Medical lead system

Abstract

Various embodiments of a medical lead system are disclosed. The lead system includes a lead body including a lumen extending along the lead body between an inlet adjacent a proximal end of the lead body and an outlet adjacent a distal end of the lead body; a fixing member; and a distal balloon connected to an exterior surface of the distal end of the lead body and fluidly connected to the outlet of the lumen. The medical lead system also includes a pressure sensor fluidly connected to the inlet of the lumen of the lead body and configured to sense a pressure within the interior volume of the distal balloon and communicate a signal indicative of the pressure to a clinician. The fixation member is further configured to extend distally to the distal balloon when the distal balloon is in the inflated configuration.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 347,308, filed on May 31, 2022, the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure generally relates to implantable lead systems, such as medical leads for implantation in the heart. Background Art

[0004] Implantable medical leads may be configured to treat a variety of cardiac dysfunctions and may include one or more electrodes and other elements for physiological sensing or therapeutic delivery. Such leads may allow electrodes to be positioned at one or more target locations to achieve these functions. Implantable medical leads may be navigated through the patient's vascular system to reach these target locations. Electrodes supported by the medical leads may establish electrical communication with cardiac tissue to sense cardiac signals generated by the heart and / or deliver cardiac pacing to the patient. An assessment of the target location is typically performed to determine a satisfactory location of the electrode within the heart to provide adequate activation of the cardiac system. Summary of the invention

[0005] The technology disclosed herein as a whole relates to a medical lead system and an implantable medical device assembly including such a lead system. The system may include a lead having a distal balloon connected to the outer surface of the distal end of the lead body of the lead. The distal balloon may be fluidically connected to the outlet of the lumen of the lead. The system may also include a pressure sensor fluidically connected to the entrance of the lumen of the lead. The pressure sensor may be configured to sense the pressure within the internal volume of the distal balloon and to communicate a signal indicating such pressure to a clinician. In one or more embodiments, the system may also include an inflation mechanism configured to be fluidically connected to the entrance of the lumen of the lead body and to manipulate the distal balloon between the contracted configuration and the inflated configuration. The pressure sensor may include any suitable sensor. In one or more embodiments, the pressure sensor may include an indicator balloon defining a contracted configuration and an inflated configuration. When the distal balloon is in the contracted configuration, the indicator balloon may be in the contracted configuration. Additionally, the indicator balloon can be in the inflated configuration when the distal balloon is in the inflated configuration.

[0006] This disclosure includes but is not limited to the following terms:

[0007] Clause 1: A medical lead system comprising a lead. The lead includes a lead body having a distal end configured to extend through a vasculature to a cavity of a patient's heart, wherein the lead body also includes a lumen extending along the lead body between an entrance adjacent the proximal end of the lead body and an exit adjacent the distal end of the lead body; a fixation member configured to extend distally to the distal end of the lead body, wherein the fixation member is configured to be fixed to tissue of the heart; and a distal balloon connected to an exterior surface of the distal end of the lead body and fluidly connected to the exit of the lumen, wherein the distal balloon defines a collapsed configuration and an inflated configuration, and further, wherein the distal balloon is configured to expand radially outward from the exterior surface of the lead body and extend distally beyond the distal end of the lead body when the distal balloon is inflated from the collapsed configuration to the inflated configuration. The medical lead system also includes a pressure sensor fluidly connected to the inlet of the lumen of the lead body and configured to sense pressure within the interior volume of the distal balloon and communicate a signal indicative of the pressure to a clinician. The fixation member is further configured to extend distally to the distal balloon when the distal balloon is in the inflated configuration.

[0008] Clause 2: The system of clause 1, further comprising an inflation mechanism configured to be fluidly connected to the inlet of the lumen of the lead body and to manipulate the distal balloon between the collapsed configuration and the inflated configuration.

[0009] Clause 3: The system of clause 2, wherein the inflation mechanism comprises a syringe or a pump.

[0010] Clause 4: The system of any one of clauses 2-3, wherein the pressure sensor is connected to the inflation mechanism.

[0011] Clause 5: A system according to any one of clauses 1 to 4, wherein the pressure sensor includes an indicator balloon that defines a contracted configuration and an inflated configuration, wherein when the distal balloon is in the contracted configuration, the indicator balloon is in the contracted configuration, and further, wherein when the distal balloon is in the inflated configuration, the indicator balloon is in the inflated configuration.

[0012] Clause 6: A system according to any of clauses 1 to 4, wherein the pressure sensor comprises a disc and a base configured to receive the disc, wherein a major surface of the disc faces a major surface of the base, wherein the signal comprises a first configuration and a second configuration of the disc, wherein a first distance between a center portion of the major surface of the disc and the major surface of the base as measured along a normal to the major surface of the disc and the major surface of the base when the disc is in the first configuration is less than a second distance between the center portion of the major surface of the disc and the major surface of the base when the disc is in the second configuration. The disc is in the first configuration when the distal balloon is in the deflated configuration, and the disc is in the second configuration when the distal balloon is in the inflated configuration.

[0013] Clause 7: The system of any one of clauses 1 to 4, wherein the pressure sensor comprises a pressure transducer.

[0014] Clause 8: The system of any one of clauses 1 to 4, wherein the pressure sensor comprises an audible alarm.

[0015] Clause 9: The system of any one of clauses 1 to 4, wherein the pressure sensor comprises an indicator light, wherein the indicator light is configured to emit light comprising a first wavelength when the distal balloon is in the deflated configuration, and to emit light comprising a second wavelength when the distal balloon is in the inflated configuration.

[0016] Clause 10: The system of any one of clauses 1 to 4, wherein the pressure sensor comprises a colored diaphragm and a frosted lens, wherein the colored diaphragm is configured to move in a direction orthogonal to the diaphragm and the frosted lens. The contact area between the colored diaphragm and the frosted lens corresponds to the pressure within the interior volume of the distal balloon.

[0017] Clause 11: The system of any of clauses 1 to 4, wherein the pressure sensor comprises a mechanical switch, wherein the signal comprises a change in a shape of the mechanical switch.

[0018] Clause 12: An implantable medical device assembly, the implantable medical device assembly comprising an implantable medical device, the implantable medical device comprising a housing and an electronics module, the electronics module being disposed within the housing and comprising a power source and a circuit electrically connected to the power source. The assembly also comprises a lead system. The lead system comprises a lead, the lead comprising a lead body, the lead body comprising a distal end, the distal end being configured to extend through a vascular system to a cavity of a patient's heart, wherein the lead body comprises an inner lumen extending along the lead body between an entrance adjacent to a proximal end of the lead body and an exit adjacent to the distal end of the lead body, wherein at least a proximal portion of the lead body is configured to be inserted into a lead opening of the housing; a fixing member, the fixing member being configured to extend distally to the lead body; The lead system further comprises a pressure sensor, which is fluidly connected to the inlet of the lumen of the lead body and is configured to sense the pressure within the internal volume of the distal balloon and to communicate a signal indicating the pressure to a clinician. The fixing member is configured to extend distally to the distal balloon when the distal balloon is in the inflated configuration.

[0019] Clause 13: An assembly according to clause 12, wherein the lead opening of the implantable medical device includes a contact portion of the circuit electrically connected to the electronic device module via a conductor, wherein the lead contact portion of the lead is configured to be electrically connected to the contact portion of the lead opening when at least a portion of the lead is disposed within the lead opening.

[0020] Clause 14: An assembly according to any of clauses 12 to 13, wherein the implantable medical device is an implantable defibrillator.

[0021] Clause 15: An assembly according to any one of clauses 12 to 13, wherein the implantable medical device is a neuromodulatory device.

[0022] Clause 16: The assembly of any of clauses 12 to 15, further comprising a desiccant disposed within the housing.

[0023] Clause 17: The assembly of any of clauses 12 to 16, further comprising an inflation mechanism configured to be fluidly connected to the inlet of the lumen and to manipulate the distal balloon between the collapsed configuration and the inflated configuration.

[0024] Clause 18: The assembly of clause 17, wherein the inflation mechanism comprises a syringe or a pump.

[0025] Clause 19: The assembly of any of clauses 17-18, wherein the pressure sensor is connected to the inflation mechanism.

[0026] Clause 20: An assembly according to any one of clauses 12 to 19, wherein the pressure sensor includes an indicator balloon defining a collapsed configuration and an inflated configuration, wherein when the distal balloon is in the collapsed configuration, the indicator balloon is in the collapsed configuration. When the distal balloon is in the inflated configuration, the indicator balloon is in the inflated configuration.

[0027] Clause 21: An assembly according to any of clauses 12 to 19, wherein the pressure sensor includes a disc and a base configured to receive the disc. The major surface of the disc faces the major surface of the base. The base includes a first configuration and a second configuration. When the disc is in the first configuration, a first distance between a center portion of the major surface of the disc and the major surface of the base as measured along a normal to the major surface of the disc and the major surface of the base is less than a second distance between the center portion of the major surface of the disc and the major surface of the base when the disc is in the second configuration. When the distal balloon is in the deflated configuration, the disc is in the first configuration, and when the distal balloon is in the inflated configuration, the disc is in the second configuration.

[0028] Clause 22: The assembly of any one of clauses 12 to 19, wherein the pressure sensor comprises a pressure transducer.

