the illustrated embodiment, the output of VAD 14 is connected to the ascending aorta via outflow cannula 18, such that VAD 14 effectively diverts blood from the left ventricle and pushes it to the aorta for circulation through the rest of the patient's vascular system.

[0071] A controller-to-VAD connection cable 26 connects the VAD 14 to an implantable controller 20 for operation of the monitoring system 10. Related controller systems suitable for use with the present disclosure are described in more detail below and in U.S. Pat. Nos. 5,888,242, 6,991,595, 8,323,174, 8,449,444, 8,506,471, 8,597,350, and 8,657,733, European Patent No. 1812094, and U.S. Patent Publication Nos. 2005 / 0071001 and 2013 / 0314047, all of which are incorporated herein by reference in their entirety for all purposes. The implantable controller 20 is configured to supply power to the VAD 14 and control the operation of the VAD 14. Implantable controller 20 is configured to be implanted in a suitable location within patient 12 spaced apart from VAD 14 , and is operatively coupled to VAD 14 via a controller-to-VAD connection cable 26 .

[0072] The TETS power receiver 22 is configured to wirelessly receive power transmitted by an external TETS power transmitter 24, which is located outside the body for powering the operation of the system 10. The TETS power receiver 22 is configured to be implanted in a suitable location within the patient 12 that is spaced apart from the VAD 14 and the controller 20. The TETS power receiver 22 is operatively coupled to the controller 20 via an implantable TETS power receiver-to-controller connection cable 28 and supplies power to the controller 20. In addition, the TETS power transmitter 24 is configured to be coupled to an electrical power source 212, such as a wall outlet or other suitable external power source.

[0073] refer to Figure 4 and Figure 5 , VAD 14 has a circular or disc-shaped housing 110 and is shown implanted in patient 12, wherein a first side 111 of housing 110 is positioned against the patient's heart 30 and a second side 113 of housing 110 faces away from heart 30. First side 111 of housing 110 includes inlet cannula 112 extending into the left ventricle LV of heart 30. Second side 113 of housing 110 has chamfered edges 114 to avoid irritation of other tissue that may come into contact with VAD 14, such as the patient's septum. In order to construct the shape of disc-shaped housing 110 shown in a compact form, stator 120 and electronics 130 of VAD 14 are positioned on the inflow side of the housing facing first side 111, and rotor 140 of VAD 14 is positioned along second side 113. This positioning of stator 120, electronics 130, and rotor 140 allows edge 114 to be chamfered along the contour of rotor 140, for example, at least as Figure 4 and Figure 5 shown.

[0074] Reference Figure 5 , the VAD 14 includes a partition wall 115 within the housing 110, the partition wall 115 defining a blood flow conduit 103. The blood flow conduit 103 extends from an inlet opening 101 of the inlet cannula 112 through the stator 120 to an outlet opening 105 defined by the housing 110. A rotor 140 is positioned within the blood flow conduit 103. The stator 120 is circumferentially disposed around a first portion 140a of the rotor 140, such as around a permanent magnet 141. The stator 120 is also positioned relative to the rotor 140 so that, in use, blood flows through the stator 120 within the blood flow conduit 103 before reaching the rotor 140. The permanent magnet 141 has a permanent magnetic north pole N and a permanent magnetic south pole S for combined active and passive magnetic suspension of the rotor 140 and for rotation of the rotor 140. The rotor 140 also has a second portion 140b including impeller blades 143. The impeller blade 143 is located in the volute 107 of the blood flow conduit such that the impeller blade 143 is close to the second surface 113 of the housing 110 .

[0075] The disc-shaped housing 110 further includes a circumferential wall 116 extending between the first face 111 and the removable cover 118. As shown, the circumferential wall 116 is formed as a hollow circular cylinder with a width W between opposing portions of the circumferential wall 116. The housing 110 also has a thickness T between the first face 111 and the second face 113, the thickness T being less than the width W. The thickness T is from about 0.5 inches to about 1.5 inches, and the width W is from about 1 inch to about 4 inches. For example, the width W may be about 2 inches, and the thickness T may be about 1 inch.

[0076] The circumferential wall 116 encloses an interior compartment 117 surrounding the dividing wall 115 and the blood flow conduit 103, wherein the stator 120 and the electronic device 130 are disposed in the interior compartment 117 around the dividing wall 115. The removable cover 118 includes a second face 113, a chamfered edge 114, and defines the outlet opening 105. The cover 118 can be threadedly engaged with the circumferential wall 116 to seal the cover 118 by engagement with the circumferential wall 116. The cover 118 includes an inner surface 118a of the cover 118, which defines a volute 107 in fluid communication with the outlet opening 105.

[0077] Within the interior compartment 117, the electronic device 130 is positioned adjacent to the first face 111, and the stator 120 is positioned adjacent to the electronic device 130 on a side of the electronic device 130 opposite to the first face 111. The electronic device 130 includes a circuit board 131 and various components carried on the circuit board 131 to control the operation of the VAD 14 (e.g., magnetic levitation and / or driving of the rotor) by controlling the power supply to the stator 120. The housing 110 is configured to receive the circuit board 131 within the interior compartment 117 substantially parallel to the first face 111 to effectively utilize the space within the interior compartment 117. The circuit board also extends radially inward toward the partition wall 115 and radially outward toward the circumferential wall 116. For example, the size of the interior compartment 117 is generally designed to be no larger than the size required for receiving the circuit board 131, as well as the space required for heat dissipation, material expansion, potting materials, and / or other elements for mounting the circuit board 131. Therefore, the outer shape of the housing 110 proximate the first face 111 generally closely conforms to the shape of the circuit board 131 to provide an outer dimension that is not significantly larger than the dimensions of the circuit board 131 .

[0078] Continue to refer Figure 5 , the stator 120 includes a back iron 121 and pole pieces 123a-123f, which are arranged spaced apart around the partition wall 115. The back iron 121 extends around the partition wall 115 and is formed as a generally flat disk of ferromagnetic material (such as steel) to conduct magnetic flux. The back iron 121 is arranged next to the control electronics 130 and provides a base for the pole pieces 123a-123f.

[0079] Each of the pole pieces 123a-123f is L-shaped and has a drive coil 125 for generating an electromagnetic field to rotate the rotor 140. For example, the pole piece 123a has a first leg 124a that contacts the back iron 121 and extends from the back iron 121 toward the second face 113. The pole piece 123a may also have a second leg 124b that extends from the first leg 124a through an opening of the circuit board 131 toward the partition wall 115 near the location of the permanent magnet 141 of the rotor 140. In one aspect, each of the second legs 124b of the pole pieces 123a-123f is inserted through the opening of the circuit board 131. In one aspect, each of the first legs 124a of the pole pieces 123a-123f is inserted through the opening of the circuit board 131. In one aspect, the opening of the circuit board encloses the first legs 124a of the pole pieces 123a-123f.

[0080] In a general aspect, the VAD 14 can include one or more Hall sensors that can provide an output voltage that is proportional to the strength of the magnetic field between at least one of the pole pieces 123a-123f and the permanent magnet 141, and the output voltage can provide feedback to the control electronics 130 of the VAD 14 to determine if the rotor 140 and / or the permanent magnet 141 are not in their expected positions for operation of the VAD 14. For example, the position of the rotor 140 and / or the permanent magnet 141 can be adjusted, for example, the rotor 140 or the permanent magnet 141 can be pushed or pulled toward the center of the blood flow conduit 103 or the center of the stator 120.

[0081] Each of the pole pieces 123a-123f also has a suspension coil 127 for generating an electromagnetic field to control the radial position of the rotor 140. Each of the drive coil 125 and the suspension coil 127 includes a plurality of windings of a conductor around the pole pieces 123a-123f. Specifically, each of the drive coils 125 is wound around two adjacent pole pieces (such as pole pieces 123d and 123e) in the pole piece 123, and each suspension coil 127 is wound around a single pole piece. The drive coil 125 and the suspension coil 127 are wound around the first leg of the pole piece 123, and the magnetic flux generated by passing current through the coils 125 and 127 during use is conducted through the first and second legs of the pole piece 123 and the back iron 121. The drive coils 125 and suspension coils 127 of the stator 120 are arranged in opposing pairs and are controlled to drive the rotor and radially levitate the rotor 140 by generating an electromagnetic field that interacts with the permanent magnetic poles S and N of the permanent magnets 141. Since the stator 120 includes both the drive coils 125 and the suspension coils 127, only a single stator is required to levitate the rotor 140 using only passive and active magnetic forces. In this configuration, the permanent magnet 141 has only one magnetic moment and is formed by a monolithic permanent magnet 141. For example, the stator 120 can be controlled as discussed in U.S. Patent No. 6,351,048, the entire contents of which are incorporated herein by reference for all purposes. The control electronics 130 and the stator 120 are connected via a controller to a VAD connection cable 26 ( Figure 4 ) receives power, data, and control signals from implant controller 20. Other related patents, namely, U.S. Pat. Nos. 5,708,346, 6,053,705, 6,100,618, 6,222,290, 6,249,067, 6,278,251, 6,351,048, 6,355,998, 6,634,224, 6,879,074, and 7,112,903, all of which are incorporated herein by reference in their entirety for all purposes.

[0082] The rotor 140 is arranged in the housing 110 so that the permanent magnet 141 of the rotor 140 is located upstream of the impeller blades, closer to the inlet opening 101. The permanent magnet 141 is received in the blood flow conduit 103 near the second leg 124b of the pole piece 123 to provide a passive axial centering force through the interaction of the permanent magnet 141 with the ferromagnetic material of the pole piece 123. When the rotor 140 is centered in the partition wall 115, the permanent magnet 141 of the rotor 140 and the partition wall 115 form a gap 108 between the permanent magnet 141 and the partition wall 151. The gap 108 can be from about 0.2 mm to about 2 mm. For example, the gap 108 can be about 1 mm. The north permanent magnetic pole N and the south permanent magnetic pole S of the permanent magnet 141 provide a permanent magnetic attraction between the rotor 140 and the stator 120, which acts as a passive axial centering force that tends to maintain the rotor 140 generally centered within the stator 120 and tends to resist the movement of the rotor 140 toward the first face 111 or toward the second face 113. When the gap 108 is small, the magnetic attraction between the permanent magnet 141 and the stator 120 is large, and the size of the gap 108 is designed to allow the permanent magnet 141 to provide a passive magnetic axial centering force with a magnitude sufficient to limit the rotor 140 from contacting the inner surface 118a of the partition wall 115 or the cover 118. The rotor 140 also includes a shroud 145 that covers the end of the impeller blade 143 facing the second face 113, and the shroud 145 helps to guide the blood flow into the volute 107. When the rotor 140 is suspended by the stator 120, the shield 145 and the inner surface 118a of the cover 118 form a gap 109 between the shield 145 and the inner surface 118a. The gap 109 is from about 0.2 mm to about 2 mm. For example, the gap 109 is about 1 mm.

[0083] As blood flows through the blood flow conduit 103, the blood flows through the central aperture 141a formed through the permanent magnet 141. The blood also flows through the gap 108 between the rotor 140 and the partition wall 115, and through the gap 109 between the shield 145 and the inner surface 108a of the cover 118. The gaps 108 and 109 are large enough to allow sufficient blood flow to limit the formation of clots that may occur when the blood is allowed to become stagnant. The gaps 108 and 109 are also large enough to limit the pressure on the blood cells, thereby preventing the blood from being damaged when flowing through the VAD 14. Because the size of the gaps 108 and 109 limits the pressure on the blood cells, the gaps 108 and 109 are too large to provide a meaningful hydrodynamic suspension effect. That is, the blood does not act as a bearing within the gaps 108 and 109, and the rotor is only magnetically suspended. In various embodiments, the size and dimensions of the gaps 108 and 109 are designed so that the blood flowing through the gaps can form a film that provides a hydrodynamic suspension effect. In this way, the rotor can be suspended by magnetic forces, hydrodynamic forces, or both.

