CN214805070U - Auxiliary system for transapical operation - Google Patents

Abstract

The utility model relates to a through apex of heart operation auxiliary system, it includes conveying system and metal support, and conveying system includes outer tube and ejector pin, and the metal support includes awl cylindric support body and arranges this internal polymer shutoff body of support in, and the metal support is in the outer tube with the state precompression of radial contraction, and the distal end of ejector pin stretches into in the outer tube and with the near-end butt of metal support. The utility model has the advantages that the metal bracket is pre-compressed in the outer sleeve in a radial contraction state, which is beneficial to making the outer sleeve thinner, thereby reducing the size of the apical foramen and reducing the operation wound; the puncture is completed by using the conveying system, a puncture kit is not needed, the operation process is simple and convenient, and the amount of bleeding is small; the fixing ring can not penetrate into the muscle tissue on the end surface of the opening of the apex of the heart, and the damage to the heart is small; the support body is woven by the metal wire is integrative, and the pliability is good, but self-adaptation compression and expansion to better, reach sealed effect more easily.

Description

Auxiliary system for transapical operation

Technical Field

The utility model belongs to the field of medical equipment, concretely relates to transapical operation auxiliary system.

Background

With the continuous improvement of the medical technology level, the cardiac surgery is developing from the original surgery of big chest-opening type to the minimally invasive type. The minimally invasive transvascular surgery is the minimally invasive surgery, but because of the problems of blood vessel problems of patients and insufficient fineness of instruments, a novel surgery mode, namely the minimally invasive transventricular surgery, is developed between the chest-expanding surgery and the minimally invasive vascular surgery. Transapical minimally invasive surgery requires an incision of about 4cm of skin and muscle tissue between two ribs to directly expose the apex of the heart. The operation does not need to saw bones, has small injury to human bodies, has a slightly larger injury than the transvascular injury, but has a short and direct operation path, so that the operation can be simpler.

For example, the transapical aortic valve replacement which is applied more at present can be carried out under the conditions that the heart does not jump continuously and the extracorporeal circulation is not needed to be established, has small wound and quick recovery, and is particularly suitable for the old and the weak patients. In performing such procedures, the valve is first inserted through the apex of the heart and then implanted into the heart through the puncture path. The distance of implantation is only 20 cm-30 cm from the apex of the heart, the distance is greatly shortened, and the operation is more convenient and accurate.

However, transapical procedures require an incision at the apex, followed by suture, puncture, and surgery through the sheath. After operation, the purse is tightened, and the cardiac apex opening is closed through myocardial contraction, so that a patient feels strong pain after the closing mode, even has heavy bleeding and infection, and further has life danger. Meanwhile, the purse-string is difficult to sew at the apex of the heart and is usually done by experienced cardiac surgeons.

CN103052359A discloses an apex closure system, which solves the above problems to some extent, but still has the following disadvantages: 1) the catheter of the delivery device is limited to allow instruments in transapical operation to pass through, so the catheter is relatively thick and penetrates through the sealing material in the stent body, so that the central hole of the sealing material is expanded, the stent body is arranged in the sleeve in an expanded form, so the diameter of the sleeve is relatively large, and the apical hole formed by pre-puncture is required to be large, and the hole diameter is usually about 6.6 mm; 2) the tissue attachment part is in a hook shape and can hook into myocardial tissue around the apical pore, so that the tissue is damaged, and the subsequent taking out of the stent body is difficult; 3) it is not disclosed how to arrange the valve in the center of the apex cordis closing device, and during the second operation, the catheter inserted into the apex cordis closing device has no effective guide to enter the catheter distal end in the heart, which increases the operation difficulty.

SUMMERY OF THE UTILITY MODEL

The utility model aims to solve the technical problem of providing a transapical operation auxiliary system, aiming at overcoming the defects of the closing device of the transapical minimally invasive operation in the prior art.

The utility model provides an above-mentioned technical problem's technical scheme as follows: the utility model provides a through apex cordis operation auxiliary system, its includes conveying system and metal support, conveying system includes outer tube and ejector pin, metal support includes awl cylindric support body and arranges in this internal polymer shutoff body of support, metal support with the state precompression of radial contraction in the outer tube, the distal end of ejector pin stretch into to in the outer tube and with metal support's near-end butt.

On the basis of the technical scheme, the utility model discloses can also do following improvement.

Further, the device also comprises a sheath tube allowing instruments in transapical operation to pass through, and after the metal stent is placed at the designated position of the apical opening, the sheath tube can pass through the center of the polymer blocking body and enter the ventricle.

