The present disclosure discloses a device including a frame having a pre-defined length and extending between a proximal end and a distal end. The frame has a first portion, a second portion, a third portion, and a fourth portion. The first portion is disposed at the distal end and makes a pre-defined angle 'f' with the distal end. The second portion is disposed adjacent to the first portion and makes a pre-defined angle 's' with the distal end. The third portion is disposed adjacent to the second portion and makes a pre-defined angle 't' with the distal end. The fourth portion is disposed at the proximal end and makes a pre-defined angle 'o' with the distal end. A first jacket is coupled to the proximal end a second jacket is coupled to the distal end.
A61B 17/04 - Surgical instruments, devices or methods for closing wounds or holding wounds closedAccessories for use therewith for suturing woundsHolders or packages for needles or suture materials
A61B 17/12 - Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
3.
A TISSUE TREATMENT SYSTEM WITH MODIFIED BAFFLE FOR ASPIRATION AND SALINE INJECT DURING CARCINOGENIC PROCEDURE OR METHOD
The present invention discloses an adapter including a cannula, at least one baffle, and at least one valve at least partially disposed within the handle. A second-flow end of the baffle is coupled to a first end of the cannula. A plurality of plates extends helically within a baffle body between a first-flow end and the second-flow end. A first port of the valve is coupled to the first-flow end of the baffle. A lumen of the cannula, a lumen of the baffle, the first port and a second port of the valve define a fluid pathway configured to facilitate aspiration of tissue fluid from a surgical site or flow of saline to the surgical site.
A61B 18/18 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
A61B 90/30 - Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
A61B 10/04 - Endoscopic instruments, e.g. catheter-type instruments
The present invention discloses a method of manufacturing a stent from a biodegradable polymer. The method commences by braiding at least a plurality of first monofilaments and a plurality of second monofilaments to form a braided structure. The braided structure is subjected to a primary shape setting at a predefined temperature for a predefined time duration. Thereafter, at least one of the first monofilaments or the second monofilaments are back braided. The stent is axially compressed to decrease the length (L3) of the stent, and increase the braiding angles of the stent. The stent is subjected to secondary shape setting at the predefined temperature for the predefined time period. The present invention further discloses a stent.
A61F 2/90 - Stents in a form characterised by wire-like elementsStents in a form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
The present invention discloses a stent including at least one first row of first struts and a plurality of second rows of second struts. The first struts extending circumferentially and disposed both at a proximal end and a distal end. The second struts extending circumferentially and axially disposed between the first rows. Further, the stent includes at least one first row of cells, at least one second row of cells, a plurality of third row of cells and a plurality of fourth row of cells. The at least one first row of cells disposed each at the proximal end and the distal end. The at least one second row of cells disposed adjacent to each of the first row of cells. The plurality of third row of cells and the plurality of fourth row of cells are placed between the second row of cells.
A61F 2/915 - Stents in a form characterised by wire-like elementsStents in a form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
A61F 2/852 - Two or more distinct overlapping stents
6.
POLYMERIC VALVULAR STRUCTURE AND METHOD OF PREPARATION THEREOF
The present invention discloses a method to prepare a polymeric film for making at least one of a valvular structure (103) and one or more sealing means (102) of a prosthetic heart valve. The method commences by pre-processing a polymer for a pre-defined time to reduce residual moisture content of the polymer. Thereafter, the pre-processed polymer is dissolved in at least one solvent yielding a polymer solution having a pre-defined concentration. The polymer solution is poured into an enclosed surface having a pre-defined area. The polymer solution is subjected to a drying technique at a first pre-defined temperature(s) and a first pre-defined pressure(s) for a first pre-defined time period(s) to yield a polymeric film having a thickness ranging from 150 microns to 220 microns. The polymeric film is washed and subjected to the drying technique at a second pre-defined temperature(s) for a second pre-defined time period(s).
The present invention discloses a method to prepare a polymeric structure for a prosthetic heart valve. The method commences by pre-processing a polymer for a pre-defined time. The pre- processed polymer is then dissolved in at least one solvent yielding a polymer solution. Thereafter, a mold is subjected to one or more dip cycles. Each dip cycle includes inserting the mold in the polymer solution, maintaining the mold inside the polymer solution for a first hold time period, and maintaining the mold outside the polymer solution for a second hold time period. The polymer solution on the mold is then subjected to a first curing technique and a second curing technique to yield the polymeric structure. The thickness of the polymeric structure ranges from 160 microns to 200 microns. Thereafter, the polymeric structure is peeled away from the mold.
