CN107468347B - Ventricular wall injection auxiliary instrument - Google Patents

Abstract

The invention discloses an auxiliary instrument for ventricular wall injection, which comprises a flexible belt body with a section of length, wherein a plurality of injection positioning holes are arranged on the flexible belt body at intervals. The ventricular wall injection auxiliary instrument can be placed on the outer surface of the heart, and an operator can respectively inject therapeutic substances such as hydrogel and the like into different areas of the ventricular wall through the positioning holes, so that the positioning precision of an injection point is effectively improved, the operation time is shortened, and the pollution of residual pigment in the body of a patient is avoided.

Description

Ventricular wall injection auxiliary instrument

Technical Field

The invention belongs to the field of medical instruments, and relates to a ventricular wall injection auxiliary instrument.

Background

Heart failure, heart failure for short, refers to the syndrome of heart circulatory disorders caused by blood stasis in the venous system and insufficient blood perfusion in the arterial system due to failure of systolic and/or diastolic function of the heart and failure of adequate discharge of venous return blood from the heart. The existing treatment methods, such as traditional drug therapy, auxiliary devices, and heart transplantation, face many difficulties, such as: many patients have recurrent symptoms after traditional drug therapy, cardiac resynchronization therapy is not suitable for all patients and is partially poorly responsive, and donor sources for heart transplantation are very limited.

The implantable hydrogel is a novel heart failure treatment technology, and particularly relates to a technology for opening the chest through a small incision and injecting non-contractile substances such as self-coagulability and biocompatibility hydrogel and the like into the wall of the left ventricle so as to change the geometric mechanism and myocardial tension of the myocardium, reduce the tension of myocardial fibers, improve the oxygen consumption and reconstruction of the myocardium, improve the cardiac function and delay or reverse the heart failure process of a patient with enlarged left ventricle.

The current implantable hydrogel surgery mainly comprises the following steps: a left intercostal incision is made by the surgeon, exposing the heart; confirming that the middle horizontal line of the left ventricle is an injection part, drawing a straight line on the ventricular wall surface of the left ventricle by using a surgical marking pen to be used as a marking line, marking a plurality of injection points by using the marking pen on the upper side and the lower side which are about 1-2 cm away from the marking line and avoid visible blood vessels, wherein the distance between every two injection points is about 1-2 cm, and then respectively injecting hydrogel into the ventricular wall by using a needle through every injection point. In the operation process, in order to reduce the injury to a patient as much as possible, the size of a wound for opening the chest needs to be strictly controlled, and operations such as marking, injection and the like are performed in an incision as small as possible; in the whole operation process, the heart is in a beating state all the time, the operation that a doctor uses a marking pen to mark a marking line and a positioning point on the surface of the heart is difficult, the operation time can be greatly prolonged, and the risk of a patient is increased; and the heart can be exposed to air for a long time, which can cause a large trauma to the patient. Meanwhile, the pigment used for marking can also be diffused and even fall off in the process of heartbeat, so that the injection point of the marking is blurred and even disappears, repeated marking needs to be performed for many times, the operation difficulty is further increased, and the marking precision is influenced. In addition, the marking pigments remain in the body of the patient after falling off, cannot be completely discharged out of the body along with the metabolism of the patient, cause pollution in the body and increase biological risks.

Disclosure of Invention

The invention aims to solve the technical problems that the existing implantable hydrogel surgical operation has long operation time, inconvenient marking operation of an injection point, inaccurate positioning of the injection point, pigment pollution caused by marking and the like, and provides a ventricular wall injection auxiliary instrument which is easy to mark, can effectively improve the positioning accuracy of the injection point and can shorten the operation time.

The technical scheme adopted by the invention for solving the technical problems is as follows:

a ventricular wall injection auxiliary instrument comprises a flexible belt body with a section of length, wherein a plurality of injection positioning holes are formed in the flexible belt body at intervals.

In the ventricular wall injection auxiliary device, the flexible belt body is preferably of a strip-shaped belt structure, and the peripheral corners of the flexible belt body are arc-shaped.

