CN109820623A - Medical device - Google Patents
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- CN109820623A CN109820623A CN201711183642.XA CN201711183642A CN109820623A CN 109820623 A CN109820623 A CN 109820623A CN 201711183642 A CN201711183642 A CN 201711183642A CN 109820623 A CN109820623 A CN 109820623A
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Abstract
The present invention provides a kind of medical devices to improve doctor to the easiness of such instrumentation, reduce operation time without the separated structure of additional tightening structure and truncation tightening structure.The medical device includes: the first fixing piece, and including the first and second connected part, the first part is used to contact with the first wall of implantation object；Second fixing piece, including third and fourth connected part, for connecting with second part, the Part IV is used to contact with the third wall of implantation object the Part III；When the Part III is separated with second part, the implantation object is in first state；When the Part III is connect with second part, the implantation object is in the second state.
Description
Technical field
The present invention relates to the field of medical instrument technology, in particular to a kind of medical device for cardiac morphology adjustment.
Background technique
Heart failure is the terminal stage of most cardiovascular disease.Although the application of heart failure medications in the past 20 years, makes patients with heart failure
It is obvious to benefit, but the death rate of terminal phase patients with heart failure is still high.The pathophysiological basis of heart failure is heart reconstruction.
Heart reconstruction clinically shows as the expansion of ventricle progressive, heart contraction and diastolic function and is damaged, and continues to develop with heart failure
Increase with the death rate related.
It is presently recommended that angiotensin converting enzyme inhibitor (ACEI)/Angiotensin Ⅱ receptor antagonist, beta receptor resistance
Stagnant dose, aldosterone receptor antagonist and following cardiac resynchronization therapy (CRT) can slow down or reverse the reconstruct of left ventricle, improve
The clinical prognosis of patients with heart failure.Certainly, consequently also there are some miniature wound interventional medical devices in relation to heart failure, substantially have
Following two:
One, left ventricle isolating device (Parachute)
Left ventricle " parachute (Parachute) " is left ventricular insufficiency caused by treatment antetheca apical myocardium infarct
Implantable Medical Device.After Anterior wall myocardial infarction, heart contraction and diastolic function are impaired.Specifically, paradoxical expansion, left ventricle
The inappropriate contraction of apex, it is asynchronous with other ventricle walls, lower the overall output amount of heart；Diastole, apex
Cicatrization increase the filling pressure in ventricular diastole latter stage；In this way, eventually lead to left ventricle volume load, ventricle wall
Power increases.So, it is implanted into Parachute in apex, it on the one hand can be by the normal geometric shape of recovery left ventricle, to reduce
Volume load is to reduce the wall tension of left ventricular cavity upper portion, on the other hand by improving the same of myocardium of apex of heart contraction
Step property further decreases left ventricular filling pressure, improves myocardium output quantity.
By in June, 2016, the whole world have nearly 500 ischemic cardiomyopathies (NYHA be classified III~IV, LVEF 15%~
40%) patient is implanted into Parachute, and surgical procedure success rate is up to 95.5%, postoperative complication (including pericardial tamponade, aorta
The damage of valve, left ventricle perforation etc.) incidence is 8.2%.Moreover, follow-up observation 24 months, compared with Baseline Data, implantation
The patients with heart failure of Parachute device, left ventricular end diastolic and end-systolic volume index (ml/m2) are substantially reduced (105.3
±25.1vs 123.1±23.1；77.3±21.2vs 89.1±21.4；P<0.0001)；Most of patients NYHA is classified by III
It is reduced to I~II grades；Walking distance increases (391m vs 369m, P < 0.005) within 6 minutes；Potential stroke incidence about 5.3%；2 years
All-cause death rate about 9.9%.
Thus, it could be seen that Parachute Major Vessels complication is low compared with TAVR operation (aortic valve replacement), and improve the heart
Dirty contraction and the effect of diastolic function are suitable with CRT treatment；NYHA classification can be reduced, 6 minutes walking distances are improved.
