JP7025766B2 - Evaluation device before sewing artificial valve annulus - Google Patents

Description

The present invention relates to an evaluation device for evaluating the transplantation effect of an artificial valve annulus before sewing.

In annuloplasty performed as a treatment for mitral regurgitation, it is necessary to evaluate in advance whether the artificial annulus to be implanted in the patient's body is optimal and determine the size of the artificial annulus. .. As an instrument used for evaluation of such an artificial annulus, an instrument in which a plate having an outer peripheral contour similar to the artificial annulus is applied to the annulus of the patient so that the suitability of the size of the artificial annulus can be determined is available. Known as the annulus sizer. An evaluation device has also been proposed in which an annular body is used instead of a plate and the annular body is temporarily fixed to the annulus with a suture thread passed through the annulus (see, for example, Patent Documents 1 and 2).

Japanese Unexamined Patent Publication No. 2008-104472 International Publication No. 2014/142030

The morphology of the mitral valve changes before and after sewing the artificial valve annulus. Since the plate-shaped annulus sizer is simply pressed against the annulus, the artificial annulus cannot be accurately evaluated based on the morphology of the mitral valve after sewing. If the annular body is temporarily fixed to the annulus using sutures as in Patent Documents 1 and 2 described above, the mitral valve can be changed to the post-sewn form to evaluate the artificial annulus. However, there is room for improvement in the method of fixing the artificial annulus using sutures. For example, in the evaluation instrument of Patent Document 1, it is necessary to wind the suture around the protrusion provided on the annular body, and in the evaluation instrument of Patent Document 2, care should be taken so that the covering material for hooking the suture is not torn. It is necessary to fix the equipment. In either case, the surgeon must have appropriate experience to properly fix the instrument, which may be difficult for an inexperienced surgeon to handle.

Therefore, an object of the present invention is to provide a pre-sewn evaluation device for an artificial annulus, which can accurately evaluate an artificial annulus regardless of the experience of the operator at the stage before the artificial annulus is sewn. do.

The pre-sewn evaluation device (1) for the artificial annulus according to one aspect of the present invention is an openable / closable separation portion for passing the suture (11) hung on the annulus (10a) of the patient to the inner peripheral side. (6) is provided at at least one place on the circumference, and the annular body (2) formed so as to exhibit a ring shape imitating an artificial valve annulus by closing the separation portion and the separation portion are closed. It is provided with a holding body (3) that can be fitted to the inner peripheral side of the annular body so that the suture can be sandwiched and held between the annular body and the ring body in the closed state .

In the evaluation instrument of the above aspect, even when a large number of sutures are hung on the annulus of the patient in advance, the sutures can be passed through the inner peripheral side of the annulus by opening the separation portion of the annulus. can. Tension is applied to the suture thread passed through the inner peripheral side of the annulus to tension the suture thread, and the direction of the suture thread is arranged so that the suture thread extends radially from the annulus. By bringing it into close contact with the annulus, the annular body can be closely arranged on the annulus. After passing the suture through the annulus, the retainer is fitted to the inner peripheral side of the annulus while maintaining a tense state so that the suture does not loosen, thereby holding the annulus with the separated portion closed. The annulus can be temporarily fixed to the annulus by sandwiching a suture between the body and the annulus. In this case, the patient's valve is in a deformed state due to the tension of the suture , the annulus is in a state where the separation part is closed, and the annulus in the closed state has a ring shape that resembles an artificial annulus. Therefore, the transplantation effect of the artificial annulus can be accurately evaluated before sewing by testing the suitability of the size of the artificial annulus, the presence or absence of regurgitation, etc. using the annular body. .. The suture was passed from the separation part to the inner peripheral side of the annulus, the direction of the suture was arranged while the suture was tensioned, the annulus was brought into close contact with the annulus , and the holding body was fitted to close the separation part. A relatively simple operation of sandwiching and holding a suture between the annular body and the holding body in the state can transform a valve such as a mitral valve into the same state as after the artificial valve annulus is sewn. Therefore, it is possible to accurately and stably evaluate the artificial valve annulus regardless of the experience of the operator.

In the pre-sewn evaluation instrument of the above aspect, the annular body is divided into a pair of halves (7) by providing the separation portions at two places, and each of the pair of halves is separated . It may be provided at the tip end portion (4b) of the forceps (4) so that the portion can be opened and closed. According to this, it is possible to easily deform the annular body between the open state and the closed state of the separated portion by opening and closing the forceps.

