WO2024118049A1 - Appareil médical à usage endorectal et procédés associés - Google Patents

Appareil médical à usage endorectal et procédés associés Download PDF

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Publication number
WO2024118049A1
WO2024118049A1 PCT/US2022/051131 US2022051131W WO2024118049A1 WO 2024118049 A1 WO2024118049 A1 WO 2024118049A1 US 2022051131 W US2022051131 W US 2022051131W WO 2024118049 A1 WO2024118049 A1 WO 2024118049A1
Authority
WO
WIPO (PCT)
Prior art keywords
inflatable balloon
medical apparatus
seal
sphincter
balloon
Prior art date
Application number
PCT/US2022/051131
Other languages
English (en)
Inventor
Courtney E. MASON
Bailey ARCHER
Sarah M. SAFFER
Alexzandra L. BOUR
Ethan C. BLANK
Original Assignee
Bard Peripheral Vascular, Inc.
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 Bard Peripheral Vascular, Inc. filed Critical Bard Peripheral Vascular, Inc.
Priority to PCT/US2022/051131 priority Critical patent/WO2024118049A1/fr
Publication of WO2024118049A1 publication Critical patent/WO2024118049A1/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
    • A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A61F2/0009—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse placed in or outside the body opening close to the surface of the body
    • A61F2/0013—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse placed in or outside the body opening close to the surface of the body inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1011—Multiple balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00274—Prostate operation, e.g. prostatectomy, turp, bhp treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A61B2017/345—Cannulas for introduction into a natural body opening
    • A61B2017/3452—Cannulas for introduction into a natural body opening for the rectum, e.g. for hemorrhoid surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B2017/348—Means for supporting the trocar against the body or retaining the trocar inside the body
    • A61B2017/3482—Means for supporting the trocar against the body or retaining the trocar inside the body inside
    • A61B2017/3484—Anchoring means, e.g. spreading-out umbrella-like structure
    • A61B2017/3486—Balloon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B2017/348—Means for supporting the trocar against the body or retaining the trocar inside the body
    • A61B2017/3492—Means for supporting the trocar against the body or retaining the trocar inside the body against the outside of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00547—Prostate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/10—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis
    • A61B90/14—Fixators for body parts, e.g. skull clamps; Constructional details of fixators, e.g. pins
    • A61B90/17—Fixators for body parts, e.g. skull clamps; Constructional details of fixators, e.g. pins for soft tissue, e.g. breast-holding devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A61M25/04—Holding devices, e.g. on the body in the body, e.g. expansible
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1002—Balloon catheters characterised by balloon shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N2005/1092—Details
    • A61N2005/1097—Means for immobilizing the patient

