JP4728064B2 - In vivo pressure measurement device - Google Patents

Description

  In the present invention, an in-vivo pressure measuring device in which the marker position is displaced by a change in external pressure is embedded in the body or blood vessel, and the position of the marker is measured by an image diagnostic device (for example, X-ray, ultrasound, CT, etc.). The present invention relates to an in-vivo pressure measuring device capable of remotely measuring an external pressure applied to the in-vivo pressure measuring device itself from outside the body. The in-vivo pressure measuring device of the present invention can non-invasively measure the blood pressure exerted on various organs in the body. The in vivo pressure measuring device of the present invention can be placed in an aneurysm closed by a stent graft, and the therapeutic effect can be determined by remotely measuring the blood pressure in the aneurysm.

In an aging society, aneurysms (see the image of the thoracic aorta 31 in FIG. 12, 33 is an aneurysm) and arterial dissection that are caused by arteriosclerosis are increasing. Conventionally, the treatment has been performed mainly in a surgical operation, but recently, a less invasive transcatheter endovascular treatment has attracted attention, and development of a new technique represented by a stent graft embedding method has been promoted. As illustrated in FIG. 13, the principle of the treatment is that the stent graft 32 is folded into a thin shape, stored in a sheath, transported into a blood vessel, and expanded and fixed to a healthy site on the central side and the peripheral side of the aneurysm 33 and the dissection space. As a result, the blood flow in the aneurysm 33 or the dissociation space is blocked to induce thrombosis, and decompression and revascularization in the aneurysm 33 or the dissociation space are achieved.
By the stent graft inserted and fixed in the blood vessel, the aneurysm 33 and the dissociation space are blocked from the blood flow, and the blood pressure is lowered, thereby eliminating the risk of expansion or rupture. Thus, the principle of treatment using the stent graft 32 for aneurysm 33 or artery dissection is to reduce the blood pressure applied to the lumen of the aneurysm or dissection.
However, if the stent graft cannot be securely fixed beyond the lesion site where there is an aneurysm or arterial dissection, and the central and peripheral healthy blood vessel sites can be securely fixed, or the fixed site will naturally expand in the remote stage after treatment. If the adhesion between the stent graft and the artery wall is poor, blood may leak into the aneurysm or dissection space from the gap between the stent graft and the artery wall to which the stent graft is fixed (end leak). Even if the blood flow and blood pressure between the aorta and the aneurysm or dissociation space can be blocked by stent grafting, narrow branch vessels (intercostal arteries, hips) that branch directly from the aneurysm or dissociation space from the beginning. If there is an artery or inferior mesenteric artery), blood will flow back from these branch arteries into the aneurysm or dissection space, and some blood pressure will be applied in the aneurysm or dissection space . In this case, blood pressure comparable to or lower than that of the original aorta is transmitted into the aneurysm or dissection space, and the original purpose expected for the stent graft is lost.

Therefore, conventionally, as a method for confirming that the stent graft is securely fixed and no blood flows into the aneurysm or dissection space, arteriography (DSA), computed tomography (CT), or ultrasound (Echo) inspection has been performed. However, these imaging tests can only visually observe the blood flow into the aneurysm or dissociation space, and blood pressure can be checked by confirming the leakage of blood into the aneurysm or dissociation space by these methods. You can estimate the existence, but you cannot measure it.
In order to solve this problem, after fixing the stent graft, a thin catheter is punctured or inserted into the aneurysm or dissection space from outside the body, and blood pressure in the aneurysm or dissection space is transmitted outside the body via the catheter and measured. There are ways to do it. For example, U.S. Patent No. 6,057,034 discloses an endoluminal device having a prosthesis and at least one indicator member added to the prosthesis, the prosthetic indicator member remotely providing suggestions regarding changes in the pressure or morphology of the prosthesis. An intraluminal device is described which is characterized by being monitored dynamically. However, the insertion or puncture of the catheter is temporary, and it is extremely difficult to continuously measure over a long period after treatment because there is a risk of infection or bleeding. For these reasons, there is no effective test method for determining the long-term results of stent grafts at this time other than confirming blood leakage using contrast CT images.
Special Table 2004-537353 (Claims)

  Currently, there are no effective methods for determining the therapeutic effect of aneurysms or arterial dissections using stent grafts other than confirming blood leakage and the size of the aneurysms or dissociation cavities using contrast CT images. The method cannot measure blood pressure and cannot predict the risk of an aneurysm or arterial dissection expanding and rupturing. In addition, there is a method in which a menstrual catheter is placed and blood pressure is measured from outside the body, but it is difficult to measure the blood pressure over a long period of time.

