Medical device

Abstract

The objective of the present invention is to provide a medical device for cauterizing nerves present outside of blood vessels, said medical device configured such that an energy transfer part and a conducting part disposed in a first shaft of a catheter device can be cooled by a liquid for perfusion during a procedure.　A medical device (10) according to the present invention has a liquid distribution part (50) that enables a liquid (liquid for perfusion) supplied from a port (224) of a second hub (220) of the energy transfer device (200) to be pumped to a leading-end part (111) of a first shaft (110) of the catheter device (100), wherein the energy transfer device can be advanced and retracted relative to the catheter device so that an energy transfer part (210) can be positioned at a prescribed location on the leading-end side of the first shaft.

Description

medical devices

[0001] The present invention relates to medical devices.

[0002] Medical devices are known that radiate energy within biological organs of the human body to treat or improve various diseases. One treatment method using such medical devices is a procedure called nerve ablation, in which nerves located outside blood vessels are cauterized.

[0003] The medical devices used in the above procedures can employ various types of energy to be applied to the treatment site. One example of such a medical device is a catheter device structure that applies thermal energy directly or indirectly to the nerve of the treatment target from near the tip (see, for example, Patent Document 1).

[0004] JP 2017-196461 A

[0005] In the catheter device described in Patent Document 1, energy is emitted from an energy application unit (ultrasound radiation source) while the tip of the catheter is positioned at a predetermined position in a blood vessel. During treatment, the distance between the energy application unit and the inner wall of the blood vessel increases, making it necessary to radiate energy at high power. Furthermore, radiating energy at high power from the energy application unit can cause the energy application unit and the electrical transmission path (conductive unit) located within the catheter to heat up and reach high temperatures. Therefore, the catheter device is required to have a structure for cooling the energy radiation unit using a perfusion fluid.

[0006] The present invention has been made in light of the above-mentioned problems, and aims to provide a medical device for cauterizing nerves located outside a blood vessel, in which an energy application unit and a conductive unit disposed within a first shaft of a catheter device can be cooled by an irrigation liquid during treatment.

[0007] The present invention can be achieved by any one of the following means (1) to (9).

[0008] a catheter device including: a first shaft configured to be insertable into a blood vessel and having one or more openings formed at its tip; and a first hub located at the base end of the first shaft; an energy applying unit configured to apply energy to peripheral nerves running parallel to the blood vessel outside the blood vessel for cauterizing the peripheral nerves; a second hub having an electrical connector for supplying electrical energy to the energy applying unit and a port for supplying a predetermined liquid therein; a long conductive unit connecting the electrical connector and the energy applying unit; and a second shaft extending from the second hub toward the energy applying unit, accommodating at least a portion of the base end of the conductive unit, and being inserted into the first hub; and a liquid circulation unit that allows the liquid supplied from the port to be delivered to the tip end of the first shaft, wherein the energy applying device is movable back and forth relative to the catheter device so as to be able to position the energy applying unit at a predetermined position on the tip end side of the first shaft.

[0009] (2) The medical device according to (1), wherein the liquid circulation portion is a fluid communication passage formed by the port portion of the second hub, an internal space of the second hub, an internal cavity of the second shaft, an internal space of the first hub, and an internal cavity of the first shaft.

[0010] (3) The medical device according to (1) or (2), wherein the second shaft is inserted into the first hub so that the distal end of the second shaft is movable between a first position defined within the first hub and a second position defined on the proximal side within the first hub relative to the first position, and the liquid circulation section is provided in both states where the distal end of the second shaft is located at the first position and where it is located at the second position.

[0011] (4) The medical device according to any one of (1) to (3), wherein the first shaft has a first opening formed at the tip, and a plurality of second openings located closer to the base end than the first opening and opening toward the side of the first shaft.

[0012] (5) The medical device according to (4), wherein the plurality of second openings are open in a direction that does not face an inner wall of the blood vessel when the first shaft is inserted into the blood vessel.

[0013] (6) The medical device according to (5), wherein the distal end of the first shaft has a curved portion having a shape curved with respect to a predetermined first reference axis, and a straight portion located on the proximal end side of the curved portion and extending in an approximately straight line along a second reference axis extending in a direction intersecting the first reference axis.

[0014] (7) The medical device according to (6), wherein the curved portion is a spiral portion that extends spirally around the first reference axis.

[0015] (8) The medical device according to (6) or (7), wherein the first shaft has: a first section provided at a position including the curved section; a second section located more proximal than the first section and having the plurality of second openings formed therein; and a third section located more proximal than the second section and provided at a position including the straight section; and wherein the inner diameters of the second section and the third section are larger than the inner diameter of the first section.

[0016] (9) The medical device according to any one of (1) to (8), wherein the energy applying unit is capable of emitting microwaves or ultrasound as the energy.

[0017] According to the medical device described in (1) above, by emitting energy from an energy application unit disposed within the first shaft of the catheter device, it is possible to cauterize peripheral nerves running parallel to the blood vessel outside the blood vessel. Furthermore, the medical device described in (1) above has a liquid circulation unit that allows a liquid (perfusion liquid) supplied from a port portion of the second hub of the energy application device to be delivered to the distal end of the first shaft. Therefore, the surgeon can cool the energy application unit and the conductive unit disposed within the first shaft of the catheter device with the perfusion liquid during the procedure.

