CN116059536A - Combined fixing device for leadless implantable medical device - Google Patents
Combined fixing device for leadless implantable medical device Download PDFInfo
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- CN116059536A CN116059536A CN202310017407.4A CN202310017407A CN116059536A CN 116059536 A CN116059536 A CN 116059536A CN 202310017407 A CN202310017407 A CN 202310017407A CN 116059536 A CN116059536 A CN 116059536A
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
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- 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
- A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
- A61N1/39—Heart defibrillators
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- 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
- A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
- A61N1/39—Heart defibrillators
- A61N1/3956—Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
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- 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
- A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
- A61N1/39—Heart defibrillators
- A61N1/3968—Constructional arrangements, e.g. casings
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Abstract
The invention relates to the field of medical instruments, in particular to a combined fixing device for leadless implantable medical equipment. The invention provides a combined type fixing device for leadless implantable medical equipment, which comprises a shell, wherein the combined type fixing device comprises a fixing cap and fixing wings, and the fixing cap comprises a fixing sleeve, fixing teeth and an electrode positioned at the center of the top of the fixing sleeve; the fixation wings include an annular fixation frame defining a longitudinal axis of the leadless implantable medical device and a fixation hook. The combined type fixing device for the leadless implantable medical device can maintain balance of the leadless implantable medical device, can well anchor the leadless implantable medical device to body tissues, and can avoid the problem that a fixing unit or the fixing device pierces the tissues.
Description
Technical Field
The invention relates to the field of medical instruments, in particular to a combined fixing device for leadless implantable medical equipment.
Background
With the continuous decrease of population fertility rate, the problem of population aging is continuously aggravated, and the problem is a common problem in countries around the world. The aging population is increasing, and there is a great market demand for high quality healthcare services. Based on this application background, leadless implantable medical devices have been proposed, which are novel implantable medical devices that integrate a pulse generator with an electrode, such as leadless cardiac pacemakers, that also generate electrical stimulation and transmit to a patient. The leadless implantable medical device is more flexible and convenient in appearance and use, is implanted in a patient, can monitor, prevent or treat the physical condition of the patient, greatly ensures the life safety and happy life of the patient, and the continuous curative effect of the leadless implantable medical device implanted in the patient depends on the capability of keeping the relative position of the leadless implantable medical device relative to the implanted tissue unchanged to a great extent.
The fixation unit or fixation device may help to secure the leadless implantable medical device to the patient tissue and hold the leadless implantable medical device in place because of small uninterrupted movements of body tissue, such as heart movements, which tend to cause the implantable medical device to slip off of body tissue due to an imbalance, thereby posing a further hazard to human health.
Therefore, in the field of medical apparatuses, how to improve the anchoring effect of the existing fixing unit or fixing device or how to arrange the fixing unit or fixing device with better fixing performance is a problem to be solved at present.
Disclosure of Invention
In view of the above, an object of the present invention is to provide a combined type fixing device for a leadless implantable medical device, which can maintain balance of the leadless implantable medical device, can well anchor the leadless implantable medical device to body tissue, and can avoid the problem that a fixing unit or fixing device pierces the tissue.
In order to achieve the above purpose, the present invention provides the following technical solutions:
in a first aspect, the present invention provides a combination fixture for a leadless implantable medical device comprising a housing, the combination fixture comprising a fixation cap and a fixation wing,
The fixing cap comprises a fixing sleeve, fixing teeth and an electrode positioned at the center of the top of the fixing sleeve;
the fixation wings include an annular fixation frame defining a longitudinal axis of the leadless implantable medical device and a fixation hook.
In a preferred embodiment, the leadless implantable medical device may be an implantable cardiac pacemaker, an implantable cardioverter defibrillator, an implantable cardiac detector, a ventricular assist, a neurostimulator, or an implantable hearing aid.
In a more preferred embodiment, the leadless implantable medical device is an implantable cardiac pacemaker.
By adopting the structure, the leadless implantable medical device can be better fixed on the tissue of the patient by adopting the fixing mode of combining the fixing cap and the fixing wing, the contact between the electrode and the tissue of the patient is more compact and firm, and the fixing mode is safe and reliable. Specifically, through the fixed mode that adopts the fixed cap to combine together with the fixed wing, can be better fix leadless implantable medical equipment on heart tissue, the electrode is inseparabler firm with heart tissue's contact, can avoid the endocardial leadless implantable medical equipment to shift and remove along with heartbeat and blood flow impact, even dislocation and landing to improve endocardial implantable medical equipment's reliability and security.
In a preferred embodiment, the fixing hook comprises a connecting section, a transition section and a hook tip section which are sequentially connected and have coplanar axes, wherein the connecting section is connected to the annular fixing frame, one end of the transition section is connected to the connecting section, and the other end of the transition section is connected to the hook tip section.
In a preferred embodiment, the retaining cap is connected to the front end of the housing by the retaining sleeve, and the electrode is connected to the leadless implantable medical device through the retaining sleeve.
In a preferred embodiment, the securing tooth comprises a securing section connected to a side wall of the securing sleeve and a free section extending straight along the securing section in a direction away from the longitudinal axis.
By adopting the structure, the fixing cap is connected to the front end of the shell through the fixing sleeve, the electrode penetrates through the fixing sleeve to be connected to the leadless implantable medical device, and meanwhile, the leadless implantable medical device can be stably fixed to tissue of a patient through the fixing teeth on the fixing cap. For example, leadless implantable medical devices may be stably secured to the auricle or apex of a patient's heart by securing teeth on a securing cap.
By adopting the structure, the fixing wings are fixed on the outer surface of the shell of the leadless implantable medical device through sleeving, welding or bonding, so that the fixing wings can be stably connected with the leadless implantable medical device, and longer fixing hooks can provide a longer distance to be close to tissues of a patient and fix the fixing wings. For example, a longer fixation hook provides a greater distance to approach and fix heart tissue, and a leadless implantable medical device may be stably fixed to heart tissue by the fixation hook.
In a preferred embodiment, the axis of the free section forms an acute angle with the longitudinal axis, the acute angle being 15 ° -75 °. For example, the angle of the acute angle may be 15 °, 16 °, 17 °, 18 °, 19 °, 20 °, 21 °, 22 °, 23 °, 24 °, 25 °, 26 °, 27 °, 28 °, 29 °, 30 °, 31 °, 32 °, 33 °, 34 °, 35 °, 36 °, 37 °, 38 °, 39 °, 40 °, 41 °, 42 °, 43 °, 44 °, 45 °, 46 °, 47 °, 48 °, 49 °, 50 °, 51 °, 52 °, 53 °, 54 °, 55 °, 56 °, 57 °, 58 °, 59 °, 60 °, 61 °, 62 °, 63 °, 64 °, 65 °, 66 °, 67 °, 68 °, 69 °, 70 °, 71 °, 72 °, 73 °, 74 °, or 75 °.
