Two-way slit valve

ES 2 328 567 T3

DESCRIPTION

Two-way valve.

Background of the invention

1. Field of the invention

The present invention relates to a slot valve that allows fluid flow in two directions, and in particular to a slot valve for use in implantable and inflatable medical devices such as gastric balloons for the treatment of obesity.

2. Description of Related Art

There are a wide variety of known inflatable devices that can be implanted in the body.

One such implantable medical device is a gastric balloon, as described in US Patent No. 5,084,061 or marketed as the BioEnterics Intragastric Balloon System (sold under the trademark BIB®). These devices are designed to provide therapy for moderately obese individuals who need to lose kilograms in preparation for surgery, or as part of a diet or behavior modification program.

The BIB System, for example, consists of a silicone elastomer gastric balloon that is inserted into the stomach and filled with fluid. Commercial gastric balloons are filled with saline or air. The gastric balloon works by filling the stomach and increasing appetite control. Gastric balloon placement is a non-surgical procedure, normally requiring no more than 20-30 minutes. The procedure is performed endoscopically in an outpatient setting, usually under local anesthesia and sedation. Placement is temporary, and gastric balloons are normally removed after six to twelve months.

A number of valves are known in the prior art for use in such gastric balloons. For example, the valve described in US Patent No. 5,084,061, shown in Fig. 1, basically consists of a flapper valve (also known as a duckbill valve) that comprises two relatively flat pieces of silicone elastomer. along its longitudinal axes and fixed by adhesive to the end of the valve stem. In operation, a fill tube, which is normally a plastic or silicone tube containing a stainless steel reinforcing rod, is inserted through an X-shaped slot, through a hole, through a stem tubular stem, through a second X-shaped slot in the membrane, and through a flapper valve until the same fill tube is inside the shell. In such a position, both the addition and removal of fluids can be performed. For fluid addition only, the fill tube does not need to penetrate through the flapper valve.

However, these types of valves have several disadvantages. Initially, these valves tend to leak. One way a duckbill valve can develop leakage is through initial filling of the balloon when one of the flat pieces of elastomer kinks or develops a bend through which fluid can pass. Another way is through the fluid removal process, which requires inserting the fill tube completely through the valve and into the envelope. After the removal of a portion of the fluid and the fill tube, the flapper valve can remain partially open. This causes even greater amounts of the fluid to be released from the implant. Consequently, there is a need for a valve that does not leak after filling or removal of the fluid from the shell.

Second, the flapper valves of the prior art have opposite problems in that it is necessary to reduce the pressure required to insert the fill tube into the valve to facilitate installation and filling, but if there is no coupling it is necessary. Tight enough between the fill tube and the valve, then the fluid pressure in the balloon or valve could pull the fill tip out of the valve before filling is complete. Also, you need to consider the amount of force required to remove the fill tube from the valve. Current designs, such as those discussed above, often require too much pressure to insert the fill tube into the valve and too much pressure to remove the fill tube from the valve. Alternatively, in cases where the pressure required to insert and remove the filling tube is not great, the filling tube could come out of the valve when the balloon is filled. Accordingly, there is a need for a valve that facilitates insertion and removal of the fill tube, but does not pull the fill tube out of the valve while the balloon is being filled. Prior art flap valves are also unsuitable at fluid inflation pressures above 30 psi (2.11 kg / cm²), which could damage the valve.

Lastly, the duckbill valves of the prior art have the disadvantage that they are only one-way valves. They cannot be used to direct fluid flow in both directions without inserting a tube completely through the valve. Situations arise where it is preferred to have a two-way valve. For example, when a device absorbs additional fluid by osmosis after it has been implanted in the body and filled to a suitable volume, it may be desirable to reduce the volume of fluids in the implant. In the duckbill valve described above, no amount of pressure on the inside of the

ES 2 328 567 T3 balloon will allow the return of the fluid contained therein. Consequently, there is a need for a valve that can allow the return flow of fluid (eg from inside to outside), in turn preventing the return of fluid when under normal pressure.

