JPS636018B2 - - Google Patents

Description

Claim 1: A penile implant comprising an elongated unitary body having a tip at one end and an anchoring stem at the other end; an intermediate section having a chamber and a radially arranged outer chamber; a passage communicating between said inner chamber and said outer chamber; a body for moving liquid into the inner chamber to pressurize the inner chamber and make it rigid; pumping means within the chamber; a pressure control valve for controlling the internal pressure of the inner chamber; the pressure control valve having (a) an inlet communicating with the inner chamber and an outlet communicating with the outer chamber; (b) a valve housing disposed within the jacket having an open head and a bottom and an inwardly directed shoulder partially closing the head; (c) extending upwardly; (d) a poppet valve mounted within said housing between its inlet and outlet having a base having a stem portion; (d) a poppet valve having a sealing edge extending around said stem portion; a sealing member located on the surface of the head; (e) applying a force to the poppet valve and propelling it toward the open head of the housing to close the valve and the seal; bring the edges into sealing contact;
The valve can be opened by applying manual pressure to the stem to reduce the internal pressure in the internal chamber of the penile implant, and automatically open the valve when the internal pressure in the internal chamber exceeds the force applied to the poppet valve. A penile implant consisting of: a means allowing the penis to open;

2. The means for applying force opens the valve when a predetermined amount of force is sensed at the poppet valve head and automatically closes the valve when the pressure sensed at the poppet valve head is less than the predetermined amount of force. 2. The penile implant of claim 1, wherein the penile implant is a graduated spring.

TECHNICAL FIELD The present invention relates to penile erection products. More particularly, it relates to an inflatable, implantable penile erection device having a simple and effective control valve.

BACKGROUND OF THE INVENTION There are cases of incomplete erection for which surgical implantation of penile erection devices is the only practical means of treatment. In such cases, several different types of implantable penile erection devices have been used in the past.

One type of implantable penile erection device that has been used in the past is an inflatable device that has two inflatable tubes, each surgically implanted into a separate corpus cavernosum of the penis. Each of these tubes is tube-connected to a relatively large reservoir of inflation and pressurization fluid that is implanted elsewhere in the body (thus requiring a separate revision surgery). Erection is achieved by expanding and pressurizing the dilator tube.

Another type of penile erection device consists of a pair of moderately rigid rods that are surgically implanted into the corpus cavernosum of the penis. A significant advantage of this device is that it requires minimal surgery since no pressure bulb is implanted. A disadvantage of this device is that the permanent stiffness of the rod can cause physical pain and discomfort to the patient.

Other implantable erectile devices that combine some of the features of both inflatable and rod devices include a rod with a sleeve disposed around the rod to form a chamber. It's within. The erection is
This is accomplished by pressurizing the chamber to lash and support the rod, and the chamber is relieved of pressure through the use of a pressure control valve.

DISCLOSURE OF THE INVENTION It is a general object of the present invention to provide an inflatable, pressurizable, implantable penile erection device with a reliable and relatively inexpensive pressure control valve.

The second purpose is to provide a penile erection device having a pressure control valve that automatically opens when the internal pressure of the device exceeds a predetermined hydraulic pressure, and that can be manually operated from the outside to indent the device, i.e., release the pressure. It is an offer.

In a preferred embodiment of the invention, the penile erection device is comprised of two homogeneous, independent, self-contained, pressurizable implants that can be completely surgically implanted within the penis as easily as rod-type implants. be done.

The implants of the preferred penile erection devices of the present invention each have a relatively short proximal stem portion, a crownless tip portion, and an elongated flexible intermediate portion having a pair of concentric cylindrical chambers. These two chambers are connected by a passageway so that liquid present in the outer chamber can move into the inner, non-expandable chamber, pressurizing it and making it rigid. The equipment includes a pump means for moving liquid under pressure from the outer chamber to the inner chamber, and a pressure control that can be used to prevent the internal pressure of the inner chamber from exceeding a predetermined pressure and to relieve pressure and dent the inner chamber. It also has a valve.

The pressure control valve of the present invention, which can be opened manually and automatically opens when the pressure in the inner chamber reaches a predetermined hydraulic pressure, is located in a passage between the two chambers and has an inlet and an outlet. a jacket; a valve housing disposed within the jacket; a poppet valve having a base, an upwardly extending stem portion, and a sealing edge disposed about the stem portion mounted within the housing; and a poppet valve. The upper sealing edge is urged into sealing contact with the seat and the inner and outer chambers are then separated until the pressure applied to the poppet overcomes the force of the spring or its equalizer and the sealing edge leaves the seat. consisting of a spring or equivalent means for closing the flow between.