Two, myocardium anchoring device (Revivent Myocardial Anchoring System)
Myocardium anchoring techniques are a kind of surgery intervention operations that is relatively easy, not needing extracorporal circulatory system support.Pass through intervention
The necrosis of anchor antetheca, ungauged regions ability cardiac muscle, restore the geometric shape and function of left ventricle.With traditional surgery heart
Room volume reduction art is compared, and myocardium anchoring techniques are a kind of invasive relatively small operations, is not needed the support of extracorporal circulatory system, is not required to
Left ventricular free wall necrotic myocardium is cut off, suture and sticking patch are not required to, it is relatively fewer to the damage of left ventricle.
There are 2 clinical trials carrying out in Europe at present, advanced stage Ischemic Cardiomyopathy row cardiac muscle is anchored and is performed the operation.With
Visit observation 30 days, 1 year, 2 years survival rates be respectively 90.7%, 88.7% and 87.1%, compared with traditional treatment method, hence it is evident that
Improve the survival rate of advanced heart failure patient；It is postoperative, 2 years, 1 year, 6 months left ventricular contraction volume indexs compared with baseline,
It is obviously improved (median is 44.1,46.7,49.3 and 68.5 respectively), walking distance is improved within LVEF and 6 minute, and steady
Surely it maintains 2 years.
However, it is found by the inventors that existing cardiac muscle anchoring device, validity and stability of anchoring etc. are both needed to improve, together
When there is also it is complicated for operation the problems such as.
Summary of the invention
In view of this, the present invention provides a kind of medical device, point without additional tightening structure and truncation tightening structure
From structure, doctor is improved to the easiness of such instrumentation, reduces operation time.
According to an aspect of the invention, there is provided a kind of medical device, including the first fixing piece and the second fixing piece；
First fixing piece includes connected first part and second part, and the first part is used for and implantation object
The first wall contact；
Second fixing piece includes connected Part III and Part IV, the Part III and the second part
Connection, the Part IV are used to contact with the third wall of the implantation object；
When the Part III is separated with the second part, the implantation object is in first state；When described
When three parts are connect with the second part, the implantation object is in the second state.
Optionally, the implantation object includes cavity, and the cavity volume of the implantation object under the second state is less than
The cavity volume of the implantation object under one state.
Optionally, the medical device further includes guide mechanism, and the guide mechanism passes through first fixing piece and institute
The second fixing piece is stated, and second fixing piece can be along the guide mechanism to the side far from or close to first fixing piece
To movement.
Optionally, the guide mechanism is seal wire.
Optionally, the medical device further includes delivery device, and the delivery device is for driving second fixing piece
Close to first fixing piece.
Optionally, the medical device further includes force measuring machine, the power being subject to for measuring second fixing piece.
Optionally, the force measuring machine is set to the distal end of delivery device, the distal end of the delivery device be used for it is described
Part IV is cooperatively connected.
Optionally, it the Part III and the second part screw thread or is connected together.
Optionally, the second part includes groove, and the Part III includes protrusion fastener.
Optionally, at least one of the first part and the second part are sequentially connected end to end structure by plurality of rods part
At.
Optionally, at least one of the Part III and the Part IV are sequentially connected end to end structure by plurality of rods part
At.
Optionally, at least one of the first part and the second part are disc structure.
Optionally, at least one of the Part III and the Part IV are disc structure.
Optionally, the first part includes anchor portion and flexible structure, and the flexible structure is used for and the implantation
Object contact；The anchor portion is pivotally arranged on pin shaft, the second part by tube-like piece with it is described
Pin shaft connection.
Optionally, the flexible structure has large scale section and small size section, and the cross sectional dimensions of the large scale section is big
In the cross sectional dimensions of the small size section, and the large scale section is close to the anchor portion.
Optionally, the rotational angle of the anchor portion is between -90 °~+90 °.
According to the technique and scheme of the present invention, first fixing piece and the second fixing piece respectively include in medical device of the invention
Connected two parts, wherein the first part of first fixing piece can contact with diaphragm right, between left ventricle, and described second
The Part IV of fixing piece can be contacted with the outer wall of left ventricle, and the Part III of second fixing piece can be with second part
Connection can enable heart be in non-tightening state and when the Part III is separated with second part, when the Part III and
When second part connects, heart may make to be in tightening state.Such cardiac muscle tightening structure, so that intracardiac tightening is more firm
It leans on, stability is also higher, can preferably restore the geometric shape and function of ventricle.