By adopting the structure, the included angle formed by the axis of the free section and the longitudinal axis is set to be an acute angle, so that the stability of the leadless implantable medical device fixed on the tissue of a patient by the fixing teeth on the fixing cap can be further improved.
In a preferred embodiment, the free segment further comprises a head end in the shape of a cone extending from the free segment, having a tapered end face that is planar, triangular or circular in shape.
In a preferred embodiment of the present invention,
The axis of the connecting section is arc-shaped and extends in a direction away from the longitudinal axis,
the axis of the transition section is circular arc-shaped and extends in a direction away from the longitudinal axis,
the axis of the hook tip section is arc-shaped and extends towards the direction of the longitudinal axis,
the axis of the connecting section, the axis of the transition section and the axis of the hook tip section are combined into a section of arc-like curve.
By adopting such a structure, the axis of the connecting section is set to be arc-shaped and extends towards the direction far away from the longitudinal axis, the axis of the transition section is set to be arc-shaped and extends towards the direction far away from the longitudinal axis, the axis of the hook tip section is set to be arc-shaped and extends towards the direction of the longitudinal axis, and the axis of the connecting section, the axis of the transition section and the axis of the hook tip section are set to be combined into a section of arc-like curve, so that the anchoring performance of the leadless implantable medical device can be improved, and the problem that the fixing unit or the fixing device pierces tissues can be avoided.
In a preferred embodiment, the connecting section has a bending radius of 1-2mm; for example, the bending radius of the connecting segment may be 1mm, 1.1mm, 1.2mm, 1.3mm, 1.4mm, 1.5mm, 1.6mm, 1.7mm, 1.8mm, 1.9mm or 2mm.
In a preferred embodiment, the transition section has a radius of curvature of 3-5mm; for example, the transition section may have a bend radius of 3.1mm, 3.2mm, 3.3mm, 3.4mm, 3.5mm, 3.6mm, 3.7mm, 3.8mm, 3.9mm, 4mm, 4.1mm, 4.2mm, 4.3mm, 4.4mm, 4.5mm, 4.6mm, 4.7mm, 4.8mm, 4.9mm, or 5mm.
In a preferred embodiment, the hook tip segment has a radius of curvature of 1-3mm. For example, the hook tip segment can have a bend radius of 1mm, 1.1mm, 1.2mm, 1.3mm, 1.4mm, 1.5mm, 1.6mm, 1.7mm, 1.8mm, 1.9mm, 2mm, 2.1mm, 2.2mm, 2.3mm, 2.4mm, 2.5mm, 2.6mm, 2.7mm, 2.8mm, 2.9mm, or 3mm.
With such a structure, the fixing hook can be stably fixed to the tissue of the patient because the bending radius of the transition section is larger than that of the connecting section. For example, the fixation hooks may be stabilized against the myocardial wall of heart tissue.
With this construction, the hook tip section has a smaller radius of curvature than the transition section, so that the fixation hook does not cause perforation when inserted into the patient's tissue. For example, the fixation hooks may be inserted into the myocardial wall of heart tissue without causing perforation.
In a preferred embodiment, the stationary teeth are made of medical grade silicone or polyurethane material.
In a preferred embodiment, the fixation hooks are made of medical grade silicone or polyurethane material.
In a preferred embodiment, the axial length of the fixing hook of the fixing wing is not greater than the circumference of the annular fixing frame of the fixing wing.
In a preferred embodiment, the fixing sleeve and the fixing teeth of the fixing cap are an integral piece; a plurality of said stationary teeth are spaced apart from one another about a sidewall of said stationary sleeve; a plurality of said stationary teeth are equally spaced apart from one another about a sidewall of said stationary sleeve; the fixed teeth are circularly arranged around the fixed sleeve; the number of the fixed teeth is 2 to 10, for example, the number of the fixed teeth may be 2, 3, 4, 5, 6, 7, 8, 9 or 10. Further, the number of the fixed teeth is 4.
In a preferred embodiment, the annular fixing frame and the fixing hooks of the fixing wings are an integral part; a plurality of the fastening hooks spaced apart from one another around a periphery of the ring-shaped fastening frame; a plurality of the fastening hooks are spaced apart from each other at equal intervals around the circumference of the ring-shaped fastening frame; the plurality of fixing hooks are circularly arranged around the annular fixing frame; the number of the fixing hooks is 2 to 10, and for example, the number of the fixing hooks may be 2, 3, 4, 5, 6, 7, 8, 9 or 10. Further, the number of the fixing hooks is 4.
In a second aspect, a fixation system for a leadless implantable medical device is provided, comprising a combined fixation apparatus for a leadless implantable medical device according to the invention.
In a preferred embodiment, the leadless implantable medical device comprises a housing, the combination fixture comprises a securing cap and a securing wing,
the fixing cap comprises a fixing sleeve, fixing teeth and an electrode positioned at the center of the top of the fixing sleeve;
the fixation wings include an annular fixation frame defining a longitudinal axis of the leadless implantable medical device and a fixation hook.
In a preferred embodiment, the leadless implantable medical device may be an implantable cardiac pacemaker, an implantable cardioverter defibrillator, an implantable cardiac detector, a ventricular assist, a neurostimulator, or an implantable hearing aid.
By adopting the structure, the leadless implantable medical device can be better fixed on the tissue of the patient by adopting the fixing mode of combining the fixing cap and the fixing wing, the contact between the electrode and the tissue of the patient is more compact and firm, and the fixing mode is safe and reliable. Specifically, through the fixed mode that adopts the fixed cap to combine together with the fixed wing, can be better fix leadless implantable medical equipment on heart tissue, the electrode is inseparabler firm with heart tissue's contact, can avoid the endocardial leadless implantable medical equipment to shift and remove along with heartbeat and blood flow impact, even dislocation and landing to improve endocardial implantable medical equipment's reliability and security.
In a preferred embodiment, the fixing hook comprises a connecting section, a transition section and a hook tip section which are sequentially connected and have coplanar axes, wherein the connecting section is connected to the annular fixing frame, one end of the transition section is connected to the connecting section, and the other end of the transition section is connected to the hook tip section.
In a preferred embodiment, the retaining cap is connected to the front end of the housing by the retaining sleeve, and the electrode is connected to the leadless implantable medical device through the retaining sleeve.