[1] In the present invention, the housing (2) has a head (9) and a tail (10),
The head (9) and tail (10) have a longitudinal direction and a side direction that intersects the longitudinal direction substantially perpendicularly,
The head (9) and the tail (10) have a first end as one end in the longitudinal direction, and a second end as the other end,
The head (9) has two first marker sheets (3, 1) and two second marker sheets (3, 2), and the first marker sheet (3.1) and the second marker sheet (3.1). 2) seal the outer periphery,
The first marker sheet (3.1) and the second marker sheet (3.2) are each formed by sandwiching a flat marker (4) between two thin layer sheets (S). Welding the outer periphery of the thin layer sheet (S), enclosing the marker (4) in the two thin layer sheets (S),
Enclose the first marker (4.1) in the first marker sheet (3.1), enclose the second marker (4.2) in the second marker sheet (3.2),
Said head (9) has an opening (9.2) at its second longitudinal end;
The tail (10) is formed from a tubular member (6), and the tubular member (6) has a first opening (6.1) at a first end in the longitudinal direction,
A first end side in the longitudinal direction of the tail (10) is attached to a second end side in the longitudinal direction of the head (9),
Gas is filled until the inside of the head (9) and the tail (10) reaches an internal pressure (PI) close to the in vivo pressure to be measured, and the second end in the longitudinal direction of the tail (10) is sealed. And seal
The first marker sheet (3.1) and the second marker sheet (3.2) of the head (9) have an internal pressure (PI) in the head (9) and tail (10), Formed from a material that deforms in response to changes in external pressure (PO) around the head (9),
When the external pressure (PO) is larger than the internal pressure (PI), the first marker sheet (3.1) and the second marker sheet (3.2) are in the internal direction of the head (9). The first marker (4.1) and the second marker (4.2) are displaced in a direction approaching each other.
When the internal pressure (PI) is greater than the external pressure (PO), the first marker sheet (3.1) and the second marker sheet (3.2) are directed outward from the head (9). The first marker (4.1) and the second marker (4.2) are displaced in a direction away from each other.
By detecting the displacement of the distance between the first marker (4 · 1) and the second marker (4 · 2) by an image diagnostic apparatus, the external pressure around the head (9) is remotely detected. An in-vivo pressure measuring device (1) capable of measuring (PO) is provided.
[2] The present invention provides the in-vivo pressure measuring device (1) according to [1], which can be attached to a strut constituting the stent graft (32) by connecting with a metal wire .
[3] The present invention has a cylindrical housing (22),
The housing (22) has a longitudinal direction and a side direction that intersects the longitudinal direction substantially perpendicularly,
The housing (22) has, in the longitudinal direction, a first end as one end and a second end as the other end,
The housing (22) has a first end closed and a second end having an opening (26),
On the first end side, a flat plate-like first marker (24.1) is arranged,
On the second end side, a flat plate-like second marker (24.2) is arranged,
Attach the plug (25) to the second marker (24.2),
A stopper (27) is attached to the second end, and the stopper (27) prevents the second marker (24, 2) and the plug (25) from coming off from the second end. And
The housing (22) is filled with gas between the first marker (24, 1) and the plug (25) until the internal pressure (PI) close to the in-vivo pressure to be measured is reached. Gas is sealed between the first marker (24 • 1) and the stopper (25),
The housing (22) is formed of a hard material,
When the external pressure (PO) is larger than the internal pressure (PI), the plug (25) is displaced in a direction approaching the first end of the housing (22). The two markers (24 · 2) and the first marker (24 · 1) are displaced in a direction approaching each other,
When the internal pressure (PI) is larger than the external pressure (PO), the plug (25) is displaced in a direction approaching the second end side of the housing (22), and accordingly the first pressure is increased. The two markers (24 · 2) and the first marker (24 · 2) are displaced in directions away from each other,
By detecting the displacement of the distance between the first marker (24 · 1) and the second marker (24 · 2) by an image diagnostic apparatus, the external pressure (PO) around the housing (22) is remotely detected. An in-vivo pressure measuring device (21) capable of measuring
[4] The present invention provides the in-vivo pressure measuring device (21) according to [3], which can be attached to a strut constituting the stent graft (32) by connecting with a metal wire .

