JPH07184940A - Artificial orthosis with texture surface - Google Patents

Abstract

PURPOSE: To provide a prosthetic device for a penis, which reduces occurrence of complications and remedies impotency. CONSTITUTION: This prosthetic device 10 for a penis to be implanted to the corpus cavernosum of the penis is equipped with at least one cylinder 12, which has an outer surface 32 of a texture-shaped-like and expedites adhesion and ingression of tissue. Also, the device is equipped with a pump assembly 18 and a reservoir 22.

Description

Detailed Description of the Invention

[0001]

FIELD OF THE INVENTION This invention relates generally to implantable prostheses, and more particularly to surgically implanted genitourinary prostheses, and more particularly to surgically implanted penile prostheses.

[0002]

2. Description of the Related Art Currently, there are 10 million men in the United States alone.
It is presumed to suffer from chronic impotence, the inability to maintain an erection state that is rigid enough or durable enough to have sexual intercourse. Of these, about 85% of cases of chronic erectile dysfunction are believed to be related to organ causes rather than psychological causes. Many of the impotences caused by these organs, and some cases of psychological causes that do not respond to treatment, are subject to penile prostheses. In fact, surgically implanting penile prostheses has become an increasingly established technique in the treatment of chronic impotence, with approximately 35,000 prostheses being implanted each year.

Several types of penile prostheses are currently available. One of them, the type known as stiff prosthesis, comprises a pair of relatively stiff, long rods, which can be found in the cavernous body of the penis, which is a column of erectile tissue over the length of the penis. Ported. These implanted rods keep the penis in a constant erection, but are difficult to cover up and can be a hindrance in some situations. Another type of semi-rigid prosthesis is
It typically consists of a bendable or flexible rod that, when implanted in the penis, maintains the penis in a manually manipulated position.
Although such an orthosis can be operated in various postures, the penis is maintained in an erected state and the atrophy state is not well imitated.

The third type of prosthesis is mechanically by far the most complex and expandable prosthesis. In this type of brace, an inflatable cylinder is implanted into the corpus cavernosum, a reservoir into the abdominal cavity, and a manual pump into the scrotum. However, the position of the reservoir and pump can be changed. In one model, all components are contained within the cavernous body of the penis. When you activate the pump, the fluid from the reservoir inflates and expands the cylinder,
Mimics the thickness and rigidity of an erect penis. By opening the valve, the fluid in the cylinder returns to the reservoir and the cylinder contracts, mimicking a normal, swollen penis. These are just a few of the many types of prostheses known.

Regardless of the type or mechanical complexity of the prosthesis, all of these various prostheses need to be implanted in the penis and (possibly) the abdominal cavity and scrotum. Where the prosthesis makes contact with the surrounding tissue, a smooth surface silicone resin is generally used. The resin is non-toxic, non-reactive, and abrasion resistant and retains function for extended periods of time. Other materials with smooth surfaces have also been used, such as some plastics.

[0006]

Generally, in response to the presence of an implanted foreign body, the body forms a fibrous pseudocapsule of scar tissue around the foreign body. This pseudo-sac of scar tissue ideally acts to support the implanted prosthesis,
It is possible for the brace to function without moving. However, with appliances having an inert, smooth surface, adhesion and tissue ingrowth of tissue around the surface and to the surface itself does not occur. The scar tissue that forms the pseudocapsule has a linear arrangement of collagen that can contract and move the implanted prosthesis. Also, because adhesion of tissue to the brace does not occur, a dead space is created around the brace and, thus, the implanted brace may migrate to the host's tissue, which may lead to cell damage and consequent infection. Danger is triggered. further,
Implants can erode the surrounding tissue, resulting in perforations. The uneven formation of fibrous scar tissue around the brace can cause contractures in various components of the implant, such as inflatable cylinders, which reduce their function.

Unfortunately, about 20% of patients implanted with a penile prosthesis have complications such as mechanical defects in the prosthesis, or erosion, infection, perforation, contractures, and uncontrollability of the device. Suffers from complications related to mobility and distress.
In most cases, treatment of complications requires removal of the device, treatment of the affected tissue, and ultimately replacement of the prosthesis. Due to the ever-increasing implantation of penile prostheses, physicians and manufacturers have been able to reduce complications mainly by improving the mechanical reliability of the brace and by using improved anti-infective agents. We are trying to reduce the outbreak.

