WO2014170825A2

WO2014170825A2 - Clamping assembly for sternal closure and ribs approximator devices and methods thereof

Info

Publication number: WO2014170825A2
Application number: PCT/IB2014/060732
Authority: WO
Inventors: Ajay K PATIL
Original assignee: Patil Ajay K
Priority date: 2013-04-19
Filing date: 2014-04-15
Publication date: 2014-10-23
Also published as: WO2014170825A3

Abstract

A clamping assembly for sternal closure and ribs approximator device, the clamping assembly comprising: a) a first coupling element joined to a first end region of a shaft, said first coupling element capable of being stationary or movable relative to said first end region; b) a second coupling element engaged with the first coupling element via a joint; c) a first clamping element engaged with the second coupling element via a joint; and d) a relative motion enabling component; wherein a joint used in the clamping assembly is a joint other than a pivot joint; and wherein the said shaft comprises a second end region.

Description

CLAMPING ASSEMBLY FOR STERNAL CLOSURE AND RIBS APPROXIMATOR

DEVICES AND METHODS THEREOF FIELD OF THE INVENTION:

This invention relates to the field of mechanical engineering and devices having further use in biomedical engineering.

Particularly, this invention relates to the field of biomedical equipment.

Specifically, this invention relates to the field of surgical devices used for approximation and closure of sternum following median sternotomy for various procedures on the heart, lungs and media-sternum.

More specifically, this invention relates to a sternal closure and ribs approximator device. BACKGROUND OF THE INVENTION:

The sternum or breastbone, in vertebrate anatomy, is a flat bone. It is shaped like a capital "T" located anteriorly to the heart in the centre of the thorax (chest). It connects the rib bones via cartilage, forming the anterior section of the rib cage with them, and thus helps to protect the lungs, heart, and major blood vessels from physical trauma. Its upper end supports the clavicles, and its margins articulate with the cartilages of the first seven pairs of ribs

A good number of surgical procedures on the thorax require median sternotomy. Median sternotomy provides a surgical approach to the heart and major arteries, lungs, mediastinum, and thoracic spine. The breast bone comprises a manibrium, superiorly, and a sternum, inferiorly.

Median sternotomy is a type of surgical procedure in which the sternum is cut longitudinally for entry into the thorax for exposure of heart and lungs during surgery. During surgery, the two halves of the bones are separated using retractors.

Following surgery, the sternum is approximated and held close together using various methods. Methods for re -approximation of sternum include using thin stainless steel wires, or stainless steel bands, or various sternal closure devices. Conventionally, thin stainless steel wires of about 1 - 1.5 mm diameter are used for closure of the sternum. Typically, a surgeon holds a needle using a strong needle holder and passes a wire around the left sternal half; either piercing the bone or going parasternal outside in. Then the wire is passed around the right sternal half inside out. The needle is cut and both the free ends of cut wires are held using clamps. After passing the required number of wires, haemostasis is checked. Then the wires are crossed individually and sternum is held closed together. The two ends of each wire are pulled across and twisted around each other so as to tighten the sternum. This procedure is repeated for all the wires. Excess wires are cut and the small twisted ends of wires are buried in the parasternal tissue to avoid cutting out of the sharp ends through skin. These wires remain permanently lodged and do not require removal unless any problem arises or unless there is a second surgical procedure.

Typically, tough stainless steel wires are widely used; but they have many disadvantages. Placement of wires often leads to bleeding from intercostals vessels during the passage of needle through parasternal tissue. Blood vessels can be punctured, leading to severe bleeding. Control of bleeding is time consuming and requires use of sutures, surgical clips, and electro cautery. This leads to increase in operating room time, exhaustion of surgical team, increase of cost of sutures and clips. Use of cautery often leads to weakening of wires and potentially decreases blood supply to the sternum leading to increased risk of sternal healing problems.