[0029] Clause 23: The assembly of any one of clauses 12 to 19, wherein the pressure sensor includes an audible alarm.

[0030] Clause 24: The assembly of any of clauses 12 to 19, wherein the pressure sensor comprises an indicator light configured to emit light comprising a first wavelength when the distal balloon is in the deflated configuration and to emit light comprising a second wavelength when the distal balloon is in the inflated configuration.

[0031] Clause 25: An assembly according to any one of clauses 12 to 19, wherein the pressure sensor comprises a colored diaphragm and a frosted lens. The colored diaphragm is configured to move in a direction orthogonal to the diaphragm and the frosted lens, wherein the contact area between the colored diaphragm and the frosted lens corresponds to the pressure of the distal balloon.

[0032] Clause 26: The assembly of any of clauses 12 to 19, wherein the pressure sensor comprises a mechanical switch. The signal comprises a change in the shape of the mechanical switch.

[0033] Clause 27: A method comprising inflating a distal balloon from a collapsed configuration to an inflated configuration by expanding the distal balloon radially outward from an exterior surface of a lead body, the lead body being configured to extend through a vasculature to a cavity of a patient's heart; extending the distal balloon distally beyond a distal end of the lead body and proximal to a fixation member when the distal balloon is inflated from the collapsed configuration to the inflated configuration; and sensing a pressure within the interior volume of the distal balloon. The method further comprises communicating a signal indicative of the pressure within the interior volume of the distal balloon to a clinician.

[0034] Clause 28: The method of clause 27, further comprising substantially surrounding a portion of the fixation member with the distal balloon when the distal balloon is inflated to the inflated configuration.

[0035] Clause 29: The method of any one of clauses 27 to 28, wherein the lead body defines a lumen that is fluidly connected to the interior volume of the distal balloon at the distal end of the lead body. The lumen extends along the lead body between an inlet adjacent to the proximal end of the lead body and an outlet adjacent to the distal end of the lead body.

[0036] Clause 30: The method of Clause 29, wherein inflating the distal balloon comprises connecting an inflation mechanism to the access port of the lead body.

[0037] Clause 31: A method according to any one of clauses 29 to 30, wherein sensing the pressure comprises fluidly connecting a pressure sensor to the inner cavity at the proximal end of the lead body, and wherein communicating the signal indicative of the pressure comprises utilizing the pressure sensor to communicate the signal indicative of the pressure within the internal volume of the distal balloon to the clinician.

[0038] Clause 32: The method of clause 31, wherein the signal comprises a visual signal.

[0039] Clause 33: The method of clause 32, wherein the pressure sensor comprises an indicator balloon, wherein the visual signal comprises an inflation volume of the indicator balloon.

[0040] Clause 34: The method of clause 32, wherein the pressure sensor comprises a pressure transducer.

[0041] Clause 35: The method of clause 32, wherein the pressure sensor includes an indicator light.

[0042] Clause 36: The method of clause 32, wherein the pressure sensor comprises a disc and a base configured to receive the disc. A major surface of the disc faces a major surface of the base, wherein the signal comprises a first configuration and a second configuration of the disc. When the disc is in the first configuration, a first distance between a center portion of the major surface of the disc and the major surface of the base as measured along a normal to the major surface of the disc and the major surface of the base is less than a second distance between the center portion of the major surface of the disc and the major surface of the base when the disc is in the second configuration. The disc is in the first configuration when the distal balloon is in the deflated configuration, and the disc is in the second configuration when the distal balloon is in the inflated configuration.

[0043] Clause 37: The method of clause 31, wherein the signal comprises an audible signal.

[0044] The details of one or more aspects of the present disclosure are set forth in the following drawings and description. Other features, objectives, and advantages of the techniques described in the present disclosure will be apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0045] Figure 1 is a conceptual illustration of one embodiment of an implantable medical device assembly entering a target site within a patient's body.

[0046] Figure 2 yes Figure 1 Schematic cross-sectional view of an embodiment of an implantable medical device assembly, a medical lead system and an implantable medical device.

[0047] Figure 3 yes Figure 2 Schematic perspective view of an implantable medical device.

[0048] Figure 4 yes Figure 2 Schematic perspective view of an implantable medical device with the cover removed for clarity.

[0049] Figure 5 yes Figure 1 A schematic cross-sectional view of a portion of a medical lead system disposed within a sheath.

[0050] Figure 6 yes Figure 1 A schematic cross-sectional view of a portion of a medical lead system positioned distal to a sheath.

[0051] Figure 7 yes Figure 1 Schematic cross-sectional view of a portion of a medical lead system of FIG. 1 with a distal balloon of the system in an inflated configuration.

[0052] Figure 8 yes Figure 1 A schematic cross-sectional illustration of a portion of a medical lead system proximate a tissue wall.

[0053] Fig. 9 yes Figure 1 A schematic cross-sectional illustration of a portion of a medical lead system near a target site on a tissue wall.

[0054] Fig.10 yes Figure 1 Schematic cross-sectional view of a portion of a medical lead system with the distal balloon in a deflated configuration.

[0055] Fig.11 yes Figure 1 Schematic cross-sectional view of a portion of a medical lead system with the distal balloon in an inflated configuration.

[0056] Fig.12 is used Figure 1 A flow chart of one embodiment of a method of a medical lead system.

[0057] Fig.13 is a schematic cross-sectional illustration of another embodiment of a pressure sensor in a collapsed configuration.

[0058] Fig.14 is in an inflated configuration Fig.13 Schematic cross-sectional view of a pressure sensor.

[0059] Fig.15 is a schematic cross-sectional illustration of another embodiment of a pressure sensor in a first configuration.

[0060] Fig.16 It is in the second configuration Fig.15 Schematic cross-sectional view of a pressure sensor.

[0061] Fig.17 is a schematic cross-sectional illustration of another embodiment of a pressure sensor in a first configuration.

[0062] Fig.18 is in the first configuration Fig.17 Schematic plan view of a pressure sensor.

[0063] Fig.19 It is in the second configuration Fig.17 Schematic cross-sectional view of a pressure sensor.

[0064] Fig. 20 is a schematic cross-sectional view of another embodiment of a pressure sensor.

[0065] Fig.21 is a schematic cross-sectional view of another embodiment of a pressure sensor.

[0066] Fig. 22 is a schematic perspective view of another embodiment of a pressure sensor.

[0067] Fig.23 is a schematic cross-sectional view of another embodiment of a pressure sensor.

[0068] Fig.24 Yes Sensing Figure 1 A flow chart of one embodiment of a method of controlling pressure of a distal balloon of a medical lead system.

[0069] Fig.25 is a graph of pressure within the interior volume of an exemplary distal balloon versus time. DETAILED DESCRIPTION

[0070] The technology disclosed herein as a whole relates to a medical lead system and an implantable medical device assembly including such a lead system. The system may include a lead having a distal balloon connected to the outer surface of the distal end of the lead body of the lead. The distal balloon may be fluidically connected to the outlet of the lumen of the lead. The system may also include a pressure sensor fluidically connected to the entrance of the lumen of the lead. The pressure sensor may be configured to sense the pressure within the internal volume of the distal balloon and to communicate a signal indicating such pressure to a clinician. In one or more embodiments, the system may also include an inflation mechanism configured to be fluidically connected to the entrance of the lumen of the lead body and to manipulate the distal balloon between the contracted configuration and the inflated configuration. The pressure sensor may include any suitable sensor. In one or more embodiments, the pressure sensor may include an indicator balloon defining a contracted configuration and an inflated configuration. When the distal balloon is in the contracted configuration, the indicator balloon may be in the contracted configuration. Additionally, the indicator balloon can be in the inflated configuration when the distal balloon is in the inflated configuration.

[0071] The medical lead system can be configured to pass through the patient's vasculature to position the distal portion of the lead body of the lead near a target area, such as an area within a cavity of the heart. For example, the medical lead system can be configured to allow a clinician to navigate the lead body through a vein of the heart (e.g., at least one of the innominate vein, the inferior vena cava (IVC), or the superior vena cava (SVC)) to a target location within the right ventricle (RV), the right atrium (RA), or another area of ​​the heart. In one or more embodiments, the medical lead system is configured so that the distal balloon can be inflated within a vein of the heart on the way to the target area, for example to minimize or eliminate physical interference between the fixation member and other anatomical structures as the medical lead system passes through the patient's body.

[0072] When the lead is set in the patient, the clinician may find it difficult to observe whether the distal balloon is in a collapsed or inflated configuration because the distal balloon is set on the distal end of the lead, especially without the use of fluoroscopy or other imaging techniques. Therefore, the clinician may not receive any feedback from the distal balloon about whether it is in an inflated or collapsed configuration. In addition, the distal balloon may leak when the lead is advanced in the patient. Such leaks may not be detected by the clinician. If the distal balloon is not fully inflated when the lead is advanced in the patient, physical interference may occur between the fixation member of the lead and other anatomical structures.

[0073] One or more embodiments of the present disclosure may provide various advantages over currently available lead systems. For example, a pressure sensor of a medical lead system may be configured to sense the pressure within the internal volume of a distal balloon and communicate a signal indicating such pressure to a clinician. Such a signal may, for example, indicate to a clinician whether the distal balloon is in an inflated configuration or a deflated configuration, or whether the balloon has lost pressure due to a leak. The pressure sensor may include any suitable type of pressure sensor, such as at least one of a mechanical sensor, an electrical sensor, an auditory sensor, or a visual sensor. In addition, one or more embodiments of the medical lead system of the present disclosure may include an inflation mechanism that is configured to be fluidly connected to an entrance of an inner cavity of a lead body and to manipulate the distal balloon between a deflated configuration and an inflated configuration.

