JP7744177B2 - Medical Devices and Medical Device Systems - Google Patents

Description

The present invention relates to a medical device and a medical device system that includes a long tubular body with an internal lumen.

Medical devices with a long tubular body having an internal cavity are widely used. One example of such a medical device is a suction catheter. A suction catheter has an aspiration lumen as the internal cavity of the tubular body. A connector or other connection part to which a syringe can be connected is provided at the proximal end of the tubular body. When the tubular body is inserted into a living body, the suction catheter aspirates thrombus present near the distal end of the tubular body by suctioning through the aspiration lumen with the syringe. One example of such a medical device is described in Patent Document 1.

Special Publication No. 2004-535885

In order to efficiently aspirate blood clots from within blood vessels, it is effective to increase the diameter of the tubing. However, even if the inner diameter of the tubing is increased, if the inner diameter of the connection part for connecting the syringe is small, blood clots will clog the connection part, preventing sufficient suction. Furthermore, when connecting a pump, suction console, or other device other than a syringe to the tubing, blood clots may similarly clog the connection part.

The present invention has been made to solve the above-mentioned problems, and aims to provide a medical device and medical device system that can ensure a sufficient inner diameter from the tip to the base end even when the diameter of the tubular body is increased.

The medical device of the present invention, which achieves the above-mentioned object, comprises a long tubular body having an inner cavity that communicates from the tip to the base end, a connecting portion provided at the base end of the tubular body and having a base end inner cavity that communicates with the inner cavity of the tubular body, and a valve body provided in the base end inner cavity, wherein the base end inner cavity has an inner diameter equal to or greater than the smallest diameter of the inner cavity, and the base end of the tubular body has an abutment portion against which the tip end of a suction device tubular body inserted from the valve body can abut , the abutment portion having a tapered portion whose inner diameter increases from the tip side to the base end side, the base end of the tapered portion being connected to the connecting portion, and the tapered portion is configured so that the tip of the suction device tubular body is positioned by abutting against its inner surface .

The medical device connecting method of the present invention, which achieves the above-mentioned objective, involves preparing a long tubular body having an inner lumen that communicates from the distal end to the proximal end, selecting a connecting part with an inner diameter equal to or greater than the smallest diameter of the lumen from among connecting parts with a proximal lumen, and connecting the selected connecting part to the proximal end of the tubular body.

In a medical device configured as described above, the proximal lumen of the connection part that connects to the tubular body has an inner diameter equal to or greater than the smallest diameter of the lumen of the tubular body. Therefore, even if the diameter of the tubular body is increased, the inner diameter of the entire medical device is sufficient, and objects passing through the lumen can pass unhindered all the way to the proximal end of the medical device.

1 is a front view showing the overall configuration of a medical device according to an embodiment. FIG. 10 is an enlarged cross-sectional view of the vicinity of a connection portion of a medical device. FIG. 10 is an enlarged cross-sectional view of the medical device with a syringe inserted through the connection portion. FIG. 10 is an enlarged cross-sectional view of the vicinity of a tapered portion when a step is provided in the tapered portion. FIG. 10 is an enlarged cross-sectional view of the medical device when the tubular body is fixed to the inner circumferential surface of the connecting portion. FIG. 10 is an enlarged cross-sectional view of a medical device in which a tapered portion is not provided in the tubular body. FIG. 10 is an enlarged cross-sectional view of a medical device in which a groove is provided in a tapered portion. FIG. 10 is a front view of a medical device system in which a medical device is combined with a second device. FIG. 1 is an enlarged cross-sectional view of the vicinity of a connection portion of a medical device system.

Embodiments of the present invention will be described below with reference to the drawings. Note that the dimensional proportions in the drawings may be exaggerated for the sake of explanation and may differ from the actual proportions. Furthermore, in this specification, the side of the medical device 10 that is inserted into a body cavity will be referred to as the "distal end" or "distal side," and the side that is operated by the operator will be referred to as the "proximal end" or "proximal side."