After haemostasis, during tightening of wires, some blood vessels may get injured leading to post-operative increasing drainage. This requires re -exploration and haemostasis. This again increases the cost of additional surgery, increases the risk of infection to patients. Also, additional blood and blood products are required for haemostasis and haemodynamical stability. It also results in increase of cost of antibiotics and blood and blood products, operating room time and increases strain on surgeons.

The sternum, following the surgery, has forces acting on it during breathing, coughing, and valsalva manoeuvre. This causes the sternum to retract away from each other causing stress on the stainless steel wire loops. The wires, being thin, can cut through bone leading to loosening of the sternal closure. This leads to sternal instability and risks of infection. This further leads to complete transaction of sternal bone and instability with infection called sternal dehiscence. This requires further surgical procedures, medications and antibiotics, prolonged hospital stay, and adds to the risk of mortality. Such complications are occasionally seen in old patients or female patients with severe osteoporosis. The incidence of sternal dehiscence is also high among patients with Type II Diabetes mellitus.

Also, since the sternal wires occasionally break during tightening or during postoperative period leading to sternal instability, the broken loop often causes discomfort to the patients and protrudes out through the skin requiring second surgical procedure.

Wires and needles are sharp and can cause injury to the surgeon or the surgical team. Each cut end of wires is held in clamps and then there are several clamps in the surgical field. The cut ends often cut through the gloves and cause injuries to the surgeon/team. This accidental injury exposes the entire surgical team to blood borne diseases including AIDS, Hepatitis or the like infections or diseases or risks.

Further, the usage of stainless steel wires is often time consuming and adds on stress to the surgeon and the surgeon's team.

Other methods used for closure of sternum are sternal bands and sternal closure devices. Sternal bands are flat bands and avoid cut-through of sternums as seen in thin wires. However, bands are time consuming and difficult to apply and also the associated locking mechanism is often complex. Also during re-entry for emergency re-explorations, the bands are difficult to remove and can cause injury to underlying important organs including the heart.

Certain additional prior art clamping devices are also available for closure of sternum. Most of these devices have complex methods of applications and are also time consuming. They, however, overcome deficiencies of wire based sternal closures.

SUMMARY OF THE INVENTION:

In an embodiment of this invention, there is provided a clamping assembly for sternal closure and ribs approximator device, the clamping assembly comprising: a) a first coupling element joined to a first end region of a shaft, said first coupling element capable of being stationary or movable relative to said first end region;

b) a second coupling element engaged with the first coupling element via a joint; c) a first clamping element engaged with the second coupling element via a joint; and

d) a relative motion enabling component;

wherein a joint used in the clamping assembly is a joint other than a pivot joint; and wherein the said shaft comprises a second end region;

and wherein the second end region of the shaft is joined to a second clamping assembly, the second clamping assembly comprising of a second clamping element; and wherein on exertion of force on the relative motion enabling component, a relative motion is made to occur between said first coupling element and said second coupling element, and between said second coupling element and said first clamping element, in a manner that the first clamping element grips or holds a sternal bone from the lower end of the sternal bone after the occurrence of relative motion, while the said shaft is mounted over the upper end of the sternal bone; and

wherein the first clamping element and second clamping element together are capable of griping or holding a sternal bone from the lower end of the sternal bone;

and methods thereof.

In an embodiment of this invention, there is provided a sternal closure and ribs approximator device with hinged assembly, said device comprising:

a) a shaft having a first end region and a second end region;

b) a first clamping assembly operationally connected to the first end region, said first clamping assembly comprising

i. a first coupling element joined to the first end region, said first coupling element capable of being stationary or movable relative to the first end region;

ii. a second coupling element engaged with the coupling element via a joint;

iii. a first clamping element engaged with the second coupling element via a joint; and

iv. a relative motion enabling component; and c) a second clamping assembly operationally connected to the second end region, said second clamping assembly comprising a second clamping element;

wherein a joint used in the first clamping assembly is a joint other than a pivot joint; and wherein on exertion of force on the relative motion enabling component, a relative motion is made to occurs between said first coupling element and said second coupling element, and between said second coupling element and said first clamping element, in a manner that the first clamping element grips or holds a sternal bone from the lower end of the sternal bone after the occurrence of relative motion, when the said shaft is mounted over the upper end of the sternal bone; and

and methods thereof.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS:

The invention will now be described in relation to the accompanying drawings, in which:

Figure 1 illustrates an exemplary schematic drawing of a sternal closure and ribs approximator device in its open configuration; and

Figure 2 illustrates an exemplary schematic drawing of a sternal closure and ribs approximator device in its closed configuration.