The advantage of adopting above-mentioned further institutional advancement is, the sheath pipe that the utensil passed through in the operation of allowing the apex cordis just inserts when really needing the operation, is favorable to the outer tube of metal support with radial bigger degree's shrink state indentation, is convenient for reduce the external diameter of outer tube that uses, reaches the effect that reduces apex cordis trompil size.

Furthermore, the far end and the near end of the bracket body are respectively provided with a fixing claw which can pop out and open outwards.

Adopt above-mentioned further institutional advancement's benefit to be, the stationary dog can open and with the terminal surface laminating at the heart point trompil far and near both ends to make the support body obtain effective spacing fixedly in the heart point trompil.

Furthermore, the fixing claws at the far end of the bracket body are firstly outwards opened and then bent towards the indoor direction of the heart to avoid puncturing the myocardial tissue at the far end face of the apical open hole.

Adopt above-mentioned further institutional advancement's benefit to be, the stationary dog does not pierce the cardiac muscle tissue, reduces the damage that the heart received, and the support is more easy to operate when being convenient for to pull down under the special circumstances simultaneously.

Further, the fixed claw of support body distal end comprises a plurality of jack catchs, the support body is arranged apex of heart trompil finger position back in, and is a plurality of the jack catchs is the petal form and outwards opens.

Adopt above-mentioned further institutional advancement's benefit to be, the stationary dog of support body distal end comprises a plurality of claws that are petal form distribution and open, and is fixed effectual, and can guarantee not to form the barb of pricking cardiac muscle tissue, and the centripetal direction extension is favorable to inserting the intracardiac guide of back to the sheath pipe simultaneously.

Furthermore, the polymer blocking body is a cylindrical body formed by splicing a plurality of pieces of polymer strips through matched inner side surfaces, and the outer side wall of the near end of each piece of polymer strip is fixedly connected with the inner side wall of the bracket body.

Adopt above-mentioned further institutional advancement's benefit to be, multivalve polymer strip piece medial surface is pressed close to the concatenation each other and has formed the one-way structure similar to heart valve, and after the operation was accomplished, the sheath pipe was extracted it and can be closed automatically and avoid the intracardiac blood to flow outward through apical foramen opening.

Furthermore, the outer side wall of the far end of each valve of the polymer strip block is fixedly connected with at least one corresponding jaw, the jaw connected with the polymer strip block is firstly outwards opened at the far end of the bracket body, and then is inwards close to the polymer strip block and connected while being bent towards the centripetal chamber.

The advantage of adopting above-mentioned further configuration improvement is that, part of the claws are connected with the outer wall of the far end of the polymer strip block, providing the closing pressure of the compression closure to the inner side, ensuring better blocking effect.

Further, the number of the polymer blocks is smaller than the number of the jaws constituting the fixed jaw.

Adopt above-mentioned further institutional advancement's benefit to be, only some jack catchs are bent back after outwards opening and are connected with polymer strip piece, and another part jack catch does not return and bends, guarantees better spacing fixed effect.

Furthermore, the polymer plugging body is a polymer cylinder, and a through hole capable of being closed by extrusion is formed in the center of the polymer cylinder.

The further structural improvement has the advantages of relatively simple structure and relatively convenient installation and fixation during production.

Further, the stent body is formed by weaving single-strand or multi-strand metal wires or cutting the single-strand or multi-strand metal wires by using laser, and the stent body is a bare stent or a covered stent.

The advantage of adopting above-mentioned further structural improvement is, the distal end of outer tube is the bevel connection form, and the outer tube can be made by similar hard material such as stainless steel or nickel titanium alloy to puncture the apex of heart, and whole is woven by the wire and is formed, and the pliability is better, can accomplish one end and move and the other end is motionless basically, guarantees longer life. It should be noted that, the utility model discloses an outer tube can directly puncture the apex of the heart (the distal end of outer tube need set up to more sharp-pointed bevel form this moment), also can accomplish earlier and send into the outer tube along the apex of the heart trompil after the puncture external member (the outer tube distal end can be bevel form or round mouth form this moment), because metal support is the precompression in the outer tube, the utility model discloses an outer tube is thinner, so above-mentioned two kinds of situations all are superior to prior art (especially the former), can effectively reduce apex of the heart trompil size.