The medical device 10 of this embodiment is configured as a suction catheter that is inserted into a biological lumen and uses a syringe 15 to aspirate objects such as thrombi present in the biological lumen. Note that the means for suction is not limited to the syringe 15, and may also be a suction bottle, pump, or the like.

As shown in FIG. 1, the medical device 10 has a long tubular body 20 and a connecting portion 30 provided at the proximal end of the tubular body 20. A syringe tubular body 40 of a syringe 15 is inserted into the connecting portion 30.

As shown in FIG. 2, the tubular body 20 has a lumen 21 along its length. Objects within a biological lumen can be aspirated through the lumen 21. The tubular body 20 has a tapered section 22 at its proximal end, whose inner diameter increases from the distal end to the proximal end. The proximal end of the tubular body 20, which has the tapered section 22, forms an abutment section 25 against which the syringe 15, which is a suction device, abuts.

The tube body 20 is preferably made of a material that has a certain degree of flexibility. Examples of such materials include polyolefins such as polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or mixtures of two or more of these; soft polyvinyl chloride resin, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, fluororesins such as polytetrafluoroethylene, polyimide, PEEK, silicone rubber, and latex rubber.

The connection part 30, to which the base end of the tubular body 20 is connected, has a hollow main body part 31 and a pressing part 32 provided at the base end of the main body part 31. The main body part 31 has a cylindrical tip part 33. The base end part 22a of the tubular body 20 is fixed to the connection part 30 so as to cover the outer surface of the tip part 33 of the main body part 31. The pressing part 32 is threadedly engaged with the main body part 31 and can move forward and backward by rotating relative to the main body part 31. The pressing part 32 has an opening 32a, allowing the tubular body to be inserted into the connection part 30.

The connection part 30 has a proximal lumen 34 that communicates with the lumen 21 of the tubular body 20. The proximal lumen 34 extends from the tip of the connection part 30 to the base end. A valve body 35 is disposed in the proximal lumen 34. The valve body 35 has a slit in the center through which a tubular body can be inserted. With the tubular body inserted, the valve body 35 is pressed toward the tip by the pressing part 32, thereby improving sealing performance.

The valve body 35 is made of an elastic material. Examples of materials that can be used to form the valve body 35 include various rubbers such as silicone rubber, fluororubber, isoprene, and natural rubber, various resins such as polyurethane, polyamide elastomer, polybutadiene, and soft polyvinyl chloride, and combinations of two or more of these.

The proximal lumen 34 has an inner diameter greater than the minimum diameter of the lumen 21 of the tubular body 20 over the entire length from the tip to the base. It is sufficient for the proximal lumen 34 to have an inner diameter at least equal to or greater than the minimum diameter of the lumen 21 of the tubular body 20.

As shown in FIG. 3 , the syringe tube 40 can be inserted into the proximal lumen 34 from the proximal end. A large-diameter syringe tube 40 can be used depending on the inner diameter of the proximal lumen 34. The syringe tube 40 passes through the valve body 35 and is positioned in the proximal lumen 34, with its tip abutting the inner surface of the tapered portion 22. In this state, the lumen 21 can be aspirated using the syringe 15. In this way, the tube 20 has a tapered portion 22 whose inner diameter increases toward the proximal end. By abutting the tip of the syringe tube 40 against the tapered portion 22, the difference in height between the lumen 21 and the syringe 15 is reduced, allowing for efficient aspiration.

In this embodiment, the outer diameter of the tubular body 20, excluding the tapered portion 22, is 5.3 mm, and the inner diameter is 4.3 to 4.7 mm. Therefore, the inner diameter of the proximal lumen 34 is set to be at least greater than 4.3 to 4.7 mm. However, the dimensions of the tubular body 20 are not limited to these and can be set as desired.

As shown in FIG. 4, a step 23 may be formed circumferentially on the inner surface of the tapered portion 22. The step 23 is formed so that the tip of the syringe tube 40 can abut against it. This allows the syringe tube 40 to stably abut against the tube 20, enabling more efficient suction.

