Implantable device and method for adjustably restricting a body lumen

Abstract

An implantable device and method for adjustably restricting a selected body lumen such as the urethra of a patient to treat urinary incontinence. The device includes an expandable element or membrane such as a balloon attached pressure-tightly to a flexible conduit at its forward end and includes a rear port portion containing an elastic septum and flow connected to the expandable element by a first passageway. The conduit contains a second passageway which allows it to be slid along an elongated guide probe initially inserted surgically into a patient's body adjacent the body lumen which is to be adjustably restricted. A suitable flowable material is injected from a syringe source into the device rear port sufficient to expand the membrane element and restrict the body lumen to the desired degree. The syringe and guide probe are removed and the skin incision is closed over the rear port end of the implanted device. The rear port septum is located under but near the patient's skin so that if it becomes necessary to post-operatively increase or decrease the degree of body lumen restriction it may be easily accessed with the needle of the syringe.

1 . An implantable device adapted for being surgically implanted within body tissue adjacent to a body lumen, the device comprising: a pressurizable expandable element, said expandable element being attached pressure-tightly onto an elongated conduit element near its forward end, said conduit element including a rear port portion and having a first passageway connecting said rear port portion and said forward expandable element, wherein said expandable element has an initial contracted shape and is expandable to an enlarged shape by addition of a flowable material provided into said rear port portion.  
   
   
       2 . The implantable device according to  claim 1  wherein said rear port portion has a cavity which is in fluid communication with said first elongated passageway, and an elastic septum is contained pressure tightly in the cavity.  
   
   
       3 . The implantable device according to  claim 1 , wherein said elongated conduit has a second elongated passageway extending from an opening in the conduit forward tip end to a location rearward from said expandable element.  
   
   
       4 . The implantable device according to  claim 1 , wherein said expandable element is attached onto said elongated conduit element by an adhesive material.  
   
   
       5 . The implantable device according to  claim 1 , wherein said rear port portion has an outside diameter larger than that of said elongated conduit.  
   
   
       6 . The implantable device according to  claim 1 , wherein the construction material is a bio compatible material selected from the group of polyurethane or silicone.  
   
   
       7 . the implantable device according to  claim 2 , wherein said elastic septum is retained in said cavity by a clamp ring located around said rear port portion.  
   
   
       8 . An implantable device assembly adapted for a device being surgically implanted into body tissue of a patient adjacent to a body lumen for restricting the body lumen, the assembly comprising: 
 (a) an elongated guide probe member adapted for being inserted as a guide means into tissue adjacent to an restrictable body lumen of a patient;    (b) an elongated implantable device adapted for being surgically implanted into the tissue adjacent to the body lumen, said implantable device including a forward expandable element and a rear port portion connected together by flexible conduit, said conduit having a first inner passageway in fluid communication between said expandable element and said rear port portion and having a second passageway arranged for being slidable over said elongated probe member;    (c) a source containing a flowable material and adapted for being removably connected to the rear port portion of said implantable device, whereby a flowable material from said source can be introduced through the rear port portion and through the first passageway of said implantable device so as to expand the forward expandable element adjacent a body lumen to at least partially and adjustably restrict the lumen.    
   
   
       9 . The implantable device assembly of  claim 8  wherein said guide probe member is a stiff elongated rod having a pointed forward end.  
   
   
       10 . The implantable device assembly of  claim 8  wherein said guide probe member is a flexible guidewire.  
   
   
       11 . The implantable device assembly of  claim 8 , wherein said implantable device rear port portion contains an elastic septum and said source is a syringe having a forward facing needle whereby said needle may be sealingly inserted through said septum and a flowable material injected from said syringe through the first passageway to expand the forward expandable element.  
   
   
       12 . The implantable device assembly of  claim 11 , wherein said syringe includes an axially movable rear plunger element, whereby the hollow needle is insertable into the elastic septum located in the rear port portion of the implantable device and a flowable material injected by the plunger element through the follow needle and first passageway to expand the forward expandable element.  
   
   
       13 . A method for variably restricting a body lumen in a patient, comprising the steps of: 
 (a) surgically inserting an elongated probe member into body tissue of a patient to a location adjacent to a body lumen to be restricted;    (b) providing an elongated implantable device having an expandable element located at its forward end and having a port portion provided at is rearward end, sliding an outer passageway of the implantable device along said probe member, so that the expandable element is positioned adjacent to the body lumen;    (c) injecting a flowable material from a source into a said implantable device rear port portion, so as to expand the expandable element sufficient to at least partially restrict the body lumen, then removing the source;    (d) withdrawing the elongated probe member from the patient's body tissue and from the outer passageway of the implantable device;    (e) positioning said implantable device rear port portion inside the body tissue and near the surface of the skin, and    (f) closing the patient's skin over the device rear port portion.    
   
   
       14 . A method for variably restricting a body lumen in a patient, comprising the successive steps of: 
 (a) surgically inserting an elongated probe member into body tissue of a patient to a location adjacent to a body lumen to be restricted;    (b) providing an elongated implantable device having an expandable element located at its forward end and sliding an outer passageway of the implantable device along the elongated probe member and positioning the expandable element adjacent to the patient's body lumen;    (c) withdrawing the elongated probe member from the patient's body tissue and from the outer passageway of the implantable device;    (d) injecting a flowable material from a source into a rear port portion of said implantable device, and expanding the expandable element sufficient to at least partially restrict the body lumen, then removing the source;    (e) positioning the rear port portion of said elongated implantable device inside the patient's body tissue near the surface of the skin, and    (f) closing an opening made in the patient's skin over the implantable device rear port portion.    
   
   
       15 . The body lumen restriction method of  claim 11 , wherein the material injected into the implantable device expandable element is selected from the group including a saline liquid solution, a gel, or a slurry of particles in a fluid carrier.  
   
   
       16 . The body lumen restriction method of  claim 13 , wherein the flowable material is a radiopaque material to facilitate fluoroscopic visualization.  
   
   
       17 . The body lumen restriction method of  claim 13 , wherein the elongated probe member and implantable device are surgically inserted to a location adjacent the urethra of a female patient.  
   
   
       18 . The body lumen restriction method of  claim 15  including placing an implantable device along two opposite sides of the urethra of a female patient.