WO2014201382A1 - Procédé d'implantation d'une prothèse pénienne gonflable et dispositif utilisé dans le procédé - Google Patents

Procédé d'implantation d'une prothèse pénienne gonflable et dispositif utilisé dans le procédé Download PDF

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Publication number
WO2014201382A1
WO2014201382A1 PCT/US2014/042345 US2014042345W WO2014201382A1 WO 2014201382 A1 WO2014201382 A1 WO 2014201382A1 US 2014042345 W US2014042345 W US 2014042345W WO 2014201382 A1 WO2014201382 A1 WO 2014201382A1
Authority
WO
WIPO (PCT)
Prior art keywords
sections
scrotum
pump
clamping device
clamp body
Prior art date
Application number
PCT/US2014/042345
Other languages
English (en)
Inventor
Doron STEMBER
Peter Stahl
Original Assignee
Icahn School Of Medicine At Mount Sinai
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Icahn School Of Medicine At Mount Sinai filed Critical Icahn School Of Medicine At Mount Sinai
Publication of WO2014201382A1 publication Critical patent/WO2014201382A1/fr

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
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/0013—Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having an inflatable pocket filled with fluid, e.g. liquid or gas
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
    • A61F2250/0012—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting elasticity, flexibility, spring rate or mechanical tension
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0059—Additional features; Implant or prostheses properties not otherwise provided for temporary