In a preferred embodiment, the securing tooth comprises a securing section connected to a side wall of the securing sleeve and a free section extending straight along the securing section in a direction away from the longitudinal axis.
By adopting the structure, the fixing cap is connected to the front end of the shell through the fixing sleeve, the electrode penetrates through the fixing sleeve to be connected to the leadless implantable medical device, and meanwhile, the leadless implantable medical device can be stably fixed to tissue of a patient through the fixing teeth on the fixing cap. For example, leadless implantable medical devices may be stably secured to the auricle or apex of a patient's heart by securing teeth on a securing cap.
By adopting the structure, the fixing wings are fixed on the outer surface of the shell of the leadless implantable medical device through sleeving, welding or bonding, so that the fixing wings can be stably connected with the leadless implantable medical device, and longer fixing hooks can provide a longer distance to be close to tissues of a patient and fix the fixing wings. For example, a longer fixation hook provides a greater distance to approach and fix heart tissue, and a leadless implantable medical device may be stably fixed to heart tissue by the fixation hook.
In a preferred embodiment, the axis of the free section forms an acute angle with the longitudinal axis, the acute angle being 15 ° -75 °. For example, the angle of the acute angle may be 15 °, 16 °, 17 °, 18 °, 19 °, 20 °, 21 °, 22 °, 23 °, 24 °, 25 °, 26 °, 27 °, 28 °, 29 °, 30 °, 31 °, 32 °, 33 °, 34 °, 35 °, 36 °, 37 °, 38 °, 39 °, 40 °, 41 °, 42 °, 43 °, 44 °, 45 °, 46 °, 47 °, 48 °, 49 °, 50 °, 51 °, 52 °, 53 °, 54 °, 55 °, 56 °, 57 °, 58 °, 59 °, 60 °, 61 °, 62 °, 63 °, 64 °, 65 °, 66 °, 67 °, 68 °, 69 °, 70 °, 71 °, 72 °, 73 °, 74 °, or 75 °.
By adopting the structure, the included angle formed by the axis of the free section and the longitudinal axis is set to be an acute angle, so that the stability of the leadless implantable medical device fixed on the tissue of a patient by the fixing teeth on the fixing cap can be further improved.
In a preferred embodiment, the free segment further comprises a head end in the shape of a cone extending from the free segment, having a tapered end face that is planar, triangular or circular in shape.
In a preferred embodiment of the present invention,
The axis of the connecting section is arc-shaped and extends in a direction away from the longitudinal axis,
the axis of the transition section is circular arc-shaped and extends in a direction away from the longitudinal axis,
the axis of the hook tip section is arc-shaped and extends towards the direction of the longitudinal axis,
the axis of the connecting section, the axis of the transition section and the axis of the hook tip section are combined into a section of arc-like curve.
By adopting such a structure, the axis of the connecting section is set to be arc-shaped and extends towards the direction far away from the longitudinal axis, the axis of the transition section is set to be arc-shaped and extends towards the direction far away from the longitudinal axis, the axis of the hook tip section is set to be arc-shaped and extends towards the direction of the longitudinal axis, and the axis of the connecting section, the axis of the transition section and the axis of the hook tip section are set to be combined into a section of arc-like curve, so that the anchoring performance of the leadless implantable medical device can be improved, and the problem that the fixing unit or the fixing device pierces tissues can be avoided.
In a preferred embodiment, the connecting section has a bending radius of 1-2mm; for example, the bending radius of the connecting segment may be 1mm, 1.1mm, 1.2mm, 1.3mm, 1.4mm, 1.5mm, 1.6mm, 1.7mm, 1.8mm, 1.9mm or 2mm.
In a preferred embodiment, the transition section has a radius of curvature of 3-5mm; for example, the transition section may have a bend radius of 3.1mm, 3.2mm, 3.3mm, 3.4mm, 3.5mm, 3.6mm, 3.7mm, 3.8mm, 3.9mm, 4mm, 4.1mm, 4.2mm, 4.3mm, 4.4mm, 4.5mm, 4.6mm, 4.7mm, 4.8mm, 4.9mm, or 5mm.
In a preferred embodiment, the hook tip segment has a radius of curvature of 1-3mm. For example, the hook tip segment can have a bend radius of 1mm, 1.1mm, 1.2mm, 1.3mm, 1.4mm, 1.5mm, 1.6mm, 1.7mm, 1.8mm, 1.9mm, 2mm, 2.1mm, 2.2mm, 2.3mm, 2.4mm, 2.5mm, 2.6mm, 2.7mm, 2.8mm, 2.9mm, or 3mm.
With such a structure, the fixing hook can be stably fixed to the tissue of the patient because the bending radius of the transition section is larger than that of the connecting section. For example, the fixation hooks may be stabilized against the myocardial wall of heart tissue.
With this construction, the hook tip section has a smaller radius of curvature than the transition section, so that the fixation hook does not cause perforation when inserted into the patient's tissue. For example, the fixation hooks may be inserted into the myocardial wall of heart tissue without causing perforation.
In a preferred embodiment, the stationary teeth are made of medical grade silicone or polyurethane material.
In a preferred embodiment, the fixation hooks are made of medical grade silicone or polyurethane material.
In a preferred embodiment, the axial length of the fixing hook of the fixing wing is not greater than the circumference of the annular fixing frame of the fixing wing.
In a preferred embodiment, the fixing sleeve and the fixing teeth of the fixing cap are an integral piece; a plurality of said stationary teeth are spaced apart from one another about a sidewall of said stationary sleeve; a plurality of said stationary teeth are equally spaced apart from one another about a sidewall of said stationary sleeve; the fixed teeth are circularly arranged around the fixed sleeve; the number of the fixed teeth is 2 to 10, for example, the number of the fixed teeth may be 2, 3, 4, 5, 6, 7, 8, 9 or 10. Further, the number of the fixed teeth is 4.
In a preferred embodiment, the annular fixing frame and the fixing hooks of the fixing wings are an integral part; a plurality of the fastening hooks spaced apart from one another around a periphery of the ring-shaped fastening frame; a plurality of the fastening hooks are spaced apart from each other at equal intervals around the circumference of the ring-shaped fastening frame; the plurality of fixing hooks are circularly arranged around the annular fixing frame; the number of the fixing hooks is 2 to 10, and for example, the number of the fixing hooks may be 2, 3, 4, 5, 6, 7, 8, 9 or 10. Further, the number of the fixing hooks is 4.
In a third aspect, there is provided a method of implanting or retrieving a leadless implantable medical device within body tissue, comprising the step of using a combination fixture for a leadless implantable medical device according to the invention.