[0018] 6A-6C are cross-sectional views of a portion indicated by a broken line 2A in FIG. 1; a portion indicated by a broken line 3A in FIG. 1; a portion indicated by a broken line 4A in FIG. 1; a perspective view showing an enlarged view of a part of a first shaft; a perspective view showing an enlarged view of the vicinity of the distal end of the first shaft; a partial cross-sectional view of the vicinity of the distal end of the first shaft; a cross-sectional view (transverse cross-sectional view) of a portion indicated by arrows 8A-8A in FIG. 6; a cross-sectional view (transverse cross-sectional view) of a portion indicated by arrows 9A-9A in FIG. 6; a cross-sectional view of an inserter provided in the medical device; a drawing for explaining an example of use of an inserter provided in the medical device; a schematic cross-sectional view (longitudinal cross-sectional view along the extension direction of a blood vessel) for explaining an example of use of a medical device; a cross-sectional view (transverse cross-sectional view) of a portion indicated by arrows 13A-13A in FIG.

[0019] Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. Note that the following description does not limit the technical scope or the meaning of terms described in the claims. Also, the dimensional proportions in the drawings are exaggerated for the convenience of explanation and may differ from the actual proportions. Also, the numerical range "X to Y" shown in this specification means "greater than or equal to X and less than or equal to Y."

[0020] 1 to 11 are diagrams illustrating the components of a medical device 10 according to an embodiment. Figures 12 and 13 are diagrams illustrating an example of use of the medical device 10. Note that Fig. 12 is a longitudinal cross-sectional view along the extension direction of a blood vessel V to be treated, and Fig. 13 is a transverse cross-sectional view of the blood vessel V to be treated (a transverse cross-sectional view of the portion indicated by arrow 13A-13A in Fig. 12).

[0021] 12 and 13 , in a procedure using the medical device 10, the surgeon (a medical professional such as a doctor) can enhance intestinal peristalsis by performing a procedure to reduce autonomic nerve activity within a blood vessel V having peripheral nerves (extravascular nerves) Na that innervate the patient's intestinal tract. By performing such a procedure, the surgeon can promote the relief of at least one of the symptoms of abdominal bloating, abdominal pain, perineal discomfort, and frequent bowel movements caused by the patient's constipation and / or abnormal intestinal peristalsis (relief of the patient's constipation and / or at least one of the symptoms caused by abnormal intestinal peristalsis).

[0022] The blood vessel V to which the treatment method is applied is not particularly limited as long as it is possible to enhance peristalsis of the patient's intestinal tract by performing a predetermined treatment according to the embodiment (e.g., denervation by applying energy). As an example, at least one of the superior mesenteric artery Va, the celiac trunk, and the inferior mesenteric artery can be suitably selected as the blood vessel V. In particular, from the viewpoint of more effectively enhancing peristalsis of the intestinal tract after treatment, the superior mesenteric artery Va can be selected as the blood vessel V. In this embodiment, an example of performing treatment on the superior mesenteric artery Va will be described (see FIGS. 12 and 13 ).

[0023] In a treatment according to the embodiment, the surgeon applies energy to one peripheral nerve Na (or multiple peripheral nerves) that runs parallel to the blood vessel V outside the blood vessel V. By applying energy to the peripheral nerve Na to damage the peripheral nerve Na, the surgeon completely or partially blocks autonomic nerve transmission to the digestive tract by the peripheral nerve Na. By performing such a treatment, the surgeon can enhance peristalsis of the intestinal tract.

[0024] The following mechanism is thought to be the reason why the peristaltic movement of the intestinal tract is activated by performing the above-mentioned treatment.

[0025] When the peripheral nerve Na is damaged by the energy irradiated from within the blood vessel V and the autonomic nerve transmission to the gastrointestinal tract by the peripheral nerve Na is completely or partially blocked, the sympathetic nervous system is relatively weakened between the sympathetic and parasympathetic nervous systems, resulting in parasympathetic dominance. Furthermore, by blocking central nerve transmission, the enteric nervous system, which autonomously controls intestinal motility in the periphery, becomes dominant, activating intestinal peristalsis. Furthermore, activation of intestinal peristalsis promotes and normalizes colonic transit time, thereby promoting the relief of at least one of the symptoms of abdominal distension, abdominal pain, perineal discomfort, and frequent bowel movements caused by constipation and / or abnormal intestinal peristalsis.

[0026] In particular, the treatment method according to this embodiment can effectively alleviate the symptoms of delayed colonic transit time constipation, a type of functional constipation in which there is no organic abnormality in the colon, and in which constipation occurs due to a decrease in intestinal peristalsis in the large intestine, resulting in a delay in the transit time of stool.

[0027] The treatment target site S (a region including one or more peripheral nerves Na shown in FIG. 13 ) for treatment using the medical device 10 is not particularly limited as long as it can enhance peristaltic movement of the intestinal tract. For example, within a blood vessel V, treatment may be performed on any range (site) in the running direction (extension direction) of the blood vessel V, or on any range (site) in the circumferential direction (circumferential direction of the cross section) of the blood vessel V. Furthermore, treatment may be performed multiple times on multiple arbitrary locations of the same blood vessel V, or on multiple arbitrary locations of multiple different blood vessels V.

[0028] In this embodiment, a treatment method will be described in which the superior mesenteric artery Va is the blood vessel V to be treated, as described above.

