CN109820623B - Medical device - Google Patents

Abstract

The invention provides a medical device, which does not need an additional tightening structure and a separation structure for cutting off the tightening structure, improves the operation easiness of doctors on the instruments and reduces the operation time of the operation. The medical device includes: a first anchor comprising first and second connected portions, the first portion for contacting a first wall of an implanted subject; the second fixing piece comprises a third part and a fourth part which are connected, the third part is used for being connected with the second part, and the fourth part is used for being in contact with a third wall of the implanted object; when the third portion is separated from the second portion, the implanted subject is in a first state; the implanted subject is in a second state when the third portion is coupled to the second portion.

Description

Medical device

Technical Field

The invention relates to the technical field of medical instruments, in particular to a medical device for adjusting the shape of cardiac muscle.

Background

Heart failure is the terminal stage of most cardiovascular diseases. Although the application of heart failure drugs has obviously benefited heart failure patients in recent 20 years, the death rate of the end-stage heart failure patients is still high. The pathophysiological basis of heart failure is cardiac remodeling. Cardiac remodeling is clinically manifested by progressive dilation of the ventricles, impaired systolic and diastolic function, which is associated with the progressive progression of heart failure and increased mortality.

The currently proposed Angiotensin Converting Enzyme Inhibitor (ACEI)/angiotensin ii receptor antagonists, beta-blockers, aldosterone receptor antagonists, and Cardiac Resynchronization Therapy (CRT) all slow or reverse left ventricular remodeling and improve the clinical prognosis for patients with heart failure. Of course, some miniature invasive interventional medical devices related to heart failure have appeared, and there are roughly two types:

first, left ventricle isolation device (Parachute)

The left ventricle "Parachute (Parachute)", is an implantable medical device for treating left ventricle dysfunction caused by anterior apical myocardial infarction. Following anterior myocardial infarction, systolic and diastolic function is impaired. Specifically, in the systole, the apex of the left ventricle contracts improperly and is asynchronous with other ventricular walls, so that the overall output of the heart is reduced; in diastole, scar formation at the apex of the heart raises the filling pressure at the end diastole of the ventricles; this ultimately leads to increased left ventricular volume loading and ventricular wall tension. Then, the implantation of Parachute at the apex of the heart can reduce the volume load by restoring the normal geometry of the left ventricle, thereby reducing the wall tension of the upper half of the left ventricular cavity, and can further reduce the filling pressure of the left ventricle and increase the myocardial output by improving the synchronism of the contraction of the cardiac muscle at the apex of the heart.

Nearly 500 ischemic cardiomyopathies (NYHA grades III-IV, LVEF 15% -40%) are implanted into Parachute globally by the time of 2016 (6 months), the success rate of surgical operation reaches 95.5%, and the incidence rate of surgical complications (including pericardial tamponade, aortic valve injury, left ventricular perforation and the like) is 8.2%. Furthermore, following 24 months of observation, the left ventricular end-diastolic and end-systolic volume indices (ml/m2) for heart failure patients implanted with the Parachute device were significantly decreased (105.3 + -25.1 vs 123.1 + -23.1; 77.3 + -21.2 vs 89.1 + -21.4; P <0.0001) compared to baseline data; NYHA grades of most patients are reduced from III to I-II grades; an increase in walking distance of 6 minutes (391m vs 369m, P < 0.005); potential stroke incidence of about 5.3%; the 2 year all-cause mortality is about 9.9%.

Thus, it can be seen that the Parachute major vascular complication is lower than that of TAVR surgery (aortic valve replacement), and the effect of improving systolic and diastolic function is comparable to CRT treatment; the NYHA classification can be reduced, and the walking distance of 6 minutes can be increased.

Second, Myocardial Anchoring device (Revivent Myocardial Anchoring System)

The myocardial anchoring technique is a relatively simple surgical intervention that does not require extracorporeal circulation support. The anterior wall necrotic, non-contractile myocardium is treated by interventional anchoring, restoring the geometry and function of the left ventricle. Compared to conventional surgical ventricular volume reduction, the myocardial anchoring technique is a relatively less invasive procedure, does not require support from extracorporeal circulation, does not require ablation of the necrotic myocardium of the free wall of the left ventricle, does not require sutures and patches, and is relatively less damaging to the left ventricle.

