SUMMERY OF THE UTILITY MODEL
In view of the above, the present application provides a ventricular aneurysm closure device that overcomes or at least partially solves the above problems.
The embodiment of the present application provides a chamber aneurysm closing means for isolating a chamber aneurysm from a normal chamber wall, the chamber wall near the chamber aneurysm is provided with a predetermined interface, the chamber aneurysm closing means comprises: a lead wire; a guide unit having a hollow cavity for connecting the predetermined interface; and the puncture unit is provided with a puncture needle and a through hole arranged at the near end of the puncture needle, the through hole is used for the lead to pass through, the puncture needle guides the lead to enter the preset interface through the cavity, and then two side walls of the chamber wall near the chamber tumor are punctured, so that two ends of the lead are tightened, and the chamber tumor is isolated from the normal chamber wall.
In an alternative embodiment, the ventricular aneurysm closure device comprises a plurality of puncture elements, wherein at least two puncture elements are used for guiding two ends of the same lead wire successively through two side walls of the ventricular wall near the ventricular aneurysm respectively so as to tighten the two ends of the same lead wire.
In an alternative embodiment, the ventricular aneurysm closure device further comprises a protective element through which the puncture needle guides the lead so that the protective element is affixed to the sidewall when the two ends of the lead are tightened.
In an optional embodiment, the chamber aneurysm enclosure device further comprises two protection units, and when the two ends of the lead are tightened, the two protection units are respectively attached to the two side walls.
In an alternative embodiment, the guide unit comprises: a guide tube; and a protective cover having: an artificial blood vessel positioned at the predetermined interface and configured to receive the guide tube; and a fixing member for fixing the guide tube.
In an alternative embodiment, the fixture includes: the first connecting sleeve is internally provided with a sealing element; the second connecting sleeve is matched and connected with the first connecting sleeve; the first connecting sleeve and the second connecting sleeve are connected with the artificial blood vessel in series.
In an alternative embodiment, the first connecting sleeve and the second connecting sleeve are connected by magnetic fit.
In an alternative embodiment, the guide tube has a one-way valve 50 therein that opens toward the predetermined port for passage of the guidewire and the puncture unit.
In an alternative embodiment, the proximal cavity of the guiding tube is funnel-shaped, and the guiding tube has a bending portion, and the bending degree of the tube body of the bending portion is 60-120 °.
In an alternative embodiment, the inner diameter of the guide tube decreases from the proximal lumen to the distal lumen.
In an alternative embodiment, a slot is provided in the through hole for restraining the lead after the lead passes through the through hole.
In an alternative embodiment, the ventricular aneurysm comprises a ventricular aneurysm formed in the left or right ventricle of the heart.
According to the technical scheme, the wall tumor closing device is simple in structure, easy to manufacture and low in manufacturing cost. In addition, the ventricular aneurysm closing device of this application can be through forming predetermined interface near the ventricular aneurysm, through the accurate location ventricular aneurysm of guide unit guide puncture unit, impale two lateral walls of the ventricular aneurysm near the ventricular aneurysm to tighten up the both ends of lead wire, keep apart ventricular aneurysm and normal ventricular wall, easy operation, the operation wound is light, and the risk is little.
Detailed Description
In order to make those skilled in the art better understand the technical solutions in the embodiments of the present application, the technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are only a part of the embodiments of the present application, but not all embodiments. All other embodiments obtained by a person of ordinary skill in the art based on the embodiments in the present application shall fall within the scope of the protection of the embodiments in the present application.
The term "distal" refers to the end of the ventricular aneurysm closure device that is proximal to the predetermined interface when the device is in use. The term "proximal" refers to the end of the aneurysm closure device that is distal to the predetermined interface when the device is in use. The term "normal ventricular wall" refers to the tissue of the left or right ventricle without the growth of a ventricular aneurysm.
An embodiment of the ventricular aneurysm closure device of the present application is for closing a ventricular aneurysm of a heart. The heart disease is the first killer of human health, after a large area of myocardial infarction of a coronary heart disease patient, ventricular wall expansion, thinning and full-thickness myocardial necrosis occur in an infarct area, the necrotic myocardium is gradually replaced by a fibrous scar ventricular wall, a thin layer of ventricular wall in a lesion area bulges outwards, the heart loses mobility or shows abnormal movement during contraction, and ventricular wall tumor is formed and is commonly found in theleft ventricle 60. Surgical resection of the ventricular aneurysms is the most positive and effective treatment, but the ventricular aneurysms are difficult to operate, high in risk, high in mortality rate and complication rate, and high in requirements on the level of operators and teams thereof. The existing minimally invasive heart ventricular aneurysm operation mode has great operation difficulty and long operation time due to the difficulty in accurate positioning.