[0029] The treatment method includes performing treatment on the vicinity of the origin of the superior mesenteric artery Va. Specifically, the treatment target site S preferably includes, for example, a range of 0 mm to 20 mm along the extension direction of the superior mesenteric artery Va, based on the opening of the superior mesenteric artery Va (the opening connecting to the aorta). By applying energy within the above range of the superior mesenteric artery Va, it is possible to effectively suppress transmission of energy to organs (e.g., the pancreas and duodenum) located peripherally of the superior mesenteric artery Va.

[0030] Furthermore, from the viewpoint of more reliably suppressing the transmission of energy to organs located on the peripheral side of the superior mesenteric artery Va, it is even more preferable that the application of energy from the superior mesenteric artery Va be carried out, for example, only within a range of 0 mm to 20 mm along the extension direction of the superior mesenteric artery Va.

[0031] The depth of energy applied from the energy application unit 210 disposed in the superior mesenteric artery Va toward the outside of the blood vessel V preferably includes, for example, a range of 1 mm to 6 mm from the intima of the superior mesenteric artery Va. The peripheral nerves Na present on the outside of the superior mesenteric artery Va are present at a relatively deep position around the origin of the superior mesenteric artery Va. More specifically, the peripheral nerves Na are present in bundles supported by connective tissue in the fatty tissue outside the superior mesenteric artery Va. Therefore, when applying energy from around the origin of the superior mesenteric artery Va, the peripheral nerves Na of the superior mesenteric artery Va can be efficiently denervated by allowing the energy to reach a position 1 mm to 6 mm into the intima of the superior mesenteric artery Va.

[0032] Next, the medical device 10 according to this embodiment will be described.

[0033] <Medical Device 10 > As shown in FIGS. 1 to 4, the medical device 10 includes a catheter device 100, an energy application device 200, and a fluid distribution section 50.

[0034] As shown in Figures 1 to 4, 12, and 13, the catheter device 100 is configured to be insertable into a blood vessel V and comprises a first shaft 110 having one or more openings 112a, 112b formed at a tip end 111, and a first hub 120 disposed at a base end 113 of the first shaft 110.

[0035] The energy application device 200 also includes an energy application unit 210 configured to apply energy to a peripheral nerve Na running parallel to the blood vessel V outside the blood vessel V in order to cauterize the peripheral nerve Na; a second hub 220 in which an electrical connector unit 240 is arranged to supply electrical energy to the energy application unit 210 and which is equipped with a port unit 224 for supplying a predetermined liquid therein; a long conductive unit 260 connecting the electrical connector unit 240 and the energy application unit 210; and a second shaft 230 extending from the second hub 220 toward the energy application unit 210, accommodating at least a portion of the base end side of the conductive unit 260, and being inserted into the first hub 120.

[0036] In the description of this specification, the side of the first shaft 110 of the catheter device 100 that is inserted into the blood vessel V (the side indicated by arrow X1) is defined as the distal side, and the side on which the second hub 220 of the energy application device 200, located opposite the distal side (the side indicated by arrow X2), is positioned is defined as the proximal side.

[0037] <Catheter Device 100> As shown in Figs. 1, 2 and 7, the first shaft 110 included in the catheter device 100 can be configured as a tubular member having an inner lumen 115 formed therein.

[0038] As shown in Figures 5, 6, and 7, the first shaft 110 has a first opening 112a formed at the tip, and a plurality of second openings (side holes) 112b located closer to the base end than the first opening 112a and opening toward the side of the first shaft 110.

[0039] The catheter device 100 can supply the contrast medium to the lumen 115 of the first shaft 110 through the port portion 124 of the first hub 120. The contrast medium supplied to the lumen 115 of the first shaft 110 can be discharged to the outside of the first shaft 110 through the plurality of second openings 112b and the first openings 112a.

[0040] The energy application device 200 can supply liquid (e.g., saline) to the lumen 235 of the second shaft 230 via the port portion 224 of the second hub 220. As will be described later, the lumen 235 of the second shaft 230 is in communication with the lumen 115 of the first shaft 110 via the first hub 120. Therefore, the liquid supplied via the port portion 224 of the second hub 220 is delivered to the lumen 115 of the first shaft 110 and can be ejected to the outside of the first shaft 110 via the multiple second openings 112b and the first openings 112a of the first shaft 110.

[0041] 6 and 7 , the first shaft 110 has a distal tip 140 made of a flexible resin material. The distal tip 140 has a first opening 112a that communicates with the inner cavity 115 of the first shaft 110. The first opening 112a forms a distal opening facing the distal side of the first shaft 110.

[0042] It should be noted that the first shaft 110 does not necessarily have to include the distal tip 140. When the first shaft 110 does not include the distal tip 140, the first opening 112a can be configured as an opening provided at the distal end of the first shaft 110.

[0043] As shown in Figure 6, the tip portion 111 of the first shaft 110 has a curved portion 116 having a shape curved with respect to a predetermined first reference axis A1, and a straight portion 118 located on the base end side of the curved portion 116 and extending in an approximately straight line along a second reference axis A2 extending in a direction intersecting the first reference axis A1.