[0074] Generally speaking, the distal balloon can be configured to expand radially outward from the lead body when the balloon is inflated from a contracted configuration to an inflated configuration. In addition, in one or more embodiments, the distal balloon can be configured to define a substantially annular shape around the lead body under an inflated condition, such that, for example, the lead body extends through an annular hole. In one or more embodiments, the fixing member is configured to extend through the annular hole. In one or more embodiments, the distal balloon is configured to expand around the distal portion of the lead body so that blood flow applies force on the balloon along the direction of blood flow (e.g., so that the balloon acts as a "sail"). The distal balloon can be configured to transfer force to the lead body to help the lead body pass through the patient's vascular system and / or heart cavity while substantially covering the fixing member. In one or more embodiments, the distal balloon is configured to be inflated to an expanded size (e.g., diameter) that is at least twenty times the diameter of the lead body. In one or more embodiments, the lead body defines an inner cavity that is configured to deliver an inflation medium to cause inflation of the distal balloon.

[0075] The medical lead system may be configured to be electrically connected to tissue in the patient's body when the distal balloon is in an inflated configuration. In one or more embodiments, the fixed member mechanically supports an electrode configured to be electrically connected to the tissue. The fixed member may be configured to position the electrode to be connected to the tissue when the fixed member extends distally to the inflated balloon. In one or more embodiments, the fixed member is configured to allow the electrode to contact the tissue when the fixed member extends distally to the inflated balloon. The medical lead system may include a conductor electrically connected to the electrode. In one or more embodiments, the medical lead system includes a processing circuit that is configured to deliver treatment to the tissue using the conductor and the electrode. The medical lead system may be configured so that a clinician can perform cardiac mapping using the electrode when the balloon is inflated, so that cardiac mapping can occur when the balloon substantially covers the fixed member to reduce and / or eliminate physical interference between the fixed member and the surrounding anatomical structure.

[0076] The distal balloon is configured to contract from the inflated configuration to substantially re-establish the contracted configuration. For example, the clinician can substantially re-establish the contracted configuration (e.g., by exhausting the balloon through the lumen) of the balloon to fix the medical lead system to the tissue using a fixing member. In one or more embodiments, the fixing member defines a spiral that extends distally to the distal end of the lead body and is at least partially covered by the distal balloon. The clinician can contract the balloon via the lumen to contract the balloon and withdraw it proximally to the distal end of the lead body so that the fixing member is substantially uncovered. The clinician can then substantially engage the tissue by, for example, twisting the lead body around the longitudinal axis to drive the spiral to the tissue surface. The distal balloon can be configured to remain attached to the lead body and be located proximal to the fixing member and / or the electrode in the contracted configuration so that the processing circuit can deliver treatment to the patient via the electrode when the balloon is in the contracted configuration.

[0077] Figures 1 to 11 1 are various views of one embodiment of an implantable medical device assembly 10 that includes an implantable medical device 12 and a medical lead system 100. Assembly 10 may be configured to deliver therapy (eg, pacing) to heart 2 of patient 4.

[0078] The implantable medical device 12 includes a housing 14 and an electronic device module 18 disposed within the housing. The electronic device module 18 may include a power source 22 and a circuit 24 electrically connected to the power source ( Figure 2 ).

[0079] The medical lead system 100 may include any suitable lead system, such as one or more embodiments of the medical lead system described in co-owned U.S. patent application Ser. No. 63 / 213,674, filed on June 22, 2021, entitled “MEDICAL LEAD SYSTEM.” The medical lead system 100 of assembly 10 includes a lead 106 having a lead body 110 including a distal portion 112 that is typically positioned at a target site 114 in a patient 4. Figure 1 As shown, the target site 114 is an area in the septal wall of the heart 2. In one or more embodiments, the medical lead 106 can be oriented so that the distal portion 112 is disposed at another portion of the heart 2. For example, the lead 106 can be oriented so that the distal portion 112 is generally disposed at the target site 116 in the septal wall. The medical lead system 100 can include additional leads coupled to the medical device 12 and extending into the heart 2.

[0080] The distal portion 112 of the lead 106 includes a distal end 120 that is configured to extend through the vasculature to a cavity of the heart 2. The lead body 110 also includes an inner lumen 142 ( Figure 2 ), the lumen extending along the lead body between an inlet 102 adjacent to a proximal end 104 of the lead body and an outlet 118 adjacent to a distal end 120 of the lead body ( Fig.10 ). As used herein, the phrase "adjacent the proximal end" refers to an element or component being disposed closer to the proximal end 104 of the lead body 110 than the distal end 120. As further used herein, the phrase "adjacent the distal end" refers to an element or component being disposed closer to the distal end 120 of the lead body 110 than the proximal end 104. At least the proximal portion 105 of the lead body 110 is configured to be inserted into the lead aperture 30 of the housing 14 of the medical device 12.

[0081] The medical lead system 100 also includes a fixation member 122 that is configured to extend distally to the distal end 120 of the lead body 110. The fixation member 122 is configured to be fixed to the tissue of the heart 2.

[0082] In addition, the guide wire system 10 includes a distal balloon 124 ( Figure 7 ), the distal balloon is connected to the outer surface 138 of the distal end 120 of the lead body 110 and is fluidly connected to the outlet 118 of the lumen 142. As used herein, the phrase "fluidically connected" refers to two or more elements or components connected using any suitable technology so that one or more fluids can be directed from one element or component to another element or component via a channel or path extending between the elements or components. The distal balloon 124 defines a collapsed configuration ( Figures 5 and 6 ) and inflated configuration ( Figure 7 The distal balloon 124 is configured to expand radially outward from the outer surface 138 of the lead body 110 and extend distally beyond the distal end 120 of the lead body when the distal balloon is inflated from the collapsed configuration to the inflated configuration. The fixation member 122 is configured to extend distally to the distal balloon when the distal balloon 124 is in the inflated configuration.

[0083] Also included in the medical lead system 100 is a pressure sensor 200 ( Figure 2 ). The pressure sensor 200 is configured to sense the pressure within the interior volume 134 of the distal balloon 124 and communicate a signal indicative of the pressure to a clinician. In one or more embodiments, the pressure sensor 200 may include a processor 201 that may be configured to monitor the pressure within the interior volume 134 of the distal balloon 124 over time. For example, Fig.251100 is a graph of pressure within the interior volume 134 of the distal balloon 124 relative to time. The pressure sensor 200 can be configured to monitor the pressure over time and determine the rate of change of the pressure via the processor 201, and determine whether the pressure remains within a desired range 1102, such as Fig.25 In one or more embodiments, the processor 201 can be configured to manipulate the inflation mechanism 202 to control the pressure within the interior volume 134 of the distal balloon 124. The processor 201 can control the inflation mechanism 202 using any suitable technique.

[0084] The pressure sensor 200 can be fluidly connected to the inlet 102 of the lumen 142 using any suitable technique. In one or more embodiments, the pressure sensor 200 can be directly connected to the inlet 102 via one or more conduits 204. Such conduits 204 can be configured to direct inflation media from at least one of the lumen 142 and the inflation mechanism 202 to the sensor 200. A fluid path 206 can be formed between the sensor 200, the lumen 142, and the distal balloon 124 via the outlet 118, which is closed and represents a pressure that can be measured by the pressure sensor 200.

[0085] In one or more embodiments, the medical lead system 100 also includes an inflation mechanism 202 that is configured to be fluidly connected to the inlet 102 of the lumen 142 and to manipulate the distal balloon 124 between the collapsed configuration and the inflated configuration. When the mechanism is fluidly connected to the inlet 102 of the lumen 142, the fluid path 206 may include the inflation mechanism 202. The inflation mechanism 202 may include any suitable device (such as a syringe or a pump) that can provide an inflation medium to the distal balloon 124 via the lumen 142. The inflation mechanism 202 may be connected to the device 12 using any suitable technique. Figure 2 As shown, mechanism 202 is connected to port 16 of device 12 such that the mechanism is fluidly connected to inlet 102 of lumen 142. The inflation medium provided to distal balloon 124 may include any suitable gas or liquid (eg, air).

[0086] The implantable medical device 12 of the system 10 may include any suitable medical device configured to be implanted in a patient. In one or more embodiments, the device 12 may be a pacemaker. Additionally, in one or more embodiments, the device 12 may be a leadless cardiac monitor. The device 12 may include any other suitable medical device, such as at least one of a defibrillator, a LVAD, a neuromodulator, or a drug pump or other implantable medical device.

[0087] The housing 14 of the device 12 can take any suitable shape or shapes and have any suitable size. In addition, the housing 14 can include any suitable material or materials, such as at least one of a metal, a polymer, or an inorganic material. Suitable materials for the housing 14 can include at least one of titanium (e.g., any suitable grade, such as grade 5 titanium), stainless steel, a polymer, a ceramic, a glass, or a combination thereof (such as a laminate, a composite, or a miscible blend or mixture). In one or more embodiments, the housing 14 can include any suitable polymer material or materials, such as at least one of an epoxy resin, a polyurethane, a silicone, a polyolefin, an acrylic polymer, a polyester, polyetheretherketone (PEEK), a polysulfone, a polymethylene oxide, or a polyethylene, or a combination thereof.