[0084] Because the rotor 140 is radially suspended by active control of the suspension coils 127 as previously described, and because the rotor 140 is axially suspended by passive interaction of the permanent magnets 141 and the stator 120, no magnetic field generating rotor suspension components are required near the second face 113. The integration of all components for rotor suspension (i.e., the suspension coils 127 and the pole pieces 123) in the stator 120 allows the profile of the cover 118 to match the shape of the impeller blades 143 and the volute 107. Additionally, the integration of the rotor suspension components in the stator 120 eliminates the need for electrical connectors extending from the compartment 117 to the cover 118, which allows the cover to be easily installed and / or removed and eliminates a potential source of pump failure.

[0085] In use, the drive coil 125 of the stator 120 generates an electromagnetic field through the pole piece 123, which selectively attracts and repels the magnetic north pole N and the magnetic south pole S of the rotor 140 to cause the rotor 140 to rotate within the stator 120. For example, one or more Hall sensors can sense the current position of the rotor 140 and / or the permanent magnet 141, wherein the output voltage of the one or more Hall sensors can be used to selectively attract and repel the magnetic north pole N and the magnetic south pole S of the rotor 140 to cause the rotor 140 to rotate within the stator 120. As the rotor 140 rotates, the impeller blades 143 force blood into the volute 107, so that the blood is forced to flow out of the outlet opening 105. Additionally, the rotor draws blood into the VAD 14 through the inlet opening 101. As blood is drawn into the blood pump through the rotation of the impeller blades 143 of the rotor 140, the blood flows through the inlet opening 101 and flows through the control electronics 130 and the stator 120 to the rotor 140. The blood flows through the aperture 141a of the permanent magnet 141, flows between the impeller blades 143, the shroud 145 and the permanent magnet 141, and flows into the volute 107. The blood also flows around the rotor 140, flows through the gap 108 and flows through the gap 109 between the shroud 145 and the inner surface 118a of the cover 118. The blood leaves the volute 107 through the outlet opening 105, which can be coupled to the outflow cannula 18.

[0086] Figure 6 yes Figure 1Schematic diagram of an embodiment of an implantable controller 20. The implantable controller 20 includes a printed circuit board assembly (PCBA) 50, a controller battery unit 52, and a haptic unit 60. In the illustrated embodiment, the PCBA 50 includes a memory 54, a processor 56, and a communication unit 58. In some embodiments, the PCBA 50 includes a motor control unit 62 that is configured to control a drive current supplied to the motor stator 120 of the VAD 14 to control the rotation rate of the rotor / impeller 140, thereby controlling the flow rate of blood flow through the VAD 14. In some embodiments, the PCBA 50 may optionally include a remote accelerometer 32 for measuring accelerations generated by operation of the VAD 14. The remote accelerometer 32 may be alternately attached to an inner surface of the housing 70 and operatively coupled to another PCBA.

[0087] The memory 54 may store appropriate instructions executable by the processor 56 for processing, for example, automatically adjusting the VAD impeller rotation speed in response to the patient's physiological needs, determining any suitable number of physiological states of the patient, monitoring the condition of the VAD 14, and / or other functions associated with other components such as remote accelerometers. The controller battery unit 52 may store energy for operating the VAD 14, the controller 20, and / or the TETS power receiver 22 during periods of time when the TETS power receiver coil is not receiving power. The communication unit 58 may be configured to transmit control commands to the VAD 14 via the implantable controller to VAD connection cable 26. The communication unit 58 may also include a suitable wireless communication unit for receiving programming updates and / or for sending alarms, VAD operating data, and / or patient physiological data to an external system monitor.

[0088] The controller 20 can be configured so that the haptic unit 60 is operated to generate a haptic alarm to alert the patient that the power stored in the controller battery unit 52 and / or the TETS receiver battery unit 40 has dropped below a suitable minimum threshold so that the patient can take action to use the TETS power transmitter 24 to transmit power to the TETS power receiver 22 to recharge the controller battery unit 52 and / or the TETS power receiver battery unit. In order to prevent a long-term potential failure of the haptic unit 60, the controller 20 can periodically command the operation of the haptic unit 60 to determine whether the haptic unit 60 is operating normally or in a faulty state. If the controller 20 determines that the haptic unit 60 is in a faulty state, the controller 20 can transmit an appropriate alarm indicating the failure of the haptic unit 60 via wireless communication of the communication unit 58.

[0089] refer to Figures 7 to 10 , discussed in detail below Figure 1The present invention relates to a configuration of a head 700 of an implantable controller 20 in a TETS power receiver 22, and a lead that can be received in the head 700, which is used to electrically couple the implantable controller 20 with the VAD 14 and / or the TETS power receiver 22 for power supply and / or communication transmission (e.g., data, control signals). It can be appreciated by those skilled in the art that the head configuration and the implantable medical device (e.g., the controller 20) described herein are only used as examples to explain the concepts of the present disclosure and do not limit the scope of the present disclosure. For example, the present disclosure may also be applicable to other implantable medical devices (e.g., having four or more conductors in the head) with higher power consumption requirements outside of a blood circulation assistance system, such as implantable neurostimulators, pacemakers, and the like. In addition, the present disclosure may be applicable to other components of a blood circulation assistance system, such as a bulkhead connector of a TETS power receiver or other implantable modules, such as the controller module discussed in U.S. Patent No. 10,610,692, all of the contents of which are incorporated herein by reference for all purposes.

[0090] Figure 7 The figure shows a portion of a head 700 of an implantable medical device coupled to a housing 70. The head 700 includes at least one socket connector stack 710 having a proximal end and a distal end. The socket connector stack 710 is disposed within the head 700 and is configured to be coupled to the housing 70. Figure 1 The VAD 14 and / or TETS 22 shown are electrically coupled. In many embodiments, the head 700 includes a box 701 and a head portion 702 extending from the distal end of the box. The box 701 is configured to receive a socket connector stack 710 and lock the socket connector stack 710 in place within the head 700. The box 701 is the proximal end of the head 700 and can be integrally formed with the rest of the head 700. In some embodiments, the box 701 can be formed separately and attached to the proximal end of the head portion 702. After the socket connector stack 710 is fully inserted into the box 701, the distal extension portion 702 accommodates and receives the socket connector stack 710. Various locking mechanisms for coupling the socket connector stack 710 to the head 700 at the proximal portion will be discussed in detail below in conjunction with Figures 11-15.

[0091] In many embodiments, the header 700 includes two receptacle connector stacks (referred to as 710A and 710B, respectively, in FIGS. 11-15 ) that are spaced apart and electrically isolated from each other. Figure 1As shown, a first socket connector stack (e.g., 710A) is configured to facilitate power supply and communication between the VAD 14 and the controller 20 via an implantable controller to VAD connection cable 26, and a second socket connector stack (e.g., 710B) is configured to facilitate power supply and communication between the TETS power receiver 22 and the controller 20 via an implantable TETS power receiver to controller connection cable 28.

[0092] refer to Figure 7 and Figure 8 , the socket connector stack 710 includes a plurality of electrical contacts 712a-712f (collectively referred to as 712) and a plurality of wiper seals 714a-714f (collectively referred to as 714). The plurality of contacts 712 are linearly spaced apart from each other by an insulating member 715, wherein the insulating member 715 provides electrical isolation between the contacts 712 and provides a support structure for additional components used to seal against liquid ingress, electrical isolation, and / or assemble the socket connector stack 710 with the header 700. In the illustrated example, the socket connector stack 710 includes six electrical contacts, two of which can be used for power transmission and four of which can be used for communication purposes (e.g., data, control signals, etc.). Each electrical contact (e.g., 712a) in the plurality of electrical contacts 712 is separated from an adjacent electrical contact by a corresponding wiper seal (e.g., 714a). The electrical contacts 712 may include, for example, annular electrical contacts spaced axially apart from each other. The electrical contacts 712 may also include segmented electrical contacts disposed at an angle relative to the longitudinal axis of the socket connector stack. In addition, the electrical contacts may include an inclined spring or a cantilever spring. The present disclosure is not limited to the type of electrical contacts.

[0093] Each scraper seal (e.g., 714a) includes a tongue or flap (e.g., scraper blade type) configured to isolate an electrical contact (e.g., 712a) from other electrical contacts. A scraper tongue (not shown) can be disposed on either side of a corresponding electrical contact (e.g., 712a) to isolate it from an adjacent electrical contact. The scraper tongue or flap is an elastic member that allows sufficient contact isolation while helping to reduce lead insertion force. However, in many high-power medical implant applications, these scraper seals may not be sufficient to isolate electrical contacts, particularly electrical contacts at the proximal and distal ends of the socket connector stack 710. For example, the scraper tongues on the proximal and / or distal ends of the socket connector stack 710 may not be sufficient to inhibit stray current from entering the electrical contacts and / or inhibit the entry of liquids from the external environment.

[0094] In order to enhance the sealing performance and electrical isolation of the head, additional sealing elements are provided at the proximal and distal ends of the socket connector stack 710, respectively. The first sealing element 720 (also referred to as the proximal sealing element 720) is provided at the proximal end of the socket connector stack 710. Similarly, the second sealing element 730 (also referred to as the distal sealing element 730) is provided at the distal end of the socket connector stack 710. The first sealing element 720 and the second sealing element 730 may include an O-ring. The sealing elements 720 and 730 are made of a suitable sealing material, such as implant grade silicone with a Shore A hardness between 30-60, and the dimensions of the sealing elements 720 and 730 are designed (e.g., an inner diameter of 0.115 inches to 0.145 inches and an outer diameter of 0.165 inches to 0.205 inches) to allow easy assembly in the socket connector stack 710. If the sealing elements 720 and 730 are too small, the fingers of the technician assembling the socket connector stack may feel fatigued, or additional assembly tools may be required. Therefore, the dimensions of the sealing elements 720 and 730 are designed such that the inner diameter of each O-ring is in the range of 0.115 inches to 0.145 inches and the outer diameter is in the range of 0.165 inches to 0.205 inches to facilitate easy assembly on the receptacle connector stack.

[0095] The first sealing element 720 is configured to inhibit liquid ingress and stray current from the external environment at the proximal end of the socket connector stack 710. The second sealing element 730 is configured to inhibit liquid ingress and stray current from the external environment at the distal end of at least one socket connector stack. The diameter size of the sealing elements 720 and 730 can also advantageously help inhibit liquid ingress. For example, a larger sealing element can provide better sealing performance compared to a smaller ring. The inner diameter of the sealing elements 720 and 730 ranges from 0.115 inches to 0.375 inches, and the outer diameter ranges from 0.145 inches to 0.515 inches, which advantageously provides improved sealing performance and is easy to assemble.