In the ventricular wall injection auxiliary device, the flexible belt body is preferably made of biocompatible materials.

In the ventricular wall injection auxiliary instrument, preferably, the injection positioning holes are arranged on the flexible band body at intervals in one or more rows along the longitudinal direction of the flexible band body.

In the ventricular wall injection auxiliary instrument, preferably, the injection positioning holes are linearly arranged in a line on the flexible belt body along the longitudinal center line of the flexible belt body;

or the injection positioning holes are symmetrically arranged in at least two rows relative to the longitudinal central line of the flexible belt body, and the injection positioning holes are transversely arranged in a straight line or transversely staggered manner.

In the ventricular wall injection auxiliary instrument, a V-shaped included angle is preferably formed by connecting lines of two adjacent rows of injection positioning holes which are transversely staggered, and the included angle ranges from 50 degrees to 70 degrees.

In the ventricular wall injection auxiliary device, the number of the injection positioning holes is preferably 4-16.

In the ventricular wall injection auxiliary instrument, the aperture range of the injection positioning holes is preferably 4-7mm, and the longitudinal distance between adjacent injection positioning holes is preferably 12-18 mm.

In the ventricular wall injection auxiliary device, preferably, a plurality of auxiliary holes are arranged around the injection positioning hole, and the diameter of each auxiliary hole is smaller than that of the injection positioning hole.

In the ventricular wall injection auxiliary device, preferably, each injection positioning hole and the auxiliary holes around the injection positioning hole form a positioning area, the diameter of the smallest enclosing circle of each positioning area is greater than or equal to 4mm, and the smallest enclosing circles of the positioning areas do not intersect with each other. The minimum enclosing circle of the positioning area refers to the circle with the smallest area in the circles which can enclose the injection positioning hole in a certain positioning area and all auxiliary holes around the injection positioning hole.

Aiming at the problems of long operation time, inconvenient injection point marking operation, inaccurate injection point positioning, pigment marking pollution and the like in implantable hydrogel surgical operation, the invention adopts the injection auxiliary instrument with the positioning hole to solve the problems, the injection auxiliary instrument is attached to the middle injection part of the left ventricle, and the injection positioning hole on the flexible belt body is the hydrogel injection point. Compared with the prior art, the method has the following beneficial effects:

(1) the positioning precision of ventricular wall injection is improved;

(2) the operation is simple and convenient, and the operation time is saved;

(3) avoid the pigment pollution used when marking the injection point.

Drawings

The invention will be further described with reference to the accompanying drawings and examples, in which:

fig. 1 is a schematic structural view of a ventricular wall injection assisting apparatus according to a first embodiment of the present invention;

FIG. 2 is a schematic structural diagram of a ventricular wall injection assisting apparatus according to a second embodiment of the present invention;

FIG. 3 is a schematic structural diagram of a ventricular wall injection assisting apparatus according to a third embodiment of the present invention;

FIG. 4 is a schematic structural diagram of a ventricular wall injection assisting apparatus according to a fourth embodiment of the present invention;

fig. 5 is a schematic structural view of a positioning region in the ventricular wall injection assist device according to the fourth embodiment of the present invention.

Detailed Description

For a more clear understanding of the technical features, objects and effects of the present invention, embodiments of the present invention will now be described in detail with reference to the accompanying drawings.

Orientation definition: for convenience of description, a position close to the operator is hereinafter defined as a proximal end, and a position far from the operator is hereinafter defined as a distal end.

The length direction of the flexible belt body is defined as a longitudinal direction, and the direction vertical to the length direction is defined as a transverse direction.

Example one

As shown in fig. 1, a ventricular wall injection auxiliary device comprises a flexible belt body with a length, wherein a plurality ofinjection positioning holes 2 are arranged on the flexible belt body 1 at intervals.