DETAILED DESCRIPTION OF THE INVENTION:

In an embodiment of this invention, there is provided a clamping assembly for sternal closure and ribs approximator device, the clamping assembly comprising:

a) a first coupling element joined to a first end region of a shaft, said first coupling element capable of being stationary or movable relative to said first end region;

d) a relative motion enabling component;

wherein a joint used in the clamping assembly is a joint other than a pivot joint; and wherein the said shaft comprises a second end region; and wherein the second end region of the shaft is joined to a second clamping assembly, the second clamping assembly comprising of a second clamping element; and wherein on exertion of force on the relative motion enabling component, a relative motion is made to occur between said first coupling element and said second coupling element, and between said second coupling element and said first clamping element, in a manner that the first clamping element grips or holds a sternal bone from the lower end of the sternal bone after the occurrence of relative motion, while the said shaft is mounted over the upper end of the sternal bone; and

and methods thereof.

a) a shaft having a first end region and a second end region;

ii. a second coupling element engaged with the coupling element via a joint;

iv. a relative motion enabling component; and

c) a second clamping assembly operationally connected to the second end region, said second clamping assembly comprising a second clamping element;

wherein a joint used in the first clamping assembly is a joint other than a pivot joint; and wherein on exertion of force on the relative motion enabling component, a relative motion is made to occurs between said first coupling element and said second coupling element, and between said second coupling element and said first clamping element, in a manner that the first clamping element grips or holds a sternal bone from the lower end of the sternal bone after the occurrence of relative motion, when the said shaft is mounted over the upper end of the sternal bone; and wherein the first clamping element and second clamping element together are capable of griping or holding a sternal bone from the lower end of the sternal bone;

and methods thereof.

The present invention in another embodiment provides a method of assembling a clamping assembly for sternal closure and ribs approximator device, the method comprising the steps of,

a) providing a first coupling element joined to a first end region of a shaft, wherein first coupling element is capable of being stationary or movable relative to said first end region;

b) engaging a second coupling element with the first coupling element via a joint;

c) engaging a first clamping element with the second coupling element via a joint; and d) providing a relative motion enabling component;

wherein the joint used in the clamping assembly is a joint other than a pivot joint; and wherein the said shaft comprises a second end region;

and wherein the second end region of the shaft is joined to a second clamping assembly, the second clamping assembly comprising of a second clamping element;

and wherein on exertion of force on the relative motion enabling component, a relative motion is made to occur between said first coupling element and said second coupling element, and between said second coupling element and said first clamping element, in a manner that the first clamping element grips or holds a sternal bone from the lower end of the sternal bone after the occurrence of relative motion, while the said shaft is mounted over the upper end of the sternal bone; and

wherein the first clamping element and second clamping element together are capable of griping or holding a sternal bone from the lower end of the sternal bone.

The present invention in another embodiment provides a method of assembling a sternal closure and ribs approximator device with hinged assembly, the method comprising the steps of,

a) connecting a first clamping assemblyto a first end region of a shaft, wherein the shaft has a first end region and a second end region; and

b) connecting a second clamping assembly to the second end region, said second clamping assembly comprising a second clamping element;

wherein said first clamping assembly comprises i. a first coupling element joined to the first end region, said first coupling element capable of being stationary or movable relative to the first end region;

ii. a second coupling element engaged with the coupling element via a joint;

iii. a first clamping element engaged with the second coupling element via a joint; and iv. a relative motion enabling component;

In an embodiment of the invention, at least one additional coupling element is engaged between the first element and the clamping element via a joint.

