Medical instrument

Abstract

To provide a medical instrument capable of preventing mispositioning of a maintenance treatment element that imparts energy to a biological tissue from a treatment target site and a treatment method for a heart failure patient. A medical instrument (10) has a shaft portion (150), an expandable and contractible expansion body (100) provided on a front end side of the shaft portion, and a maintenance treatment element (109) that is disposed on the expansion body and imparts energy to a biological tissue, the expansion body having a recessed portion (115) recessed in a direction intersecting an axial direction of the shaft portion, the maintenance treatment element being disposed in the recessed portion.

Description

[0001] This invention is a divisional application based on the invention application filed on July 2, 2018, with international application number PCT / JP2018 / 025095, national application number 201880043317.X which entered the Chinese national phase, and entitled "Medical Device and Disposal Method". Technical Field

[0002] This invention relates to a medical device having a maintenance treatment element that provides energy to biological tissues. Background Technology

[0003] Chronic heart failure is a known heart disease. Based on cardiac function indicators, chronic heart failure is broadly classified into systolic heart failure and diastolic heart failure. Patients with diastolic heart failure experience increased blood pressure in the left atrium and decreased cardiac pumping function due to myocardial hypertrophy and increased stiffness (rigidity). Consequently, patients may experience symptoms of heart failure such as pulmonary edema.

[0004] In addition, there are heart diseases such as pulmonary hypertension that cause increased blood pressure on the right side of the heart and decreased heart pumping function, resulting in symptoms of heart failure.

[0005] In recent years, shunt surgery, which creates a shunt (through-hole) in the atrial septum to facilitate the escape of elevated atrial pressure and thus alleviate heart failure symptoms, has gained attention in patients with heart failure.

[0006] For example, in the shunt procedure described in Patent Document 1 below, a medical device for forming a shunt is delivered to the interatrial septum via a transvenous route, and a shunt is formed in the interatrial septum. Furthermore, in the above-mentioned shunt procedure, after the shunt is formed in the interatrial septum, in order to maintain the desired size of the shunt for a specified period, a treatment is performed using an ablation catheter or the like equipped with electrodes (maintenance treatment elements) to modify the biological tissue around the shunt.

[0007] Existing technical documents

[0008] Patent documents

[0009] Patent Document 1: Japanese Patent Application Publication No. 2017-60825 Summary of the Invention

[0010] In the above-mentioned shunt treatment, if the electrode placed in the catheter is misaligned during the ablation process, it will be difficult to maintain the desired size of the shunt channel, and the treatment effect may be reduced.

[0011] The present invention was made to solve the above-mentioned problems, and its object is to provide a medical device that can prevent the maintenance treatment elements that impart energy to biological tissues from being misplaced from the treatment site, and a treatment method for patients with heart failure.

[0012] The medical device of the present invention comprises: a shaft portion; an expandable and contractible expander provided at the front end of the shaft portion; and a maintenance treatment element disposed on the expander portion and performing a prescribed maintenance treatment on biological tissue, the expander portion having a recessed portion in a direction intersecting the axial direction of the shaft portion, the maintenance treatment element being disposed in the recessed portion.

[0013] The treatment method of the present invention includes: an expansion step of expanding a perforation formed in the interatrial septum in a manner that connects the right atrium and the left atrium of a patient with heart failure; a confirmation step of confirming the blood circulation dynamics near the perforation; and a maintenance step of performing a maintenance treatment to maintain the size of the perforation.

[0014] Invention Effects

[0015] The aforementioned medical device prevents the maintenance treatment element positioned in the recess from dislodging from the treatment site by placing the recess formed during the expansion and deformation of the expander at the treatment site (e.g., the edge of a through-hole formed in the interatrial septum). Thus, the physician or other practitioner using the medical device can perform appropriate treatment based on the maintenance treatment element.

[0016] The aforementioned treatment method includes a confirmation step to assess the dynamic blood circulation near the perforation formed in the atrial septum. Therefore, physicians and other practitioners can obtain indicators during the treatment process to determine whether the perforation in the atrial septum has formed to the desired size, thus improving the treatment outcome for heart failure. Attached Figure Description

[0017] Figure 1 This is a perspective view of a medical device schematically illustrating an embodiment of the present invention.

[0018] Figure 2 This is a perspective view of the front end of the medical device as seen from the front side.

[0019] Figure 3 This is a perspective view of the front end of the medical device as seen from below.

[0020] Figure 4 This is a cross-sectional view of the maintenance and treatment element section when viewed from the front of the medical device of the embodiment, and it is a diagram showing the state in which the expansion body is housed in the storage sheath.

[0021] Figure 5This is a cross-sectional view of the maintenance and handling element section when viewed from the front of the medical device of the embodiment, and it is a diagram showing the state after the expansion body is exposed from the storage sheath.

[0022] Figure 6 This is a flowchart illustrating the steps of the processing method in the implementation method.

[0023] Figure 7 This is a diagram illustrating the steps of the treatment method of the embodiment, and it schematically shows a cross-sectional view of the patient's heart.

[0024] Figure 8 This is a diagram illustrating the steps of the treatment method of the embodiment, and a cross-sectional view schematically showing the process of confirming the blood circulation dynamics near the through-hole formed in the interatrial septum.

[0025] Figure 9 This is a diagram used to illustrate the processing method of the embodiment, and is a cross-sectional view schematically showing the process of forming a through hole in the interatrial partition.

[0026] Figure 10 This is a diagram used to illustrate the treatment method of the embodiment, and is a cross-sectional view schematically showing the process of inserting a medical device into a through hole formed in the interatrial septum.

[0027] Figure 11 This is a diagram used to illustrate the treatment method of the embodiment, and is a cross-sectional view schematically showing the process of placing an expansion body of a medical device in a through hole formed in the interatrial septum.

[0028] Figure 12 This is a diagram used to illustrate the treatment method of the embodiment, and is a cross-sectional view schematically showing the process of expanding the through hole formed in the intercompartment.

[0029] Figure 13 This is a diagram used to illustrate the treatment method of the embodiment, and is a cross-sectional view schematically showing the process of performing maintenance treatment on the through hole formed in the interatrial septum.

[0030] Figure 14 This is a diagram used to illustrate the treatment method of the embodiment, and is a cross-sectional view schematically showing the situation after the expansion of the medical device is removed from the through hole formed in the interatrial septum.

[0031] Figure 15 It is shown in magnification Figure 13 The diagram shows the portion 15A indicated by the dashed line.

[0032] Figure 16 From Figure 13 The front view of the through hole as seen in the direction of arrow 16A.

[0033] Figure 17 This is a flowchart illustrating the steps of the processing method for a modified example.

[0034] Figure 18 This is a diagram used to illustrate the treatment method of the modified example, and is a cross-sectional view schematically showing the process of expanding the through hole formed in the intercompartment (first expansion process).

[0035] Figure 19 This is a diagram used to illustrate the treatment method of the modified example, and is a cross-sectional view schematically showing the process of expanding the through hole formed in the intercompartment (second expansion process).

[0036] Figure 20 This is a diagram used to illustrate the treatment method of the modified example, and is a cross-sectional view schematically showing the process of performing maintenance treatment on the through hole formed in the interseptum.

[0037] Figure 21 This is a diagram used to illustrate the treatment method of the modified example, and is a cross-sectional view schematically showing the situation after the expansion of the medical device is removed from the through hole formed in the interatrial septum.

[0038] Figure 22 This is a cross-sectional view showing the medical device of variant 1.

[0039] Figure 23 It is shown in magnification Figure 22 The diagram shows the portion 23A indicated by the dashed line.

[0040] Figure 24 This is a front view of the front end of the medical device of Modified Example 2, and it shows the state in which the expander is housed in the storage sheath.

[0041] Figure 25 This is a front view of the front end of the medical device of Modified Example 2, and a view showing the state after the expander is exposed from the storage sheath.

[0042] Figure 26 This is a cross-sectional view schematically illustrating an example of a maintenance procedure for maintaining the size of the through-hole formed in the interatrial septum.

[0043] Figure 27 This is a cross-sectional view schematically illustrating an example of a maintenance procedure for maintaining the size of the through-hole formed in the interatrial septum.

[0044] Figure 28 This is a cross-sectional view schematically illustrating an example of a maintenance procedure for maintaining the size of the through-hole formed in the interatrial septum.

[0045] Figure 29 From Figure 28 The front view of the through hole as seen in the direction of arrow 29A.

[0046] Figure 30 This is a cross-sectional view schematically illustrating an example of a process for confirming the dynamics of blood circulation near the perforation formed in the interatrial septum.

[0047] Figure 31 This is a cross-sectional view schematically showing an example of an expansion body.

[0048] Figure 32 This is a cross-sectional view schematically showing an example of an expansion body.

[0049] Figure 33 This is a cross-sectional view schematically showing an example of an expansion body.