[0096] In order to promote improved sealing process and size capability, a sealing housing is provided. The proximal sealing housing 725 is configured to receive the first sealing element 720, and the distal sealing housing 735 is configured to receive the second sealing element 730. The proximal sealing housing 725 and the distal sealing housing 735 can have similar sizes and structures to facilitate mass production, and the size is designed to be easy to assemble the corresponding sealing elements. In some embodiments, the proximal sealing housing 725 and the distal sealing housing 735 are manufactured and assembled separately from the socket connector stack 710. In some embodiments, the proximal sealing housing 725 and the distal sealing housing 735 are integrally formed with the socket connector stack 710 to further minimize any gaps for liquid entry, thereby improving the sealing performance of the head 700. Each proximal sealing housing 725 can also include a retaining mechanism that is configured to engage with the socket connector stack 710 and the head 700. Example retention structures are discussed below with reference to FIGS. 11-15 , in which the proximal seal housings 725 are referred to as 725A, 725B, 725C, 725D, and 725E, respectively, each having a specific type of retention mechanism.

[0097] In addition, an outer sealing element 722 is provided on the outside of the socket connector stack 710 to seal any gap between the box 701 and the proximal housing 725. The outer sealing element 722 has a larger diameter than the proximal sealing element 720. The outer sealing element 722 is disposed in a groove formed in the box 701. The outer sealing element 722 can also be an O-ring that provides additional sealing to inhibit the ingress of liquid from the proximal end. The outer sealing element 722 can be concentric with the first sealing element 720.

[0098] In order to evaluate the improvement, different seals were experimented. The example experimental setting includes soaking an implantable device (with or without the proximal and distal enhanced sealing elements of the present invention) with different sealing configurations between the lead and the socket connector in water for a period of time (e.g., 3 months or more). Under the immersion state, the leakage current of the electrical contacts (e.g., at the distal and proximal ends) from the socket connector and the lead of each implantable device is monitored. In particular, in each of these experiments, the readings read from all contacts in the head measure the leakage current from contact to contact, and the readings read from all contacts in the head to the external environment measure the leakage current from the internal contact to the external environment. The device without enhanced sealing elements exhibits a contact-to-contact leakage current and a contact-to-environment leakage current greater than 1 μA, which causes these devices to eventually fail due to high leakage current. In contrast, the experimental device configured with the proximal seal 720 and the distal seal 730 according to the present disclosure exhibits negligible leakage current. Notably, no contact-to-contact leakage current or contact-to-ambient leakage current greater than 1 μA was detected, clearly demonstrating the improved sealing performance of the reinforced sealing component.

[0099] In many embodiments, the wiper seal (e.g., 714a) includes a wiper tongue extending from an inner surface toward the electrical contact (e.g., 712a). For example, the wiper seal 714 has a hollow cylindrical shape or an annular shape and has a tongue extending from the inner diameter of the ring or cylinder. When the socket connector stack 710 receives the lead (e.g., Fig. 9 When inserting the lead 910 shown in the socket connector stack 710, the scraper tongue moves backward relative to the axial insertion direction (e.g., like a scraper blade). After the insertion of the lead is completed, the scraper tongue attempts to maintain its original position. When returning to the original position, the scraper tongue may push the lead (e.g., lead 910), causing the lead to be displaced axially or misaligned with the electrical contact 712 of the socket connector stack 710. In other words, the interaction between the socket connector stack 710 and the lead tends to produce a hydrostatic effect or a piston-cylinder effect, in which the lead 910 may move relative to the desired axial insertion position within the socket connector stack 710. This phenomenon can be described as a "spring-back" effect. For example, due to this spring-back effect, the lead 910 may experience an axial displacement of approximately 0.010 inches to 0.15 inches.

[0100] In many embodiments, spring-back reduction features are provided to reduce or prevent axial displacement from a desired position, or misalignment between the leads 910 and the connector stack 710. Figure 7As shown, a rebound reducer 740 is disposed at the proximal end of the socket connector stack 710 to reduce the rebound effect experienced by the lead insertion. In many embodiments, the rebound reducer 740 is an O-ring. The rebound reducer 740 has a diameter larger than the diameter of the proximal sealing element 720. The rebound reducer 740 can be installed in the box 701 of the head 700. The inner diameter of the rebound reducer 740 is in the range of about 0.275 inches to about 0.375 inches, and the outer diameter of the rebound reducer 740 is in the range of about 0.335 inches to about 0.515 inches.

[0101] In many embodiments, the head 700 can also include a septum or vent 705 located distal to the socket connector stack 710 to prevent hydrostatic locking between the implantable lead 910 and the socket connector stack 710. The septum 705 can provide another opening for liquid ingress and stray currents. In this regard, the distal sealing element 730 can effectively inhibit liquid ingress and any stray currents from the septum.

[0102] Figure 8 The figure shows a header 700 having a socket connector stack 710 disposed in the header 700 and configured to receive a Fig. 9 . The box 701 receives the socket connector stack 710 and holds it in the head 700. The socket connector stack 710 extends axially in the head 700 so that the electrical contacts 712 and the wiper seal 714 are completely located within the distal extension 702 of the head 700. The box 701 includes a locking device 801 (e.g., a set screw), which is configured to securely engage the lead 910 within the socket connector stack 710. For example, the locking device 801 is a screw that can be adjusted (e.g., tightened or loosened) to engage or disengage the lead 910. The lead 910 is attached to the proximal lead housing 920. The lead housing 920 includes a slot or groove 901, which is configured to receive the locking device 801, such as Fig.10 A locking device 801, such as a screw, may be tightened to securely engage and prevent axial movement of the leads 910 relative to the socket connector stack 710 after the leads 910 are inserted therein.

[0103] Lead 910 is an elongated shaft including a plurality of electrical contacts 912 axially spaced apart from one another. The relative positions of electrical contacts 912a-912f correspond to the positions of a plurality of electrical contacts 712a-712f of socket connector stack 710. After assembly, electrical contacts 912 are electrically coupled to corresponding electrical contacts 712. In the example shown, each of electrical contacts 912 is an annular contact. Electrical contacts 912 can be connected to wires inside lead 910 that extend from inside lead 910 to an electrical connector or interface 914 in proximal lead housing 920. Electrical connector 914 includes wires from lead 910 that are coupled to or integrated in an implantable controller to VAD connection cable 26 or a TETS power receiver to controller connection cable 28 to electrically couple lead 910 to VAD 14 or TETS power receiver 22.

[0104] After the leads 910 are inserted into the socket connector stack 710, as shown in FIG. Fig.10 As shown, electrical connector 912 is electrically coupled to corresponding electrical connector 712 of socket connector stack 710, and is further coupled to electrical connector 914. The electrical connection between connectors 712, 912, and 914 facilitates the connection of implantable controller 20 with VAD 14 and / or TETS power receiver 22 (such as via header 700). Figure 1 The connector assembly, including the socket connector stack 710 coupled to the leads 910 in the header 700, is electrically coupled to other electronic components of the implantable controller 20 sealed in the housing 70 of the controller 20. In some embodiments, a feed-through assembly between the header 700 and the housing 70 of the controller 20 facilitates electrical connection of the connector assembly with other electronic components of the controller 20 (e.g., a processor 56 configured to control the speed of the VAD, a memory 54 for storing data, a rechargeable battery 52 for storing power received from the TETS power receiver 22, etc., as described above). Figure 6 Electrical coupling as shown).

[0105] As previously described, inserting the leads 910 into the socket connector stack 710 creates a spring-back effect. Fig.10As shown, the rebound reducer 740 engages the circumference of the proximal lead housing 920 and fixes the lead 910 in place relative to the box 701, thereby reducing any rebound effect experienced by the lead 910 due to the scraping seal 714 of the socket connector stack 710. The rebound reducer 740 can be an O-ring that can inhibit the entry of liquid from the external environment through the lead 910 into the socket connector stack 710 at the proximal end. Additionally, the distal sealing element 730 provides a seal for the electrical contacts at the distal end, and the proximal sealing element 720 provides another sealing layer between the electrical contacts at the proximal end and the environment. Therefore, the distal sealing element 730 and the proximal sealing element 720 together with the rebound reducer 740 can advantageously enhance the sealing performance of the implantable medical device.

[0106] Reference now Fig.11A , a snap-fit ​​device for attaching a socket connector stack 710A and / or 710B to a header 700 is shown. The header 700 includes internal channels for receiving a first socket connector stack 710A and a second socket connector stack 710B, respectively. The internal channels are spaced apart from each other and electrically isolated.

[0107] Fig. 11B Shown is the enlarged part of the snap element of snap device.Specifically, snap element 1102 is provided at the near end of first socket connector stacking 710A (and similarly provided on second socket connector stacking 710B).In many embodiments, snap device is provided on proximal seal housing 725A.As shown in the figure, proximal seal housing 725A is configured to include snap element 1102.Proximal housing 725A is coupled to socket connector stacking 710A at the proximal end.Socket connector stacking 710A can be inserted in the distal extension 702 in the head 700 by the passage 751 in the box 701.

[0108] The snap element 1102 is a cantilever element having a deflectable flange at the distal end. When the socket connector stack 710A is inserted through the channel 751, the flange of the snap element 1102 engages with the inner surface of the head 700, thereby fixing the socket connector stack 710A to the head 700. The proximal housing 725A also mounts the proximal sealing element 720 (such as Figure 7 ) and an outer sealing element 722, which is disposed proximal to the snap element 1102 and coaxial with the proximal sealing element 720. In addition, a groove may be provided to receive the outer sealing element 722. Thus, after assembly, the proximal sealing element 720 (see Figure 7 ) and outer sealing element 722 inhibit liquid from entering the header 700 through the proximal end of the socket connector stack 710A.

[0109] Fig. 12A and Fig. 12BThe figure shows a retention mechanism including a threaded fit for holding the socket connector housing 710A with the head 700. Threads 1210 are formed at the proximal portion of the socket connector stack 710A and are configured to engage with corresponding threads 1212 formed in the channel 751 of the box 701 to secure the socket connector stack 710A to the head 700. In many embodiments, the threads 1210 are formed on the outer periphery of the proximal seal housing 725B1, which is fixedly attached to or integrally formed at the proximal portion of the socket connector stack 710A. The proximal seal housing 725B1 is also configured to receive the proximal seal element 720 (see Figure 7 ) and an outer sealing element 722. For example, the proximal seal housing 725B1 includes a groove for mounting sealing elements 720 and 722 (e.g., O-rings). The sealing elements 720 and 722 are disposed at the proximal end of the threads 1210 to provide a seal between the head 700 and the socket connector stack 710A and inhibit the ingress of liquid from the external environment. Therefore, when the proximal seal housing 725B1 is threadedly coupled to the channel 751 of the box 701, the sealing elements 720 and 722 inhibit the ingress of liquid into the head 700 or the socket connector stack 710A.

[0110] Fig. 12A Also illustrated is a second socket connector stack 710B having a similar structure to the first socket connector stack 710A. The first socket connector 710A and the second socket connector 710B are spaced apart from each other and are disposed in a hollow passage in the head 700. The second socket connector stack 710B is threadedly connected to a second passage 752 formed in the box 701. For example, the second proximal seal housing 725B2 includes an external thread (similar to the thread 1210 of the first proximal seal housing 725B1) that engages with the thread of the second passage 752. Since the hollow passage of the head 700 is electrically isolated, the electrical coupling between the socket stacks 710A and 710B is achieved via electrical contacts and electronic components disposed in the controller 20.

[0111] Fig. 12BAlso shown is a front view of the second proximal seal housing 725B2 (and similarly applicable to the proximal seal housing 725B1) assembled in the box 701. As shown, after assembly, the end face of the second seal housing 725B2 is flush with the outer surface 701s of the box 701, or the end face of the second seal housing 725B2 is located inside the channel 752 of the box 701 to provide a seamless outer surface of the head. As also shown, the inner portion 1215 of the second proximal seal housing 725B2 (and similarly the proximal seal housing 725B1) may include an attachment device that is configured to attach the second proximal seal housing 725B2 to the socket connector stack 710B. In many embodiments, the inner portion 1215 may include threads (at Fig. 12B In some embodiments, the end surface of the second sealed housing 725B2 may also include an assembly feature (e.g., a hole or other device) for inserting and removing the socket connector stack 710B from the header 700.