The present invention has been made to solve the above problems, and an object thereof is to provide a prosthesis which reduces the occurrence of complications.

[0009]

SUMMARY OF THE INVENTION The present invention provides a penile prosthesis which is used to correct impotence and which can undergo repeated circumferential expansion and contraction. The prosthesis comprises at least one flexible extension member for implantation in the corpus cavernosum of the penis, which extension member is composed substantially of silicone rubber and which is fluid impermeable to define an interior chamber and an exterior surface. Has an internal surface. This outer surface has texture means formed directly on this outer surface that remain exposed to body tissue,
Encapsulation of scar tissue that promotes tissue adhesion and tissue ingrowth over nearly the entire length of the implanted extension member, thereby minimizing contracture and increasing swelling, compliance, and malleability. This makes it possible to repeatedly expand and contract in the circumferential direction, and at the same time prevent the formation of a dead space around the extension member, thereby causing infection due to cell damage,
Significantly reduces erosion, puncture, and uncontrolled movement of the brace. The outer surface texture has a pore size distribution in the range of about 60 microns to about 567 microns.

In the present invention, the outer surface may completely surround the extension member.

In the present invention, there is no opening through the outer surface of the extension member.

In the present invention, the appliance further comprises a fluid reservoir and a fluid pump, the reservoir in fluid communication with the pump, and the pump in fluid communication with the inflatable extension member.

In the present invention, the outer surface has a textured surface shape for promoting tissue adhesion and tissue ingrowth.

In the present invention, the texture of the outer surface has a pore density of about 2.4 pores per square millimeter surface area.

In the present invention, the texture of the outer surface has an average pore size of about 263 microns.

According to another aspect of the present invention, there is provided a penile prosthesis for correcting erectile dysfunction which can be repeatedly expanded and contracted in the circumferential direction. The prosthesis comprises at least one extension member for implantation in the corpus cavernosum of the penis, the extension member being substantially composed of silicone rubber and having a fluid impermeable inner surface and a texturing means over substantially the entire surface area. And an outer surface formed with the textured means formed directly on the outer surface to be left exposed to body tissue, thereby adhering to and adhering tissue over substantially the entire length of the implanted extension member. Encourages tissue ingrowth, which minimizes contracture and allows repeated circumferential expansion and contraction due to encapsulation of scar tissue with enhanced expansion, compliance, and malleability At the same time, it prevents the formation of dead space around the extension member, which significantly reduces infection, erosion, perforation and uncontrolled movement of the brace due to cell damage. Make. The outer surface texture has a pore size distribution in the range of about 60 microns to about 567 microns.

In the present invention, the outer surface completely surrounds the extension member.

In the present invention, there is no opening through the outer surface of the extension member.

The present invention provides a prosthesis that reduces the occurrence of complications. INDUSTRIAL APPLICABILITY The penile prosthesis of the present invention has a surface shape similar to that of a tissue in which adhesion of a tissue and ingrowth of the tissue are performed and contraction of scar tissue is controlled, and has a component that contacts body tissue It includes many components typically deployed in penile prostheses. The surface profile is preferably a textured profile, which surface can be an integral part of the brace or the cover of each component of the brace.

According to the invention, the penile prosthesis comprises at least one extension member for implantation in the corpus cavernosum of the penis, the extension member for adhesion of tissue to the extension member and tissue ingrowth. It has a facilitating outer surface profile.

In accordance with another aspect of the invention, the implantable genitourinary appliance has an outer surface profile that promotes tissue adhesion and tissue ingrowth.

According to yet another aspect of the present invention, a penile prosthesis comprises at least one extension member for implantation in a corpus cavernosum, the extension member having a textured shape for contacting body tissue. Has an outer surface of.

These and other objects, advantages, features and aspects of the present invention will be apparent as set forth below.