Definitions

  • This invention relates generally to the field of inflatable penile prostheses and surgical methodologies for the implantation of inflatable penile prostheses. More particularly, the invention relates to an improved implantation process and devices used in the improved process.
  • Inflatable penile prostheses address the problem of erectile dysfunction in men.
  • Inflatable penile prosthesis systems are known, and may comprise a pair of inflatable elongated cylinders positioned within the penis, a pump positioned within the scrotum, and a fluid reservoir implanted within the abdomen.
  • Flexible tubular conduits connect the elements of the system.
  • U.S. Patent No. 8,192,3 2 An example of such a system is shown in U.S. Patent No. 8,192,3 2, the disclosure of which is incorporated herein by reference, which issued on June 5, 2012, to Morningstar et al.
  • the pump is repeatedly compressed to transfer fluid from the reservoir to the cylinders.
  • a release mechanism is provided in conjunction with the pump which when activated allows the fluid to return to the reservoir.
  • the scrotum or lower abdomen of a patient is incised to gain access to the penile corpora cavernosa.
  • the paired corpora are then incised in order to provide access to the internal portion of the erectile bodies.
  • the corpora cavernosa are then dilated with one or more dilation tools and prosthetic cylinders are inserted into the penis.
  • the pump is positioned within the scrotum and connected by tubing to the other elements of the device.
  • the reservoir is placed in the abdomen and also connected by tubing to the other device elements.
  • IPP inflatable penile prosthesis
  • the invention is in general a process, and a device used in the process, to prevent post- operative migration of the pump of an inflatable penis prosthesis system within the scrotum.
  • the process comprises implantation of the inflatable penis prosthesis system in typical surgical manner, including the step of positioning the IPP pump in the scrotum to provide access for insertion of the pump, with the added steps of providing an external ciamp, immediately post-operatively positioning the clamp externally on the scrotum in a manner that restricts movement of the pump within the scrotum, and leaving the clamp in position until the problem of accumulation of pooled blood and edematous fluid in the scrotum has minimized or is no longer present, preferably for a time period of about 4 to 48 hours and preferably for a time period of about 6 to 24 hours.
  • the pump would be overwhelmingly more likely to remain in position even if the scrotum continues to experience some degree of swelling for the next several days.
  • the clamping device may have various embodiments differing in size, shape and closure mechanism suitable for retention and restriction of the pump, the release mechanism or the tubular conduits.
  • the clamping device may be clamshell-shaped or ring- shaped with a pair of opposing encircling arms, the configuration being preferably optimized to minimize focused pressure points and overall compressive force.
  • the clamping device may be formed of a transparent material or be fenestrated for observation of the underlying skin tissue.
  • the clamping device may for example be self-biasing because of the material of composition or be provided with a mechanical biasing mechanism, such as a spring or a turn- screw, to maintain the opposing halves of the clamps in the closed status.
  • the biasing mechanism may be adjustable to allow for adjustment of the compressive force or may be structured to automatically expand in order to accommodate excessive swelling. Padding, foam or the like may be positioned on the interior sides of the clamp.
  • Fig. 1 is a side view of a clamp according to one embodiment of the invention.
  • Fig, 2 is a front view of the clamp of Fig. 1 ;
  • Fig. 3 is a front view of a clamp according to an alternative embodiment of the invention.
  • Fig. 4 is a side view of the clamp of Fig. 3;
  • Fig. 5 is a top view of the clamp of Fig. 3;
  • Fig. 6 is a front view of a clamp according to another alternative embodiment of the invention.
  • Fig. 7 is a top view of the clamp of Fig, 6;
  • Fig. 8 is a schematic showing the clamp of Fig. 2 positioned on a patient to prevent migration of the pump; and Fig. 9 is a side view of the clamp of Fig. 1 with padding provided thereon.
  • the invention is in general a process, and a device used in the process, to prevent post-operative migration of the pump of an inflatable penis prosthesis system within the scrotum.
  • the process comprises implantation of the inflatable penis prosthesis system in typical surgical manner, including the step of providing an incision in the scrotum and/or lower abdomen to provide access for insertion of the IPP device including the scrotal pump, with the added steps of providing an external clamp, immediately post-operatively positioning the clamp externally on the scrotum in a manner that restricts movement of the pump within the scrotum, and leaving the clamp in position until the problem of accumulation of pooled blood and edematous fluid in the scrotum is no longer likely to displace the pump from a dependent position within the scrotum, for a time period of about 4 to 48 hours and preferably for a time period of about 6 to 24 hours.
  • the implanted pump is thus captured and nested within the structure of the clamp so as to retain the implanted pump in place within the scrotum and prevent or restrict migration of the pump within the scrotum.
  • the retaining force applied by the clamp is transferred through the scrotum to the implanted pump.
  • both the scrotum and implanted pump lie between the clamp body, clamping forces generated by the clamp body are exerted on both the scrotum and implanted pump. While the forces applied are sufficient to achieve the stated objective, the forces do not adversely impact the patient's health and do not adversely impact the integrity and operation of the parts of the prosthesis system.
  • a representative inflatable penile prosthesis system 10 is shown to comprise a pair of cylinders (inflatable members) 1 1 inserted into the penis, a reservoir 12 implanted within the body and suitable for retention of a fluid, a pump 13 suitable for transferring the fluid from the reservoir 12 to the cylinders 1 1, flexible tubular conduits 14 connecting the reservoir 12, pump 13 and cylinders 1 1 , and a fluid release mechanism 15 to allow the fluid to return from the cylinders 1 1 to the reservoir 12.
  • the pump 13 is typically a hand-operated device, whereby the patient transfers fluid by successively compressing the pump 13 in a bellows-type manner using his fingers to apply pressure through the scrotum.
  • the pumps 13 may be round, elliptical, cylindrical, barrel-shaped, etc.
  • the fluid release mechanism 15 is likewise operated by finger manipulation through the scrotum. Such systems are known in the art.
  • Implantation of the inflatable penile prosthesis system 10 is typically accomplished by a method comprising making incisions in the erectile bodies (corpora cavernous) for insertion of the cylinders 11 and positioning the pump 13 within the scrotum. After proper positioning of the operational components of the inflatable penile prosthesis system 10, the incisions are sutured or otherwise closed.
  • a clamping device 20 is externally positioned and affixed onto the scrotum, the clamping device 20 being sized and shaped to restrict movement of the pump 13 within the scrotum, and in particular being adapted to restrict movement of the pump 13 away from the more dependent or lowermost portion of the scrotum which may occur as the result of post-operative accumulation of pooled blood and edematous fluid in the scrotum or other forces that displace the pump 13, and to keep it positioned in the most optimal location for the patient to access the pump once the immediate post-operative period has passed.
  • the clamping device 20 may have various embodiments differing in size, shape and closure mechanism 21 suitable for retention and restriction of the pump 13 by encasing and securing the pump 13, the release mechanism 15 and/or the tubular conduits 14, several embodiments of which are illustrated in Figs. 1-4.
  • the clamping device 20 is formed of a clamp body and may be a generally clamshell-shaped device with a pair of opposing halves 22a and 22b (first and second sections) (e.g., cup-shaped members which can be thought of as being tissue contacting portions) each possessing a concave or cupped interior side 23, a pair of handle members 24, and a closure mechanism 23 comprising a spring member 25 mounted at a pivot or hinge axis 26, the closure mechanism 21 being structured such that the opposing halves 22a and 22b are biased toward each other in a clamping status when no force is applied to the handle members 24 and may be separated for affixation or removal of the clamping device 20 by forcing the handle members 24 together to widen the gap between the opposing halves 22a and 22b.
  • first and second sections e.g., cup-shaped members which can be thought of as being tissue contacting portions
  • the opposing halves 22a and 22b do not contact each other when in the clamping position to ensure that the intervening scrotal tissue and IPP components are not under undue pressure when it is applied to the scrotum.
  • the configuration of the opposing halves 22a and 22b are preferably optimized to maximize contact surface area for a given closing force, thereby reducing focused pressure points.
  • the clamp body can thus be thought of as having first and second sections (first and second parts) with the cup-shaped halves 22a, 22b being formed at upper portions thereof and the handle members 24 are formed at lower portions thereof.
  • the halves 22a, 22b thus move between an open position (to allow insertion of the scrotum) and a closed position (normal rest position and a position when the clamp body is seated against the exterior of the scrotum); however, the halves 22a, 22b are preferably spaced from one another and not in contact in both the open and closed positions.
  • the clamping device 20 may comprise a generally ring-shaped main body (arcuate-shaped body) 27 with a pair of opposing encircling arms 28 extending laterally from the main body 27.
  • the ring-shaped body 27 is not a continuous structure in that the body has two ends that are spaced apart so as to define a gap (space) therebetween.
  • the opposing arms 28 (which can be arcuate-shaped) are formed at or proximate the ends of the main body 27.
  • the main body 27 is composed of a resilient material, such as a polymer for example, whereby the generally curved, U-shaped or C-shaped arms 28 may be spread apart manually or with a tool such that the clamping device 20 may be properly positioned on the scrotum to limit migration of the pump 13.
  • a resilient material such as a polymer for example
  • the clamp 30 is provided with wider halves 32 similar to those of the embodiment shown in Figs. 1 and 2, the halves 32 being opened by pressing together handles 34, wherein the halves 32 are provided with opposing arms 38 similar to the embodiment of Figs. 3, 4 and 5, such that with the clamp 30 closed about the pump 13, an opening is provided of sufficient diameter such that passage of the conduits 14 is not interfered with.
  • the clamping device 20 may be formed of a transparent material or be fenestrated for observation of the underlying skin tissue.
  • the clamping device 20 may for example be self- biasing because of the material of composition, as shown in the embodiment of Figs. 3 and 4, or may be provided with a mechanical biasing mechanism 21, as shown in Figs. 1 and 2, such as with the spring member 25, a turn-screw or mechanical device (not shown).
  • the biasing mechanism 21 may be adjustable to allow for adjustment of the compressive force or may be structured to automatically expand in order to accommodate excessive swelling.
  • the biasing mechanism can be manipulated (using an actuator or the like) to reduce (lessen) the degree of the applied compressive force or the biasing mechanism itself can be designed such that if a counter force (swelling) is generated, the opposing sections (e.g., halves) can separate further apart to accommodate such counter force.
  • padding, foam or the like may be positioned on the interior sides 23 or along the edges of the clamp 20. It will be appreciated that the padding 35 can be provided on at least any of the tissue contacting surfaces of any of the clamps shown herein, For example, padding can be provided along the inner concave-shaped surfaces of the arms 28 of the clamp shown in Figs. 3-5.
  • the kit includes the clamping device described herein and one or more component of the penis prosthesis system.
  • the kit can include the clamping device and at least the pump.
  • the clamping device is preferably selected in view of the pump and in particular, the pump is selected in view of the shape and/or dimensions of the pump to allow the clamping device to capture and retain the pump as described herein.
  • the kit can also include the other components of the system including one or more of the conduits, inflatable members, and reservoir.