(1) The in-vivo pressure measuring device of the present invention is placed in an aneurysm or dissection space through a thin sheath, or connected to a stent graft, and is placed in the aneurysm or dissection space at the same time as the stent graft. Detect blood pressure in aneurysms or dissociation spaces, and detect or measure blood pressure changes indirectly by capturing marker displacement with an image diagnostic device (eg, fluoroscopy, X-ray imaging, CT imaging, etc.) be able to. Since the in-vivo pressure measuring device of the present invention can be placed semipermanently in an aneurysm or in a dissociation space, X-ray photography, CT photography, echo, etc. are performed at any time for a long period of time, and the course of aneurysm or arterial dissection Can be observed.
(2) If the blood pressure increase in the aneurysm or dissociation space is confirmed by pressure measurement, blood leakage is confirmed by contrast CT and appropriate treatment such as re-stent graft insertion or surgical repair is performed. Can be implemented. As a result, an aneurysm or dissection space that is seen in a remote stage can be prevented in advance, which is a useful diagnostic tool for many arterial disease patients.

  FIG. 1 is a schematic view of an in-vivo pressure measuring device of the present invention [(A) is a front view, (B) is a side view], FIG. 2 is a schematic view of the in-vivo pressure measuring device of the present invention (manufacturing process 1), FIG. Fig. 4 is a schematic diagram of the in-vivo pressure measuring device of the present invention (manufacturing process 2), Fig. 4 is a schematic diagram of the in-vivo pressure measuring device of the present invention (manufacturing step 3), and Fig. 5 is a schematic diagram of the in-vivo pressure measuring device of the present invention. Manufacturing process 4), FIG. 6 is a schematic diagram of the in-vivo pressure measuring device of the present invention (completed drawing after the manufacturing process is completed), FIG. 7 is a schematic diagram showing another embodiment of the in-vivo pressure measuring device of the present invention, FIG. FIG. 1 is a schematic diagram showing an operation example of the in-vivo pressure measuring device of FIG. 7, FIG. 9 is a schematic diagram showing an operation example of the in-vivo pressure measuring device of FIG. 7, and FIG. 10 is an operation example of the in-vivo pressure measuring device of FIG. FIGS. 3 and 11 are schematic views showing an in-vivo pressure measuring device placed in a thoracic aortic aneurysm.