In an embodiment of the invention, a series of coupling element is engaged between the first element and the clamping element via a joint, wherein each of the said coupling elements is coupled to at least two coupling elements via a joint.

In an embodiment of the invention, a joint enabled in the device may be a hinge joint.

In an embodiment of the invention, a joint enabled in the device may be a gliding joint.

In an embodiment of the invention, the second clamping assembly may be identical to the first clamping assembly.

In an embodiment of the invention, the second clamping assembly may employ a pivot joint.

In an embodiment of the invention, a first end region of the shaft is the region between the first end of the shaft up to 50 percent of the distance between the centre of the shaft and the first end of the shaft. In an embodiment of the invention, a joint is enabled by a pintle.

In an embodiment of the invention, a relative motion enabling component comprises of a fastening device.

In an embodiment of the invention, a relative motion enabling component is a set of one or more chords which when tightened shall cause the relative motion to occur.

In an embodiment of the invention, a first end region of the shaft is the region between the first end of the shaft upto 40 percent of the distance between the centre of the shaft and the first end of the shaft.

In an embodiment of the invention, a first end region of the shaft is the region between the first end of the shaft up to 30 percent of the distance between the centre of the shaft and the first end of the shaft.

In an embodiment of the invention, a first end region of the shaft is the region between the first end of the shaft up to 25 percent of the distance between the centre of the shaft and the first end of the shaft.

In an embodiment of the invention, a first end region of the shaft is the region between the first end of the shaft up to 20 percent of the distance between the centre of the shaft and the first end of the shaft.

In an embodiment of the invention, the lower end of the at least one clamping element may comprise any shape of surface for grasping such as but not limited to projections, teeth, ridges, spikes, extensions, protrusions or any combination thereof.

In an embodiment of the invention, if there are more than one clamping elements, two or more clamping elements may be operated in synchronism, simultaneously or individually.

In an embodiment of the invention, the shaft may comprise of one or more sub components. In an embodiment of the invention, the shaft may be made up of fastening two or more elements.

In an embodiment of the invention, the shaft may be of variable length with a length varying mechanism.

In an embodiment of the invention, the shaft may comprise of a locking mechanism.

In an embodiment of the invention, the shaft may comprise of one or more apertures on its surface.

In an embodiment of the invention, the device of the present invention may have high crack resistance, wear resistance, corrosion resistance and dimensional stability.

In an embodiment of the invention, one or more parts or components of the device of the present invention may be made up of any suitable biocompatible material such as but not limited to stainless steel, titanium, iron, cobalt, nickel, tantalum, zirconium, silver, gold, cobalt-chromium alloys, titanium alloys, nitinol, silicone rubber, acrylic resins, polyurethanes, polypropylene, polyethylene, polymethylmethacrylate, nylon, or ultra-high molecular weight polyethylene, polyglecaprone, polydioxanone and ceramics such as alumina, zirconia and hydroxyapatite, polylactides, polyglycolides, and copolymers thereof; poly(hydroxybutyric acid); poly(lactide-co-(8-caprolactone-)); poly(glycolide-co-(e- caprolactone)); polycarbonates, poly(pseudo amino acids); poly(amino acids); poly(hydroxyl alkanoate); polyanhydride or any combination thereof.

In an embodiment of the invention, one or more parts or components of the device of the present invention may be made up of any suitable metal such as but not limited to iron, copper, aluminum, gold, silver, bronze, platinum, tungsten, cadmium, zinc, tin, germanium, lead, nickel, tantalum, or any combination thereof.

In an embodiment of the invention, one or more parts or components of the device of the present invention may be coated with suitable therapeutic agent such as but not limited to antimicrobial agents, antibiotics, antiviral agents, anti-inflammatory agents, analgesic agents, haemostatic agents, anaesthetics, steroids, immunomodulating agents or agents such as bone morphogenic protein (BMP) or bone growth promoting agents or any combination thereof.