In a preferred embodiment, the leadless implantable medical device comprises a housing, the combination fixture comprises a securing cap and a securing wing,
the fixing cap comprises a fixing sleeve, fixing teeth and an electrode positioned at the center of the top of the fixing sleeve;
the fixation wings include an annular fixation frame defining a longitudinal axis of the leadless implantable medical device and a fixation hook.
In a preferred embodiment, the leadless implantable medical device may be an implantable cardiac pacemaker, an implantable cardioverter defibrillator, an implantable cardiac detector, a ventricular assist, a neurostimulator, or an implantable hearing aid.
In a more preferred embodiment, the leadless implantable medical device is an implantable cardiac pacemaker.
By adopting the structure, the leadless implantable medical device can be better fixed on the tissue of the patient by adopting the fixing mode of combining the fixing cap and the fixing wing, the contact between the electrode and the tissue of the patient is more compact and firm, and the fixing mode is safe and reliable. Specifically, through the fixed mode that adopts the fixed cap to combine together with the fixed wing, can be better fix leadless implantable medical equipment on heart tissue, the electrode is inseparabler firm with heart tissue's contact, can avoid the endocardial leadless implantable medical equipment to shift and remove along with heartbeat and blood flow impact, even dislocation and landing to improve endocardial implantable medical equipment's reliability and security.
In a preferred embodiment, the fixing hook comprises a connecting section, a transition section and a hook tip section which are sequentially connected and have coplanar axes, wherein the connecting section is connected to the annular fixing frame, one end of the transition section is connected to the connecting section, and the other end of the transition section is connected to the hook tip section.
In a preferred embodiment, the retaining cap is connected to the front end of the housing by the retaining sleeve, and the electrode is connected to the leadless implantable medical device through the retaining sleeve.
In a preferred embodiment, the securing tooth comprises a securing section connected to a side wall of the securing sleeve and a free section extending straight along the securing section in a direction away from the longitudinal axis.
By adopting the structure, the fixing cap is connected to the front end of the shell through the fixing sleeve, the electrode penetrates through the fixing sleeve to be connected to the leadless implantable medical device, and meanwhile, the leadless implantable medical device can be stably fixed to tissue of a patient through the fixing teeth on the fixing cap. For example, leadless implantable medical devices may be stably secured to the auricle or apex of a patient's heart by securing teeth on a securing cap.
By adopting the structure, the fixing wings are fixed on the outer surface of the shell of the leadless implantable medical device through sleeving, welding or bonding, so that the fixing wings can be stably connected with the leadless implantable medical device, and longer fixing hooks can provide a longer distance to be close to tissues of a patient and fix the fixing wings. For example, a longer fixation hook provides a greater distance to approach and fix heart tissue, and a leadless implantable medical device may be stably fixed to heart tissue by the fixation hook.
In a preferred embodiment, the axis of the free section forms an acute angle with the longitudinal axis, the acute angle being 15 ° -75 °. For example, the angle of the acute angle may be 15 °, 16 °, 17 °, 18 °, 19 °, 20 °, 21 °, 22 °, 23 °, 24 °, 25 °, 26 °, 27 °, 28 °, 29 °, 30 °, 31 °, 32 °, 33 °, 34 °, 35 °, 36 °, 37 °, 38 °, 39 °, 40 °, 41 °, 42 °, 43 °, 44 °, 45 °, 46 °, 47 °, 48 °, 49 °, 50 °, 51 °, 52 °, 53 °, 54 °, 55 °, 56 °, 57 °, 58 °, 59 °, 60 °, 61 °, 62 °, 63 °, 64 °, 65 °, 66 °, 67 °, 68 °, 69 °, 70 °, 71 °, 72 °, 73 °, 74 °, or 75 °.
By adopting the structure, the included angle formed by the axis of the free section and the longitudinal axis is set to be an acute angle, so that the stability of the leadless implantable medical device fixed on the tissue of a patient by the fixing teeth on the fixing cap can be further improved.
In a preferred embodiment, the free segment further comprises a head end in the shape of a cone extending from the free segment, having a tapered end face that is planar, triangular or circular in shape.
In a preferred embodiment of the present invention,
The axis of the connecting section is arc-shaped and extends in a direction away from the longitudinal axis,
the axis of the transition section is circular arc-shaped and extends in a direction away from the longitudinal axis,
the axis of the hook tip section is arc-shaped and extends towards the direction of the longitudinal axis,
the axis of the connecting section, the axis of the transition section and the axis of the hook tip section are combined into a section of arc-like curve.
By adopting such a structure, the axis of the connecting section is set to be arc-shaped and extends towards the direction far away from the longitudinal axis, the axis of the transition section is set to be arc-shaped and extends towards the direction far away from the longitudinal axis, the axis of the hook tip section is set to be arc-shaped and extends towards the direction of the longitudinal axis, and the axis of the connecting section, the axis of the transition section and the axis of the hook tip section are set to be combined into a section of arc-like curve, so that the anchoring performance of the leadless implantable medical device can be improved, and the problem that the fixing unit or the fixing device pierces tissues can be avoided.
In a preferred embodiment, the connecting section has a bending radius of 1-2mm; for example, the bending radius of the connecting segment may be 1mm, 1.1mm, 1.2mm, 1.3mm, 1.4mm, 1.5mm, 1.6mm, 1.7mm, 1.8mm, 1.9mm or 2mm.
In a preferred embodiment, the transition section has a radius of curvature of 3-5mm; for example, the transition section may have a bend radius of 3.1mm, 3.2mm, 3.3mm, 3.4mm, 3.5mm, 3.6mm, 3.7mm, 3.8mm, 3.9mm, 4mm, 4.1mm, 4.2mm, 4.3mm, 4.4mm, 4.5mm, 4.6mm, 4.7mm, 4.8mm, 4.9mm, or 5mm.
In a preferred embodiment, the hook tip segment has a radius of curvature of 1-3mm. For example, the hook tip segment can have a bend radius of 1mm, 1.1mm, 1.2mm, 1.3mm, 1.4mm, 1.5mm, 1.6mm, 1.7mm, 1.8mm, 1.9mm, 2mm, 2.1mm, 2.2mm, 2.3mm, 2.4mm, 2.5mm, 2.6mm, 2.7mm, 2.8mm, 2.9mm, or 3mm.
With such a structure, the fixing hook can be stably fixed to the tissue of the patient because the bending radius of the transition section is larger than that of the connecting section. For example, the fixation hooks may be stabilized against the myocardial wall of heart tissue.
With this construction, the hook tip section has a smaller radius of curvature than the transition section, so that the fixation hook does not cause perforation when inserted into the patient's tissue. For example, the fixation hooks may be inserted into the myocardial wall of heart tissue without causing perforation.
