CN117122821B - Medical implantation wire and implantation type medical equipment - Google Patents
Medical implantation wire and implantation type medical equipment Download PDFInfo
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- CN117122821B CN117122821B CN202311400028.XA CN202311400028A CN117122821B CN 117122821 B CN117122821 B CN 117122821B CN 202311400028 A CN202311400028 A CN 202311400028A CN 117122821 B CN117122821 B CN 117122821B
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- 238000002513 implantation Methods 0.000 title claims abstract description 39
- 239000004020 conductor Substances 0.000 claims abstract description 111
- 230000002107 myocardial effect Effects 0.000 claims abstract description 31
- 210000000596 ventricular septum Anatomy 0.000 claims abstract description 23
- 239000013598 vector Substances 0.000 claims description 95
- 239000007943 implant Substances 0.000 claims description 31
- 238000009413 insulation Methods 0.000 claims description 28
- 238000000576 coating method Methods 0.000 claims description 24
- 239000011248 coating agent Substances 0.000 claims description 23
- 210000005241 right ventricle Anatomy 0.000 claims description 4
- 230000000149 penetrating effect Effects 0.000 claims description 3
- 230000008878 coupling Effects 0.000 claims description 2
- 238000010168 coupling process Methods 0.000 claims description 2
- 238000005859 coupling reaction Methods 0.000 claims description 2
- 238000010292 electrical insulation Methods 0.000 claims 1
- 230000006378 damage Effects 0.000 abstract description 5
- 210000001519 tissue Anatomy 0.000 description 22
- 208000033988 Device pacing issue Diseases 0.000 description 8
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- 210000001174 endocardium Anatomy 0.000 description 7
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- 230000000747 cardiac effect Effects 0.000 description 6
- 238000000034 method Methods 0.000 description 5
- 230000001225 therapeutic effect Effects 0.000 description 5
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- 239000008280 blood Substances 0.000 description 4
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- 230000004761 fibrosis Effects 0.000 description 4
- 230000000638 stimulation Effects 0.000 description 4
- 238000009434 installation Methods 0.000 description 3
- 230000028161 membrane depolarization Effects 0.000 description 3
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- 206010028594 Myocardial fibrosis Diseases 0.000 description 2
- NRTOMJZYCJJWKI-UHFFFAOYSA-N Titanium nitride Chemical compound [Ti]#N NRTOMJZYCJJWKI-UHFFFAOYSA-N 0.000 description 2
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- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Chemical compound [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 description 2
- 229920000052 poly(p-xylylene) Polymers 0.000 description 2
- 229920001343 polytetrafluoroethylene Polymers 0.000 description 2
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- 208000013875 Heart injury Diseases 0.000 description 1
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- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 description 1
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- 210000003742 purkinje fiber Anatomy 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/362—Heart stimulators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/375—Constructional arrangements, e.g. casings
- A61N1/37512—Pacemakers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/375—Constructional arrangements, e.g. casings
- A61N1/37518—Anchoring of the implants, e.g. fixation
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Radiology & Medical Imaging (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Heart & Thoracic Surgery (AREA)
- Cardiology (AREA)
- Biophysics (AREA)
- Electrotherapy Devices (AREA)
Abstract
The invention provides a medical implantation lead, which comprises a first conductor, a second conductor and an electrode assembly, wherein the electrode assembly comprises a conductor connecting needle, an insulating layer, an insulating block, an inner insulating sleeve, a first electrode, an outer insulating sleeve, an insulating bush and a second electrode, the far end of the first conductor is connected with the conductor connecting needle, the insulating block, the first electrode, the insulating bush and a mounting seat are sequentially and tightly sleeved from the far end of the conductor connecting needle, the second conductor is sleeved outside the first electrode, the near end of the second electrode is sleeved at the far end of the mounting seat, and the second electrode is electrically connected with the first conductor through the mounting seat. When the second electrode fully enters the ventricular septum myocardial tissue, the first electrode pierces the right ventricular septum, thereby ensuring that the right ventricular septum is effective for pacing. The invention can pace the left bundle support part, realize the pace of the right bundle support part, and the spiral head electrode is easy to enter the myocardial tissue, so that the damage of the myocardial tissue is minimized and the implantation success rate is improved.
Description
Technical Field
The invention relates to the technical field of implantable medical equipment, in particular to a medical implantation lead and implantable medical equipment.
Background
The cardiac pacemaker is an electronic therapeutic instrument implanted in a human body, and can send electric pulses through a pulse generator and deliver therapeutic stimulation to the heart of a patient through conduction of a lead so as to excite and shrink the heart, thereby achieving the aim of treating cardiac dysfunction. As shown in fig. 1, a pulse generator 1 is schematically illustrated, the pulse generator 1 is provided with a housing 11 and a head 12, a switch control circuit is provided in the housing 11, the head 12 is connected with a connector 3, and the connector 3 is used as an electrical connection interface between the pulse generator 1 and the medical implant lead 2. The material of the connector 3 may be chosen to be biocompatible and to suitably conduct and transmit electrical signals from the pulse generator 1. In general, the medical implant lead 2 comprises a first electrical conductor 21, a second electrical conductor 22 (not shown in the figures) and an electrode assembly 23, the electrode assembly 23 being connected to the connector 3 via the first electrical conductor 21, the electrode assembly 23 being provided with a spiral electrode which can be implanted in the myocardial tissue 4 of a patient. Thus, the pulse generator 1 can detect the electrical activity of the heart by means of the medical implant lead 2 and perform a suitable electrical stimulation therapy by means of the electrode assembly 23.