[0112] Fig.13A A retaining ring 1310 is shown for coupling the receptacle connector stack 710B to the header 700 . Fig. 13B The figure shows an enlarged portion of the proximal end of the socket connector stack 710B coupled with the retaining ring 1310. The retaining ring 1310 is a semicircular ring shaped to fit the proximal portion of the socket connector stack 710B and abuts against the inner surface of the head 700 so that the socket connector stack 710B is securely engaged in the channel of the head 700. In many embodiments, the proximal seal housing 725C is configured to receive the retaining ring 1310 while being coupled to the socket connector stack 710B. The proximal seal housing 725C includes a retaining groove 1312 corresponding to the shape and size of the retaining ring 1310. For example, the shape of the retaining groove 1312 can be semicircular and have the same thickness as the retaining ring 1310. The retaining groove 1312 is formed on the portion of the proximal seal housing 725C located inside the head 700 to facilitate coupling with the inner surface of the head 700.

[0113] To assemble the retaining ring 1310, the receptacle connector stack 710B is inserted into the box 701 of the head 700. The distal extension 702 of the head 700 is partially open (e.g., the top) so that the retaining ring 1310 can be placed in the retaining groove 1312. Once the retaining ring 1310 is assembled, as shown in FIG. Fig. 13B As shown, the open portion of the distal extension 702 of the header 700 can be closed, such as by overmolding the header material (e.g., epoxy) to enclose the header 700 with the receptacle connector stack 710B disposed therein.

[0114] Fig.14A The figure shows a press fit or interference fit for coupling the socket connector stack 710A to the header 700, and Fig. 14B The figure shows a cross section of a press-fit socket connector stack 710A. The press-fit is provided by designing the outer perimeter size of the socket connector stack 710A to fit tightly in the channel 751 of the box 701 of the head 700. In many embodiments, to facilitate the press-fit, a proximal seal housing 725D is attached at the proximal end of the socket connector stack 710A, and the outer perimeter size of the proximal seal housing 725D is designed to closely engage with the inner perimeter of the channel 751. In the example shown, the distal portion of the proximal seal element 725D has an outer diameter that is slightly larger (e.g., 0.1%-5% larger) than the inner diameter of the channel 751.

[0115] like Fig. 14B As shown, the proximal seal housing 725D is also equipped with an outer seal element 722 and a proximal seal element 720. The seal elements 722 and 720 are located at the proximal end of the head 700. Therefore, when the distal end portion of the proximal seal housing 725D is tightly engaged with the channel 751 to fix the socket connector stack 710A to the head 700, the proximal seal elements 720 and 722 inhibit the ingress of liquid from the proximal end, thereby providing improved sealing performance based on some seals achieved by press fitting.

[0116] Fig.15A The diagram shows a compression rib fit for coupling the receptacle connector stack 710A to the header 700, and Fig. 15B The figure shows a cross section of a socket connector stack with an extruded rib fit. The extruded rib fit is provided by ribs 1510 formed on the periphery of the socket connector stack 710A. The ribs 1510 are configured to be squeezed or embedded in the inner periphery of the channel 751 when engaging with the channel 751 of the box 701. In many embodiments, in order to promote the extruded rib fit, the proximal seal housing 725E is attached to the proximal end of the socket connector stack 710A, and the periphery of the proximal seal housing 725E includes ribs 1510. In the example shown, the distal portion of the proximal seal element 725E has an outer diameter defined by the ribs 1510. The outer diameter of the ribs 1510 is slightly larger than the inner diameter of the channel 751 (e.g., 0.1%-5% larger) to promote the ribs to be tightly engaged in the inner periphery of the channel 751.

[0117] Similar to Fig. 14BAs shown, the proximal seal housing 725E is also equipped with an outer seal element 722 and a proximal seal element 720. The seal elements 722 and 720 are located at the proximal end of the head 700. Therefore, when the rib 1510 at the distal portion of the proximal seal housing 725E engages with the channel 751 to fix the receptacle connector stack 710A to the head 700, the proximal seal elements 720, 722 inhibit the ingress of liquid from the proximal end, thereby improving the sealing performance in addition to some sealing achieved by the compression rib fit.

[0118] Conventional implantable leads are typically short and rigid, and may use up to three electrical conduction lines within a limited diameter of approximately 3.2 mm. However, as described above, some high-power implantable medical devices (such as the VAD controller of the present invention) may require six conduction lines (including power lines, ground lines, and communication lines), each with redundancy to improve the operational safety of the implantable device and the patient. Adding more conduction lines within a small and limited diameter (e.g., less than 3.2 mm) is not easy, and there are many challenges associated with manufacturing and maintaining the integrity of the lead structure. For example, stacking conduction lines on top of each other within a diameter of approximately 3.2 mm results in a longer but thinner diameter (girth) male lead plug, which may have reliability issues.

[0119] According to the present disclosure, implantable leads are configured to accommodate six complete electrical conduction circuits while achieving increased strength within the desired lead diameter. In particular, the stable male lead plug of the present invention coaxially stacks a plurality of conductors that can be linearly spaced apart from each other, and includes an elongated rigid reinforcing member for increasing stiffness and hardness. The conductor may be an annular electrical contact. The implantable lead may be axially modular to accommodate one or more conduction circuits. For example, the conduction circuits may be flexible wires of different lengths, each of which may transmit a signal received by the electrical contact. Multiple electrical contacts and conduction circuits are configured so that the implantable lead plug does not need to tighten a set screw or other external activation device to electrically activate one or more conduction circuits. The conduction circuit may be a flexible wire, a rigid and flat electrical metal circuit, or other electrical conduction circuit. The conduction circuit is referred to as a wire, which is only used as an example to explain the concept of the present disclosure, without limiting the scope of the present disclosure. The implantable lead may accommodate a flexible wire of a specific diameter to meet the conduction and heating specifications associated with the implantable medical device. In many embodiments, the implantable lead may include a stem on one end for handling the lead (eg, made of titanium or other biocompatible material), and a shoulder on the stem may provide as an additional sealing interface.

[0120] Figure 16-Figure 27 The figures show different configurations of the stable implantable lead of the present invention. For example, Figure 16-Figure 18The figure shows an implantable lead with six electrical contacts and six wires. Figure 22-Figure 26 The figure shows an implantable lead with four electrical contacts and six wires. Fig. 27 The figure shows an implantable lead with three electrical contacts and six wires.

[0121] Reference now Fig.16 , Fig.16 The figure shows a perspective view of an implantable lead 1600 according to many embodiments. The implantable lead 1600 includes an elongated shaft 1610, a plurality of electrical contacts 1611-1616, and a plurality of wires 1621-1626. The implantable lead 1600 may also include a reinforcing member 1620 and a stem 1630, wherein the reinforcing member 1620 is used to increase the strength and rigidity of the lead and the stem 1630 is used to improve the handling and coupling of the lead. For example, the proximal portion of the elongated shaft 1610 can be coupled to the stem 1620. To manufacture the lead, multiple components including the elongated shaft 1610, the wires 1621-1626, and / or the reinforcing member 1620 can be overmolded. Overmolding long wires and / or reinforcing members may present manufacturing challenges due to the fluidity of the molding material and the tendency of the wires and reinforcing members to move when the molding material cures or hardens. Thus, in addition to meeting electrical conduction and signal transmission requirements associated with implantable devices, the lengths and dimensions of the wires and reinforcement members described herein are also advantageous from a manufacturing perspective.

[0122] The elongated shaft 1610 has a distal end 1601, a proximal end 1602, and a uniform diameter between the distal end 1601 and the proximal end 1602. The distal end 1601 may be chamfered so that the elongated shaft 1610 can be properly aligned and placed in a receiving member (such as a socket connector stack). The elongated shaft 1610 may have a diameter of approximately 3.2 mm. For example, Fig.19 As shown, the elongated shaft 1610 has an inner diameter 1606 and an outer diameter 1607. In an example, the outer diameter 1607 can be 3.2 mm, and the inner diameter 1606 can be less than 3.2 mm (e.g., 3 mm, 2.9 mm, or less). The wires 1621-1622 are coupled (e.g., welded) at the inner diameter 1606 of the elongated shaft 1610. The coating thickness on the outer wire diameter can be approximately 0.5 mm or less. Reference Fig.16 , the length L of the elongated shaft 1610 can be in the range of from 31 mm to 33 mm. It should be understood that the present disclosure is not limited to a specific length, and other lengths of the elongated shaft 1610 are possible. For example, the length L can be in the range of from 6 mm to 50 mm. The elongated shaft 1610 can be made of a moldable insulating material 1605 (see Fig.17). The insulating material may include, but is not limited to, polyetheretherketone (PEEK), thermoplastic polyurethane (TPU), such as Tecothane, Estane, or polysulfone. For example, the elongated shaft 1610 may be made of a resin (e.g., polyether-based thermoplastic polyurethane) that is corrosion-resistant and exhibits biostability over a wide range of hardness.

[0123] A plurality of electrical contacts 1611-1616 are arranged on the outer surface of the elongated shaft 1610. A plurality of electrical contacts are separated by injection-molded insulating materials for electrical isolation. For example, electrical contacts 1611-1616 are arranged on the outer surface of the elongated shaft 1610 and are axially spaced apart from each other. The spacing between the electrical contacts and the insulating material provide electrical isolation between each contact. In one embodiment, a plurality of electrical contacts include a first electrical contact 1611 and a second electrical contact 1612 for power transmission, a third electrical contact 1613 and a fourth electrical contact 1614 for communication, and a fifth electrical contact 1615 and a sixth electrical contact 1616 for grounding. In one embodiment, each of the electrical contacts 1611-1616 can be an annular contact. The annular contacts are coaxial and linearly spaced apart from each other along the elongated shaft 1610. Each of the annular contacts can have substantially the same diameter and axial length. However, the present disclosure is not limited to a specific type of contact or a specific axial length of the contact. Each of the electrical contacts 1611-1616 can be electrically coupled to a corresponding wire in the wires 1621-1626 within the elongated shaft 1610. For example, the wires can be welded, bonded, screwed, or directly attached to the corresponding contacts. The electrical contacts 1611-1616 and the wires 1621-1626 are made of corrosion-resistant and conductive materials that can be safely implanted in a patient. For example, the electrical contacts and wires are made of a platinum-iridium alloy, or a nickel-cobalt-based alloy of a multiphase alloy.

[0124] In one embodiment, Fig.16 and Fig.17 As shown, a first electrical contact 1611 and a second electrical contact 1612 for power transmission are arranged at the distal end portion of the elongated shaft. A fifth electrical contact 1615 and a sixth electrical contact 1616 for grounding are arranged at the proximal end portion of the elongated shaft. A third electrical contact 1613 and a fourth electrical contact 1614 for communication are arranged between the proximal end portion and the distal end portion of the elongated shaft. However, other variations or combinations of electrical contacts and their corresponding functions are also possible without limiting the scope of the present disclosure.