In a preferred embodiment, the stationary teeth are made of medical grade silicone or polyurethane material.
In a preferred embodiment, the fixation hooks are made of medical grade silicone or polyurethane material.
In a preferred embodiment, the axial length of the fixing hook of the fixing wing is not greater than the circumference of the annular fixing frame of the fixing wing.
In a preferred embodiment, the fixing sleeve and the fixing teeth of the fixing cap are an integral piece; a plurality of said stationary teeth are spaced apart from one another about a sidewall of said stationary sleeve; a plurality of said stationary teeth are equally spaced apart from one another about a sidewall of said stationary sleeve; the fixed teeth are circularly arranged around the fixed sleeve; the number of the fixed teeth is 2 to 10, for example, the number of the fixed teeth may be 2, 3, 4, 5, 6, 7, 8, 9 or 10. Further, the number of the fixed teeth is 4.
In a preferred embodiment, the annular fixing frame and the fixing hooks of the fixing wings are an integral part; a plurality of the fastening hooks spaced apart from one another around a periphery of the ring-shaped fastening frame; a plurality of the fastening hooks are spaced apart from each other at equal intervals around the circumference of the ring-shaped fastening frame; the plurality of fixing hooks are circularly arranged around the annular fixing frame; the number of the fixing hooks is 2 to 10, and for example, the number of the fixing hooks may be 2, 3, 4, 5, 6, 7, 8, 9 or 10. Further, the number of the fixing hooks is 4.
In a preferred embodiment, the fixing wing is arranged at a position between 1/3 of the distance from the shell to the tail of the electrode.
In a preferred embodiment, the fixing sleeve and the fixing teeth may be in an integral structure and fixed on the outer surface of the front end of the shell through a casting body.
In a preferred embodiment, the annular fixing frame is detachably or fixedly connected with the shell.
Compared with the prior art, the invention has the beneficial effects that:
the combined fixing device for the leadless implantable medical device can better fix the leadless implantable medical device on the tissue of a patient by adopting a fixing mode of combining the fixing cap and the fixing wing. Specifically, the combined fixing device for the leadless implantable medical device can better fix the leadless implantable medical device on heart tissue by adopting a fixing mode of combining the fixing cap and the fixing wing, and the electrode is more tightly and firmly contacted with the heart tissue.
The fixing cap used in the combined fixing device for the leadless implantable medical device is connected to the front end of the shell through the fixing sleeve, the electrode penetrates through the fixing sleeve to be connected to the leadless implantable medical device, and meanwhile, the leadless implantable medical device can be stably fixed on tissues of a patient through the fixing teeth on the fixing cap. In particular, leadless implantable medical devices may be stably secured to the auricle or apex of a patient's heart by securing teeth on a securing cap.
The fixing cap used in the combined fixing device of the leadless implantable medical device can further improve the stability of fixing the leadless implantable medical device on the tissue of a patient by setting the included angle formed by the axis of the free section and the longitudinal axis as an acute angle.
The fixing wings in the combined fixing device for the leadless implantable medical device can be stably connected with the leadless implantable medical device by sleeving, welding or bonding the fixing wings on the outer surface of the shell of the leadless implantable medical device, and longer fixing hooks provide a longer distance to approach the patient device and fix the device. In particular, the leadless implantable medical device may be stably secured to patient tissue by a longer fixation hook that provides a greater distance to approach the myocardium and secure the patient device.
The fixing wing in the combined fixing device for the leadless implantable medical device can improve the anchoring performance of the leadless implantable medical device and avoid the problem that the fixing unit or the fixing device pierces tissues by setting the axis of the connecting section, the axis of the transition section and the axis of the hook tip section to be combined into a section of arc-like curve.
The fixing wing used in the combined fixing device of the leadless implantable medical device can enable the fixing hook to be stably fixed on the tissue of a patient because the bending radius of the transition section is larger than that of the connecting section. Specifically, the fixation hook can be stably fixed to the myocardial wall of heart tissue. On the other hand, since the bending radius of the hook tip section is smaller than that of the transition section, the fixation hook can be inserted into the tissue of the patient without causing perforation. In particular, the fixation hooks may be inserted into the myocardial wall of heart tissue without causing perforation.
Drawings
FIG. 1 is a schematic perspective view of a modular fixture for a leadless implantable medical device according to an embodiment of the invention;
FIG. 2 is a schematic cross-sectional view of a modular fixture for a leadless implantable medical device according to an embodiment of the invention;
FIG. 3 shows a schematic structural view of a fixation cap of a combination fixation device for a leadless implantable medical device, in accordance with an embodiment of the invention;
FIG. 4 shows a schematic structural view of a fixation wing of a modular fixation device for a leadless implantable medical device, in accordance with an embodiment of the invention;
fig. 5 shows a fixation effect diagram of a combined fixation device for a leadless implantable medical device, according to an embodiment of the invention.
Reference numerals:
10: a fixing cap; 11: an electrode; 12: a fixed sleeve; 13: a fixed tooth; 131: a fixed section; 132: a free section; 1321: a headend; 20: a fixed wing; 21: an annular fixing frame; 22: a fixed hook; 221: a connection section; 222: a transition section; 223: a hook tip section; 30: leadless implantable medical devices; 31: a housing; a: a longitudinal axis.
Detailed Description
The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. The following description of at least one exemplary embodiment is merely exemplary in nature and is in no way intended to limit the invention, its application, or uses. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
In the description of the present invention, unless specifically stated otherwise, the relative arrangement of parts and steps, numerical expressions and numerical values set forth in these embodiments do not limit the scope of the present invention. Meanwhile, it should be understood that the sizes of the respective parts shown in the drawings are not drawn in actual scale for convenience of description. Techniques, methods, and apparatus known to one of ordinary skill in the relevant art may not be discussed in detail, but should be considered part of the authorization specification where appropriate. In all examples shown and discussed herein, any specific values should be construed as merely illustrative, and not a limitation. Thus, other examples of the exemplary embodiments may have different values. It should be noted that: like reference numerals and letters denote like items in the following figures, and thus once an item is defined in one figure, no further discussion thereof is necessary in subsequent figures.
In describing the present invention, spatially relative terms such as "above … …," "above … …," "upper surface at … …," "above," and the like may be used herein for ease of description to describe one device or feature's spatial positional relationship to another device or feature as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "above" or "over" other devices or structures would then be oriented "below" or "beneath" the other devices or structures. Thus, the exemplary term "above … …" may include both orientations of "above … …" and "below … …". The device may also be positioned in other different ways (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.