Referring to fig. 1, regarding the pacing technique, since the hill system is a conduction system of the heart, which can be likened to a circuit system of the heart, which is very fast compared to conduction of the myocardial cells, a pacing signal issued from the sinus node can be rapidly conducted to the myocardial cells through a rapid pathway between the atrioventricular node, the right bundle branch 41/left bundle branch 42 (left anterior/posterior branch) and the purkinje fiber 43, and then an electrical signal is transferred to cause mechanical contraction of the cardiac muscle, so that the right ventricle 44 and the left ventricle 45 are contracted almost simultaneously with pacing by the hill system, so that the damage of the cardiac function is not increased.
Traditional his system pacing includes left bundle branch regional pacing (LBBaP) or Left Bundle Branch Pacing (LBBP). Left bundle branch region pacing (LBBaP) is to fix a special ventricular pacing electrode through the ventricular septum in the left bundle branch region (LBBa), directly pace the Left Bundle Branch (LBB) 42, and can quickly excite the conductive bundle branch to realize electro-mechanical synchronous contraction of the heart, and meanwhile, can avoid some defects of the shi bundle pacing, such as high pacing threshold, low sensing, cross sensing, unstable electrode and the like. However, since the pacing electrode of LBBaP needs to pass through the ventricular septum and be fixed in the left bundle branch region, the fixed position of the pacing electrode is deeper and farther than the fixed position of the pacing electrode of his bundle pacing.
Disclosure of Invention
In order to achieve the above and other objects, the present invention is achieved by the following technical solutions: a medical implant lead comprising a first electrical conductor, a second electrical conductor, and an electrode assembly, the distal ends of the first electrical conductor and the second electrical conductor being connected to the electrode assembly, the electrode assembly comprising: a conductor connecting pin connected to the first conductor; an insulation block for insulating between the conductor connecting pin and the first electrode; a first electrode, a proximal end of the first electrode being proximate to the insulating block; the second electrode is a spiral electrode; the proximal end of the second electrode is arranged on the mounting seat, and the mounting seat is electrically connected with the second electrode; an insulating bushing for insulating between the first electrode and the second electrode; the distal end of the first electrode penetrates out of the insulating bush through the inside of the insulating bush, the mounting seat is sleeved at the distal end of the insulating bush, and the length of the second electrode is longer than the length of the first electrode penetrating out of the insulating bush; the conductor connecting pin is inserted into the mounting seat through the insulating block, the first electrode and the insulating bush in an electric insulation way, and the distal end of the conductor connecting pin is electrically connected with the mounting seat.
In one embodiment, the surface of the conductor connecting pin is covered with an insulating coating extending from the proximal end to a position a first length from the distal end.
In an embodiment, the first electrode is a unitary structure comprising a first body, a second body, and a third body; the first main body and the second main body form a step shape, the second main body is a ring electrode which is remained in a ventricle, and the third main body is a needle electrode which enters myocardial tissue; the conductor connecting pin penetrates through the first main body and the second main body through the first hole.
In an embodiment, a surface of the third body is covered with an insulating coating extending from a junction of the second body and the third body to a distal end of the third body, the distal tip portion of the third body not being covered with the insulating coating.
In one embodiment, the insulation layer is sleeved outside the first conductor; the insulation layer is sleeved with the inner insulating sleeve; the second conductor is sleeved on the first main body and is electrically connected with the first main body; the electric cable further comprises an outer insulating sleeve, and the outer insulating sleeve is sleeved outside the second conductor.
In one embodiment, the insulating bush is provided with a second hole and a third hole which are through holes; the conductor connecting needle passes through the second hole, and the distal end of the first electrode passes through the third hole; the mounting seat is provided with a fourth hole and a fifth hole, the fourth hole is a through hole, the far end of the insulating bush penetrates through the fourth hole, the fifth hole is a blind hole, and the far end of the conductor connecting needle is electrically connected with the mounting seat through the fifth hole.
In an embodiment, the surfaces of the mount and the second electrode are covered with an insulating coating that extends from the proximal end of the mount to a position a second length from the distal tip of the second electrode.
In an embodiment, the length of the first electrode extending out of the insulating bush is 2-3.5mm, and the length of the second electrode is 8-12 mm.
In an embodiment, the distal ends of the first electrode and the second electrode each include an uninsulated portion, and the distance between the uninsulated portions ranges from 2mm to 6mm.
In one embodiment, the first electrode pierces the right side compartment when the second electrode fully enters the compartment during implantation.
In one embodiment, when the second electrode is fully advanced into the ventricular septum myocardial tissue, the first electrode is advanced into the right bundle branch or right bundle branch region and the second electrode is advanced into the left bundle branch or left bundle branch region.
The present invention also provides an implantable medical device comprising the medical implant lead, the first electrode comprising a second body that remains in the right ventricle after implantation and a third body that enters the ventricular septum, further comprising: a first sensing vector, the third body and the second electrode forming the first sensing vector; a second sensing vector, the second body and the second electrode forming the second sensing vector, the second sensing vector and the first sensing vector being redundant sensing vectors; a first pacing vector, the third body and the second electrode forming the first pacing vector; a second pacing vector, the second body and the second electrode forming the second pacing vector, the first pacing vector and the second pacing vector being redundant pacing vectors to each other; and the pulse generator is used for sensing and pacing, senses electrocardiosignals according to the first sensing vector or the second sensing vector and paces according to the first pacing vector or the second pacing vector.
In an embodiment, the first sensing vector is a vector defined by positions of left and right branches where the distal tip of the third body and the distal tip of the second electrode are positioned after being implanted into the ventricular septum, or a vector defined by positions of left and right branch areas; the second sensing vector is a vector defined by the position of the second body in the ventricle and the position of the left bundle branch or left bundle branch region where the distal tip of the second electrode is implanted after the ventricular septum.
In an embodiment, the first pacing vector is a vector defined by the positions of the left bundle branch and the right bundle branch where the distal tip of the third body and the distal tip of the second electrode are located after implantation into the ventricular septum, or a vector defined by the positions of the left bundle branch region and the right bundle branch region; the second pacing vector is a vector defined by a position of the second body in a ventricle and a position of a left bundle branch or left bundle branch region where the distal tip of the second electrode is located after implantation of the ventricular septum.