[0088] The housing 14 can be a unitary housing. In one or more embodiments, the housing 14 can include two or more parts that are connected using any suitable one or more techniques, such as welding, mechanical fastening, adhesion, thermal bonding, diffusion bonding, laser-assisted diffusion bonding, solvent bonding, overmolding, etc. In addition, the housing 14 can be formed using any suitable one or more techniques (e.g., injection molding, thermoforming, lamination, overmolding, casting, insert molding, etc.).

[0089] The housing 14 may include any suitable port or socket that can connect the device to an external component or system. For example, the housing 14 may include a lead opening 30 disposed in any suitable portion or portions of the housing. The lead opening 30 may take any suitable shape or shapes and have any suitable size. The housing 14 may also include a set screw block 50 disposed in any suitable portion or portions of the housing, the set screw block being configured to receive a set screw 52, ​​the set screw including an aperture or lumen 53 for guiding inflation fluid from the inflation mechanism 202 to the lumen 142 of the lead 14. The set screw block 50 may take any suitable shape or shapes and have any suitable size. The set screw block 50 may receive a set screw 52, ​​the set screw being configured to retain the lead 14 in the lead opening 30. The port 16 may be disposed through a silicone grommet 17, through which an inflation medium may be provided to the distal balloon 124 using the inflation mechanism 202. The port 16 may be disposed in any suitable portion of the housing 14. In one or more embodiments, an inflation medium can be delivered by inserting inflation mechanism 202 into sealing grommet 17 and aperture 53, such that the inflation medium can pass through the aperture and enter lumen 142 of lead 14. In one or more embodiments, a gap can be formed between aperture 53 of set screw 52 and lead 14, such that the inflation medium can exit the aperture and be directed into lead aperture 30, where the inflation medium can be further directed into entrance 102 of lumen 142.

[0090] Implantable medical device 12 may further include any suitable material disposed within housing 14. For example, a desiccant may be disposed at any suitable location within housing 14. The desiccant may include any suitable material that can absorb moisture present within housing 14, such as at least one of a molecular sieve, silica gel, or a combination of a silicone elastomer mixed with one of the desiccant materials.

[0091] Additionally, one or more polymeric fill materials may be disposed in any suitable location within housing 14. The polymeric fill material may include any suitable material or materials, such as at least one of a medical adhesive, a medical grade silicone, an epoxy, or a polyurethane.

[0092] The implantable medical device 12 may also include electronic circuitry housed within the housing 14, wherein the electronic circuitry may be configured to deliver cardiac pacing. Figure 2 As shown, the electronic device module 18 may include a substrate 20, a power supply 22 disposed on the substrate, and a circuit 24 also disposed on the substrate and electrically connected to the power supply. The power supply 22 may include any suitable one or more power supplies, such as one or more batteries. Although the power supply 22 is depicted as including two power supplies, it may include any suitable number of power supplies, such as one, two, three, four, five or more power supplies. The power supply 22 may be disposed on any suitable one or more portions of the substrate 20. In one or more embodiments, the power supply 22 may be disposed at any suitable location in the housing 14, rather than being disposed on the substrate.

[0093] Also disposed on substrate 20 is circuitry 24. Such circuitry 24 may include any suitable device or component, such as at least one of a capacitor, a transistor, an integrated circuit including a controller or multiplexer, a sensor, an accelerometer, an inductive charging coil, an antenna, an optical component such as a transmitter and a detector, etc. Such components may be electrically connected to power source 22 or one or more components using any suitable one or more techniques. In addition, circuitry 24 may be disposed on any suitable portion of substrate 20. In one or more embodiments, one or more components of circuitry 24 may be disposed within or on housing 14 separately from one or more additional components of the circuitry, and these components may be electrically connected to power source 22 and one or more additional components using any suitable one or more techniques. In one or more embodiments, circuitry 24 and power source 22 may be coated with an intermediate barrier to form a conformal coating. Any suitable technique may be utilized. For example, chemical vapor deposition may be utilized to provide a coating of parylene or any other material that provides a protective barrier for circuitry 24 and power source 22.

[0094] The assembly 10 also includes a medical lead system 100 having a lead 106 configured to be electrically connected to an electronics module 18 disposed in the housing 14 of the device 12. The lead 106 may include any suitable lead, such as an industry standard or custom format pacing, defibrillation, or neurostimulation lead, etc. Although depicted as including one lead 106, the system 100 may include any suitable number of leads electrically connected to the electronics module 18. Any suitable one or more techniques may be used to electrically connect the lead 106 to the electronics module 18. In one or more embodiments, at least a proximal portion 107 of the lead 106 may be disposed within the lead aperture 30 of the housing 14 such that when the proximal portion of the lead is disposed within the lead aperture, the lead contact 109 is electrically connected to the contact 34 disposed within the lead aperture 30. In one or more embodiments, the lead 106 may include a second lead contact 111 configured to electrically connect the lead to a second contact 36 disposed within the lead aperture 30 when the proximal portion 107 of the lead is disposed within the lead aperture. The contact 34 and the second contact 36 may be electrically connected to the electronics module 18 via a conductor 40, such as Figure 3 shown.

[0095] As mentioned herein, the lead 106 includes a fixation member 122 mechanically supported by the distal portion 112 of the lead. The fixation member 122 is configured to penetrate tissue of the patient 4 at or near a target site, such as the target sites 114, 116. For example, the fixation member 122 may be configured to penetrate cardiac tissue of the septal wall in the right ventricle (RV), right atrium (RA), left ventricle (LV), and / or left atrium (LA) of the heart 2, or penetrate cardiac tissue in another region of the heart 2. In one or more embodiments, the fixation member 122 is configured to remain substantially stationary relative to the distal end 120 of the lead 106, such that the fixation member is substantially fixed in place on the distal portion 112 of the lead body. In one or more embodiments, the fixation member 122 may be configured to translate relative to the distal end 120 of the lead 106. For example, the fixation member 122 may be configured to translate distally or proximally within the lumen defined by the distal portion 112. The fixing member 122 may have various shapes, such as a spiral, a tooth, a screw, a ring, etc.

[0096] In one or more embodiments, the fixing member 122 mechanically supports the electrode 123, which is configured to be electrically connected to the tissue when the fixing member positions the electrode near the target site 114, 116. In one or more embodiments, the electrode is configured to provide pacing to the heart 2. The electrode can be electrically connected to one or more conductors 148 extending through the lead body 110. In one or more embodiments, the conductor is electrically connected to the circuit 24 of the medical device 12, wherein the circuit is configured to use the conductor to deliver a therapeutic signal to the electrode and / or sense a cardiac signal from the electrode. The fixing member 122 can be configured to position the electrode so that the electrode conducts the electrical signal to the target tissue of the heart 2, thereby depolarizing the myocardium of, for example, the ventricle, and thereby contracting at regular intervals.

[0097] The medical lead system 100 also includes a distal balloon 124 attached to an exterior surface 138 of the distal end 120 of the lead body 110. The distal balloon 124 defines an interior volume 134 that is configured to receive an inflation medium (e.g., air, saline, or another medium) and cause inflation of the balloon 124. In one or more embodiments, the lead body 110 defines an inner lumen 142 that is fluidly coupled to the interior volume and configured such that a clinician can deliver an inflation medium to the interior volume 134 defined by the distal balloon 124. The distal balloon 124 is configured to inflate from a collapsed configuration that defines an initial size (e.g., an initial diameter) and to expand radially outward from the distal end 120 of the lead body 110 to an inflated configuration that defines an expanded size (e.g., an expanded diameter). The distal balloon 124 is Figure 7 110 is depicted in an inflated configuration. The distal balloon 124 is configured to extend distally beyond the distal end 120 of the lead body 110 when the balloon is in the inflated configuration. In one or more embodiments, the distal balloon 124 defines a substantially annular shape that surrounds the distal portion 112 and the distal end 120 of the lead body 110 when the balloon is in the inflated configuration. In addition, the fixation member 122 (e.g., the distal end of the fixation member 122) is configured to extend distally to the balloon when the distal balloon 124 is in the inflated configuration. The distal balloon 124 can be configured to substantially surround a portion of the fixation member 122 in the inflated configuration, for example, to minimize and / or eliminate physical interference between the fixation member and other anatomical structures in the patient's body.

[0098] The clinician can manipulate the lead body 110 through the vasculature of the patient 4 to position the distal portion 112 at or near a target site (such as target sites 114, 116). The medical lead system 100 can be configured to allow the clinician to manipulate the lead body 110 through the vasculature when the distal balloon 124 is in an inflated configuration. For example, with the distal balloon 124 in an inflated configuration, the clinician can guide the distal portion 112 of the lead body 110 through the superior vena cava (SVC) into the RA and through the tricuspid valve (TV) into the RV to access the target site 114 on the atrioventricular septal wall. The distal balloon 124 can substantially surround a portion of the fixation member 122 to at least maintain radial displacement between the fixation member and an anatomical structure within the patient 4 (e.g., the TV or other structure within the heart 2) during passage of the distal portion. The medical lead system 100 can be configured to accommodate other pathways or techniques to reach a target site within the patient 4 with the distal balloon 124 in an inflated configuration. For example, the medical lead system 100 can be configured such that the inflated configuration accommodates another venous pathway through the innominate vein, the inferior vena cava (IVC), and / or another venous pathway to the cavity of the heart 2.