The flexible belt body 1 is a strip-shaped belt structure, and the peripheral corners are arc-shaped. The length and width of the flexible band body 1 are set according to the length and width of the injection site required for the operation. The length is 50-80mm, the width is 15-25mm, and the thickness is 1-2mm, preferably the length is 70mm, the width is 25mm, and the thickness is 1.5 mm. The flexible area body 1 adopts corner all around to be the arc structure, can avoid haring the heart surface, and circular arc radius R is about 4 mm. The flexible band body 1 is made of biocompatible material, such as silicon gel with a hardness of 10A, which does not generate body reaction during operation, and has a hardness capable of adapting to the outer surface structure of the heart and attaching to the heart.

A plurality ofinjection positioning holes 2 are arranged on the flexible belt body 1 at intervals. The number ofinjection positioning holes 2 is related to the size of the heart of the patient, and the number ofinjection positioning holes 2 is generally 4 to 16, preferably 6 to 13. The plurality ofinjection positioning holes 2 are distributed in at least one row on the flexible belt body 1. Generally, theinjection positioning holes 2 are arranged on the flexible tape body 1 at intervals of one or more rows along the longitudinal direction of the flexible tape body 1. In the present embodiment, a row ofinjection positioning holes 2 is provided, and the number of theinjection positioning holes 2 is 6. In order to facilitate the operation and to keep the position of the ventricular wall injection assisting device stable in the operation, theinjection positioning hole 2 is preferably arranged in the middle of the flexible band body 1, that is, theinjection positioning hole 2 is linearly arranged on the flexible band body 1 along the longitudinal center line of the flexible band body 1.

The longitudinal distance between two adjacent pilot holeinjection pilot holes 2 ranges from 12 to 18mm, in this embodiment 15 mm. The reason for so setting up is that, the hydrogel can increase the thickness of ventricular wall rapidly and effectively after injecting in a plurality of regions on the ventricular wall of patient's heart, alleviates heart failure, but the injection point is too intensive, again causes too much damage to patient's heart, consequently, reaches treatment after the hydrogel injection can be guaranteed to 6 injection points of longitudinal separation 15mm, avoids the excessive damage that leads to patient's heart many times injection simultaneously.

The diameter of theinjection positioning hole 2 is greater than or equal to 4 mm. In this embodiment, the diameter of theinjection positioning hole 2 is 5 mm. The reason for this arrangement is that the diameter of the coronary artery distributed in the middle of the left ventricle of the patient to be injected is usually less than 4mm, and when the diameter of theinjection positioning hole 2 is greater than or equal to 4mm, the patient can observe through theinjection positioning hole 2, and avoid the visible blood vessel to complete the injection.

The ventricular wall injection aid of the present embodiment is used as follows:

after the heart is exposed by opening the chest, the middle horizontal position of the left ventricle is confirmed to be an injection position, the flexible belt body 1 of the ventricular wall injection auxiliary instrument is attached to the middle injection position of the left ventricle, and theinjection positioning hole 2 on the flexible belt body 1 is a hydrogel injection point. Avoiding the visible blood vessels, aligning with theinjection positioning hole 2, using an injection needle to approximately penetrate into the left ventricle wall in the direction vertical to the flexible belt body 1, injecting about 0.3ml of implantable hydrogel at each injection point, and withdrawing the flexible belt body 1 after injection.

Compared with the prior art, the ventricular wall injection auxiliary device of the embodiment has at least the following beneficial effects:

(1) the injection precision is improved;

(2) the operation is simple, and the operation time is saved;

(3) avoiding pigment pollution.

Example two

The embodiment is an improvement on the first embodiment. That is, theinjection positioning hole 2 in the first embodiment is changed from one row to: theinjection positioning holes 2 are symmetrically arranged in at least two rows about the longitudinal center line of the flexible tape body 1. The number of rows specifically set is determined according to actual needs, and two rows are generally preferred.