Definitions

  • Endorectal balloons have several uses, including for prostate immobilization and drug delivery in the rectum.
  • an endorectal balloon When an endorectal balloon is inflated in the rectum, this tends to cause an involuntary bowel movement that pushes it back out. This can make the procedure more difficult and prolong it as a result.
  • an apparatus for performing a medical procedure including an endorectal balloon adapted to be maintained securely in place upon inflation in the rectum and thus prevent unintended expulsion.
  • An object of the disclosure is to provide a medical apparatus for endorectal use that includes a balloon specially adapted to maintain the position of the apparatus at a selected location and thus prevent unintended expulsion, despite the potential for an involuntary bowel movement.
  • a seal would also be provided that is likewise adapted to seal the rectum while maximizing patient comfort.
  • a medical apparatus for use in connection with a rectum including an inner sphincter and an outer sphincter.
  • the apparatus comprises a shaft.
  • a first inflatable balloon is carried by and attached to a distal end portion of the shaft and adapted for engaging the inner sphincter.
  • the first inflatable balloon has a frusto- conical shape, and a seal is carried by and attached to a proximal end portion of the shaft.
  • the shaft comprises an inflation lumen for inflating the first inflatable balloon.
  • the first inflatable balloon has a proximal balloon end larger in diameter than a distal balloon end.
  • the seal may comprise a second inflatable balloon, and the shaft includes an inflation lumen for inflating the second inflatable balloon, as well as the first inflatable balloon.
  • a diameter of a distal end of the second inflatable balloon may be less than a diameter of a proximal end of the first inflatable balloon.
  • the seal may comprise a frusto-conical shape, and may have a proximal seal end smaller in diameter than a distal seal end.
  • the first balloon may be spaced apart from the seal, such as in a distal direction.
  • a medical apparatus for use in connection with a rectum including an inner sphincter and an outer sphincter.
  • the apparatus includes a shaft having a proximal end and a distal end.
  • a first inflatable balloon is carried by the distal end of the shaft and adapted for engaging the inner sphincter.
  • the first inflatable balloon has a proximal end larger in diameter than a distal end.
  • the first inflatable balloon has a frusto-conical shape.
  • the shaft may comprises an inflation lumen for inflating the first inflatable balloon, as well as the second inflatable balloon (which lumen may comprise two structures for independently inflating the first and second balloons).
  • a seal may be provided for sealing the rectum adjacent to the outer sphincter.
  • the seal may comprises a second inflatable balloon.
  • a diameter of a distal end of the second inflatable balloon may be less than a diameter of the proximal end of the first inflatable balloon.
  • the seal may comprise a frusto-conical shape, with a proximal end smaller in diameter than a distal end.
  • the first inflatable balloon may be spaced apart from the seal.
  • a further aspect of the disclosure relates to a method of sealing a rectum including an inner sphincter and an outer sphincter.
  • the method includes inserting a catheter into the rectum including a first inflatable balloon for engaging the inner sphincter and a second inflatable balloon for sealing the rectum adjacent to the outer sphincter.
  • the method may further include the step of inflating the first inflatable balloon to form a frusto-conical first inflated balloon, as well as the step of inflating the first inflatable balloon to form a frusto-conical first inflated balloon.
  • Still a further aspect of the disclosure pertains to a method of sealing a rectum including an inner sphincter and an outer sphincter.
  • the method comprises engaging the inner sphincter with a first inflatable balloon having a frusto-conical construction.
  • the method may further include engaging the outer sphincter with a seal.
  • the seal may comprise a second inflatable balloon, and further comprising the step of inflating both the first inflatable balloon and the second inflatable balloon.
  • FIG. 1 is a perspective view of a medical apparatus for endorectal use according to one aspect of the disclosure.
  • FIG. 1A is a cross-sectional view of the medical apparatus for endorectal use of FIG. 1, taken along line 1A-1A of FIG. 1.
  • FIG. IB is a cross-sectional view of the medical apparatus for endorectal use of FIG. 1, taken along line 1B-1B of FIG. 1.
  • FIG. 2 is a cross-sectional view of the medical apparatus for endorectal use.
  • FIG. 3 is a plan view of the medical apparatus for endorectal use.
  • the apparatus 10 includes a shaft 12.
  • a first inflatable balloon 14 is attached to the shaft 12, such as along a distal end portion.
  • the first balloon 14 is adapted for engaging a portion of the rectum, such as adjacent to the location of the inner sphincter I (see FIGS. 2-3).
  • the first inflatable balloon 14 has a frusto-conical shape and, in particular, a distal end 14a that is smaller in diameter than a proximal end 14b, but could take other similar shapes as well without being precisely frusto-conical (for example, a wedge-shape).
  • a seal 16 is also carried by the shaft 12 spaced proximally from the first balloon 14 and adapted to provide a sealing action by being positioned adjacent to the outer sphincter 0 (see FIGS. 2-3).
  • the seal 16 may comprise a structure for selectively sealing the rectum, such as a second inflatable balloon 18, which also may be attached to the shaft 12 proximally of the first balloon 14.
  • the second inflatable balloon 18 may also be of a frusto-conical (or similar) shape and, in particular, have a distal end 18a larger in diameter than a proximal end 18b.