A delivery system for delivering a self-expandable braided stent is disclosed. The delivery system includes a handle that contains a roller assembly. The roller assembly includes a roller, a base plate, a connecting shaft and a slider block. The slider block is supported on an inner tube. The delivery system includes a hypotube that is fixedly coupled to the slider block and co-axially receives the inner tube. The stent is mounted on the hypotube in a crimped state. An outer sheath is provided over the hypotube to cover the stent. On rotation of the roller, the slider block enables the forward and backward movement of the hypotube along the longitudinal axis 'x' over the inner tube relative to the outer sheath.
A61F 2/95 - Instruments specially adapted for placement or removal of stents or stent-grafts
A61F 2/966 - Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
An embolization device having a proximal lobe and a distal lobe connected by a bridge is disclosed. The proximal lobe has a braided mesh structure with a gradually increasing diameter from a first proximal end to a first distal end. The braided mesh structure is made from a plurality of wires and includes narrow pores to completely cut-off blood supply at an implantation site. The distal lobe is a braided mesh structure that extends from a second proximal end to a second distal end. The second distal end has a concave configuration which reduces overall length of the device thereby enhancing applicability of the device to varied implantation sites. The distal lobe includes a larger surface area than the proximal lobe thereby inhibiting chances of migration of the device and recanalization of the vessel.
A valvuloplasty balloon catheter (100) is disclosed. The valvuloplasty balloon catheter (100) comprises of an inflatable member (40) having anchor shaped ends and a tubular member (50). The tubular member (50) comprises of a proximal section (50a), a distal section (50b) and a middle section (50c). The middle section (50c) includes a proximal middle portion (50c1), a distal middle portion (50c2) and an intermediate portion (50c3). The proximal middle portion (50c1) and the distal middle portion (50c2) includes a plurality of closed cells (54). At least one of the proximal section (50a) or the distal section (50b) includes a plurality of first struts (52) being anchor shaped. The plurality of closed cells (54) includes one or more zig-zag elements being placed over tapered end of the inflatable member (40) thereby allowing uniform and smooth expansion of the tubular member (50). The intermediate portion 50c3 includes a plurality of s-shaped links.
A radially expandable and collapsible prosthetic aortic valve suitable for mounting on a balloon of a delivery catheter in a radially collapsed condition is disclosed. The prosthetic aortic valve includes a support frame having three circumferentially extending rows of angled struts. Any two consecutive angled struts of a row of circumferentially extending angled struts form a peak/a valley. The adjacent rows of angled struts are connected to each other by links (either a diamond shaped cell or a rhombus body, thereby forming two rows of cells. The prosthetic aortic valve includes three leaflets, an internal skirt and an external skirt. The support frame and the delivery catheter provide an easy and accurate method for deployment of the prosthetic aortic valve at a target location.
A method for implanting a prosthetic valve in a patient's body with minimum misalignment of commissures of the prosthetic valve to the commissures of a native aortic valve is disclosed. AoCA of a native aortic valve of a patient to be treated is determined and the prosthetic valve having three commissures is crimped on a delivery system having one or more aligners marked on its outer shaft. The aligners follow same axis. Crimping is done using a crimper and/or a confirmation gauge that includes one or more angle markings. Crimping is performed such that one of the commissures of the prosthetic valve is axially aligned with the AoCA identified on the angle markings on one of the crimper/confirmation gauge and at the same time, the one or more aligners face upwards. The crimped prosthetic valve is implanted by maintaining the aligner(s) pointing upward during the entire implantation procedure.
A device and method of radially collapsing a medical device is disclosed. The device is in the form of an improved crimper which is capable of crimping a medical device. The crimper includes without limitation one or more of, a base plate, a stopper, two side plates, two housing plates with a handle, a plurality of jaws, two guide plates, at least one gear ring and a plurality of gear pins. The jaws, when assembled, collectively form an iris opening. The assembly of the crimper has a central opening through which the iris opening can be accessed. The device to be crimped is introduced in the central opening and held within the iris opening. The crimping is achieved by reducing the size of the iris opening (by moving the jaws simultaneously with respect to each other in synchronized manner) which in turn reduces the diameter of the prosthetic device.