The structure, size, specification and material of the flexible belt body 1 are the same as those of the first embodiment, and a strip belt with the length of 60mm and the width of 30mm can be selected, as shown in fig. 2, the number of the injection positioning holes 2 is two, and each row is provided with 6injection positioning holes 2 and 12 injection positioning holes 2. For the convenience of injection, two rows ofinjection positioning holes 2 are generally arranged in the middle of the flexible belt body 1, and preferably, two rows ofinjection positioning holes 2 are symmetrically arranged along the longitudinal center line, wherein 12injection positioning holes 2 are transversely arranged in a straight line on the flexible belt body 1 (i.e., symmetrically distributed about the longitudinal center line) or transversely staggered about the longitudinal center line. Theinjection positioning holes 2 of the present embodiment are arranged in a straight line transversely along the longitudinal center line on the flexible tape body 1, and all theinjection positioning holes 2 are arranged in a rectangular shape.

The diameter of theinjection positioning hole 2 is 4.5mm, the longitudinal spacing S1 between each two adjacent injection positioning holes 2 is 16mm, and the transverse spacing S2 between two rows of injection positioning holes 2 is 16 mm.

Other structures are the same as those in the first embodiment, and are not described herein again. The operation process also refers to the first embodiment.

In this embodiment, the addition of multiple injection points provides better treatment for patients with greater left ventricular dilation.

EXAMPLE III

The embodiment is an improvement on the basis of the second embodiment. Theinjection positioning holes 2 in the second embodiment are changed from being arranged linearly along the transverse direction of the central line on the flexible belt body 1 to being arranged in a staggered way along the transverse direction of the central line. The staggered arrangement means that oneinjection positioning hole 2 in one row is arranged between two adjacentinjection positioning holes 2 in the other row in the transverse direction, namely the staggered arrangement is angular arrangement, a connecting line between two adjacent rows ofinjection positioning holes 2 in the transverse staggered arrangement forms a V-shaped included angle alpha, and the included angle alpha ranges from 50 degrees to 70 degrees.

As shown in fig. 3, theinjection positioning holes 2 are distributed on the flexible band body 1 in a V-shaped arrangement, the included angle α between the connecting lines of the three injection positioning holes 2 is 64 °, and the staggered arrangement can increase the injection points in the injection region of the heart, thereby having better treatment effect on patients with larger left ventricular dilation degree. In the embodiment, 7 injection positioning points are arranged on the upper row, 6 injection positioning points are arranged on the lower row, and 13 injection positioning points are calculated.

The structure, size, specification and material of the flexible belt body 1 are the same as those of the first embodiment, a strip-shaped belt with the length of 75mm and the width of 20mm can be selected, and the diameter D of theinjection positioning hole 2 is preferably 4.5mm or 4 mm. The longitudinal interval between two adjacentinjection positioning holes 2 in each row is 18mm, and the transverse interval between adjacentinjection positioning holes 2 in two adjacent rows is 16 mm.

The rest of the structure and the operation process refer to the first embodiment, and are not described herein again.

In this embodiment, the addition of multiple injection points provides better treatment for patients with greater left ventricular dilation. The positioning points which are arranged in a staggered mode are more in line with the anatomical structure of the heart, coronary vessels which are longitudinally distributed in the middle of the left ventricle can be avoided, transversely distributed vessels on the surface of the heart can be avoided, the safety is further improved, and the use is more flexible and convenient.

Example four

As shown in fig. 4 and 5, the present embodiment is an improvement on the third embodiment. A plurality of auxiliary holes 3 are provided around theinjection positioning hole 2, and the diameter of the auxiliary holes 3 is smaller than that of theinjection positioning hole 2. The number of auxiliary holes 3 may be 3 to 6, preferably 4 to 6. The auxiliary holes 3 are provided for the purpose of: the doctor can select to inject ininjection locating hole 2 or arbitrary auxiliary hole 3 in the injection region, can avoid visual blood vessel effectively, can let the injection point of aquogel distribute more evenly simultaneously, consequently injection efficiency is higher, and therapeutic effect is better.

Theinjection pilot hole 2 forms apilot region 10 with its surrounding pilot holes 3. The diameter of the smallest enclosing circle of eachpositioning region 10 is greater than or equal to 4mm, and the smallest enclosing circles of the plurality ofpositioning regions 10 do not intersect with each other. The smallest circle surrounding thepositioning region 10 is a circle having the smallest area among circles that can surround the injection positioning hole in acertain positioning region 10 and all the auxiliary holes around the injection positioning hole.

