WO2002102230A2 - Penile prosthesis and method of implantation - Google Patents
Penile prosthesis and method of implantation Download PDFInfo
- Publication number
- WO2002102230A2 WO2002102230A2 PCT/US2002/018902 US0218902W WO02102230A2 WO 2002102230 A2 WO2002102230 A2 WO 2002102230A2 US 0218902 W US0218902 W US 0218902W WO 02102230 A2 WO02102230 A2 WO 02102230A2
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- prosthesis device
- penile prosthesis
- mantle
- magnet
- elastic
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/26—Penis implants
Definitions
- the present invention relates generally to medical prostheses, particularly to urological prosthe8ses and methods of implantation for improved erectile function, and particularly to penile implants comprising an elastic mantle, internal elements and filling material for implanting into the corpora cavernosa, without requiring a surgical operation, and an implantation method therefore.
- penile prostheses include surgically positioned pumps for creating high pressure of liquid in the elastic silicon mantle, for example, U.S. Pat. No. 5,658,329; U.S. Pat. No. 5,803,897; U.S. Pat. No. 4,566,446; U.S. Pat. No. 4,782,826; U.S. Pat. No. 4,224,934; U.S. Pat. No. 4,235,227; U.S. Pat. No. 4,201,202; U.S. Pat. No. 4,342,308; U.S. Pat. No. 4,009,711; U.S. Pat. No. 3,853,122; U.S. Pat. No. 3,954,102; U.S. Pat. No.
- the prior art also teaches devices which use an external source of electricity and a source of alternating magnetic field changing with the frequency of 50 to 1000 Hz which influence the internal element located in the penis.
- This element senses the magnetic field and causes liquid in the inner reservoir to move from the reservoir into the elastic mantles located in the corpora cavernosa, and causes the penis to erect.
- U.S. Pat. No. 4,584,994; U.S. Pat. No. 5,427,605; U.S. Pat. No. 4,491,461 and U.S. Pat. No. 5,803,897 describes a permanent magnet which makes seesaw movements under the influence of this field. This in turn causes liquid from the reservoir to pump into the elastic mantles, thus serving as an internal element sensing alternating magnetic field of the external source.
- U.S. Pat. No. 5,230,694 describes penile prostheses not containing pumps and reservoirs with a liquid, but is provided with an internal element with alternating rigidity placed in an elastic mantle which is closed by plugs at its side.
- the element is made in the form of a spring having coils which can be moved manually from one end of the prosthesis which is fixed to the patient's body, to its other end, thereby causing the penis to erect.
- the position of the spring's coils is fixed by the group of permanent magnets. These magnets are in the form of stems which are parallel to one another and are homopolarly turned to each other. The magnets' ends touching the moving spring coils are equipped with conic bulges which couple with the spring coils.
- the magnets hold the spring coils by their bulges by repelling each other.
- a construction is not sufficiently reliable. This is because it is necessary to squeeze the magnets in order to empty the erecting chambers. And since the magnets are located in the spring, it is necessary to squeeze the spring in the direction perpendicular to its longitudinal axis.
- the spring is highly rigid and one has to squeeze the penis strongly from the outside using one's fingers, which is a painful procedure.
- the implantation of the prosthesis requires similar surgical procedures as described above for currently available penile prostheses.
- the present invention overcomes the problems associated with previous devices and implantation methods by preferably implanting a penile prosthesis without requiring a complicated surgical procedure thereby making the procedure cost-effective and possible in an outpatient setting.
- the penile prosthesis device of the present invention includes an elastic mantle in the shape of a balloon or tube, the mantle is plugged at each end and is filled with a biocompatible liquid.
- the prosthesis device is inserted into the cavernous cavity by means of a trocar, and requires no surgical procedure.
- An additional embodiment of the invention includes a prosthesis unit having alternating rigidity and a catch for locking its position using a plurality of permanent magnets.
- the prosthetic device unit having the alternating rigidity comprises a thin wire, preferably made of steel, and a plurality of short discrete cylindrical elements. Each of the cylindrical elements further includes an axis hole through which passes the above-mentioned wire. The elements are coupled to each other end to end.
- every discrete element of the unit with alternating rigidity is made in the form of a cylinder with the alternating cut done in such a way that the outer diameter of the front of the minimal cut corresponds to the inner diameter of the front of the maximal cut.
- the discrete elements of the unit with alternating rigidity are made of ferromagnetic and non-ferromagnetic material and are located along the wire in the form of interchanging rows.
- One of the ends of the wire is attached to the plug at the first end of the elastic mantle.