The present invention discloses a stent. A proximal most ring is disposed at a proximal end and a distal most ring is disposed at a distal end. A plurality of rings extends between the proximal ring and the distal ring. A first link couples a crown of one of the proximal most ring or the distal most ring to a respective adjacent crown of an adjacent ring. A second link couples a crown of a ring to a respective adjacent crown of an adjacent ring. A plurality of rows open cells is flanked by two or more rows of closed cells. A plurality of radiopaque markers coupled to the proximal most ring are circumferentially offset from a plurality of markers coupled to the distal most ring. The proximal most ring and the distal most ring of the stent are configured to flare by a pre-defined angle (x).
An implant (100) for treatment of regurgitation in a mitral valve (100) is disclosed. The implant (100) comprising at least one fastener (50) including a top portion (52) and a shank (54). The top portion (52) including a ring (51a) and a plurality of crowns (60). The crowns (60) include a primary arm (61) and a secondary arm (63), the primary arm (61) being longer than the secondary arm (63). The ring (51a) is attached at a proximal end (51) of the shank (54) and a nut (53a) is attached at a distal end (53) of the shank (54). The primary arm (61) is attached to the ring (51a) and the secondary arm (63) is attached to the nut (53a). The top portion (52) is rotated in a predefined direction leading to upward movement of the nut (53a) in order to actuate the implant (100).
A device and method of radially collapsing a medical device is disclosed. The device is in the form of an improved crimper which is capable of crimping a medical device. The crimper includes without limitation one or more of, a base plate, a stopper, two side plates, two housing plates with a handle, a plurality of jaws, two guide plates, at least one gear ring and a plurality of gear pins. The jaws, when assembled, collectively form an iris opening. The assembly of the crimper has a central opening through which the iris opening can be accessed. The device to be crimped is introduced in the central opening and held within the iris opening. The crimping is achieved by reducing the size of the iris opening (by moving the jaws simultaneously with respect to each other in synchronized manner) which in turn reduces the diameter of the prosthetic device.
A device and method of radially collapsing a medical device is disclosed. The device is in the form of an improved crimper which is capable of crimping a medical device. The crimper includes without limitation one or more of, a base plate, a stopper, two side plates, two housing plates with a handle, a plurality of jaws, two guide plates, at least one gear ring and a plurality of gear pins. The jaws, when assembled, collectively form an iris opening. The assembly of the crimper has a central opening through which the iris opening can be accessed. The device to be crimped is introduced in the central opening and held within the iris opening. The crimping is achieved by reducing the size of the iris opening (by moving the jaws simultaneously with respect to each other in synchronized manner) which in turn reduces the diameter of the prosthetic device.
A radially expandable and collapsible prosthetic aortic valve suitable for mounting on a balloon of a delivery catheter in a radially collapsed condition is disclosed. The prosthetic aortic valve includes a support frame having three circumferentially extending rows of angled struts. Any two consecutive angled struts of a row of circumferentially extending angled struts form a peak/a valley. The adjacent rows of angled struts are connected to each other by links (either a diamond shaped cell or a rhombus body, thereby forming two rows of cells. The prosthetic aortic valve includes three leaflets, an internal skirt and an external skirt. The support frame and the delivery catheter provide an easy and accurate method for deployment of the prosthetic aortic valve at a target location.
A radially expandable and collapsible prosthetic aortic valve suitable for mounting on a balloon of a delivery catheter in a radially collapsed condition is disclosed. The prosthetic aortic valve includes a support frame having three circumferentially extending rows of angled struts. Any two consecutive angled struts of a row of circumferentially extending angled struts form a peak/a valley. The adjacent rows of angled struts are connected to each other by links (either a diamond shaped cell or a rhombus body, thereby forming two rows of cells. The prosthetic aortic valve includes three leaflets, an internal skirt and an external skirt. The support frame and the delivery catheter provide an easy and accurate method for deployment of the prosthetic aortic valve at a target location.
A method for implanting a prosthetic valve in a patient's body with minimum misalignment of commissures of the prosthetic valve to the commissures of a native aortic valve is disclosed. AoCA of a native aortic valve of a patient to be treated is determined and the prosthetic valve having three commissures is crimped on a delivery system having one or more aligners marked on its outer shaft. The aligners follow same axis. Crimping is done using a crimper and/or a confirmation gauge that includes one or more angle markings. Crimping is performed such that one of the commissures of the prosthetic valve is axially aligned with the AoCA identified on the angle markings on one of the crimper/confirmation gauge and at the same time, the one or more aligners face upwards. The crimped prosthetic valve is implanted by maintaining the aligner(s) pointing upward during the entire implantation procedure.