Another type of valve often used in implant technology is a diaphragm valve, such as described in US Patent No. 6,419,699 issued to McGhan Medical Corporation. The diaphragm valve requires the insertion of a rigid male component over the inflation tube to open the valve and allow fluid transfer. Upon removal of the inflation tube, fluid pressure within the implant forces the valve to close and creates a tight seal. As in the case of the flapper valve, said valve does not show any means for there to be a back flow through the valve.

Other valves that are used in medical applications include a connector for an instrument insertion port described in US Patent No. 5,599,327, a non-fixation surgical valve such as described in US Patent No. 5,916,198, and a needleless injection site as described in US Patent No. 6,261,268. Each of these valves or connectors has drawbacks that are solved by the present invention. Initially, both US Patents 5,599,327 and US 6,261,268 contemplate an opening in the valve that forms a seal upon application of mechanical pressure by a medical instrument. Consequently, both US Patents 5,599,327 and US 6,261,268 require the use of oversized components and mechanical force to create a closure. Such components and the use of mechanical force are rarely used in implant technology. Furthermore, US Patent No. 5,916,198 describes a one-way valve that is closed by blowing gases acting on an inner valve surface through a passage in one of the valve segments. Consequently, the valve contemplated by US Patent No. 5,916,198 does not overcome the drawbacks of the prior art mentioned above.

Thus, the present invention aims to overcome these problems associated with prior art valves.

US-A-6,039,748 describes a trocar for removing large masses of tissue during laparoscopic procedures. The trocar comprises a cutting member and a laparoscopic grasping instrument, the laparoscopic grasping instrument being inserted through the opening of the trocar. The trocar may include a valve to prevent loss of insufflation gas when no instrument passes through the opening.

The present invention relates to a two-way valve that can be used in an implantable medical device such as an inflatable balloon.

These or other features of the present invention will become apparent from the subsequent discussion to be made in the detailed description that follows.

Summary of the invention

The present invention and its various embodiments are defined in the claims.

The present invention relates to a two-way valve having first and second ends. The two-way valve may include a substantially cylindrical valve body having a groove connecting the first and second ends of the valve and the concave sections formed at the first and second ends.

In one embodiment of the present invention a slot valve is provided for use with a medical implant, the valve comprising:

a valve body having a proximal end and a distal end;

a flange (also referred to herein as a flange surface) at the proximal end of the valve body and having a flange opening therein;

a first chamber defined in said valve body and in communication with the flange opening, the first chamber being able to accept an inflation tube when inserted through said flange opening;

a second chamber having a concave section, said second chamber being disposed between said first chamber and the distal end of the valve body;

a slot formed in the valve body and connecting said concave section and the distal end of the valve body;

characterized in that the valve body is structured to receive an inflation tube through the flange opening whereby the pressurized fluid introduced from the inflation tube into the second chamber causes the slot to open and pass distally through from the distal end of the valve body.

ES 2 328 567 T3

The slot valve can have a concave section at one or both ends, which are connected by the slot formed in the valve body.

In another embodiment of the present invention an implantable and inflatable apparatus is provided comprising a valve slot of the invention.

In another embodiment of the present invention, a medical apparatus for the treatment of obesity is provided. The medical apparatus includes a balloon made of a suitable polymer or elastomeric material for insertion into the stomach, and a slot valve according to the invention for the communication of a fluid from an inflation tube to the balloon.

Other features, configurations, and advantages of the present invention will become apparent from the following detailed description of the invention with reference to the following drawings, in which:

Brief description of the drawings

Fig. 1 is a cross-sectional view of a prior art gastric balloon with a one-way valve;

Fig. 2 is a cross-sectional view of a prior art one-way valve;

Fig. 3 is a side view of a two-way slot valve according to one of the embodiments of the present invention;

Fig. 4 is a cross-sectional view of the two-way valve, shown in Fig. 3;

Fig. 5 is a detailed view of a part of the two-way valve shown in fig. 4;

Fig. 6 is a top view of the two-way valve shown in fig. 4;

Fig. 7 is a side view of a fill tube;

Fig. 8 is a side view of an inflation tip; Y

FIG. 9 is a cross-sectional view of the inflation tip of FIG. 8.