Compared with the prior art, the beneficial effects of the utility model are that:

1) the metal stent is pre-compressed in the outer sleeve in a radially contracted state, compared with the situation that the metal stent is arranged in the outer sleeve in an expanded state in the prior art, the utility model is obviously beneficial to making the outer sleeve thinner, thereby effectively reducing the size of the puncture hole of the apex of the heart, the puncture hole of the apex of the heart in the prior art is usually more than 6.6mm, and the utility model only needs the puncture hole of the apex of the heart to be 2-3mm, has smaller operation wound and effectively improves the condition of heavy bleeding at the apex of the heart;

2) the distal end of the outer sleeve is in an oblique opening shape, so that the outer sleeve can be conveniently inserted into the apical open hole, the outer sleeve can complete puncture at the apical and reach a preset position during operation, a puncture kit or a balloon reaming is not needed, excessive bleeding is avoided, and the wound area is reduced;

3) the fixing ring at the far end of the support body is arranged into a form of firstly stretching outwards and then stretching towards the indoor direction, so that the support body is ensured to have a limiting effect on one hand, and can be effectively fixed at the opening of the cardiac apex, and on the other hand, the support body does not form a barb when stretching towards the indoor direction, so that the support body cannot pierce the muscular tissue of the inner end face of the opening of the cardiac apex, the damage to the heart is small, meanwhile, when the support needs to be detached under special conditions, the support without the barb is easy to pull out, large damage cannot be caused, and in addition, the clamping jaws stretching towards the indoor direction also have a certain effect of guiding the sheath catheter to a specified operation position;

4) when the polymer blocking body is composed of a multi-petal polymer strip block, part of the clamping jaws are firstly opened outwards and then folded back and then can be connected with the outer wall of the far end of the polymer strip block, so that better closing pressure can be provided (the polymer blocking body has better effect of unidirectional conduction towards the heart), and the insertion of a sheath tube can also be effectively guided during the operation;

5) the metal part of the plugging bracket is integrally woven by metal wires, and the structure has the characteristics of self-adaptive compression and expansion and good flexibility, thereby achieving a sealing effect better and more easily.

Drawings

FIG. 1 is a sectional view of a transapical surgery assisting system provided by the present invention;

FIG. 2 is a schematic illustration of the auxiliary system of FIG. 1 after insertion into an apical opening;

FIG. 3 is a schematic view of the auxiliary system of FIG. 1 after the distal fixation claws are spread after insertion into the apical opening;

FIG. 4 is a schematic view of the auxiliary system shown in FIG. 1 after the fixing claws at the distal and proximal ends are opened and the outer cannula is removed after being inserted into the apical opening;

FIG. 5 is a schematic view of a sheath inserted into the proximal end of a metal stent during surgery;

FIG. 6 is a schematic view showing the sheath tube extending into the ventricle through the metal stent during the operation;

FIG. 7 is an isometric view of a metal stent with a polymeric occluding body in the form of a multi-lobed polymeric strip;

FIG. 8 is an isometric view of a metal stent with a polymer occluding body being a polymer cylinder;

FIG. 9 is a schematic view of a stent body (bare stent) woven from wire;

FIG. 10 is a cross-sectional view of a metal stent with a polymeric occluding body comprised of two pieces of polymeric strips;

FIG. 11 is a cross-sectional view taken along A-A of the metal stent of FIG. 10;

FIG. 12 is a cross-sectional view of a metal stent with a polymeric occluding body comprised of three-lobed polymeric strips;

FIG. 13 is a cross-sectional view taken along A-A of the metal stent of FIG. 12;

FIG. 14 is a cross-sectional view of a metal stent with a polymeric occluding body comprised of ten polymeric strips;

fig. 15 is a cross-sectional view of the metal stent of fig. 14 taken along a-a.

In the drawings, the components represented by the respective reference numerals are listed below:

100. an outer sleeve; 101. a top rod; 200. a stent body; 201. a polymeric occluding body; 202. a claw; 300. a sheath tube.

Detailed Description

The principles and features of the present invention will be described with reference to the drawings and the embodiments, which are provided for illustration only and are not intended to limit the scope of the invention.

In the description of the present invention, if terms indicating orientation such as "upper", "lower", "left", "right", "top", "bottom", "inner", "outer", etc. are used, the indicated orientation or positional relationship is based on the orientation or positional relationship shown in the drawings, and is only for convenience of description and simplification of description, but does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus, should not be construed as limiting the present invention.

As shown in fig. 1 to 15, the utility model provides a transapical operation auxiliary system, it includes conveying system and metal support, conveying system includes outer tube 100 and ejector pin 101, metal support includes awl cylindric support body 200 and arranges in polymer shutoff body 201 in the support body 200, metal support with the state precompression of radial contraction in outer tube 100, the distal end of ejector pin 101 stretch into in outer tube 100 and with metal support's near-end butt.