A method for implanting a prosthetic valve in a patient's body with minimum misalignment of commissures of the prosthetic valve to the commissures of a native aortic valve is disclosed. AoCA of a native aortic valve of a patient to be treated is determined and the prosthetic valve having three commissures is crimped on a delivery system having one or more aligners marked on its outer shaft. The aligners follow same axis. Crimping is done using a crimper and/or a confirmation gauge that includes one or more angle markings. Crimping is performed such that one of the commissures of the prosthetic valve is axially aligned with the AoCA identified on the angle markings on one of the crimper/confirmation gauge and at the same time, the one or more aligners face upwards. The crimped prosthetic valve is implanted by maintaining the aligner(s) pointing upward during the entire implantation procedure.
A stent system is disclosed. The stent system includes a balloon catheter having a balloon with a proximal zone, a transition zone and a distal zone including progressively decreasing diameters respectively. The stent of a pre-defined length includes a main branch segment, a transition segment and a side branch segment. The stent includes an expanded state and a crimped state. The stent is mounted over the balloon in the crimped state such that the main branch segment is mounted over the proximal zone, the transition segment is mounted over the transition zone and the side branch segment is mounted over the distal zone. In expanded state, the main branch segment, the transition segment and the side branch segment of the stent correspond to the respective zones of the balloon. The transition segment includes plural rows of elongated members connected to each other.
A61F 2/954 - Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
A61F 2/91 - Stents in a form characterised by wire-like elementsStents in a form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
A61F 2/958 - Inflatable balloons for placing stents or stent-grafts
A valvuloplasty balloon catheter (100) is disclosed. The valvuloplasty balloon catheter (100) comprises of an inflatable member (40) having anchor shaped ends and a tubular member (50). The tubular member (50) comprises of a proximal section (50a), a distal section (50b) and a middle section (50c). The middle section (50c) includes a proximal middle portion (50c1), a distal middle portion (50c2) and an intermediate portion (50c3). The proximal middle portion (50c1) and the distal middle portion (50c2) includes a plurality of closed cells (54). At least one of the proximal section (50a) or the distal section (50b) includes a plurality of first struts (52) being anchor shaped. The plurality of closed cells (54) includes one or more zig-zag elements being placed over tapered end of the inflatable member (40) thereby allowing uniform and smooth expansion of the tubular member (50). The intermediate portion (50c3) includes a plurality of s-shaped links.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
24.
A PROCESS FOR PREVENTION OF DEGRADATION AND DEGENERATION OF TISSUE USED IN BIOPROSTHESIS
There is disclosed a process for treatment to avert enzymatic degradation and tissue degeneration of bovine pericardium tissue, used for making bioprosthesis for implant application, comprising the steps of collecting and harvesting raw bovine pericardial tissue; chemically cross-linking the rinsed tissue to generate fixed tissue; laser cutting said fixed tissue to produce tissue leaflet; chemically treating said tissue leaflet with AAS; chemically sterilising and storing the fixed bovine pericardium tissue to maintain the structural integrity and characteristics; and wherein all the above steps are carried out in a low-oxygen and controlled temperature environment.
A prosthetic heart valve assembly is disclosed. The said assembly includes a prosthetic heart valve (10). The said valve (10) is mounted over a balloon (5) for deployment at a target location. The dimensions of the said valve (10) mimic the anatomy of a native heart valve. The delivery catheter (100) is used for deployment of the prosthetic heart valve (10). The delivery catheter (100) includes a handle (11), a multi-layered outer shaft (1) and/or an inner shaft (3) including an inner second end (3b). A support tube (7) is disposed on top of the inner second end (3b) and includes one or more holes (7a) for passing an inflation fluid and is provided with the balloon (5) on its outer surface. One or stoppers (9) are provided on the support tube (7) and within the balloon (5) and include a first portion (C) and a second portion (D).
A clot retrieval device (1) having an end region (100) and a working region (200) is disclosed. The end region (100) further includes a plurality of tangential struts (110) and curved struts (105). Each tangential strut (110) extends from an edge of a respective curved strut (105). The working region (200) is placed adjacent to the end region (100). The working region (200) includes a plurality of small-sized cells (220) and large-sized cells (225). The small-sized cells (220) and large-sized cells (225) form a reticulated structure. The large-sized cell (225) includes an area multiple times than the small-sized cell (220). The rows of small-sized cells (220) are placed at an offset with each other creating a tread like pattern.