- a part of the rigid pipe attached on the inner surface of the elastic mantle near its second end, is injected into the prosthesis.
- the first magnet of the catch of the unit's position with alternating rigidity is attached by one of its ends or poles to the inside part of the rigid pipe.
- the prosthesis is equipped with an external diiver interacting with the internal catch of the unit.
- the external driver is made in the form of a third permanent magnet which interacts with the internal movable magnet by means of the magnetic field.
- the third magnet is in the form of a heavy walled pipe and an inner diameter corresponding to the size of the penis.
- the external driver is equipped with an element for uncoupling the third permanent magnet and the internal movable magnet.
- the uncoupling element is made in the form of a ferromagnetic pipe which is inserted into the inner hole of the third magnet, and is able to move on the axis while the conjugated surfaces of the ferromagnetic pipe and the magnet are covered with a material such as Teflon, that provides a suitable drag coefficient.
- the uncoupling element further has the catch of position as described in detail in Fig. 6 for an uncoupling element used for two opening halves with a faster.
- the elastic mantle may be equipped with an external arm made of thin non-elastic net attached at its ends to the plugs.
- the elastic mantle may also have a syringe activated checkvalve attached in one of the pipes.
- the penile prosthesis unit with the alternating rigidity and its catch enable the prosthesis to reduce to its original state or in the non-erectile state.
- the prosthesis can be inserted with ease into the corpora cavernosa by a trocar like larger caliber needle, thus avoiding the need for surgical procedures involving incisions, as is the case now, when implanting a penile prosthesis.
- An additional aspect of the present invention is the method of implantation of the semirigid, malleable, rod penile prosthesis and the like.
- the elastic mantle may be partially pre-filled, or the filling material may be inserted into the elastic mantle already placed in the corpora cavernosa, through a needle catheter and valve.
- the filling material may include standard physiological solution, biocompatible elastomer, silicone, oil, or other material in liquid form. This material may cure or harden after filling.
- the implantation method may include a step of expanding the cavity by using a high-pressure balloon, similar to angioplasty balloons.
- a further benefit of the implantation method of the present invention is the minimum erectile tissue disruption created by insertion of the unfilled or partially filled elastic mantle directly into the corpora cavernosa of the penis.
- the elastic mantle may be filled with small diameter elements, such as malleable rods or other elements of similar diameter, through a needle-catheter approximately 2.5 to 6 mm in diameter, preferably 4 to 4.5 mm in diameter, without making a surgical incision in the penis.
- the mantle After its insertion, the mantle is filled with a sufficient amount of a liquid which may or may not be self-curing. Filling the mantle is done through a valve, either by a needle catheter or by a smaller caliber needle. If a self-curing biocompatible elastomer, for example, silicone or the like, is inserted, its curing time after its injection into the elastic mantle is predetermined.
- a self-curing biocompatible elastomer for example, silicone or the like
- Fig. 1 presents the drawing of the implanted penile prosthesis in the condition in which it is implanted in to the penis.
- Fig. 2 shows the process of implantation of the prosthesis into the penis through a trocar.
- Fig. 3 shows the process of filling the implanted prosthesis by a biocompatible liquid through a valve at the distal tip of the erectile chamber.
- Fig. 4 shows the drawing of the prosthesis filled by abiocompatible liquid.
- Fig. 5 shows the drawing of the prosthesis implanted into the penis, with the magnet put onto penis influencing the catch of the position of the element with alternating rigidity.
- the element with permanent rigidity is in the condition of the maximal rigidity, while the penis is erected.
- Fig. 6 shows the construction of the external magnet consisting of two opening halves.
- Fig. 7 shows the construction of the external magnet provided with the collapsible magnetic shield and the lock.
- Fig. 8 presents the fragment of the unit of alternating rigidity.
- Fig. 9 illustrates the process of insertion of the unfilled (or partially filled) elastic mantle with the pre-installed malleable rod into the penis through a needle-catheter entering the tip of the corpus cavernosum.
- Fig. 10 shows the process of filling the elastic mantle located inside the corpus cavernosum by physiological solution or by a self-curing biocompatible liquid elastomer.
- the Implanted Penile Prosthesis (figure 1) contains the elastic mantle 1 made of a biocompatible elastic material such as medical grade silicone elastomer, in the form of a pipe with plugs 2 and 3 at its ends, as well as the unit with alternating rigidity, made in the form of flexible wire 4, preferably made of medical grade stainless steel passing through the discrete elements 5 put on it.
- Discrete elements 5 include polyetheretherketone (PEEK) or polyetherimide (PEI).
