RU2338561C2 - Valve with groove and medical apparatus for adiposity treatment - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: valve includes an end face of the flange with an aperture in it, the valve case, the first cavity formed in the case of the valve for reception of a delivery tube, inserted through an aperture in a flange end face, the concave section close to the first cavity and a groove in the case of the valve. The medical apparatus including the pumped up cylinder, is made of a polymeric material, the cross-over valve with a groove, crossed attached to the cylinder cover. The valve end face is located flush-mounted with an external surface of a cylinder and covered with elastoplastic for bond of a cylinder and the cross-over valve.

EFFECT: invention provides creation of a return stream through the valve; an easy insert and change of the grout pipe.

13 cl, 10 dwg

Description

1. Field of invention

This invention relates to a bypass valve with a groove that provides a two-way fluid flow, in particular to a valve with a groove for use in conjunction with implantable, inflatable medical devices, such as gastric balloon for the treatment of obesity.

2. Description of the relevant area

There is a wide range of inflatable devices that can be implanted into the body.

One such inflatable medical device is a gastric balloon described in US Pat. No. 5,084,061, marketed under the name "BioEnterics Intragastric Cylinder System" (sold under the BIB trademark). These devices are intended for the treatment of people with moderate obesity who need lose pounds in preparation for surgery, or as part of a diet or behavior modification program.

The BIB system, for example, consists of a silicone gastric balloon, which is inserted into the stomach and filled with fluid. Gastric cylinders are available. filled with saline or air. Gastric balloon function is to fill the stomach and control appetite. Placing this balloon is not a surgical procedure and usually takes 20-30 minutes. This procedure is performed on an outpatient basis using endoscopy using local anesthesia and sedatives. The placement of such cylinders is temporary, and they are usually removed after 6-12 months.

Many valves are known in the art for use with such gastric containers. For example, the valve described in US Pat. No. 5,084,061 and shown in FIG. 1 consists mainly of a plate valve (also known as a flat valve) comprising two relatively flat pieces of silicone elastomer connected by longitudinal edges and glued to the end of the stem valve. During the operation, the fill tube, which is usually a plastic or silicone tube containing a stainless steel stiffener, is inserted through the X-shaped groove in the membrane, through the hole, through the hollow valve stem, through the second X-shaped groove in the membrane and through the plate valve until the filling tube itself is inside the shell. In this position, you can perform the addition and removal of fluid. If you only need to add fluid, the priming pipe must not pass through a plate valve.

However, valves of this type have several disadvantages. Firstly, these valves are leaky. Leaks may occur in the flat valve when the balloon is first filled, when one of the flat pieces of elastomer bends or forms a bend through which fluid can escape. Also, leaks occur during the liquid removal process when it is necessary to completely insert the filling tube through the valve into the shell. When part of the fluid and the filling tube are removed, the plate valve may remain partially open. As a result, a much larger amount of fluid leaves the implant. According to this. there is a need for a valve that will not leak when liquid is poured into the shell or when it is removed.

Secondly, previous plate valves have encountered the problem of reducing the pressure required to insert the filling pipe into the valve to facilitate installation and filling, but if the tightening between the filling pipe and the valve is not sufficiently tight, the fluid pressure in the cylinder or valve may push the tip of the filling device out of the valve until filling is complete. In addition, the force required to remove the filling tube from the valve must be considered. Ongoing projects like the one discussed above often require too much pressure to remove the fill tube from the valve and to insert it into the valve. On the other hand, in cases where the pressure for inserting the tube into the valve and removing it is not large, the filling tube may slip out of the valve while filling the cylinder. Therefore, there is a need for a valve that offers easy insertion and removal of the filling tube, but the filling tube does not pop out of the valve while filling the cylinder. Previous plate valves are also not suitable for pumping fluid at pressures above 30 psi. inch, and this pressure can damage them.

And finally, the disadvantage of flat valves is the fact that they are one-way. They cannot be used to direct the fluid flow in two directions without first inserting the tube completely into the valve. There are situations when it is preferable to have a two-way valve. For example, if the device absorbs additional fluid through osmosis after it is introduced into the human body and is filled to the appropriate volume, you may want to reduce the volume of this implant. In the flat valve described above, the internal pressure of the cylinder will not allow the liquid contained in it to escape. Therefore, there is a need for a valve that can allow reverse fluid flow (for example, from the inside out), while preventing fluid from escaping under normal pressure.

Another type of valve commonly used in implant technology is a membrane valve, such as discussed in US Pat. No. 6,419,699, issued to McGhan Medical Corporation. The diaphragm valve requires a stiffening component to be inserted into the injection tube to open the valve and allow fluid to move. When this tube is removed, the fluid pressure in the implant will cause the valve to close and create a tight seal. As with a plate valve, such a valve does not allow backflow through the valve.

