JPH04250154A - Viscous fluid jet operation device - Google Patents

Abstract

PURPOSE:To improve the precision operating performance and safety by providing a jet generating means consisting of a pressurizing device, a fluid supply device, and a nozzle device or a catheter provided with the nozzle device, and jetting a fluid having a viscosity higher than that of water as a fluid. CONSTITUTION:A jet nozzle part 31 is provided on the top end part of a pressure resisting tube 3 to which a hand piece 2 usable as a catheter for internal use such as a blood vessel, and a pressure pump tube 4, a tube 5, an air trap 6 and a bottle needle 7 are successively connected and integrated to the pressure resisting tube 3 to form a viscous jet operation device. This operation device is operated by a driving pump 11. The driving pump 11 successively presses the pump tube 4 inserted and fixed between a roller part 12 and an outer circumferential part 13 surrounding it by the rotation of the roller part 12 to pressurize a viscous fluid containing a defoaming agent and a surfactant in the tube, and the fluid is thus jetted through the nozzle part 31 as a jet fluid.

Description

[Detailed description of the invention]

0001

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to a viscous jet surgical device. More specifically, the present invention relates to a jet surgical device that is capable of highly precise operation, is highly safe, and is expected to have effects such as thrombus removal.

0002

[Prior art and its problems] Conventional surgical tools include steel scalpels, electric scalpels, ultrasonic scalpels, and laser scalpels for the purpose of incising, resecting, and cutting organs. It has been adopted in various ways and combinations depending on the site and method. For example, steel scalpels are used in many surgeries because they are cheap and easy to handle, but they have the drawback of cutting all tissues without distinction. Therefore, there is a risk of inadvertently cutting blood vessels, nerves, etc., and the operation requires caution and skill.

[0003]Although electric scalpels are easy to handle and have become popular to a certain extent, they cause thermal damage to the surgically affected area and there is a risk of burns during operation. Although ultrasonic scalpels have the advantage of being able to remove the target tissue without cutting blood vessels or nerves, they are expensive, complicated to operate, and can cause problems with the equipment itself. There is a problem in that it is easy to occur.

On the other hand, laser scalpels allow surgery without contact, cause less damage to the surgically affected area, and have excellent features such as hemostasis, but the device itself is expensive and requires incisions. It is difficult to control the depth of resection, and there is a risk of major bleeding because it cannot be performed selectively on tissues. As described above, each of the various conventional surgical devices has its disadvantages, and in each case, considerable skill and care are required to use them.

Recently, in order to improve the shortcomings of these surgical methods, a method of applying a pressurized water jet to certain limited areas has been studied.
It has been applied clinically. In this method of using a pressurized jet water stream, by adjusting the fluid pressure and injection amount within a certain appropriate range, it is possible to separate cord-like objects such as the vascular system and nervous system from surrounding tissues without cutting them. It also has the advantage that loose tissue can be removed from the surgical site along with the jet fluid.

[0006] Therefore, its applicability is wide, including cutting and incision using high-pressure fluid of 10 MPa or the like in target organ tissues, exfoliation using low-pressure fluid of 1 MPa or lower, or parenchymal cell removal in soft areas. It is thought that it can also be used to separate cords. 1 more
Cleaning using low pressure fluid of MPa or less is also applicable. Physiological saline or the like may also be used as the water flow in this case. Furthermore, it is possible to perform cooling or heating by appropriately adjusting the temperature of the fluid, etc.
Research and experiments have been progressing on the idea that it has a wide range of uses and effects.

[0007] However, in the conventional pressurized jet water surgical device, the spray nozzle forming part is very large, has poor operability, and cannot be used in delicate areas. In addition, there has been no method of applying the pressurized jet stream to a simple and easy-to-operate probe or handpiece or to removal of occlusive substances in blood vessels without sacrificing the effectiveness of the pressurized jet flow. Furthermore, when the pressurized fluid is ejected and collides with the affected area, the loose tissue of the affected area, water, and air are mixed, and the mixture is vigorously agitated by the pressurized fluid jet and foams. Therefore, drawbacks have been pointed out, such as making it difficult to identify the appropriate affected area for treatment and contaminating the surrounding area with flying bubbles.

[0008] As a solution to these drawbacks, a surgical nozzle device that performs suction at the same time as jetting fluid has been proposed, but this device requires a complicated device as a whole.
Particularly for operations performed under sterile conditions, the device must be sterilized after each operation, which poses a problem in that operation and handling are complicated. Furthermore, other technical difficulties arise when manufacturing a nozzle device that produces a jet of fluid.