[Principle of the in-vivo pressure measuring device of the present invention]
The in-vivo pressure measuring device according to the present invention includes at least two markers 4 (first marker 4 • 1, second marker 4 • 2) , first marker 24 • 1, and second marker 24 • 2 in housings 2 and 22. The change of the pressure inside and outside the housing 2, 22 is embedded, and at least one of the markers (first marker 4, 1, second marker 4, 2) , first marker 24, 1, second marker 24 is embedded. Detecting by using the diagnostic imaging device by the displacement of 2 .
[Outline of in-vivo pressure measuring device 1]
As illustrated in FIG. 1, the in-vivo pressure measuring device 1 of the present invention seals a gas inside a housing 2 in which a marker 4 (first marker 4 • 1, second marker 4 • 2) is mounted. 2 is formed of a material that deforms in response to an external pressure change, and the marker 4 (first marker 4. 1, second marker 4. 2) moves with deformation of the housing 2, and the marker 4 (first marker 4 . The in- vivo pressure measuring device 1 can remotely measure the pressure outside the device by detecting the movement of the one marker 4 · 1, the second marker 4 · 2) by a living body penetrating device (X-ray, ultrasonic wave or CT). It is.
[In-vivo pressure measuring device 1]
Further, the in-vivo pressure measuring apparatus 1 will be described with reference to the descriptions of FIGS.
The housing 2 has a head portion 9 and a tail portion 10 as shown in FIGS.
The head 9 and the tail 10 have a longitudinal direction and a side direction that intersects the longitudinal direction substantially perpendicularly.
The head portion 9 and the tail portion 10 have a first end portion as one end portion and a second end portion as the other end portion in the longitudinal direction.
The head 9 has two first marker sheets 3 and 1 and two second marker sheets 3 and 2 stacked to seal the outer periphery of the first marker sheet 3 and the second marker sheet 3 and 2. [Refer to FIGS. 3 and 6, where 5 is a (heat) seal part]
2 and 3, each of the first marker sheet 3 · 1 and the second marker sheet 3 · 2 includes a flat marker 4 (first marker 4 · 1) between two thin layer sheets S. , The outer periphery of the two thin layer sheets S is welded, and the marker 4 (first marker 4. Markers 4 and 2) are enclosed.
The first marker 4 · 1 is enclosed in the first marker sheet 3 · 1, and the second marker 4 · 2 is enclosed in the second marker sheet 3 · 2.
As shown in FIG. 6, the head 9 has an opening 9.2 at the second end in the longitudinal direction.
As shown in FIGS. 1 and 4 to 6, the tail portion 10 is formed from a tubular member 6, and the tubular member 6 is formed at the first end 6. 1 at the first end in the longitudinal direction and at the second end. It has a second opening 6.2.
A first end portion side in the longitudinal direction of the tail portion 10 is attached to a second end portion side in the longitudinal direction of the head portion 9.
The inside of the head 9 and the tail 10 is filled with gas until the internal pressure PI is close to the in-vivo pressure to be measured, and the second end in the longitudinal direction of the tail 10 is sealed and sealed.
In the first marker sheet 3. 1 and the second marker sheet 3 2 of the head 9, the internal pressure PI in the head 9 and the tail 10 is deformed in response to a change in the external pressure PO around the head 9. It is made of material.
When the external pressure PO is larger than the internal pressure PI, the first marker sheet 3 · 1 and the second marker sheet 3 · 2 are deformed so as to contract toward the inside of the head 9, and accordingly, the first marker 4 -1 and 2nd marker 4 * 2 are displaced to the direction which approaches mutually.
When the internal pressure PI is larger than the external pressure PO, the first marker sheet 3 · 1 and the second marker sheet 3 · 2 are deformed so as to expand toward the outside of the head 9, and accordingly, the first marker 4 1 and the second markers 4 and 2 are displaced in directions away from each other.
By detecting the displacement of the distance between the first marker 4 · 1 and the second marker 4 · 2 by the image diagnostic apparatus, the external pressure PO around the head 9 can be measured remotely .
The in-vivo pressure measuring device 1 can be manufactured as illustrated in FIGS.
First, a marker sheet 3 (first marker sheet 3.1, second marker sheet 3.2 ) sandwiching a marker 4 (first marker 4.1, second marker 4.2 ) between two sheets S The two marker sheets 3 (first marker sheet 3 • 1, second marker sheet 3 • 2) are overlapped and heat-sealed (in FIG. 3, reference numeral 5 denotes a substantially circular heat seal portion). ).
A tubular member 6 is inserted from the lower part (second end) between the two marker sheets 3 ( first marker sheet 3 . The surroundings are further heat sealed (in FIG. 4, reference numeral 7 is a heat seal portion).
Furthermore, as illustrated in FIG. 5, two marker sheets 3 (first marker sheet 3. 1, second marker ) molded into a bag shape by heat sealing from the lower part (second end part) of the tubular member 6. Gas is introduced into the sheets 3 and 2) , and the lower part of the tubular member 6 (second opening 6.2 at the second end) is heat-sealed (in FIG. 5, reference numeral 8 is a heat-seal part). The first opening 6.1 at the first end communicates with the opening 9.2 of the head 9.