Further, each of the pair of halves may be detachably provided with respect to the tip of the forceps. According to this, when a plurality of annular bodies having different sizes according to the annulus of the patient are prepared in advance, an annular body having a size expected to be suitable for the patient can be appropriately selected and attached to the forceps. .. If the evaluation result is unsuitable, an annular body of different sizes can be attached to the forceps to easily perform re-evaluation.

In the pre-sewing evaluation instrument of the above aspect, the holding body may be provided at the tip end portion of the handle portion (5) having the handle portion (5a) that can be arranged along the forceps. According to this, it is possible to relatively easily fit the holding body to the annular body arranged on the annulus of the patient via the support.

Further, the holding body may be detachably provided with respect to the tip end portion of the handle portion. In this case, the holding body can be easily replaced. Alternatively, the support can be operated as a disposable part while the support is sterilized and reused.

In the above description, reference numerals of the accompanying drawings are added in parentheses to facilitate understanding of the present invention, but the present invention is not limited to the illustrated form.

The perspective view which shows the evaluation instrument which concerns on one embodiment of this invention in the state which the annular body and the holding body are separated. The perspective view which shows the state which combined the annular body and the holding body. The figure which shows the state which the suture thread was hung on the annulus for using the evaluation instrument. The figure which shows how the suture is hung on an annular body. The figure which shows the state of arranging sutures. The figure which shows the state which brought the annular body into contact with an annulus. The figure which shows the state which fitted the holding body.

1 and 2 show a pre-mounting evaluation device for an artificial valve wheel according to an embodiment of the present invention. The evaluation instrument 1 includes an annular body 2 and a holding body 3, a forceps 4 for operating the annular body 2, and a support 5 for operating the holding body 3. The annular body 2 is configured by combining a pair of halves 7 that can be divided by two separation portions 6A and 6B (hereinafter, may be represented by reference numeral 6). By closing the separator 6, the splits 7 are continuous with each other, thereby forming a single closed ring-shaped ring 2.

The annular body 2 is a ring that matches or approximates that of an artificial valve annulus (not shown) that is scheduled to be attached to a patient in a state in which the separation portion 6 is closed (hereinafter referred to as a closed state). It is formed to exhibit a shape. As is well known, as for the artificial valve annulus, a plurality of artificial annulus rings having different sizes are provided according to the patient's annulus, and one artificial annulus suitable for the patient is selected from the artificial annulus rings. Sewn on the annulus. Therefore, as for the annular body 2, a plurality of annular bodies 2 are prepared corresponding to each of the plurality of artificial valve rings having different sizes. Then, an annular body 2 having a size expected to fit the patient is selected and attached to the forceps 4.

In the separation portion 6B located on one side of the annular body 2 (lower side in FIGS. 1 and 2), each divided body 7 is fitted to the respective tip portions 4b of the pair of forceps pieces 4a of the forceps 4. A cylindrical mounting portion 7a that can be matched is provided. The mounting portion 7a is removable from the tip portion 4b of the forceps 4. Thereby, the annular bodies 2 having different sizes can be appropriately selected and attached to the common forceps 4. However, each half-split body 7 may be detachably integrated with each of the forceps pieces 4a of the forceps 4, so that different forceps 4 may be used for each of the annular bodies 2 having different sizes.

The retainer 3 is formed in a single closed ring shape. The shape and size of the holding body 3 are set so as to be substantially in close contact with the inner peripheral side of the annular body 2 in the closed state. The degree of close contact is set so that the suture can be sandwiched between the closed annular body 2 and the holding body 3 with an appropriate force. The force that pinches the suture is, for example, even if a tension of a magnitude that is expected to act when the artificial annulus is sewn to the annulus is applied to the suture, the suture still has the annular body 2 and the holding body 3. It is set to the range that can be held without coming off between.