Due to the application of the technical scheme, compared with the prior art, the invention has the following advantages:
1. when the deep implantation of the ventricular septum is realized, only the spiral head electrode enters myocardial tissue, and the medical implantation lead part does not enter together, so that the damage of the myocardial tissue is minimized;
2. the spiral head electrode is easy to penetrate into myocardial tissue, the difficulty in implantation is reduced, the implantation success rate is greatly improved, and particularly for cases of myocardial fibrosis, the implantation success rate is remarkably improved;
3. the pacing at the left bundle supporting part simultaneously realizes the right interval pacing, so that the pacing of a clinical conduction system achieves the optimal effect;
4. the needle-shaped pacing electrode can greatly reduce the pacing threshold value, and the ring electrode positioned in the blood pool has good sensing characteristics;
5. the redundancy of the sensing vector and the pacing vector is realized, more reliable sensing signals and pacing signals are provided, and the problems of poor sensing or poor pacing caused by various reasons (such as myocardial cell fibrosis) can be avoided.
Drawings
FIG. 1 shows a cardiac pacemaker operating scenario;
FIG. 2 is a schematic view of a medical implant lead according to the present invention;
FIG. 3 is a schematic cross-sectional view of a medical implant lead according to the present invention;
FIG. 4 is a schematic view of a first electrode according to the present invention;
FIG. 5 is a schematic view of an insulating bushing and mount of the present invention;
FIG. 6 shows an exploded view of the components of the present invention;
FIG. 7 is an assembly flow chart of the present invention;
fig. 8 is a schematic view showing an implantation state of the present invention.
1-a pulse generator; 11-a housing; 12-head; 13-a first perceptual vector; 14-a second perceptual vector; 15-a first pacing vector; 16-a second pacing vector; 2-a medical implant lead; 21-a first electrical conductor; 22-a second electrical conductor; 23-an electrode assembly; 231-conductor connection pins; 2311-a base; 2312-threading a needle; 232-an insulating layer; 233-insulating blocks; 234-inner insulating sleeve; 235-a first electrode; 2351-a first body; 2352-a second body; 2353-a third body; 2354—a first aperture; 236-an outer insulating sleeve; 237-insulating bushing; 2371-a second aperture; 2372-third aperture; 238-mount; 2381-fourth aperture; 2382-fifth aperture; 2383-first step; 2384-a second step; 239-a second electrode; a 3-connector; 4-myocardial tissue; 41-right bundle branch; 42-left bundle branch; 43-purkinje fiber; 44-right ventricle; 45-left ventricle.
Detailed Description
Please refer to fig. 1 to 8. Other advantages and effects of the present invention will become apparent to those skilled in the art from the following disclosure, which describes the embodiments of the present invention with reference to specific examples.
It should be understood that the structures, proportions, sizes, etc. shown in the drawings are for illustration purposes only and should not be construed as limiting the invention to the extent that it can be practiced, since modifications, changes in the proportions, or adjustments of the sizes, which are otherwise, used in the practice of the invention, are included in the spirit and scope of the invention which is otherwise, without departing from the spirit or scope thereof. Also, the terms "left", "right", "upper", "lower" and "a" are used herein for descriptive purposes only and are not intended to limit the scope of the invention as embodied or construed in any manner without substantially altering the technical context.
In the present invention, for a clearer description, the following description is made: the observer views fig. 1 with the end remote from the pulse generator 1 being the "distal end" which is also the end near the myocardial tissue 4; the end close to the pulse generator 1 is the "proximal end". The reference numerals used for the components in the present specification, such as "first", "second", etc., are used for distinguishing the described objects, and do not have any sequential or technical meaning. The term "coupled", where the context clearly indicates otherwise, includes both direct and indirect coupling.
Please refer to fig. 2 and 3, wherein the proximal end of the medical implant lead 2 and the connector 3 are omitted, but the understanding of the overall solution of the present invention is not affected by the person skilled in the art, and the present description is clear and complete.
The invention provides a medical implant lead 2, which comprises a first conductor 21, a second conductor 22 and an electrode assembly 23, wherein the second conductor 22 is positioned on the outer side of the first conductor 21, and the first conductor 21, the second conductor 22 and the electrode assembly are coaxially assembled. The proximal ends of the first electrical conductor 21 and the second electrical conductor 22 are connected to the pulse generator 1 via the connector 3, and the distal ends are connected to the electrode assembly 23.
The electrode assembly 23 includes a conductor connection needle 231, and the distal end of the first electrical conductor 21 is connected to the conductor connection needle 231; the insulation layer 232 is sleeved outside the first conductor 21, and the distal end is electrically connected with the conductor connecting needle 231; further comprising an insulating block 233, the insulating block 233 being abutted against the distal end of the first electrical conductor 21, the conductor connecting pin 231 passing through the insulating block 233; the insulation sleeve 234 is sleeved outside the insulation layer 232 and the conductor connecting needle 231, the distal end of the insulation sleeve 234 is abutted to the proximal end of the insulation block 233, and the proximal end extends to the connector 3 for insulation between the first conductor 21 and the second conductor 22; the device further comprises a first electrode 235, wherein the proximal end of the first electrode 235 is abutted against the distal end of the insulating block 233, i.e. the proximal end of the first electrode 235 is abutted against the distal end of the insulating block 233, or a certain gap is left, or the two are connected through a filler, such as medical connection glue; the conductor connecting needle 231 passes through the first electrode 235, and the distal end of the second electric conductor 22 abuts against the step of the first electrode 235; also comprises an outer insulating sleeve 236, the outer insulating sleeve 236 is sleeved outside the second electric conductor 22, and the proximal end extends to the connector 3; further comprising an insulation bushing 237, the insulation bushing 237 being serially connected to the distal end of the first electrode 235, the distal end of the first electrode 235 passing through the insulation bushing 237 through the inside of the insulation bushing 237, the distal end of the conductor connecting needle 231 passing through the insulation bushing 237; the installation seat 238 is sleeved at the distal end of the insulation bushing 237, and the distal end of the conductor connecting needle 231 is embedded into the installation seat 238 and is electrically connected with the installation seat 238; and a second electrode 239, wherein a proximal end portion of the second electrode 239 is arranged on the mounting base 238, the mounting base 238 is electrically connected with the second electrode 239, and a proximal end of the second electrode 239 abuts against a platform surface of the mounting base 238.