Currently, 2 clinical trials are in progress in Europe, and patients with advanced ischemic cardiomyopathy undergo myocardial anchorage surgery. The survival rates of 30 days, 1 year and 2 years after follow-up observation are respectively 90.7%, 88.7% and 87.1%, and compared with the traditional treatment method, the survival rate of the patients with late-stage heart failure is obviously improved; after surgery, the left ventricular systolic volume index at 2 years, 1 year, and 6 months was significantly improved compared to baseline (median 44.1, 46.7, 49.3, and 68.5, respectively), LVEF and 6 min ambulation distance were both increased, and remained stable for 2 years.

However, the inventor found that the conventional myocardial anchoring device has problems that the anchoring effectiveness and stability need to be improved, and the operation is complicated.

Disclosure of Invention

In view of this, the present invention provides a medical device, which does not require an additional separate structure for tightening and cutting the tightening structure, thereby improving the ease of operation of the medical device by a doctor and reducing the operation time of the surgical device.

According to one aspect of the present invention, there is provided a medical device comprising a first anchor and a second anchor;

the first fixing piece comprises a first part and a second part which are connected, and the first part is used for contacting with a first wall of an implanted object;

the second fixing piece comprises a third part and a fourth part which are connected, the third part is connected with the second part, and the fourth part is used for being in contact with a third wall of the implanted object;

when the third portion is separated from the second portion, the implanted subject is in a first state; the implanted subject is in a second state when the third portion is connected to the second portion.

Optionally, the implant object comprises a cavity, and the cavity volume of the implant object in the second state is smaller than the cavity volume of the implant object in the first state.

Optionally, the medical device further comprises a guiding mechanism, the guiding mechanism penetrates through the first fixing piece and the second fixing piece, and the second fixing piece can move along the guiding mechanism in a direction away from or close to the first fixing piece.

Optionally, the guide mechanism is a guide wire.

Optionally, the medical device further comprises a pushing mechanism for driving the second fixing member to approach the first fixing member.

Optionally, the medical device further comprises a force measuring mechanism for measuring the force to which the second fixture is subjected.

Optionally, the force measuring mechanism is disposed at a distal end of the pushing mechanism, and the distal end of the pushing mechanism is used for being in fit connection with the fourth portion.

Optionally, the third portion is in threaded or snap-fit connection with the second portion.

Optionally, the second portion comprises a groove and the third portion comprises a protruding catch.

Optionally, at least one of the first portion and the second portion is formed by connecting a plurality of rod pieces end to end in sequence.

Optionally, at least one of the third portion and the fourth portion is formed by connecting a plurality of rod pieces end to end in sequence.

Optionally, at least one of the first portion and the second portion is a disc structure.

Optionally, at least one of the third portion and the fourth portion is a disc structure.

Optionally, the first portion comprises an anchoring portion and a flexible structure for contacting the implanted subject; the anchoring portion is rotatably disposed on a pin, and the second portion is connected to the pin by a tubular member.

Optionally, the flexible structure has a large-sized section and a small-sized section, the large-sized section has a cross-sectional dimension larger than that of the small-sized section, and the large-sized section is close to the anchoring portion.

Optionally, the anchor portion is rotated between-90 ° and +90 °.

According to the technical scheme of the invention, the first fixing piece and the second fixing piece in the medical device respectively comprise two connected parts, wherein the first part of the first fixing piece can be contacted with a diaphragm between the right ventricle and the left ventricle, the fourth part of the second fixing piece can be contacted with the outer wall of the left ventricle, the third part of the second fixing piece can be connected with the second part, when the third part is separated from the second part, the heart can be in an unstrained state, and when the third part is connected with the second part, the heart can be in a tightened state. The myocardial tightening structure ensures that the intracardiac tightening is firmer and has higher stability, and the geometric shape and the function of the ventricle can be better recovered.