[0009] In addition, in recent years, the target areas for incision, removal, cutting, etc. are not only outside the body surface, but have also been applied to small areas inside the body surface, especially in areas such as removal of occlusive substances from coronary arteries and peripheral blood vessels. For this reason, optimization of pressurized fluid jets requires highly accurate machining of the shape of the nozzle tip, internal flatness, etc., and furthermore, it is necessary to process the nozzle tip shape and inner surface flatness with high precision. Although there was a need to put ultra-compact nozzles into practical use, the reality was that many issues remained to be solved.

[0010] In view of this situation, the inventor of the present invention has already developed an inexpensive and
In addition, we have proposed a method that can perform ultra-compact and highly accurate fluid injection, and we have also proposed a method for manufacturing a simple water jet probe using an improved injection jet nozzle. That is, one end of a pressure-resistant hollow tube or a hollow part made of a material different from that of the pressure-resistant tube but with the same or approximately the same outer diameter, a conical nozzle having a specific angular range is configured inside thereof, and the nozzle tip is The part is provided with pores, and a desired injection jet is formed by the correlation between the shape of the conical nozzle and the pore diameter.

[0011] A pressure-resistant tube having a structure for generating a jet flow with a pressure of 2 to 30 MPa at its distal end; a pump tube connected to the catheter;
A water jet surgical device has been proposed in which a tube connected to a pump tube; an air trap connected to the tube; and a bottle needle connected to the air trap are integrally constructed.

[0012] In this surgical device, the jet fluid ejected from the jet nozzle generates a so-called jet stream, and in order to cause incision, resection, cutting, and ablation actions on the soft tissue of the living body,
In general, a jet flow with a pressure of 2 to 30 MPa is required, and for these conditions, the inner conical angle of the jet nozzle is appropriate, and the exit port generates the pressure necessary to generate the jet flow from the exit port. This was based on the knowledge that this could be achieved if the surface was treated to such an extent that turbulence would not occur at the diameter of the cone and at the internal angle of the cone.

[0013] Such a nozzle generally has a circular mouth with a diameter of about 0.1 to 0.5 mm, although it varies depending on the pressure of the fluid, and its inner surface is flat and has an apex angle of 5 mm.
It can be conical in the range ~20° or any shape can be chosen, such as an ellipse, square, rectangle, etc., with a cross-sectional area of 0.005 to 0.2 mm2. Locally obstructive substances within blood vessels, e.g. atheroma,
The above-mentioned pressure-resistant tube may be used alone when removing a part such as a blood clot, but when used for general tissue incision, excision, cutting, or peeling operations, the pressure-resistant tube may be sprayed from the nozzle. A hand piece can be constructed in which a suction port for sucking fluid is provided nearby, and the suction ports are arranged in parallel or coaxially.

The surgical water jet surgical device proposed by the inventor of the present invention as described above is useful as a disposable nozzle-equipped catheter, etc., and can be inserted into a suitable holder (hand piece). It can be used in the Open Surgery method. However, although the water jet surgical device has such excellent features, there are still some problems from the viewpoint of improving precision operation performance and safety.

[0015] That is, this surgical device mainly uses Op.
Since we had the en-Surgery law in mind,
For example, its action and operation are not practical for intravascular operations, and there have been insufficient measures against invasion of body cavities and organs in the body and the scattering of jet water droplets. For example, splashes caused by jet water droplets not only obstruct the field of view, but can also cause hepatitis, etc.
This poses an infection problem for medical workers, such as the dissemination of anti-B antigens.

[0016] Therefore, there has been a strong desire to realize a jet type surgical device that is more precise and has excellent safety.

[0017]

[Means for Solving the Problems] To solve the above-mentioned problems, the present invention employs a new method that has never been conceived or tried before, that is, using a viscous fluid. , we propose a new device that converts this viscous flow into a jet flow. The device of the present invention is characterized in that it has a jet flow generating means consisting of a pressurizing device, a fluid supply device, and a nozzle device or a catheter equipped with a nozzle device, and jets out a flow with a higher viscosity than water as the fluid. .