A preferred implant comprising all of the elements of the present penile erection device can be implanted into the corpus cavernosum in the same manner as a rod-type penile implant. When these preferred implants are in place, their inner chambers become pressurized and rigid by pumping fluid from the outer chamber into the non-expandable inner chamber under pressure, and the penis becomes erect. The inner chamber is depressurized by actuation of a pressure control valve.

The penile erection device of the present invention is compact;
In addition to requiring minimal surgery, this also has the advantage of minimizing the number of fluid connections and thus reducing the risk of leakage.

The above-mentioned objects and advantages, as well as other objects and advantages, will become apparent from the description of the present invention.

[Brief explanation of the drawing]

FIG. 1 is a side view (partially in section) of a preferred embodiment of the penile erection device of the present invention, showing two identical penile implants surgically implanted in a man in a non-pressurized state; One is shown. FIG. 2 is a side view similar to FIG. 1 except that the graft is pressurized. FIG. 3 is an enlarged cross-sectional view taken along line 3--3 of FIG. FIG. 4 is an enlarged cross-sectional view taken along line 4--4 of FIG. FIG. 5 is an enlarged view (partially in section) of the distal end of the implant of FIG. 1, showing the position of the pump arrangement when the pump is used to pressurize the interior chamber; FIG. 6 is an enlarged view of the pressure control valve showing the position of the valve arrangement when the valve is closed. FIG. 7 is a view similar to FIG. 6 except that the valve is open.

BEST MODE FOR CARRYING OUT THE INVENTION A preferred embodiment of the penile erection device of the present invention is illustrated in the accompanying drawings, which include a pair of elongated penile implants 1
1, 11'. The two implants are identical, therefore only one will be detailed.

As best seen in Figures 1 and 2 of the accompanying drawings, the implant 11 has a body-side stem portion 12, an intermediate cylindrical portion 13, and a distal tip portion 14. A stem portion 12 made of relatively rigid material is embedded in the root of the corpus cavernosum, and a soft, relatively flexible intermediate cylindrical portion 13 and tip portion 14 are embedded in the corpus cavernosum of the weeping penis. . As shown in Figures 3 and 4, each of the implants 11, 11' is placed in a separate corpus cavernosum of the penis.

The intermediate cylindrical portion 13 of the graft 11 contains a pair of concentric cylindrical sleeves 15, 16 that are fluid-tightly attached to the stem portion 12 and the tip portion 14, respectively, to form a pair of concentric chambers 17, 18. It is preferable to do so. This sleeve 15 forms the wall of the interior chamber 17
is made of a relatively inelastic material such as silicone-coated mesh or woven fabric so that chamber 17 is non-expandable under pressure. This sleeve 15 is similar to the sleeve 1 disposed outside of it.
6 to form an outer chamber 18. The sleeve 16 may be made of an extensible material such as unreinforced silicone rubber. Sleeves 15 and 1
6 and between the stem portion 12 and the tip portion 14 may be created with a suitable adhesive or other suitable means.

As shown in FIGS. 1 and 3, when the graft 11 is in an unpressurized state, both chambers 17 and 18 contain an incompressible hydraulic fluid, which can be a biocompatible fluid such as saline or a free-flowing silicone gel. 19, which is practically filled. In the unpressurized state, the soft, flexible intermediate cylindrical portion 13 of the implant 11 is pliable, allowing the penis to assume a substantially normal floppy position, as shown in FIG. . However, when the implant 11 is under pressure, as shown in FIGS. 2 and 4, the intermediate cylindrical portion 13 becomes rigid as a result of the inextensible interior chamber 17 being completely filled with pressurized fluid, and the penis becomes erect.

Pumping means (designated 20) for pressurizing the interior chamber 17 and the pressure control valve 21 for limiting the hydraulic pressure within this interior chamber 17 will now be described.

As best shown in FIG.
There is a passage 22 leading to a pump chamber 23. As shown therein, the outlet of passage 22 is closed with a one-way flap valve 24 which opens only when the hydraulic pressure in passage 22 exceeds the hydraulic pressure in pump chamber 23.