Specifically, the second electrode 239 is spiral, the second electrode 239 is one of pacing electrodes of a conduction system, and the pitch of the proximal portion, i.e., the portion disposed on the mount 238, is smaller than the pitch of the distal end, and the pitch of the proximal end is 0 or near 0.
Further, the distal end of the second electrode 239 is provided with a longer tip, and the spiral tip is easy to penetrate into the myocardial tissue 4, so as to greatly improve the success rate of implantation.
Referring to fig. 3 and 6, the conductor connecting pin 231 includes a base 2311, and the base 2311 has a tubular structure as shown in fig. 6; also included is a needle 2312, the needle 2312 being fixedly coupled to the distal end face of the base 2311. The first electrical conductor 21 penetrates into the tubular cavity of the base 2311, and the first electrical conductor 21 and the base 2311 are combined by welding, interference fit or the like.
Specifically, the inner diameter of the tubular structural cavity of the base 2311 is slightly larger than the diameter of the first electrical conductor 21; the first electrical conductor 21 is conveniently connected to the inside of the tubular structure of the base 2311 by the radial expansion effect of the first electrical conductor 21 during laser welding.
Further, the base 2311 and the needle 2312 are made of a conductive material as one body or are assembled by a separate material through conductive connection.
Further, the base 2311 may be optionally configured, the first electrical conductor 21 may be directly welded to the piercing needle 2312, or the first electrical conductor 21 may be split into several strands to form the piercing needle 2312, which may be adopted by a person skilled in the art according to common general knowledge.
Specifically, as shown in the filled-in hatched portion in fig. 6, the conductor connecting pin 231 is partially surface-insulated, the surface of the piercing pin 2312 is covered with an insulating coating, and the insulating coating extends from the distal end surface of the base 2311 to a position of a first length of 0.3-0.9mm at the distal end of the piercing pin 2312.
Specifically, the insulating coating covered on the surface of the needle 2312 may be a PTFE coating, a Parylene coating, a titanium nitride coating, an oxide insulating coating, or other insulating coatings known to those skilled in the art.
Referring to fig. 4 and 6, the first electrode 235 includes a first main body 2351, and the second electric conductor 22 is sleeved outside the first main body 2351; the device further comprises a second main body 2352, the second main body 2352 is a ring electrode, the proximal end face of the second main body 2352 is fixedly connected with the distal end face of the first main body 2351, the first main body 2351 and the second main body 2352 form a step shape, the distal end face of the second main body 2352 is abutted with the proximal end face of the insulating bushing 237, and a certain gap is reserved between the two; the device further comprises a third main body 2353, wherein the third main body 2353 is a needle electrode and is fixedly connected to the distal end face of the second main body 2352; the first hole 2354 is a through hole, the first hole 2354 penetrates the first body 2351 and the second body 2352, and the needle 2312 penetrates the first hole 2354 and penetrates the first body 2351 and the second body 2352.
Specifically, the first body 2351, the second body 2352 and the third body 2353 are integrally constructed, and the diameter of the first body 2351 is smaller than the diameter of the second body 2352. The distal end of the second electrical conductor 22 is sleeved on the first main body 2351, the first electrical conductor and the second electrical conductor are electrically connected, the surface of the second electrical conductor 22 is covered with the outer insulation sleeve 236, the sum of the section heights of the second electrical conductor 22 and the outer insulation sleeve 236 is smaller than or equal to the step height formed by the first main body 2351 and the second main body 2352, the distal end face of the outer insulation sleeve 236 is abutted to the proximal end face of the second main body 2352, and body fluid is prevented from entering the inside of the medical imbedding wire 2 through the abutting face by sealing at the abutting face.
Further, the outer insulating sleeve 236 is adhered to the second electrical conductor 22 by glue, and when the medical implant lead 2 is implanted, the first electrode 235 and the second electrode 239 are driven to rotate during the process of rotating the outer insulating sleeve 236, so that the second electrode 239 is convenient to enter the myocardial tissue 4.
Specifically, as shown by the filled-in hatched portion in fig. 4, the surface of the third body 2353 is covered with an insulating coating that extends from the junction of the second body 2352 and the third body 2353 to the distal end of the third body 2353, the distal tip portion of the third body 2353 is uninsulated, and the uninsulated portion is connected to the right bundle branch 41 or right bundle branch region in the room space.
Further, the length of the non-insulated portion of the third body 2253 is 1-3mm, preferably 2mm, with smaller non-insulated portions being able to reduce pacing current and reduce pacing threshold, reducing power consumption of the pacemaker.
Specifically, the needle 2312 passes through the first hole 2354, the insulating portion of the needle 2312 passes beyond the openings of the proximal and distal ends of the first hole 2354, and the insulating coating of the needle 2312 functions to insulate the needle 2312 and the first electrode 235 from short circuits.