It should be noted that, because the metal bracket is pre-compressed in the outer sleeve in a radially contracted state, when the metal bracket is placed in the apical foramen, and the metal bracket is gradually ejected out from the distal end of the outer sleeve by the ejector rod, the metal bracket can expand to a certain extent, so as to better fit with the wall of the apical foramen, and the polymer plugging body in the metal bracket can also obtain greater pressure from the myocardium of the wall of the foramen, thereby ensuring the closing effect. The tapered cylindrical stent body is thick at the distal end and thin at the proximal end (as shown in fig. 4, 9, 10, 12 and 14), and the tapered cylindrical stent body forms an included angle of less than or equal to 160 degrees, so that better clamping force can be provided, and blood flow cannot flow out.

On the basis of the above embodiment, as shown in fig. 5 and 6, a sheath 300 for allowing the instrument in the transapical operation to pass is further included, and after the metal stent is placed at the designated position of the apical opening, the sheath 300 can pass through the center of the polymer blocking body 201 into the ventricle.

It should be noted that the sheath is used when the patient needs to perform the operation after the metal stent is placed and installed.

On the basis of the above embodiments, as shown in fig. 4 to 10, the distal end and the proximal end of the stent body 200 are respectively provided with a fixing claw capable of popping and expanding outwards.

It should be noted that, when the metal support is pre-compressed in the outer sleeve, the fixing claws at the distal and proximal ends are tightly attached to the inner wall of the outer sleeve as the support body, and when the fixing claws extend out of the outer sleeve, the fixing claws are released to spring outwards and expand, and the expanded fixing claws are tightly abutted to the distal end surface and the proximal end surface of the apical opening respectively, so that the metal support is fixed in the apical opening.

In a preferred embodiment of the present invention, the fixing claws at the distal end of the stent body 200 are first opened outward and then bent toward the heart chamber so as not to pierce the myocardial tissue at the distal end surface of the apical opening.

On the basis of the above embodiment, the fixing claw at the distal end of the stent body 200 is composed of a plurality of claws 202, and after the stent body 200 is placed at the apex cordis opening designated position, the claws 202 are opened outward in a petal shape.

It should be noted that the proximal fixation claw is preferably shaped as shown in fig. 4 to 10, and is not divided into a plurality of claws, but rather is an integral flange which fits over the proximal end face of the apical opening and also does not penetrate into the myocardial tissue, and which fits over the outer edge of the myocardial tissue to reduce its effect on other tissues and avoid injury.

In a preferred embodiment of the present invention, as shown in fig. 7, the polymer blocking body 201 is a cylindrical body formed by splicing multiple pieces of polymer strips through matching inner side surfaces, and each piece of polymer strip is fixedly connected to the outer side wall of the proximal end of the polymer strip and the inner side wall of the stent body 200.

It should be noted that binding connection, glue bonding or other connection modes can be adopted between the interior of the metal bracket and the high molecular polymer, and the high molecular polymer can be made of materials such as TPU, PTFE, terylene and the like.

On the basis of the above embodiment, as shown in fig. 7 and fig. 12-15, the outer side wall of the distal end of each petal of the polymer strip block is fixedly connected with at least one corresponding jaw 202, and the jaw 202 connected with the polymer strip block is firstly opened outwards at the distal end of the stent body 200 and then is connected to be close to the polymer strip block inwards while being bent towards the ventricle.

On the basis of the above embodiment, the number of the polymer blocks is smaller than the number of the jaws 202 constituting the fixed jaw. As shown in fig. 7, there are 10 jaws, 4 of which are connected to the polymer bar.

In another embodiment of the present invention, as shown in fig. 8, the polymer plugging body 201 is a polymer cylinder, and a through hole capable of being closed by extrusion is formed in the center of the polymer cylinder. Wherein the through-holes may be shaped like a quincunx hole as shown in fig. 8.

In the above embodiments, the distal end of the outer sheath 100 is beveled, the stent body 200 is woven from single or multiple wires or cut using a laser, and the stent body 200 is a bare stent (fig. 9) or a stent graft (fig. 7 and 8).

It should be noted that the metal part of the plugging stent is integrally woven by metal wires, and the structure has the characteristic of self-adaptive compression and expansion, so that the sealing effect is better and easier to achieve. For example: when the cardiac surgery is performed through the plugging bracket passage, the plugging bracket can adaptively expand according to the size of the outer diameter of the surgical sheath, and is tightly attached to the surgical sheath, so that the sealing effect in the surgical process is ensured; when the operation sheath tube is withdrawn or the operation is finished, the blocking bracket can shrink in a self-adaptive manner to block blood flow.