To the accomplishment of the foregoing and related ends, the invention comprises the features hereinafter fully described and particularly pointed out in the claims. Embodiments of the present invention will be described in detail in the following description and the accompanying drawings.
However, this is merely an example of the various ways in which the subject matter of the invention may be used. It should be appreciated that the scope of the invention is determined by the claims and their equivalents.

[0025]

By providing a component having a textured surface according to the present invention, unlike a smooth surface, a textured shape is directly formed on the outer surface of the implanted component, and this surface is formed on the body tissue. It will be exposed.
Thus, as the body heals, there is a more disordered distribution of collagen deposits across the textured surface, with tissue adhesions and tissue ingrowth over an increasingly wide range of the surface area of the textured surface. Thus, the scar tissue formed adjacent to the implanted component adheres to the outer surface of the textured component, forming a complete encapsulation of the scar tissue. According to the present invention, scar tissue may adhere to the textured surface of the component, so that the tissue tends to form uniformly over the entire surface of the implanted prosthesis. For this reason,
Contractures are minimized and an encapsulation of scar tissue is formed that is distensible, compliant, and flexible.

[0026]

DETAILED DESCRIPTION In the accompanying drawings, similar components are designated with similar reference numerals. FIG. 1 illustrates an inflatable penile prosthesis 10 according to one embodiment of the present invention. The implantable penile prosthesis 10 is a typical inflatable implant with discrete components, such as, for example, the product manufactured by American Medical Supply. However, the present invention is equally applicable to rigid and semi-rigid rod-shaped implants, and other types of inflatable implants such as appliances having self-contained pumps and fluid reservoirs, and others. It can also be applied to genitourinary transplants. The penile prosthesis 10 includes a pair of flexible and inflatable cylinders 12, each having an inflatable distal portion 14 and a relatively rigid proximal end portion 16. The interior 17 of the inflatable distal portion 14 is in fluid communication with a pump assembly 18 via a fluid line 20, which in turn is in fluid communication with a reservoir 22 via a fluid line 24. The pump assembly 18 stores the fluid in the reservoir 2.
2 mechanically actuated spherical pump 26 for delivery to the inflatable cylinder 12, a relief valve 28 to prevent excessive inflation, and a reservoir for fluid in the inflatable distal portion 14 of the inflatable cylinder 12. It has a deflation valve 30 for returning to 22.

The internal components of reservoir 22, pump assembly 18, and inflatable cylinder 12 may be constructed of any suitable material that is non-reactive and non-toxic, and will be in contact with the surrounding body tissue. The 10 external components are McGhan Medical.
A textured medical grade silicone rubber manufactured under the tradename Biocell by the Company), preferably with a surface profile that favors tissue adhesion and tissue ingrowth. It is covered with a toxic, non-reactive material or the outer surface is formed by this material.

The textured biocell material has a pore density of about 2.4 pores per square millimeter surface area,
Pore sizes range from about 60 microns to about 567 microns with an average pore size of about 263 microns. Inflatable cylinder 12, or the rigid or semi-rigid rod of other prostheses, is particularly important to have such textured outer surface 32 because these components are the most susceptible to movement and stress. Is. The texture is formed directly on the outer surface 32 of the cylinder 12 and constitutes an integral part of it and remains exposed to body tissue upon implantation, as described below. The textured outer surface 32 completely surrounds the cylinder 12 and does not have an opening therethrough as shown.

Furthermore, in order to reduce the occurrence of complications due to penile prostheses, a fluid reservoir 22 in contact with body tissue.
It is desirable that the outer surface 34 also has a surface shape that allows good tissue adhesion and tissue ingrowth. Similarly,
Many of the other components such as pump assembly 18 and fluid lines 20, 24 may also be constructed of materials having a textured surface.

FIG. 2 schematically shows a penis 40 into which the inflatable penile prosthesis 10 as described above is implanted. The scrotum is shown at 42 and the pelvic area is shown at 44. The penis 40 includes a cavernous body 46, which is a cylinder of fibrous erectile tissue that forms the back and sides of the penis 40 and gives the penis 40 width and shape. The rigid or semi-rigid rods of the inflatable cylinder 12 or other appliance are implanted into these cavernous bodies 46. Each of the inflatable cylinders 12 is sized to extend from the proximal end 52 to the distal end 48 of the cavernous body 46 of the penis and substantially fills the interior of the cavernous body 46 of the penis. Pump assembly 1
8 is deployed in the scrotum 42 and communicates with the interior 17 of the inflatable distal portion 14 of the inflatable cylinder 12 via a suitable fluid line 20. Reservoir 22 is typically deployed in the abdominal cavity (not shown) and fluid line 24 as described above.
To the pump assembly 18 via.