[0050] Figure 34 This is a cross-sectional view schematically showing an example of an expansion body.

[0051] Figure 35 This is a cross-sectional view schematically showing an example of an expansion body.

[0052] Figure 36 From Figure 35 The front view of the through hole as seen in the direction of arrow 36A.

[0053] Figure 37 This is a cross-sectional view schematically showing an example of an expansion body.

[0054] Figure 38 From Figure 37 The front view of the through hole as seen in the direction of arrow 38A.

[0055] The reference numerals in the attached figures are explained as follows:

[0056] 10 Medical Devices

[0057] 100 expansion body

[0058] 108 Distribution Department

[0059] 109. Maintenance and treatment elements (energy transfer elements)

[0060] 110 First Expansion Section

[0061] 111 Front-end side tilting part

[0062] 113 Base end inclined portion

[0063] 115 concavity

[0064] 115a bottom

[0065] 115b Front Side Erected Section

[0066] 115c Base end side upright part

[0067] 120 Second Expansion Section

[0068] 130 Third Expansion Section

[0069] 140 Fourth Expansion Section

[0070] 150 shaft section

[0071] 151 Storage Sheath

[0072] 153 outer shaft

[0073] 155 inner shaft

[0074] 157 Traction Axle

[0075] 159 Guidewire lumen

[0076] 160 Hands-on Operations Department

[0077] 170 Front-end Chip

[0078] 210 guidewire

[0079] 220 intubation device

[0080] 230 Puncture instruments

[0081] 240 Instruments for dynamic monitoring of blood circulation

[0082] 250, 260 pressure measuring tubing

[0083] H Heart

[0084] HA interatrial spacing

[0085] HLa left atrium

[0086] HLw left ventricle

[0087] HRa right atrium

[0088] Hc cut section

[0089] Hd Modification Department

[0090] Hh Through Hole

[0091] Hhe The edge of the through hole

[0092] Inferior vena cava (IV). Detailed Implementation

[0093] Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. Furthermore, the following description does not limit the technical scope or the meaning of the terminology used in the claims. Additionally, the dimensions of the drawings are sometimes exaggerated for ease of explanation and differ from the actual scale.

[0094] like Figure 1 , Figure 13 , Figure 14 As shown, in summary, the medical device 10 of this embodiment is configured as a device that can be used to relieve or treat symptoms of heart failure by expanding the through hole Hh formed in the atrial septum HA of the patient's heart H to a predetermined size and further maintaining the through hole Hh at the predetermined size.

[0095] Figures 1-5 This is a diagram used to illustrate the various parts of the medical device 10. Figure 1 This is a three-dimensional diagram showing the overall structure of medical device 10. Figure 2 and Figure 3 This is a magnified perspective view of the front end of the medical device 10. Figure 4 and Figure 5 This is a front view illustrating the storage method of the expander 100.

[0096] in addition, Figures 6 to 16 This is a diagram illustrating the treatment method using medical device 10. Figure 6 It is a flowchart that roughly illustrates the various steps of the processing method. Figure 7 and Figure 8 It is a diagram that roughly shows the patient's heart and a portion of the procedures involved in the treatment. Figures 9-16 It is a cross-sectional view used to illustrate each step of the treatment method.

[0097] In the instruction manual, the side of the medical device 10 that is inserted into the living body (the side where the expander 100 is disposed) is referred to as the anterior end side (distal end side), the side of the medical device 10 with its hand-operated portion 160 is referred to as the basal end side (proximal end side), and the direction in which the shaft portion 150 extends is referred to as the axial direction. Furthermore, the anterior end portion refers to a defined range from the anterior end (farthest anterior end) to the basal end side, and the basal end portion refers to a defined range from the basal end (farthest basal end) to the anterior end side.

[0098] The following details the medical device 10 and its disposal method.

[0099] like Figures 1-3 As shown, the medical device 10 has: an elongated shaft portion 150; an expandable and contractible expander 100 disposed at the front end of the shaft portion 150; and a maintenance treatment element (energy transfer element) 109 disposed on the expander 100 and imparting energy to biological tissues.

[0100] The expansion body 100 will be described.

[0101] like Figure 2 and Figure 3 As shown, the expansion body 100 has multiple expansion portions 110, 120, 130, and 140 disposed at different positions on the circumferential direction (R direction in the figure) of the shaft portion 150.

[0102] Each expansion portion 110, 120, 130, and 140 is configured to expand and contract. In this embodiment, the expanded state of the expander 100 refers to the expanded state of each expansion portion 110, 120, 130, and 140, and the contracted state of the expander 100 refers to the contracted state of each expansion portion 110, 120, 130, and 140. Furthermore, Figures 1-3 The expansion body 100 is shown after expansion.

[0103] Furthermore, for convenience, in the description, expansion portion 110 is referred to as the first expansion portion, and similarly, it will be referred to as the second expansion portion 120, the third expansion portion 130, and the fourth expansion portion 140 below. Moreover, since each expansion portion 110, 120, 130, and 140 has substantially the same structure, the specific structure will be described using the first expansion portion 110 as an example, and descriptions of the other expansion portions 120, 130, and 140 will be appropriately omitted.

[0104] The first expansion portion 110 forms a predetermined recess 115 after expansion and deformation. The recess 115 has a direction intersecting the axial direction of the shaft portion 150. Figure 2 The shape is concave in the vertical direction shown. The energy-maintaining treatment element 109, which imparts energy to the edge Hhe of the through-hole Hh formed in the interatrial septum HA, is disposed in the concave portion 115 (see reference). Figure 15 ).

[0105] The recesses 115 formed in the expanders 100 (each expander portion 110, 120, 130, 140) need only be formed in at least the expanded state of the expander 100. For example, they can be formed in both the unexpanded state and the expanded state of the expander 100. Furthermore, the size of the recesses 115 (the amount of axial recess) relative to the degree of expansion (expansion amount) of the expander 100 is not particularly limited, as long as the recesses 115 can be positioned relative to the treatment target area (e.g., the edge Hhe of the through hole Hh formed in the interatrial septum HA) during treatment based on the maintenance treatment element 109. Additionally, the number and shape of the expanders provided in the expander 100 can be appropriately changed.

[0106] Each of the multiple expansion portions 110, 120, 130, and 140 of the expander 100 has a recess 115 formed therein. A maintenance treatment element 109 is disposed in each of the recesses 115 formed in each of the expansion portions 110, 120, 130, and 140. Therefore, practitioners such as doctors can simultaneously treat four sites during treatment based on the medical device 10 via the maintenance treatment elements 109 disposed in each of the expansion portions 110, 120, 130, and 140 (see reference). Figure 16 ).

[0107] like Figure 2 and Figure 3 As shown, each expansion portion 110, 120, 130, 140 of the expander 100 is composed of a pre-shaped linear component to form a recess 115 after expansion deformation.

[0108] The expander 100 is configured with four expander portions 110, 120, 130, and 140 disposed on the front end side, along with the traction shaft 157 described later (see reference). Figure 1 It expands and contracts through push-pull operations.

[0109] like Figure 3 As shown, a base portion 105 is formed on the base end side of each expansion portion 110, 120, 130, and 140 for integral connection of each expansion portion 110, 120, 130, and 140. In addition, a front end portion 106 is formed on the front end side of each expansion portion 110, 120, 130, and 140 for integral connection of each expansion portion 110, 120, 130, and 140.

[0110] The linear components constituting each expansion section 110, 120, 130, and 140 can be made of a relatively small-diameter metal material with a circular cross-section. When the linear components are made of metal, elastic alloys such as titanium-based alloys (Ti-Ni, Ti-Pd, Ti-Nb-Sn, etc.), copper-based alloys, stainless steel (SUS304), β-titanium steel, Co-Cr alloys, and nickel-titanium alloys can be used. However, there are no particular restrictions on the material, cross-sectional shape, or outer diameter of the linear components; they can be chosen arbitrarily.

[0111] Furthermore, as described later, each expansion portion 110, 120, 130, 140 performs positioning during treatment based on the maintenance treatment element 109 by engaging (locking) the recess 115 with the edge Hhe of the through hole Hh formed in the interatrial septum HA. Figure 15At this point, in order to prevent the expansion portions 110, 120, 130, and 140 from shifting from the edge Hhe of the through hole Hh, each expansion portion 110, 120, 130, and 140 preferably possesses a certain degree of hardness. From this viewpoint, each expansion portion 110, 120, 130, and 140, for example, when using a wire with a circular cross-section, preferably has a wire diameter of 0.3 mm to 0.8 mm and is formed of a material such as a Ni-Ti alloy.

[0112] Furthermore, the expansion portions 110, 120, 130, and 140, for example, can accommodate the maximum external dimension L1 during contraction. Figure 4 The dimension shown (from the central axis C1 of the shaft portion 150 upwards or downwards or left and right) is formed to be 1mm to 3mm, and the dimension L2 (which allows for the maximum external shape during expansion) is formed. Figure 5 The dimensions shown (from the central axis C1 of the shaft portion 150 upwards or downwards or left and right) are formed to be 4mm to 15mm.