Detailed description of the preferred embodiments

In Fig. 3 a slot valve 10 according to a first embodiment of the present invention is shown. The valve comprises a valve body 14 and a flange 12. In connection with the description of the present invention, the end of the valve 10 on which the flange 12 is located will be called the upper part of the valve and the opposite end the bottom. Valve 10 is preferably made of elastomeric material such as silicone; however, other materials could be used without departing from the scope of the present invention. Valve body 14 is preferably molded in a substantially cylindrical shape. The cylindrical shape is preferred as it provides additional stiffness and stiffness for the valve.

Figs. 4 and 5 depict cross-sectional views of valve 10. Fig. 6 shows a top view of valve 10. Starting at flange surface 12 of the top of valve 10, there is an opening 16 through the valve. flange 12, which is in communication with interior surfaces of valve 10. Immediately below opening 16 is a first chamber 18. Below first chamber 18 is a neck 19. The neck 19 separates the first chamber 18 from a second chamber 26. At the bottom of the second chamber there is a concave surface 20. The concave surface 20 provides orientation to a probe in the event that the sealing properties of the valve 10 must be mechanically improved. The concave surface 20 assists in the guidance of a probe (not shown) that can be used to force the valve open and allow reverse flow of the fluid contained by the valve 10.

After the concave surface 20 there is a groove 24 in a substantially solid part of the body 14. The groove 24 connects and is in fluid communication with a second surface 22, which could be concave as illustrated, or flat. In an application such as a gastric balloon, fluid enters the balloon envelope as it exits the underside of groove 24. Groove 24 can be lubricated with silicone oil. The use of silicone oil facilitates the insertion of a withdrawal tip (not shown) in cases where it is desired to overcome the sealing properties of valve 10, and serves to reduce the opportunity for cross-links when valve body 14 It is made of silicone.

Fig. 7 represents a fill tube 30. The fill tube is made up of a long, flexible tube 34 having an opening therein, an injection tip 32, and a connector 35 for connecting the fill tube to a supply of fluid (not shown). The flexible tube 34 may be provided with reference length markers 36 to provide medical personnel with a visual indication of the position of the fill tube 30 within

ES 2 328 567 T3 of the patient. As illustrated in Figs. 8 and 9, injection tip 32 has a hole 37 extending therethrough and allowing fluid communication through flexible tube 34, and injection tip 32. One end of the injection tip it can be tapered to a wedge shape 38 having its smallest cross section at the distal end of injection tip 32. The wedge shape 38 aids the insertion of the injection tip 32 into the slot valve 10. In addition, the injection tip may include a reduced diameter portion 40, and an insertion stop 42 to be safely inserted into the opening 16 of the valve 10. The other end of the injection tip 32 is provided with tabs 44 to keep the flexible tube 34 in tight contact with the injection tip.

In use, the fill tube 30 is connected to the valve 10 by inserting the injection tip 32 into the opening 16 of the valve 10. The injection tip 32, when fully inserted into the valve, extends to a point approximately flush with an upper surface of the second chamber 26. The substantially wedge shape 38 of the injection tip coincides with the orientation of the first chamber 18, and the narrow cross-sectional portion of the injection tip 32 is held firmly by the neck 19 of the valve 10 to form a seal that prevents the return of fluid from second chamber 26 into first chamber 18 and out through opening 16. Insertion stop 42 in injection tip 32 prevents the injection tip from inserting into valve 10 beyond a predetermined point. When fully inserted, insertion stop 42 rests against flange 12 of valve 10. Aperture 16 is of a size that, upon insertion of injection tip 32, a second seal is formed by flange interference. 12 and the reduced diameter portion 40 of the injection tip. This second closure also ensures that fluid does not leave valve 10 and prevents other contaminants from entering valve 10.