Landscapes

  • 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

L'invention concerne un procédé chirurgical et un dispositif utilisé dans le procédé, pour empêcher la migration post-opératoire de la pompe d'un système de prothèse pénienne gonflable à l'intérieur du scrotum. Le procédé consiste en une implantation du système de prothèse pénienne gonflable de manière chirurgicale classique, incluant une étape de positionnement de la pompe de prothèse à l'intérieur du scrotum pour permettre un accès pour l'utilisation ultérieure de la pompe, avec les étapes supplémentaires de pose d'un clamp externe, de positionnement post-opératoire du clamp extérieurement sur le scrotum d'une manière qui restreint le mouvement de la pompe à l'intérieur du scrotum.
PCT/US2014/042345 2013-06-14 2014-06-13 Procédé d'implantation d'une prothèse pénienne gonflable et dispositif utilisé dans le procédé WO2014201382A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201361835022P 2013-06-14 2013-06-14
US61/835,022 2013-06-14

Publications (1)

Publication Number Publication Date
WO2014201382A1 true WO2014201382A1 (fr) 2014-12-18

Family

ID=52022809

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2014/042345 WO2014201382A1 (fr) 2013-06-14 2014-06-13 Procédé d'implantation d'une prothèse pénienne gonflable et dispositif utilisé dans le procédé

Country Status (1)

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WO (1) WO2014201382A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9907653B2 (en) 2015-07-27 2018-03-06 Coloplast A/S Pump bulb for an implantable penile prosthetic

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4318396A (en) * 1980-05-15 1982-03-09 Medical Engineering Corporation Penile prosthesis
US4537183A (en) * 1983-04-08 1985-08-27 Mentor Corporation Connector device for connecting elastic tubing of an implantable device
US5163897A (en) * 1989-10-25 1992-11-17 Lester Persky Incontinent prothesis and method
US20040215056A1 (en) * 2003-04-25 2004-10-28 Ling Jeremy J. Penile prosthesis with improved tubing junction
US20050075534A1 (en) * 2003-10-02 2005-04-07 Ams Research Corporation Penile prosthesis devices and methods

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4318396A (en) * 1980-05-15 1982-03-09 Medical Engineering Corporation Penile prosthesis
US4537183A (en) * 1983-04-08 1985-08-27 Mentor Corporation Connector device for connecting elastic tubing of an implantable device
US5163897A (en) * 1989-10-25 1992-11-17 Lester Persky Incontinent prothesis and method
US20040215056A1 (en) * 2003-04-25 2004-10-28 Ling Jeremy J. Penile prosthesis with improved tubing junction
US20050075534A1 (en) * 2003-10-02 2005-04-07 Ams Research Corporation Penile prosthesis devices and methods

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9907653B2 (en) 2015-07-27 2018-03-06 Coloplast A/S Pump bulb for an implantable penile prosthetic

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