Referring to fig. 3 and 5, the mounting seat 238 is sleeved at the distal end of the insulating bush 237, the proximal end face of the mounting seat 238 abuts against the stepped end face of the insulating bush 237, the tubular portion of the insulating bush 237 is embedded into the mounting seat 238, the third main body 2353 penetrates out of the distal ends of the insulating bush 237 and the mounting seat 238, the second electrode 239 is sleeved at the distal end of the mounting seat 238, the proximal end of the second electrode 239 abuts against the stepped end face of the mounting seat 238, and the mounting seat 238 is electrically connected with the second electrode 239. The insulating bush 237 is provided with a second hole 2371 and a third hole 2372, which are through holes, the needle 2312 passes through the second hole 2371, and the third main body 2353 passes through the third hole 2372. A fourth hole 2381 and a fifth hole 2382 are formed in the mounting seat 238, the fourth hole 2381 is a through hole, the distal end of the insulation bushing 237 passes through the fourth hole 2381, the fifth hole 2382 is a blind hole, and the tail end of the needle penetrating 2312 is embedded into the fifth hole 2382; the proximal end of the mounting seat 238 is a first step 2383 in a shape of a truncated cone, the distal end is a second step 2384 in a shape of a sleeve, and the second electrode 239 is sleeved on the second step 2384. The third body 2353 passes through the insulation bush 237 and the mount 238, and the needle 2312 passes through the insulation bush 237 to pass through the mount 238.
Specifically, the positions and diameters of the first hole 2354, the second hole 2371 and the fifth hole 2382 are identical, and the needle 2312 sequentially passes through the first hole 2354, the second hole 2371 and the fifth hole 2382. The inner diameter of the third hole 2372 is matched with the outer diameter of the third main body 2353, and the outer diameter of the third hole 2372 is matched with the inner diameter of the fourth hole 2381.
Further, when assembled in the axial direction, the tubular portion of the insulating bush 237 is inserted into the fourth hole 2381 of the mount 238, the insulating bush 237 serves as insulation and fixation between the third body 2353 and the mount 238 in the radial direction, and after assembled, the insulating bush 237 insulates the distal end of the second body 2352 from the second electrode 239 in the axial direction, thereby electrically insulating the first electrode 235 and the second electrode 239 as a whole.
Further, the uninsulated portion of the needle 2312 enters the fifth hole 2382 and is electrically connected to the mount 238, and the mount 238 is electrically connected to the second electrode 239, so that the first conductor 21 is electrically connected to the second electrode 239.
Further, as shown in the filled-in hatched portion in fig. 2, the distal end of the mount 238 and the surface of the second electrode 239 are covered with an insulating coating, which extends from the stepped distal end face of the mount 238 to a position at a second length from the distal tip of the second electrode 239, for example, 1 to 3mm, and the tip portion uncovered with the insulating coating is electrically connected to the left bundle branch 42 or the left bundle branch region for releasing a stimulating current to the left bundle branch 42 or sensing an exciting signal of the left bundle branch 42 or the left bundle branch region.
Further, the length of the second electrode 239 is greater than the length of the first electrode 235 that extends beyond the mount 238. Specifically, if the length of the first electrode 235 extending out of the mounting seat 238 is greater than the length of the spiral second electrode 239, so that the length of the first electrode 235 can reach the left bundle branch 42 or the left bundle branch region, since the distal end of the first electrode 235 is needle-shaped, the actual contact area is smaller, the first electrode 235 may not be accurately positioned to the left bundle branch 42 or the left bundle branch region, thereby resulting in poor pacing stimulation effect, and a doctor needs to repeatedly test different implantation positions in order to obtain better pacing effect, thereby increasing the risk of cardiac injury. The length of the second electrode 239 is longer than the length of the first electrode 235, and increasing the length of the uninsulated portion of the tip of the second electrode 239 increases the range of effective stimulation/sensing area (longitudinal height or lateral length) of the second electrode 239 in the myocardial tissue 4, so that the second electrode 239 has a greater chance of contact with the left bundle branch 42 to make it easier for the second electrode 239 to reach the left bundle branch 42 or left bundle branch region during implantation.
Further, the distal end of the first electrode 235 is a needle electrode, so that the inner pericardium is not easily broken when implanted, because the inner pericardium is a membrane having a certain toughness, and has a certain elastic force when the needle electrode perpendicular to the surface enters, and when implanted, pressure needs to be applied perpendicular to the surface of the inner pericardium, and because the implanted lead is flexible, even if the implanted lead can be used for assistance, the force applied perpendicularly is always limited. In the present invention, the distal end of the first electrode 235 is a needle electrode, the second electrode 239 is a spiral electrode, the second electrode 239 can be driven by rotating the medical implantation wire 2, on one hand, the tip of the second electrode 239 enters the myocardial tissue 4 at an inclined angle to receive smaller resistance, on the other hand, the second electrode 239 advances forward in the rotating process, and after advancing to a certain depth, the first electrode 235 is carried into the endocardium, so that the needle electrode can be implanted into the endocardium by rotating the medical implantation wire 2.
Further, the second electrode 239 is fixed to the body of the medical implant lead 2 through the mounting base 238, the insulating bush 237, the first electrode 235, the second conductor 22, and the outer insulating sleeve 236, so that the second electrode 239 rotates following the rotation of the medical implant lead 2, and the rotation of the medical implant lead 2 during operation is converted into the implantation of the second electrode 239 into the endocardium, so that the first electrode 235 is driven to enter the endocardium, that is, the pressure required by the first electrode 235 to break through the endocardium and perpendicular to the surface of the endocardium is increased by rotating the second electrode 239.
Further, the distance that the tip of the second electrode 239 extends distally is greater than the distance that the first electrode 235 extends distally, so that when the medical implant lead 2 is rotated, the second electrode 239 contacts with the myocardial tissue 4 before the first electrode 235, and the second electrode 239 drives the first electrode 235 to break through the endocardium, thereby reducing the operation difficulty during surgical implantation.
Further, the distance between the uninsulated portion at the front end of the second electrode 239 and the uninsulated portion at the front end of the first electrode 235 is a fixed distance, and the distance is 2-6 mm.