In embodiment of an invention, one or more parts or components of the device of the present invention may be coated with suitable coating material selected form the group of titanium and hydroxyapatite (HA), polytetrafluoroethylene (PTFE), ceramic, polymer or any combination thereof. The coating can be done to enhance biocompatibility, biostability, wear resistance, strength and lubricity.

In an embodiment of the invention, the device of the present invention is visible to different types of medical imaging such as but not limited to magnetic resonance imaging (MRI), tomography, x-ray, ultrasound, or any combination thereof.

In an embodiment of the invention, the device of the present invention is of any suitable cross sectional size or shape.

In an embodiment of the invention, the device and methods of the present invention may install, embed or connect one or more cameras to the system.

In an embodiment of the invention, the device of the present invention used in the surgical procedure such as but not limited to median sternotomy.

In an embodiment of the invention, the sternal closure and ribs approximator devices protects the sternum following the surgery and provide complete stability to sternum against the force acting on it such as but not limited to breathing, violent coughing, deep respiration, valsalva manoeuvre, physical shock, high blood pressure, muscle force, body fluid pressure or any combination thereof.

In an embodiment of the invention, the device of the present invention may be adjustable to fit in groves and cavities along the surface of a sternal bone.

In an embodiment of the invention, at least one holder may be used to hold or secure the device of the present invention. In an embodiment of the invention, one or more devices in accordance of the present invention may be coupled together and may be secured simultaneously by using at least one holder.

In an embodiment of the invention, the device of the present invention may consist of at least one breaking point. The breaking point allows easy and rapid dismantling of the components of the device.

In an embodiment of the invention, one or more devices in accordance of the present invention may be used for a single sternum, wherein the said sternal closure device may be used to secure first and second portions of severed sternum.

In an embodiment of the invention, the device and method of the present invention may be used to treat bone fractures such as but not limited to closed (simple) fracture, open (compound) fracture, complete fracture, incomplete fracture, linear fracture, transverse fracture, oblique fracture, spiral fracture, comminuted fracture, impacted fracture, avulsion fracture or any combination thereof.

In an embodiment of the invention, the device and methods of the present invention may install, embed or connect one or more sensors to the system, such as but not limited to, temperature sensors, chemical sensors, pressure sensors, internal damage sensors, heart beat sensors, blood flow sensors, and the like, or a combination thereof. The sensors may be connected to a computing device or programmable logic controller, proportional-integral- derivative controllers. The combination of sensors and controllers may be used to monitor and control the device and methods of the present invention

In an embodiment of the invention, the device of the present invention used in the surgical procedure such as but not limited to median sternotomy. In an embodiment of the invention, the sternal closure and ribs approximator devices protects the sternum following the surgery and provide complete stability to sternum against the force acting on it such as but not limited to breathing, violent coughing, deep respiration, valsalva manoeuvre, physical shock, high blood pressure, muscle force, body fluid pressure or any combination thereof.

In an embodiment of the invention, the one or more parts or components of the system of the present invention may be connected and fixed, or may be detachable and re -attachable, detachable component can be attached or fixed with one or more of other components using mechanisms such as but not limited to screw threads, twist and lock mechanism, magnetic locking, vacuum induced locking, friction fit, snap fit, or any combination thereof.

In an embodiment of the invention, the components of the present invention may be connected or arranged by using any suitable method and may include without limitation use of one or more of welding, adhesives, riveting, fastening devices such as but not limited to screw, nut, bolt, hook, clamp, clip, buckle, nail, pin, ring, or the like.

The term "sternal closure device" and "sternal closure and ribs approximator device" may be alternatively used for the purpose of the present invention.

In an embodiment of the invention, a joint may be a spring such as but not limited to tension/extension spring, compression spring, torsion spring, constant spring, variable spring, coil spring, flat spring, machined spring, cantilever spring, coil spring or helical spring, compression springs, volute spring, tension or extension spring, hairspring or balance spring, leaf spring, v-spring, belleville washer or belleville spring, constant-force spring, gas spring, ideal spring, main spring, negator spring, progressive rate coil spring, rubber band, spring washer, torsion spring, wave spring, or any combination thereof.