The second part of the first fixing part is locked with the third part of the second fixing part, so that an additional separate structure of a tightening structure and a truncated tightening structure can be omitted, the intracardiac tightening structure is simpler, a doctor can operate the instrument more easily, and the operation time of the operation is shortened. Moreover, the relative position of the first fixing part and the second fixing part is adjusted by locking the first fixing part and the second fixing part, so that the adjustment range and the adjustment space of the cardiac muscle are larger, and the effectiveness and the stability of intracardiac tightening can be better ensured.

Drawings

The drawings are included to provide a better understanding of the invention and are not to be construed as unduly limiting the invention. Wherein:

FIG. 1a is a schematic view of a first fastener of a medical device according to an embodiment of the invention;

FIG. 1b is a schematic view of a second fastener of a medical device according to an embodiment of the invention;

FIG. 2a is a schematic view of a guidewire disposed within the heart in accordance with one embodiment of the present invention;

FIG. 2b is a schematic representation of an intracardiac implant of a first fixation device and a second fixation device in an unstrained state in accordance with an embodiment of the present invention;

FIG. 2c is a schematic view of the heart in a tightened state after being tightened by the first and second securing members in accordance with one embodiment of the present invention;

FIG. 3a is a schematic view of a first fixing member and a second fixing member being screwed together according to an embodiment of the present invention;

FIG. 3b is a schematic view of the first fixing element and the second fixing element locked together by the elastic ball according to an embodiment of the present invention;

FIG. 3c is a schematic view of the first fixing element and the second fixing element being locked together by the elastic buckle according to an embodiment of the present invention;

FIG. 3d is a schematic view of the first fixing element and the second fixing element being locked together by a buckle according to an embodiment of the present invention;

FIG. 3e is a schematic view of a first portion of a first anchor contacting a diaphragm via a flexible structure, in accordance with one embodiment of the present invention;

FIG. 4a is a schematic view of a first portion of a first fastener according to one embodiment of the invention;

FIG. 4b is a schematic view of a first portion of a first fixing element having a pin according to an embodiment of the present invention;

FIG. 4c is a schematic view of a first portion of a first fixing element for rotation about the axis A of the pin shaft according to one embodiment of the present invention;

FIG. 5a is a schematic view of a first fastener according to an embodiment of the invention;

FIG. 5b is a schematic view of a first fastener of another embodiment of the invention;

FIG. 5c is a schematic view of a first fastener element according to another embodiment of the invention;

FIG. 6a is a schematic view of a second fastener according to an embodiment of the invention;

FIG. 6b is a schematic view of a second fastener according to another embodiment of the invention;

fig. 6c is a schematic view of a second fixing member according to another embodiment of the present invention.

The reference numerals are explained below:

1-first fixing member: 11-first part, 12-second part, 13-tubular member, 14-flexible structure, 111-anchoring part, 112-rotation connecting part, 113-pin shaft, 121-lock hole, 122-inner concave hole, 123-clamp hole, 124-clamp groove, 125-matching part;

2-second fixing piece: 21-third part, 22-fourth part, 23-another tubular member, 211-extending column, 212-elastic ball, 213-elastic buckle, 214-elastic arm, 221-connecting part;

3-guide wire; 4-pushing mechanism, 41-pushing pipe; 5-force measuring mechanism.

Detailed Description

To make the objects, advantages and features of the present invention more apparent, the medical device of the present invention will be described in further detail with reference to the accompanyingdrawings 1 to 6. It is to be noted that the drawings are in a very simplified form and are not to precise scale, which is merely for the purpose of facilitating and distinctly claiming the embodiments of the present invention.

As used in this specification, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise. The term "proximal" generally refers to the end of the corresponding member that is closer to the operator, and "distal" refers to the end of the corresponding member that is further from the operator. As used in this specification, the term "inner" generally refers to an axial direction close to the corresponding member, and the term "outer" generally refers to an axial direction away from the corresponding member.