[0044] The first shaft 110 includes the curved portion 116, and thus when the distal end portion 111 of the first shaft 110 is inserted into the blood vessel V, the distal end portion 111 of the first shaft 110 can be positioned so that at least a portion of the distal end portion 111 of the first shaft 110 abuts against the inner wall Vi of the blood vessel V (see FIGS. 12 and 13 ). With at least a portion of the distal end portion 111 of the first shaft 110 abutting against the inner wall Vi of the blood vessel V, the surgeon can radiate energy from the energy application unit 210 disposed in the lumen 115 of the distal end portion 111 of the first shaft 110, thereby efficiently transmitting energy to the surrounding nerve Na located outside the blood vessel V.

[0045] Furthermore, the first shaft 110 has a straight portion 118 that is positioned closer to the proximal end than the curved portion 116, and thus when the first shaft 110 is inserted into the blood vessel V, the first shaft 110 can be positioned so that a position closer to the proximal end than the curved portion 116 abuts against the upper end of the blood vessel V (for example, the upper end around the origin connecting the aorta to the superior mesenteric artery Va). By positioning the straight portion 118 of the first shaft 110 so that it abuts against the inner wall Vi of the blood vessel V, the surgeon can firmly support the first shaft 110 against the blood vessel V by the straight portion 118, and can prevent the curved portion 116 from shifting position.

[0046] As shown in FIG. 6, the curved portion 116 can be configured, for example, by a spiral portion 117 that extends spirally around the first reference axis A1.

[0047] In the catheter device 100, the bending section 116 is configured with the helical section 117. Therefore, when the first shaft 110 is inserted into the blood vessel V, the helical section 117 extends helically within the blood vessel V and abuts in a continuous manner over a predetermined range of the inner wall Vi of the blood vessel V. Therefore, as shown in FIG. 12 , the portion where the helical section 117 is formed can be continuously abutted against the inner wall Vi of the blood vessel V. This allows the catheter device 100 to position the energy application unit 210 at any position in the extension direction and circumferential direction of the blood vessel V within the range where the helical section 117 is formed. Therefore, energy can be easily and efficiently applied to the peripheral nerve Na from a position close to the inner wall Vi of the blood vessel V.

[0048] The specific shape of the spiral portion 117 (e.g., the pitch of the spiral, the number of turns, the outer diameter of the spiral, the winding direction of the spiral, etc.) is not particularly limited, as long as any point of the spiral portion 117 can be abutted against the inner wall Vi of the blood vessel V when the first shaft 110 is placed inside the blood vessel V.

[0049] Furthermore, the bending portion 116 need only be capable of bringing at least a portion of the distal end portion 111 of the first shaft 110 into contact with the inner wall Vi of the blood vessel V, and is not limited to a shape such as the spiral portion 117. The bending portion 116 can also be configured to have, for example, a zigzag curved shape about the first reference axis A1, a circular shape, an elliptical shape, a rectangular shape, or the like that intersects with the first reference axis A1, or a U-shape that is folded back from the distal end to the proximal end.

[0050] 12, the second openings 112b are open in a direction that does not face the inner wall Vi of the blood vessel V when the first shaft 110 is inserted into the blood vessel V. The opening direction of the second openings 112b can be defined as a direction facing inward, where the first reference axis A1, which is the reference for the spiral shape of the spiral portion 117, is located (see FIG. 6).

[0051] The plurality of second openings 112b are arranged in a second portion 119b located on the proximal end side of the spiral portion 117. In this embodiment, each second opening 112b is configured as a circular hole. Three second openings 112b are arranged at predetermined intervals so that they are located at different positions in the extension direction of the first shaft 110. The opening area of ​​each second opening 112b is configured to be smaller than the opening area of ​​the first opening 112a.

[0052] Each of the plurality of second openings 112b is open in a direction that does not face the inner wall Vi of the blood vessel V, and therefore, when the first shaft 110 is inserted into the blood vessel V, the second openings 112b can be prevented from being blocked by the inner wall Vi of the blood vessel V. Furthermore, the plurality of second openings 112b are arranged at predetermined positions that are further away from the base end than the first opening 112a located at the tip of the first shaft 110. Therefore, even when the tip side of the first shaft 110 is inserted into the blood vessel V to a location where the cross-sectional area is narrowed at the back side, the proximal portion of the blood vessel V can be imaged by ejecting contrast medium from each of the second openings 112b.

[0053] The number, arrangement, shape, opening area, etc. of second openings 112b are not particularly limited as long as the contrast medium can be ejected from a position closer to the proximal end than first openings 112a.

[0054] As shown in Figures 5, 6, and 7, the first shaft 110 has a first portion 119a located at a position including the curved portion 116, a second portion 119b located closer to the base end than the first portion 119a and having a plurality of second openings 112b formed therein, and a third portion 119c located closer to the base end than the second portion 119b and including the straight portion 118.

[0055] 8 and 9, the inner diameter d2 of the second portion 119b and the third portion 119c can be formed to be larger than the inner diameter d1 of the first portion 119a. Note that while Fig. 9 shows an orthogonal cross section of the second portion 119b, in this embodiment, the third portion 119c is also configured to have substantially the same cross-sectional shape (inner diameter d2, etc.) as the second portion 119b.

[0056] The first shaft 110 has a relatively small inner diameter of the first section 119a, which is provided in a predetermined range from the distal end to the proximal end of the first shaft 110. This prevents the energy application unit 210 from being positioned at a position radially outwardly offset from the center position on an orthogonal cross section of the lumen 115 at a location corresponding to the first section 119a. For example, if the energy application unit 210 is positioned at a position significantly offset radially outward from the center position during treatment, this may result in a bias in the intensity distribution of the energy radiated from the energy application unit 210 or a resonance shift (if the energy application unit 210 is configured as an antenna element). The first shaft 110 including the first section 119a can prevent the above-mentioned problems from occurring.