[In-vivo pressure measuring device 21]
Further, as illustrated in FIG. 7, the in-vivo pressure measuring device 21 of the present invention seals the first marker 24. 1 and gas inside a housing 22 having an opening 26 formed at one end thereof. A plug body 25 fitted with the second markers 24 and 2 is enclosed inside.
A stopper 27 is mounted in the vicinity of the opening 26 so that the plug 25 does not come off the housing 22.
The opening 26 is closed by the plug body 25, but the second marker 24. 2 is displaced inside the housing 22 due to fluctuations in the internal pressure and the external pressure of the housing 22, and the second marker 24. By detecting the displacement by the biological permeation device, the pressure outside the device can be measured remotely.
Furthermore, the in-vivo pressure measuring device 21 will be described with reference to the description of FIGS.
The in-vivo pressure measuring device 21 has a cylindrical housing 22 as shown in FIGS.
The housing 22 has a longitudinal direction and a side direction that intersects the longitudinal direction substantially perpendicularly.
The housing 22 has a first end portion as one end portion and a second end portion as the other end portion in the longitudinal direction.
The housing 22 is closed at the first end and has an opening 26 at the second end.
A flat first marker 24. 1 is arranged on the first end side, and a flat second marker 24. 2 is arranged on the second end side.
A plug body 25 is attached to the first end portion side of the second marker (24.2).
A stopper 27 is attached to the second end. The stopper 27 prevents the second markers 24, 2 and the plug body 25 from being detached from the second end.
The housing 22 is filled with gas between the first marker 24. 1 and the plug body 25 until the internal pressure PI is close to the in-vivo pressure to be measured, and the first marker 24. 1 and the plug body are filled. 25 is sealed with gas.
The housing 22 is made of a hard material.
When the external pressure PO is larger than the internal pressure PI, the plug body 25 is displaced in a direction approaching the first end of the housing 22, and accordingly, the second marker 24. 2 and the first marker 24. Displace in the direction of approaching each other.
When the internal pressure PI is greater than the external pressure PO, the plug body 25 is displaced in a direction approaching the second end side of the housing 22, and accordingly, the second marker 24. 2 and the first marker 24. , They are displaced in directions away from each other.
The external pressure PO around the housing 22 can be measured remotely by detecting the displacement of the distance between the first marker 24. 1 and the second marker 24.

[Materials for in-vivo pressure measuring devices 1 and 21]
The material of the sheet S constituting the housing 2 is preferably a sterilizable material such as polytetrafluoroethylene (PTFE), polyethylene, or polypropylene film (which may be subjected to metal deposition or the like).
In short, when the sheet S is formed into a bag shape or a balloon shape and sealed with a gas (carbon dioxide gas or the like) to form a housing 2 having a predetermined internal pressure, the housing 2 responds to a change in external pressure. Any material that deforms (for example, the housing 2 contracts if the external pressure is higher than the internal pressure of the housing 2 and expands if the external pressure is lower than the internal pressure of the housing 2) may be used.
The housing 22 may be anything that is hard and sterilizable.
[Operational principle of in-vivo pressure measuring device 1]
The in-vivo pressure measuring apparatus 1 can remotely measure the deformation of the housing 2 and the displacement of the marker 4 (first marker 4 • 1, second marker 4 • 2) by X-ray, ultrasound or CT. The pressure around the in-vivo pressure measuring device 1 can be measured remotely. It is also possible to calculate a specific pressure by measuring and converting the deformation amount of the housing 2 and the displacement amount of the marker 4 (the first marker 4 • 1, the second marker 4 • 2) .
[Operational principle of in-vivo pressure measuring device 21]
The in-vivo pressure measuring device 21 can remotely measure the pressure around the in-vivo pressure measuring device 21 by remotely measuring the displacement of the second markers 24, 2 by X-rays, ultrasonic waves, or CT. It is also possible to calculate a specific pressure by measuring and converting the displacement amount of the second marker 24.
[Marker]
Said marker (4, 1,4, 2,, 24, and 1, 24, 2) to be mounted or encapsulated in a living body pressure measuring apparatus 1, 21 of the present invention, the image diagnosis apparatus, as long as it can detect the displacement The material (stainless steel, gold, platinum, etc.) and shape can be anything.