The medical device provided by the invention is mainly used for fixing cardiac muscle, so that the necrotic anterior wall and the cardiac muscle without contractility are treated by the interventional fixing piece, and the geometric shape and the function of the left ventricle are recovered.

Fig. 1a is a schematic view of a first fixingmember 1 according to an embodiment of the present invention, and fig. 1b is a schematic view of asecond fixing member 2 according to an embodiment of the present invention, and as shown in fig. 1a and fig. 1b, the medical device according to the present embodiment includes the first fixingmember 1 and the second fixingmember 2. Thefirst fixing member 1 includes afirst portion 11 and asecond portion 12 connected to each other. Thesecond attachment member 2 comprises athird portion 21 and afourth portion 22 connected to each other.

The first andsecond portions 11, 12 may be generally i-shaped, and preferably thefirst portion 11 has a cross-sectional dimension greater than the cross-sectional dimension of thesecond portion 12 to facilitate better myocardial contraction. Thefirst part 11 and thesecond part 12 include but are not limited to be integrally formed, and may be assembled together after being separately formed. Thethird portion 21 and thefourth portion 22 may also be generally i-shaped, preferably thethird portion 21 has a smaller cross-sectional dimension than thefourth portion 22 to better tighten the myocardium. Thethird portion 21 and thefourth portion 22 are also, but not limited to, integrally formed, and may be assembled after being separately formed.

Next, referring to fig. 2c, after the medical device of the present embodiment is implanted into the heart, thethird portion 21 of the second fixingmember 2 is finally connected to thesecond portion 12 of the first fixingmember 1, so as to lock the first fixingmember 1 and the second fixingmember 2, thereby completing the adjustment of the geometry and function of the left ventricle.

Thesecond part 12 and thethird part 21 may be shaped to match or adapt to each other, wherein one of the parts may be snapped into the other part, and may be relatively still without external force or without exceeding a limited external force, for example, thesecond part 12 and thethird part 21 may be connected by means of a snap, a groove, or the like. Alternatively, thesecond portion 12 and thethird portion 21 may be connected by fastening means such as screw threads. In practice, however, it is preferred that the connection of thesecond part 12 to thethird part 21 is effected in a manner that is not easily releasable, thereby ensuring the reliability of the intracardiac tightening.

Further, as shown in fig. 3a, thesecond part 12 and thethird part 21 can be fastened by screwing. Specifically, thesecond portion 12 is provided with an internal thread, thethird portion 21 is provided with an external thread, for example, the lockinghole 121 on thesecond portion 12 is provided with an internal thread, and theextension column 211 on thethird portion 21 is provided with an external thread, and theextension column 211 is inserted into thelocking hole 121 to be locked by the internal thread.

In another embodiment, as shown in fig. 3b, thesecond part 12 and thethird part 21 may be locked by a ball-and-socket type snap. More specifically, thesecond portion 12 is provided with an innerconcave hole 122, thethird portion 21 is provided with anelastic ball 212, and the shape of the innerconcave hole 122 can match or adapt to theelastic ball 212.

In another embodiment, as shown in fig. 3c, thesecond part 12 and thethird part 21 may be locked by a resilient buckle. Specifically, thesecond portion 12 is provided with alocking hole 123, thethird portion 21 is provided with anelastic buckle 213, and theelastic buckle 213 is locked in thelocking hole 123 and is locked with thelocking hole 123. In this embodiment, the surface of theelastic buckle 213 is formed with a protrusion along the circumferential direction, which is matched or adapted to the shape of the inner groove in thefastening hole 123.

In another embodiment, as shown in fig. 3d, thesecond part 12 and thethird part 21 can be locked by a snap fit. For example, thesecond portion 12 is provided with alocking slot 124, and thethird portion 21 is provided with aspring arm 214, so that thespring arm 214 can be pressed to insert the protrusion of thespring arm 214 into thelocking slot 124 for locking. In this embodiment, the twoelastic arms 214 are disposed oppositely, and eachelastic arm 214 is integrally formed as a cantilever structure, and a fastening portion is formed thereon, and the fastening portion is inserted into theslot 124 for locking.