- PEEK polyetheretherketone
- PEI polyetherimide
- these elements can have the form of short cylinders with alternating cut made in such a way that the outer diameter of the front of the less cut corresponds to the internal diameter of the front with larger cut.
- the discrete elements 5 can be made of ferromagnetic (5a) and non-ferromagnetic (5b) materials located along the wire 4, in interchanging rows. Bonding elements include ultra- violet cured adhesives.
- Plug 3 has a syringe activated checkvalve 6 for filling through it the mantle 1 by a biocompatible liquid 7 (Figure 3).
- One end of the flexible wire is fixed to the distal plug 3, the other end is connected with movable magnet 8.
- This magnet can be moved in a piece of the a rigid pipe 9 attached to the plug 2. It is directed toward the movable magnet 8 by its inverse pole and is fixed to the end of the rigid pipe 9 ( Figure 4).
- the device has also an external driver 8.
- This driver is made in the form a permanent magnet 11 (Figure 6), in the form of a cylinder.
- the internal diameter of the magnet 11 is chosen in such a way that the magnet can be freely put around and removed from the penis after an of erection is achieved ( Figure 1).
- Magnet 11 is equipped by the uncoupling element with the movable magnet 8 providing changes of magnetic connection between them. This can be provided by means of making magnet 11 in the form of two detachable halves provided with a lock 12 ( Figure 6), or by means of an additional ferromagnetic shield 13 ( Figure 7) of cylindrical form, which can be moved coaxially in magnet 11 and is provided with a lock 14.
- the permanent magnets comprise of a metal alloy Nd-Fe-B coating with parylene.
- the Implantable Penile Prosthesis is inserted into the corpora cavernosa 15 of the penis 16 through a trocar 17 ( Figure 2) in the state when the elastic mantle 1 is not filled with the biocompatible liquid.
- the elastic mantle 1 is vacuumed, and further is filled with the biocompatible liquid by means of the injector 18.
- the elastic mantle 1 gets larger in its size and fills the cavity of corpora cavernosa. Since this cavity can be of irregular form, the elastic mantle 1 can be provided with the external ⁇ on- elastic arm 19 made in the form of the net or mantle freely put in the initial position on the elastic mantle 1 and attached to its both sides are plugs 2 and 3.
- the non-elastic arm comprises of an ultra thin polyester tubing or net. The arm can be freely expanded together with the elastic mantle reaching the maximal diameter of corpora cavernosa. Then it prevents the elastic mantle from further deformation keeping its cylindrical form.
- the described construction provides a reliable functioning of the penile prosthesis and makes the conventional surgical implantation unnecessary, thus resulting in a simpler and less costly process of implantation.
- the elastic balloon (which can be supplied with reinforced walls) pre-determining its inflated shape 3 usually made of silicone elastomer or other biocompatible material with some physical properties (Figure 1) is inserted into coipora cavernosa 1 of the penis 2 through a needle-catheter 4.
- the balloon 3 can be empty or partially filled by a physiological solution 5, or by a self-curing biocompatible liquid material mixture (as silicone, for example).
- Semirigid or malleable rods 6 or other elements of the construction can be pre-installed into the balloon 3.
- Figure 2 After inserting the balloon 3 into the corpora cavernosa, it is completely filled (Figure 2) by the physiological solution 5 or by a self-curing biocompatible liquid material mixture.
- the balloon can be filled by means of the syringe 7 through a needle 8 inserted through a valve 9.
- the balloon is filled with a physiological solution, after retrieval of the injection needle the prosthesis will mimic a natural erection. If a self-curing biocompatible liquid material with predetermined curing time is injected, after solidification of the material the prosthesis will mimic a natural erection.
- the corporal cavities can be expanded by using a high pressure balloon (similar to angioplasty balloons) inserted into the corpora cavernosa through the above mentioned needle catheter.
- a high pressure balloon similar to angioplasty balloons
- the described method of the prosthesis's implantation enables to avoid surgical incisions to the penile tissues, thus reducing the cost of the implantation and diminishing the risk of postoperative complications.