  • the diameter of the distal end 18a of the second inflatable balloon 18 is also less than the diameter of the proximal end 14b of the first inflatable balloon 14, which accounts for the typical different diameters of the rectum when the apparatus 10 is positioned therein (the outer sphincter 0 typically being narrower than the inner sphincter I).
  • the shaft 12 may include at least two inflation lumens 12a, 12b for independently supplying an inflation fluid to the first and second inflatable balloons 14, 18.
  • the first lumen 12a includes a first port 12c for communicating with an interior compartment of the first inflatable balloon 14, and the second lumen 12b includes a second port 12d distal of the first port 12c for communicating with an interior compartment of the second inflatable balloon 18.
  • the lumens 12a, 12b may be arranged in a side by side configuration (at least up until the location of the first port 12c, after which a single lumen 12a only may extend to the first balloon 14), but could also be coaxial.
  • the shaft 12 also includes a distal portion 12e extending distally of the second inflatable balloon 18, which includes a distal tip that may be sealed.
  • a proximal portion 12f also extends proximally of the first inflatable balloon 14, and an intermediate portion 12g is between the balloons 14, 18.
  • the proximal portion 12f may be adapted to attach to an indeflator 20 for supplying inflation fluid to the balloons 14, 18, and releasing fluid therefrom, such as by including a luer connector or the like.
  • the medical apparatus 10 is inserted into the rectum R with the balloons 14, 18 in an uninflated condition, such as with the aid of a suitable lubricant.
  • the first balloon 14 When the first balloon 14 is located in the inner sphincter I adjacent to a target area for treatment, such as the prostate P, the first balloon 14 may be inflated, such as by using indeflator 20 associated with first lumen 12a of shaft for delivering a fluid thereto, such as saline.
  • the location may be selected, for instance, to immobilize the prostate for radiation treatment, for the delivery of a drug or other treatment agent, or both.
  • Positioning of the apparatus 10 and, in particular, the first balloon 14 may be determined using a variety of measures. For example, visible markings, such as a scale, on the shaft 12, to indicate a relative distance of insertion. Additionally or alternatively, markings visible under fluoroscopy or via echogenicity may also be used on the shaft 12 or balloons 14, 18.
  • the seal formed by the second balloon 18 is located adjacent to the outer sphincter O of the rectum R, such as external thereto.
  • the second balloon 18 may also then be inflated, such as using indeflator 20 for supplying fluid to the second inflation lumen 12b.
  • the arrangement is such that the frusto-conical shape of the first balloon 14 in an inflated condition results in a wedging action that helps to maintain it in position in the inner sphincter I, despite an involuntary reflex promoting ejection.
  • the wider distal end 14a of balloon 14 wedges against the inner sphincter I to prevent expulsion from the rectum R.
  • the seal created, such as by the second balloon 18, is thus likewise maintained in position adjacent to the outer sphincter 0, so as to seal the rectum R.
  • the ability to selectively and independently control the amount of inflation of the first and second balloons 14, 18 using indeflator 20 results in an increase in the successful completion of the endorectal procedure, and also contributes to an increase in patient comfort.
  • the balloons 14, 18 may simply be deflated and the shaft 12 removed from the rectum R.
  • the balloons 14, 18 may be provided with a frusto-conical shape as a result of a blowmolding process.
  • the materials used may be elastic or semi-elastic polymers, such as for example a polyurethane or polyamide, and in any case a non-latex material to reduce the potential for allergic reactions.
  • the shaft 12 may comprise a flexible polymer as well, such as the abovereferenced materials. Attachment of the balloons 14, 18 to the shaft 12 may be achieved by adhesive bonding, laser welding, or like procedures that may be used to form a secure, fluid-tight seal.
  • a medical apparatus for use in connection with a rectum including an inner sphincter and an outer sphincter comprising: a shaft; a first inflatable balloon adapted for engaging the inner sphincter, the first inflatable balloon having a frusto-conical shape; and a seal carried by proximally of the first inflatable balloon.
  • a medical apparatus for use in connection with a rectum including an inner sphincter and an outer sphincter comprising: a shaft having a proximal end and a distal end; and a first inflatable balloon carried by the distal end of the shaft and adapted for engaging the inner sphincter, the first inflatable balloon having a proximal end larger in diameter than a distal end.
  • a diameter of a distal end of the second inflatable balloon is less than a diameter of the proximal end of the first inflatable balloon.
  • the shaft comprises an inflation lumen for inflating the second inflatable balloon.
  • a method of sealing a rectum including an inner sphincter and an outer sphincter comprising: inserting a catheter into the rectum including a first inflatable balloon for engaging the inner sphincter and a second inflatable balloon for sealing the rectum.
  • a method of sealing a rectum including an inner sphincter and an outer sphincter comprising: engaging the inner sphincter with a first inflatable balloon having a frusto-conical shape.
  • a compartment refers to one or more than one compartment.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Child & Adolescent Psychology (AREA)
  • Anesthesiology (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Transplantation (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Cardiology (AREA)
  • Hematology (AREA)
  • Pathology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