It should be understood that thelocking hole 121, theconcave hole 122, the lockinghole 123 or the lockinggroove 124 may be alternatively disposed on thethird portion 21, and thesecond portion 12 is correspondingly alternatively disposed with the extendingcolumn 211, theelastic ball 212, theelastic buckle 213 or theelastic arm 214. Preferably, the lockinghole 121, theconcave hole 122, the lockinghole 123 or thelocking slot 124 are disposed on thesecond portion 12, and theextension column 211, theelastic ball 212, theelastic buckle 213 or theelastic arm 214 is disposed on thethird portion 21, so as to facilitate the connection between thesecond portion 12 and thethird portion 21 for the doctor to operate. However, the present invention is not limited to a specific connection manner of thesecond portion 12 and thethird portion 21, as long as the connection therebetween is not easily detached.

Referring to fig. 2a to 2c for use of the medical device of the present embodiment, fig. 2a is a schematic view of aguide wire 3 disposed in an endocardium provided by an embodiment of the present invention, fig. 2b is a schematic view of an intracardiac implant provided by an embodiment of the present invention, in which a first fixingmember 1 and asecond fixing member 2 are implanted and are in an unstrained state, and fig. 2c is a schematic view of an intracardiac implant provided by an embodiment of the present invention, in which the first fixingmember 1 and the second fixingmember 2 are tightened, in a tightened state, according to the specific process:

first, as shown in fig. 2a, aguide wire 3 is implanted in the heart (shortly, intracardiac) to establish a delivery channel in the heart, which includes the left ventricle LV, the right ventricle RV, and the septum SE (i.e., the diaphragm); theguide wire 3 herein is preferably used as a guiding mechanism of the present embodiment in addition to guiding the delivery sheath to guide the second fixingmember 2 to move along theguide wire 3 toward or away from the first fixingmember 1;

thereafter, as shown in fig. 2b, the delivery sheath (not shown) loaded with the first fixingmember 1 is moved to a designated position along theguide wire 3, and then the delivery sheath is removed to release the first fixingmember 1, after which thefirst portion 11 of the first fixingmember 1 contacts and is fixed to the inner wall of the right ventricle RV at the septum SE, and thesecond portion 12 of the first fixingmember 1 contacts and is preferably fixed to the inner wall of the left ventricle LV at the septum SE, and a portion of theguide wire 3 needs to be at least outside the left ventricle LV and even to protrude out of the body;

continuing to refer to fig. 2b, thesecond fixing element 2 is put in place with thethird portion 21 of thesecond fixing element 2 inside the left ventricle LV and contactable with the inner wall of the left ventricle LV remote from the septum SE, while thefourth portion 22 of saidsecond fixing element 2 is outside the left ventricle LV and in contact with and preferably fixed to the outer wall of the left ventricle LV;

then, operating the second fixingmember 2 to move the whole body along theguide wire 3 to the direction close to the first fixingmember 1 until the second fixingmember 2 moves to the position where thethird portion 21 and thesecond portion 12 need to be connected, and keeping the relative positions of thesecond portion 12 and thethird portion 21 fixed by rotating thethird portion 21 or pushing thethird portion 21 into the clamping groove, so as to obtain the heart structure shown in fig. 2 c; at this time, thesecond portion 12 and thethird portion 21 are locked together, so as to fix the geometry of the left ventricle LV, and thus the function of the left ventricle LV can be improved or even restored; finally, theguide wire 3 is withdrawn.

It is noted that the heart structure in fig. 2c, with the cross-sectional lines omitted, is actually the heart structure (mainly the left ventricle LV) in fig. 2b in a tightened state. Obviously, after adjustment, the left ventricle LV of the present embodiment is transformed from the non-tightened state shown in fig. 2b to the tightened state shown in fig. 2c, and the volume of the left ventricle LV in the tightened state is significantly smaller than that in the non-tightened state.