The following further describes specific implementations of embodiments of the present application with reference to the drawings of the embodiments of the present application.
Referring to fig. 1-6, in one particular implementation of the present application, awall tumor enclosure 10 is provided for isolating awall tumor 20 from anormal chamber wall 30, the chamber wall in the vicinity of thewall tumor 20 being provided with apredetermined interface 40. The chamber wall in the vicinity of the chamber wall tumor does not define the distance between the nearby chamber wall and the chamber wall tumor, i.e. thepredetermined interface 40 can be positioned as the case may be for different chamber wall tumors. The ventricular aneurysm may be a ventricular aneurysm or the like formed in theleft ventricle 60 or theright ventricle 70 of the heart. In the case of a ventricular aneurysm commonly formed in theleft ventricle 60 of the heart, thepredetermined interface 40 may be provided on the outer sidewall of theleft ventricle 60.
The ventricularaneurysm closure device 10 comprises: alead 101; aguide unit 102 having ahollow cavity 112 for connecting thepredetermined interface 40; and apuncture unit 103, which has apuncture needle 113 and a throughhole 123 disposed at the proximal end of thepuncture needle 113, wherein the throughhole 123 is used for thelead wire 101 to pass through, thepuncture needle 113 guides thelead wire 101 to enter thepredetermined interface 40 through thecavity 112, and then pierces twoside walls 31 of the chamber wall near the ventricular aneurysm, so as to tighten the two ends of thelead wire 101 and isolate the ventricular aneurysm from the normal chamber wall. The ventricularaneurysm closing device 10 can accurately position the ventricular aneurysm region, and is simple to operate, light in operation wound, small in risk and low in cost.
Thelead 101 may be a riveted wire or any other suitable linear body. Theguide unit 102 may be a tubular body. In an embodiment of the present application, the guidingunit 102 includes: aguide tube 122; and aprotective cover 132, theprotective cover 132 having: anartificial blood vessel 1321 positioned at thepredetermined interface 40 and configured to receive theguide tube 122; and afixing piece 1322 for fixing theguide tube 122. Thefixing member 1322 may be configured in a variety of ways, and in an alternative embodiment, thefixing member 1322 may be provided as a hollow collar to facilitate coupling of thefixing member 1322 in series with thevascular prosthesis 1321.
In one embodiment of the present application, thefixing member 1322 includes: afirst connection sleeve 1301, in which a sealing element 1303 is arranged; asecond connection sleeve 1302, which is connected with thefirst connection sleeve 1301 in a matching way; thefirst connection sleeve 1301 and thesecond connection sleeve 1302 are connected in series with theartificial blood vessel 1321. Thus, theguide tube 122 may be inserted into theanchor 1322 and thevascular prosthesis 1321 and contact or enter theright ventricle 70 via thepredetermined interface 40. In an embodiment of the present application, the sealing element 1303 includes agasket 1304 and asilicone body 1305 detachably or fixedly connected, and thegasket 1304 and thesilicone body 1305 may function as a seal. However, the material of the sealing element 1303 is not limited thereto, and may be any other suitable material and structure.
Thefirst connection sleeve 1301 and thesecond connection sleeve 1302 are connected in a magnetic fit manner or in other fit connection manners such as clamping. Thefirst connection sleeve 1301 and thesecond connection sleeve 1302 may be fixedly connected or detachably connected. In an embodiment of the present application, thefirst connection sleeve 1301 is a magnetic ring sleeve wrapped by a silicone sleeve, thesecond connection sleeve 1302 is a steel sleeve formed by magnetic-conductive stainless steel, and the magnetic ring sleeve and the steel sleeve are connected by magnetic matching. In another embodiment of the application, the steel sleeve can be embedded with a magnetic ring, the magnetic pole of the steel sleeve is opposite to that of the magnetic ring sleeve, and magnetic matching connection is realized through opposite attraction.
Theguide tube 122 may be provided with a one-way valve 50 therein that opens toward the intendedport 40 for passage of thelead 101 andpuncture unit 103. Therear cavity 112 of theguide tube 122 is funnel-shaped, and theguide tube 122 has abending portion 1221, and through a lot of experiments performed by the utility model, the position of thepuncture needle 113 piercing theside wall 31 of the chamber wall near the cell tumor can be easily adjusted by adjusting the bendingportion 1221 when the bending degree of the tube body of the bendingportion 1221 is 60-120 °.