[0113] Figure 15 An enlarged view of the expander 100 in its expanded state is shown.

[0114] like Figure 15 As shown, the first expansion portion 110 has: a front end side inclined portion 111 that is inclined at an angle toward the axis of the shaft portion 150; a base end side inclined portion 113 that is inclined at an angle toward the axis of the shaft portion 150; and a recess 115 that extends between the front end side inclined portion 111 and the base end side inclined portion 113.

[0115] The recess 115 has: along the axial direction ( Figure 15 The bottom 115a extends in the left-right direction; compared to the bottom 115a, the front end side formed in the axial direction ( Figure 15 (in the right direction) and from the bottom 115a towards the direction intersecting the axis ( Figure 15 The front end side upright portion 115b, which rises upwards (in the upper direction); and the base end side formed in the axial direction compared to the bottom 115a. Figure 15 (left side) and from the bottom 115a towards the direction intersecting the axis ( Figure 15 The base end side erected portion 115c is erected on the upper side of the middle. Furthermore, the front end side erected portion 115b and the base end side erected portion 115c are formed in the expanded state such that their length dimensions in the expansion direction (the height direction intersecting the axial direction) are approximately the same.

[0116] The retaining element 109 is disposed at the bottom 115a of the recess 115. Therefore, as Figure 15As shown, when the recess 115 is positioned relative to the edge Hhe of the through hole Hh formed in the interatrial septum HA, the holding and handling element 109 positioned at the bottom 115a of the recess 115 contacts the edge Hhe of the through hole Hh. Furthermore, the first expansion portion 110 maintains the relative position of the holding and handling element 109 and the edge Hhe of the through hole Hh by accommodating a portion of the edge Hhe of the through hole Hh within the recess 115, preventing misalignment between them.

[0117] like Figure 15 As shown, the axial dimension (width dimension) W1 of the recess 115 of the first expansion portion 110 can, for example, be formed to be larger than the axial dimension W2 of the edge Hhe of the through hole Hh. Furthermore, in this embodiment, the width dimension W1 of the recess 115 is the length of the line segment connecting the highest point of the front end side upright portion 115b and the highest point of the base end side upright portion 115c. When the width dimension of the recess 115 is formed in the above-described manner, the recess 115 can more reliably accommodate the edge Hhe of the through hole Hh, thus appropriately preventing the edge Hhe of the through hole Hh from dislodging from the recess 115. The width dimension W1 of the recess 115 can, for example, be formed to be 1 mm to 8 mm.

[0118] The retaining element 109 can also be formed throughout the entire recess 115 (including the entire area of ​​the bottom 115a, the front end side raised portion 115b, and the base end side raised portion 115c). Alternatively, the retaining element 109 can be disposed in the entire area of ​​the bottom 115a that contacts the edge Hhe of the through hole Hh (the entire axial area of ​​the bottom 115a). By arranging the retaining element 109 as described in the above-described configuration examples, the retaining element 109 can make more reliable contact with the edge Hhe of the through hole Hh, thus allowing for appropriate heat application to the edge Hhe of the through hole Hh. Furthermore, the expansion body 100 may not form the recess 115 before expansion (in the contracted state), provided that the recess 115 is formed at least in the expanded state.

[0119] Furthermore, as in this embodiment, when the expansion body 100 is composed of multiple expansion portions 110, 120, 130, and 140, the position of the holding element 109 can be different for each expansion portion 110, 120, 130, and 140, or the holding element 109 can be arranged at the same or different positions for any expansion portion. Moreover, as described later, the holding element 109 can be arranged outside the bottom 115a of the recess 115 (see [reference]). Figure 23 Similarly, the maintenance element 109 can be configured at any position for each expansion section.

[0120] like Figure 13and Figure 15 As shown, the expansion body 100 has a flow section 108 that allows blood to flow through the through hole Hh (indicated by arrow b in each figure) when a recess 115 is disposed in the through hole Hh formed in the patient's atrial partition HA.

[0121] like Figure 2 and Figure 5 As shown, when the expansion bodies 110, 120, 130, and 140 are in their expanded states, i.e., when the expansion body 100 is in its expanded state, gaps (spaces) are formed circumferentially between the expansion bodies 110, 120, 130, and 140. Figure 13 and Figure 15 As shown, with the dilator 100 inserted into the through hole Hh, blood is allowed to flow from the left atrium HLa to the right atrium HRa via the flow section 108 formed in the aforementioned gap.

[0122] As in this embodiment, when the expander 100 has four expansion portions, four flow portions (gap) 108 of approximately the same size are formed between each expansion portion. Furthermore, the shape, size, structure, and number of the flow portions 108 are not particularly limited. For example, as described later, the flow portions 108 may also be formed by holes or cuts in the expander (see [reference]). Figure 31 , Figure 34 wait).

[0123] X-ray imaging marks can be provided on the expander 100 (e.g., each of the expander portions 110, 120, 130, 140). For example, the X-ray imaging marks can be formed on the expander 100 at locations indicating the positions of the maintenance treatment element 109. The X-ray imaging marks can be formed, for example, using X-ray-non-transmissive materials such as metals like platinum, gold, silver, titanium, tungsten, or their alloys.

[0124] The sustaining element 109 disposed in the expansion body 100 can be, for example, composed of a heating element (electrode chip) that receives high-frequency electrical energy from an external device, i.e., an energy supply device (not shown), and generates heat. The sustaining element 109 is connected to the energy supply device by a wire (lead) covered with an insulating coating material (not shown). This wire passes through the cavity 105a formed in the base 105 of the expansion body 100 (described later) and is electrically connected to the sustaining element 109 disposed in each of the expansion portions 110, 120, 130, and 140.

[0125] The power supply device can be, for example, a known high-frequency power supply device equipped with a CPU that functions as a control unit. The supply and cessation of high-frequency power to the maintenance processing element 109 can be controlled, for example, by the CPU.

[0126] The maintenance treatment element 109 can be configured as a monopolar electrode, for example. In this case, when performing treatment using the medical device 10, an electrode plate (not shown) can be used, for example. When performing treatment using the medical device 10, the electrode plate is installed on the patient's body surface, and a possible current loop is formed between the maintenance treatment element 109, the patient, and the electrode plate, thereby allowing current to be passed through the edge Hhe of the through hole Hh formed in the interatrial septum HA.

[0127] The maintenance treatment element 109 may also be composed of a bipolar electrode through which current is passed between each expansion portion 110, 120, 130, 140. Furthermore, the maintenance treatment element 109 of the medical device 10 may be configured to perform ablation based on high-frequency electrical energy. However, it may be composed of an energy transfer element that imparts energy to the edge Hhe of the through hole Hh, such as elements that affect heating or cooling through microwave energy, ultrasonic energy, coherent light such as lasers, heated fluids, cooled fluids, chemical media, elements that generate frictional heat, or heaters equipped with wires. The specific configuration is not particularly limited.

[0128] Next, the shaft portion 150 will be described.

[0129] like Figure 1 , Figure 2 , Figure 3 As shown, the shaft portion 150 includes: a storage sheath 151 capable of housing the expanded body 100 in a retracted state; an outer shaft 153 inserted within the storage sheath 151; an inner shaft 155 inserted within the outer shaft 153; a traction shaft 157 inserted within the inner shaft 155; and a front-end chip 170 disposed at the front end of the shaft portion 150.

[0130] The sheath 151 stores the expanded body 100 in its contracted state. The sheath 151 is configured to move forward and backward along the axial direction of the shaft portion 150. When the expanded body 100 is expanded, the sheath 151 is moved relative to the expanded body 100 toward the base end side, thereby setting the expanded body 100 to a state where it protrudes from the front end of the sheath 151.

[0131] The storage sheath 151 can move axially along the shaft portion 150, for example, by being held by a practitioner such as a doctor and moved in the back-and-forth direction. Additionally, as... Figure 1 As shown, for example, a liquid supply section (e.g., a three-way valve) 180 for supplying injection fluid between the sheath 151 and the outer shaft 153, and a pipe 185 connected to the liquid supply section 180 can be provided.

[0132] The front end of the outer shaft 153 is configured to protrude from the sheath 151, and the base end is connected to the hand-held operating part 160. For example... Figure 3As shown, the base 105 of the expander 100 is inserted into the inner cavity of the outer shaft 153.

[0133] The base 105 of the expander 100 is composed of a tubular component extending axially. For example... Figure 5 As shown, an inner shaft 155 is inserted into the base 105 of the expansion body 100. In addition, a traction shaft 157 is inserted into the inner cavity of the inner shaft 155.