The jet device using viscous flow of the present invention was first completed through detailed study of the working mechanism of water jet and its practicality as a surgical method.
This has been realized as an extremely precise and highly safe surgical device. In the device of this invention, for example,
Various aqueous solutions with higher viscosity than water, alcohols, glycols, ethers, amines, edible oils, vegetable oils, blood, plasma, artificial blood, and various other organic fluids are used, and thrombolytic agents and antifoaming agents are added to these liquids. Agents and/or surfactants, as well as various drugs can be contained. These drugs themselves may also be used.

When such a highly viscous fluid is injected into a liquid, a jet stream with excellent directionality and focusing can be obtained, and at a position a short distance from the nozzle outlet, the jet velocity rapidly decreases, causing harmful It has no effect. This highly viscous jet stream can be realized, for example, as the surgical device shown in FIG. That is, the surgical device (1) of the present invention includes an injection nozzle portion (31) at the tip of the pressure tube (3), and this injection nozzle portion (31) is shown in FIG.
As shown in the figure, the inner surface is flat, the inner surface has a conical shape with an apex angle θ in the range of about 5° to 20°, and the diameter of the exit hole of the nozzle part (31) is 0.1 to 0.5 mm. The hole can be selected to have an arbitrary shape of about 0.005 to 0.2 mm2. With such an arrangement, a viscous flow jet with the desired pressure is emitted. The material for the pressure-resistant tube (3) needs to be pressure-resistant enough to withstand the pressure of the viscous fluid sprayed from the nozzle part (31) that is integrally formed at the tip, but even a normal pressure-resistant tube will not work. It can be used without any problems. Furthermore, it is also effective for glass materials.

Furthermore, this pressure-resistant tube (3) can be used as a catheter intended for use in the body, such as in blood vessels. The structure of the fluid injection nozzle part (31) can be easily manufactured continuously during the manufacturing process of the pressure-resistant tube (3), and when it is configured integrally with the pressure-resistant tube (3), the fluid injection can be layered. It becomes easy to form the structure fluidly. Furthermore, it can also be easily made of other materials, such as meltable materials such as glass and quartz, polymer materials, metal materials, and the like. A pressure-resistant pump tube (4) connected to such a pressure-resistant tube (3) and this pressure-resistant pump tube (4)
A tube (5) connected to this tube (5), an air trap (6) connected to this tube (5), and this air trap (6)
The viscous jet surgical device of the present invention can be obtained by integrally configuring the bottle needle (7) connected to the bottle needle (7).

The pressure-resistant pump tube (4) must have elasticity and durability to withstand the pressure applied by, for example, a roller pump. In this case, the pressure may be applied by a finger type pump instead of a roller pump. Bottle needle (
The tube (5) on the 7) side may be any tube that is sufficient to transport the fluid under normal conditions, such as a tube made of vinyl chloride,
It may be made of nylon, polyethylene, or the like. Also, the air trap (6) connected to this tube (5)
) has the characteristics of preventing air bubbles from being mixed in, monitoring fluid supply, and preventing backflow of fluid, and any material having such characteristics can be used.

Furthermore, in the viscous fluid jet surgical device of the present invention, the hand piece (2) may be attached to the pressure tube (3) as shown in FIG. This hand piece (2) may be provided with a suction port. For the connection between the hand piece (2) and the pressure-resistant tube (3), and between the pressure-resistant tube (3) and the pump tube (4), the connection using a lure male or female, screw type, adhesive, crimp, etc. can be selected as appropriate. be done. On the other hand, pump tube (4)
, tube (5), air trap (6) and bottle needle (
7) can also be constructed as an integrated body, and the pressure tube (3) and the hand piece (2) can be connected to each other in sequence. Furthermore, it is also possible to integrate all the devices themselves from the beginning. In this case, it is also possible to make it disposable.

For example, FIG. 4 shows an example of how the surgical device (1) of the present invention as described above is used. As shown in the figure, the surgical device (1) is driven by a pump (11).
It is operated by. This pump (11) has a roller part (12) at the top, and the pump tube (4) of the device of the present invention is inserted and fixed between the roller part (12) and the outer peripheral part (13) surrounding it. do. In actual operation, the roller part (12) of the roller pump rotates when electricity is input from an external power source, and as the roller rotates, the pump tube (4) is sequentially pressed, and the viscous fluid inside the tube is pressurized. . As a result, the pressurized fluid is compressed and supplied toward the handpiece (2), either from the injection port by opening and closing the switch (14) linked to the injection port, or by controlling the rotation of the roller part (12). A jet fluid is ejected. As mentioned above, the drive pump (
11) is activated, the bottle needle (7) connected to the liquid storage tank
The viscous fluid stored in the storage tank is sequentially transported from the tube (5) toward the handpiece (2) and is injected from the injection port, thereby producing a desired jet flow. It becomes possible to incise, excise, cut, peel or clean organs. In this case, means for suctioning the viscous fluid remaining at the surgical site is employed as necessary.