Wherein, the Part III by the second part and the second fixing piece of the first fixing piece is sealed, can save additional
Tightening structure and truncation tightening structure separated structure, the structure of intracardiac tightening is more simple, and doctor is easier
Such instrument is operated, operation time is shortened.Moreover, passing through the sealed come real of the first fixing piece and the second fixing piece itself
The adjustment of both existing relative position can better assure intracardiac tightening so that the range and adjustment space of cardiac muscle adjustment are bigger
Validity and stability.
Detailed description of the invention
Attached drawing for a better understanding of the present invention, does not constitute an undue limitation on the present invention.Wherein:
Fig. 1 a is the structural schematic diagram of the first fixing piece of the medical device of one embodiment of the invention；
Fig. 1 b is the structural schematic diagram of the second fixing piece of the medical device of one embodiment of the invention；
Fig. 2 a is the intracardiac schematic diagram equipped with seal wire of one embodiment of the invention；
Fig. 2 b is that the intracardiac of one embodiment of the invention is implanted with the first fixing piece and the second fixing piece and in not tightening shape
Schematic diagram when state；
Fig. 2 c is that the intracardiac of one embodiment of the invention is in tightening state after the first fixing piece and the tightening of the second fixing piece
When schematic diagram；
Fig. 3 a is first fixing piece of one embodiment of the invention and the schematic diagram that the second fixing piece passes through screw-threaded coupling；
Fig. 3 b is first fixing piece of one embodiment of the invention and the schematic diagram that the second fixing piece is locked by elastic ball；
Fig. 3 c is first fixing piece of one embodiment of the invention and the schematic diagram that the second fixing piece is locked by elastic buckles；
Fig. 3 d is first fixing piece of one embodiment of the invention and the schematic diagram that the second fixing piece passes through snap lock；
Fig. 3 e is first part's showing by flexible structure and membrane contacts of first fixing piece of one embodiment of the invention
It is intended to；
Fig. 4 a is the schematic diagram of the first part of first fixing piece of one embodiment of the invention；
Fig. 4 b is that the first part of first fixing piece of one embodiment of the invention is equipped with the schematic diagram of pin shaft；
Fig. 4 c is that the first part of first fixing piece of one embodiment of the invention is used to show around what the axis A of pin shaft was rotated
It is intended to；
Fig. 5 a is the schematic diagram of first fixing piece of one embodiment of the invention；
Fig. 5 b is the schematic diagram of first fixing piece of another embodiment of the present invention；
Fig. 5 c is the schematic diagram of first fixing piece of another embodiment of the present invention；
Fig. 6 a is the schematic diagram of second fixing piece of one embodiment of the invention；
Fig. 6 b is the schematic diagram of second fixing piece of another embodiment of the present invention；
Fig. 6 c is the schematic diagram of second fixing piece of another embodiment of the present invention.
The reference numerals are as follows:
The first fixing piece of 1-: 11- first part, 12- second part, 13- tube-like piece, 14- flexible structure, 111- anchor portion
Point, the rotating junction 112-, 113- pin shaft, 121- lockhole, 122- concave hole, 123- card hole, 124- card slot, the auxiliary section 125-；
The second fixing piece of 2-: 21- Part III, 22- Part IV, another tube-like piece of 23-, 211- extending column, 212- bullet
Property ball, 213- elastic buckles, 214- elastic arm, 221- interconnecting piece；
3- seal wire；4- delivery device, 41- push pipe；5- force measuring machine.
Specific embodiment
To keep the purpose of the present invention, advantages and features clearer, below in conjunction with 1~6 couple of doctor proposed by the present invention of attached drawing
Device is treated to be described in further detail.It should be noted that attached drawing is all made of very simplified form and uses non-accurate ratio
Example, only for the purpose of facilitating and clarifying the purpose of the embodiments of the invention.
As used in this specification, singular "a", "an" and "the" includes plural reference, unless interior
In addition appearance explicitly points out outer.It is as used in this specification, term "or" be usually to include the meaning of "and/or" and into
Enforcement, in addition in addition non-content explicitly points out.Term " proximal end " typically refers to one end that counterpart member depends on proximal operator,
" distal end " refers to the one end of counterpart member far from operator.As used in this specification, term " inside " typically refers to
Close to the axis direction of counterpart member, term " outside " typically refers to the axis direction far from counterpart member.