Appareil médical destiné à une utilisation endorectale. L'appareil comprend une tige portant un premier ballonnet gonflable conçu pour venir en prise avec un sphincter interne. Le premier ballonnet gonflable peut avoir une forme tronconique, avec une extrémité distale ayant un diamètre plus grand qu'une extrémité proximale. Un joint est porté par la tige et conçu pour sceller le rectum adjacent au sphincter externe. Le joint peut comprendre un second ballonnet gonflable, qui peut également avoir une forme tronconique, avec une extrémité distale ayant un diamètre plus grand qu'une extrémité proximale. Des procédés associés sont en outre divulgués.
PCT/US2022/051131 2022-11-29 2022-11-29 Appareil médical à usage endorectal et procédés associés WO2024118049A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/US2022/051131 WO2024118049A1 (fr) 2022-11-29 2022-11-29 Appareil médical à usage endorectal et procédés associés

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2022/051131 WO2024118049A1 (fr) 2022-11-29 2022-11-29 Appareil médical à usage endorectal et procédés associés

Publications (1)

Publication Number Publication Date
WO2024118049A1 true WO2024118049A1 (fr) 2024-06-06

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ID=84799620

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998047557A1 (fr) * 1997-04-23 1998-10-29 Pera Giuseppe Procede de diagnostic, de traitement, et de prophylaxie de l'ejaculation precoce, et catheter de diagnostic, de traitement, et de prophylaxie de l'ejaculation precoce
DE4436796C2 (de) * 1994-07-15 2000-11-09 Via Log Medikalprodukte Gmbh K Verschlußmittel zum Verschließen eines natürlichen Darmausgangs
WO2002002032A2 (fr) * 2000-06-30 2002-01-10 Argomed, Ltd. Stent prostatique dote d'un dispositif d'ancrage de tissu localise, et procedes permettant d'inhiber l'obstruction de l'uretre prostatique
EP2911732B1 (fr) * 2012-10-28 2017-11-29 Edge Medical, LLC Appareil pour faciliter le traitement d'organe

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4436796C2 (de) * 1994-07-15 2000-11-09 Via Log Medikalprodukte Gmbh K Verschlußmittel zum Verschließen eines natürlichen Darmausgangs
WO1998047557A1 (fr) * 1997-04-23 1998-10-29 Pera Giuseppe Procede de diagnostic, de traitement, et de prophylaxie de l'ejaculation precoce, et catheter de diagnostic, de traitement, et de prophylaxie de l'ejaculation precoce
WO2002002032A2 (fr) * 2000-06-30 2002-01-10 Argomed, Ltd. Stent prostatique dote d'un dispositif d'ancrage de tissu localise, et procedes permettant d'inhiber l'obstruction de l'uretre prostatique
EP2911732B1 (fr) * 2012-10-28 2017-11-29 Edge Medical, LLC Appareil pour faciliter le traitement d'organe

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