[0134] like Figure 3 As shown, the inner shaft 155 protrudes towards the front end of the outer shaft 153. The base end of the traction shaft 157 extends towards the base end of the hand-held operating part 160 (see reference). Figure 1 The front end of the traction shaft 157 extends towards the front end of the inner shaft 155. Furthermore, the front end of the traction shaft 157 is connected to the front end portion 106 of the expander 100. The traction shaft 157 is configured to move axially forward and backward via the operating dial 163, described later.

[0135] like Figures 1-3 As shown, the expander 100 is configured to protrude from the storage sheath 151 and be expandable and deformable in a state disposed between the storage sheath 151 and the front chip 170. The operator can move the front end portion 106 of the expander 100, which is connected to the traction shaft 157, towards the base end by moving the traction shaft 157 towards the base end. Through this operation, the distance between the front end portion 106 of the expander 100 and the base 105 of the expander 100 decreases. Furthermore, as... Figure 2 and Figure 3 As shown, the expander 100 contracts along the axial direction while simultaneously expanding in a direction intersecting the axial direction. Figure 2 (Expanding in the vertical or horizontal direction).

[0136] like Figure 3 As shown, a guidewire lumen 159 extending axially is formed in the traction shaft 157, the front end portion 106 of the expander 100 disposed at the front end of the traction shaft 157, and the front end chip 170 disposed at the front end portion 106 of the expander 100. When performing treatment using the medical device 10, as... Figure 1 As shown, the guide wire 210 can be inserted into the guide wire lumen 159 and the movement of the shaft portion 150 and the expansion body 100 can be guided by the guide wire 210.

[0137] like Figure 2 and Figure 5As shown, an inner cavity 105a is formed at the base 105 of the expansion body 100 for a wire (not shown) to be inserted for connection with the maintenance treatment element 109. The wire can be arranged, for example, along the inner side of each expansion portion 110, 120, 130, 140. By arranging it in this way, when performing treatment based on the expansion body 100, the wire can be prevented from being placed on the recess 115 and thus hindering smooth treatment. In addition, the wire is led out from the base end side of the hand-held operation portion 160, for example, like the traction shaft 157, and is electrically connected to an external device, i.e., an energy supply source (not shown), via a pre-designated connector or the like.

[0138] like Figure 3 As shown, the front-end chip 170 has a tapered shape that decreases in size towards the front end. An opening 171 for guiding the guide wire 210 towards the front end is formed at the front end of the front-end chip 170. The front-end chip 170 has the function of preventing damage to biological tissues when the medical device 10 moves within a living organism, and assisting in the insertion of the medical device 10 through a through-hole Hh formed in the interatrial septum HA. Furthermore, the front-end chip 170 can, for example, be made to have X-ray imaging properties.

[0139] As in this embodiment, when the expander 100 has four expansion portions 110, 120, 130, and 140, for example... Figure 4 As shown, each expansion portion 110, 120, 130, and 140 can be stored inside the storage sheath 151.

[0140] Specifically, when viewed from the front, each of the expansion portions 110, 120, 130, and 140 is arranged in a manner that does not overlap with the central axis C1 of the shaft portion 150 in the vertical and horizontal directions. In other words, each of the expansion portions 110, 120, 130, and 140 is not arranged in a circumferential relative position with respect to the central axis C1. For example, the first expansion portion 110 and the third expansion portion 130, which are vertically opposite each other, can be arranged with respect to the central axis C1 of the shaft portion 150 along... Figure 4 , Figure 5 The second expansion portion 120 and the fourth expansion portion 140, which are opposite each other in the left and right direction, can be positioned relative to the central axis C1 of the shaft portion 150 along... Figure 4 , Figure 5 The expansion sections 110, 120, 130, and 140 are configured with a vertical offset. When these expansion sections are configured in this way, as shown... Figure 4As shown, after the expander 100 is housed within the sheath 151, the contraction directions of the expanders 110, 120, 130, and 140 no longer overlap in the vertical and horizontal directions when viewed from the front. Therefore, the shape of the expander 100 becomes smaller when contracted. As a result, the expander 100 can be housed more compactly within the sheath 151, and the diameter of the sheath 151 can be reduced.

[0141] The housing sheath 151, outer shaft 153, and inner shaft 155 can be made of resin materials commonly used in conduits, for example. As an example, polyethylene, polypropylene, ethylene-propylene copolymers, ethylene-vinyl acetate copolymers, and other polyolefins, thermoplastic resins such as soft polyvinyl chloride, silicone rubber, latex rubber, and various other rubbers, polyurethane elastomers, polyamide elastomers, polyester elastomers, and other elastomers, polyimide, crystalline polyethylene, crystalline polypropylene, and other crystalline plastics can be used. Furthermore, a woven mesh structure made of stainless steel or similar materials can be added as a reinforcement.

[0142] The traction shaft 157 can be made of a material, for example, a long wire coated with a resin material such as polyvinyl chloride, polyethylene, polypropylene, or ethylene-propylene copolymer, which is made of a super-elastic alloy such as nickel-titanium alloy or copper-zinc alloy, a metal material such as stainless steel, or a resin material with high rigidity.

[0143] The front-end chip 170 can be formed, for example, from polymeric materials such as polyolefin, polyvinyl chloride, polyamide, polyamide elastomer, polyurethane, polyurethane elastomer, polyimide, fluororesin, or mixtures thereof, or multilayer tubes made of two or more of the above polymeric materials.

[0144] Next, the manual operation unit 160 will be explained.

[0145] like Figure 1 As shown, the hand-held operating unit 160 includes: a housing 161; an operating dial 163 disposed in the housing 161; and a conversion mechanism 164 that converts the rotational motion of the operating dial 163 into the forward and backward movement of the traction shaft 157.

[0146] The outer casing 161 is composed of a housing capable of being gripped by fingers or the like. A simplified diagram of a switching mechanism 164 is disposed inside the outer casing 161. An operation dial 163 is partially exposed from the outer casing 161 and can be operated via fingers or the like. Figure 1 The expansion body 100 rotates in the r1-r2 direction. The traction shaft 157, which causes the expansion body 100 to expand and contract, is connected to the operation dial 163 via the conversion mechanism 164.

[0147] When the operating dial 163 is rotated in the direction of arrow r1, the medical device 10 moves the traction shaft 157 towards the base end, and in conjunction with this movement, expands the expander 100. Conversely, when the operating dial 163 is rotated in the direction of arrow r2, the medical device 10 moves the traction shaft 157 towards the front end, and in conjunction with this movement, contracts the expander 100. The conversion mechanism 164 can be, for example, a rack and pinion mechanism that converts the rotation of the operating dial 163 into the forward and backward movement (linear movement) of the traction shaft 157.

[0148] Furthermore, the combination of the rotation direction of the operating dial 163 and the movement direction of the traction shaft 157 can be appropriately changed. In addition, a mechanism for moving the traction shaft 157 forward and backward without being linked to the rotation operation of the operating dial 163 can be provided in the hand-held operating unit 160.

[0149] like Figure 1 As shown, a pipe 165 for supplying injection fluid or the like between the inner shaft 155 and the traction shaft 157 can be provided on the hand-operated part 160. A valve body or the like can be appropriately provided on the housing 161 to prevent the injection fluid supplied through the pipe 165 from flowing into the base end side of the housing 161.

[0150] The housing 161 of the hand-held operating unit 160 can be made of, for example, a rigid resin material or a metal material.

[0151] Next, the processing method of this embodiment will be described.

[0152] The treatment methods described in this embodiment include various treatments for patients suffering from heart failure (left ventricular failure). More specifically, such as... Figure 7 As shown, the above treatment method is used for patients with chronic heart failure who have elevated blood pressure in the left atrium HLa due to myocardial hypertrophy and increased stiffness (rigidity) in the left ventricle HLw of the heart H.

[0153] Reference Figure 6 In summary, the treatment method includes the following steps: forming a perforation Hh in the interatrial septum HA (S11); placing an expander 100 within the perforation Hh (S12); expanding the perforation Hh (S13); monitoring the blood circulation dynamics near the perforation Hh (S14); performing a maintenance treatment to maintain the size of the perforation Hh (S15); and monitoring the blood circulation dynamics near the perforation Hh after the maintenance treatment (S16). Each step will be described below.

[0154] like Figure 7As shown, the surgeon or other operator, while creating the perforation Hh, advances the intubation device 220, which includes a guide sheath 220a and a dilator 220b, to the vicinity of the interatrial septum HA. The intubation device 220 can, for example, be advanced to the right atrium HRa via the inferior vena cava IV. Alternatively, the intubation device 220 can be advanced using a guidewire 210, which is known in the medical field. The operator can insert the guidewire 210 into the dilator 220b and advance the intubation device 220 along the guidewire 210.

[0155] Furthermore, the insertion of the cannula 220 into the body and the insertion of the guidewire 210 can be performed using methods known in the medical field (such as using a vascular insertion cannula).

[0156] Next, the practitioner performs the procedure of forming a through hole Hh in the interatrial septum HA (S11).