As shown in FIG. 2, when mimicking the atrophied state of the penis, the inflatable cylinder 12 is at least partially deflated and the stored fluid is retained in the reservoir 22. When an erection is desired, the valve pump 26 is manually activated via the scrotum 42. Actuation of valve pump 26 forces fluid from reservoir 22 into interior 17 of inflatable distal portion 14 of inflatable cylinder 12, causing cylinder 12 to expand. When the inflatable cylinder 12 is in the inflated state, as shown in FIG. 3, the inflatable cylinder 12 is in a thickened and relatively rigid extended state. Similarly, the penis 40 is also pushed up in a rigid posture in the axial direction, imitating an erection. To return the penis 40 to the atrophied state by returning the inflatable cylinder 12 to the contracted state, similarly push the deflation valve 30 through the scrotum 42,
The fluid contained in the interior 17 of the distal portion 14 of the inflatable cylinder 12 is returned to the reservoir 22.

"North American Urology Clinical Lectures", February 1989, Volume 16, Issue 1 (Urologic Clinics of North A
Many surgical methods are known for implanting penile prostheses, as generally described in America, February 1989, Volume 16, No. 1). Incorporated as a reference). One exemplary method is generally an incision in the penis scrotum, that is, a distal end 48 of the penis 40, shown generally at 54 in FIG. 3, from the scrotum 42 through the base of the penis 40. Includes an incision in the portion extending toward. The cavernous body 46 of the penis is then measured and unfolded, and an appropriately sized inflatable cylinder 12 is selected. Typically, a thread is tied to the distal end 14 of the inflatable cylinder 12, and the thread exits the glans penis 50 through the corpus cavernosum 46. The distal portion 14 of the inflatable cylinder 12 is then inserted through the incision 54 in the base of the penis 40 and pushed toward the distal end 48 of the corpus cavernosum 46.
By pulling a thread connected to the distal portion 14 of the cylinder 12 outward from the glans 50 of the penis, the inflatable cylinder is pulled through the cavernous body 46 of the penis, thereby allowing the distal portion 14 to reach the posterior portion of the glans penis. Let The proximal end 16 of the inflatable cylinder 12 is then inserted through the incision 54 into the cavernous body 46 of the penis and pushed back to the root end 52 of the cavernous body 46 of the penis. Proximal end 16 of inflatable cylinder 12
Is generally solid and relatively stiff, so that it can be easily pushed into the root end 52 of the corpus cavernosum 46 without the need for guiding threads. The same or similar steps are then repeated to equip another penis cavernous body 46 with a second inflatable cylinder 12. The pump assembly 18 is then inserted into the scrotum 42, the reservoir 22 is fitted to the abdominal cavity, and the fluid line 2
By passing 0, 24 between the components equipped in the body,
Properly interconnect each component. After that, the incision portion 54 is closed.

[0033]

By providing a component having a textured surface according to the present invention, unlike a smooth surface, a textured shape is directly formed on the outer surface of the implanted component, which surface is Being exposed to tissue. Thus, as the body heals, the more disordered distribution of collagen deposits across the textured surface, with the beneficial consequence of tissue adhesions and tissue ingrowth over an increasingly wide range of surface area of the textured surface. It was Thus, the scar tissue formed adjacent to the implanted component adheres to the outer surface of the textured component, forming a complete encapsulation of the scar tissue. In the case of encapsulated tissue, which typically forms around a material with a smooth surface implanted in the body, such tissue does not adhere to the smooth surface, resulting in the formation of dead spaces around it. Often, the encapsulation is insufficient.