[0125] The plurality of wires 1621-1626 are electrically coupled to the plurality of electrical contacts and extend axially within the elongated shaft 1610. In many embodiments, the plurality of wires 1621-1626 may be radially disposed approximately 60 degrees apart from one another (see Fig.19). In one embodiment, the plurality of wires include: a first wire 1621 and a second wire 1622, the first wire 1621 and the second wire 1622 being electrically coupled to the first electrical contact 1611 and the second electrical contact 1612, respectively; a third wire 1623 and a fourth wire 1624, the third wire 1623 and the fourth wire 1624 being electrically coupled to the third electrical contact 1613 and the fourth electrical contact 1614, respectively; and a fifth wire 1625 and a sixth wire 1626, the fifth wire 1625 and the sixth wire 1626 being electrically coupled to the fifth electrical contact 1615 and the sixth electrical contact 1616, respectively. Therefore, the length of the sixth wire 1626 is the shortest, while the length of the first wire 1621 is the longest. Each of the plurality of wires 1621-1626 has a diameter of approximately 0.3 mm to 1 mm, and has different lengths within the elongated shaft 1610. The length of the wire exposed from the stem can range from 1 mm to 50 mm to establish an electrical connection with a connector or medical device. In many embodiments, each of the wires 1621-1626 also includes an insulating cover (e.g., 1621a) that is disposed outside each wire, but is not disposed at locations where the wires are electrically connected to the corresponding electrical contacts 1611-1616. The insulating cover provides additional electrical insulation between the wires within the slender shaft 1610 and the reinforcement member 1620, and also provides insulation when the wires 1621-1626 are exposed from the stem 1630.

[0126] The reinforcing member 1620 is disposed axially within the elongated shaft 1610. The reinforcing member 1620 and the plurality of electrically isolated wires 1621-1626 are constrained within the diameter of the elongated shaft. In many embodiments, the plurality of wires are radially disposed approximately 60 degrees apart from one another and are disposed circumferentially around the reinforcing member 1620 (see Fig.19 ). The reinforcing member 1620 has a diameter ranging from 0.5 mm to 1.5 mm, and a length that is less than the length L of the elongated shaft 1610. For example, the length of the reinforcing member 1620 can be approximately 2.5 mm to 3 mm shorter than the length L of the elongated shaft 1610. In some embodiments, the reinforcing member 1620 can extend partially along the length of the elongated shaft 1610. For example, the reinforcing member 1620 can extend from the first electrical contact 1611 at the distal portion of the elongated shaft 1610 to the sixth electrical contact at the proximal portion of the elongated shaft 1610. In another example, the reinforcing member 1620 can further extend to the proximal end of the stem 1630 and extend therefrom. In many embodiments, the reinforcing member 1620 can be made of a biocompatible material, such as titanium or other rigid materials that are corrosion-resistant. The titanium reinforcing member does not interfere with the electrical communications or signals carried by the wires 1621-1626 because these wires are isolated from the reinforcing member 1620, so the reinforcing member is non-conductive.

[0127] Fig. 20 The figure shows an example cross-section of a stem 1630 according to many embodiments. The stem 1630 can be a hollow cylinder having a distal portion 1631 that is configured to receive the proximal portion of the elongated shaft 1610. Thus, the stem 1630 can also be referred to as a proximal lead housing (e.g., Fig. 9 16). The distal portion 1631 of the stem 1630 has an inner diameter D1, which is approximately equal to the outer diameter of the proximal portion of the slender shaft 1610 so as to fitably receive the proximal portion of the slender shaft 1610. The distal portion 1631 can also include a hole 1637, which is used to securely couple the slender shaft 1610 to the stem 1630. For example, the hole 1637 can be used to receive an adhesive, a fastener, or other fastening device to couple the slender shaft 1610. In many embodiments, the hollow cylinder can include a stepped inner diameter, wherein the diameter at the proximal portion 1639 of the stem 1630 is greater than the diameter D1 to accommodate additional components, such as an electrical connector.

[0128] Stem 1630 includes a shoulder 1632 for receiving a sealing element at distal end portion 1631, and a groove 1634 configured to receive a locking assembly (e.g., a set screw) for securely coupling implantable lead 1600 to a head assembly of a second implantable medical device (e.g., see Fig.21 The head assembly 2120 of the implantable controller 2110, or Figure 1 ). In many embodiments, stem 1630 can also include another groove 1636 that is configured to receive another sealing element (e.g., an O-ring) to prevent liquid ingress and / or facilitate handling of the lead from the proximal portion of stem 1630.

[0129] In many embodiments, stem 1630 may be sized to fit the different types of implantable leads discussed herein. Fig.18 The stem 1830 of (in) has a substantially similar structure to 1630, and the inner diameter of the stem 1830 is configured to receive the implantable lead 1800. For example, the stem 1830 also includes a distal portion 1831 for receiving the distal portion of the slender shaft 1810, a shoulder 1832, and grooves 1834 and 1836 (similar to elements 1632, 1634 and 1636). Similarly, ( Fig. 22 The stem 2230 can be configured to receive a proximal portion of a stepped diameter elongated shaft.

[0130] In one embodiment, Fig.16 and Fig.17As shown, implantable lead 1600 may be used as a ventricular assist device (VAD) lead (e.g., coupled to Figure 1 In many embodiments, another implantable lead (having a similar structure to lead 1600) can be a transcutaneous energy transfer system (TETS) receiver lead (e.g., coupled to Figure 1 The transcutaneous energy transfer system (TETS) receiver lead is also referred to as the second implantable lead 1800 (see, for example, Fig.18 ) and are discussed in further detail below.

[0131] Second implantable lead 1800 may have a similar structure to implantable lead 1600. In one embodiment, Fig.18 As shown, the elongated shaft 1810 of the second implantable lead 1800 has a larger diameter than the diameter of the elongated shaft 1610 of the implantable lead 1600 (also referred to as the first implantable lead 1600). The larger diameter ensures that the implantable lead 1600 and the second implantable lead 1800 can be properly assembled within the corresponding connector stack of the head assembly of the implantable controller. Fig.21 An example implantable controller 2110 is shown.

[0132] Implantable controller 2110 may include a first socket connector stack 2121 configured to receive a first implantable lead 1600 to connect an implantable heart pump (eg, Figure 1 and Figure 214) is electrically coupled to the implantable controller 2110; and a second socket connector stack 2122, the second socket connector stack 2122 is configured to receive a second implantable lead 1800 to electrically couple a TETS receiver (e.g., TETS receiver 22) to the implantable controller 2110. The first socket connector stack 2121 is spaced apart from the second socket connector stack 2122 within the head assembly 2120 and is electrically isolated from each other. Each socket connector stack has a specific electrical connection for receiving a specific lead. For example, the first socket connector stack 2121 includes electrical contacts 1611′-1616′ corresponding to the corresponding contacts 1611-1616 for receiving the first implantable lead 1600; and the second socket connector stack 2122 includes electrical contacts 1811′-1816′ corresponding to the corresponding contacts 1811-1816 for receiving the second implantable lead 1800. Contacts 1611'-1616' and 1811'-1816' are further connected to circuitry in implantable controller 2110 to control the implantable device. Leads 1600 and 1800 cannot be assembled interchangeably within head assembly 2120. Thus, implantable leads 1600 and 1800 having different diameter sizes can be provided to ensure that the leads are not mistakenly assembled in an incorrect socket connector stack and to prevent any electrical damage to the implanted device (e.g., TETS receiver).

[0133] Return to reference Fig.18 , a second implantable lead 1800 (similar to implantable lead 1600) includes a second elongated shaft 1810, a second set of six electrical contacts 1811-1816 coaxially mounted on the outer surface of the second elongated shaft 1810, and a second set of six electrical wires 1821-1826 disposed within the second elongated shaft 1810. Each of the electrical wires 1821-1826 can be coupled to a corresponding electrical contact in the second set of electrical contacts 1811-1816 at one end and coupled to a TETS receiver at the opposite other end. A second reinforcement member 1820 can be disposed within the second elongated shaft 1810 and electrically isolated from the second set of six electrical wires 1821-1826.

[0134] In one embodiment, the arrangement of the electrical contacts of the implantable lead 1600 can be different from the arrangement of the second implantable lead 1800. For example, the second set of six electrical contacts 1811-1816 of the second implantable lead 1800 includes a first electrical contact 1811, which can be used as a first voltage (e.g., 5V) source for powering the controller 2110 and can be disposed at the distal portion of the second implantable lead 1800. The second electrical contact 1812 can be used as a ground and is disposed proximal to the proximal end of the first electrical contact 1811. The third electrical contact 1813 can be used as a power terminal and is disposed proximal to the proximal end of the second electrical contact 1812. The fourth electrical contact 1814 can be used as a communication line for communicating with a TETS receiver and is disposed proximal to the third electrical contact 1813. The fifth electrical contact 1815 can be used as another ground and is disposed proximal to the proximal end of the fourth electrical contact 1814. The sixth electrical contact 1816 can serve as another power terminal and is disposed at the proximal portion of the second implantable lead 1800 .

[0135] Figure 22-Figure 24 The figure shows a stepped implantable lead 2200 according to another embodiment. The stepped implantable lead 2200 can operate in a similar manner to the implantable lead 1600 or 1800. In particular, the stepped or tapered structure of the elongated shaft can provide improved rigidity, strength, and improved packaging of wires of different sizes. For example, the wires for conducting power can be larger and arranged at the proximal portion of the elongated shaft. The stepped implantable lead 2200 can be coupled to a corresponding stepped socket connector stack 2250, which can be arranged in a head assembly (e.g., head 700) of an implantable device. The stepped diameter lead and socket connector stack can provide multiple advantages. For example, since the lead does not have to engage with all the seals (e.g., scraper seals, proximal seals) of the socket connector stack throughout the insertion length, the lead insertion force can be reduced. During the insertion process, since the lead and the seal (e.g., scraper seal) do not need to engage within the entire stroke, their wear will be reduced. The power efficiency can be improved by deploying high power lines at larger contact diameters while using lower power specification contacts at smaller contact locations. The larger diameter can create a harder, more stable, and more reliable lead. The larger contacts are separated by larger wiper seals, which can produce better moisture and contact isolation. In addition, the stepped small contacts help reduce costs. The stepped implantable lead 2200 is discussed further below.

[0136] The stepped implantable lead 2200 can include a stepped diameter elongated shaft 2210 having a proximal portion and a distal portion. The proximal portion has a diameter greater than the diameter of the distal portion. In one embodiment, a reinforcing member 2220 (similar to reinforcing member 1620) or a tapered reinforcing member 2220 can be disposed within the elongated shaft 2210 for increased strength and rigidity. A stem 2230 (similar to stem 1630) can be coupled to the proximal portion of the stepped diameter elongated shaft 2210.

[0137] Similar to the electrical contacts 1611-1616 or 1811-1816, a plurality of electrical contacts 2211-2216 are disposed on the outer surface of the stepped diameter elongated shaft 2210 and are axially spaced apart from each other. For example, the plurality of electrical contacts include a first electrical contact 2211 and a second electrical contact 2212 for power transmission, a third electrical contact 2213 and a fourth electrical contact 2214 for communication, and a fifth electrical contact 2215 and a sixth electrical contact 2216 for grounding. Each of the electrical contacts 2211-2216 can be coupled to a corresponding electrical contact 2211-2216.