Specifically, according to different pitches, the medical implant lead 2 may have different pitch specifications, and adapt to patients with different bundle pitches, so as to achieve the purpose of optimal matching, thereby obtaining better therapeutic effect.
Further, the length of the second electrode 239 may be 8-12 mm, the distal length of the first electrode 235 may be 12mm, and the length of the first electrode 235 extending out of the mounting seat 238 and the insulating bush 237 may be 2-3.5mm.
Further, the second electrode 239 has elasticity, the second electrode 239 is made of elastic material, such as platinum, stainless steel, titanium, nickel-titanium alloy, the diameter of the second electrode 239 is set to be 1-1.8mm, and the screw pitch is set to be 0.8-1.5mm.
Specifically, the spiral shape of the second electrode 239 has two advantages, namely, the success rate of implantation can be improved during implantation, and the elastic deformation of the second electrode 239 can offset part of stress, so that the stress of myocardial motion on the joint of the first conductor 21 and the electrode assembly 23 during or after implantation is reduced, and the service life of the medical implant lead 2 is prolonged.
Specifically, to enhance the insulating effect between the first electrode 235 and the second electrode 239, the proximal end face of the cannula 2282 may extend beyond the proximal end face of the mount 238.
Specifically, when deep implantation is performed, the longer second electrode 239 enters the myocardial tissue 4, the distal end portion of the guide wire 2 does not need to enter together, and tunneling holes are avoided in the inter-ventricular space, so that damage to the myocardial tissue 4 is minimized, and the spiral second electrode 239 easily penetrates the myocardial tissue 4, so that the implantation success rate can be greatly improved.
Further, when the second electrode 239 completely enters the ventricular septum the myocardial tissue 4, the first electrode 235 pierces the right ventricular septum, thereby ensuring that the right ventricular septum can effectively pace.
As shown in fig. 7, the assembly process of the medical implant lead 2 is specifically shown in steps S1 to S6:
s1: connecting the distal end of the first electrical conductor 21 with the proximal end of the conductor connecting pin 231;
s2: sequentially passing through the insulating block 233, the first electrode 235, the insulating bush 237, and the mount 238 from the distal end of the conductor connecting pin 231; wherein the insulating block 233, the first electrode 235, the insulating bushing 237, and the mount 238 are disposed in close proximity; the connection end surfaces among the insulating block 233, the first electrode 235 and the insulating bush 237 are adhered by medical glue, glue is coated on the connection end surfaces in advance before the components are connected, and then the components are connected, or the components are closely arranged and then glue is coated on the joint of the connection end surfaces, and the self-flowing characteristic of the glue is utilized to enter the connection end surfaces to form an adhesive effect.
S3: the proximal end of the mount 238 is soldered to the conductor connecting pin 231, and during soldering, the uninsulated portion of the conductor connecting pin 231 is kept electrically connected to the inside of the fifth hole 2382. This step completes the electrical connection between the first conductor 21 and the first electrode 235. After the mount 238 and the conductor connecting pin 231 are welded, the mount 238 and the insulating bush 237 are bonded.
S4: the proximal end of the second electrode 239 is welded to the stepped distal end face of the mount 238, and the welded assembly formed by the mount 238 and the second electrode 239 is insulated after this step. The common insulation treatment method is to coat an insulating material such as silicone rubber, polyurethane or polyethylene on the surface, wherein the insulating coating can be an insulating coating formed by a vacuum vapor deposition process of PTFE, parylene and the like, and the insulating coating can also be a titanium nitride coating.
S5: the insulating layer 232 is coated on the portion of the first electric conductor 21 close to the conductor connecting pin 231, the inner insulating sleeve 234 is sleeved outside the insulating layer 232, and the distal end of the inner insulating sleeve 234 is abutted against the proximal end of the insulating block 233. In this step, the insulating layer 232 is attached to the first electrical conductor 21 by heat shrinkage or interference fit, etc. by means of heat shrinkage or the like. The insulating layer 232 may also be preassembled on the first electrical conductor 21.
S6: the second electrical conductor 22 is welded to the first body 2351 of the first electrode 235, the outer insulating sleeve 236 is sleeved on the second electrical conductor 22, and the distal end of the outer insulating sleeve 236 abuts against the second body 2352. The distal end of the outer insulation sleeve 236 is sealed with the end surface of the second body 2352, which abuts against the second body, by using glue, so as to prevent the leakage of the medical implant lead 2.
The order of step S3 and step S4 may be reversed, i.e. the mounting base 238 is welded to the proximal end of the second electrode 239, and then the mounting base 238 is welded to the distal non-insulated portion of the conductor connecting pin 231, so as to electrically connect the mounting base 238 and the conductor connecting pin 231.
Referring to fig. 1 and 8, after the electrode assembly 23 is implanted in the compartment, the second electrode 239 is entirely disposed in the compartment, and the third body 2353 is disposed in the compartment. The mount 238 and the second body 2352 are positioned outside of the ventricular septum, and the second body 2352 is positioned in the blood pool of the ventricle. When sensing an electrocardiograph signal, a first sensing vector 13 is formed between the second body 2352 and the tip of the second electrode 239, and a second sensing vector 14 is formed between the tip of the first electrode 235 and the tip of the second electrode 239. Compared with the prior art that only one pair of sensing vectors are arranged on the pacing electrode of the physiological system, the invention simultaneously arranges the first sensing vector 13 and the second sensing vector 14 to form the sensing vectors which are redundant with each other, and has the advantage of being capable of preventing the problem of poor sensing caused by insulating tissues covered on the surface of the left bundle branch 42 or the right bundle branch 41, myocardial cell fibrosis, electrode position movement and the like.