[0057] Furthermore, first shaft 110 has a relatively large inner diameter at second section 119b and third section 119c, which are located closer to the proximal end than first section 119a, and therefore a large clearance can be ensured in lumen 115 at the locations corresponding to sections 119b and 119c. This allows the contrast medium and perfusion liquid to flow smoothly through sections 119b and 119c, and allows the contrast medium and perfusion liquid to be more reliably discharged from second opening 112b formed in second section 119b.

[0058] 8 and 9, the portion corresponding to the first portion 119a of the first shaft 110 can be formed with a thinner tube wall thickness than the portions corresponding to the second portion 119b and the third portion 119c of the first shaft 110. This allows the first shaft 110 to be configured such that the inner diameter d2 of each of the portions 119b and 119c is larger than the inner diameter d1 of the first portion 119a.

[0059] The first portion 119a can be configured to have higher flexibility than the second portion 119b and the third portion 119c. This configuration allows the first shaft 110 to have high flexibility at the first portion 119a where the curved portion 116 is formed, and high rigidity at the portions 119b and 119c located proximal to the first portion 119a. This prevents the curved portion 116, at least a portion of which abuts against the inner wall Vi of the blood vessel V, from damaging the inner wall Vi of the blood vessel V, while providing the first shaft 110 with high support force capable of supporting the abutment of the curved portion 116 against the inner wall Vi of the blood vessel V at the portions 119b and 119c proximal to the curved portion 116. The degree of flexibility can be adjusted, for example, by changing the materials used to form the portions 119a, 119b, and 119c of the first shaft 110.

[0060] As shown in FIG. 6 , a portion of the distal end of second section 119b can be configured to have a predetermined curved shape between straight section 118 and curved section 116. This portion can also be configured to have a curved shape with a larger radius of curvature than spiral section 117, for example. By having a portion of second section 119b with a relatively large radius of curvature as described above, stagnation of the flow of contrast agent and perfusion liquid within second section 119b can be prevented. This allows the contrast agent and perfusion liquid to be more smoothly discharged from second opening 112b formed in second section 119b.

[0061] The portion of the first shaft 110 that extends further to the base end side than the third section 119c can be configured to have substantially the same cross-sectional shape (inner diameter, etc.) as the third section 119c.

[0062] The first shaft 110 can be made of, for example, a resin material known in the catheter field. The first shaft 110 may also be made of a single-layer or multi-layer resin tube member, or may have a braided wire or the like embedded therein to reinforce its rigidity. The outer surface of the first shaft 110 may also be coated with a hydrophilic coating or the like. These points also apply to the second shaft 230, which will be described later.

[0063] As shown in Figures 2 and 3, the first hub 120 has a tip tube portion 121 located at the tip end, a hub main body 123 having an internal space 125 that communicates with the interior of the tip tube portion 121, a port portion 124 having a flow path that communicates with the internal space 125 of the hub main body 123, and an opener 127 that is positioned closer to the base end than the port portion 124.

[0064] The first hub 120 can be configured, for example, as a Y-connector known in the catheter field (for example, a Y-connector with a valve mechanism that can be opened and closed by an opener 127).

[0065] Wings 130 can be disposed on the distal end side of the front tube portion 121 of the first hub 120. As with the Y connector, wings 130 known in the catheter field can be used. The proximal end portion 113 of the first shaft 110 is fixed to the wings 130.

[0066] Proximal end openings 113a provided in proximal end portion 113 of first shaft 110 are arranged to communicate with internal spaces 135 of wings 130. Internal spaces 135 of wings 130 communicate with internal spaces 125 of hub body 123 via tip tube portion 121. Therefore, when contrast medium is supplied from port portion 124 of first hub 120, the contrast medium flows into lumen 115 of first shaft 110 via port portion 124, internal space 125 of hub body 123, internal spaces 135 of wings 130, and proximal end openings 113a. The contrast medium that has flowed into lumen 115 of first shaft 110 is discharged to the outside of first shaft 110 via first opening 112a and multiple second openings 112b provided in distal end portion 111 of first shaft 110.

[0067] 3 , the opener 127 is disposed at a position closer to the proximal end than the proximal end 126 of the hub body 123. The second shaft 230 of the energy application device 200 is inserted through the inside of the opener 127 and into the internal space 125 of the hub body 123.

[0068] As shown in FIGS. 1, 10 and 11, the medical device 10 can include a predetermined inserter 300.

[0069] The inserter 300 has a tip opening 301a provided in the tip portion 301, a base opening 303a provided in the base portion 303, and an inner cavity 305 that connects the tip opening 301a and the base opening 303b.

[0070] The distal end 301 of the inserter 300 is provided with a tapered section in which the outer diameter and inner diameter gradually decrease toward the distal end. In addition, the proximal end 303 of the inserter 300 is provided with a tapered section in which the outer diameter and inner diameter gradually increase toward the proximal end.

[0071] 10 , the inserter 300 is placed near the distal end 111 of the first shaft 110. When the inserter 300 is placed near the distal end 111 of the first shaft 110, the curved portion 116 (spiral portion 117) of the first shaft 110 is corrected to a substantially straight shape along the shape of the inner surface of the inserter 300.