Inside the pump chamber 23 are axial passages 26,
26' and a longitudinal passageway 27 passing therethrough.
It is a support member 25 having. This support member 2
5 extends from the hollow interior 14a of the conical tip 14, the pump chamber 23, and the interior chamber 17, and provides communication therebetween. Passage 2 opposite the conical tip 14
The end of 7 has an umbrella-shaped flexible check valve 2 inside it.
It has a large outlet 28 in which 9 is located. This check valve 29 is normally fitted into a valve seat, and the passage 27 is closed by the hydraulic pressure within the chamber 17. However, when the wall of the pump 20 is throttled as shown in FIG. 5, the internal liquid pressure in the pump chamber 23 and the passage 27 exceeds the internal liquid pressure in the chamber 27, and the end of the check valve 29 is bent, causing the liquid to flow as shown by the arrow. is introduced into the chamber 17 through the check valve 29.

The graft 11 is attached to the resilient wall 2 of the pump 20
0a is sequentially squeezed to pressurize the pressure fluid 19 from the pump chamber 23 to the non-extensible inner chamber 17, and then pressurizes the wall 20a by causing it to assume its normal shape. When the pump wall 20a is first throttled, the liquid 19 originally in the pump chamber 23 is forced out of the outlet 28 through the axial passages 26, 26' and the longitudinal passage 27, and the end of the check valve 29 is forced out of the outlet 28. The seat is removed and liquid 19 is allowed to flow around valve 29 and into chamber 17 (as indicated by the arrow in FIG. 5). The increased pressure in pump chamber 23 causes flap valve 24 to close passage 22 on its seat, preventing flow to chamber 18. Thereafter, when the wall 20a assumes its normal position, the internal pressure in the pump chamber 23 decreases, and as a result, the flap valve 24 moves away from the valve seat, allowing the liquid 19 to flow from the chamber 18 into the pump chamber 23. Whenever the internal pressure of the pump chamber 23 is higher than the internal pressure of the chamber 18, the flap valve 24 closes the passage 22 on its valve seat.
Once the chamber 17 is sufficiently pressurized and rigid, the pumping is stopped and the outlet 28 of the passage 27 is closed by the pressure of the fluid in the chamber 17 against the outer surface 29a on the enlarged head of the check valve 29. As a result, chamber 17 remains in a state as shown in FIG. 2 until pressure control valve 21 opens, allowing fluid to flow back into chamber 18 and causing graft 11 to assume an unpressurized state as shown in FIG. filled with liquid,
It is pressurized and remains rigid.

If desired, the non-stretchable inner chamber 17 can be filled and pressurized by manually squeezing the penis to release the liquid 19 in the chamber 18.
passes through the passage 22 and leaves the flap valve 24;
This can be facilitated by assisting in pressurizing the pump chamber 23.

Various pump mechanisms other than those shown in the accompanying drawings may also be used. However, the pump must be of the type that opens when the throttle is tightened and automatically closes when the throttle is stopped.

The preferred pressure control valve 21 can be opened manually or automatically when the internal pressure of the chamber 17 exceeds a predetermined level.

As best shown in FIGS. 6 and 7, the pressure control valve 21 has an outer jacket 30 having an inlet 31 communicating with an inner chamber 17 and an outlet 32 leading to an outer chamber 18. Disposed between the inlet 31 and the outlet 32 is a valve housing 33. Poppet 34 with stem portion 35
is movably mounted within the housing 33.
As shown in FIG. 6, the poppet 34 has an annular seal 36 disposed around the stem 35.
The sharp edge 3 of the seal 36 is attached to the flat portion of the lower surface of the flange 39 that partially closes the tip of the housing 33.
8 is supported within the housing 33 by a spring 37 in sealing engagement. The force of spring 37 applied to the underside of poppet 34 normally forces valve 29
is closed, keeping the sharp edge 38 of the seal 36 in liquid-tight contact with the flat lower surface 39a of the flange 39 to prevent liquid from flowing from the inlet 31 to the outlet 32 or vice versa.

When valve 21 is opened, liquid may be allowed to flow from chamber 17 to chamber 18 by applying manual pressure to point 30a of jacket 30 to deflect jacket 30 into contact with stem 35 of poppet 34. Further movement of the jacket 30 moves the poppet 34 toward the spring 37, causing the sealing edge to move out of sealing engagement with the underside 39a of the flange 39 of the housing 33 (see FIG. 7). As a result, the liquid 19 flows from the pressurized inner chamber 17 to the outer chamber 18 . When the deflection pressure applied to the jacket 30 and stem 35 is removed, the spring 37 causes the flat lower surface 39 of the flange 39 to
The sealing engagement between a and sharp edge 38 is restored and flow from inlet 31 to outlet 32 is blocked.