Medical device provided by the invention is mainly used for myocardium fixation, with by intervention fixing piece treat antetheca necrosis,
The cardiac muscle of ungauged regions ability restores the geometric shape and function of left ventricle.
Fig. 1 a is the schematic diagram for the first fixing piece 1 that one embodiment of the invention provides, and Fig. 1 b is that one embodiment of the invention mentions
The schematic diagram of the second fixing piece 2 supplied, as illustrated in figs. 1A and ib, the medical device of the present embodiment include the first fixing piece 1 with
And second fixing piece 2.First fixing piece 1 includes connected first part 11 and second part 12.Second fixing piece 2
Including connected Part III 21 and Part IV 22.
The first part 11 and second part 12 substantially can be in I-shaped, it is preferred that the first part 11 it is transversal
Face size is greater than the cross sectional dimensions of second part 12, in order to preferably tighten cardiac muscle.The first part 11 and second
Dividing 12 includes but is not limited to be integrally formed, and can also be fitted together after seperated molding.The Part III 21 and Part IV
22 equally substantially can be in I-shaped, it is preferred that the cross sectional dimensions of the Part III 21 is less than the cross section of Part IV 22
Size, preferably to tighten cardiac muscle.The Part III 21 and Part IV 22 also include but is not limited to be integrally formed, can also be with
It is mutually assembled after fission molding.
Then combine shown in Fig. 2 c, by the implantation of the medical device of the present embodiment it is intracardiac after, the third of second fixing piece 2
Part 21 is finally connect with the second part 12 of the first fixing piece 1, is locked the first fixing piece 1 and the second fixing piece 2 with this
It is fixed, to complete the adjustment of left ventricular geometry and function.
The second part 12 can be with Part III 21, and the shape of the two is mutually matched or is mutually adapted, wherein one
A component can be fastened in another component, no external force or be not above limit external force under conditions of be able to achieve it is relatively quiet
Only, such as the second part 12 is connected with Part III 21 by buckle, groove mode.It or is the second part
12 can also realize connection by fastening means such as screw threads with Part III 21.However, in fact it is preferred to some be not easy to free
Mode realizes the connection of second part 12 Yu Part III 21, and the reliability of intracardiac tightening is ensured with this.
Furthermore, it is understood that as shown in Figure 3a, the second part 12 can be threadably secured locking with Part III 21.Tool
For body, it is provided with internal screw thread on the second part 12, external screw thread is provided on the Part III 21, such as at second
It is provided with internal screw thread in the lockhole 121 divided on 12, and is provided with external screw thread on the extending column 211 on Part III 21, it is described
Extending column 211 is inserted into the locking of 121 internal screw thread of lockhole.
In another embodiment, as shown in Figure 3b, the second part 12 can pass through bulb shape card with Part III 21
Padlock is tight.More specifically, it is provided with concave hole 122 on the second part 12, is arranged on the Part III 21 flexible
The shape of ball 212, the concave hole 122 can match or be adapted with elastic ball 212.
In another embodiment, as shown in Figure 3c, the second part 12 can pass through elastic padlock with Part III 21
Tightly.Specifically, being provided with card hole 123 on the second part 12, elastic buckles 213, institute are provided on the Part III 21
It states elastic buckles 213 to be sticked in card hole 123, and is locked with card hole 123.In the present embodiment, the table of the elastic buckles 213
Face is circumferentially formed with protrusion, the protrusion in card hole 123 in set groove and in shape match or be adapted.
In other one embodiment, as shown in Figure 3d, the second part 12 can pass through snap lock with Part III 21
Tightly.For example, it is provided with card slot 124 on the second part 12, is provided with elastic arm 214 on the Part III 21, so that
Elastic arm 214 can be extruded so that the protruding portion of elastic arm 214 is inserted into card slot 124 and realizes locking.In the present embodiment, the elastic arm
214 are two and are oppositely arranged, and each elastic arm 214 is formed with holding section integral into a cantilever design thereon, and the holding section is inserted
Enter card slot 124 realize it is sealed.