Further, the pressure tube (3) can be inserted into a blood vessel by percutaneous or surgical means and used for incision to remove an obstruction formed in the blood vessel. A percutaneous coronary angioplasty catheter, a vascular catheter, or a channel hole provided in an endoscope can be used. The excised, incised, and crushed occlusion material can also be aspirated using the mechanism provided in the catheter or endoscope described above.

The viscous jet surgical device of the present invention can be used to perform incisions and resections of parenchymal organs (such as the liver and pancreas), dissection of pelvic cavities with complicated blood vessels and nerves (such as colon cancer and uterine cancer), and trauma surgery. It has great power and excellent adaptability for cleaning surgical areas and removing foreign bodies. Furthermore, since the jet stream has the property of flowing along or wrapping around outer walls of different hardness such as the cords of blood vessels and the surfaces of internal organs, it also has an excellent peeling effect. The incision made with this surgical method causes almost no bleeding, except for slight bleeding from the capillaries (which will stop naturally if left untreated).
Cord-like bodies such as small blood vessels remain as if they were forming a net around the incision site. By tying this net-like blood vessel with silk thread or coagulating it with a high-frequency coagulation device, and then cutting it, the organ can be easily excised without bleeding.

[0026] The nozzle-equipped catheter is placed in a suitable holder (
Open sur by inserting it into the handpiece)
It goes without saying that this catheter is used in the Gery method, but by inserting this catheter into the channel of an endoscope, the jet can be applied surgically even under endoscopic operation. This endoscopic jet method has the potential not only to be applied to endobronchial lesions in the upper and lower gastrointestinal tracts and lungs, but also to pave the way as a new treatment method in most fields where endoscopy is performed. These include ventriculoscopy, biliary tract/hepatoscopy, cystoscopy, hysteroscopy, and treatment in the otorhinolaryngology field. In addition, percutaneous transluminal angioplasty in the field of heart and vascular surgery (
It also has high potential for application in angioplasty).

[0027] Hereinafter, examples will be shown and the excellent features of the viscous jet surgical device will be specifically explained.

[0028]

[Example] a) The mechanism of action when a jet stream is ejected into water was investigated. This consideration is the most fundamental aspect of this invention. The action of the jet stream, that is, the acting force that can be said to be the driving force for incision, exfoliation, and cleaning (
F) is the average mass of the jet (m) and its average velocity (v
), it is expressed as F=1/2 mv2. Since m takes a constant value depending on the solution and the nozzle diameter, it is important to evaluate the jet velocity and velocity distribution.

Glass tubes with inner diameters of 8 mm and 18 mm are considered as model blood vessels, and the water-filled glass tubes shown in FIG.
This evaluation is performed by injecting a jet stream using the device exemplified in . As a control, we took up the case of injection into an aquarium without a glass tube. The velocity distribution of the jet stream in water and the two-dimensional dispersion state of the jet stream were measured using a dual-beam differential laser Doppler current meter.

The results were as follows: 1) The jet velocity at the nozzle exit part in the aqueous solution and in the air showed almost the same values as shown in Table 1. Furthermore, when water with the same density was jetted in an aqueous solution, the speed of the jet was sharply reduced compared to that in air, as seen in FIG. This condition was also the same in glass tubes and water tanks. Since the directivity or convergence of the streamlines of the jet is well maintained, it is thought that the flow velocity of the jet stream with a diameter of 0.2 mm will not be affected even in a glass tube with an inner diameter of 8 mm.

[0031]

[Table 1]

On the other hand, in the endoscopic application of the jet, in order to improve the ability to target the target area, the jet is ejected very close to the inside of various biological ducts and hollow organs (blood vessels, intrahepatic bile ducts, etc.). It will be done. Therefore, it can be concluded that even if the injection is performed in liquid, the same effect as injecting in the air can be expected. It has been histopathologically confirmed that the tissue dissection ability under liquid is the same as that in air.