Theinjection positioning hole 2 is used as a main hole, and the auxiliary hole 3 is used as an auxiliary hole to form main and auxiliary matching. Since thepositioning section 10 is composed of theinjection positioning hole 2 and the plurality of auxiliary holes 3, the diameters of the respectiveinjection positioning holes 2 and auxiliary holes 3 are smaller than the diameter of eachinjection positioning hole 2 in embodiment one. As shown in fig. 4 and 5, the diameter of the smallest enclosing circle of thepositioning areas 10 is 7mm, and eachpositioning area 10 is distributed with aninjection positioning hole 2 with the diameter d1 of 2mm, and 6 auxiliary holes 3 with the diameter of 1.6mm are arranged circumferentially around the center of theinjection positioning hole 2. The auxiliary holes 3 are uniformly arranged around theinjection positioning hole 2.

In this embodiment, the operator can select the positioning holes or any auxiliary holes in thepositioning region 10 for injection, which not only can effectively avoid the visible blood vessels, but also can make the injection points of the hydrogel more uniformly distributed, so that the injection efficiency is higher and the treatment effect is better.

It is to be understood that, in addition to the above embodiments, the number ofinjection positioning holes 2 may be smaller than the above embodiments, 4, 5, 7, or the number ofinjection positioning holes 2 may be larger than the above embodiments, for example, 15, 16, etc.

In conclusion, the flexible belt body with the plurality of injection positioning holes is used as the ventricular wall injection auxiliary instrument, so that the positioning precision of ventricular wall injection can be improved, the operation is simple and convenient, and the operation time is saved; and can avoid the pollution caused by residual pigment in the body of the patient.

The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents and improvements made within the spirit and principle of the present invention are intended to be included within the scope of the present invention.

Claims (10)

1. A ventricular wall injection auxiliary instrument is used for implantable hydrogel surgical operation and is characterized by comprising a flexible belt body with a section of length, wherein the hardness of the flexible belt body can adapt to the structure of the outer surface of the heart and is attached to the heart; a plurality of injection positioning holes are formed in the flexible belt body at intervals; the diameter of the injection positioning hole is larger than or equal to 4 mm.

2. The ventricular wall injection aid according to claim 1, wherein the flexible band has an elongated strip-like structure with curved corners.

3. The ventricular wall injection aid of claim 1, wherein the flexible band is made of a biocompatible material.

4. The ventricular wall injection aid of claim 1, wherein the injection positioning holes are spaced one or more rows longitudinally along the flexible band.

5. The ventricular wall injection aid of claim 4, wherein the injection positioning holes are arranged in a line on the flexible band along a longitudinal centerline of the flexible band;

or the injection positioning holes are symmetrically arranged in at least two rows relative to the longitudinal central line of the flexible belt body, and the injection positioning holes are transversely arranged in a straight line or transversely staggered manner.

6. The ventricular wall injection aid according to claim 5, wherein a line connecting two adjacent rows of the injection positioning holes arranged in a staggered manner in the transverse direction forms a V-shaped included angle, and the included angle is 50-70 degrees.

7. The ventricular wall injection aid according to any one of claims 1-6, wherein the number of injection positioning holes is 4-16.

8. The ventricular wall injection aid according to any one of claims 1-6, wherein the diameter of the injection pilot hole is in the range of 4-7mm, and the longitudinal spacing between adjacent injection pilot holes is 12-18 mm.

9. The ventricular wall injection aid according to any one of claims 1-6, wherein a plurality of auxiliary holes are provided around the injection locating hole, the auxiliary holes having a diameter smaller than the diameter of the injection locating hole.

10. The ventricular wall injection aid of claim 9, wherein the injection locating hole and the plurality of auxiliary holes around it form locating areas, each of the locating areas has a diameter of a smallest circle of enclosure greater than or equal to 4mm, and the smallest circles of enclosure of the locating areas do not intersect with each other.

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