The inner diameter of theguide tube 122 from therear end cavity 112 to thefront end cavity 112 may gradually decrease. The structure of the one-way valve 50 can effectively prevent the backflow ejection of blood inside the heart through theguide tube 122.
In one embodiment of the present application, the ventricularaneurysm closure device 10 comprises a plurality of puncturingunits 103, wherein at least two puncturingunits 103 are used for sequentially guiding two ends of thesame guidewire 101 through twosidewalls 31 of the ventricular wall near the ventricular aneurysm, respectively, so as to tighten the two ends of thesame guidewire 101. For example, taking a ventricular aneurysm as an example, if the ventricularaneurysm closure device 10 comprises two puncturingunits 103, the throughhole 123 of one of the puncturingunits 103 passes through thelead 101, one end of thelead 101 is guided through the twoside walls 31 of the ventricular wall near the ventricular aneurysm to the outside of theleft ventricle 60, the throughhole 123 of theother puncturing unit 103 passes through the other end of thelead 101, and the other end of thelead 101 is also guided through the twoside walls 31 of the ventricular wall near the ventricular aneurysm to the outside of theleft ventricle 60, so that the two ends of thelead 101 can be tied together to form a knot on the outside of theleft ventricle 60 to isolate the ventricular aneurysm from the normal ventricular wall alone. This repeated use of more pairs ofpuncture units 103 allows for the formation of multiple knots in the outside of theleft ventricle 60 to more securely isolate the ventricular aneurysm from the normal wall.
In one embodiment of the present application, the ventricularaneurysm closure device 10 further comprises aprotection unit 109, and thepuncture needle 113 guides thelead 101 through theprotection unit 109, so that when the two ends of thelead 101 are tightened, theprotection unit 109 is attached to thesidewall 31. In an alternative embodiment, the cellaneurysm enclosure device 10 comprises twoprotection units 109, and when the two ends of thelead 101 are tightened, the twoprotection units 109 are respectively attached to the twosidewalls 31.
As shown in fig. 1 and 3, when thepuncture needle 113 enters the guidingunit 102, one of the puncture needles 113 guides thelead 101 to pass through one of theprotection units 109, when thepuncture needle 113 passes through the outside of theleft ventricle 60, the lead 101 passes through theother protection unit 109, when theother puncture needle 113 passes through the outside of theleft ventricle 60 as described above, thelead 101 also passes through theother protection unit 109, and then when both ends of thelead 101 are fastened at the outside of theleft ventricle 60, one of theprotection units 109 is attached to the chamber space between theright ventricle 70 and theleft ventricle 60, and theother protection unit 109 is attached to the outside of theleft ventricle 60. The number of theprotection units 109 is not limited to two, andmore protection units 109 may be selected according to the circumstances, for example, the size of theprotection units 109. Theprotection unit 109 may be a biocompatible spacer.
In an embodiment of the present application, a slot is disposed in the throughhole 123 for limiting thelead 101 after the lead 101 passes through the throughhole 123, so as to prevent the lead 101 from sliding off the throughhole 123. The proximal end of thepuncture needle 113 may be provided with a handle to facilitate placement of thepuncture needle 113 into theguide unit 102. The one-way valve 50 may be a 2-4-leaflet valve with the opening facing the predetermined port, and may be made of soft silicone or other available materials.
The present application further provides a ventricularaneurysm closure device 10 as described above, comprising: thelead 101 is passed through the throughhole 123, and thepuncture needle 113 guides thelead 101 through thelumen 112 of theguide unit 102 into thepredetermined port 40, thereby piercing bothside walls 31 of the chamber wall near the aneurysm, thereby tightening both ends of thelead 101 and isolating the aneurysm from the normal chamber wall.
As an example of an operation method, the ventricularaneurysm closing device 10 comprises at least two puncturingunits 103, such that the throughhole 123 of one of the puncturingunits 103 passes through thelead wire 101, one end of thelead wire 101 is guided through bothside walls 31 of the ventricular wall near the ventricular aneurysm to the outside of theleft ventricle 60, and the throughhole 123 of theother puncturing unit 103 passes through the other end of thelead wire 101, and the other end of thelead wire 101 is also guided through bothside walls 31 of the ventricular wall near the ventricular aneurysm to the outside of theleft ventricle 60, whereby both ends of thelead wire 101 can be tied as a knot on the outside of theleft ventricle 60, isolating the ventricular aneurysm from the normal ventricular wall. Theother puncture unit 103 may perform the puncture as described above and may be tied to form a knot on the outside of theleft ventricle 60 as well.