Valve 21 also serves as a safety valve for the penile implant. When the hydraulic pressure in the interior chamber 17 exceeds the predetermined safety pressure, the pressure sensed at the upper surface 36a of the seal 36 exceeds the force of the predetermined load spring 37, and the sharp sealing edge 38 is forced to the lower surface 39a of the shoulder 39. released from sealing engagement with. The liquid then flows from the inner chamber 17 to the outer chamber 18 until a safe pressure is reached, at which point the sharp edge 38 is again moved by the spring 37.
It enters sealing engagement with the underside 39a of shoulder 39.

In the preferred embodiment of the valve 21, best shown in FIGS. 6 and 7, there is a pair of outlets 40, 41 at the bottom of the seal 36. These outlets 40, 41 keep the bottom area of the seal 36 at low pressure, ie the pressure of the external chamber 18. As a result, when insufficient pressure is applied to the head of the seal 36, which is placed within the confines of the annular sharp edge 38, to open the valve 21, the sharp edge 38 is forced into a good seal with the underside 39a of the shoulder 39. Achieve engagement.

Pressurizing the non-stretchable interior chamber 17 of the penile implant provides the necessary stiffness to maintain the penis in an erect state. Therefore, it must have sufficient volume and size to accomplish this function. In contrast, the outer chamber 18 primarily serves as a pressurized fluid reservoir for the inner chamber and is sized accordingly.

The exact dimensions of the inner and outer chambers are not critical as long as they are sufficient to achieve the desired function.

Sleeve 1 forming the wall of the “inextensible” chamber 17
5 should be relatively inelastic and is preferably made of silicone coated Dacron mesh or woven fabric which does not stretch when filled with liquid and pressurized. In contrast, sleeve 16 may be stretchable or non-stretchable. Sleeves 15, 16 may vary in diameter, but are typically sized so that the non-pressurized graft fills the corpus cavernosum. The term "inextensible" or "inelastic" refers to a material that has the desired properties that enable it to achieve the above function.

The proximal stem portion 12 of the graft preferably has a Shore A hardness of about 70, and the distal tip 14 preferably has a Shore A hardness of about 20, both of which have sufficient tensile strength for the purpose. In the preferred embodiment shown, the tip is tapered and made of a self-sealing silicone elastomer that allows fluid to be added to and removed from the implant with a thin, hollow needle or syringe.

The term "substantially full" as used herein to describe the liquid content of a chamber means that the chamber contains approximately 60% of its volume of non-compressible liquid such as water, brine, free-flowing gel, etc.
It means containing ~95% or more. The actual fluid content may be varied, but the implant must be sufficiently flexible to allow the penis to assume its normal, floppy state even when "substantially full."

Preferably, all parts and components of the prosthesis are made of or coated with medical grade silicone rubber that is non-reactive, non-toxic and well tolerated by adjacent body tissues. Silicone rubber is preferred because it can withstand long-term wear and is functional. However, other materials can be used if they have the desired properties.

The preferred method of implantation of the present erectile device is through an incision in the penis. After making an appropriate incision, each corpus cavernosum is expanded proximally and the graft is inserted. Appropriate anatomical measurements are taken to ensure that the proximal stem of the implant(s) is positioned at the base of the penis beneath the pelvic bone. One or more implants with appropriately sized intermediate and distal tips are inserted into the corpus cavernosum of the penis. The distal tip is placed in the glans end of the corpus cavernosum. The proximal stem of the graft is then anchored into the root of the corpus cavernosum.

The same procedure as above is performed on the other side of the penis to complete the surgery. Preferably, the proximal stems of the two implants diverge laterally to accommodate the anatomical portion, providing lateral stability to the penis and preventing rotation of the implants. Then close the notch.

The above description is illustrative, and many modifications and changes may be made without departing from the spirit and scope of the invention.
For example, the described implant has a solid stem for anchoring it, but could be hollow if desired.
Additionally, although the outer chamber serving as a reservoir is described and illustrated as being concentric with the inner chamber, this reservoir may serve as one or more radially arranged smaller individual outer chambers, if desired. It may be provided by Furthermore, in some cases, the pump 20 and the valve 21
The position of may be reversed.

The interior chamber 17 may also include rods such as those shown in U.S. Pat. No. 4,201,202 to reduce volume or provide additional support.

The novel pressure control valve of the present invention can also be used in other implantable medical devices.