[0138] In one embodiment, Fig.23 and Fig.24 As shown, the stepped diameter elongated shaft 2210 may include a tapered diameter that gradually increases from the distal portion to the proximal portion, wherein each of the six electrical contacts 2211-2216 has a different diameter. For example, the first portion may have a first diameter d1 and be configured to receive the first contact 2211; the second portion may have a second diameter d2 and be configured to receive the second contact 2212; the third portion may have a third diameter d3 and be configured to receive the third contact 2213; the fourth portion may have a fourth diameter d4 and be configured to receive the fourth contact 2214; the fifth portion may have a fifth diameter d5 and be configured to receive the fifth contact 2215; the sixth portion may have a sixth diameter d6 and be configured to receive the sixth contact 2216. The gradually increasing diameter size allows for a larger contact diameter near the lead base, which increases the rigidity of the lead. In addition, the larger sealing surface on the lead base also provides greater moisture protection, which can allow the removal of vents / diaphragms in the connector stack 2250 because the largest diameter contacts 2216 engage last, reducing liquid ingress and hydrostatic pressure. The stepped diameter configuration can also reduce insertion force when inserting the leads into the socket connector stack 2250 and minimize electrical / mechanical contact.

[0139] In another embodiment, the stepped diameter elongated shaft 2210 includes three sections (not shown) of different diameters, each section being configured to receive two electrical contacts. For example, the first diameter section may be configured to receive a first electrical contact and a second electrical contact for power transmission at the distal portion of the elongated shaft; the second diameter section may be configured to receive a third electrical contact and a fourth electrical contact for communication between the distal and proximal portions of the elongated shaft; and the third diameter section may be configured to receive a fifth electrical contact and a sixth electrical contact for grounding at the proximal portion of the elongated shaft. In one embodiment, the second diameter section (e.g., diameter D3) may have a larger diameter than the first section (e.g., diameter D1), and the third diameter section (e.g., diameter D5) may have a larger diameter than the second diameter section (e.g., diameter D3). It should be understood that the present disclosure is not limited to the number of different diameter sections. Those skilled in the art may modify the stepped diameter elongated shaft 2210 to include two, three, four, five, or more stepped sections or a continuous tapered design.

[0140] Figure 25-26 Implantable leads 2500 and 2600 are illustrated, respectively, with four electrical contacts disposed on an elongated shaft according to one embodiment. For example, implantable lead 2500 may be a VAD lead and another implantable lead 2600 may be a TETS receiver lead. Similar to implantable leads 1600 and 1800, leads 2500 and 2600 may include elongated shafts 2510 and 2610, respectively, but with four electrical contacts disposed thereon. In particular, Figure 25-27 The short, rigid, robust male lead plug reduces the overall lead length by stacking the conductors side by side while keeping all six electrical lines within a constrained diameter of approximately 3.2 mm.

[0141] The use of four electrical contacts facilitates redundancy of one type of electrical contact. For example, redundancy can be used for any one of the electrical contacts related to power, grounding, or communication lines. In one embodiment, the implantable lead 2500 may include a first electrical contact 2511 used as a ground, a second electrical contact 2512 used to transmit power, and a third electrical contact 2513 and a fourth electrical contact 2514 used as a communication line. In one embodiment, another implantable lead 2600 may include a first electrical contact 2611 used to transmit power, a second electrical contact 2612 used as a ground, a third electrical contact 2513 used as a power line of a fixed voltage (e.g., 5V), and a fourth electrical contact 2614 used as a communication line.

[0142] In addition, each of implantable leads 2500 and 2600 can include four wires 2521-2524 and 2621-2624, respectively. Each wire can be coupled to a corresponding electrical contact 2511-2514 or 2611-2614. Alternatively, the implantable lead can be configured to include six wires by coupling two wires to one or more of the electrical contacts. For example, two wires can be coupled to each of the first electrical contact and the second electrical contact.

[0143] The use of four electrical contacts helps reduce the length of elongated shafts 2510 and 2610 compared to implantable lead 1600 or 1800. The reduced length can improve rigidity without incorporating a stiffening member. Alternatively or additionally, stiffening member 2520 or 2620 can be constrained within elongated shaft 2510 or 2610, respectively, to further improve rigidity.

[0144] Fig. 27 The figure shows an implantable lead with three electrical contacts according to another embodiment. Using three electrical contacts, the implantable lead can be shorter than the four-contact lead 2500, 2600 or the six-contact lead 1600, 1800, and is strong enough that no reinforcing member is required. The implantable lead 2700 may include an elongated shaft 2710, which is similar to the elongated shaft 1610 or 1810, but is shorter in length. The implantable lead 2700 may include a first electrical contact 2711, a second electrical contact 2712, and a third electrical contact 2713 disposed on the elongated shaft 2710. The electrical contacts 2711-2713 can be used for power transmission, communication, and grounding. Although only three electrical contacts 2711-2713 are used, the implantable lead 2700 may include six wires disposed in the elongated shaft 2710 and coupled to the electrical contacts 2711-2713, as shown in the figure. For example, each electrical contact (e.g., first contact 2711) can be coupled to two wires (e.g., wires 271 and 2722). In one embodiment, each electrical contact can be divided into two half-moon shapes and isolated from each other to create complete redundancy in the radial direction. Therefore, half of each electrical contact can be coupled to one wire.

[0145] In one or more embodiments of the present disclosure, an implantable medical device including an implant connector having an enhanced sealing element for improving sealing performance includes a housing, a head coupled to the housing, and at least one socket connector stack disposed in the head. At least one socket connector stack includes a plurality of electrical contacts and a plurality of wiper seals. Each of the plurality of electrical contacts is separated by a corresponding wiper seal. A first sealing element is disposed at the proximal end of at least one socket connector stack, and a second sealing element is disposed at the distal end of at least one socket connector stack. Optionally, the first sealing element and the second sealing element may include O-rings. Optionally, the inner diameter of each O-ring is in the range of 0.115 inches to 0.375 inches, and the outer diameter of each O-ring is in the range of 0.145 inches to 0.515 inches. Optionally, the first sealing element is configured to prevent liquid ingress and stray current from an external environment at the proximal end of at least one socket connector stack, and the second sealing element is configured to prevent liquid ingress and stray current from an external environment at the distal end of at least one socket connector stack. Optionally, the implantable medical device further comprises a proximal sealing housing, which is configured to receive a first sealing element. Similarly, the distal sealing housing is configured to receive a second sealing element. Optionally, the proximal sealing housing and the distal sealing housing are separate components assembled together with at least one socket connector stack. Optionally, the proximal sealing housing and the distal sealing housing are integrally formed with at least one socket connector stack. Optionally, the proximal sealing housing comprises a retaining mechanism, which is configured to engage with at least one socket connector stack and head. The retaining mechanism comprises at least one of a press fit, an extrusion rib fit, a snap fit, a retaining ring, or a threaded fit. Optionally, the implantable medical device further comprises a third sealing element, which is disposed near the first sealing element and at least one socket connector stack more proximal to limit the rebound effect caused by one or more scraping seals in a plurality of scraping seals. Optionally, the implantable medical device is a ventricular assist device (VAD) implantable controller, and the VAD implantable controller is configured to generate a control signal to control blood flow and provide power to the VAD. Optionally, the header includes two socket connector stacks spaced apart from each other, each connector stack including six contacts for powering and communicating with the VAD and TETS. Optionally, at least one socket connector includes a first socket connector stack that is spaced apart from and electrically isolated from a second socket connector stack.

[0146] In one or more embodiments of the present disclosure, a fully implantable left ventricular assist system (FILVAS) includes a heart pump, an implantable transcutaneous energy transfer system (TETS) receiver, a first implantable lead, a second implantable lead, and an implantable controller. The heart pump is configured to pump blood from the ventricle of the patient's heart to the artery to supplement or replace the blood pumped from the ventricle to the artery. The TETS receiver is configured to receive and transmit power to continuously operate the heart pump. The implantable controller is communicatively coupled to the heart pump via the first implantable lead and communicatively coupled to the TETS receiver via the second implantable lead. Optionally, the implantable controller includes: a housing; a head, the head is coupled to the housing; a first socket connector stack, the first socket connector stack is disposed in the head, and is configured to receive the first implantable lead and establish an electrical coupling between the implantable controller and the heart pump; and a second socket connector stack, the second socket connector stack is disposed in the head, and is configured to receive the second implantable lead and establish an electrical coupling between the implantable controller and the TETS receiver. Each of the first and second socket connector stacks includes: a plurality of electrical contacts configured to couple with a corresponding implantable lead; a plurality of scraper seals, each electrical contact isolated by a corresponding scraper seal; a proximal sealing element disposed at the proximal end of the corresponding socket connector stack; and a distal sealing element disposed at the distal end of the corresponding socket connector stack. Optionally, the proximal sealing element and the distal sealing element are O-rings. Optionally, the fully implantable left ventricular assist system also includes a proximal sealing housing for each of the first and second socket connector stacks, the proximal sealing housing configured to accommodate the proximal sealing element and coupleable to the proximal end of the corresponding socket connector stack. The distal sealing housing is configured to accommodate the distal sealing element and coupleable to the distal end of the corresponding socket connector stack. Optionally, each proximal sealing housing includes a retaining mechanism configured to engage with the corresponding socket connector stack and the head. Optionally, the head also includes a rebound reducer disposed in the head and located at the proximal end of the corresponding proximal sealing element. The rebound reducer is configured to engage with the corresponding implantable lead and limit the rebound effect caused by the force applied by one or more of the plurality of scraper seals experienced by the corresponding implantable lead when the corresponding implantable lead is inserted into the corresponding socket connector stack. Optionally, the rebound reducer is a canted spring, an O-ring, or a resilient (complaint) member. Optionally, the head also includes a box with a groove for accommodating the rebound reducer. Optionally, the head also includes a vent or diaphragm, which is located distal to the distal sealing element of the corresponding socket connector stack to prevent hydrostatic locking between the corresponding implantable lead and the corresponding socket connector stack.The distal sealing element inhibits the ingress of liquid from the vent or diaphragm. Optionally, the first implantable lead includes an electrical contact configured to couple with a corresponding electrical contact of the first socket connector stack, and a cable for facilitating communication and power supply between the implantable controller and the heart pump. The second implantable lead includes an electrical contact configured to couple with a corresponding electrical contact of the second socket connector stack, and a cable for facilitating communication and power supply between the implantable controller and the TETS receiver. Optionally, the first socket connector stack is spaced apart and electrically isolated from the second socket connector stack by a corresponding proximal sealing element and a corresponding distal sealing element.