The size of the holding body 3 may be set according to the size of the inner circumference of the annular body 2. When the appropriate size of the holding body 3 changes depending on the size of the outer circumference of the annular body 2, a plurality of holding bodies 3 may be prepared according to the size of the annular body 2. On the other hand, when the size of the inner circumference of the annular body 2 is different but the size of the inner circumference thereof is the same, or when the difference in the size of the inner circumference of the annular body 2 is within a negligible range from the viewpoint of holding the suture thread 11. The retainer 3 may have a constant size. In the former case, it is necessary to appropriately replace the holding body 3 according to the selection of the annular body 2. In order to enable such replacement, the holding body 3 may also be provided with a mounting portion 3a for the support body 5, and the mounting portion 3a may be provided detachably with respect to the support body 5. If a common retainer 3 can be used regardless of the size of the annular body 2, the retainer 3 may be inseparably integrated with the support 5. However, even if the size of the holder 3 can be made common, the holder 3 can be attached to and detached from the support 5, whereby the support 5 is sterilized and reused, and the holder 3 is disposable. It can also be operated as a part.

The support 5 includes a handle portion 5a extended in a shaft or rod shape, and a knob portion 5b attached to the rear end side of the handle portion 5a. The handle portion 5a can be arranged along the forceps 4. The mounting portion 3a of the holding body 3 is mounted on the tip portion 5c of the handle portion 5a. In the state where the holding body 3 is combined with the annular body 2 (FIG. 2), the handle portion 5a extends beyond the fulcrum portion 4c of the forceps 4 to the vicinity of the claw portion 4e on the finger insertion portion 4d side. The knob portion 5b is located in the vicinity of the claw portion 4e.

The forceps 4 is provided with a holding portion 4f for holding the support 5 in a fixed position so as to be aligned with the fulcrum portion 4c. As an example, the holding portion 4f has a shape to which the handle portion 5a of the support 5 can be fitted. By fitting the handle portion 5a to the holding portion 4f in a state where the holding body 3 is fitted to the annular body 2, the forceps 4 and the support 5 are integrated into the annular body 2 and the holding body as shown in FIG. It is possible to keep the 3 in close contact with each other. At that time, the grip portion 5b is located slightly biased toward the fulcrum portion 4c with respect to the finger insertion portion 4d of the forceps 4. As a result, there is no risk that the support 5 will interfere with the operation of the forceps 4.

Next, an example in which the evaluation instrument 1 is applied to the mitral valve plasty will be described with reference to FIGS. 3 to 7. In order to use the evaluation device 1 of this embodiment, first, various procedures such as artificial chordae tendineae, leaflet resection, and papillary muscle shortening are performed on the mitral valve of the patient as necessary. Then, as shown in FIG. 3, a large number of suture threads 11 (only a part thereof is exemplified in the figure) are hung on the annulus 10a of the mitral valve 10. In this case, the suture thread 11 is hung in the same manner as when the artificial valve annulus is sewn.

Next, as shown in FIG. 4, the annular body 2 is set to a state in which the separating portion 6 is opened (hereinafter referred to as an open state), and the suture thread 11 is placed on the inner peripheral side of the annular body 2 via the separating portion 6. Through. Although FIG. 4 shows how the suture thread 11 is passed from the upper separation portion 6A, it is also possible to pass the suture thread 11 to the inner peripheral side of the annular body 2 via the lower separation portion 6B. .. Further, FIG. 4 shows that the annular body 2 is arranged in the vicinity of the annulus 10a and passed through the suture thread 11, but it is not always necessary to position the annular body 2 in the vicinity of the annulus 10a at this stage.

After passing the suture thread 11, as shown in FIG. 5, the direction of the suture thread 11 is arranged so that the suture thread 11 extends radially from the annulus 10a, and the forceps 4 is operated to separate the separation portion 6. By closing, the annular body 2 is deformed into a closed state. Next, as shown in FIG. 6, tension is applied to the suture thread 11 to make the suture thread 11 tense, and the annular body 2 is brought into close contact with the annulus 10a. As a result, the annular body 2 can be closely arranged on the annulus 10a, and the mitral valve 10 can be deformed in the same manner as when the artificial annulus is attached. After that, as shown in FIG. 7, the holding body 3 is fitted to the inner circumference of the annular body 2 while maintaining the tension state of the suture thread 11 so that the suture thread 11 does not loosen.

By the above procedure, the suture thread 11 is sandwiched and held between the annular body 2 and the holding body 3, and the annular body 2 is brought into close contact with the annulus ring 10a in a state where the tension force of the suture thread 11 is applied to the annulus ring 10a. It can be temporarily fixed in the state. In this case, the mitral valve 10 is in a deformed state in the same manner as when the artificial valve annulus is sewn. Therefore, by determining the suitability of the size of the annular body 2 and further performing a reflux test, it is possible to accurately evaluate the transplantation effect of the artificial valve annulus that is scheduled to be attached to the patient. If the evaluation result is unsuitable, the annular body 2 is removed after removing the holding body 3, the annular body 2 is removed from the forceps 4, and the annular bodies 2 having different sizes are reattached to the forceps 4. After that, the annular body 2 may be fixed on the annulus 10a and the evaluation may be performed again by the same procedure as described above.