Other valves used in medicine include a device insert connector as described in US Pat. No. 5,599,327 (Patent 327), a surgical valve without connections, described in Patent No. 5916198 (Pat. 198), and a needle without an injection tip described in US Pat. No. 6261268 (patent 268). Each of these valves and connectors has the disadvantages that are eliminated by this invention. Firstly, both patents 327 and 268 consider a hole in the valve, which forms a seal when mechanical pressure is applied by a medical device. Accordingly, both patent 268 and patent 327 require the use of bulk components and the application of mechanical force to create a seal. Such components and the application of mechanical force are not suitable for use in implant technology. Moreover, Patent 198 describes a one-way valve that is closed by a blown gas acting on the inner surface of the valve as it passes into one of the valve segments. Accordingly, the valve described in patent 198 does not eliminate the previously discussed disadvantages.

Therefore, the present invention addresses these problems with the previously discussed valves. This invention relates to a two-way valve, which is suitable for use in an implantable medical device, such as a gastric balloon.

These and other characteristics of the present invention will become apparent from the further detailed description below.

SUMMARY OF THE INVENTION

This invention relates to a two-way valve having first and second sides. The two-way valve includes a cylindrical body having a groove connecting the first and second sides of the valve and the cavity on the first and second side.

Further, the present invention relates to a bypass valve with a groove having a flange surface with a hole in it. The bypass valve with a groove has a body connected to the flange and a cavity formed in the valve body so that a filling tube that can be inserted through an opening in the end of the flange can enter it. The bypass valve with a groove also includes a concave section on one or the other side, which are connected by a groove cut in the valve body.

This invention also relates to an implantable inflatable device that has a bypass valve with a groove. This grooved bypass valve includes an end face of the flange with a hole in it. The valve also includes a valve body. connected to the end face of the flange, a first cavity formed in the valve body. so that a pumping tube can be inserted through it, inserted through an opening in the end of the flange, a concave section on one or both sides of the valve, and a groove in the valve body connecting these two sides.

This invention also relates to a medical device for the treatment of obesity. The medical device includes a balloon made of a suitable polymer or elastomer for insertion into the stomach and a bypass valve with a groove for bypassing fluid from the filling tube into the balloon. This grooved bypass valve includes an end to the flange. having an opening, a valve body connected to an end face of the flange, a first cavity formed in the valve body so that a pump tube can pass through it. inserted through a hole in the end of the flange, a concave section on one or both sides of the valve and a groove in the valve body connecting the two.

Other characteristics, features and advantages of this invention will become apparent when considering the following detailed description of the invention in conjunction with the following drawings:

Brief Description of the Drawings

Figure 1 is a cross section of an existing intragastric balloon with a one-way valve;

Figure 2 is a cross section of an existing one-way valve;

Figure 3 is a side view of a two-way bypass valve with a groove corresponding to one embodiment of the present invention;

Figure 4 is a cross section of a two-way valve shown in figure 3;

Figure 5 is an enlarged view of a part of the two-way valve shown in figure 4;

6 is a top view of a two-way valve in accordance with another aspect of the present invention;

FIG. 7 is a side view of a filling tube in accordance with yet another aspect of the present invention; FIG.

Fig. 8 is a side view of a discharge tip in accordance with another aspect of the present invention;

Fig.9 is a cross section of the discharge tip for filling the cylinder shown in Fig; and

10 is a cross-sectional view of a two-way valve in accordance with yet another aspect of the present invention.

Detailed Description of a Preferred Embodiment of the Invention

A bypass valve 10 with a groove corresponding to the first embodiment of the present invention is shown in FIG. The valve includes a valve body 14 and a flange 12. In accordance with the description of this invention, the side of the valve 10 on which the flange 12 is located will be called the top of the valve, and the opposite side will be called the bottom of the valve. The valve 10 is preferably made of an elastomer, such as silicone, however, other materials can be used without departing from the scope of the invention. The valve body 14 is preferably cast in a cylindrical shape. A cylindrical shape is preferred as it gives added rigidity to the valve.

Figures 4 and 5 show cross sections of valve 10. Figure 6 shows a top view of valve 10. We start from the end of flange 12 at the top of valve 10, there is a hole 16 that is connected to the inner surfaces of valve 10. Just below the hole 16 there is a first cavity 18. Below the first cavity 18 there is a neck 19. This neck 19 separates the first cavity 18 from the second cavity 26. In the bottom of the second cavity there is a concave surface 20.

Concave surface 20 is preferred since it provides a guide for the probe in the event that the tightness characteristics of valve 10 need to be overcome mechanically. The concave surface 20 facilitates the direction of the probe (not shown), which can be used to force the valve to open, which makes it possible to provide a reverse fluid flow through the valve 10.