In the description of the present invention, unless otherwise indicated, the meaning of "a plurality" is two or more. For example, the plurality of fixing hooks means two fixing hooks or more than two fixing hooks; the terms "upper," "lower," "left," "right," "front," "rear," "inner," "outer," "vertical," "horizontal," "leading," "trailing," and the like are used for convenience in describing and simplifying the description based on the orientation or positional relationship shown in the drawings, and do not denote or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus should not be construed as limiting the invention. Furthermore, the terms "first," "second," "third," "fourth," and the like are used merely to distinguish between a plurality of similar elements and are not intended to represent any difference in importance or order among the elements; moreover, the terms "first," "second," "third," "fourth," and the like are used for descriptive purposes only and are not to be construed as indicating or implying an implicit indication of the number of features indicated; thus, a feature defining "a first", "a second", "a third", "a fourth", etc. may explicitly or implicitly include one or more such feature.
In the description of the present invention, it should be noted that, directions or positional relationships indicated by terms "head end", "front end", "rear end", and "proximal end", "distal end", etc., are directions or positional relationships based on those shown in the drawings, are merely for convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element to be referred to must have a specific direction, be constructed and operated in a specific direction, and thus should not be construed as limiting the present invention; the terms "head end," "front end," "tail end," and "proximal end," "distal end" are relative orientations, relative positions, directions of elements or actions relative to one another from the perspective of a physician using the medical device, although the terms "head end," "front end," "tail end," and "proximal end," "distal end" are not limiting, the terms "tail end," "proximal end" generally refer to the end of the medical device that is proximal to the physician during normal operation, while "head end," "front end," "distal end" generally refer to the end that first enters the patient's body.
In the description of the present invention, it should be noted that, unless explicitly specified and limited otherwise, the terms "connected," "connected," and "connected" are to be construed broadly, and may be either fixedly connected, detachably connected, or integrally connected, for example; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium. The specific meaning of the above terms in the present invention will be understood in specific cases by those of ordinary skill in the art.
For ease of description, the positional relationship of other devices is described in terms of a fixture that is placed on a horizontal table top or other carrying platform.
It should be appreciated that reference throughout this specification to "one embodiment," "an embodiment," or "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, the appearances of the phrases "in one embodiment," "in an embodiment," or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.
Referring to fig. 1, there is shown a schematic perspective view of a modular fixture for a leadless implantable medical device, in accordance with an embodiment of the invention; referring to fig. 2, a schematic cross-sectional view of a combined fixture for a leadless implantable medical device according to an embodiment of the invention is shown; referring to fig. 3, there is shown a schematic structural view of a fixing cap of a combination fixing device for a leadless implantable medical device according to an embodiment of the present invention; referring to fig. 4, there is shown a schematic structural view of a fixation wing of a combination fixation device for a leadless implantable medical device, in accordance with an embodiment of the invention; referring to fig. 5, a fixation effect diagram of a combined fixation device for a leadless implantable medical device of an embodiment of the invention is shown.
As shown in fig. 1 to 4, the combined fixture for the leadless implantable medical device 30 includes a fixture cap 10 and a fixture wing 20, the fixture cap 10 including a fixture sleeve 12, a fixture tooth 13, and an electrode 11 positioned at the top center of the fixture sleeve; the fixation wings 20 comprise an annular fixation frame 21 and a fixation hook 22, wherein the annular fixation frame 21 defines a longitudinal axis a of a leadless implantable medical device 30, the leadless implantable medical device 30 comprising a housing 31, the leadless implantable medical device 30 being an implantable cardiac pacemaker.
In the embodiment of the invention, the leadless implantable medical device 30 can be better fixed on heart tissue by adopting the fixing mode of combining the fixing cap 10 and the fixing wing 20, the electrode 11 is more tightly and firmly contacted with the heart tissue, the fixing mode is safe and reliable, and the leadless implantable medical device 30 in the heart cavity can be prevented from shifting and moving along with the impact of the heartbeat and the blood flow, even dislocating and sliding, thereby improving the reliability and the safety of the leadless implantable medical device 30 in the heart cavity.
In the embodiment of the present invention, the fixing hook 22 includes a connecting section 221, a transition section 222 and a hook tip section 223, which are sequentially connected and have coplanar axes, the connecting section 221 is connected to the annular fixing frame 21, one end of the transition section 222 is connected to the connecting section 221, and the other end of the transition section 222 is connected to the hook tip section 223.
In the embodiment of the invention, the connecting section 221, the transition section 222 and the hook tip section 223 of the fixed hook 22 are connected in a smooth transition mode, so that the discomfort of the fixed hook on the body of a patient during use can be reduced.
In the embodiment of the present invention, the fixing cap 10 is connected to the front end of the housing 31 through the fixing sleeve 12, and the electrode 11 is connected to the leadless implantable medical device 30 through the fixing sleeve 12.
In an embodiment of the invention, the fixed tooth 13 comprises a fixed segment 131 connected to the side wall of the fixed sleeve 12 and a free segment 132 extending straight along the fixed segment 131 in a direction away from said longitudinal axis a.
In an embodiment of the present invention, leadless implantable medical device 30 may be an implantable cardiac pacemaker.
In the embodiment of the present invention, the fixing cap 10 is connected to the front end of the housing 31 through the fixing sleeve 12, the electrode 11 is connected to the leadless implantable medical device 30 through the fixing sleeve 12, and the leadless implantable medical device 30 can be stably fixed on the auricle or the apex of the heart of the patient through the fixing teeth 13 on the fixing cap 10.
In the embodiment of the present invention, the fixing wings 20 are fixed to the outer surface of the housing 31 of the leadless implantable medical device 30 by means of sleeving, welding or bonding, so as to stably connect with the leadless implantable medical device 30, and the longer fixing hooks 22 provide a longer distance to approach the myocardium and fix the patient tissue, so that the implantable medical device 30 can be stably fixed to the patient tissue by means of the fixing hooks 22.
In an embodiment of the present invention, the axis of the free segment 132 forms an acute angle with the longitudinal axis A, the acute angle being 15-75. For example, the acute angle may be 15 °, 16 °, 17 °, 18 °, 19 °, 20 °, 21 °, 22 °, 23 °, 24 °, 25 °, 26 °, 27 °, 28 °, 29 °, 30 °, 31 °, 32 °, 33 °, 34 °, 35 °, 36 °, 37 °, 38 °, 39 °, 40 °, 41 °, 42 °, 43 °, 44 °, 45 °, 46 °, 47 °, 48 °, 49 °, 50 °, 51 °, 52 °, 53 °, 54 °, 55 °, 56 °, 57 °, 58 °, 59 °, 60 °, 61 °, 62 °, 63 °, 64 °, 65 °, 66 °, 67 °, 68 °, 69 °, 70 °, 71 °, 72 °, 73 °, 74 °, or 75 °.