[0157] like Figure 9 As shown, the operator creates a perforation Hh in the interatrial septum HA by inserting a prescribed puncture instrument 230 from the right atrium HRa side toward the left atrium HLa side. The puncture instrument 230 can be, for example, a wire with a sharp tip. The puncture instrument 230 is inserted... Figure 7 The dilator 220b shown is inserted into and delivered to the interatrial septum HA. The puncture instrument 230 can be delivered to the interatrial septum HA in place of the guidewire 210 after the guidewire 210 has been removed from the dilator 220b.

[0158] After creating a perforation Hh using the puncture instrument 230, the operator inserts a dilator 220b into the perforation Hh to dilate it. Next, the operator removes the puncture instrument 230 from the dilator 220b. After removing the puncture instrument 230, the operator advances the guidewire 210 to the left atrium HLa using the cannula 220. Then, the guidewire 210 is left in place, and the dilator 220b and guide sheath 220a are removed.

[0159] The operator can also use the medical device 10 instead of the intubator 220 to perform the procedure of forming a perforation Hh in the interatrial septum HA (S11). In this case, the storage sheath 151 of the medical device 10 can be used instead of the guide sheath 220a, and the front chip 170 of the medical device 10 can be used instead of the dilator 220b. When the medical device 10 is used instead of the intubator 220 in this way, the next procedure can be performed without removing the medical device 10 after the perforation Hh is dilated by the front chip 170. Alternatively, the front end of the medical device 10 can also be equipped with the function of puncturing the interatrial septum HA. Thus, the interatrial septum HA can be punctured by the medical device 10, and the perforation Hh can also be dilated.

[0160] Furthermore, the specific construction of the puncture instrument 230 used for penetrating the interatrial septum HA and the specific steps taken until the penetrating hole Hh are not limited to the contents described above.

[0161] Next, the practitioner performs the procedure of placing the expansion body 100 inside the through hole Hh (S12).

[0162] like Figure 10 As shown, the operator guides the medical device 10 along the guide wire 210. At this time, the operator inserts the front end of the medical device 10 (the front end of the shaft portion 150) into the through hole Hh. The through hole Hh is dilated by inserting the medical device 10.

[0163] like Figure 11 As shown, after the practitioner inserts the medical instrument 10 into the through hole Hh, the sheath 151 is retracted, exposing the expander 100. The expander 100 is positioned to extend in a direction approximately orthogonal to the opening direction of the through hole Hh (the vertical direction in the figure). At this time, the recesses 115 of the expansion portions 110, 120, 130, and 140 of the expander 100 are positioned inside the through hole Hh.

[0164] Next, the practitioner performs the procedure of expanding the through hole Hh (S13).

[0165] like Figure 12 As shown, the practitioner expands the expander 100 with it positioned inside the through hole Hh. The expander 100 expands the through hole Hh to a size larger than the diameter of the expander 220b or the diameter of the storage sheath 151. When the expander 100 expands, the expansion portions 110, 120, 130, and 140 contact the edge Hhe of the through hole Hh at four points. Therefore, the through hole Hh... Figure 16 The shape shown is expanded into a roughly polygonal shape (quadrilateral in the example). In the process of expanding the through-hole Hh (S13), the expansion and contraction of the expander 100 can be performed once or repeatedly while the expander 100 is positioned inside the through-hole Hh. By repeatedly expanding and contracting the expander 100, the biological tissue of the interatrial septum HA surrounding the edge Hhe of the through-hole Hh can be relaxed and made more susceptible to elastic deformation. Therefore, the practitioner can accurately expand the through-hole Hh to the desired size during the procedure using the expander 100. Figure 15 As shown, the maintenance treatment element 109 of each expansion portion 110, 120, 130, 140 maintains good contact with the edge Hhe (biological tissue near the edge Hhe) of the through hole Hh contained inside the recess 115 before and after the expansion of the expansion body 100.

[0166] When the dilator 100 expands, blood flow from the left atrium HLa to the right atrium HRa is maintained via the flow portion 108 formed in the dilator 100. Because the blood pressure in the left atrium HLa becomes greater than that in the right atrium HRa in patients with chronic heart failure due to myocardial hypertrophy of the left ventricle HLw, blood passing through the perforation Hh flows from the left atrium HLa to the right atrium HRa.

[0167] Next, the practitioner performs a procedure to check the blood circulation dynamics near the perforation Hh (S14).

[0168] like Figure 8 As shown, the operator, for example, delivers the blood circulation dynamics confirmation device 240 to the right atrium HRa via the inferior vena cava IV. The blood circulation dynamics confirmation device 240 can be, for example, a known echo catheter. The operator can display the echo image acquired by the blood circulation dynamics confirmation device 240 on a display device such as a monitor, and confirm the blood flow through the perforation Hh based on the display results. Furthermore, the blood circulation dynamics confirmation process can begin at any time before, during, or after the dilation of the perforation Hh. Additionally, the blood circulation dynamics confirmation process can be completed either after the perforation Hh has been dilated by the dilator 100 or at any other time.

[0169] The operator can confirm whether the blood circulation dynamics are as intended (whether the blood flow from the left atrium HLa to the right atrium HRa is the desired amount) by performing the above procedures. If the operator determines that the blood flow is less than desired based on the confirmation of blood circulation dynamics, the blood flow after the maintenance treatment described later may become insufficient; therefore, the expansion amount of the dilator 100 can be increased. On the other hand, if the operator determines that the blood flow is more than desired based on the confirmation of blood circulation dynamics, the blood flow after the maintenance treatment may become excessive; therefore, the expansion amount of the dilator 100 can be reduced.

[0170] Furthermore, the practitioner can, for example, assess blood circulation dynamics after expanding the dilator 100 with a relatively small amount of expansion, and then gradually increase the expansion amount of the dilator 100. By gradually increasing the size of the perforation Hh, it is possible to prevent the perforation Hh from deforming rapidly and drastically. This reduces the burden on the atrial septum HA. Moreover, it can prevent damage such as tearing from occurring in the biological tissue near the perforation Hh of the atrial septum HA. In addition, the procedure of assessing blood circulation dynamics can be appropriately performed each time the dilation procedure is completed.

[0171] Additionally, the practitioner can assess blood circulation dynamics after expanding the expander 100 with a relatively large amount of expansion, and then gradually reduce the expansion amount of the expander 100. In this way, by expanding the perforation Hh relatively large in the initial stage of expansion, it is possible to appropriately suppress the contraction of the perforation Hh due to the elastic deformation of the biological tissue after maintenance treatment.

[0172] Next, the practitioner performs a maintenance procedure (S15) to maintain the size of the through hole Hh.

[0173] like Figure 13 and Figure 15 As shown, the practitioner applies high-frequency energy to the edge Hhe of the through hole Hh by placing the maintenance treatment element 109, which is located on the recess 115 of the expander 100, near the edge Hhe of the through hole Hh using the maintenance treatment element 109. This high-frequency energy is used to burn (heat burn) the edge Hhe of the through hole Hh. During the burning process using the maintenance treatment element 109, the contact between the maintenance treatment element 109 located on the recess 115 and the edge Hhe of the through hole Hh is well maintained. When the biological tissue near the edge Hhe of the through hole Hh is burned by the maintenance treatment element 109, a modified portion Hd, formed by modifying the biological tissue, is formed near the edge Hhe. Because the biological tissue in the modified portion Hd becomes inelastic, the through hole Hh can maintain its shape after being expanded by the expander 100.

[0174] When heat is applied to the edge Hhe of the through hole Hh from the maintaining treatment element 109, each expansion portion 110, 120, 130, 140 contacts the edge Hhe and maintains its expanded state. Therefore, as Figure 16 As shown, after the maintenance treatment, the shape of the through hole Hh in top view becomes approximately polygonal. Additionally, the portion excluding the part with modified portion Hd formed by heat imparted by the maintenance treatment element 109 (in...) Figure 16 The portion extending in a roughly straight line between the modified portions Hd (as shown in the top view) is less affected by the heat supplied from the maintaining treatment element 109, and therefore has a smaller degree of scorching (degree of modification) compared to the modified portions Hd. In this way, by locally scorching multiple portions instead of the entire circumference of the edge portion Hhe of the through hole Hh, thrombosis around the through hole Hh can be prevented.

[0175] Furthermore, the maintenance treatment can also be performed while the expander 100 is expanding. Additionally, the maintenance treatment can also be performed while the expander 100 is rotating (see [reference]). Figure 16 (As shown by the arrow). At this time, the direction of rotation of the expander 100 is not particularly limited.

[0176] After calcination based on the maintenance treatment element 109, the periphery of the edge Hhe of the through hole Hh can be rapidly cooled using the blood passing through the through hole Hh. Therefore, the spread of the effect of the heat imparted by the maintenance treatment element 109 to the surrounding area of ​​the modified part Hd can be suppressed.