[0147] In one or more embodiments of the present disclosure, an implantable lead for an implantable medical device is described. The implantable lead includes an elongated shaft, a stem, a plurality of electrical contacts, a reinforcing member, and a plurality of wires. The elongated shaft has a proximal end and a distal end, the elongated shaft has a diameter of approximately 3.2 mm, and the stem is coupled to the proximal end of the elongated shaft. A plurality of electrical contacts are disposed on the outer surface of the elongated shaft and are axially spaced apart from each other. The plurality of electrical contacts include a first electrical contact and a second electrical contact for power transmission, a third electrical contact and a fourth electrical contact for communication, and a fifth electrical contact and a sixth electrical contact for grounding. The reinforcing member is axially disposed within the elongated shaft. A plurality of wires are electrically coupled to the plurality of electrical contacts and extend axially within the elongated shaft. The plurality of wires include: a first wire and a second wire, the first wire and the second wire are electrically coupled to the first electrical contact and the second electrical contact, respectively; a third wire and a fourth wire, the third wire and the fourth wire are electrically coupled to the third electrical contact and the fourth electrical contact, respectively; and a fifth wire and a sixth wire, the fifth wire and the sixth wire are electrically coupled to the fifth electrical contact and the sixth electrical contact, respectively. The reinforcing member and the plurality of wires electrically isolated from each other are configured to be constrained within the diameter of the elongated shaft. Optionally, the plurality of wires are radially arranged at intervals of approximately 60 from each other and are circumferentially arranged around the reinforcing member. Optionally, each of the plurality of electrical contacts includes an annular contact, wherein the annular contacts are coaxial and linearly spaced from each other along the elongated shaft. Optionally, the electrical contacts and the wires are made of corrosion-resistant and conductive materials. Optionally, the implantable lead also includes an insulating cover, which is arranged on each of the plurality of wires. Optionally, the plurality of electrical contacts are separated by injection-molded insulating material for electrical isolation. Optionally, a first electrical contact and a second electrical contact for power transmission are disposed at a distal portion of the elongated shaft. A fifth electrical contact and a sixth electrical contact for grounding are disposed at a proximal portion of the elongated shaft. A third electrical contact and a fourth electrical contact for communication are disposed between the proximal portion and the distal portion of the elongated shaft. Optionally, the stem portion includes: a shoulder, the shoulder being located at the distal portion of the stem portion, the elongated shaft being configured at the shoulder to accommodate a sealing element of a head assembly; and a groove, the groove being configured to accommodate a locking assembly for securely coupling the lead to a head assembly of a second implantable medical device. Optionally, the implantable lead includes a ventricular assist device (VAD) lead or a transcutaneous energy transfer system (TETS) receiver lead. Optionally, the implantable lead is coupled to a socket connector stack of an implantable controller.

[0148] In one or more embodiments of the present disclosure, a fully implantable left ventricular assist system (FILVAS) is described. The system includes an implantable heart pump, an implantable transcutaneous energy transfer system (TETS) receiver, a first implantable lead, a second implantable lead, and an implantable controller. The implantable heart pump is configured to pump blood from the ventricle of the patient's heart to the artery to supplement or replace the blood pumped from the ventricle to the artery. The implantable transcutaneous energy transfer system (TETS) receiver is configured to receive and transmit power to continuously operate the implantable heart pump. The first implantable lead is coupled to the implantable heart pump. The first lead includes: a first elongated shaft; a first group of six electrical contacts, the first group of six electrical contacts are coaxially mounted on the outer surface of the first elongated shaft; a first group of six wires, the first group of six wires are disposed in the first elongated shaft, each wire is coupled to a corresponding electrical contact in the first group of six electrical contacts at one end, and is coupled to the implantable heart pump at the opposite end; and a first reinforcement member, the first reinforcement member is disposed in the first elongated shaft and is electrically isolated from the first group of six wires. A second implantable lead is coupled to the TETS receiver. The second lead includes: a second elongated shaft; a second set of six electrical contacts, the second set of six electrical contacts being coaxially mounted on an outer surface of the second elongated shaft; a second set of six electrical wires, the second set of six electrical wires being disposed within the second elongated shaft, each of the electrical wires being coupled at one end to a corresponding electrical contact in the second set of six electrical contacts and coupled to the TETS receiver at an opposite end; and a second reinforcement member, the second reinforcement member being disposed within the second elongated shaft and electrically isolated from the second set of six electrical wires. The diameter of the second implantable lead is greater than the diameter of the first implantable lead. The implantable controller includes: a first socket connector stack, the first socket connector stack being configured to accommodate the first implantable lead to electrically couple the implantable heart pump to the implantable controller; and a second socket connector stack, the second socket connector stack being configured to accommodate the second implantable lead to electrically couple the TETS receiver to the implantable controller. The first socket connector stack is spaced apart from the second socket connector stack. Optionally, the first group of six electrical contacts of the first implantable lead includes: a first electrical contact and a second electrical contact for power transmission, a third electrical contact and a fourth electrical contact for communication, and a fifth electrical contact and a sixth electrical contact for grounding. The second group of six electrical contacts of the second implantable lead includes: a first electrical contact and a second electrical contact for power transmission, a third electrical contact and a fourth electrical contact for communication, and a fifth electrical contact and a sixth electrical contact for grounding. Optionally, the first implantable lead includes: the first electrical contact and the second electrical contact for power transmission are arranged at the distal portion of the first implantable lead. The fifth electrical contact and the sixth electrical contact for grounding are arranged at the proximal portion of the first implantable lead. The third electrical contact and the fourth electrical contact for communication are arranged between the proximal portion and the distal portion of the first implantable lead.Optionally, the second implantable lead includes: a first electrical contact, the first electrical contact serving as a first voltage source and disposed at a distal portion of the second implantable lead; a second electrical contact, the second electrical contact serving as a ground and disposed proximal to the proximal end of the first electrical contact; a third electrical contact, the third electrical contact serving as a power terminal and disposed proximal to the proximal end of the second electrical contact; a fourth electrical contact, the fourth electrical contact serving as a communication line and disposed proximal to the proximal end of the third electrical contact; a fifth electrical contact, the fifth electrical contact serving as another ground and disposed proximal to the proximal end of the fourth electrical contact; and a sixth electrical contact, the sixth electrical contact serving as another power terminal and disposed at a proximal portion of the second implantable lead. Optionally, the proximal portion of the second implantable lead has a diameter greater than a diameter of the proximal portion of the first implantable lead. Optionally, the first implantable lead includes a first stem, the first stem is disposed at the proximal portion of the first elongated shaft, and the second implantable lead includes a second stem, the second stem is disposed at the proximal portion of the second elongated shaft. The diameter of the second stem portion is greater than the diameter of the first stem portion. Optionally, each of the first stem portion and the second stem portion includes a shoulder and a groove, the shoulder is used to mount a seal, and the groove is used to lock the corresponding lead to the head assembly of the implantable controller. Optionally, the first socket connector stack and the second socket connector stack each include a proximal sealing element and a distal sealing element. Optionally, each of the first implantable lead and the second implantable lead does not require tightening of a set screw to electrically activate one or more conductive lines.

[0149] Unless specifically stated otherwise, separator language such as "at least one of X, Y, or Z" is intended to be understood as being generally used within the context of indicating that an item, project, etc. may be X, Y, or Z, or any combination thereof (e.g., X, Y, and / or Z). Thus, such separator language is generally not intended to, and should not, imply that certain embodiments require that at least one of X, at least one of Y, or at least one of Z be present.

[0150] Although certain embodiments have been described, these embodiments are presented by way of example only and are not intended to limit the scope of the present disclosure. In fact, the novel methods, devices, and systems described herein may be embodied in a variety of other forms; furthermore, various omissions, substitutions, and changes in the form of the methods, devices, and systems described herein may be made without departing from the spirit of the present disclosure. The appended claims and their equivalents are intended to cover forms or modifications that fall within the scope and spirit of the present disclosure.

[0151] All references, including publications, patent applications, and patents, cited herein are hereby incorporated by reference as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein.

Claims

1. An implantable medical device comprising: case; a head coupled to the housing; as well as at least one socket connector stack disposed in the header, the at least one socket connector stack comprising a plurality of electrical contacts and a plurality of wiper seals; Wherein each of the plurality of electrical contacts is separated by a corresponding wiper seal, and wherein a first sealing element is disposed at a proximal end of the at least one socket connector stack and a second sealing element is disposed at a distal end of the at least one socket connector stack.

2. The implantable medical device according to claim 1, wherein: The first sealing element and the second sealing element include O-rings.

3. The implantable medical device according to claim 2, wherein: The inner diameter of each O-ring is in the range of 0.115 inches to 0.375 inches, and the outer diameter of each O-ring is in the range of 0.145 inches to 0.515 inches.

4. The implantable medical device according to any one of claims 1 to 3, characterized in that The first sealing element is configured to inhibit liquid ingress and stray electrical currents from an external environment at the proximal end of the at least one receptacle connector stack, and The second sealing element is configured to inhibit liquid ingress and stray electrical currents from the external environment at the distal end of the at least one receptacle connector stack.

5. The implantable medical device of any one of claims 1 to 4, further comprising: a proximal seal housing configured to receive the first seal element; as well as A distal seal housing is configured to receive the second seal element.

6. The implantable medical device according to claim 5, characterized in that The proximal seal housing and the distal seal housing are integrally formed within the at least one receptacle connector stack.

7. The implantable medical device according to claim 5, characterized in that The proximal seal housing includes a retention mechanism configured to engage the at least one receptacle connector stack and the header.

8. The implantable medical device according to claim 7, wherein: The retaining mechanism includes at least one of the following: a press fit, wherein the outer periphery of the proximal seal housing is sized to closely fit the inner periphery at the proximal end of the head; an extrusion rib fit, wherein the outer periphery of the proximal seal housing includes one or more ribs configured to embed into the inner periphery at the proximal end of the head; a snap fit, wherein the outer periphery of the proximal seal housing includes one or more snap elements configured to engage the inner periphery at the proximal end of the head; a retaining ring attached to the outer periphery of the proximal seal housing to fix the proximal housing to the housing and limit axial movement at the proximal end; or A threaded fit wherein the outer periphery of the proximal seal housing includes threads configured to engage threads on the inner periphery at the proximal end of the housing.

9. The implantable medical device of any one of claims 1 to 8, further comprising: A third sealing element is disposed adjacent the first sealing element and more proximal to the at least one receptacle connector stack to limit a rebound effect caused by one or more of the plurality of wiper seals.

10. The implantable medical device according to any one of claims 1 to 9, characterized in that The implantable medical device is a ventricular assist device (VAD) implantable controller configured to generate control signals to control blood flow and to provide power to the VAD.

11. The implantable medical device according to claim 10, wherein: The header includes two receptacle connector stacks spaced apart from each other, each connector stack including six contacts for powering and communicating with the VAD and an implantable transcutaneous energy transfer system, TETS, receiver.

12. The implantable medical device according to any one of claims 1 to 9, characterized in that The at least one socket connector stack includes a first socket connector stack that is spaced apart and electrically isolated from a second socket connector stack.

13. A fully implantable left ventricular assist system, comprising: a heart pump configured to pump blood from a ventricle of the patient's heart to an artery to supplement or replace blood pumped from the ventricle to the artery; an implantable transcutaneous energy transfer system (TETS) receiver configured to receive and transfer power to continuously operate the heart pump; The first implantable lead; a second implantable lead; as well as an implantable controller communicatively coupled to the heart pump via the first implantable lead and to the TETS receiver via the second implantable lead, Wherein, the implantable controller comprises: case; a head coupled to the housing; a first socket connector stack disposed in the header and configured to receive the first implantable lead and establish an electrical coupling between the implantable controller and the heart pump; and a second socket connector stack disposed in the header and configured to receive the second implantable lead and establish an electrical coupling between the implantable controller and the TETS receiver; and Wherein, each of the first socket connector stack and the second socket connector stack includes: a plurality of electrical contacts, which are configured to couple with corresponding implantable leads; a plurality of scraper seals, each electrical contact is isolated by a corresponding scraper seal; a proximal sealing element, which is arranged at the proximal end of the corresponding socket connector stack; and a distal sealing element, which is arranged at the distal end of the corresponding socket connector stack.

14. The fully implantable left ventricular assist system according to claim 13, wherein: The proximal sealing element and the distal sealing element are O-rings.

15. The fully implantable left ventricular assist system of claim 13 or claim 14, further comprising for each of the first and second receptacle connector stacks: a proximal seal housing configured to receive the proximal seal element and coupleable to the proximal end of the corresponding receptacle connector stack; and A distal seal housing is configured to receive the distal seal element and is coupleable to the distal end of the corresponding receptacle connector stack.

16. The fully implantable left ventricular assist system according to claim 15, characterized in that: Each proximal seal housing includes a retention mechanism configured to engage the corresponding receptacle connector stack and the header.