In embodiments of the present invention, the stability of the fixation teeth 13 on the fixation cap 20 to secure the leadless implantable medical device 30 to the tissue of the patient can be further enhanced by setting the angle formed by the axis of the free segment 132 and the longitudinal axis a to be acute.
In an embodiment of the present invention, the free segment 132 further includes a head end 1321, where the head end 1321 is in the shape of a cone extending from the free segment 132 and has a tapered end surface, and the end surface is a plane, triangle, or arc surface.
In the embodiment of the present invention, the axis of the connecting section 221 is arc-shaped and extends in a direction away from the longitudinal axis a, the axis of the transition section 222 is arc-shaped and extends in a direction away from the longitudinal axis a, and the axis of the hook tip section 223 is arc-shaped and extends in a direction toward the longitudinal axis a, and the axis of the connecting section 221, the axis of the transition section 222 and the axis of the hook tip section 223 are combined into a segment of arc-like curve.
In the embodiment of the present invention, by setting the axis of the connection section 221 to be circular arc-shaped and extend in a direction away from the longitudinal axis a, setting the axis of the transition section 222 to be circular arc-shaped and extend in a direction away from the longitudinal axis a, setting the axis of the hook tip section 223 to be circular arc-shaped and extend in a direction toward the longitudinal axis a, and setting the axis of the connection section 221, the axis of the transition section 222 and the axis of the hook tip section 223 to merge into a segment-like circular arc curve, the anchoring performance of the leadless implantable medical device 30 can be improved while avoiding the problem that the fixation unit or the fixation device pierces the tissue.
In the embodiment of the present invention, the bending radius of the connection section 221 is 1-2mm; for example, the bend radius of the connection segment 221 may be 1mm, 1.1mm, 1.2mm, 1.3mm, 1.4mm, 1.5mm, 1.6mm, 1.7mm, 1.8mm, 1.9mm, or 2mm.
In the embodiment of the present invention, the bending radius of the transition section 222 is 3-5mm; for example, the radius of curvature of the transition section 222 may be 3.1mm, 3.2mm, 3.3mm, 3.4mm, 3.5mm, 3.6mm, 3.7mm, 3.8mm, 3.9mm, 4mm, 4.1mm, 4.2mm, 4.3mm, 4.4mm, 4.5mm, 4.6mm, 4.7mm, 4.8mm, 4.9mm, or 5mm.
In the embodiment of the present invention, the bending radius of the hook tip segment 223 is 1-3mm. For example, the hook tip segment 223 can have a bend radius of 1mm, 1.1mm, 1.2mm, 1.3mm, 1.4mm, 1.5mm, 1.6mm, 1.7mm, 1.8mm, 1.9mm, 2mm, 2.1mm, 2.2mm, 2.3mm, 2.4mm, 2.5mm, 2.6mm, 2.7mm, 2.8mm, 2.9mm, or 3mm.
In the embodiment of the present invention, since the radius of curvature of the transition section 222 is larger than that of the connection section 221, the fixation hook 22 can be stably fixed to the myocardial wall of the heart tissue. Since the radius of curvature of the hook tip segment 223 is smaller than the radius of curvature of the transition segment 222, the fixation hook 22 can be inserted into the myocardial wall of heart tissue without causing perforation.
In the embodiment of the present invention, the fixing teeth 13 are made of medical grade silica gel or polyurethane material, and the fixing hooks 22 are made of medical grade silica gel or polyurethane material.
In the embodiment of the present invention, the axial length of the fixing hook 22 of the fixing wing 20 is not greater than the circumference of the annular fixing frame 21 of the fixing wing 20, and the fixing wing 20 is disposed at a position between 1/3 of the distance from the housing 31 to the tail of the electrode 11.
In the embodiment of the invention, the fixed sleeve 12 and the fixed teeth 13 of the fixed cap 10 are integrally formed; a plurality of stationary teeth 13 spaced apart from each other around the sidewall of the stationary sleeve 12; a plurality of fixing teeth 13 are spaced apart from each other at equal intervals around the side wall of the fixing sleeve 12; a plurality of fixed teeth 13 are circularly arranged around the fixed sleeve 12; the number of the fixing teeth 13 is 2 to 10, and for example, the number of the fixing teeth 13 may be 2, 3, 4, 5, 6, 7, 8, 9 or 10. Further, the number of the fixed teeth 13 is 4.
In the embodiment of the present invention, the plurality of fixing teeth 13 extend outwards from the fixing end 131 along the side wall of the fixing sleeve 12 and are opened outwards in an umbrella shape in a direction deviating from the fixing sleeve 12, the fixing teeth 13 form an acute included angle with the fixing sleeve 12, and the opening angle is an acute angle of 15 degrees to 75 degrees. The head end 1321 of the free section 132 of the fixed tooth 13 is used to hook the heart muscle of the auricle or apex, and after implantation in the endocardium, the fixed tooth 13 is clamped into the trabecula.
In the embodiment of the present invention, the annular fixing frame 21 and the fixing hook 22 of the fixing wing 20 are integrally formed; the plurality of fixing hooks 22 are spaced apart from each other around the circumference of the ring-shaped fixing frame 21; the plurality of fixing hooks 22 are spaced apart from each other at equal intervals around the circumference of the ring-shaped fixing frame 21; the plurality of fixing hooks 22 are circularly arranged around the annular fixing frame 21; the number of the fixing hooks 22 is 2 to 10, and for example, the number of the fixing hooks 22 may be 2, 3, 4, 5, 6, 7, 8, 9, or 10. Further, the number of the fixing hooks 22 is 4.
In the embodiment of the present invention, the whole appearance of the plurality of fixing hooks 22 is spiral, the fixing hooks 22 are expanded or contracted along the radial direction of the housing 31, and when the fixing hooks 22 are implanted, the fixing hooks can be expanded to deviate from the housing 31, so as to provide a supporting and fixing effect for the leadless implantable medical device 30, and the fixing effect of the fixing cap 10 is enhanced, thereby fixing the leadless implantable medical device 30 in the heart chamber on heart tissue more firmly.
In the embodiment of the present invention, the fixing sleeve 12 and the fixing teeth 13 may be integrally formed and fixed to the outer surface of the front end of the housing 31 by a casting.
In the embodiment of the present invention, the annular fixing frame 21 is detachably connected or fixedly connected with the housing 31.