Specifically, the tip of the third body 2353 is connected to the right bundle branch 41 or the right bundle branch region, and the first sensing vector 13 includes a component electric signal of the cardiac depolarization electric signal between the tip of the first electrode 235 and the tip of the second electrode 239, which is denoted as a first electric signal; the second sensing 15 vector includes component signals of the cardiac depolarization electrical signal between the second body 2352 and the second electrode 239, noted as second electrical signals. In some cases, the first signal may not be sensed, or in case the first signal is too weak, the second signal may still be sensed normally as a redundant signal of the first signal, thereby ensuring that the pulse generator 1 is able to perform an appropriate diagnostic or therapeutic action based on the sensed signal.
The pulse generator 1 includes a switch control circuit, where the switch control circuit is configured to control a sensing loop formed by the first electrode 235 and the second electrode 239, and a third sensing vector and a fourth sensing vector may be further set by controlling the switch circuit, where the third sensing vector and the fourth sensing vector are opposite to the first sensing vector 13 and the second sensing vector 14.
Further, when the pulse generator 1 paces the myocardial tissue 4, a first pacing vector 15 is formed between the tip of the first electrode 235 and the tip of the second electrode 239, and a second pacing vector 16 is formed between the second body 2352 and the tip of the second electrode 239. The first pacing vector 15 and the second pacing vector 16 form mutually redundant pacing vectors, so that the second pacing vector 16 may be used instead of the first pacing vector 15 when the physiological system pacing of the pacemaker is not effective. It should be noted that since the second body 2352 is at a different physiological position than the tip of the first electrode 235, the pacing thresholds at which the first pacing vector 15 and the second pacing vector 16 capture the myocardium are different, and the purpose of switching the effective pacing vector is achieved by adjusting the different pacing thresholds.
In summary, the first electrode 235 of the present application, including the second body 2352 located in the blood pool of the right ventricle 44 and the third body 2353 located in the inter-ventricular space, the tip of the first electrode 235 and the second body 2352 form the first sensing vector 13, the tip of the first electrode 235 and the third body 2353 form the second sensing vector 14, the second sensing vector 14 can be used as a redundant vector, when the first sensing vector 13 fails, it is ensured that the pulse generator 1 can still sense the cardiac depolarization signal, the sensing reliability is ensured, and the actual pacing therapeutic effect is generated by controlling different pacing vectors by controlling the pacing threshold, and the effectiveness of the pacing therapy itself is ensured by the dual pacing vector.
In clinical applications, the lead may accommodate such physiological changes by sensing redundancy and adjusting pacing thresholds if a portion of the patient is not effectively sensed from the left 42 or right 41 bundle branch when fibrosis occurs in the myocardium adjacent the first 235 and second 239 electrodes.
In conclusion, when the invention realizes the deep implantation of the inter-ventricular septum, only the spiral head electrode enters myocardial tissue, and the medical implantation lead part does not enter together, thereby minimizing the damage of the myocardial tissue; the spiral head electrode is easy to penetrate into myocardial tissue, the difficulty in implantation is reduced, the implantation success rate is greatly improved, and particularly for cases of myocardial fibrosis, the implantation success rate is remarkably improved; the pacing at the left bundle supporting part simultaneously realizes the right interval pacing, so that the pacing of a clinical conduction system achieves the optimal effect; the needle-shaped pacing electrode can greatly reduce the pacing threshold value, and the ring electrode positioned in the blood pool has good sensing characteristics; the redundancy of the sensing vector and the pacing vector is realized, more reliable sensing signals and pacing signals are provided, and the problems of poor sensing or poor pacing caused by various reasons (such as myocardial cell fibrosis) can be avoided.
Therefore, the invention effectively overcomes various defects in the prior art and has high industrial utilization value. The above embodiments are merely illustrative of the principles of the present invention and its effectiveness, and are not intended to limit the invention. Modifications and variations may be made to the above-described embodiments by those skilled in the art without departing from the spirit and scope of the invention. Accordingly, it is intended that all equivalent modifications and variations of the invention be covered by the claims, which are within the ordinary skill of the art, be within the spirit and scope of the present disclosure.
Claims (14)
1. A medical implant lead comprising a first electrical conductor, a second electrical conductor, and an electrode assembly, the first electrical conductor and the second electrical conductor being insulated from each other, a distal end of the first electrical conductor and the second electrical conductor being connected to the electrode assembly, the electrode assembly comprising:
a conductor connecting pin connected to a distal end of the first electrical conductor;
an insulating block through which the conductor connecting pin passes with electrical insulation, the insulating block being for insulation between the conductor connecting pin and the first electrode;
the proximal end of the first electrode is close to the insulating block, the distal end of the second conductor is sleeved on the outer side of the first electrode, and the second conductor is electrically connected with the first electrode;
the second electrode is a spiral electrode;
the proximal end of the second electrode is arranged on the mounting seat, and the mounting seat is electrically connected with the second electrode;
an insulating bushing for insulating between the first electrode and the second electrode;
the mounting seat is sleeved at the far end of the insulating bush, the far end of the first electrode penetrates out of the insulating bush and the mounting seat through the inside of the insulating bush, and the length of the second electrode is longer than the length of the first electrode penetrating out of the insulating bush;
the conductor connecting pin passes through the insulating block, the first electrode and the insulating bush in an electric insulation way and is inserted into the mounting seat, the far end of the conductor connecting pin is electrically connected with the mounting seat, and the second electrode is electrically connected with the first conductor through the mounting seat and the conductor connecting pin.
2. A medical implant lead according to claim 1, wherein the surface of the conductor coupling needle is covered with an insulating coating extending from the proximal end to a first length from the distal end.
3. The medical implant lead of claim 1, wherein the first electrode is a unitary structure comprising a first body, a second body, and a third body; the first main body and the second main body form a step shape, the second main body is a ring electrode which is remained in a ventricle, and the third main body is a needle electrode which enters myocardial tissue; the conductor connecting pin penetrates through the first main body and the second main body through the first hole.