It will be appreciated that above-mentioned lockhole 121, concave hole 122, card hole 123 or card slot 124 can also be changed and be set to third portion
Divide on 21, then accordingly change is provided with extending column 211, elastic ball 212, elastic buckles 213 or elastic arm to the second part 12
214.Preferably, lockhole 121, concave hole 122, card hole 123 or card slot 124 are arranged on second part 12, and extending column 211,
Elastic ball 212, elastic buckles 213 or elastic arm 214 are arranged on Part III 21, can be with more convenient doctor in operation by second
Part 12 is connected with Part III 21.However, specific connection type of the present invention for second part 12 and Part III 21
It does not limit particularly, as long as not easily to fall off after ensuring the two connection.
The use of medical device about the present embodiment sees Fig. 2 a to Fig. 2 c, and Fig. 2 a is that one embodiment of the invention provides
The intracardiac schematic diagram equipped with seal wire 3, Fig. 2 b be one embodiment of the invention provide intracardiac implant the first fixing piece 1 and second
Fixing piece 2 and be in non-tightening state when schematic diagram, Fig. 2 c be one embodiment of the invention provide it is intracardiac by the first fixing piece 1
Schematic diagram when with after the tightening of the second fixing piece 2 in tightening state, detailed process are as follows:
Firstly, as shown in Figure 2 a, a seal wire 3 is implanted into heart (referred to as intracardiac), it is defeated to establish one in heart
Channel is sent, which includes left ventricular LV, right ventricle RV and septum of ventricles of heart SE (i.e. diaphragm)；Seal wire 3 herein is except guiding conveying
Outside sheath, further preferably it is used as the guide mechanism of the present embodiment, to guide the second fixing piece 2 along seal wire 3 to close to or far from the
The direction of one fixing piece 1 is mobile；
Later, as shown in Figure 2 b, the delivery sheath (not shown) for being loaded with the first fixing piece 1 is enabled to enter along seal wire 3
Designated position, removes the delivery sheath then to discharge the first fixing piece 1, after release, the first part of first fixing piece 1
11, which are located at the inner wall at septum of ventricles of heart SE with right ventricle RV, contacts and fixes, at the same the second part 12 of first fixing piece 1 with
Left ventricular LV is located at the inner wall at septum of ventricles of heart SE and contacts and preferably fix, and a part of the seal wire 3 at least need to be in left ventricle
The outside of LV is even stretched out external；
Then, with continued reference to Fig. 2 b, the second fixing piece 2 is put to suitable position, and makes the third portion of the second fixing piece 2
Divide 21 to be located at the inside of left ventricular LV, and can be contacted with left ventricular LV far from the inner wall of septum of ventricles of heart SE, while described second is fixed
The Part IV 22 of part 2 is located at the outside of left ventricular LV, and contacts with the outer wall of left ventricular LV and preferably fix；
Later, the second fixing piece 2 is operated, moves its entirety to the direction close to the first fixing piece 1 along seal wire 3, directly
Be moved to the position that Part III 21 and second part 12 need to connect to the second fixing piece 2, by rotation Part III 21 or
It pushes Part III 21 to enter card slot, makes second part 12 keep relative position to fix with Part III 21, figure can be obtained
Cardiac structure shown in 2c；At this point, the second part 12 is locked with 21 phase of Part III, to fix the several of left ventricular LV
What form, so that the function of left ventricular LV can be improved and even restore；Finally, withdrawing from seal wire 3.
It should also be noted that hatching is omitted in the cardiac structure in Fig. 2 c, it is actually heart knot shown in Fig. 2 b
State of the structure (mainly left ventricular LV) after tightening.Obviously, after being adjusted, the left ventricular LV of the present embodiment is from Fig. 2 b institute
The non-tightening state shown changes for tightening state shown in Fig. 2 c, and the volume of the left ventricular LV under tightening state is significantly less than
The volume of left ventricular LV under non-tightening state.
In turn, it is contacted by a fixing piece with the right ventricle RV inner wall being located at septum of ventricles of heart SE compared in traditional technology
And it is fixed, and contacted by another fixing piece with the outer wall of left ventricular LV, the medical device of the embodiment of the present invention can make
Intracardiac tightening is more firm, and stability is also higher, can preferably restore the geometric shape and function of ventricle.Particularly, described
First fixing piece 1 can also be directly connected to the second fixing piece 2, be received in this way, eliminate additional tightening structure and truncation
Intracardiac tightening behaviour can be realized only by the sealed of the first fixing piece 1 and the second fixing piece 2 itself in the separated structure of locking structure
Make, structure is more simple, and the operation of intracardiac tightening is more convenient, it is possible thereby to save the time of surgical procedure, improves operation effect
Rate.Moreover, by the sealed adjustment to realize the two relative position of the first fixing piece 1 and the second fixing piece 2 itself, so that the heart
The range and adjustment space of interior adjustment are bigger, better ensure the validity and stability of intracardiac tightening.