As shown in FIG. 5, the base end 22a of the tapered portion 22 may be fixed by abutting against the inner circumferential surface of the tip end 33 of the connecting portion 30. In this case, the tip end of the syringe tube 40 can also abut against the tapered portion 22.

As shown in Figure 6, the tubular body 20 may not have a tapered portion. In this case, an expanded diameter portion 41 whose inner diameter increases from the base end toward the tip end is provided at the tip of the syringe tubular body 40, and by positioning the expanded diameter portion 41 in the lumen 21 of the tubular body 20, the lumen 21 and the syringe tubular body 40 can be connected without any steps.

As shown in FIG. 7, a groove 24 may be provided on the inner surface of the tapered portion 22 along the longitudinal direction. One or more grooves 24 may be provided circumferentially. The groove 24 can accommodate the guidewire 18 that passes longitudinally through the lumen 21 and the proximal lumen 34. As a result, even if the tip of the syringe tube 40 abuts against the tapered portion 22 when the guidewire 18 is inserted into the lumen 21, the guidewire 18 is accommodated in the groove 24, preventing a gap from forming between the inner surface of the tapered portion 22 and the syringe tube 40, and preventing a decrease in suction efficiency.

As shown in FIG. 8, the medical device 10 may be used as a medical device system by inserting a second device 11 into the interior. The second device 11 has a small-diameter shaft portion 50 that is longer than the tubular body 20, and a hub 51 is provided at the proximal end of the small-diameter shaft portion 50. A syringe or the like can be connected to the hub 51. As shown in FIG. 9, the small-diameter shaft portion 50 inserted into the medical device 10 passes through the valve body 35 and extends along the proximal lumen portion 34 and the lumen 21.

After suctioning a thrombus or the like with the medical device 10, a contrast agent is injected to determine whether or not a thrombus is present in the biological lumen. A thrombolytic agent may also be injected before suction by the medical device 10 begins. When attempting to inject a liquid into a living body from the tip of the tubular body 20, the proximal lumen 34 and lumen 21 have large volumes. Therefore, if fluid is injected directly from the connection portion 30 of the medical device 10, a large amount of fluid will remain in the proximal lumen 34 and lumen 21. Injecting fluid using the second device 11 allows for a crossover from the tip to the base of the medical device 10, reducing the amount of fluid wasted during injection.

In Figures 8 and 9, the second device 11 is a dilator, but the second device 11 may be any tubular body, such as a small-diameter catheter, that can be inserted into the lumen 21 and the proximal lumen portion 34.

When using a medical device, a connector may be selected to match the inner diameter of the tubular body to be inserted. First, a long tubular body with a lumen that connects from the tip to the base end is prepared. Next, from among the connectors with a base end lumen, a connector with an inner diameter equal to or greater than the smallest diameter of the lumen of the tubular body over the entire length from the tip to the base end is selected. Next, the selected connector is connected to the base end of the tubular body. Once the connector is connected to the tubular body, the tubular body is inserted into the living body and treatment is performed. Any type of connector can be selected as needed.

As described above, the medical device 10 according to this embodiment includes a long tubular body 20 having a lumen 21 that extends from the distal end to the proximal end, a connecting portion 30 provided at the proximal end of the tubular body 20 and having a proximal lumen 34 that communicates with the lumen 21 of the tubular body 20, and a valve body 35 provided in the proximal lumen 34. The proximal lumen 34 has an inner diameter equal to or greater than the minimum diameter of the lumen 21, and the proximal end of the tubular body 20 has an abutment portion 25 that abuts against the distal end of a suction device inserted through the valve body 35. The medical device connecting method according to this embodiment includes preparing a long tubular body 20 having a lumen 21 that extends from the distal end to the proximal end, selecting a connecting portion 30 from the connecting portions 30 that have a proximal lumen 34 and have an inner diameter equal to or greater than the minimum diameter of the lumen 21 of the tubular body 20 throughout its entire length from the distal end to the proximal end, and connecting the selected connecting portion 30 to the proximal end of the tubular body 20. In the medical device 10 and medical device 10 connection method configured in this manner, the proximal lumen 34 of the connection part 30 connected to the tubular body 20 has an inner diameter equal to or greater than the minimum diameter of the lumen 21 of the tubular body 20. Therefore, even if the diameter of the tubular body 20 is increased, the inner diameter of the entire medical device 10 is sufficiently ensured, and objects passing through the lumen 21 can pass unimpeded all the way to the base end of the medical device 10.