Valve 10 may be attached to an inflatable medical device such as a gastric balloon, a breast implant, such as a Becker-style breast implant, a tissue expander, or the like. Other non-inflatable applications of the valve include devices such as a bypass drug delivery system or therapeutic delivery system, a feeding tube, or the like. Accordingly, these variations are within the scope of the present invention. When the device is a gastric balloon, valve 10 is attached to the sheath substantially as illustrated in Figs. 1 and 2 of the prior art. The surface of the flange 12 is positioned flush with the outer surface of the balloon and can be covered by an elastomeric material that secures the components together forming an integral gastric balloon and valve combination. The gastric balloon is inserted into a patient in a deflated state and inflated after insertion. After insertion of the gastric balloon, fluid, usually sterile saline, is inserted into the gastric balloon through filling tube 30. Other fluids, including air, silicone, pseudogel, oil, etc., could be used to fill a implant.

To inflate the gastric balloon, the valve 10 must have a slot 24. The slot 24 is preferably a single two-sided separation of the valve body 14. The slot 24 is formed during manufacture by inserting a thin, sharp tool (not shown) into the valve body 14. The length of the groove 24 is variable depending on the valve application and the desired valve opening pressure. In certain applications, it may be necessary to ensure that the slot valve allows back flow more easily. In such cases, a shorter groove length would be used, while in cases where the valve must contain higher pressure, a longer groove length is desirable.

To effect inflation through fill tube 30, injection tip 32 is inserted into opening 16 of flange 12. The distal end of injection tip 32 is extended to form a seal with neck 19. When the Pressurized fluid is injected through the fill tube 30 and the orifice 37 of the injection tip 32, a higher pressure is created in the second chamber 26 which has two effects. The first is to increase the closing pressure of the neck 19 at the injection tip 32. The second effect is to force the slot 24 to open. The smaller wall thickness of the valve body 14 in the area of ​​the second chamber 26 is more easily deformable by the pressurized fluid injected into the second chamber 26 than the area of ​​the groove 24. The increase in pressure causes the second chamber 26 to expand in a direction substantially perpendicular to the direction of the slot 24. This expansion in turn causes the slot 24 to open and allows the flow of fluid from the second chamber 26 through from slot 24 and into the implant. The opening of the slot is aided by the concave surface 20. Likewise, if the second surface 22 is also concave, sufficient pressure can be applied to the shell to overcome the resistance to the back flow of the valve to allow fluid flow through the slot 24 to the exterior of the implant. Due to the relative sizes of the second chamber 26 and the concave surface 22, a higher pressure is necessary in order to allow the return flow of the implant fluid to the exterior of the valve than is necessary for inflation. For this reason, the balloon or other implant can also be deflated or reduced in volume by inserting a small diameter probe completely through the valve and into the implant shell. The concave surface 20 assists in guiding the small diameter tube or probe into and through the valve body 14.

Valve 10 and fill tip 32, when used together, create a system that overcomes many of the drawbacks of the prior art. Through the use of the aperture 16 and its interaction with the reduced diameter portion 40 of the injection tip 32, and also due to the interaction of the neck 19 with the injection tip 32, the injection tip is firmly held in place. in place and is prevented from being pushed out of valve 10 during fluid injection through valve 10. Furthermore, due to these same characteristics, removal of the injection tip 32, when desired by the user, is greatly facilitated, requiring less than 4 lbs. (17.8 N) force to withdraw the tip of a balloon, filled to 700 cm³. Likewise, valve 10 provides a device that does not leak under normal operating conditions, yet still allows flow.

ES 2 328 567 T3 of two directions. The valve of the present invention allows continuous flow of fluid at 30 psi (2.11 Kg / cm²) and can safely withstand fluid fill pressures up to 40 psi (2.81 Kg / cm²) without damage to the valve.

Although the invention has been illustrated and described particularly with reference to certain preferred embodiments, those skilled in the art will appreciate that various changes and modifications can occur without departing from the scope of the invention.