In an alternative embodiment, the ventricularaneurysm enclosure device 10 comprises at least twoprotection units 109, and when the two ends of thelead 101 are tightened, the at least twoprotection units 109 are respectively attached to the twosidewalls 31. Specifically, when thepuncture needle 113 enters the guidingunit 102, one of the puncture needles 113 may guide thelead 101 to pass through one of theprotection units 109, when thepuncture needle 113 passes through the outer side of theleft ventricle 60, thelead 101 may be further guided to pass through theother protection unit 109, when theother puncture needle 113 passes through the outer side of theleft ventricle 60 as described above, thelead 101 may also be guided to pass through theother protection unit 109, and when both ends of thelead 101 are fastened at the outer side of theleft ventricle 60, one of theprotection units 109 may be attached to the chamber space between theright ventricle 70 and theleft ventricle 60, and theother protection unit 109 may be attached to the outer side of theleft ventricle 60. The number of theprotection units 109 is not limited to two, andmore protection units 109 may be selected according to the circumstances, for example, the size of theprotection units 109.
In one embodiment, a section of theartificial blood vessel 1321 is sleeved into thesecond connection sleeve 1302 at one end, and the other end is positioned on a preset interface of the outer wall of theright ventricle 70 of the ventricular aneurysm heart by a suturing technique to establish a passage, the sealing member 1303 of thefirst connection sleeve 1301 is sleeved on the distal end of theguide tube 122, and theguide tube 122 is inserted into thesecond connection sleeve 1302 and theartificial blood vessel 1321, at which time, thesecond connection sleeve 1302 is connected with thefirst connection sleeve 1301 in a matching manner. In another embodiment, thesecond connection sleeve 1302 and thefirst connection sleeve 1301 are automatically attracted closed by magnetism.
As another embodiment of the operation method, a small hole is created on the chest wall of the patient, one end of anartificial blood vessel 1321 is sleeved into a steel sleeve, the other end of the artificial blood vessel is positioned on a preset interface on the outer wall of theright ventricle 70 of the ventricular aneurysm heart through a small incision suturing technology to establish a channel, aguide tube 122 is taken, asilica gel body 1305 of a magnetic ring sleeve is sleeved on the distal end of theguide tube 122, theguide tube 122 is inserted into the steel sleeve and theartificial blood vessel 1321, and at the moment, the magnetic ring sleeve and the steel sleeve are automatically sucked and closed. Under ultrasound guidance, theguide tube 122 is inserted into theright ventricle 70 via a preset interface, against the interventricular septum; taking apuncture needle 113, penetrating a thread head of a riveting thread from the throughhole 123 and clamping the thread head into the clamping groove, penetrating an inner gasket at the thread tail, pinching a needle handle of thepuncture needle 113, inserting thepuncture needle 113 into theguide tube 122 from a middle seam of the one-way valve 50 in the rear cavity of the tube, entering theright ventricle 70, piercing the ventricular septum, passing through theleft ventricle 60, avoiding the ventricular aneurysm region, piercing theside wall 31 of theleft ventricle 60, and inserting an outer gasket; and the thread tail penetrates into the throughhole 123 of theother puncture needle 113 again, the steps are repeated until theother puncture needle 113 punctures theside wall 31 of theleft ventricle 60, theother puncture needle 113 is inserted into the outer gasket, the thread head and the thread tail are drawn out, the riveting thread is tightened, the riveting is tightened, and more pairs of puncture needles 113 are used for further tightening and sealing the ventricular aneurysm through repeated riveting operation for many times, so that the ventricular aneurysm is necrotic.
The cell wall tumour is riveted shut as shown in figure 5 and may be left uncut if the cell wall tumour is not too large, and if cutting is required the effect is as shown in figure 6.
The operation method can accurately position the ventricular aneurysm region, and is simple to operate, light in operation wound, small in risk and low in cost.
Finally, it should be noted that: the above embodiments are only used for illustrating the technical solutions of the embodiments of the present application, and are not limited thereto; although the present application has been described in detail with reference to the foregoing embodiments, it should be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some technical features may be equivalently replaced; and such modifications or substitutions do not depart from the spirit and scope of the corresponding technical solutions in the embodiments of the present application.