In accordance with the present invention, scar tissue may adhere to the textured surface of the component so that it tends to form uniformly over the entire surface of the implanted prosthesis. Thus, contracture is minimized and a scar tissue encapsulation is formed that is distensible, compliant, and flexible. As a result, the prosthesis with a textured surface is well supported by the adherent encapsulated tissue and migration of the prosthesis relative to adjacent tissue is significantly reduced. Therefore, infection due to cell damage, erosion, perforation, and uncontrolled movement of the brace are significantly reduced. Mechanical defects in the brace due to contracture may also be reduced.

[Brief description of drawings]

1 is a partial cross-sectional view of an inflatable penile prosthesis including a component having a textured surface of the present invention.

FIG. 2 is a cross-sectional view of a penis in an atrophied state with an inflatable prosthesis in place.

FIG. 3 is a cross-sectional view showing an expanded state of the inflatable device shown in FIG.

[Explanation of symbols]

 10 Penis Prosthesis 12 Inflatable Cylinder 18 Pump Assembly 20, 24 Fluid Line 22 Reservoir 32 Cylinder Texture External Surface

 ─────────────────────────────────────────────────── ─── Continued Front Page (71) Applicant 592108621 Rally Sea. Perry LARRY PERRY United States Tennessee 37013, Antioch, Country Ridge Dir. 3333 (72) Inventor G. Patrick Maxwell United States Tennessee 37205, Nashville, Gerald Place 4416 (72) Inventor Jack Fisher United States Tennessee 37215, Nashville, Fredricksburg D.R. 5884 (72) Inventor Larry Sea. Perry United States Tennessee 37013, Antioch, Country Ridge Dial. 3333

Claims (10)

[Claims] 1. A penile prosthesis used to correct erectile dysfunction, capable of repeated circumferential expansion and contraction, wherein the at least one flexible extension for implantation into the corpus cavernosum of the penis. A member, the extension member being substantially composed of silicone rubber and having a fluid impermeable inner surface defining an interior chamber and an outer surface, the outer surface remaining exposed to body tissue. By having a textured means formed directly on this outer surface that is in condition, it promotes tissue adhesion and tissue ingrowth over substantially the entire implanted extension member, thereby minimizing contracture. Encapsulation of scar tissue with enhanced expansion, compliance, and malleability allows for repeated circumferential expansion and contraction, while at the same time preventing the formation of dead space around the extension member, This causes infection due to cell damage,
A brace that significantly reduces erosion, perforations, and uncontrolled movement of the brace, wherein the texture of the outer surface has a pore size distribution in the range of about 60 microns to about 567 microns. 2. A penile prosthesis for correcting impotence, which can be repeatedly expanded and contracted in the circumferential direction, comprising at least one extension member for implantation in the corpus cavernosum of the penis. The extension member is composed substantially of silicone rubber and has a fluid impermeable inner surface and an outer surface having a textured means formed over substantially its entire surface area, the textured means remaining exposed to body tissue. Is formed directly on the outer surface of the implant, which promotes tissue adhesion and tissue ingrowth over substantially the entire implanted extension member, which minimizes contracture and expands. Encapsulation of scar tissue with improved flexibility, compliance, and malleability allows for repeated circumferential expansion and contraction, while at the same time preventing the formation of dead space around the extension member. Which significantly reduces infection by cell damage, erosion, perforation, and uncontrolled migration of the brace, the texture of the outer surface having a pore size ranging from about 60 microns to about 567 microns. Brace with distribution. 3. The appliance according to claim 1, wherein the outer surface completely surrounds the extension member. 4. The appliance according to claim 1, wherein there is no opening through the outer surface of the extension member. 5. The appliance according to claim 1, further comprising a fluid reservoir and a fluid pump, the reservoir in fluid communication with the pump, and the pump in fluid communication with the inflatable extension member. 6. The outer surface has a textured surface profile to promote tissue adhesion and tissue ingrowth.
The appliance according to claim 5. 7. The appliance according to claim 1, wherein the texture of the outer surface has a pore density of about 2.4 pores per square millimeter surface area. 8. The texture of the outer surface is about 2
The brace of claim 1 having an average pore size of 63 microns. 9. The appliance according to claim 2, wherein the outer surface completely surrounds the extension member. 10. The brace of claim 2, wherein there is no opening through the outer surface of the extension member.