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- Health & Medical Sciences (AREA)
- Reproductive Health (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
Description
Claims
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CA002418837A CA2418837A1 (en) | 2001-06-15 | 2002-06-14 | Penile prosthesis and method of implantation |
US10/496,946 US20050113637A1 (en) | 2001-06-15 | 2002-06-14 | Penile prosthesis and method of implantation |
AU2002310424A AU2002310424A1 (en) | 2001-06-15 | 2002-06-14 | Penile prosthesis and method of implantation |
EP02737501A EP1395210A2 (en) | 2001-06-15 | 2002-06-14 | Penile prosthesis and method of implantation |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/882,194 US6579230B2 (en) | 2001-06-15 | 2001-06-15 | Penile prosthesis and method of implantation |
US09/882,194 | 2001-06-15 |
Publications (2)
Publication Number | Publication Date |
---|---|
WO2002102230A2 true WO2002102230A2 (en) | 2002-12-27 |
WO2002102230A3 WO2002102230A3 (en) | 2003-07-24 |
Family
ID=25380089
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2002/018902 WO2002102230A2 (en) | 2001-06-15 | 2002-06-14 | Penile prosthesis and method of implantation |
Country Status (5)
Country | Link |
---|---|
US (2) | US6579230B2 (en) |
EP (1) | EP1395210A2 (en) |
AU (1) | AU2002310424A1 (en) |
CA (1) | CA2418837A1 (en) |
WO (1) | WO2002102230A2 (en) |
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2011072692A1 (en) * | 2009-12-15 | 2011-06-23 | Coloplast A/S | Instrument configured to prepare a penis for implantation of a penile prosthetic |
US8002692B2 (en) | 2009-12-16 | 2011-08-23 | Coloplast A/S | Method of preparing a penis for implantation of a penile prosthetic |
US8192352B2 (en) | 2009-12-15 | 2012-06-05 | Coloplast A/S | Instrument configured to prepare a penis for implantation of a penile prosthetic |
US9549729B2 (en) | 2015-02-06 | 2017-01-24 | Coloplast A/S | System for implanting a penile prosthetic includes a suture and a needle inserted into a tool |
US9724502B2 (en) | 2015-07-10 | 2017-08-08 | Coloplast A/S | Dilator and method for penile prosthetic implantation |
Families Citing this family (26)
Publication number | Priority date | Publication date | Assignee | Title |
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US6579230B2 (en) * | 2001-06-15 | 2003-06-17 | Impetus Ltd. | Penile prosthesis and method of implantation |
US20070010815A1 (en) * | 2005-06-30 | 2007-01-11 | Sdgi Holdings, Inc. | Fixation systems with modulated stiffness |
US8052593B2 (en) | 2006-10-24 | 2011-11-08 | Ams Research Corporation | Implantable malleable penile prosthetic device |
US8911350B2 (en) * | 2007-10-23 | 2014-12-16 | Ams Research Corporation | Malleable prosthesis with enhanced concealability |
US8114011B2 (en) * | 2007-10-23 | 2012-02-14 | Ams Research Corporation | Corrugated inflatable penile prosthesis cylinder |
US8123674B2 (en) * | 2007-11-12 | 2012-02-28 | Ams Research Corporation | Corrugated expansion-constraining sleeve for an inflatable penile prosthesis cylinder |
US10070955B2 (en) * | 2007-11-15 | 2018-09-11 | Boston Scientific Scimed, Inc. | Prosthesis with bendable central region |
US8052594B2 (en) * | 2007-11-20 | 2011-11-08 | Ams Research Corporation | Prosthetic device with protrusions for girth |
US7988568B2 (en) * | 2008-01-17 | 2011-08-02 | Nike, Inc. | Golf clubs and golf club heads with adjustable center of gravity and moment of inertia characteristics |
AU2009301391B2 (en) * | 2008-10-10 | 2015-10-22 | Medicaltree Patent Ltd | Stimulation of penis erection |
US8231521B2 (en) * | 2009-09-22 | 2012-07-31 | Coloplast A/S | Penile prosthesis insertion tool and system |
BR112012006396A2 (en) * | 2009-09-22 | 2016-04-12 | Coloplast As | implantable penile prosthesis system, insertion tool, implantable penile prosthesis, and methods for implanting a penile prosthesis in a patient and for suture-free implantation of a penile prosthesis in a patient. |
US7938770B2 (en) * | 2009-09-22 | 2011-05-10 | Coloplast A/S | Penile prosthesis, penile prosthesis insertion tool and system thereof |
US9801702B2 (en) | 2010-12-16 | 2017-10-31 | Boston Scientific Scimed, Inc. | Artificial sphincter system and method |