[0099] In one or more embodiments, radial expansion of the distal balloon 124 around the distal portion 112 of the lead body 110 causes blood flow to exert a force on the balloon in the direction of the blood flow. Thus, the distal balloon 124 can essentially act as a sail to assist the clinician during delivery to the target site 114, 116. In addition, the distal balloon 124 can transmit the force applied to the distal portion 112 of the lead body 110 to help the distal portion pass through the vasculature of the patient 4 (e.g., through the heart 2) while substantially covering the fixation member 122. For example, in the inflated configuration, blood flow from the RA to the RV of the heart 2 can exert a force on the distal balloon 124, which helps the lead body distal portion 112 pass through the TV of the heart 2. The distal balloon 124 can transmit a force to the distal portion 112 to help the distal portion pass through the TV while substantially covering the fixation member 122 to minimize and / or eliminate physical interference between the fixation member 122 and the TV.

[0100] The medical lead system 100 is configured to map (e.g., electrophysiological mapping) an area of ​​the heart 2 to locate an initial target site (e.g., target sites 114, 116). In one or more embodiments, the medical lead system 100 is configured to perform mapping when the distal balloon 124 is in an inflated configuration. The fixation member 122 can be configured to position the mechanically supported electrode sufficiently close to the tissue of the heart 2 so that the electrode can establish electrical communication with the tissue for mapping.

[0101] The medical lead system 100 can be configured to perform contact-based and / or substantially contactless pacing mapping of the heart 2 using electrodes. With the distal balloon 124 in an inflated configuration, the clinician can navigate the lead body distal portion 112 to a potential implantation site (e.g., target site 114, 116), and evaluate the suitability of each potential site by observing the signals (e.g., ECG signals and / or EGM signals) generated by the heart 2 as the electrodes are electrically connected to the tissue. When the clinician determines that the medical lead system 100 is located at an appropriate target site, the clinician can deflate the distal balloon 124 to allow the fixing member 122 to be inserted at the target site. When the clinician deflates the distal balloon 124, the balloon can substantially re-establish the deflated configuration.

[0102] In one or more embodiments, the medical lead system 100 is configured to monitor the internal volume 134 ( Figures 7 to 9 ). For example, medical lead system 100 may include pressure sensor 200 configured to sense pressure within interior volume 134 and communicate a signal indicative of the pressure to processing circuitry of an output device. Medical lead system 100 may be configured such that a clinician may monitor pressure as lead body 110 passes through the vasculature of patient 4 and / or a cavity of heart 2 to provide an indication of the position of lead body 110 within patient 4. For example, the signal indicative of the pressure may provide an indication that lead body 110 has entered a cavity of heart 2.

[0103] Figure 5 is a schematic cross-sectional view of a portion of a medical lead system 100 configured to deliver a lead body 110 en route to a vasculature or other region within a patient 4 to position a distal portion 112 of the lead body 110 proximate a target site. Figure 5 The lead body 110 is illustrated positioned within the sheath lumen 126 of the sheath 128. The sheath 128 may be, for example, an introducer sheath configured to provide access to the jugular vein, the innominate vein, and / or the subclavian vein. In one or more embodiments, the sheath 128 is a delivery catheter. The sheath 128 includes an inner wall 127 defining the sheath lumen 126, and also includes a sheath opening 130 leading to the sheath lumen 126. The distal balloon 124 is attached to the distal portion 112 of the lead body 110. The fixing member 122 extends distally (e.g., in the distal direction D) to the distal end 120 of the distal portion 112 of the lead body 110. The inner wall 127, the distal portion 112, the distal end 120, the balloon 124, and the fixing member 122 are depicted in dashed lines within the sheath lumen 126.

[0104] Figure 5The medical lead system 100 is illustrated with the distal balloon 124 in a deflated configuration. The medical lead system 100 is configured to translate through the sheath lumen 126 to pass through the sheath opening 130 when the distal balloon 124 is in the deflated configuration. The fixation member 122 mechanically supports the electrode 123, which is configured to electrically communicate with tissue when positioned near a target site (such as target sites 114, 116) within the patient 4.

[0105] Figure 6 is a schematic cross-sectional view of a medical lead system 100 configured to position a distal balloon 124 outside a sheath lumen 126 such that the balloon can be inflated en route to position a distal portion 112 of a lead body 110 proximate a target site within a patient 4 . Figure 6 The distal balloon 124 is illustrated in a collapsed configuration and has a maximum initial dimension D1 (e.g., diameter) perpendicular to the longitudinal axis L defined by the lead body 110. The medical lead system 100 defines a maximum initial dimension D1 to allow the lead body 110 to translate through the sheath lumen 126 and the sheath opening 130. In one or more embodiments, the lead body 110 includes a marker 132 (e.g., located proximal to the distal balloon 124) that is configured to indicate that the distal balloon is located distal to the sheath opening 130, allowing the balloon 124 to expand freely without being constrained by the sheath lumen 126 (e.g., inner wall 127). The marker 132 can be configured to be visible on an imaging system, such as a fluoroscope, ultrasound, or other system configured to provide an image of the medical lead system 100 within the patient 4.

[0106] Figure 7 1 is a schematic cross-sectional view of the medical lead system 100, wherein the distal balloon 124 is in an inflated configuration. The distal balloon 124 defines an internal volume 134, which is configured to contain an inflation medium so that the balloon is Figures 5 and 6 The contracted configuration changes to Figure 7 In one or more embodiments, the interior volume 134 is at least partially defined by an inner surface 136 of the distal balloon 124 and an outer surface 138 of the lead body distal portion 112. The lead body 110 defines a lumen 142 that is configured to provide inflation medium to the interior volume 134.

[0107] In the inflated configuration, the distal balloon 124 defines a maximum expanded dimension D2 (e.g., diameter) perpendicular to the longitudinal axis L. The maximum expanded dimension D2 of the inflated configuration is greater than the maximum initial dimension D1 of the collapsed configuration. In the inflated configuration, the distal balloon 124 extends distally to the distal end 120 of the lead body 110, wherein a portion of the fixing member 122 extends distally to the balloon. In the inflated configuration, the distal balloon 124 may substantially surround the longitudinal axis L, such that the balloon 124 substantially forms a buffer circumferentially around the fixing member 122. In one or more embodiments, the distal balloon 124 defines a substantially annular shape that surrounds the distal portion 112 and the distal end 120 of the lead body 110 when the balloon is in the inflated configuration. The distal balloon 124 may be configured such that the distal portion 112 extends at least partially within the hole defined by the substantially annular shape. In one or more embodiments, the fixing member 122 is configured to extend at least partially through the hole defined by the substantially annular shape.

[0108] Figure 8 The medical lead system 100 is illustrated with the distal balloon 124 in an inflated configuration proximate a tissue wall 140. The tissue wall 140 may be, for example, a heart 2 ( Figure 1 The distal balloon 124 substantially surrounds the longitudinal axis L and extends distally to the distal end 120 of the lead 106, such that the distal balloon 124 forms a buffer around the fixation member 122 to minimize and / or eliminate physical interference between the fixation member 122 and other anatomical structures in the patient 4 on the way to the tissue wall 140. Fig. 9 The medical lead system 100 is illustrated in which the distal balloon 124 is in an inflated configuration and the electrode 123 has been positioned sufficiently close to be in electrical communication with the tissue wall 140. The medical lead system 100 can be configured such that the electrode 123 is in electrical communication with the tissue wall by substantially contacting the tissue wall 140 and / or in electrical communication with the tissue wall in a substantially contactless manner (e.g., using the conductivity of the intervening blood volume). The electrode 123 can be electrically connected to one or more conductors 148 extending through the lead body 110 and electrically connected to the processing circuit 24 ( Figure 2 ). With the electrode 123 sufficiently close to the tissue wall 140, the clinician can navigate the distal portion 112 of the lead body 110 to potential implantation sites and assess the suitability of each potential site by observing the signals relayed from the electrode 123 to the circuit 24. Fig. 9As shown, when the distal balloon 124 is in an inflated configuration, the clinician can perform cardiac mapping using the electrodes 123. Cardiac mapping can occur when the distal balloon 124 substantially covers the fixation member 122 to reduce and / or eliminate physical interference between the fixation member and surrounding anatomical structures in the patient 4. When the clinician determines that the medical lead system 100 is located at an appropriate target site, the clinician can deflate the distal balloon 124 to allow the fixation member 122 to be inserted at the target site.

[0109] Fig.10 A schematic cross-sectional view of a portion of the medical lead system 100 is illustrated with the distal balloon 124 in a deflated configuration. Fig.11 is a schematic cross-sectional view of the portion of the medical lead system 100 with the distal balloon 124 in an inflated configuration. Fig.10 and Fig.11 The cross section is taken with a cutting plane parallel to the page and the longitudinal axis L.