In addition, the medical device of the present embodiment simplifies the structure of medical device using seal wire 3 as guide mechanism, section
The use cost of device is saved.When practical operation, the first fixing piece 1 and the second fixing piece 2 is set to pass through seal wire 3, and make second
Fixing piece 2 can be slided along seal wire 3, especially when the second fixing piece 2 is slided along seal wire 3 to the direction close to the first fixing piece 1
When dynamic, can accurately it cooperate with the first fixing piece 1 on seal wire 3, tightening operation is more convenient, and operating accuracy is high,
The tightening of cardiac muscle can be completed, preferably effectively to promote the therapeutic effect of cardiac muscle tightening.
Further directed to the first fixing piece 1, it may also include tube-like piece 13, one end of the tube-like piece 13 and first part 11
Connection, the other end are connect with second part 12, and three is not limited to be integrally formed, and is also possible to seperated molding.Preferably, the pipe
One end of shape part 13 is connect by flexible structure 14 with first part 11.The flexible structure 14 has flexibility, when practical application, such as
Shown in Fig. 3 e, the first part 11 can be contacted and be fixed with septum of ventricles of heart SE by flexible structure 14, can increase first in this way
The frictional force that part 11 is contacted with tissue to prevent its tension in tightening process from falling off, while can also reduce receipts
The wound caused by tissue during tight.
In one embodiment, inside a part of length insertion septum of ventricles of heart SE of the flexible structure 14, another part is long
Degree contacts in right ventricle RV with the side wall of septum of ventricles of heart SE.(not shown) in other embodiments, the flexible structure 14 it is complete
Minister's degree contacts with the side wall of septum of ventricles of heart SE in right ventricle RV and (does not have the structure of any substance to enter in septum of ventricles of heart).
The flexible structure 14 can not only be presented as flexibility in structure, can also also be presented as in the selection of material soft
Property.In the present embodiment, the flexible structure 14 can have large scale section and small size section, and the large scale section is close to first part
11 settings, the small size section are arranged close to tubular body 13, and the cross sectional dimensions of the large scale section is greater than the small size
The cross sectional dimensions of section.
Further, the second part 12 is preferably elastic construction, is such as process by shape-memory material, either,
The second part 12 can be rotated relative to tube-like piece 13, be conveyed in order to which second part 12 can be fitted into delivery sheath.
Further, as shown in Fig. 4 a to Fig. 4 c, the first part 11 may include anchor portion 111 and rotating junction
112.The rotating junction 112 is set to the bottom of anchor portion 111 (bottom with the inner wall of right ventricle for contacting).It can
Choosing, the rotating junction 112 includes two flanks being oppositely arranged, which is realized hingedly by pin shaft 113, is made
Obtaining anchor portion 111 can rotate relative to tube-like piece 13, so that it is defeated to enable anchor portion 111 that can be collapsible into a rotating manner
It send in sheath.In turn, described even one end of tube-like piece 13 and pin shaft 113 are connected.
As illustrated in fig. 4 c, in practice, the anchor portion 111 can be rotated around the axis A of pin shaft 113, rotational angle
It is preferred that this range can guarantee that anchor portion 111 can be contacted with tissue in place between -90 °~+90 °.Its
In, using the position of anchor portion 111 and tube-like piece 13 when perpendicular as benchmark is rotated, it can further rotate clockwise 90 °, or
90 ° are rotated counterclockwise, and is defined counterclockwise for the negative direction of rotation, is clockwise the positive direction of rotation.
With continued reference to Fig. 2 b and Fig. 2 c, for the medical device it is also preferable to include delivery device 4, the delivery device 4 can be with
The detachable connection of Part IV 22 of second fixing piece 2.Optionally, the delivery device 4 includes a hollow push pipe
41, the distal end of the push pipe 41 with Part IV 22 for matching.