DESCRIPTION OF THE ACCOMPANYING DRAWINGS:

In accordance with an exemplary schematic drawing of an embodiment of the invention, Figure 1 represents a front view a sternal closure and ribs approximator device in its opened configuration, wherein there is provided a shaft (11). The first clamping assembly comprises of first coupling element (13) is joined to first end region (12) of said shaft (11), second coupling element (15) is engaged with the first coupling element via one of joints (14), and similarly a first clamping element (16) engaged with the second coupling element (15) via a joint. Further the said device comprises a relative motion enabling component.

In accordance with an exemplary schematic drawing of an embodiment of the invention, Figure 2 represents a front view a sternal closure and ribs approximator device in its closed configuration, wherein the closed configuration enabled on exertion of force on the relative motion enabling component which causes relative motion between the first coupling element (13) and second coupling element (15) and between second coupling element (15) and first clamping element (16). The first clamping assembly and a second clamping assembly is capable of griping or holding a sternal bone from the lower end of the sternal bone after the occurrence of relative motion, wherein a shaft (11) is mounted over the upper end of the sternal bone.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising," when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude or rule out the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof.

While this detailed description has disclosed certain specific embodiments of the present invention for illustrative purposes, various modifications will be apparent to those skilled in the art which do not constitute departures from the spirit and scope of the invention as defined in the following claims, and it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the invention and not as a limitation.

Claims

CLAIMS:

1. A clamping assembly for sternal closure and ribs approximator device, the clamping assembly comprising:

b) a second coupling element engaged with the first coupling element via a joint;

c) a first clamping element engaged with the second coupling element via a joint; and

d) a relative motion enabling component;

2. A sternal closure and ribs approximator device with hinged assembly, said device comprising:

a) a shaft having a first end region and a second end region;

i. a first coupling element joined to the first end region, said first coupling element capable of being stationary or movable relative to the first end region; ii. a second coupling element engaged with the coupling element via a joint;

iv. a relative motion enabling component; and

3. A method of assembling a clamping assembly for sternal closure and ribs approximator device, the method comprising the steps of,

b) engaging a second coupling element with the first coupling element via a joint; c) engaging a first clamping element with the second coupling element via a joint; and

d) providing a relative motion enabling component;

4. A method of assembling a sternal closure and ribs approximator device with hinged assembly, the method comprising the steps of,

wherein said first clamping assembly comprises

ii. a second coupling element engaged with the coupling element via a joint;

iv. a relative motion enabling component;

wherein the first clamping element and second clamping element together are capable of griping or holding a sternal bone from the lower end of the sternal bone .A sternal closure and ribs approximator device, as claimed in any of the preceding claims, wherein at least one additional coupling element is engaged between the first element and the clamping element via a joint.

5. A sternal closure and ribs approximator device, as claimed in any of the preceding claims, wherein a series of coupling element is engaged between the first element and the clamping element via a joint, and wherein each of the said coupling elements is coupled to at least two coupling elements via a joint.

6. A sternal closure and ribs approximator device, as claimed in any of the preceding claims, wherein the second clamping assembly is identical to the first clamping assembly.

7. A sternal closure and ribs approximator device, as claimed in any of the preceding claims, wherein a first end region of the shaft is the region between the first end of the shaft up to 50 percent of the distance between the centre of the shaft and the first end of the shaft.

8. A sternal closure and ribs approximator device, as claimed in any of the preceding claims, wherein a joint is enabled by a pintle.

9. A sternal closure and ribs approximator device, as claimed in any of the preceding claims, wherein a relative motion enabling component comprises of a fastening device.

10. A sternal closure and ribs approximator device, as claimed in any of the preceding claims, wherein a relative motion enabling component is a set of one or more chords which when tightened cause the relative motion to occur.