IMPLANTABLE BIOCOMPATIBLE EXPANDER SUITABLE FOR TREATMENT OF CONSTRICTIONS OF BODY LUMEN

• US 20170135830A1
• Filed: 11/14/2016
• Published: 05/18/2017
• Est. Priority Date: 11/12/2015
• Status: Active Grant

• Current Assignee: The Provost, Fellows, Foundation Scholars, and other members of Board, of the College of the Holy and Undivided Trinity of Queen Elizabeth near Dublin
• Original Assignee: The Provost Fellows Foundation Scholars & The Other Members of Board of The College of The Holy
• Inventors: Harkin, Conor, Garrett, Ryan, Murphy, Bruce, Redmond, James, Burke, Michael, Ni Ghriallais, Riona
• Granted Patent: US 10,682,245 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 1/307 for the urinary organs, e.g. urethroscopes, cystoscopes
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/047 Urethrae
• CPC Class Codes: A61F 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0023 triangular
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0056 W-shaped, e.g. M-shaped, sigma-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0095 Saddle-shaped
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

An implantable biocompatible expander suitable for implantation into a urinary duct, comprises an elongated sinusoidal ring comprising at least two proximal prongs and at least two distal prongs, wherein the expander is resiliently deformable from a relaxed radially expanded orientation to a radially contracted orientation suitable for transluminal delivery through the urinary duct. The expander is configured to exert an outward radial force against a wall of the urinary duct when in-situ within the urinary duct. In particular, the expander is suitable for treatment of benign prostatic hyperplasia and configured for implantation into the prostatic urethra between, and substantially spanning the prostatic urethra between, the bladder neck and external sphincter.

Claims

1. An implantable biocompatible expander suitable for treatment of benign prostatic hyperplasia (BPH), the expander comprising a single elongated undulating ring having three proximal prongs and three distal prongs, or five proximal prongs and five distal prongs, wherein the expander is resiliently deformable from a relaxed radially expanded orientation to a radially contracted orientation suitable for transluminal delivery through the urethra, wherein the expander is configured to span a substantial section of the prostatic urethra between the bladder neck and external sphincter and cause in-situ expansion of the substantial section of the prostatic urethra.

2. An implantable biocompatible expander according to claim 1 in which the single elongated undulating ring is a single elongated sinusoidal ring.

3. An implantable biocompatible expander according to claim 1 having an anchoring element configured to anchor the expander in the prostatic urethra during use, in which at least a part of the anchoring element is biodegradable to facilitate release of the expander after a period of time.

4. An implantable biocompatible expander according to claim 3 in which the anchoring element comprises a strut-embracing collar and one or more projections extending proud of the collar.

5. An implantable biocompatible expander according to claim 1 having a length of 10-45 mm and a width of 6-30 mm in a relaxed, expanded, state.

6. An implantable biocompatible expander according to claim 1 in which the distal and/or proximal prongs are longitudinally staggered.

7. An implantable biocompatible expander according to claim 1 in which an apex of one of more of the prongs comprises a loop or lip.

8. An implantable biocompatible expander according to claim 1 in which an apex of one of more of the prongs comprises a loop or lip, and in which the loop or lip projects radially into the expander or radially out of the expander.

9. An implantable biocompatible expander according to claim 1 in which the elongated undulating ring is cylindrical, conical, frusto-conical, tapered inwardly at each end, or tapered inwardly towards in mid-section.

10. An implantable biocompatible expander according to claim 1 in which the undulating ring comprises elongated struts connecting the distal and proximal prongs and open areas between the struts and prongs, wherein a radially outwardly facing surface of the prongs and struts is less than 5% of the total open areas.

11. An implantable biocompatible expander according to claim 1 in which the undulating ring is formed from wire having a cross-sectional diameter of 0.2 to 1.0 mm.

12. An implantable biocompatible expander according to claim 1 in which the undulating ring is formed from a single wire.

13. An implantable biocompatible expander according to claim 1 in which the undulating ring is formed from a single wire, and in which one end of the wire is configured to form an anchoring element.

14. An implantable biocompatible expander according to claim 1, in which the expander is configured to effect in-situ dilation of the prostatic urethra at the target location without blocking the verumontanum.

15. A method of treating benign prostatic hyperplasia in a mammal, which method employs an implantable biocompatible expander configured for resilient deformation and self-expansion from a radially contracted orientation suitable for transluminal delivery through a urinary duct to a radially expanded orientation capable of effecting in-situ dilation of the prostatic urethra, wherein the expander is configured to fit within the prostatic urethra between the bladder neck and the external sphincter, the method comprising the steps of implanting the expander into the prostatic urethra at a target location between the bladder neck and the external sphincter, whereby the expander in the radially expanded orientation effects in-situ dilation of the prostatic urethra between the bladder neck and the external sphincter.

16. A method according to claim 15, and comprising the steps of:

delivering the expander in a radially contracted orientation through the urethra to the target location within the prostatic urethra between the bladder neck and the external sphincter; and

allowing the expander expand at the target location to a radially expanded orientation against the wall of the prostatic urethra.

17. A method according to claim 15, in which the expander is configured to effect in-situ dilation of the prostatic urethra at the target location without blocking the verumontanum.

18. A method according to claim 15, in which the expander is configured to span a substantial section of the prostatic urethra between the bladder neck and the external sphincter.

19. A method according to claim 15, in which the expander is configured to anatomically conform to the lumen of the prostatic urethra.

20. A method according to claim 15, in which the implantable biocompatible expander is formed from an undulating structural element formed into a ring shape