Rotating Puncture Needle for Minimally Invasive Sling Implantation

Resolve Bottlenecks,
Find Innovative Solutions
Generate Solutions

Solution Overview

Problem

Current surgical methods for treating urinary incontinence and pelvic organ prolapse involve invasive procedures that risk infection, damage to the urethra or vaginal wall, and require incisions, leading to significant patient burden and complications.

Innovation Solution

A puncture apparatus with a rotatable puncture member and vaginal-insertion assembly that allows for minimally invasive insertion of a sling-like implant by creating a path between the urethra and vagina without incision, using a supporting member and inserter to guide the puncture member and prevent damage to surrounding tissues.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a surgical knife is used to incise the vagina for sling implantation, then the sling can be implanted into the body, but the invasiveness of the procedure increases and the risk of infection and tissue damage increases

Engineering Contradiction:
Improvesafety of procedureVSAvoidinvasiveness and infection risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent introduces a puncture needle as an intermediary tool to create a passage through the vaginal wall without requiring a surgical incision. The needle serves as a mediator that allows the sling to be implanted through a minimally invasive puncture path, thereby reducing the harmful effects of traditional surgical incisions while maintaining the ability to implant the sling effectively.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces the mechanical cutting action of a surgical knife with a puncturing mechanism. Instead of using a blade to incise and create a wound, the system uses a pointed needle to puncture through the tissue, creating a small passage that heals faster and carries lower infection risk, thus substituting a less harmful mechanical action for the traditional cutting method.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Object-affected harmful factors

If a puncture needle is used to create a passage without incision, then invasiveness is reduced, but the difficulty of properly locating and guiding the needle increases

Engineering Contradiction:
ImproveinvasivenessVSAvoiddifficulty of needle guidance
Core Design Contradiction:
Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The patent introduces a guide member as an intermediary device that facilitates the proper positioning and guidance of the puncture needle. The guide member acts as a mediator between the operator and the needle, providing structural support and directional control to ensure the needle reaches the correct location through the vaginal wall without requiring complex manual manipulation.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent employs a guide member that extends through the vagina and provides a three-dimensional framework for needle insertion. By adding this spatial dimension with the guide member, the system transforms the complex task of freehand needle guidance into a more controlled process where the needle follows the predefined path of the guide member, thereby easing the operational difficulty.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

3Reliability

If the vagina is incised for mesh implantation to treat pelvic organ prolapse, then the prolapse can be supported, but the risk of sling exposure from wound and infection increases

Engineering Contradiction:
Improveeffectiveness of prolapse treatmentVSAvoidinfection risk and sling exposure
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent uses a puncture needle as an intermediary tool to create a closed passage for mesh implantation, avoiding the need for an open surgical incision. This intermediary puncture method allows the mesh to be delivered through a sealed tract, reducing the risk of sling exposure to the vaginal cavity and minimizing infection risk while maintaining the effectiveness of the prolapse treatment.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent converts the potential harm of needle puncture (which could create an uncontrolled wound) into a benefit by using the needle to create a precise, controlled, and sealed passage. The puncture tract serves as a protected conduit that delivers the mesh while maintaining tissue integrity and preventing exposure, thus transforming a potentially harmful action into a safe and effective delivery method.

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

4Ease of manufacture

If traditional surgical incision is used, then the procedure can be completed, but the burden on the patient increases due to greater invasiveness

Engineering Contradiction:
Improvefeasibility of procedureVSAvoidpatient burden
Core Design Contradiction:
Ease of manufactureVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the traditional surgical cutting mechanism with a puncture-based mechanism. Instead of using a knife to make an incision that requires suturing and healing, the system uses a needle to create a small puncture that heals rapidly without sutures, thereby maintaining procedural feasibility while dramatically reducing patient burden and recovery time.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent changes the key parameter of tissue disruption from a large-scale incision to a small-scale puncture. By altering the physical parameter of the surgical intervention (from cutting to puncturing), the procedure maintains its ability to deliver the implant while minimizing tissue damage, reducing pain, and decreasing patient burden throughout the recovery process.

Inventive Principle:
Principle #35Parameter changes

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The apparatus reduces invasiveness, minimizes the risk of infection and tissue damage, and facilitates safe implantation of the sling, thereby reducing patient burden and improving procedural safety.

Implementation Method 1

a puncture member rotatably mounted on the supporting member to rotate about a rotation center... as the puncture member is rotated about the rotation center

Methodology Applied
Scientific EffectRotational motion:

Implementation Method 2

The inserter is configured to cover at least the distal-most end portion of the vaginal-insertion member to guide the distal-most end portion of the vaginal-insertion member into the vaginal opening

Methodology Applied
Scientific EffectMechanical guidance:

Data Source

PatentUS9011475B1Puncture apparatus
Publication Date: 2015.04.21 TERUMO KK
  • US9011475B1 patent drawing
  • US9011475B1 patent drawing
  • US9011475B1 patent drawing

AI summary

A puncture apparatus includes a puncture needle for puncturing living body tissue, an axial portion, a puncture member including an interlock portion interlocking the puncture needle and the axial portion, an elongated urethral-insertion member insertable into the urethra, an elongated vaginal-insertion member insertable into the vagina; and a supporting member supporting the puncture member, the urethral-insertion member and the vaginal-insertion member. The distal end of the puncture needle includes a sharp needle tip, and the needle is bent in an arc shape centered on the axial portion. The axial portion is freely rotatable on the supporting member, and the supporting member restricts the positional relation between the puncture member and the urethral-insertion member such that when the puncture member rotates and punctures the living body tissue, the needle tip passes a far-position side from the center of the puncture needle compared with the urethral-insertion member or an extended line of such member.