[0177] The maintenance treatment is not limited to heating based on maintenance treatment element 109 (heating based on high-frequency energy), but can also utilize microwave energy, ultrasonic energy, coherent light such as lasers, heated fluids, cooled fluids, methods of heating or cooling through chemical media, methods using heaters equipped with wires, methods of generating frictional heat, and methods using indwelling devices described later (see below). Figure 26 , Figure 27 ), based on the cutting method described later (see Figure 29 This can be implemented through methods such as combining them arbitrarily.

[0178] Next, the practitioner performs a procedure to check the blood circulation dynamics near the perforation Hh after the maintenance treatment is performed (S16).

[0179] The procedure for confirming blood circulation dynamics can be performed using the blood circulation dynamics confirmation device 240, as described above. After confirming the blood circulation dynamics near the perforation Hh following the maintenance treatment, if the blood flow through the perforation Hh is at the desired level, the operator removes the medical device 10 from the perforation Hh. When removing the medical device 10, the operator contracts the dilator 100, placing it within the storage sheath 151. Then, the medical device 10 is withdrawn from the body along the guidewire 210.

[0180] like Figure 14 As shown, the blood flow through the perforation Hh is adequately maintained even after the medical device 10 is removed from the perforation Hh. As previously described, in this embodiment, since the blood flow dynamics near the perforation Hh are monitored before and after maintaining the perforation Hh, the post-treatment blood flow can be adjusted to the desired level. As a result, the blood flow from the patient's left atrium HLa towards the right atrium HRa becomes appropriate, further improving the treatment effect of heart failure and reducing the burden on the patient after treatment.

[0181] For example, by checking the blood circulation dynamics near the perforation Hh after maintenance treatment, if the blood flow is less than desired, the operator can repeat the dilation of the perforation Hh or the maintenance treatment. By repeating these treatments, the size of the perforation Hh can be adjusted to achieve the desired blood flow. Furthermore, in the treatment using the medical device 10 of this embodiment, since the check of blood circulation dynamics, maintenance treatment, and dilation of the perforation Hh can be performed with the dilator 100 disposed within the perforation Hh, the above-described procedures can be performed at any time without changing the medical device 10. The operator can more accurately adjust the size of the perforation Hh to achieve the desired blood circulation dynamics by combining the above-described procedures.

[0182] For example, when performing a maintenance treatment again, the expansion body 100 can be rotated and the position of the maintenance treatment element 109 can be offset to form the modified portion Hd at different locations. By performing the treatment in this way, since the modified portion Hd can be formed at different locations on the edge Hhe of the through hole Hh, the shape of the through hole Hh after the maintenance treatment can be maintained more appropriately. In addition, for example, the temperature applied to the maintenance treatment element 109 can be changed for each expansion portion 110, 120, 130, 140, or the temperature applied to the maintenance treatment element 109 can be changed every time a maintenance treatment is performed.

[0183] As described above, the treatment method of this embodiment includes: (i) an expansion step of expanding a perforation Hh formed in the interatrial septum HA such that the right atrium HRa of a patient with heart failure is connected to the left atrium HLa; (ii) a confirmation step of confirming the blood circulation dynamics near the perforation Hh; (iii) a maintenance step of performing a maintenance treatment to maintain the size of the perforation Hh; and (iv) a confirmation step of confirming the blood circulation dynamics near the perforation Hh after the maintenance treatment.

[0184] Next, the function of this embodiment will be explained.

[0185] The medical device 10 of this embodiment includes: a shaft portion 150; an expandable and contractible expander 100 provided at the front end of the shaft portion 150; and a maintenance treatment element 109 disposed on the expander 100 and imparting energy to biological tissue. The expander 100 has a recess 115 in a direction that intersects the axial direction of the shaft portion 150 when it is expanded and deformed. The maintenance treatment element 109 is disposed in the recess 115.

[0186] The aforementioned medical device 10 prevents the maintenance treatment element 109 disposed in the recess 115 from dislodging from the treatment site by placing the recess 115 formed during the expansion and deformation of the dilator 100 in the treatment site (e.g., the edge Hhe of the through hole Hh formed in the interatrial septum HA). Thus, the practitioner using the medical device 10 can perform appropriate treatment based on the maintenance treatment element 109.

[0187] In addition, the expansion body 100 of the medical device 10 has a flow section 108 that allows blood to flow through the through hole Hh when a recess 115 is disposed in the through hole Hh formed in the patient's atrial partition HA.

[0188] According to the aforementioned medical device 10, the operator can prevent obstruction of blood flow through the perforation Hh during procedures such as placing the dilator 100 into the perforation Hh and performing dilation based on the dilator 100 or treatment based on the maintenance treatment element 109. Therefore, the burden on the patient's body caused by the closure of the perforation Hh can be reduced. In addition, since the operator can monitor the blood flow dynamics near the perforation Hh while the dilator 100 is placed inside the perforation Hh, the size of the perforation Hh can be adjusted appropriately.

[0189] In addition, the expansion body 100 of the medical device 10 has recesses 115 at different positions in the circumferential direction of the expansion body 100 in the expanded and deformed state, and the holding treatment element 109 is disposed on each of the plurality of recesses 115.

[0190] According to the aforementioned medical device 10, the surgeon can simultaneously apply heat to the biological tissue at the treatment site from the maintenance treatment element 109 disposed on each of the plurality of recesses 115 provided in the expander 100, thus enabling efficient surgical procedures. Furthermore, since the plurality of recesses 115 provided in the expander 100 are appropriately positioned relative to the treatment site, the desired site can be treated more reliably even when heat is applied to multiple sites simultaneously.

[0191] In addition, the expander 100 of the medical device 10 is composed of a pre-shaped linear component to form a recess 115 after expansion and deformation.

[0192] According to the aforementioned medical device 10, the operator can form a recess 115 in the expander 100 by performing an operation that expands and deforms the expander 100. Therefore, the operator can smoothly and easily perform the procedure using the expander 100.

[0193] Furthermore, the recess 115 of the expansion body 100 has: a bottom 115a; a front end side raised portion 115b formed on the front end side in the axial direction compared to the bottom 115a and rising from the bottom 115a in a direction intersecting the axial direction; and a base end side raised portion 115c formed on the base end side in the axial direction compared to the bottom 115a and rising from the bottom 115a in a direction intersecting the axial direction. Moreover, the holding and handling element 109 is disposed on the bottom 115a of the recess 115.

[0194] According to the aforementioned medical device 10, by arranging the expansion body 100 such that the treatment site (e.g., the edge Hhe of the through hole Hh formed in the interatrial septum HA) is accommodated in the recess 115, the operator can make the maintenance treatment element 109 disposed at the bottom 115a of the recess 115 more reliably contact the treatment site, thus enabling the operation to be performed smoothly.

[0195] Furthermore, the shaft portion 150 of the medical device 10 has a storage sheath 151 capable of housing the expanded body 100 in a retracted state, and a front-end chip 170 disposed on the front end side of the storage sheath 151, with its outer diameter decreasing towards the front end side. Moreover, the expanded body 100 is configured to protrude from the storage sheath 151 and can expand and deform in a state disposed between the storage sheath 151 and the front-end chip 170.

[0196] According to the aforementioned medical device 10, the operator can store the constricted dilator 100 within the storage sheath 151 and smoothly perform the delivery operation until the dilator 100 is delivered to the treatment site (e.g., the edge Hhe of the through hole Hh formed in the interatrial septum HA). Furthermore, by setting the dilator 100 to a state where it is delivered to the treatment site and the front-end chip 170 is positioned inward (distal) relative to the treatment site, the operator can easily position the dilator 100 relative to the treatment site by exposing it from the storage sheath 151. Moreover, by expanding the dilator 100 while it is positioned at the treatment site, the operator can position the maintenance treatment element 109 disposed in the recess 115 of the dilator 100 at the treatment site.

[0197] In addition, the treatment method of this embodiment includes: an expansion step of expanding the perforation Hh formed in the interatrial septum HA in a manner that connects the right atrium HRa and the left atrium HLa in patients with heart failure; a confirmation step of confirming the blood circulation dynamics near the perforation Hh; and a maintenance treatment step of maintaining the size of the perforation Hh.

[0198] Based on the above-described procedure, the surgeon can determine whether the perforation Hh formed at the desired size during surgery by monitoring the blood circulation dynamics near the perforation Hh in the atrial septum HA. This allows the surgeon to improve the treatment outcome for heart failure.

[0199] Next, the handling methods for the modified examples will be explained.

[0200] like Figure 17 As shown, the modified method includes a first expansion step (S23) and a second expansion step (S25) as expansion steps for the through hole. Steps other than those described above (S23, S25) are substantially the same as those described in the preceding embodiments, and therefore are omitted from the description. Furthermore, points not specifically mentioned can be performed using the same steps as those described above. In addition, in this modified example, the step (S24) for confirming blood circulation dynamics can be appropriately omitted.