Furthermore, compared to the conventional technique in which one fixing member is contacted and fixed to the inner wall of the right ventricle RV at the septum SE, and another fixing member is contacted to the outer wall of the left ventricle LV, the medical device of the embodiment of the present invention can tighten the heart more firmly, provide higher stability, and better recover the geometry and function of the ventricle. Particularly, the first fixingpart 1 can be directly connected with thesecond fixing part 2, so that an additional separation structure for tightening and cutting off the tightening structure is omitted, the intracardiac tightening operation can be realized only by means of locking of the first fixingpart 1 and thesecond fixing part 2, the structure is simpler, the intracardiac tightening operation is more convenient, the time of the operation can be saved, and the operation efficiency is improved. Moreover, the relative position of the first fixingpart 1 and thesecond fixing part 2 is adjusted by locking the two fixing parts, so that the range and the adjustment space of intracardiac adjustment are larger, and the effectiveness and the stability of intracardiac tightening are better ensured.

In addition, the medical device of the embodiment uses theguide wire 3 as a guide mechanism, so that the structure of the medical device is simplified, and the use cost of the device is saved. During actual operation, make first mounting 1 and second mounting 2pass seal wire 3 to make second mounting 2 can slide alongseal wire 3, especially when second mounting 2 slides to the direction that is close to first mounting 1 alongseal wire 3, can accurately cooperate with first mounting 1 on theseal wire 3, it is comparatively convenient to tighten up the operation, and the operation accuracy is high moreover, can accomplish the tightening up of cardiac muscle better, with the treatment that the cardiac muscle tightened up is promoted effectively.

Further, the first fixingmember 1 may further include atubular member 13, one end of thetubular member 13 is connected to thefirst portion 11, and the other end is connected to thesecond portion 12, which are not limited to be integrally formed, but may be separately formed. Preferably, one end of saidtubular element 13 is connected to thefirst portion 11 by means of aflexible structure 14. Theflexible structure 14 is flexible, and in practical application, as shown in fig. 3e, thefirst portion 11 can be contacted and fixed with the septum SE through theflexible structure 14, so that the friction force of thefirst portion 11 in contact with the human tissue can be increased, thereby preventing thefirst portion 11 from being pulled off in the tightening process, and simultaneously reducing the trauma to the tissue in the tightening process.

In one embodiment, a portion of the length of theflexible structure 14 is inserted inside the septum SE and another portion of the length is in contact with the side wall of the septum SE inside the right ventricle RV. In other embodiments (not shown), the entire length of theflexible structure 14 is in contact with the side wall of the septum SE in the right ventricle RV (i.e., no substantial structure enters the septum).

Theflexible structure 14 may be embodied not only as flexible in structure, but also in the choice of materials. In this embodiment, theflexible structure 14 may have a large-size section disposed adjacent to thefirst portion 11 and a small-size section disposed adjacent to thetubular body 13, the large-size section having a cross-sectional dimension greater than that of the small-size section.

Further, thesecond portion 12 is preferably of a resilient construction, such as being formed from a shape memory material, or thesecond portion 12 is rotatable relative to thetubular member 13, such that thesecond portion 12 can be loaded into a delivery sheath for delivery.

Further, as shown in fig. 4a to 4c, thefirst portion 11 may include ananchor portion 111 and arotation coupling portion 112. Therotation connecting portion 112 is provided at the bottom of the anchoring portion 111 (the bottom for contacting the inner wall of the right ventricle). Optionally, therotation connection 112 comprises two opposite wings hinged by apin 113, so that the anchoringportion 111 can rotate relative to thetubular member 13, thereby allowing the anchoringportion 111 to be retracted into the delivery sheath in a rotational manner. Further, one end of the connectingtubular member 13 is fixedly connected to thepin shaft 113.

In practice, as shown in fig. 4c, the anchoringportion 111 can be rotated about the axis a of thepin 113, preferably by an angle of between-90 ° and +90 °, which ensures that the anchoringportion 111 is in contact with the body tissue at the appropriate location. Wherein the position of the anchoringportion 111 perpendicular to thetubular member 13 is used as a rotation reference, and the rotation can be further rotated clockwise by 90 °, or counterclockwise by 90 °, and the counterclockwise direction is defined as a negative direction of rotation, and the clockwise direction is defined as a positive direction of rotation.