[0072] When inserting the medical device 10 into the blood vessel V, the surgeon removes the energy application device 200 from the catheter device 100. With the energy application device 200 removed from the catheter device 100, the surgeon corrects the curved portion 116 of the first shaft 110 to a substantially straight state using the inserter 300 as described above. With the curved portion 116 corrected to a substantially straight state, the surgeon inserts a guidewire, which was inserted into the blood vessel V prior to the medical device 10, from the proximal end side of the guidewire through the first opening 112a of the first shaft 110 along the entire length of the catheter device 100. By moving the catheter device 100 along the guidewire, the surgeon can smoothly insert a certain range of the distal end 111 of the first shaft 110 of the catheter device 100 to a predetermined position within the blood vessel V.

[0073] After inserting a certain range of the distal end 111 of the first shaft 110 into the blood vessel V using the above procedure, the surgeon removes the guidewire outside the living body via the catheter device 100. After being used to insert the medical device 10, the inserter 300 is moved along the outer surface of the first shaft 110 to the vicinity of the first hub 120, as shown in FIGS. 1 and 11 . The inserter 300 can be configured to be connectable to the first hub 120, for example. The inserter 300 can be used as a kink protector that protects the first shaft 110 by partially covering the first shaft 110 when connected to the first hub 120.

[0074] The surgeon removes the guide wire outside the living body through the catheter device 100, and then inserts the energy application device 200 from the first hub 120 of the catheter device 100. The surgeon can position the energy application unit 210 at a predetermined position on the distal end 111 of the first shaft 110 by moving the energy application device 200 along the first shaft 110 of the catheter device 100. The surgeon can also use the opener 127 to seal between the first hub 120 and the second shaft 230 of the energy application device 200, thereby preventing leakage of liquid or the like to the proximal end side of the first hub 120.

[0075] The first shaft 110 has a structure that is pre-shaped so that, in a natural state where no external force is applied, a curved portion 116 (spiral portion 117) is formed in at least a portion of the distal end portion 111. Therefore, when the guidewire is removed from the first shaft 110 and the inserter 300 is moved toward the proximal end of the distal end portion 111, the curved portion 116 (spiral portion 117) returns to a predetermined curved shape and at least a portion of the curved portion abuts against the inner wall Vi of the blood vessel V (see FIGS. 12 and 13 ).

[0076] <Energy application device 200> As shown in Figure 13, the energy application unit 210 is configured to be able to emit energy that can reach the surrounding nerve Na located outside the blood vessel V when placed in the inner cavity 115 of the first shaft 110.

[0077] The energy applying unit 210 can be configured, for example, by an antenna element capable of radiating microwaves. When the energy applying unit 210 is configured by an antenna element, the center frequency of the antenna element can be set to, for example, any of 915 MHz, 2.45 GHz, 5.8 GHz, and 24.125 GHz.

[0078] The energy application unit 210 may be configured, for example, by an ultrasonic element capable of emitting ultrasonic waves. However, the specific structure of the energy application unit 210 is not particularly limited as long as it is capable of cauterizing the surrounding nerves Na running parallel to the outside of the blood vessel V. The energy application unit 210 may have a configuration capable of cauterizing the surrounding nerves Na using, for example, simple high frequency, bipolar high frequency, high intensity focused ultrasound, light, heat, cold radiation, optic therapy, magnetic, electrical, electromagnetic, cryotherapy, plasma, mechanical energy, chemical energy, kinetic energy, potential energy, nuclear energy, or the like.

[0079] As shown in FIGS. 1 and 4 , the second hub 220 of the energy application device 200 is located proximal to the first hub 120 of the catheter device 100 .

[0080] An electrical connector portion 240 is housed in the internal space 225 of the second hub 220. The electrical connector portion 240 is covered by a predetermined housing 250.

[0081] The electrical connector 240 is configured to be connectable to a power supply 400, which is an external device, via a cord 410. Inside the electrical connector 240, various electrical elements and the like for receiving power from the power supply 400 are arranged.

[0082] The energy applying unit 210 and the electrical connector unit 240 are connected via a conductive unit 260. The energy applying unit 210 receives power from the electrical connector unit 240 via the conductive unit 260.

[0083] When the energy applying unit 210 is configured with an antenna element, the conductive unit 260 can be configured with a known coaxial cable capable of supplying current to the antenna element. Note that when the energy applying unit 210 is configured with a component other than an antenna element, the conductive unit 260 can be configured with various electrical structural members that enable the transmission of energy to the energy applying unit 210.

[0084] As shown in FIGS. 1 and 4, a kink protector 227 may be disposed at the proximal end of the second hub 220 of the energy delivery device 200.

[0085] 4, the internal space 225 of the second hub 220 is in communication with the port portion 224. A clearance is provided between the electrical connector portion 240 housed in the internal space 225 of the second hub 220 and the inner surface of the second hub 220, allowing the irrigation fluid supplied from the port portion 224 to flow therethrough.

[0086] In addition, the internal space 225 of the second hub 220 is blocked at a portion closer to the base end than the point of communication with the port portion 224 to prevent the irrigation liquid from moving further proximal than the port portion 224.

[0087] A proximal end 233 of a second shaft 230 is connected to the distal end of the second hub 220. An internal space 225 of the second hub 220 communicates with a proximal end opening 233a provided in the proximal end 233 of the second shaft 230.