It is described push pipe 41 distal end may be selected with Part IV 22 with screw thread, buckle, snap-on etc. detachably into
Row connection.In practice, the inner cavity that the seal wire 3 may pass through push pipe 41 is stretched out in vitro, so that doctor operates seal wire 3 in vitro.
However, the push pipe 41 is not limited to push the second fixing piece 2 to the direction of the first fixing piece 1, so that the second fixing piece 2 is close
First fixing piece 1 also can pull the second fixing piece 2 to the direction far from the first fixing piece 1, so that the second fixing piece 2 is far from the
One fixing piece 1.
Preferably, the medical device further includes force measuring machine 5, make for measuring axial direction suffered by the second fixing piece 2
Firmly, the mainly axial force that is subject to of Part IV 22.The force measuring machine 5 is preferably disposed on push pipe 41 and the 4th
The position that part 22 is connected specifically may be provided at the distal end of push pipe 41, to perceive the deformation of the distal end, and be based on active force
With reaction force principle, the axial force that Part IV 22 is subject to is known in the deformation by pushing 41 distal end of pipe, so as to doctor
Can the axial force determine the validity and safety of surgical procedure, such as judge whether that axial force is excessive and causes
Fixing piece from falling etc..The force measuring machine 5 can be one or more foil gauges and constitute, preferably several, take all foil gauges
The mean value of the strain obtained is measured to calculate axial force, can be further improved the accuracy of measurement.
With continued reference to Fig. 1 b, the Part IV 22 of second fixing piece 2 includes an interconnecting piece 221, is used for and push
The distal end of pipe 41 is cooperatively connected.The interconnecting piece 221 be it is hollow, allow seal wire 3 pass through.In addition, the Part IV 22
It can be connected by another tube-like piece 23 with Part III 21.Similarly, the Part III 21, another tube-like piece 23, Part IV
22 can be integrally formed, or can fit together after seperated molding.
Further, either the first fixing piece 1 or the second fixing piece 2, they wrap up one layer of macromolecule braided fabric,
It can not only realize the quick endothelialization of these fixing pieces, but also frictional force when contact can be increased, prevent from falling off.
Further, the medical device may include multiple groups fixing piece, and every group of fixing piece includes that first matched is consolidated
Determine part 1 and the second fixing piece 2.Multiple groups fixing piece is preferably adjusted with the different location in aforementioned mode of operation implantation heart with this
The geometric shape of whole left ventricle reaches better surgical effect.
Subsequently, structure and the realization side of the first fixing piece 1 and the second fixing piece 2 will be further described in conjunction with attached drawing
Formula.
In one embodiment, as shown in Figure 5 a, in the first part 11 of first fixing piece 1 and second part 12 extremely
Few one is made of a rod piece.It is therein, the settable cooperation in side of the second part 12 far from first part 11
Portion 125 is formed with aforementioned lockhole 121, concave hole 122, card hole 123 or card slot 124 in the auxiliary section 125.
In another embodiment, as shown in Figure 5 b, at least one of the first part 11 and second part 12 by
Plurality of rods part is sequentially connected end to end, including but not limited to three in figure piece rod piece, is also possible to three below and above.?
In another embodiment, as shown in Figure 5 c, at least one of the first part 11 and second part 12 are disc structure.
Compared to single rod piece, by the structure of the first fixing piece 1 and tissue contact portion be designed as plurality of rods part or
Disc structure can increase contact area, thus increasing friction force, it is ensured that the first fixing piece 1 is not easily to fall off.
It is similar with the first fixing piece 1, in one embodiment, as shown in Figure 6 a, the third portion of second fixing piece 2
At least one of 21 and Part IV 22 are divided to be made of a rod piece.In another embodiment, as shown in Figure 6 b, described
At least one of three parts 21 and Part IV 22 are sequentially connected end to end by plurality of rods part, including but not limited in figure
Three rod pieces are also possible to three below and above.In another embodiment, as fig. 6 c, 21 He of Part III
At least one of Part IV 22 is disc structure.
Similarly, compared to single rod piece, the second fixing piece 2 and the structure of tissue contact portion are designed as plurality of rods
Part or disc structure can increase contact area, thus increasing friction force, it is ensured that the second fixing piece 1 is not easily to fall off.