Behind the concave surface 20 there is a groove 24 in the integral part of the housing 14. This groove 24 passes liquid and connects to the second surface 22, which can be concave, as shown, or flat. In a gastric balloon type application, fluid enters the membrane as it exits from the lower end of groove 24. This groove 24 may be lubricated with silicone oil. The use of silicone oil facilitates the insertion of a removable tip (not shown) in cases where it is necessary to overcome the sealing characteristics of the valve 10, and serves to reduce the possibility of structuring if the valve body 14 is made of silicone.

7 shows a fill tube 30. The fill tube includes a long flexible tube 34 having a clearance, a discharge tip 32, and a connector 35 for connecting the fill tube to a fluid source (not shown). The flexible tube 34 may be provided with indicators 36 of a reference length so that medical personnel can monitor the position of the filling tube 30 within the patient. As shown in Figs. 8 and 9, the discharge tip 32 has an opening 37 that allows fluid to flow through the flexible tube 34 and through the discharge tip 32. One of the ends of the tip may have a wedge shape 38, the smallest cross section of which is located at the distal end of the discharge tip 32. The wedge shape 38 facilitates insertion of the pressure tip 32 into the bypass valve 10 with a groove. In addition, the discharge tip may include a reduced diameter portion 40 and an insert restrictor 42 for opening 16 of the valve 10. The other end of the discharge tip 32 has teeth 44 to secure the flexible tube 34 in a sealed connection to the discharge tip.

In use, the filling tube 30 is connected to the valve 10 by inserting the injection (injection) tip 32 into the hole 16 of the valve 10. The injection tip, when fully inserted into the valve, is approximately flush with the upper surface of the second cavity 26. The wedge-shaped shape of the injection tip corresponds to the orientation of the first cavity 18, and a portion of the discharge tip 32 with a narrow cross-section is rigidly held by the neck 19 of the valve 10, thereby forming a seal that prevents exit liquid from the second cavity 26 into the first cavity 18 through the hole 16. The limiter of the insert 42 on the discharge tip 32 prevents the insertion of the tip into the valve 10 after a predetermined point. When fully inserted, the insert stop 42 abuts the flange 12 of the valve 10. The hole 16 is sized so that when the pressure tip 32 is inserted, a second seal is formed by fitting the flange 12 and a portion of the pressure tip of a smaller diameter 40. This second seal ensures that the fluid does not exits the valve 10, and prevents dirt from entering the inlet of the valve 10.

The valve 10 can be connected to an inflatable medical device, such as a gastric balloon, a breast implant, such as a Becker breast implant, tissue stretcher and the like. Other non-inflatable valve applications include devices such as parallel drug distribution systems or therapeutic distribution systems, tube feeding systems and the like. In line with this, such options are also covered by this invention. If the device in which the valve is used is a gastric balloon, the valve 10 is attached to the casing, as shown in FIGS. 1 and 2. The end face of the valve 12 is flush with the outer surface of the balloon and can be coated with elastomers that connect the components together to form a single unit, consisting of a gastric balloon and valve. The gastric balloon is inserted into the patient in a deflated state and is inflated after insertion. After insertion of the gastric balloon through the filling tube 30, liquid is introduced into it, usually a sterile saline solution. Other media, such as air, silicone, pseudogel, oil, etc., can be used to fill the implant.

To inflate the gastric balloon, the valve 10 must have a groove 24. The groove 24 is preferably one partition that separates the two sides of the valve body 14. The groove 24 is formed during manufacture by inserting a sharp thin instrument (not shown) into the valve body. The length of the groove 24 depends on the application of the valve and the desired valve opening pressure. In certain applications, it may be necessary for a grooved valve to provide greater backflow. In such cases, a groove of shorter length will be used; in the same place where the valve should support a greater pressure, a longer groove is desirable.

In order to ensure inflation through the filling tube 30, the discharge tip 32 is inserted into the hole 16 of the flange 12. If pressure liquid is introduced through the filling tube 30 and the diaphragm 37 of the discharge tip 32, a higher pressure is created in the second cavity 26, resulting in a double effect. Firstly, the sealing pressure of the neck 19 on the discharge tip 32 increases. Secondly, the groove 24 opens. The wall of the valve body 14 of reduced thickness in the region of the second cavity 26 deforms more quickly under the influence of fluid under pressure introduced into the second cavity 26. than the groove zone 24. The increased pressure forces the second cavity 26 to expand in the direction perpendicular to the groove 24. This expansion, in turn, leads to the opening of the groove 24 and allows the flow of fluid from the second cavity 26 to pass through the groove 24 into the implant. The opening of the groove is facilitated by the concave surface 20. Similarly, if the second surface 22 is also concave, sufficient pressure must be applied to the sheath to overcome the valve's resistance to backflow and allow fluid to flow through the groove 24 to the outer surface of the implant. Due to the relative dimensions of the second cavity 26 and the concave surface 22, a much greater pressure is required to provide a reverse fluid flow from the implant than to pump. For this reason, the balloon or other implant can also be lowered or lowered a little by inserting a small probe or tube through the valve into the shell of the implant. Concave surface 20 helps guide a small diameter probe or tube into valve body 14.