[0088] As shown in FIG. 2 , the second shaft 230 extends from the second hub 220 toward the distal end, and a distal end portion 231 is disposed within the internal space 125 of the first hub 120 .

[0089] The conductive portion 260 is inserted into the inner cavity 115 of the first shaft 110 via the internal space 225 of the second hub 220 , the second shaft 230 , the internal space 125 of the first hub 120 , and the wings 130 .

[0090] The energy application device 200 is capable of moving the second shaft 230 back and forth relative to the catheter device 100 so that the energy application section 210 can be positioned at a predetermined position on the tip side of the first shaft 110 (e.g., a predetermined position of the curved section 116).

[0091] 1, 2, and 7, arrow f indicates the direction in which the energy application unit 210 and a portion of the second shaft 230 advance along the inner cavity 115 of the first shaft 110. Arrow b indicates the direction in which the energy application unit 210 and a portion of the second shaft 230 retreat along the inner cavity 115 of the first shaft 110.

[0092] The surgeon can grasp the second hub 220 with his / her fingers or the like and slide the second hub 220 back and forth along the central axis C1 of the second shaft 230, thereby moving the energy application device 200 together with the second hub 220 back and forth relative to the catheter device 100.

[0093] As shown in Figures 12 and 13, the surgeon can selectively position the energy application unit 210 at any location on the curved portion 116 by moving the energy application unit 210 along the curved portion 116 while a part of the curved portion 116 (spiral portion 117) is in contact with the inner wall Vi of the blood vessel V.

[0094] <Fluid Circulation Section 50 > The fluid circulation section 50 enables the perfusion fluid supplied from the port section 224 of the second hub 220 to be delivered to the distal end 111 of the first shaft 110 .

[0095] The medical device 10 has the fluid circulation part 50, and thus can cool the electrical connector part 240 disposed in the internal space 225 of the second hub 220, the conductive part 260 extending from the electrical connector part 240 to near the distal end 111 of the first shaft 110, and the energy application part 210 disposed at the distal end of the conductive part 260, by the perfusion fluid circulating through the fluid circulation part 50. This makes it possible to prevent the above-mentioned parts 240, 260, 210 from excessively increasing in temperature during treatment using the medical device 10.

[0096] 2 , 3 , and 4 , the fluid circulation section 50 can be configured as a fluid communication path formed by the port section 224 of the second hub 220, the internal space 225 of the second hub 220, the lumen 235 of the second shaft 230, the internal space 125 of the first hub 120, and the lumen 115 of the first shaft 110. In other words, the irrigation fluid supplied via the port section 224 of the second hub 220 flows from the base end to the distal end through the above-mentioned sections 225, 235, 125, and 115, thereby cooling the electrical connector section 240, the conductive section 260, and the energy application section 210 during the flow. The irrigation fluid that has flowed to the distal end 111 of the first shaft 110 is discharged to the outside of the first shaft 110 through the plurality of second openings 112 b and first openings 112 a formed in the first shaft 110.

[0097] 2 , the second shaft 230 is inserted into the first hub 120 so that a distal end 231 of the second shaft 230 is movable between a first position P1 defined within the first hub 120 and a second position P2 defined closer to the base end within the first hub 120 than the first position P1. There are no particular limitations on the specific locations of the first position P1 and the second position P2, and they can be set at any positions within the first hub 120.

[0098] The medical device 10 is provided with the liquid circulation section 50 in both states where the distal end 231 of the second shaft 230 is located at the first position P1 and where it is located at the second position P2.

[0099] Specifically, when the distal end portion 231 of the second shaft 230 is located at the first position P1, the distal end portion 231 of the second shaft 230 abuts against a portion that protrudes toward the inner circumference of the tip tube portion 121, and the first position P1 of the distal end portion 231 of the second shaft 230 is defined. In this state, the irrigation liquid can be caused to flow distally beyond the distal end portion 231 of the second shaft 230 through the distal end opening 231a of the second shaft 230. Furthermore, when the distal end portion 231 of the second shaft 230 is located at the second position P2, the irrigation liquid can be caused to flow distally beyond the distal end portion 231 of the second shaft 230 through the distal end opening 231a of the second shaft 230 and the internal space 125 of the hub body 123.

[0100] As described above, the medical device 10 according to this embodiment is a catheter device 100 including: a first shaft 110 configured to be insertable into a blood vessel V and having one or more openings 112 a, 112 b formed at the tip portion 111; a first hub 120 disposed at the base end 113 of the first shaft 110; an energy application unit 210 configured to be able to apply energy to a peripheral nerve Na running parallel to the blood vessel V outside the blood vessel V in order to cauterize the peripheral nerve Na; a second hub 220 in which an electrical connector unit 240 for supplying electrical energy to the energy application unit 210 is disposed and which includes a port unit 224 for supplying a predetermined liquid therein; The energy application device (200) includes: a long conductive portion (260) that connects the air connector portion (240) and the energy application portion (210); a second shaft (230) that extends from the second hub (220) toward the energy application portion (210), accommodates at least a portion of the base end side of the conductive portion (260), and is inserted into the first hub (120); and a liquid circulation portion (50) that enables liquid supplied from the port portion (224) to be delivered to the tip portion (111) of the first shaft (110).The energy application device (200) is movable forward and backward relative to the catheter device (100) so that the energy application portion (210) can be positioned at a predetermined position on the tip side of the first shaft (110).