[0033] As can be seen from Figure 5, in order to prevent erroneous injection to a distant part or unintended injection, if the distance from the nozzle is at least 5 mm, the acting force of the jet will drop to 1/4. ), the velocity of the jet will be reduced and it will no longer have any harmful effects. Therefore, it can be said that the submerged injection method is extremely safe. 2) Blood is viscous and is considered a non-Newtonian body. In angioplasty, the jet is ejected within the blood vessel, so we experimentally diluted the ethylene glycol solution to approximately the same viscosity as blood and then ejected the jet. FIG. 6 shows the results. As seen here, it was found that the initial velocity of viscous jets is maintained longer than that of water, and then rapidly decreases.

From this study, it has been found that viscous jets are extremely useful not only in endoscopic non-invasive surgery on body cavities and internal organs, but also in applications within blood vessels. In addition, from a safety perspective, it is highly useful as a countermeasure against the scattering of water droplets in the jet flow, which has been a considerable problem with water jet surgical methods. In other words, the droplets created by the fine water droplets at the initial stage of water jet spraying (the fine water droplets that are generated when the water jet jet first hits the target object) not only obstruct the field of view (making it difficult to perform surgery), but also sometimes This may also pose an infection problem for medical workers, such as the dissemination of HB antigens that cause hepatitis. Currently, attempts are being made to reduce the jet flow rate by using small-diameter nozzles, but this has not provided a fundamental solution. In operation using the device of the present invention, these droplets do not leak to the outside, so there is no risk of danger, and this provides a solution to the technical problems of conventional water jet surgical methods.

[0035] The tissue dissection ability test using a viscous jet as described above was performed on the excised or anesthetized organs of experimental animals while immersed in physiological saline. ), using an X-ray contrast agent, a plasma expander, and an amine surfactant, and by searching histopathological specimens. In addition, in angioplasty using jet endoscopy, the most important issues from a safety perspective are the destructive effect on atheromas and thrombus, the effect of the jet on normal blood vessels, and especially the consideration of vascular perforation. This study was conducted using a rabbit artery by injecting a jet under various conditions. The search was conducted using a scanning electron microscope to evaluate the influence on the inside of the tissue using its surface shape or histopathological specimens. Excellent properties were confirmed.

[0036] Control of jet flow injection has heretofore been effected manually or by a foot switch. This method did not cause many problems in the open surgery method, but the endoscopic jet method requires precise control of injection. Therefore, we investigated a system that automatically performs injection by setting the injection time and pause time using a sequencer, and created a new prototype of a jet flow switching device.
developed.

[0037] Regarding the control of jet flow injection, a prototype switching device using analog and digital therapy methods was developed. This control device can arbitrarily set the injection time and rest time using a sequencer, and the close switching of the jet stream can be used in open surgery.
It is now possible to use both the catheter method and the catheter method.

[0038]

According to the present invention, as explained in detail above, it is possible to cut, incise, and excision organs, etc., and remove obstructions in blood vessels, etc., precisely and safely using a simple method. In addition, mechanical removal of the thrombus can be effectively achieved by using a jet flow with a higher viscosity than that of water, and by using a viscous flow,
The potency of action is increased, the range of action is localized, and safety is increased. Therefore, it can be said that it has great medical utility value.

[Brief explanation of the drawing]

FIG. 1 is a side view illustrating a surgical device of the present invention.

FIG. 2 is a sectional view of the injection nozzle part of the device of the invention.

FIG. 3 is a side view illustrating the device of the invention with a handpiece attached.

FIG. 4 is a perspective view illustrating an operating system for a surgical device according to the present invention.

FIG. 5 is a correlation diagram showing changes in jet flow velocity.

FIG. 6 is a correlation diagram showing changes in jet flow velocity.

[Explanation of symbols]

1 Viscous fluid jet surgical device 2 Handpiece 3 Pressure resistant tube 31 Nozzle part 4 Pump tube 5 Tube 6 Air trap 7 Bottle needle 11 Drive pump 12 Roller part 13 Outer periphery 14 Switch

Claims (3)

[Claims] 1. A viscous device comprising a jet flow generating means comprising a pressurizing device, a fluid supply device, and a nozzle device or a catheter equipped with a nozzle device, and jetting a fluid with a higher viscosity than water as the fluid. Fluid jet surgical device. 2. The viscous jet surgical device according to claim 1, wherein the highly viscous fluid contains a thrombolytic agent. 3. The viscous jet surgical device according to claim 1, wherein the highly viscous fluid contains an antifoaming agent and/or a surfactant.