The abutment portion 25 may have a tapered portion 22 whose inner diameter increases from the distal end to the proximal end, and the proximal end 22a of the tapered portion 22 may be connected to the connecting portion 30. This allows a tubular body such as a syringe inserted into the proximal lumen to abut against the tapered portion 22, reducing the step from the lumen 21 to the syringe 15 and allowing for efficient suction. The tapered portion 22 may be such that both the inner and outer diameters of the tubular body 20 increase from the distal end to the proximal end, or the outer diameter of the tubular body 20 may be constant along its length, with only the inner diameter increasing from the distal end to the proximal end.

The tapered portion 22 may have a step 23 on its inner surface along the circumferential direction. This allows the tubular body inserted into the proximal lumen to stably abut against the tapered portion, enabling more efficient suction.

The tapered portion 22 may have a groove 24 on its inner surface along the length. This prevents a gap from forming between the inner surface of the tapered portion 22 and the syringe tube 40, even if the tip of the syringe tube 40 abuts against the tapered portion 22 when the guidewire 18 is inserted into the lumen 21, because the guidewire 18 is housed in the groove 24. This prevents a decrease in suction efficiency.

The medical device may further include a second device 11 having a small-diameter shaft portion 50 that is inserted throughout the entire length of the lumen 21 of the tubular body 20 and the proximal lumen 34 of the connecting portion 30. When injecting fluid into a living body, using the second device 11 can prevent fluid from remaining in the large-volume proximal lumen 34, reducing the amount of injected fluid wasted.

The present invention is not limited to the above-described embodiment, and various modifications may be made by those skilled in the art within the technical spirit of the present invention. In the above-described embodiment, the suction device abuts the inner surface of the lumen 21 at the abutment portion 25, but it may also abut the proximal end surface of the tubular body 20.

REFERENCE SIGNS LIST 10 Medical device 11 Second device 15 Syringe 18 Guide wire 20 Tubular body 21 Lumen 22 Tapered portion 22a Base end portion 23 Step portion 24 Groove portion 25 Contact portion 30 Connection portion 31 Main body portion 32 Pressing portion 32a Opening 33 Tip portion 34 Base end lumen portion 35 Valve body 40 Syringe tubular body 41 Enlarged diameter portion 50 Small diameter shaft portion 51 Hub

Claims (4)

a long tubular body having a lumen communicating from the distal end to the proximal end;
a connecting portion provided at a proximal end of the tubular body and having a proximal end lumen portion communicating with the lumen of the tubular body;
a valve body provided in the proximal end lumen portion,
the proximal lumen portion has an inner diameter equal to or greater than the minimum diameter of the lumen,
a proximal end of the tubular body having an abutment portion against which a distal end of the suction device tubular body inserted from the valve body can abut;
The contact portion has a tapered portion whose inner diameter increases from the distal end side to the proximal end side,
a base end of the tapered portion is coupled to the connecting portion,
The medical device is configured such that the tip of the suction device tube is placed against the inner surface of the tapered portion . The medical device according to claim 1 , wherein the tapered portion has a step on the inner surface along the circumferential direction. The medical device of claim 1 , wherein the tapered portion has a groove on the inner surface along the length thereof. A first device which is the medical device according to any one of claims 1 to 3 ;
a second device having a small diameter shaft portion that is inserted through the lumen of the tubular body and the entire length of the proximal lumen of the connecting portion.