[0101] According to the medical device 10, by emitting energy from the energy application unit 210 disposed in the first shaft 110 of the catheter device 100, it is possible to cauterize the peripheral nerve Na running parallel to the blood vessel V outside the blood vessel V. The medical device 10 also has a liquid circulation unit 50 that enables the liquid (perfusion liquid) supplied from the port unit 224 of the second hub 220 of the energy application device 200 to be delivered to the distal end 111 of the first shaft 110. Therefore, the surgeon can cool the energy application unit 210 and the conductive unit 260 disposed in the first shaft 110 of the catheter device 100 with the perfusion liquid during treatment.

[0102] The medical device according to the present invention has been described above through embodiments, but the present invention is not limited to the content described in the specification and can be modified as appropriate based on the description of the claims.

[0103] In the above-described embodiment, the superior mesenteric artery Va is exemplified as the blood vessel V to be treated by the medical device 10. However, there are no particular limitations on the blood vessel V to be treated by the medical device. For example, the pulmonary vein can be selected as the blood vessel to be treated. By locally applying energy to the surrounding nerves running outside the pulmonary artery to cauterize them, it is possible to treat or recover from diseases such as atrial fibrillation.

[0104] Furthermore, any components not specifically described in the specification may be added to the medical device, and additional components described in the specification may be omitted as appropriate. Furthermore, any procedure not specifically described in the specification may be added to the treatment using the medical device, and additional procedures described in the specification may be omitted as appropriate. Furthermore, the order of the procedures in the treatment method may be rearranged as appropriate, as long as the effects of the invention can be achieved.

[0105] 10 Medical device 50 Fluid circulation portion 100 Catheter device 110 First shaft 111 Distal end portion of first shaft 112a First opening 112b Second opening 113 Base end portion of first shaft 113a Base end opening of first shaft 115 Lumen of first shaft 116 Curved portion 117 Spiral portion 118 Straight portion 119a First portion 119b Second portion 119c Third portion 120 First hub 121 Tip tube portion 123 Hub body 124 Port portion of first hub 125 Internal space of hub body 200 Energy application device 210 Energy application portion 220 Second hub 224 Port portion of second hub 225 Internal space of second hub 230 Second shaft 231 Distal end portion of second shaft 231a Distal end opening of second shaft 233 Base end portion of second shaft 233a Base end opening portion of second shaft 235 Lumen of second shaft 240 Electrical connector portion 260 Conductive portion 300 Inserter 400 Power supply portion A1 First reference axis A2 Second reference axis C1 Central axis of second shaft Na Surrounding nerve OA Central position of blood vessel P1 First position P2 Second position S Treatment target portion V Blood vessel Vi Inner wall of blood vessel Va Superior mesenteric artery

Claims

1. A medical device comprising: a catheter device comprising: a first shaft configured to be insertable into a blood vessel and having one or more openings formed at its tip; and a first hub located at the base end of the first shaft; an energy application unit configured to apply energy to peripheral nerves running parallel to the blood vessel outside the blood vessel in order to cauterize the peripheral nerves; a second hub having an electrical connector located thereon for supplying electrical energy to the energy application unit and having a port located thereon for supplying a predetermined liquid; an elongated conductive unit connecting the electrical connector and the energy application unit; and a second shaft extending from the second hub toward the energy application unit, accommodating at least a portion of the base end of the conductive unit and being inserted into the first hub; and a fluid circulation unit that allows the liquid supplied from the port to be delivered to the tip end of the first shaft, wherein the energy application device is movable back and forth relative to the catheter device so as to enable the energy application unit to be positioned at a predetermined position on the tip end side of the first shaft.

2. The medical device of claim 1, wherein the liquid flow portion is a fluid communication passage formed by the port portion of the second hub, the internal space of the second hub, the lumen of the second shaft, the internal space of the first hub, and the lumen of the first shaft.

3. The medical device of claim 2, wherein the second shaft is inserted into the first hub so that the distal end of the second shaft is movable between a first position defined within the first hub and a second position defined at a position closer to the base end within the first hub than the first position, and the liquid circulation section is provided in both states where the distal end of the second shaft is located at the first position and where it is located at the second position.

4. The medical device of claim 1, wherein the first shaft has a first opening formed at the tip and a plurality of second openings located on the base end side of the first opening and opening toward the side of the first shaft.

5. The medical device according to claim 4, wherein the plurality of second openings are open in a direction that does not face the inner wall of the blood vessel when the first shaft is inserted into the blood vessel.

6. A medical device as described in claim 5, wherein the distal end of the first shaft has a curved portion having a shape curved with respect to a predetermined first reference axis, and a straight portion located on the proximal end side of the curved portion and extending in an approximately straight line along a second reference axis extending in a direction intersecting the first reference axis.

7. The medical device according to claim 6, wherein the curved portion is a spiral portion that extends spirally around the first reference axis.

8. The medical device described in claim 6, wherein the first shaft has a first portion provided at a position including the curved portion, a second portion located more proximal than the first portion and having the plurality of second openings formed therein, and a third portion located more proximal than the second portion and provided at a position including the straight portion, and the inner diameters of the second portion and the third portion are larger than the inner diameter of the first portion.

9. A medical device according to any one of claims 1 to 8, wherein the energy applying section is capable of emitting microwaves or ultrasound as the energy.

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