[0110] The distal portion 112 of the lead body 110 can define a lumen 142 that extends at least partially through the distal portion 112 of the lead body 110. In one or more embodiments, the longitudinal axis L extends through the lumen 142 and intersects the distal end 120 of the lead 106. The lead body 110 (e.g., the lead body distal portion 112) can include a wall 144 defining an interior surface 146, wherein the interior surface defines the lumen 142. The wall 144 can further define an exterior surface 138 that is opposite to the interior surface 146. In one or more embodiments, the lumen 142 extends to a proximal opening 139 ( Figure 1 ). Lead body 110 can be configured such that when lead body 110 is extended through the vasculature of patient 4, proximal opening 139 is outside the patient's body ( Figure 1 In one or more embodiments, lead body 110 is configured such that when distal portion 112 is positioned within a cavity of heart 2, proximal opening 139 is external to the patient's body ( Figure 1 ).

[0111] The medical lead system 100 may include a conductor 148 in electrical communication with the electrode 123. In one or more embodiments, the fixation member 122 defines the electrode 123, and the conductor 148 is in electrical communication with the electrode 123 via the fixation member 122. For example, the fixation member 122 may include a conductive material covered by an insulating layer, and the electrode 123 may be a portion of the conductive material from which the insulating layer is removed.

[0112] Conductor 148 may extend through lumen 142, although this is not required. In one or more embodiments, conductor 148 is configured to be in electrical communication with circuit 24 of implantable medical device 12 to deliver therapy to patient 4 using electrode 123. In one or more embodiments, when lead body 110 extends through the vasculature of patient 4 ( Figure 1 ), and / or when the lead body distal portion 112 is positioned within a cavity of the heart 2 ( Figure 1 ), conductor 148 is configured to extend to a location outside the patient's body.

[0113] In one or more embodiments, the medical lead system 100 is configured such that when the lead body 110 extends through the vasculature of the patient 4, the lumen 142 is fluidly isolated from the patient 4 ( Figure 1 ). The medical lead system 100 can be configured such that when the distal end 120 of the lead body 110 is within the vasculature of the patient 4, the lumen 142 is fluidly isolated from the distal end. In one or more embodiments, the medical lead system 100 includes a stopper 150 that is configured to fluidly isolate the lumen 142 from the distal end 120 of the lead body 110 when the distal end 120 is within the vasculature of the patient 4. In one or more embodiments, the stopper 150 is configured to mechanically support the fixation member 122. Thus, the lumen 142 can be configured such that the lumen 142 is fluidly coupled to the proximal opening (e.g., Figure 2 , and when the distal end 120 is within the vascular system of the patient 4, the inner cavity is fluidly isolated from the distal end.

[0114] The distal balloon 124 may include a balloon body 152 configured to elastically expand when the balloon transitions from a deflated configuration to an inflated configuration (e.g., when an inflation medium is provided to the interior volume 134). The balloon body 152 may define a balloon interior surface 136. In one or more embodiments, the balloon body 152 extends at least partially around a perimeter defined by the distal exterior surface 138 (e.g., a perimeter perpendicular to the longitudinal axis L). In one or more embodiments, the balloon body 152 extends substantially completely around the perimeter defined by the distal exterior surface 138.

[0115] The balloon body 152 (e.g., the balloon inner surface 136) and a portion of the distal outer surface 138 may define the interior volume 134. In one or more embodiments, the distal portion 112 of the lead body 110 defines the distal outer surface 138 to include a first outer surface 138a and a second outer surface 138b, wherein the first outer surface is proximal to the second outer surface 138b. The balloon body 152 and the second outer surface 138b may define at least a portion of, or in some cases substantially all of, the interior boundary of the interior volume 134. In one or more embodiments, the second outer surface 138b extends substantially from the first outer surface 138b to the distal end 120.

[0116] The medical lead system 100 includes one or more structures defining a lumen 142 that is configured to deliver an inflation medium to the interior volume 134 to cause inflation of the distal balloon 124. In one or more embodiments, the lead body 110 defines a lumen 142 that is configured to deliver an inflation medium. The lead distal portion 112 may include one or more side lumens, such as a side lumen 154 and a side lumen 156, that are configured to fluidly couple the lumen 142 and the interior volume 134 so that the inflation medium provided to the lumen can flow to the interior volume 134 via the side lumens 154, 156. In one or more embodiments, at least one of the side lumens 154, 156 defines an outlet 118 of the lumen 142.

[0117] As described herein, the distal balloon 124 is configured to Fig.10 ) inflated to the inflated configuration ( Fig.11), expands radially outward from the distal outer surface 138 (e.g., the second outer surface 138b) and extends distally beyond the distal end 120. In one or more embodiments, the balloon body 152 is attached to the outer surface 138 of the lead body 110 at least at a position 158 and is configured to extend distally to the position when the balloon is in an inflated configuration. In one or more embodiments, the balloon body 152 is attached to the outer surface 138 at a first position 160 and a second position (such as position 158), wherein the first position 160 is proximal to the second position 158. The balloon body 152 may define a midpoint M between the first position 160 and the second position 158 (e.g., substantially midway between them) and separate a proximal balloon portion 162 and a distal balloon portion 164. The proximal balloon portion 162 may extend between the first position 160 and the midpoint M, and the distal balloon portion 164 may extend between the midpoint M and the second position 158. The distal balloon 124 can be configured such that when the balloon is in the inflated configuration, the distal balloon portion 164 is distal to the second location 158. In one or more embodiments, the distal balloon 124 (e.g., the balloon body 152) is configured to be proximal to the distal end 120 of the lead body 110 when the balloon is in the deflated configuration. The distal balloon 124 (e.g., the balloon body 152) can be configured to expand in a direction perpendicular to the longitudinal axis L when the balloon 124 expands radially outward from the distal exterior surface 138.

[0118] The pressure sensor 200 is fluidly connected to the entrance 102 of the inner cavity 142 of the lead body 110. Such a sensor 200 may include any suitable type of sensor configured to sense the pressure within the internal volume 134 of the distal balloon 124 and convey a signal indicating the pressure to a clinician. In one or more embodiments, the pressure sensor 200 includes at least one of a pressure transducer, an audible alarm, an indicator light, or a mechanical switch. For example, in one or more embodiments, the pressure sensor 200 may include an indicator light configured to emit light having a first wavelength when the distal balloon 124 is in a contracted configuration, and emit light having a second wavelength when the distal balloon is in an inflated configuration. In one or more embodiments, the first wavelength is different from the second wavelength. In an embodiment where the pressure sensor 200 includes a mechanical switch, the signal provided to the clinician may include a change in the shape of the mechanical switch. For example, in one or more embodiments, the pressure sensor 200 may include a diaphragm that can provide visual confirmation that the interior of the distal balloon 124 is pressurized, or an audible snap or click associated with the diaphragm moving through the toggle position when the distal balloon is pressurized.

[0119] Figure 13 to Figure 14 It is available with Figures 1 to 11A schematic cross-sectional view of one embodiment of a pressure sensor 300 for use with the system 10. Figure 2 All design considerations and possibilities described for pressure sensor 200 apply equally to Figure 13 to Figure 14 The pressure sensor 300 includes an indicator balloon 302, which can be connected to the inlet 102 of the inner cavity 142 of the lead body 110 through a catheter 306. The indicator balloon 302 can define a deflated configuration ( Fig.13 ) and inflated configuration ( Fig.14 ). When the distal balloon 124 is in the deflated configuration, the indicator balloon 302 is in the deflated configuration. In addition, when the distal balloon 124 is in the inflated configuration, the indicator balloon 302 is in the inflated configuration.

[0120] In one or more embodiments, the internal volume 304 of the indicator balloon 302 can represent the internal volume 134 of the distal balloon 124. For example, a suitable transfer function can be utilized that relates the internal volume 304 of the indicator balloon 302 to the internal volume 134 of the distal balloon 124. Such internal volume 304 of the indicator balloon 302 can be related to the pressure in the fluid path 206 formed by the sensor 300, the lumen 142 of the lead 106, the inflation mechanism 202 when it is fluidly connected to the inlet 102 of the lead, and the distal balloon 124. Thus, the pressure within the indicator balloon 302 can be related to the pressure within the distal balloon 124. The indicator balloon 302 can provide a signal indicating the pressure within the internal volume of the distal balloon 124, which can be communicated to the clinician. In one or more embodiments, such a signal can be provided by the value of the internal volume of the indicator balloon 302 (i.e., the size of the indicator balloon observed by the clinician).

[0121] Figure 15 to Figure 16 is a schematic cross-sectional view of another embodiment of a pressure sensor 400. Figure 2 The pressure sensor 200 and Figure 13 to Figure 14 All design considerations and possibilities described for pressure sensor 300 apply equally to Figure 15 to Figure 16 The pressure sensor 400 includes a disk 402 and a base 404 configured to receive the disk. The base 404 can be connected to the inlet 102 of the inner cavity 142 of the lead body 110 through a conduit 406. The main surface 407 of the disk 402 faces the main surface 408 of the base 404. The pressure sensor 400 is configured to provide a first configuration ( Fig.15 ) and the second configuration ( Fig.16). When the disc 402 is in the first configuration, a first distance 410 between a central portion 412 of a major surface of the disc and a major surface of the base 404 as measured along a normal 414 to major surface 407 of the disc and major surface 408 of the base 404 is less than a second distance 413 between a central portion of a major surface of the disc and a major surface of the base when the disc is in the second configuration. The disc 402 is in the first configuration when the distal balloon 124 is in the deflated configuration, and the disc is in the second configuration when the distal balloon is in the inflated configuration.

