Method and apparatus for rectal anaesthesia
Inventors
LUBOWSKI, David Zachary • Tiller, Robert
Assignees
Publication Number
US-11524140-B2
Publication Date
2022-12-13
Expiration Date
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Abstract
A system and method for delivering a medicament including a catheter configured for implantation in different target tissue sites, extending from a proximal end to a distal end, and having a sidewall which defines an internal lumen. The distal end has one or more apertures in the sidewall for the release of the medicament into the target tissue site; the system also comprises a medicament reservoir fluidly communicable with the internal lumen of each catheter, an adhesive member configured to adhere to the skin of the patient around the exit wound and having an opening therein to allow the catheters to pass through the adhesive member and a retaining member configured to be overlaid on the adhesive member and comprising a guide surface configured to receive a length of the two or more catheters and a plurality of retaining portions to retain the catheters against the guide surface.
Core Innovation
The present invention relates to a method and apparatus for the management of patient pain after a hemorrhoidectomy or similar surgery through nerve anaesthesia. The invention provides a system for delivering a medicament to a target tissue site in a patient over a period of time comprising a catheter configured for implantation in a target tissue site extending from a proximal end to a distal end and having a sidewall which defines an internal lumen, said distal end having one or more apertures in the sidewall for the release of the medicament into the target tissue site, a medicament reservoir fluidly communicable with the internal lumen of the catheter, an adhesive member configured to adhere to the skin of the patient around the exit wound and having an opening therein to allow the catheter to pass through the adhesive member, and a retaining member configured to be overlaid on the adhesive member and comprising a guide surface configured to receive a length of the catheter and a plurality of retaining portions to retain the catheters against the guide surface.
Postoperative pain after haemorrhoidectomy can be significant because of the extensive network of nerves within the anal canal; currently local anaesthetic injected immediately after surgery lasts for up to 24 hours and the patient is then given oral opioids which may have unwanted risks and side effects, severe postoperative pain may also prolong the hospital stay and affect the comfort and wellbeing of the patient. It is therefore desirable to provide a method and apparatus for the controlled delivery of a medicament such as an anaesthetic to a nerve branch of a patient following a hemorrhoidectomy, or similar surgery of the anal canal.
The disclosure further provides methods and related devices and kits to position and implant one or more catheters to deliver medicament to tissue adjacent to nerve branches, including methods for positioning a catheter using a stimulator trocar comprising a nerve stimulator to identify a target tissue site and thereafter leaving the distal end of the catheter implanted, a surgical kit comprising two or more catheters, trocars, a pump and medicament reservoir, and a wearable apparatus comprising a belt, channel, catheter and pump for delivery of medicament.
Claims Coverage
Two independent claims were identified with seven main inventive features extracted from the independent claims.
Catheter with internal lumen and apertures
A catheter which extends from a proximal end to a distal end and has a sidewall which defines an internal lumen, said distal end having one or more apertures either in the sidewall or at the distal end for a release of the medicament into a target tissue site;
Stimulator trocar comprising a nerve stimulator
A stimulator trocar comprising an elongate body which is made from a material having a greater rigidity than the catheter, the stimulator trocar comprising a nerve stimulator configured to stimulate nerves in the target tissue site;
Advancing and positioning with trocar and catheter
Advancing the stimulator trocar and the catheter through a tissue of the patient;
Actuation and identification by sphincter contraction
Actuating the nerve stimulator at a determined frequency and adjusting a positioning of the stimulator trocar and the distal end of the catheter until a physical contraction of the external anal sphincter is observed at a frequency that correlates with the determined frequency of the nerve stimulator;
Disconnecting stimulator leaving catheter implanted
Disconnecting the nerve stimulator from the catheter and withdrawing the nerve stimulator through a first incision leaving the distal end of the catheter implanted in the target tissue site.
Tunnelling trocar between lateral incision and incision near anus
Making a lateral incision in the skin of the thigh and a first incision on one side of the anus and tunnelling a trocar from the lateral incision through the tissue and towards the first incision, or from the first incision through the tissue and towards the lateral incision, connecting a tip of the trocar to the proximal end of the catheter and withdrawing the trocar through the tissue until a desired length of the catheter is pulled through so the distal end of the catheter extends from the first incision;
Connecting catheter to reservoir and infusing medicament
Connecting the proximal end of the catheter to a reservoir of the medicament and infusing the medicament through the internal lumen of the catheter to deliver the medicament to the target tissue site.
The independent claims focus on an implantable catheter having an internal lumen and distal apertures, the use of a more rigid stimulator trocar comprising a nerve stimulator to position the catheter by eliciting external anal sphincter contraction, releasing the stimulator and leaving the catheter implanted, tunnelling approaches to position catheters via lateral and perianal incisions, and connecting the catheter to a medicament reservoir to infuse medicament to the target tissue site.
Stated Advantages
Having separate pumping members for each catheter has the advantage of a greater control on flow to each target tissue site.
A coiled region of the catheter acts as a strain relief and prevents pulling or tugging at the wound site which could open the wound and cause discomfort for the patient and an increased risk of infection.
The retainer both protects the wound of the patient and prevents strain on catheters which could cause them to be pulled out of the incision, thereby preventing dislodgement.
Documented Applications
Management of patient pain after a haemorrhoidectomy or similar surgery through nerve anaesthesia by delivering an anaesthetic to an area of tissue around a nerve of a patient following a haemorrhoidectomy or similar surgery of the anal canal.
Implantation of one or more catheters with distal ends positioned adjacent to branches of the pudendal nerves (left and right) to deliver analgesic medicament, such as ropivacaine, for postoperative analgesia after haemorrhoidectomy.
A wearable apparatus comprising a belt, channel, catheter and pump to hold and pump medicament from a reservoir into a catheter for delivery to a patient.
A surgical kit comprising two or more catheters, an adhesive member, an open ring-shaped retaining member, tunnelling trocars, a stimulator trocar with nerve stimulator, a pump and medicament reservoir, and a sheet for application to the patient's skin around the surgical site.
Positioning and implanting catheters to deliver medicament to tissue adjacent to the anal and/or rectal branches of the pudendal nerves.
Postoperative bilateral infusion of ropivacaine through implanted catheters to provide analgesia after haemorrhoid surgery as documented in the examples.
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