[0201] like Figure 18 As shown, in the first expansion step (preparatory expansion step), the operator expands the expander 100 to a predetermined amount while it is positioned within the through-hole Hh. The operator then monitors the blood circulation dynamics near the through-hole Hh while the expander 100 is in its expanded state. At this time, by confirming whether the blood circulation dynamics have reached the desired size, the operator can obtain an indicator of the extent to which the expander 100 and the through-hole Hh will be expanded in the next step, the second expansion step (over-expansion step).

[0202] Next, as Figure 19 As shown, the practitioner performs the second expansion step. In the second expansion step, the expander 100 is expanded by a greater amount compared to when it was expanded in the first expansion step. The approximate standard for the amount of expansion of the expander 100 is adjusted after the maintenance treatment step (S26) to consider the amount of contraction that the perforation Hh would experience due to the elastic deformation of the biological tissue. Specifically, in the second expansion step, the amount of contraction that would occur when expanding a membranous tissue such as an interatrial septum (during physical expansion) is considered, and after the maintenance treatment is completed, the amount of expansion (expansion diameter) of the expander 100 is set so that the size (inner diameter) of the perforation Hh is the same as the amount of expansion during the first expansion step.

[0203] After the practitioner performs the second expansion procedure, as Figure 20 The maintenance treatment is performed as shown. Similar to the previous embodiment, a modified portion Hd is formed at the edge Hhe of the through hole Hh by performing the maintenance treatment. After performing the maintenance treatment, as shown... Figure 21As shown, the expander 100 is removed from the through hole Hh. When the expander 100 is removed from the through hole Hh, the through hole Hh shrinks due to the elastic deformation of the biological tissue. The size of the through hole Hh becomes the same as the size expanded during the first expansion process.

[0204] Next, the surgeon confirms the blood circulation dynamics near the perforation Hh and confirms whether the blood flow from the left atrium HLa to the right atrium HRa has become the desired amount.

[0205] As described above, in this modified treatment method, since an over-dilation process based on the dilator 100 is performed before the maintenance treatment, the decrease in blood flow due to the elastic contraction of the biological tissue can be suppressed. Therefore, after the dilator 100 is removed from the perforation Hh, the blood circulation dynamics are maintained at approximately the same level as those confirmed during the first dilation process. Thus, the blood flow from the patient's left atrium HLa to the right atrium HRa becomes appropriate, further improving the treatment effect of heart failure and reducing the burden on the patient after treatment.

[0206] Furthermore, in the modified treatment method, for example, it is possible to perform a maintenance treatment while over-expanding the expander 100. Alternatively, it is possible to perform a maintenance treatment while rotating the expander 100. Furthermore, it is also possible to over-expand the expander 100 again after the maintenance treatment, and then perform the maintenance treatment again. In this case, the practitioner can also perform the maintenance treatment at a position different from the position where the modified portion Hd has been formed by rotating the expander 100 and adjusting the position of the maintenance treatment element 109. Furthermore, the rotation of the expander 100, the over-expansion of the expander 100, and the maintenance treatment can be performed multiple times in this order, and the order can be appropriately changed to perform the treatment multiple times.

[0207] As described above, the treatment method of this modified example includes: (i) a first expansion step of expanding the perforation Hh formed in the interatrial septum HA in a manner that connects the right atrium HRa and the left atrium HLa in a patient with heart failure; (ii) a second expansion step of expanding the perforation Hh to a greater extent than the first expansion step (increasing the expansion diameter); and (iii) a step of maintaining the perforation Hh after the second expansion step.

[0208] Next, modified medical devices and other treatment methods will be described. Furthermore, the treatment using the devices or components described below can be appropriately incorporated into the aforementioned treatment methods. Figure 6 , Figure 17 ), and can also be appropriately replaced with the corresponding treatments.

[0209] Figure 22 and Figure 23 The medical device of variant 1 is shown.

[0210] like Figure 22 and Figure 23 As shown, in this modified medical device, a holding and handling element 109 is provided on the front end side upright portion 315b of the recess 315 of the expander 300. Furthermore, although in Figure 22 , Figure 23 The illustration is simplified, but the front end side of the raised portion 315b of the recess 315 of each expansion portion 320, 330, 340 other than the first expansion portion 310 of the expansion body 300 is also provided with a holding and handling element 109.

[0211] The front side upright portion 315b is formed as a dimension in the height direction ( Figure 23 The vertical dimension is larger than that of the base-side upright portion 315c. The bottom 315a extends between the front-side upright portion 315b and the base-side upright portion 315c.

[0212] When performing maintenance treatment on the through hole Hh, such as Figure 23 As shown, a holding element 109 is positioned relative to the edge Hhe (the edge of the front end side in the insertion direction of the expansion body 100) of the through hole Hh. During this positioning, the operator, for example, temporarily positions the holding element 109 positioned in the recess 315 relative to the through hole Hh on the front end side (right side in the figure) and then moves the expansion body 100 towards the base end side (left side in the figure), thereby positioning the holding element 109 at the edge Hhe of the through hole Hh.

[0213] As shown in this modified example, by placing the maintenance treatment element 109 on the front end side of the recess 315 erected portion 315b, the contact area between the maintenance treatment element 109 and the edge Hhe of the through hole Hh can be increased. Therefore, the size of the through hole Hh after maintenance treatment can be appropriately maintained.

[0214] Furthermore, the holding element 109 can also be disposed, for example, on the base-end side upright portion 315c. In this case, the base-end side upright portion 315c can be formed, for example, with a dimension in the height direction ( Figure 23 The vertical dimension is larger than that of the front end side erected portion 315b. In addition, in this configuration, when the maintenance treatment element 109 is positioned at the edge Hhe of the through hole Hh, the operator, for example, after temporarily positioning the maintenance treatment element 109 positioned at the base end side (left side in the figure) compared to the through hole Hh, moves the expansion body 100 towards the front end side (right side in the figure), thereby enabling the maintenance treatment element 109 to be positioned at the edge Hhe of the through hole Hh.

[0215] Furthermore, the configuration of the maintaining disposal element 109 can be extended in the aforementioned embodiment's expansion body 100 (refer to...) Figure 15 The positions described in the diagram, such as those of the front end side upright portion 315b or the base end side upright portion 315c, can be appropriately combined. For example, when the expander has multiple expanders, the above-described configurations can be appropriately combined to form an expander.

[0216] Figure 24 and Figure 25 The medical device of variant 2 is shown.

[0217] In the medical device 10 of the aforementioned embodiment, each expansion portion 110, 120, 130, and 140 is arranged in a manner that does not overlap with the central axis C1 of the shaft portion 150 in the vertical and horizontal directions when viewed from the front (see reference). Figure 4 and Figure 5 On the other hand, in this modified example, the expansion portions 110, 120, 130, and 140 are arranged such that the opposing expansion portions overlap each other in the vertical or horizontal direction when viewed from the front. When the expansion portions 110, 120, 130, and 140 are arranged in this way, although it becomes difficult to achieve miniaturization of the sheath 151, the use of the expansion body 100 can be carried out smoothly.

[0218] Figure 26 and Figure 27 A variation of the maintenance treatment is shown.

[0219] In the aforementioned embodiments, the maintenance treatment utilizes the effect of the maintenance treatment element 109 disposed in the expansion body 100 on imparting heat to the biological tissue to form a modified portion Hd (see reference). Figure 15 However, the maintenance treatment is only required to maintain the through hole Hh at the desired size, and the specific method is not limited. For example, as shown in this modified example, the size of the through hole Hh can also be maintained by using a prescribed retainer or the like.

[0220] like Figure 26 As shown, during the maintenance process, the size of the through hole Hh can be maintained by placing a specified component 391 at the edge Hhe of the through hole Hh. The component 391 can be, for example, a clip-on component made of a biocompatible material, a spiral component, or a support component that inserts into the entire through hole Hh.

[0221] In addition, for example Figure 27As shown, in the maintenance process, the size of the through-hole Hh can also be maintained by placing a material 392, such as a gel or adhesive made of a biodegradable material, at the edge Hhe of the through-hole Hh. Furthermore, known materials can be used as the biodegradable material. Alternatively, for example, a biocompatible material or a suture made of a biodegradable material can be used to suture the edge Hhe of the through-hole Hh, thereby maintaining the size of the through-hole Hh.

[0222] Furthermore, components 391 reserved to maintain the size of the through hole Hh, or various materials 392 reserved at the edge Hhe of the through hole Hh, can be mounted on the recess 115 of the expander 100 (see reference). Figure 2 It is delivered to the through hole Hh.

[0223] In addition, for example Figure 28 and Figure 29 As shown, maintenance treatment can also be performed using an expansion body 100 with a specified cut-off portion 116.