As described above, according to the evaluation instrument 1 of the present embodiment, a large number of sutures 11 hung on the annulus 10a are passed from the separation portion 6 of the annular body 2 to the inner peripheral side thereof, and the sutures 11 are used. Since the evaluation can be performed by a relatively simple operation of fitting the holding body 3 in a state where tension is applied while arranging the directions, no special experience is required for using the evaluation instrument 1. Therefore, regardless of the experience of the operator, the evaluation of the artificial valve annulus can be accurately and stably performed.

The present invention is not limited to the above-mentioned forms, and may be carried out in various forms. For example, the operation of the annular body 2 is not limited to the example using the forceps 4. As long as the annular body 2 can be switched between the open state and the closed state, an appropriate tool may be used to operate the annular body 2. The operation of the holder 3 is not limited to the support 5, and an appropriate tool may be used.

In the above embodiment, the annular body 2 is divided into a pair of divided bodies 7 by providing the separating portions 6 at two locations on the circumference of the annular body 2, but the separating portion 6 is in an open state of the annular body 2. It may be provided so that it can be changed between the closed state and the closed state. For example, the separating portion 6 may be provided at one position on the circumference of the annular body 2, and the annular body 2 may be provided with an elastic restoring force that keeps the annular body 2 in a closed state. In that case, when the suture thread 11 is passed through the inner peripheral side of the annular body 2, a force is applied to push the annular body 2 into the open state using an appropriate tool, and the force is removed after the suture thread 11 is passed. Then, the annular body 2 may be restored to the closed state.

The holding body 3 is not limited to the example formed in a single ring shape. Like the annular body 2, the holding body 3 may be formed in a shape that can be opened and closed at at least one separating portion. For example, a separating portion may be provided at one position on the circumference of the holding body 3, and an elastic restoring force in the direction in which the separating portion opens may be applied to the holding body 3. In that case, when the holding body 3 is inserted into the inner circumference of the annular body 2, the holding body 3 is closed, and then the holding body 3 is deformed by an elastic restoring force so as to be in close contact with the annular body 2, and then sutured. It is possible to easily and surely sandwich the thread 11.

In the above embodiment, the holding body 3 is fitted to the inner peripheral side of the annular body 2 so that the suture 11 passed through the inner peripheral side of the annular body 2 is sandwiched between the annular body 2 and the holding body 3. However, in the pre-sewn evaluation device of the present invention, the holding body is not always essential. For example, in the above embodiment, the mitral valve 10 can be held in a deformed state by pressing the forceps 4 against the annulus 10a and pulling the suture 11 to maintain the tension. The holding body 3 may be omitted if such a deformed state can be maintained without fitting the holding body 3.

1 Pre-sewn evaluation instrument 2 Ring body 3 Holder 4 Forceps 5 Support 5a Handle 6A, 6B Separation part 7 Split body 10 Mitral valve 10a Valve ring 11 Suture thread

Claims (5)

An openable / closable separation part for passing the suture thread hung on the patient's annulus to the inner peripheral side is provided at at least one place on the circumference, and the ring imitating the artificial annulus by closing the separation part. An annular body formed to exhibit a shape , and
A holding body that can be fitted to the inner peripheral side of the annular body so that the suture can be sandwiched and held between the annular body and the annular body in which the separation portion is closed.
Pre-sewn evaluation device for artificial valve annulus equipped with. By providing the separation portions at two locations, the annular body is divided into a pair of halves.
The pre-sewn evaluation device according to claim 1, wherein each of the pair of halves is provided at the tip of a forceps so that the separated portion can be opened and closed. The pre-sewn evaluation device according to claim 2, wherein each of the pair of halves is detachably provided with respect to the tip of the forceps. The pre-sewn evaluation device according to claim 2 or 3 , wherein the holding body is provided at the tip end portion of the handle portion of a support having a handle portion that can be arranged along the forceps. The pre-sewn evaluation device according to claim 4 , wherein the holding body is detachably provided with respect to the tip end portion of the handle portion.

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