The valve 10 and the filling tip 32 together create a system that avoids many of the disadvantages of its predecessors. Due to the use of the hole 16 and its interaction with the reduced diameter portion 40 of the discharge tip 32, and also due to the interaction of the neck 19 with the discharge tip 32, the discharge tip is firmly held in place and cannot escape from the valve 10 during the injection of fluid through the valve 10. In addition, due to the same characteristics, the removal of the discharge tip 32 at the request of the user is greatly simplified, since to remove the tip from the cylinder into which the 700 cc of liquid is required at least 4 pounds (17.8 N). Moreover, the valve 10 ensures that this device does not leak under normal operating conditions, and also allows a two-way flow. The valve of the invention allows for a continuous flow of fluid at a pressure of 2.11 kg / sq. cm and can withstand pressure without damage up to 2.81 kg per square meter. cm.

Figure 10 represents another aspect of the present invention. Figure 10 shows a valve 11, which has many characteristics of the valve 10 shown in figures 3-6. The valve 11 has a first concave surface 20, a second concave surface 22 and a groove 24 in the housing 14. The valve 11 works just like the valve 10. When a predetermined fluid pressure is applied to the first or second concave surface, 20 or 22, the groove 14 will open and allow passage of fluid. However, at a pressure below a predetermined value, there will be no flow through the valve with a groove. The relative geometric shape of the concave surfaces 20, 22, the length of the groove 24 and the valve body 14 determine the opening pressure of the valve 11, and also determine whether it is necessary to increase the pressure for flow in one direction compared to flow in the other direction. Such a valve would be useful where the use of the flange 12, as shown in figure 3, is undesirable or impossible, for example, in the tube of the forced feeding system or when bypassing the drug distribution system.

Although the invention has been shown and described with an example of a particular preferred embodiment, those skilled in the art will quickly appreciate that various changes and modifications can be made while remaining within the scope of this invention.

Claims (13)

1. The bypass valve with a groove for medical inflated devices, comprising a housing and a flange located in its upper part with a hole made in the end of the flange, the first cavity located below, formed in the housing for receiving the discharge tube inserted through the hole in the end of the flange, the second cavity , a neck separating the first cavity from the second cavity, in the bottom of which there is a concave surface, and a groove located behind the concave surface, made in the housing, connecting the concave surface with the second curved surface and able to open under fluid pressure. 2. The bypass valve according to claim 1, characterized in that the hole in the end of the flange is configured to receive part of the tips of the discharge tube and secure the tube in the valve. 3. The bypass valve according to claim 2, characterized in that the hole is arranged to engage with the reduced diameter portion of the tip of the discharge tube to secure the tip in the valve. 4. The bypass valve according to claim 1, characterized in that the neck is configured to accommodate part of the tip of the discharge tube when inserted. 5. The bypass valve according to claim 4, characterized in that at least part of the neck corresponds to the shape of the part of the tip of the discharge tube. 6. The bypass valve according to claim 1, characterized in that the medical inflatable apparatus is a gastric balloon. 7. The bypass valve according to claim 1, characterized in that the medical inflatable apparatus is a breast implant. 8. The bypass valve according to claim 1, characterized in that the medical inflatable apparatus is a means for tensioning the tissues. 9. A medical device for treating obesity, including an inflated balloon made of polymer material and a relief valve with a groove according to claim 1, attached to the membrane of the balloon, while the end of the relief valve is flush with the outer surface of the balloon and covered with an elastomer to connect the balloon and bypass valve. 10. The medical device according to claim 9, characterized in that the hole in the end of the valve flange is configured to receive part of the tip of the discharge tube and secure the tube in the valve. 11. The medical device according to claim 9, characterized in that the hole in the end of the flange of the bypass valve is configured to engage with a portion of a reduced diameter of the tip of the discharge tube to secure the tip in the bypass valve. 12. The medical device according to claim 9, characterized in that the neck of the bypass valve is configured to accommodate part of the tip of the discharge tube when inserted. 13. The medical device according to item 12, wherein at least a portion of the neck of the bypass valve matches the shape of the portion of the tip of the discharge tube.

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