[0224] exist Figure 28 The expansion body 100 shown has a cut-off portion 116 disposed on the front end side of the recess 115, forming a raised portion 115b. For example, Figure 28 As shown, the expander 100 is moved towards the base end side (left side in the figure) from the state where the front end upright portion 115b is positioned at the front end side of the through hole Hh (right side in the figure), as... Figure 29 As shown, a cutting portion Hc can be formed at the edge Hhe of the through hole Hh. Because the cutting portion Hc formed by the truncated portion 116 becomes less susceptible to elastic shrinkage of biological tissue, the through hole Hh can be maintained at a certain position. Figure 29 The shape shown.

[0225] Furthermore, the cutting portion 116 can be constructed, for example, from a knife, electric knife, laser knife, or the like, having a blade surface formed in a sharp shape. Additionally, the cutting portion 116 can be combined with the aforementioned holding and handling element 109 within an expansion body 100. Furthermore, the cutting portion 116 can also be disposed, for example, in the base-end side of the recess 115's upright portion 115c. In this configuration, for example, a cutting portion Hc can be formed at the edge Hhe of the through hole Hh by moving the expansion body 100 towards the front end.

[0226] Figure 30 A variation of the procedure for confirming the dynamics of blood circulation is shown.

[0227] In the foregoing embodiments, an example of confirming blood circulation dynamics near the through-hole Hh using a blood circulation dynamics confirmation device 240 (e.g., an echo catheter) disposed in the right atrium HRa was described. However, confirmation of blood circulation dynamics can also be performed, for example, using pressure measurement catheters 250 and 260. Specifically, as Figure 30 As shown, a pressure measuring catheter 250 is advanced from the inferior vena cava IV to the right atrium HRa, and further advanced from the inferior vena cava IV, right atrium HRa, and through the perforation Hh to the left atrium HLa. The operator obtains the pressure (blood pressure) of the right atrium HRa and the left atrium HLa through the pressure measuring catheters 250 and 260, and displays the obtained pressures on a monitor. The operator can then use the monitor display to confirm the pressure difference between the right atrium HRa and the left atrium HLa to monitor blood circulation dynamics.

[0228] For pressure measurement catheters 250 and 260, known catheter devices can be appropriately used. Furthermore, pressure measurement catheter 250, delivered to the left atrium HLa, can be, for example, via the guidewire lumen 159 of medical device 10 (see reference). Figure 3 Delivery. Furthermore, confirmation of blood circulation dynamics can also be achieved, for example, by inserting an echo catheter into the esophagus and obtaining echo images of the heart from the esophageal side.

[0229] Next, an example of an expansion body for expanding a through-hole Hh will be described.

[0230] The dilators described below have the function of dilating the perforation Hh and the function of not obstructing blood flow to the perforation Hh when placed in the perforation Hh. Therefore, by using the dilators described below, it is possible to confirm the dynamics of blood circulation near the perforation Hh while the dilator is inserted into the perforation Hh.

[0231] Figure 31 The expansion body 400 shown has an expandable frame (strut) 410 and a flow portion 408 formed by gaps formed in the frame 410. The expansion body 400 can be manufactured, for example, by forming a prescribed pattern of cuts in a metal pipe.

[0232] Figure 32 The expansion body 500 shown has a main body 510 composed of multiple wires and a flow section 508 composed of holes connecting the inside and outside of the main body 510.

[0233] Figure 33 The expansion body 600 shown has a main body 610 made of plate-shaped (e.g., flat plate-shaped) components and a flow portion 608 made of gaps formed in the main body 610.

[0234] Figure 34 The expansion body 700 shown has a main body 710 composed of a plate-like member and a flow portion 708 composed of holes formed in the main body 710. The front end portion of the main body 710 ( Figure 34 The right side of the cone is formed into a shape that tapers towards the front end.

[0235] Figure 35 and Figure 36 The expander 800 shown has multiple expandable portions 810, 820, 830, and 840 formed from plate-like members. In the contracted state, the expander 800 is arranged such that each of the expandable portions 810, 820, 830, and 840 is wound circumferentially along the shaft portion 150. Figure 36 (The state is shown by the dashed line). When the expander 800 expands, gaps constituting the flow section 808 are formed between each of the expansion sections 810, 820, 830, and 840.

[0236] Figure 37 and Figure 38 The expander 900 shown has multiple expandable portions 910, 920, 930, and 940, each composed of a balloon. In the contracted state, the expander 900 is arranged such that each expandable portion 910, 920, 930, and 940 is wound circumferentially around the shaft portion 150. Figure 38 (The state shown by the dashed line). For example, when fluid is supplied to the expander 900 via the shaft 150, etc., as... Figure 38 As shown, each expansion portion 910, 920, 930, and 940 expands, thereby expanding the through hole Hh. Furthermore, when the expander 900 expands, gaps constituting the flow portion 908 are formed between each expansion portion 910, 920, 930, and 940. The specific shape of the expansion portion (balloon) 900 is not particularly limited to that shown in the illustration.

[0237] As described above, the expander used in the expansion of the through-hole Hh can be inserted into the through-hole Hh, and its shape, material, and specific structure are not particularly limited, as long as it does not obstruct the blood flow through the through-hole Hh. For example, as long as it is Figure 37 The balloon structure shown allows for expansion of the expander via fluid supply. Furthermore, when the expander is constructed using a self-expanding material, expansion / contraction can be achieved by manipulating the expander's protrusion from the sheath or similar component. Additionally, the expander can be configured to be detachable from the shaft or similar component and can be positioned within a through-hole.

[0238] The medical device and treatment method of the present invention have been described above through various embodiments and modifications. However, the present invention is not limited to the contents described in the embodiments, but can be appropriately modified based on the claims.

[0239] For example, the use of the medical device is not limited to the treatment of heart failure, but can be applied to various surgeries aimed at maintaining treatment elements. Furthermore, it is possible to appropriately omit the additional components described in the embodiments, and in particular to add additional components that are not described.

[0240] Furthermore, one approach to the treatment method may include at least the following steps: an expansion step of dilating the perforation formed in the interatrial septum; a confirmation step of confirming the blood circulation dynamics near the perforation; and a maintenance step of maintaining the size of the perforation. Other approaches to the treatment method may include at least the following steps: a first expansion step of dilating the perforation formed in the interatrial septum; a second expansion step of dilating the perforation to a greater extent than the first expansion step; and a maintenance step of maintaining the perforation after the second expansion step.

[0241] In addition, the above-mentioned treatment methods can also be widely applied to heart failure caused by increased blood pressure on the left atrial side, heart failure caused by increased blood pressure on the right atrial side, and symptoms of general heart failure (including cases other than diastolic heart failure).

[0242] This application is based on Japanese Patent Application No. 2017-131216, filed on July 4, 2017, the disclosure of which is incorporated herein by reference in its entirety.

Claims

1. A medical device, characterized in that, have: Shaft portion; An expandable and contractible expansion body is provided at the front end of the shaft portion; and Maintenance treatment elements configured in the expansion body to perform prescribed maintenance treatments on biological tissues. The expander has a recess that is recessed in a direction intersecting the axial direction of the shaft portion. The maintenance treatment element is an energy transfer element capable of transferring energy to the edge of the through hole when the recess is provided in the through hole formed in the patient's room partition. The expansion amount of the expander can be increased when the recess is provided in the through hole formed in the patient's room partition.

2. The medical device according to claim 1, characterized in that, The expansion has a flow portion that allows blood to flow through the through-hole when the recess is provided in the through-hole formed in the patient's atrial partition.

3. The medical device according to claim 1 or 2, characterized in that, The expander has the recess at multiple different locations in the circumferential direction of the expander. The maintenance treatment element is disposed in each of the plurality of recesses.

4. The medical device according to any one of claims 1 to 3, characterized in that, The expander is composed of pre-shaped linear components in such a way that the recess is formed during expansion deformation.

5. The medical device according to claim 4, characterized in that, The recess of the expansion body has: bottom; A front end portion formed on the axial direction relative to the bottom, and rising from the bottom in a direction intersecting the axial direction; and Compared to the bottom, a base-end side formed in the axial direction and rising from the bottom in a direction intersecting the axial direction, is a base-end side upright portion. The maintenance and handling element is disposed on at least one of the bottom and the front side upright portion.

6. The medical device according to claim 5, characterized in that, The front end side upright portion and the base end side upright portion are formed such that their height dimensions are approximately the same in the direction intersecting the axial direction. The maintenance and treatment elements are located at the bottom.

7. The medical device according to claim 5, characterized in that, Compared to the base-end erected portion, the front-end side erected portion has a larger height dimension in the direction intersecting the axial direction. The maintenance and treatment element is disposed on the front side upright portion.

8. The medical device according to any one of claims 1 to 7, characterized in that, The expander has multiple expandable portions capable of expanding and contracting. Each of the plurality of expansion portions is not positioned relative to the central axis of the shaft portion in the circumferential direction.

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