In the embodiment of the present invention, the fixing teeth 13 are fixed on the outer surface of the fixing sleeve 12 at the front end of the leadless implantable medical device 30 by a conveying device before the leadless implantable medical device 30 is implanted, and can be placed in the conveying device together with the leadless implantable medical device 30, and enter the heart chamber for fixing by catheter intervention.
Likewise, fixation hooks 22 are secured to the outer surface of housing 31 of leadless implantable medical device 30 prior to implantation of leadless implantable medical device 30 and may be placed in a delivery apparatus with leadless implantable medical device 30 for fixation by catheter intervention into the heart chamber.
As shown in fig. 5, before the leadless implantable medical device 30 is implanted, the fixing teeth 13 on the fixing cap 10 are retracted toward the side wall of the fixing sleeve 12 and are accommodated in the delivery device, and the fixing wings 20 are accommodated in the delivery device in a retracted state against the outer surface of the housing 31 of the leadless implantable medical device 30. When the leadless implantable medical device 30 is implanted in the heart, a minimally invasive operation is performed to form an opening reaching a blood vessel on a patient, then a delivery device provided with the leadless implantable medical device 30 is inserted into the opening, the leadless implantable medical device 30 and a combined fixing device are further delivered to a preset position of the auricle or the apex of the heart along the blood vessel, the leadless implantable medical device 30 and the combined fixing device are pushed out of the delivery device by the delivery device, the electrode 11 positioned at the center of the top of the fixing sleeve 12 is contacted with the endocardium, the fixing cap 10 is released, the fixing teeth 13 on the fixing cap 10 are opened in a direction away from the fixing sleeve 12, the heart muscle of the auricle or the apex of the heart is hooked by the head end 1321 of the fixing teeth 13, and after the implantation of the leadless implantable medical device is clamped into a muscle trabecula, the electrode 11 is difficult to move after the electrode 11 is contacted with the endocardium, and the leadless implantable medical device 30 is prevented from being separated from the heart muscle. After the fixing cap 10 is deployed, the leadless implantable medical device 30 is continuously pushed by the conveying device, the fixing hooks 22 on the fixing wings 20 are released and then spread out from the direction of the shell 31, and are abutted against the myocardial wall, the fixing wings 20 and the cardiac muscle form a supporting and fixing effect on the fixing of the fixing cap 10, and the fixing wings 20 and the fixing cap 10 together fix the leadless implantable medical device 30 in heart tissues. After implantation, the delivery device is withdrawn from the patient, leaving the leadless implantable medical device 30 in the patient. And finally treating the operation wound.
It should be noted that, in the present specification, each embodiment is described in a progressive manner, and each embodiment is mainly described as different from other embodiments, and identical and similar parts between the embodiments are all enough to be referred to each other.
While alternative embodiments of the present invention have been described, additional variations and modifications in those embodiments may occur to those skilled in the art once they learn of the basic inventive concepts. It is therefore intended that the following appended claims be interpreted as including alternative embodiments and all such alterations and modifications as fall within the scope of the embodiments of the invention.
Finally, it is also noted that in the present invention, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that an article or terminal that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such article or terminal. Without further limitation, an element defined by the phrase "comprising one … …" does not exclude that an additional identical element is present in an article or terminal device comprising the element.
While the foregoing has been described in some detail by way of illustration of the principles and embodiments of the invention, and while in accordance with the principles and implementations of the invention, those skilled in the art will readily recognize that the invention is not limited thereto.
Claims (10)
1. A combination fixture for a leadless implantable medical device comprising a housing, the combination fixture comprising a fixation cap and a fixation wing, characterized in that,
the fixing cap comprises a fixing sleeve, fixing teeth and an electrode positioned at the center of the top of the fixing sleeve;
the fixation wings include an annular fixation frame defining a longitudinal axis of the leadless implantable medical device and a fixation hook.
2. The combination fixture for leadless implantable medical devices of claim 1 wherein the fixation hook comprises a connecting section, a transition section and a hook tip section connected in sequence and having coplanar axes, the connecting section being connected to the annular mount, one end of the transition section being connected to the connecting section, the other end of the transition section being connected to the hook tip section.
3. The combination fixture for a leadless implantable medical device of claim 1 wherein said cap is connected to a front end of said housing by said fixation sleeve through which said electrode is connected to said leadless implantable medical device.
4. The combination fixation device for a leadless implantable medical device of claim 1 wherein the fixation teeth comprise a fixation section attached to a sidewall of the fixation sleeve and a free section extending linearly along the fixation section in a direction away from the longitudinal axis.
5. The combination fixture for a leadless implantable medical device of claim 4 wherein the axis of the free segment forms an acute angle with the longitudinal axis, the acute angle being 15 ° -75 °.
6. The combination fixture for a leadless implantable medical device of claim 4 wherein the free segment further comprises a head end in the shape of a cone extending from the free segment having a tapered end surface that is planar, triangular, or arcuate.
7. The combination fixture for a leadless implantable medical device of claim 2,
the axis of the connecting section is arc-shaped and extends in a direction away from the longitudinal axis,
the axis of the transition section is circular arc-shaped and extends in a direction away from the longitudinal axis,
the axis of the hook tip section is arc-shaped and extends towards the direction of the longitudinal axis,
the axis of the connecting section, the axis of the transition section and the axis of the hook tip section are combined into a section of arc-like curve.
8. The combination fixture for a leadless implantable medical device of claim 7,
the bending radius of the connecting section is 1-2mm;
preferably, the bending radius of the transition section is 3-5mm;
preferably, the bending radius of the hook tip section is 1-3mm.
9. A fixation system for a leadless implantable medical device comprising a combined fixation apparatus for a leadless implantable medical device as defined in any one of claims 1-8.
10. A method of implanting or retrieving a leadless implantable medical device in body tissue, comprising the step of using a combination fixture for a leadless implantable medical device as defined in any one of claims 1-8.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202310017407.4A CN116059536A (en) | 2023-01-06 | 2023-01-06 | Combined fixing device for leadless implantable medical device |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202310017407.4A CN116059536A (en) | 2023-01-06 | 2023-01-06 | Combined fixing device for leadless implantable medical device |
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| Publication Number | Publication Date |
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| CN116059536A true CN116059536A (en) | 2023-05-05 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202310017407.4A Pending CN116059536A (en) | 2023-01-06 | 2023-01-06 | Combined fixing device for leadless implantable medical device |
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| Country | Link |
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| CN (1) | CN116059536A (en) |
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2023
- 2023-01-06 CN CN202310017407.4A patent/CN116059536A/en active Pending
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