The different structure mode of the first fixing piece 1 and the second fixing piece 2 is described in detail in above-described embodiment, when
So, the present invention includes but is not limited to structure type cited in above-mentioned implementation, any in structure provided by the above embodiment
The content converted on the basis of form belongs to the range that the present invention is protected.Those skilled in the art can be according to above-mentioned
The content of embodiment is drawn inferences about other cases from one instance.
Technical solution according to an embodiment of the present invention, the first fixing piece and the second fixing piece are each in medical device of the invention
From including connected two parts, wherein the first part of first fixing piece can contact with diaphragm right, between left ventricle,
And the Part IV of second fixing piece is contacted with the outer wall of left ventricle, and the Part III of second fixing piece can be with
Second part connection, such cardiac muscle tightening structure, so that intracardiac tightening is more firm, stability is also higher, can be preferably
Restore the geometric shape and function of ventricle.
It is noted that being realized by the way that the second part of the first fixing piece and the Part III of the second fixing piece are sealed
Intracardiac tightening operation can save the separated structure of additional tightening structure and truncation tightening structure, and the structure of intracardiac tightening is more
To be simple, and doctor is made to be easier to operate to such instrument, operation time is shorter.In addition, by the first fixing piece with
The sealed adjustment to realize the two relative position of second fixing piece itself, so that the range and adjustment space of cardiac muscle adjustment are more
Greatly, the validity and stability of intracardiac tightening can be better assured.
Foregoing description is only the description to present pre-ferred embodiments, not to any restriction of the scope of the invention, this hair
Any change, the modification that the those of ordinary skill in bright field does according to the disclosure above content, belong to the protection of claims
Range.
Claims (10)
1. a kind of medical device characterized by comprising
One first fixing piece, including connected first part and second part, the first part is used for the with implantation object
The contact of one wall；And
One second fixing piece, including connected Part III and Part IV, the Part III is used for and the second part
Connection, the Part IV are used to contact with the third wall of the implantation object；
When the Part III is separated with the second part, the implantation object is in first state；When the third portion
When point connecting with the second part, the implantation object is in the second state.
2. medical device as described in claim 1, which is characterized in that the medical device further includes a guide mechanism, described
Guide mechanism passes through first fixing piece and second fixing piece, and second fixing piece can be along the guide mechanism
It is mobile to the direction far from or close to first fixing piece.
3. medical device as claimed in claim 2, which is characterized in that the guide mechanism is a seal wire.
4. medical device as described in claim 1, which is characterized in that the medical device further includes a delivery device, described
Delivery device is for driving second fixing piece close to first fixing piece.
5. medical device as described in claim 1, which is characterized in that the medical device further includes a force measuring machine, is used for
Measure the power that second fixing piece is subject to.
6. medical device as claimed in claim 5, which is characterized in that the force measuring machine is set to the remote of a delivery device
End, the distal end of the delivery device are used to be cooperatively connected with the Part IV.
7. medical device as described in claim 1, which is characterized in that the Part III and the second part screw thread or card
Close connection.
8. medical device as claimed in claim 7, which is characterized in that the second part includes a groove, the third portion
Dividing includes a protrusion fastener.
9. medical device as described in claim 1, which is characterized in that the first part includes anchor portion and flexible knot
Structure, the flexible structure are used for and the implantation object contact；A pin shaft is pivotally arranged in the anchor portion
On, the second part is connect by a tube-like piece with the pin shaft.
10. medical device as claimed in claim 9, which is characterized in that the rotational angle of the anchor portion -90 °~+
Between 90 °.
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| CN201711183642.XA CN109820623B (en) | 2017-11-23 | 2017-11-23 | Medical device |
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| CN201711183642.XA CN109820623B (en) | 2017-11-23 | 2017-11-23 | Medical device |
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| CN109820623B CN109820623B (en) | 2021-02-23 |
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| CN201711183642.XA Active CN109820623B (en) | 2017-11-23 | 2017-11-23 | Medical device |
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| CN109820623B (en) | 2021-02-23 |
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Effective date of registration: 20220311 Address after: 201203 No. 1601, Zhangdong Road, Pudong New Area, Shanghai Patentee after: Minimally invasive Investment Holdings Ltd. Address before: 201 203 No. 501 Newton Road, China (Shanghai) Free Trade Pilot Area, Pudong New Area, Shanghai Patentee before: SHANGHAI MICROPORT MEDICAL (GROUP) Co.,Ltd. |