[0122] The disk 402 may take any suitable shape or shapes in a plane parallel to the major surface 407 of the disk, such as an oval, rectangular, or polygonal shape. Additionally, the base 404 may take any suitable shape or shapes in a plane parallel to the major surface 407 of the disk 402. The disk 402 may be connected to the base 404 using any suitable technique. For example, the disk 402 may be constrained along the edge 416 within a notch or slot (not shown) in the sidewall 418 of the base 404.

[0123] Figures 17 to 19 are various views of another embodiment of a pressure sensor 500. Figure 2 Pressure sensor 200, Figure 13 to Figure 14 The pressure sensor 300 and Figure 15 to Figure 16 All design considerations and possibilities described for pressure sensor 400 apply equally to Figures 17 to 19 The pressure sensor 500 includes a colored diaphragm 502 and a frosted lens 504. The colored diaphragm 502 and the frosted lens 504 can be disposed in a base 512 that is fluidly connected to the inlet 102 of the inner cavity 142 via a conduit 506. The colored diaphragm 502 is configured to move in a direction along a normal 515 to a major surface 518 of the frosted lens 504. A contact area 507 ( Figure 18 to Figure 19 ) corresponds to the pressure of the inner volume 134 of the distal balloon 124. For example, Fig.18 As shown, the contact area 507 is within a first indicator area 508. Such an indicator area 508 may be associated with the deflated configuration of the distal balloon 124. Fig.19 As shown, the contact area 507 fills the second indication area 510, which has a Fig.18 The second indicator area 510 can be related to the inflated configuration of the distal balloon 124.

[0124] The colored diaphragm 502 and the frosted lens 504 may be disposed in the base 512 using any suitable technique. Fig.17As shown, the colored membrane 502 is fixed along the edge 514 so that the edge is constrained, while the central portion 516 is free to move relative to the pressure in the internal volume 134 of the distal balloon 124 and contacts the frosted lens 504 to form a contact area 507, which is indicative of the pressure in the internal volume 134 of the distal balloon 124. The colored membrane 502 and the frosted lens 504 can take any suitable one or more shapes in a plane orthogonal to the normal 515 of the major surface 518 of the lens, such as Fig.17 When the central portion 516 is displaced due to the pressure in the air flow path, the central portion is forced into close contact with the main surface 518 of the frosted lens 504, thereby significantly changing the visual appearance of the lens. As the pressure in the air flow path decreases, the diaphragm 502 moves in a direction away from the frosted lens 504, causing the visual appearance of the frosted lens to return to its original state.

[0125] Fig. 20 is a schematic cross-sectional view of another embodiment of a pressure sensor 700. All design considerations and possibilities described herein with respect to pressure sensors 200, 300, 400, and 500 apply equally to Fig. 20 The pressure sensor 700 is a pressure sensor 700. In one or more embodiments, the sensor 700 can be considered as a mechanical switch type sensor, wherein the signal conveyed to the clinician may include a change in the shape of the mechanical switch of the sensor. The sensor 700 includes a body 702 and a spring-loaded plunger 704 disposed in a channel 706 extending into the body. The channel 706 is fluidly connected to a catheter 708, which can be connected to the inlet 102 of the inner cavity 142. The spring-loaded plunger 704 is configured to move in a direction along the channel axis 701, and the channel 706 extends along the channel axis. The pressure in the channel 706 corresponds to the pressure in the internal volume 134 of the distal balloon 124, so that when the internal volume reaches the desired pressure, the plunger 704 extends beyond the upper surface 710 of the valve 712 connected to the body 702, that is, the pressure sensor 700 conveys a signal indicating the pressure to the clinician. In one or more embodiments, the valve 712 can be used to control the activation of the plunger 704. In addition, such a valve can be used as a contraction switch, which can be used to at least partially contract the distal balloon 124.

[0126] Fig.21 is a schematic cross-sectional view of another embodiment of a pressure sensor 800. All design considerations and possibilities described herein with respect to pressure sensors 200, 300, 400, 500, and 700 are equally applicable to Fig.21The pressure sensor 800 of FIG. 800 is a pressure sensor. In one or more embodiments, the sensor 800 may be considered a mechanical switch type sensor, wherein the signal conveyed to the clinician may include a change in the shape of the mechanical switch of the sensor. The pressure sensor 800 includes a body 802 and a pop-up indicator 804 disposed within a channel 806 of the body. The indicator 804 includes a sidewall 810 and a rod 808 connected to the sidewall. When fluid pressure is applied to the valve 800, the sidewall 810 prolapses or flips, causing the rod 808 to protrude beyond the body 802. Once the pressure is removed from the valve 800, the sidewall 810 returns to a relaxed state, which causes the rod 808 to retract into the body 802. The indicator 802 may be associated with the pressure of the internal volume 134 of the distal balloon 124, such that when the internal volume is at a desired pressure, the rod 808 extends beyond the body 802. As a result, the pressure sensor 800 senses the pressure within the internal volume 134 of the distal balloon 124 and conveys a signal indicating the pressure to the clinician.

[0127] Fig. 22 is a schematic cross-sectional view of another embodiment of a pressure sensor 900. All design considerations and possibilities described herein with respect to pressure sensors 200, 300, 400, 500, 700, and 800 are equally applicable to Fig. 22 The pressure sensor 900 is a pressure sensor of the embodiment of the present invention. In one or more embodiments, the sensor 900 can be considered a mechanical switch type sensor, wherein the signal conveyed to the clinician may include a change in the shape of the mechanical switch of the sensor. The sensor 900 includes a body 902 and a tube 904 disposed within a housing 910 connected to the body. The tube 904 is fluidly connected to the inlet 102 of the inner cavity 142 by a conduit 906. As shown in Fig.23 It can be seen that Fig.23 yes Fig. 22 Schematic top plan view of pressure sensor 900, wherein housing 910 is removed for clarity, indicating tab 912 can be connected to end 914 of tube 904. As shown, tube 904 can be in a coiled configuration and flat or contracted. When fluid pressure is applied to sensor 900, wall 916 of tube 904 can expand as the tube inflates. This expansion of wall 916 causes tube 904 to unfold, thereby moving indicating tab 912 within window 918 of housing 910. The position of indicating tab 912 within window 918 can be related to the pressure of the internal volume 134 of distal balloon 124. As a result, the movement of indicating tab 912 indicates to the clinician the change in the pressure of the internal volume 134 of distal balloon 124, that is, pressure sensor 900 conveys a signal indicating pressure to the clinician.

[0128] Fig.12A method 600 for positioning a lead body 110 within a patient 4 is illustrated in FIG. Although the method 600 is described with respect to the medical lead system 100, the method may be used with any suitable medical lead system.

[0129] The method includes inflating the distal balloon 124 from a collapsed configuration to an inflated configuration at 602. The method may include expanding the distal balloon 124 radially outward from the outer surface 138 of the distal portion 112 of the lead body 110 as the distal balloon 124 is inflated from the collapsed configuration to the inflated configuration. In one or more embodiments, the method includes positioning the lead body 110 within the vasculature of the patient 4 prior to inflating the distal balloon 124 from the collapsed configuration to the inflated configuration.

[0130] In one or more embodiments, the method further includes issuing an inflation medium into the interior volume 134 defined by the distal balloon 124 to inflate the balloon from the collapsed configuration to the inflated configuration. The method may include issuing the inflation medium through a lumen 142 fluidly connected to the interior volume 134. In one or more embodiments, the inflation medium is issued through the lumen 142 to the interior volume 134 via the side lumens 154, 156 (i.e., the outlet 118).

[0131] When the distal balloon 124 is inflated, the balloon body 152 can extend distally to the distal end 120 of the lead body 110. In one or more embodiments, the balloon body 152 is attached to the outer surface 138 at a position on the outer surface, and when the distal balloon 124 is inflated, a portion of the balloon body is displaced from a position proximal to the position to a position distal to the position. In one or more embodiments, when the distal balloon 124 is in a collapsed configuration, the balloon body 152 is attached to the outer surface 138 at a first position and a second position distal to the first position and the distal balloon portion 164 is distal to the first position and proximal to the second position. When the distal balloon 124 is inflated, the distal balloon portion 164 can extend distally to the distal end 120.

[0132] The method 600 also includes, at 604, extending a fixation member 122 mechanically supported by the distal portion 112 distally beyond the distal balloon 124 when the balloon is in the inflated configuration. The fixation member 122 can define a helix including a helical distal end, wherein the helical distal end can extend distally beyond the distal balloon portion 164 when the distal balloon 124 is in the inflated configuration. When the distal balloon 124 is in the inflated configuration and the fixation member 122 is extended distally to the balloon, the balloon can extend radially around a portion of the fixation member 122. In one or more embodiments, when the distal balloon 124 is in the inflated configuration and the fixation member 122 is extended distally to the balloon, the balloon substantially surrounds a portion of the fixation member 122.

[0133] Fig.24 is a flow chart of one embodiment of a method 1000 of inflating the distal balloon 124 and sensing pressure within its interior volume 134. Figures 1 to 12 The implantable medical device assembly 10 is described, but the method 1000 can be used with any suitable assembly.