With continued reference to fig. 2b and 2c, the medical device preferably further comprises a pushingmechanism 4, wherein the pushingmechanism 4 is detachably connectable to thefourth portion 22 of thesecond fastening member 2. Optionally, the pushingmechanism 4 comprises a hollow pushingtube 41, and the distal end of the pushingtube 41 is adapted to cooperate with thefourth portion 22.

The distal end of thepush tube 41 may optionally be detachably connected to thefourth portion 22 by threads, snaps, or the like. In practice, saidguide wire 3 can be extended outside the body through the lumen of thepusher tube 41, in order for the physician to manipulate theguide wire 3 outside the body. However, the pushingtube 41 is not limited to pushing the second fixingmember 2 toward the first fixingmember 1 so that the second fixingmember 2 is close to the first fixingmember 1, and may pull the second fixingmember 2 away from the first fixingmember 1 so that the second fixingmember 2 is away from the first fixingmember 1.

Preferably, the medical device further comprises a force measuring means 5 for measuring the axial force to which thesecond fixing element 2 is subjected, mainly the axial force to which thefourth portion 22 is subjected. Theforce measuring mechanism 5 is preferably disposed at a position on the pushingtube 41 connected to thefourth portion 22, and may be specifically disposed at a distal end of the pushingtube 41 to sense deformation of the distal end, and based on a principle of an acting force and a reaction force, an axial acting force applied to thefourth portion 22 is obtained through the deformation of the distal end of the pushingtube 41, so that a doctor can determine validity and safety of a surgical operation by the axial acting force, for example, judge whether the axial acting force is too large to cause a fixing member to fall off, and the like. Theforce measuring mechanism 5 may be composed of one or more strain gauges, preferably a plurality of strain gauges, and the axial acting force is calculated by taking the average value of the strains measured by all the strain gauges, so that the measurement accuracy can be further improved.

With continued reference to FIG. 1b, thefourth portion 22 of the second fixingmember 2 includes a connectingportion 221 for mating connection with the distal end of the pushingtube 41. The connectingportion 221 is hollow and allows theguide wire 3 to pass through. Furthermore, thefourth portion 22 may be connected to thethird portion 21 by afurther tubular member 23. Similarly, thethird portion 21, the othertubular member 23 and thefourth portion 22 may be integrally formed or may be assembled after being separately formed.

Furthermore, no matter the first fixingpart 1 or thesecond fixing part 2, the first fixing part and the second fixing part are wrapped by a layer of polymer braided fabric, so that not only can the fixing parts be quickly endothelialized, but also the friction force during contact can be increased, and the falling-off is prevented.

Still further, the medical device may comprise a plurality of sets of fixation members, each set comprising afirst fixation member 1 and asecond fixation member 2 cooperating. The multiple groups of fixing pieces are implanted into different positions in the heart in the operation mode, so that the geometric shape of the left ventricle can be better adjusted, and a better operation effect is achieved.

Next, the structure and implementation of the first fixingmember 1 and the second fixingmember 2 will be further described with reference to the accompanying drawings.

In one embodiment, as shown in fig. 5a, at least one of thefirst portion 11 and thesecond portion 12 of the first fixingmember 1 is formed of a rod. The side of thesecond portion 12 away from thefirst portion 11 may be provided with a matchingportion 125, and thelocking hole 121, theconcave hole 122, the lockinghole 123 or the lockinggroove 124 is formed in the matchingportion 125.

In another embodiment, as shown in fig. 5b, at least one of thefirst portion 11 and thesecond portion 12 is formed by connecting a plurality of rods end to end in sequence, including but not limited to three rods in the figure, and may be less than or more than three rods. In another embodiment, as shown in fig. 5c, at least one of the first andsecond portions 11, 12 is a disc structure.