17. A totally implantable left ventricular assist system according to any one of claims 13 to 16, characterized in that: The header also includes: a rebound reducer disposed within the head and located proximal to the corresponding proximal sealing element, wherein the rebound reducer is configured to engage the corresponding implantable lead and limit a rebound effect experienced by the corresponding implantable lead caused by a force applied by one or more of the plurality of wiper seals when the corresponding implantable lead is inserted into the corresponding socket connector stack.

18. The fully implantable left ventricular assist system of claim 17, wherein: The rebound reducer is a tilt spring, an O-ring, or an elastic member.

19. The fully implantable left ventricular assist system of claim 17, wherein: The head also includes a box having a recess for receiving the rebound reducer.

20. The totally implantable left ventricular assist system according to any one of claims 13 to 19, characterized in that: The header also includes: a vent hole located distal to the distal sealing element of the corresponding socket connector stack for preventing hydrostatic locking between the corresponding implantable lead and the corresponding socket connector stack, The distal sealing element inhibits liquid from entering through the vent hole.

21. The totally implantable left ventricular assist system according to any one of claims 13 to 20, characterized in that: the first implantable lead including electrical contacts configured to couple with corresponding electrical contacts of the first receptacle connector stack, and an electrical cable for facilitating communication and powering between the implantable controller and the heart pump; and The second implantable lead includes electrical contacts configured to couple with corresponding electrical contacts of the second socket connector stack, and an electrical cable for facilitating communication and powering between the implantable controller and the TETS receiver.

22. A totally implantable left ventricular assist system according to any one of claims 13 to 21, characterized in that: The first receptacle connector stack is spaced apart and electrically isolated from the second receptacle connector stack by the respective proximal seal elements and the respective distal seal elements.

23. An implantable lead of an implantable medical device, the implantable lead comprising: an elongated shaft having a proximal end and a distal end, the elongated shaft having a diameter of approximately 3.2 mm; a stem coupled to the proximal end of the elongated shaft; a plurality of electrical contacts disposed on an outer surface of the elongated shaft and axially spaced apart from one another, the plurality of electrical contacts including first and second electrical contacts for power transmission, third and fourth electrical contacts for communication, and fifth and sixth electrical contacts for grounding; a reinforcing member disposed axially within the elongated shaft; as well as a plurality of wires electrically coupled to the plurality of electrical contacts and extending axially within the elongated shaft, wherein the plurality of wires include: a first wire and a second wire, the first wire and the second wire being electrically coupled to the first electrical contact and the second electrical contact, respectively; a third wire and a fourth wire, the third wire and the fourth wire being electrically coupled to the third electrical contact and the fourth electrical contact, respectively; and a fifth wire and a sixth wire, the fifth wire and the sixth wire being electrically coupled to the fifth electrical contact and the sixth electrical contact, respectively; Wherein, the reinforcement member and the plurality of electrically isolated electrical wires are configured to be constrained within the diameter of the elongated shaft.

24. The implantable lead of claim 23, wherein: The plurality of wires are radially disposed at intervals of approximately 60 degrees and are circumferentially disposed around the reinforcement member.

25. The implantable lead according to claim 23 or 24, characterized in that Each of the plurality of electrical contacts comprises an annular contact, wherein the annular contacts are coaxial and linearly spaced apart from one another along the elongated axis.

26. The implantable lead according to any one of claims 23 to 25, characterized in that The electrical contacts and the electrical wires are made of corrosion-resistant and electrically conductive materials.

27. The implantable lead of claim 26, wherein: The electrical contacts and the electrical wires are made of a platinum-iridium alloy, or a nickel-cobalt based alloy of a multi-phase alloy.

28. The implantable lead of any one of claims 23 to 27, further comprising an insulating cover disposed over each of the plurality of wires.

29. The implantable lead according to any one of claims 23 to 28, characterized in that The plurality of electrical contacts are separated by injection molded insulating material for electrical isolation.

30. The implantable lead according to any one of claims 23 to 29, wherein: The first electrical contact and the second electrical contact for power transmission are disposed at a distal end portion of the elongated shaft; The fifth electrical contact and the sixth electrical contact serving as ground are disposed at a proximal end portion of the elongated shaft; and The third and fourth electrical contacts for communication are disposed between the proximal and distal portions of the elongated shaft.

31. The implantable lead according to any one of claims 23 to 30, characterized in that Each of the plurality of wires has a diameter of approximately 0.0015 mm and a length exposed from the stem ranging from 7 mm to 8 mm; and The reinforcement member has a diameter in the range of 0.5 mm to 1.5 mm and a length in the range of 28 mm to 30 mm.

32. The implantable lead according to any one of claims 23 to 31, characterized in that The stem portion comprises: a shoulder at a distal portion of the stem, the elongated shaft being configured at the shoulder to receive a sealing element of a head assembly; and A recess is configured to receive a locking assembly for securely coupling the lead to the head assembly of a second implantable medical device.

33. The implantable lead according to any one of claims 23 to 32, characterized in that The implantable lead comprises a ventricular assist device (VAD) lead or a transcutaneous energy transfer system (TETS) receiver lead.

34. The implantable lead according to any one of claims 23 to 33, characterized in that The implantable leads are coupled to a socket connector stack of an implantable controller.

35. A fully implantable left ventricular assist system, comprising: an implantable cardiac pump configured to pump blood from a ventricle of a patient's heart to an artery to supplement or replace blood pumped from the ventricle to the artery; an implantable transcutaneous energy transfer system (TETS) receiver configured to receive and transfer power to continuously operate the implantable heart pump; a first implantable lead coupled to the implantable heart pump, the first implantable lead comprising: a first elongated shaft; a first set of six electrical contacts coaxially mounted on an outer surface of the first elongated shaft; a first set of six electrical wires disposed within the first elongated shaft, each electrical wire coupled at one end to a corresponding electrical contact of the first set of six electrical contacts and coupled at an opposite end to the implantable heart pump; and a first stiffening member disposed within the first elongated shaft and electrically isolated from the first set of six electrical wires; a second implantable lead coupled to the TETS receiver, the second implantable lead comprising: a second elongated shaft; a second set of six electrical contacts coaxially mounted on an outer surface of the second elongated shaft; a second set of six wires disposed within the second elongated shaft, each wire coupled at one end to a corresponding electrical contact of the second set of six electrical contacts and coupled at an opposite end to the TETS receiver; and a second stiffening member disposed within the second elongated shaft and electrically isolated from the second set of six wires, wherein the second implantable lead has a larger diameter than the first implantable lead; and An implantable controller comprising: a first socket connector stack, the first socket connector stack being configured to receive the first implantable lead to electrically couple the implantable heart pump to the implantable controller; and a second socket connector stack, the second socket connector stack being configured to receive the second implantable lead to electrically couple the TETS receiver to the implantable controller, the first socket connector stack being spaced apart from the second socket connector stack.

36. The totally implantable left ventricular assist system of claim 35, wherein: the first set of six electrical contacts of the first implantable lead comprises: first and second electrical contacts for power transmission, third and fourth electrical contacts for communication, and fifth and sixth electrical contacts for grounding; and The second set of six electrical contacts of the second implantable lead includes first and second electrical contacts for power transmission, third and fourth electrical contacts for communication, and fifth and sixth electrical contacts for grounding.

37. The totally implantable left ventricular assist system of claim 36, wherein: The first implantable lead comprises: the first electrical contact and the second electrical contact for power transmission being disposed at a distal portion of the first implantable lead; The fifth electrical contact and the sixth electrical contact serving as a ground are disposed at a proximal portion of the first implantable lead; and The third electrical contact and the fourth electrical contact for communication are disposed between the proximal portion and the distal portion of the first implantable lead.

38. The totally implantable left ventricular assist system of claim 35, wherein: The second implantable lead comprises: a first electrical contact serving as a first voltage source and disposed at a distal portion of the second implantable lead; a second electrical contact, the second electrical contact serving as a ground and disposed proximate to a proximal end of the first electrical contact; a third electrical contact serving as a power terminal and disposed proximate to a proximal end of the second electrical contact; a fourth electrical contact, the fourth electrical contact serving as a communication line and disposed proximate to a proximal end of the third electrical contact; a fifth electrical contact serving as another ground and disposed proximate to a proximal end of the fourth electrical contact; and A sixth electrical contact serving as another power terminal and disposed at a proximal end portion of the second implantable lead.

39. A totally implantable left ventricular assist system as claimed in any one of claims 35 to 38, characterized in that: The proximal portion of the second implantable lead has a diameter greater than the proximal portion of the first implantable lead.

40. A totally implantable left ventricular assist system as claimed in any one of claims 35 to 39, characterized in that: The first implantable lead includes a first stem portion, which is disposed at a proximal portion of the first slender shaft, and the second implantable lead includes a second stem portion, which is disposed at a proximal portion of the second slender shaft, wherein a diameter of the second stem portion is greater than a diameter of the first stem portion.

41. The totally implantable left ventricular assist system of claim 40, wherein: Each of the first stem portion and the second stem portion includes a shoulder for mounting a seal and a groove for locking a corresponding lead to a head assembly of the implantable controller.

42. A totally implantable left ventricular assist system as claimed in any one of claims 35 to 41, characterized in that: The first receptacle connector stack and the second receptacle connector stack each include a proximal sealing element and a distal sealing element.

43. A totally implantable left ventricular assist system as claimed in any one of claims 35 to 42, characterized in that: Each of the first implantable lead and the second implantable lead does not require tightening of a set screw to electrically activate one or more conductive lines.

44. An implantable lead of an implantable medical device, the lead comprising: a stepped diameter elongated shaft having a proximal portion and a distal portion, the proximal portion having a larger diameter than the distal portion; a plurality of electrical contacts disposed on an outer surface of the stepped diameter elongated shaft and spaced apart from each other in an axial direction, the plurality of electrical contacts comprising first and second electrical contacts for power transmission, third and fourth electrical contacts for communication, and fifth and sixth electrical contacts for grounding, wherein one or more of the electrical contacts have different diameters; and A plurality of wires electrically coupled to the plurality of electrical contacts and extending axially within the stepped diameter elongated shaft, wherein the plurality of wires include: a first wire and a second wire, the first wire and the second wire being electrically coupled to the first electrical contact and the second electrical contact, respectively; a third wire and a fourth wire, the third wire and the fourth wire being electrically coupled to the third electrical contact and the fourth electrical contact, respectively; and a fifth wire and a sixth wire, the fifth wire and the sixth wire being electrically coupled to the fifth electrical contact and the sixth electrical contact, respectively.

45. The implantable lead of claim 44, wherein: The stepped diameter elongated shaft comprises: a first diameter portion configured to receive the first and second electrical contacts for power transmission at the distal end portion of the elongated shaft; a second diameter portion configured to receive the third and fourth electrical contacts for communication between the distal and proximal ends of the elongated shaft; and A third diameter portion is configured to receive the fifth and sixth electrical contacts at the proximal end portion of the elongated shaft for use as a ground.

46. ​​The implantable lead of claim 45, wherein: The second diameter portion has a larger diameter than the first diameter portion; and the third diameter portion has a larger diameter than the second diameter portion.

47. The implantable lead of claim 44, wherein: The stepped diameter elongated shaft includes a tapered diameter that increases from the distal portion to the proximal portion, wherein each of the six electrical contacts has a different diameter.

48. The implantable lead of any one of claims 44 to 47, further comprising a tapered reinforcement member disposed axially within the stepped diameter.

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