[0134] At 1002, the distal balloon 124 is inflated from a collapsed configuration to an inflated configuration by expanding the distal balloon 124 radially outward from an exterior surface 138 of a lead body 110 configured to extend through the vasculature to a cavity of a heart 4 of a patient 2 using any suitable technique. Any suitable technique may be used, such as by utilizing Figure 2 The inflation mechanism 202 is used to inflate the distal balloon 124. At 1004, when the distal balloon 124 is inflated from the collapsed configuration to the inflated configuration, the distal balloon may extend distally beyond the distal end 120 of the lead body 110 and be located proximal to the fixation member 122. In addition, at 1006, any suitable technology may be used to sense the pressure within the internal volume 134 of the distal balloon 124. For example, in one or more embodiments, a pressure sensor 200 may be used to sense the pressure within the internal volume 134 of the distal balloon 124. At 1008, a signal indicating the pressure within the internal volume 134 of the distal balloon 124 may be communicated to the clinician using any suitable one or more technologies. For example, such a signal may include Figure 13 to Figure 14 The sensor 300 indicates the internal volume of the balloon 302, which indicates the pressure within the internal volume 134 of the distal balloon 124. In one or more embodiments, at 1010, when the distal balloon 124 is inflated to the inflated configuration, a portion of the fixation member 122 can be substantially surrounded by the distal balloon.

[0135] It should be understood that the various aspects disclosed herein may be combined in combinations different from those specifically presented in the specification and drawings. It should also be understood that, depending on the example, certain actions or events of any of the processes or methods described herein may be performed in a different order, may be added, merged, or omitted entirely (e.g., not all described actions or events may be required to perform these techniques). In addition, although for clarity, certain aspects of the present disclosure are described as being performed by a single module or unit, it should be understood that the techniques of the present disclosure may be performed by a combination of units or modules associated with, for example, a medical device.

[0136] In one or more examples, the described techniques can be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions can be stored as one or more instructions or codes on a computer-readable medium and executed by a hardware-based processing unit. A computer-readable medium may include a computer-readable storage medium, which corresponds to a tangible medium, such as a data storage medium (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and can be accessed by a computer).

[0137] Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuits. Thus, the term "processor" as used herein may refer to any of the aforementioned structures or any other physical structure suitable for implementing the described techniques. Additionally, these techniques may be fully implemented in one or more circuits or logic elements.

Claims

1. A medical lead system, comprising: A lead wire, the lead wire comprising: a lead body including a distal end configured to extend through vasculature to a cavity of a patient's heart, wherein the lead body further includes a lumen extending along the lead body between an inlet proximal to the proximal end of the lead body and an outlet proximal to the distal end of the lead body; a fixation member configured to extend distally to the distal end of the lead body, wherein the fixation member is configured to be fixed to tissue of the heart; and a distal balloon connected to an exterior surface of the distal end of the lead body and fluidly connected to the outlet of the lumen, wherein the distal balloon defines a collapsed configuration and an inflated configuration, and further wherein the distal balloon is configured to expand radially outward from the exterior surface of the lead body and extend distally beyond the distal end of the lead body when the distal balloon is inflated from the collapsed configuration to the inflated configuration; and a pressure sensor fluidly connected to the inlet of the lumen of the lead body and configured to sense pressure within the interior volume of the distal balloon and communicate a signal indicative of the pressure to a clinician; Wherein the fixation member is further configured to extend distally to the distal balloon when the distal balloon is in the inflated configuration.

2. The system of claim 1, further comprising an inflation mechanism configured to be fluidly connected to the inlet of the lumen of the lead body and to manipulate the distal balloon between the collapsed configuration and the inflated configuration.

3. The system of claim 2, wherein the inflation mechanism comprises a syringe or a pump.

4. A system according to any one of claims 1 to 3, wherein the pressure sensor includes an indicator balloon, which defines a contracted configuration and an inflated configuration, wherein when the distal balloon is in the contracted configuration, the indicator balloon is in the contracted configuration, and further, wherein when the distal balloon is in the inflated configuration, the indicator balloon is in the inflated configuration.

5. A system according to any one of claims 1 to 3, wherein the pressure sensor includes a disk and a base configured to receive the disk, wherein a major surface of the disk faces a major surface of the base, wherein the signal includes a first configuration and a second configuration of the disk, wherein when the disk is in the first configuration, a first distance between a center portion of the major surface of the disk and the major surface of the base as measured along a normal to the major surface of the disk and the major surface of the base is less than a second distance between the center portion of the major surface of the disk and the major surface of the base when the disk is in the second configuration, wherein the disk is in the first configuration when the distal balloon is in the deflated configuration, and the disk is in the second configuration when the distal balloon is in the inflated configuration.

6. The system of any one of claims 1 to 3, wherein the pressure sensor comprises a pressure transducer.

7. A system according to any one of claims 1 to 3, wherein the pressure sensor includes an indicator light, wherein the indicator light is configured to emit light comprising a first wavelength when the distal balloon is in the contracted configuration, and to emit light comprising a second wavelength when the distal balloon is in the inflated configuration.

8. A system according to any one of claims 1 to 3, wherein the pressure sensor includes a colored diaphragm and a frosted lens, wherein the colored diaphragm is configured to move in a direction orthogonal to the diaphragm and the frosted lens, and wherein a contact area between the colored diaphragm and the frosted lens corresponds to the pressure within the internal volume of the distal balloon.

9. An implantable medical device assembly, comprising: An implantable medical device comprising a housing and an electronics module disposed within the housing and comprising a power source and a circuit electrically connected to the power source; and A lead system, the lead system comprising: A lead wire, the lead wire comprising: a lead body including a distal end configured to extend through vasculature to a cavity of a patient's heart, wherein the lead body includes a lumen extending along the lead body between an inlet proximal to the proximal end of the lead body and an outlet proximal to the distal end of the lead body, wherein at least a proximal portion of the lead body is configured to be inserted into the lead aperture of the housing; a fixation member configured to extend distally to the distal end of the lead body, wherein the fixation member is configured to be fixed to tissue of the heart; and a distal balloon connected to an exterior surface of the distal end of the lead body and fluidly connected to the outlet of the lumen, wherein the distal balloon defines a collapsed configuration and an inflated configuration, and further wherein the distal balloon is configured to expand radially outward from the exterior surface of the lead body and extend distally beyond the distal end of the lead body when the distal balloon is inflated from the collapsed configuration to the inflated configuration; and a pressure sensor fluidly connected to the inlet of the lumen of the lead body and configured to sense pressure within the interior volume of the distal balloon and communicate a signal indicative of the pressure to a clinician; Wherein the fixation member is configured to extend distally to the distal balloon when the distal balloon is in the inflated configuration.

10. A component according to claim 9, wherein the lead opening of the implantable medical device includes a contact portion electrically connected to the circuit of the electronic device module via a conductor, and wherein the lead contact portion of the lead is configured to be electrically connected to the contact portion of the lead opening when at least a portion of the lead is disposed within the lead opening.

11. The assembly of any one of claims 9 to 10, wherein the implantable medical device is one of an implantable defibrillator or a neuromodulation device.

12. The assembly of any one of claims 9 to 11, further comprising an inflation mechanism configured to be fluidly connected to the inlet of the lumen and to manipulate the distal balloon between the collapsed configuration and the inflated configuration.

13. The assembly of claim 12, wherein the pressure sensor is connected to the inflation mechanism.

14. A component according to any one of claims 9 to 13, wherein the pressure sensor includes an indicator balloon, which defines a contracted configuration and an inflated configuration, wherein when the distal balloon is in the contracted configuration, the indicator balloon is in the contracted configuration, and further, wherein when the distal balloon is in the inflated configuration, the indicator balloon is in the inflated configuration.

15. A component according to any one of claims 9 to 13, wherein the pressure sensor includes a disk and a base configured to receive the disk, wherein a major surface of the disk faces a major surface of the base, wherein the disk includes a first configuration and a second configuration, wherein when the disk is in the first configuration, a first distance between a center portion of the major surface of the disk and the major surface of the base as measured along a normal to the major surface of the disk and the major surface of the base is less than a second distance between the center portion of the major surface of the disk and the major surface of the base when the disk is in the second configuration, wherein when the distal balloon is in the deflated configuration, the disk is in the first configuration, and when the distal balloon is in the inflated configuration, the disk is in the second configuration.

16. An assembly according to any one of claims 9 to 13, wherein the pressure sensor comprises a pressure transducer.

17. An assembly according to any one of claims 9 to 13, wherein the pressure sensor includes an audible alarm.

18. A component according to any one of claims 9 to 13, wherein the pressure sensor includes an indicator light, wherein the indicator light is configured to emit light comprising a first wavelength when the distal balloon is in the contracted configuration, and to emit light comprising a second wavelength when the distal balloon is in the inflated configuration.

19. A component according to any one of claims 9 to 13, wherein the pressure sensor includes a colored diaphragm and a frosted lens, wherein the colored diaphragm is configured to move in a direction orthogonal to the diaphragm and the frosted lens, and wherein a contact area between the colored diaphragm and the frosted lens corresponds to the pressure of the distal balloon.

20. An assembly according to any one of claims 9 to 13, wherein the pressure sensor comprises a mechanical switch, wherein the signal comprises a change in the shape of the mechanical switch.

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