[In-vivo pressure measuring device placement method in the body]
An example of a method for placing the in-vivo pressure measuring devices 1 and 21 of the present invention in an aneurysm will be described below with reference to FIG. The in-vivo pressure measuring device 1 is compressed and folded, and the in-vivo pressure measuring device 21 is stored in a thin and flexible tube (hereinafter referred to as “pressure measuring sheath”) as it is.
An incision is made in the buttocks, the femoral artery 31 is exposed, and about half of the femoral artery 31 is incised. A pressure measurement sheath (not shown) is inserted from the cut femoral artery 31, and the tip of the pressure measurement sheath is inserted into the aneurysm 33 along the artery. At the same time, an incision is made on the opposite buttock, and the stent graft 32 is delivered to the aneurysm 33 in accordance with a normal stent graft placement technique. With the tip of the pressure measurement sheath inserted into the aneurysm 33, the stent graft 32 is opened and placed. Subsequently, the in-vivo pressure measurement device is opened from the distal end of the pressure measurement sheath into the aneurysm 33, and the pressure measurement sheath is extracted from the gap between the artery wall and the stent graft 32 and recovered outside the body.
As another indwelling method, the in vivo pressure measuring devices 1 and 21 are connected to the stent graft 32, and when the stent graft 32 is indwelled, the in vivo pressure measuring devices 1 and 21 are simultaneously placed in the aneurysm 33 or the dissection space. The method of doing is mentioned.
More specifically, the in-vivo pressure measuring devices 1 and 21 are connected to the struts constituting the stent graft 32 with metal wire wires or the like, and the in-vivo pressure measuring devices 1 and 21 are placed when the stent graft 32 is placed. It is guided and placed in the aneurysm 33. The connection position of the in vivo pressure measuring devices 1 and 21 to the stent graft 32 is as follows:
It can be set freely according to the position of the aneurysm 33 of the patient.
Since the in-vivo pressure measuring devices 1 and 21 can be placed semipermanently, they can be repeatedly measured over a long period of time.