Compared with a single rod piece, the structure of the part, in contact with human tissues, of thefirst fixing piece 1 is designed into a structure of a plurality of rod pieces or discs, so that the contact area can be increased, the friction force is increased, and thefirst fixing piece 1 is ensured not to fall off easily.

Similar to thefirst attachment member 1, in one embodiment, as shown in fig. 6a, at least one of thethird portion 21 and thefourth portion 22 of thesecond attachment member 2 is formed by a rod member. In another embodiment, as shown in fig. 6b, at least one of thethird portion 21 and thefourth portion 22 is formed by connecting a plurality of rods end to end in sequence, including but not limited to three rods in the figure, and may be less than or more than three rods. In another embodiment, as shown in fig. 6c, at least one of thethird portion 21 and thefourth portion 22 is a disc structure.

In a similar way, compared with a single rod piece, the structure of the contact part of thesecond fixing piece 2 and the human tissue is designed into a structure of a plurality of rod pieces or discs, so that the contact area can be increased, the friction force is increased, and thesecond fixing piece 1 is ensured to be not easy to fall off.

The above embodiment describes in detail different structural manners of the first fixingmember 1 and the second fixingmember 2, but it should be understood that the present invention includes but is not limited to the structural forms listed in the above embodiment, and any modifications based on the structural forms provided in the above embodiment are within the scope of the present invention. One skilled in the art can take the contents of the above embodiments to take a counter-measure.

According to the technical scheme of the embodiment of the invention, the first fixing piece and the second fixing piece in the medical device respectively comprise two connected parts, wherein the first part of the first fixing piece can be contacted with the diaphragm between the right ventricle and the left ventricle, the fourth part of the second fixing piece is contacted with the outer wall of the left ventricle, and the third part of the second fixing piece can be connected with the second part, so that the myocardial tightening structure has the advantages of firmer intracardiac tightening, higher stability and better recovery of the geometric shape and the function of the ventricles.

It is worth mentioning that the intracardiac tightening operation is realized by the locking of the second part of the first fixing member and the third part of the second fixing member, an additional separate structure of a tightening structure and a truncated tightening structure can be omitted, the intracardiac tightening structure is simpler, the physician can operate the instrument more easily, and the operation time is shorter. In addition, the relative positions of the first fixing part and the second fixing part are adjusted by locking the first fixing part and the second fixing part, so that the adjustment range and the adjustment space of the cardiac muscle are larger, and the effectiveness and the stability of intracardiac tightening can be better ensured.

The above description is only for the purpose of describing the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention, and any variations and modifications made by those skilled in the art based on the above disclosure are within the scope of the appended claims.

Claims (7)

1. A medical device, comprising:

a first anchor comprising a first portion and a second portion connected, the first portion for contacting a first wall of an implanted subject; and

a second fixture including a third portion and a fourth portion connected, the third portion for connection to the second portion, the fourth portion for contact with a third wall of the implant;

when the third portion is separated from the second portion, the implanted subject is in a first state; when the third portion is connected to the second portion, the implanted article is in a second state;

the medical device further comprises a guide wire, the guide wire penetrates through the first fixing piece and the second fixing piece, the second fixing piece can move along the guide wire in the direction far away from or close to the first fixing piece, and the third portion is in threaded or clamped connection with the second portion.

2. The medical device of claim 1, further comprising a pushing mechanism for driving the second securing member adjacent to the first securing member.

3. The medical device of claim 1, further comprising a force measuring mechanism for measuring a force experienced by the second securing member.

4. The medical device of claim 3, wherein the force measuring mechanism is disposed at a distal end of a pushing mechanism, the distal end of the pushing mechanism being adapted for mating engagement with the fourth portion.

5. The medical device of claim 1, wherein said second portion includes a recess and said third portion includes a protruding catch.

6. The medical device of claim 1, wherein the first portion includes an anchoring portion and a flexible structure for contacting the implanted subject; the anchoring portion is rotatably disposed on a pin, and the second portion is connected to the pin by a tubular member.

7. The medical device of claim 6, wherein the anchor portion has an angle of rotation between-90 ° and +90 °.

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