4. A medical implant lead according to claim 3, wherein the surface of the third body is covered with an insulating coating extending from the junction of the second body and the third body to the distal end of the third body, the distal tip portion of the third body not being covered with an insulating coating.
5. A medical implant lead according to claim 3, further comprising an insulating layer, said insulating layer being sheathed outside said first electrical conductor; the insulation layer is sleeved with the inner insulating sleeve; the second conductor is sleeved on the first main body and is electrically connected with the first main body; the electric cable further comprises an outer insulating sleeve, and the outer insulating sleeve is sleeved outside the second conductor.
6. The medical implant lead according to claim 1, wherein the insulating bush is provided with a second hole and a third hole which are through holes; the conductor connecting needle passes through the second hole, and the distal end of the first electrode passes through the third hole; the mounting seat is provided with a fourth hole and a fifth hole, the fourth hole is a through hole, the far end of the insulating bush penetrates through the fourth hole, the fifth hole is a blind hole, and the far end of the conductor connecting needle is electrically connected with the mounting seat through the fifth hole.
7. The medical implant lead of claim 6, wherein surfaces of the mount and the second electrode are covered with an insulating coating that extends from a proximal end of the mount to a location a second length from a distal tip of the second electrode.
8. The medical implant lead according to claim 1, wherein the length of the first electrode extending out of the insulating bush is 2-3.5mm, and the length of the second electrode is 8-12 mm.
9. The medical implant lead according to claim 1, wherein the distal ends of the first electrode and the second electrode each comprise an uninsulated portion, and the distance between the uninsulated portions is in the range of 2-6 mm.
10. A medical implant lead comprising any of claims 1-9, wherein the first electrode pierces the right ventricular septum when the second electrode fully enters the septum during implantation.
11. The medical implant lead of claim 10, wherein when the second electrode is fully advanced into the ventricular septum myocardial tissue, the first electrode is advanced into the right bundle branch or right bundle branch region and the second electrode is advanced into the left bundle branch or left bundle branch region.
12. An implantable medical device comprising a medical implant lead according to any one of claims 1, 2 or 6-9, the first electrode comprising a second body that remains in the right ventricle after implantation and a third body that enters the ventricular septum, further comprising:
a first sensing vector, the third body and the second electrode forming the first sensing vector;
a second sensing vector, the second body and the second electrode forming the second sensing vector, the second sensing vector and the first sensing vector being redundant sensing vectors;
a first pacing vector, the third body and the second electrode forming the first pacing vector;
a second pacing vector, the second body and the second electrode forming the second pacing vector, the first pacing vector and the second pacing vector being redundant pacing vectors to each other;
and the pulse generator is used for sensing and pacing, senses electrocardiosignals according to the first sensing vector or the second sensing vector and paces according to the first pacing vector or the second pacing vector.
13. The implantable medical device of claim 12, wherein the first sensing vector is a vector defined by the positions of left and right bundle branches where the distal tip of the third body and the distal tip of the second electrode are positioned after implantation into a ventricular septum, or a vector defined by the positions of left and right bundle branch regions; the second sensing vector is a vector defined by the position of the second body in the ventricle and the position of the left bundle branch or left bundle branch region where the distal tip of the second electrode is implanted after the ventricular septum.
14. The implantable medical device of claim 12, wherein the first pacing vector is a vector defined by the positions of left and right bundle branches where the distal tip of the third body and the distal tip of the second electrode are located after implantation of the ventricular septum, or a vector defined by the positions of left and right bundle branch regions; the second pacing vector is a vector defined by a position of the second body in a ventricle and a position of a left bundle branch or left bundle branch region where the distal tip of the second electrode is located after implantation of the ventricular septum.
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| CN202311400028.XA CN117122821B (en) | 2023-10-26 | 2023-10-26 | Medical implantation wire and implantation type medical equipment |
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| CN202311400028.XA CN117122821B (en) | 2023-10-26 | 2023-10-26 | Medical implantation wire and implantation type medical equipment |
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| CN117122821B true CN117122821B (en) | 2024-01-30 |
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| CN109224286A (en) * | 2017-07-11 | 2019-01-18 | 柏林希尔斯控股公司 | Implantable DC electrode component |
| CN115569302A (en) * | 2022-12-09 | 2023-01-06 | 苏州无双医疗设备有限公司 | Implantable lead and manufacturing method of proximal lead thereof |
| CN115869534A (en) * | 2021-09-29 | 2023-03-31 | 江苏畅医达医疗科技有限公司 | Implanted electrode and peripheral nerve stimulation system thereof |
| CN116440413A (en) * | 2022-05-31 | 2023-07-18 | 无双医疗(美国)有限公司 | Catheter and lead for conductive system |
| CN116726398A (en) * | 2022-07-08 | 2023-09-12 | 无双医疗(美国)有限公司 | Lead of cardiac conduction system with defibrillation function |
| CN116747445A (en) * | 2022-07-07 | 2023-09-15 | 无双医疗(美国)有限公司 | Leadless cardiac conduction system pacemaker and delivery system |
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| CN109224286A (en) * | 2017-07-11 | 2019-01-18 | 柏林希尔斯控股公司 | Implantable DC electrode component |
| CN115869534A (en) * | 2021-09-29 | 2023-03-31 | 江苏畅医达医疗科技有限公司 | Implanted electrode and peripheral nerve stimulation system thereof |
| CN116440413A (en) * | 2022-05-31 | 2023-07-18 | 无双医疗(美国)有限公司 | Catheter and lead for conductive system |
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| CN115569302A (en) * | 2022-12-09 | 2023-01-06 | 苏州无双医疗设备有限公司 | Implantable lead and manufacturing method of proximal lead thereof |
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| CN117122821A (en) | 2023-11-28 |
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