Example 1
As illustrated in FIG. 2, two thin layer sheets are sandwiched between two thin layer sheets S made of polyethylene with a stainless marker 4 (first marker 4. 1, second marker 4. The marker sheet 3 (first marker sheet 3.1, second marker sheet 3.2) was created by heat-sealing the outer periphery of S. A marker 4 made of stainless steel, gold, or platinum was embedded in the two thin layer sheets S.
Further, as illustrated in FIG. 3, two of the marker sheets 3 (first marker sheet 3 • 1, second marker sheet 3 • 2) were overlapped and heat-sealed (welded) into a substantially circular shape by heat press. (Reference numeral 5 in FIG. 3 is a substantially circular heat seal portion).
Further, as illustrated in FIG. 4, a tubular member 6 made of polypropylene (a straw-shaped core rod) is interposed between the two marker sheets 3 (first marker sheet 3 • 1, second marker sheet 3 • 2 ). The both ends of the tubular member 6 were heat-sealed. (Reference numeral 7 in FIG. 4 is a heat seal portion).
Further, as illustrated in FIG. 5, carbon dioxide is filled from the lower part of the tubular member 6 into the housing 2 formed into a bag shape by heat sealing, the lower part of the tubular member 6 is heat sealed, and the outer periphery is trimmed. Thus, the in-vivo pressure measuring device 1 was completed (FIG. 6). The internal volumes of the head 9 and tail 10 were equal.
The in-vivo pressure measuring device 1 was placed in a glass desiccator, and the internal pressure of the desiccator was changed. In the description of this embodiment, the “internal pressure” of the desiccator is the external pressure (PO: scheduled to be measured) with respect to the gas pressure (internal pressure: PI) of carbon dioxide filled in the housing 2 of the in-vivo pressure measuring device 1. (Assuming in-vivo pressure).
If the internal pressure (external pressure: PO) in the desiccator is 40 mmHg or less, the housing 2 of the in-vivo pressure measuring device 1 is not deformed at all . If the internal pressure (external pressure: PO) in the desiccator is 80 mmHg or more, the in-vivo pressure measuring device 1 is complete. (Two first markers 4 · 1 and second markers 4 · 2 were brought into close contact with each other). When the internal pressure (external pressure: PO) in the desiccator is between 40 mmHg and 80 mmHg, the in-vivo pressure measuring device 1 deforms its shape according to the internal pressure , and the two first markers 4 increase as the internal pressure (external pressure: PO) increases. ・ The distance between 1 and the second marker 4 ・ 2 decreased.
Example 3
As illustrated in FIG. 7, a cylindrical housing 22 made of PTFE [cylindrical with bottom; one end is closed, and the other end is opened (opening 26 is formed). ] The first marker 24. 1 made of stainless steel, platinum, or gold was attached to the bottom (first end portion side) of [].
Further, a stainless steel or gold second marker 24, 2 was attached to the plug 25 made of silicone rubber, and inserted into the housing 22 through the opening 26. A stopper 27 was attached to the opening 26 so that the plug 25 was not removed. Carbon dioxide was filled into the housing 22 at an internal pressure of 20 mmHg, and the in-vivo pressure measuring device 21 was completed.
The silicone rubber plug 25 is highly airtight but moves up and down within the housing 22 without resistance.
The in-vivo pressure measuring device 21 was placed in a glass desiccator, and the internal pressure of the desiccator was changed.
In the description of the present embodiment, the “internal pressure” of the desiccator is the external pressure (PO: scheduled to be measured) relative to the gas pressure (internal pressure: PI) of carbon dioxide filled in the housing 22 of the in-vivo pressure measuring device 21. (Assuming in-vivo pressure).
When the internal pressure (external pressure: PO) in the desiccator was 20 mmHg or less, the plug body 25 of the in-vivo pressure measuring device 21 did not move at all (see FIG. 8).
When the internal pressure (external pressure: PO) in the desiccator was 40 mmHg, the plug body 25 of the in-vivo pressure measuring device 21 moved to the intermediate position of the housing 22 (see FIG. 9).
When the internal pressure (external pressure: PO) in the desiccator is 80 mmHg, the plug body 25 of the in-vivo pressure measuring device 21 is further reduced to 1/4 from the intermediate position toward the bottom (first end side) of the housing 22 . It moved to the position of distance (refer FIG. 10).
Thus, it was confirmed that the pressure around the in-vivo pressure measuring device 21 can be measured from the moving distance of the second marker 24.

Schematic of the in-vivo pressure measuring device of the present invention [(A) is a front view, (B) is a side view] Schematic of the in-vivo pressure measuring device of the present invention (manufacturing process 1) Schematic of the in-vivo pressure measuring device of the present invention (manufacturing process 2) Schematic of the in-vivo pressure measuring device of the present invention (manufacturing process 3) Schematic of the in-vivo pressure measuring device of the present invention (manufacturing process 4) Schematic of the in-vivo pressure measuring device of the present invention (complete drawing after completion of the manufacturing process) Schematic which shows the other Example of the in-vivo pressure measuring apparatus of this invention. FIG. 1 is a schematic diagram illustrating an operation example of the in-vivo pressure measuring device of FIG. Schematic diagram showing an operation example of the in-vivo pressure measuring device of FIG. FIG. 3 is a schematic diagram showing an operation example of the in-vivo pressure measuring device of FIG. Image of in-vivo pressure measurement device placed in a thoracic aortic aneurysm Chest aortic aneurysm image Image of treatment of thoracic aortic aneurysm with stent graft

Explanation of symbols

1 In vivo pressure measuring device 2 Housing S sheet
3-1 first marker sheet
3 · 2 second marker sheet 4 marker
4-1 first marker
4 - 2 second marker 5 heat-sealed portion 6 the tubular member (core rod)
6.1 First opening
6.2 Second opening 7, 8 Heat seal 9 Head
9.2 Opening 10 Tail 21 In vivo pressure device 22 Housing 24 1 First marker 24 2 Second marker 25 Plug 26 Opening 27 Stopper 31 Image of aorta 32 Stent graft image 33 Image of aortic aneurysm

Claims (4)