The utility model provides a brief introduction of method of using of transapical operation auxiliary system as follows: in use, the outer sleeve 100 is punctured at the apex of the heart, and the outer sleeve 100 is advanced to a predetermined position (as shown in fig. 2) by the imaging device, with the metal stent inside the outer sleeve 100 of the delivery system. After reaching the preset position, the outer catheter 100 is withdrawn and the metal stent (comprising the stent body 200 and the polymer occluding body 201) is gradually released by the ejector rod 101 (as shown in fig. 3). When the metal stent is completely released (as shown in fig. 4), the polymer occluding body 201 in the metal stent is in a closed state, i.e. the cardiac muscle and the compressive force of the metal stent itself to the polymer occluding body make them tightly fit and occlude the puncture. Meanwhile, the two ends of the bracket body 200 are bent, so that the metal bracket is tightly attached to the heart tissue, and the bracket is ensured to be stably fixed at the puncture position. When an operation is needed, the sheath 300 can be passed into the heart from the outside of the metal through the polymer blocking body 201 (as shown in fig. 5), and guided by the fixing claws to reach a designated position, and the relevant operation is performed (as shown in fig. 6). After the operation is completed, the sheath tube 300 is only required to be moved out of the metal bracket, and the metal bracket can be restored to a closed state so as to block the opening and prevent the blood flow from flowing out. The utility model provides a heart apex auxiliary device system can use repeatedly to the operation wound is less, can accomplish a plurality of complicated operations through it.

The above description is only for the preferred embodiment of the present invention, and is not intended to limit the present invention, and any modifications, equivalent replacements, improvements, etc. made within the spirit and principle of the present invention should be included within the protection scope of the present invention.

Claims (10)

1. The transapical surgery auxiliary system is characterized by comprising a conveying system and a metal support, wherein the conveying system comprises an outer sleeve (100) and an ejector rod (101), the metal support comprises a conical cylindrical support body (200) and a polymer plugging body (201) arranged in the support body (200), the metal support is pre-compressed in the outer sleeve (100) in a radially contracted state, and the far end of the ejector rod (101) extends into the outer sleeve (100) and is abutted to the near end of the metal support.

2. The system as claimed in claim 1, further comprising a sheath (300) for allowing the passage of instruments during transapical surgery, wherein the sheath (300) can be passed through the center of the polymer occluding body (201) into the ventricle after the metal stent is placed at the designated position of the apex opening.

3. The system as claimed in claim 1, wherein the distal end and the proximal end of the stent body (200) are respectively provided with fixing claws which can pop open outwards.

4. The system as claimed in claim 3, wherein the fixing claws at the distal end of the stent body (200) are first opened outward and then bent toward the direction of the ventricle so as not to pierce the myocardial tissue at the distal end face of the opening of the apex.

5. The system as claimed in claim 4, wherein the fixing claw at the distal end of the stent body (200) is composed of a plurality of claws (202), and the claws (202) are opened outward in a petaloid shape after the stent body (200) is placed at the designated position of the apex opening.

6. The transapical surgical assistant system according to claim 5, wherein the polymer blocking body (201) is a cylindrical body formed by splicing multiple pieces of polymer strips through matched inner side surfaces, and the outer side wall of the proximal end of each piece of polymer strip is fixedly connected with the inner side wall of the bracket body (200).

7. The transapical surgical assistant system according to claim 6, wherein the outer sidewall of the distal end of each polymeric strip is fixedly connected to at least one corresponding jaw (202), and the jaw (202) connected to the polymeric strip is first opened to the outside at the distal end of the stent body (200) and then is connected to the polymeric strip by being inwardly adjacent to the polymeric strip while being bent toward the inside of the ventricle.

8. A transapical surgical assistant system according to claim 7, wherein the number of the polymer strips is smaller than the number of the jaws (202) constituting the fixed jaw.

9. The system as claimed in claim 5, wherein the polymer blocking body (201) is a polymer cylinder, and a through hole capable of being pressed and closed is formed in the center of the polymer cylinder.

10. The system as claimed in any one of claims 1 to 9, wherein the distal end of the outer sheath (100) is beveled, the outer sheath is made of stainless steel or nitinol to puncture the apex of the heart, the stent body (200) is woven from single or multiple wires or cut using a laser, and the stent body (200) is a bare stent or a covered stent.

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