KR101235864B1 (en) | 2011-06-23 | 2013-02-20 | 배범철 | Implement for erecting penis |
US10130346B2 (en) * | 2012-07-24 | 2018-11-20 | Omrix Biopharmaceuticals Ltd. | Device and method for the application of a curable fluid composition to a bodily organ |
US9480566B2 (en) | 2014-08-08 | 2016-11-01 | Coloplast A/S | Tool with a groove useful for implanting a penile prosthetic cylinder |
US9486231B2 (en) | 2014-08-08 | 2016-11-08 | Coloplast A/S | Tool with a clasp useful for implanting a penile prosthetic cylinder |
US9724197B2 (en) | 2014-09-10 | 2017-08-08 | Coloplast A/S | Tool with a suction feature useful for implanting a penile prosthetic cylinder |
US9642707B2 (en) | 2014-09-29 | 2017-05-09 | Coloplast A/S | Tool with a pincher useful for implanting an inflatable penile cylinder |
US9855144B2 (en) | 2015-09-09 | 2018-01-02 | Coloplast A/S | Penile prosthetic with an insertion tool contained inside an inflatable bladder |
EP3150174B1 (en) | 2015-09-30 | 2021-08-11 | Coloplast A/S | A penile prosthetic with an insertion sleeve attachable to an inflatable bladder |
US10952855B2 (en) | 2016-03-24 | 2021-03-23 | Boston Scientific Scimed, Inc. | Inflatable penile prosthesis with reversible flow pump assembly |
EP3357458A1 (en) | 2017-02-02 | 2018-08-08 | Coloplast A/S | Inflatable penile prosthetic system |
US11311403B2 (en) | 2019-12-02 | 2022-04-26 | Brian Elder | Erectile dysfunction device and method |
KR102427812B1 (en) * | 2019-12-26 | 2022-07-29 | 한양대학교 산학협력단 | An Apparatus for Increasing Penis |
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US6099518A (en) * | 1998-10-20 | 2000-08-08 | Boston Scientific Corporation | Needle herniorrhaphy devices |
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US5899849A (en) * | 1997-09-22 | 1999-05-04 | Elist; James | Subcutaneous penile implant |
US6193753B1 (en) * | 1998-02-26 | 2001-02-27 | James D. Nordheim | External penile prosthesis |
US6102849A (en) * | 1999-04-03 | 2000-08-15 | Hakac; John R. | Non-surgical penile prosthesis |
US6579230B2 (en) * | 2001-06-15 | 2003-06-17 | Impetus Ltd. | Penile prosthesis and method of implantation |
-
2001
- 2001-06-15 US US09/882,194 patent/US6579230B2/en not_active Expired - Fee Related
-
2002
- 2002-06-14 CA CA002418837A patent/CA2418837A1/en not_active Abandoned
- 2002-06-14 AU AU2002310424A patent/AU2002310424A1/en not_active Abandoned
- 2002-06-14 US US10/496,946 patent/US20050113637A1/en not_active Abandoned
- 2002-06-14 WO PCT/US2002/018902 patent/WO2002102230A2/en not_active Application Discontinuation
- 2002-06-14 EP EP02737501A patent/EP1395210A2/en not_active Withdrawn
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
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US4881530A (en) * | 1988-01-19 | 1989-11-21 | Medical Engineering Corporation | Penile prosthesis |
US5064434A (en) * | 1990-04-04 | 1991-11-12 | Haber Terry M | Genitourinary implant |
US6099518A (en) * | 1998-10-20 | 2000-08-08 | Boston Scientific Corporation | Needle herniorrhaphy devices |
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2011072692A1 (en) * | 2009-12-15 | 2011-06-23 | Coloplast A/S | Instrument configured to prepare a penis for implantation of a penile prosthetic |
US8192352B2 (en) | 2009-12-15 | 2012-06-05 | Coloplast A/S | Instrument configured to prepare a penis for implantation of a penile prosthetic |
US8002692B2 (en) | 2009-12-16 | 2011-08-23 | Coloplast A/S | Method of preparing a penis for implantation of a penile prosthetic |
US9549729B2 (en) | 2015-02-06 | 2017-01-24 | Coloplast A/S | System for implanting a penile prosthetic includes a suture and a needle inserted into a tool |
US9724502B2 (en) | 2015-07-10 | 2017-08-08 | Coloplast A/S | Dilator and method for penile prosthetic implantation |
Also Published As
Publication number | Publication date |
---|---|
WO2002102230A3 (en) | 2003-07-24 |
AU2002310424A1 (en) | 2003-01-02 |
US20050113637A1 (en) | 2005-05-26 |
US6579230B2 (en) | 2003-06-17 |
US20020193659A1 (en) | 2002-12-19 |
CA2418837A1 (en) | 2002-12-27 |
EP1395210A2 (en) | 2004-03-10 |
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