The housing (2) has a head (9) and a tail (10),
The head (9) and tail (10) have a longitudinal direction and a side direction that intersects the longitudinal direction substantially perpendicularly,
The head (9) and the tail (10) have a first end as one end in the longitudinal direction, and a second end as the other end,
The head (9) has two first marker sheets (3, 1) and two second marker sheets (3, 2), and the first marker sheet (3.1) and the second marker sheet (3.1). 2) seal the outer periphery,
The first marker sheet (3.1) and the second marker sheet (3.2) are each formed by sandwiching a flat marker (4) between two thin layer sheets (S). Welding the outer periphery of the thin layer sheet (S), enclosing the marker (4) in the two thin layer sheets (S),
Enclose the first marker (4.1) in the first marker sheet (3.1), enclose the second marker (4.2) in the second marker sheet (3.2),
Said head (9) has an opening (9.2) at its second longitudinal end;
The tail (10) is formed from a tubular member (6), and the tubular member (6) has a first opening (6.1) at a first end in the longitudinal direction,
A first end side in the longitudinal direction of the tail (10) is attached to a second end side in the longitudinal direction of the head (9),
Gas is filled until the inside of the head (9) and the tail (10) reaches an internal pressure (PI) close to the in vivo pressure to be measured, and the second end in the longitudinal direction of the tail (10) is sealed. And seal
The first marker sheet (3.1) and the second marker sheet (3.2) of the head (9) have an internal pressure (PI) in the head (9) and tail (10), Formed from a material that deforms in response to changes in external pressure (PO) around the head (9),
When the external pressure (PO) is larger than the internal pressure (PI), the first marker sheet (3.1) and the second marker sheet (3.2) are in the internal direction of the head (9). The first marker (4.1) and the second marker (4.2) are displaced in a direction approaching each other.
When the internal pressure (PI) is greater than the external pressure (PO), the first marker sheet (3.1) and the second marker sheet (3.2) are directed outward from the head (9). The first marker (4.1) and the second marker (4.2) are displaced in a direction away from each other.
By detecting the displacement of the distance between the first marker (4 · 1) and the second marker (4 · 2) by an image diagnostic apparatus, the external pressure around the head (9) is remotely detected. An in-vivo pressure measuring device (1) characterized in that (PO) can be measured. The in-vivo pressure measuring device (1) according to claim 1, wherein the in-vivo pressure measuring device (1) can be attached to a strut constituting the stent graft (32) by a metal wire. A cylindrical housing (22),
The housing (22) has a longitudinal direction and a side direction that intersects the longitudinal direction substantially perpendicularly,
The housing (22) has, in the longitudinal direction, a first end as one end and a second end as the other end,
The housing (22) has a first end closed and a second end having an opening (26),
On the first end side, a flat plate-like first marker (24.1) is arranged,
On the second end side, a flat plate-like second marker (24.2) is arranged,
Attach the plug (25) to the second marker (24.2),
A stopper (27) is attached to the second end, and the stopper (27) prevents the second marker (24, 2) and the plug (25) from coming off from the second end. And
The housing (22) is filled with gas between the first marker (24, 1) and the plug (25) until the internal pressure (PI) close to the in-vivo pressure to be measured is reached. Gas is sealed between the first marker (24 • 1) and the stopper (25),
The housing (22) is formed of a hard material,
When the external pressure (PO) is larger than the internal pressure (PI), the plug (25) is displaced in a direction approaching the first end of the housing (22). The two markers (24 · 2) and the first marker (24 · 1) are displaced in a direction approaching each other,
When the internal pressure (PI) is larger than the external pressure (PO), the plug (25) is displaced in a direction approaching the second end side of the housing (22), and accordingly the first pressure is increased. The two markers (24 · 2) and the first marker (24 · 2) are displaced in directions away from each other,
By detecting the displacement of the distance between the first marker (24 · 1) and the second marker (24 · 2) by an image diagnostic apparatus, the external pressure (PO) around the housing (22) is remotely detected. An in-vivo pressure measuring device (21) characterized in that The in-vivo pressure measuring device (21) according to claim 3, wherein the in-vivo pressure measuring device (21) can be attached to and attached to a strut constituting the stent graft (32) by a metal wire.

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