A61B 17/22 - Implements for squeezing-off ulcers or the like on inner organs of the bodyImplements for scraping-out cavities of body organs, e.g. bonesSurgical instruments, devices or methods for invasive removal or destruction of calculus using mechanical vibrationsSurgical instruments, devices or methods for removing obstructions in blood vessels, not otherwise provided for
A flow diverter and its delivery system is disclosed. The delivery system assembly comprises of a flow diverter (100) and a delivery system (400) that is configured to deploy the flow diverter (100). The delivery system (400) comprises of an introducer sheath, a delivery wire (403), a plurality of markers and a resheathing pad (405). The plurality of markers includes a proximal marker (407a) that includes an indented structure to provide smooth friction thereof against the introducer sheath, a distal marker (407c) and a resheathing marker (407b). The resheathing marker (407b) and the distal marker (407c) have a tapered profile which help to maintain position of the flow diverter (100) during deployment. The resheathing pad (405) is configured to support the flow diverter (100) in crimped state for allowing ease of multiple resheathing thereby resulting in accurate deployment of the flow diverter (100).
A valvuloplasty balloon catheter is disclosed. The valvuloplasty balloon catheter (100) comprises of an inflatable member (40) having tapered ends and a tubular member (50) mounted over the inflatable member (40). The tubular member (50) comprises of a proximal section (50a), a distal section (50b) and a middle section (50c). The middle section (50c) includes a proximal middle portion (50c1), a distal middle portion (50c2) and an intermediate portion (50c3). The proximal middle portion (50c1) and the distal middle portion (50c2) includes a plurality of closed cells (54). At least one of the proximal section (50a) or the distal section (50b) includes a plurality of first struts (52) being tapered. The plurality of closed cells (54) includes one or more zig-zag elements being placed over the tapered end of the inflatable member (40) thereby allowing uniform and smooth expansion of the tubular member (50).
A stent system is disclosed. The stent system includes a balloon catheter having a balloon with a proximal zone, a transition zone and a distal zone including progressively decreasing diameters respectively. The stent of a pre-defined length includes a main branch segment, a transition segment and a side branch segment. The stent includes an expanded state and a crimped state. The stent is mounted over the balloon in the crimped state such that the main branch segment is mounted over the proximal zone, the transition segment is mounted over the transition zone and the side branch segment is mounted over the distal zone. In expanded state, the main branch segment, the transition segment and the side branch segment of the stent correspond to the respective zones of the balloon. The transition segment includes plural rows of elongated members connected to each other.
A stent system (100) is disclosed. The system (100) includes a balloon catheter (10) having a balloon (10b). The balloon (10b) has a tapered intermediate portion (D3) disposed between a second proximal end (a2) and a first distal end (b1) of the balloon (10b). The system (100) further includes a stent (20) with a proximal end (20c), a distal end (20d) and a pre-defined length extending between the proximal end (20c) and the distal end (20d). The stent (20) has a crimped state and a deployed state and is mounted over tapered intermediate portion (D3) of the balloon (10b) in the crimped state with a guide-catheter compatibility of 5F. In the deployed state, the stent (20) attains a tapered profile corresponding to the tapered intermediate portion (D3) of the balloon (10b). The tapered profile of stent (20) includes a taper from the proximal end (20c) to the distal end (20d).
A prosthetic heart valve assembly is disclosed. The said assembly includes a prosthetic heart valve (10). The said valve (10) is mounted over a balloon (5) for deployment at a target location. The dimensions of the said valve (10) mimic the anatomy of a native heart valve. The delivery catheter (100) is used for deployment of the prosthetic heart valve (10). The delivery catheter (100) includes a handle (11), a multi-layered outer shaft (1) and/or an inner shaft (3) including an inner second end (3b). A support tube (7) is disposed on top of the inner second end (3b) and includes one or more holes (7a) for passing an inflation fluid and is provided with the balloon (5) on its outer surface. One or stoppers (9) are provided on the support tube (7) and within the balloon (5) and include a first portion (C) and a second portion (D).
A prosthetic heart valve is disclosed. The prosthetic heart valve includes a frame having a proximal end, a distal end and three rows of cells such as, a primary, a secondary and a base row. The valve includes a plurality of commissure posts provided in the primary row of the frame. An inner skirt is attached to an inner side of the frame. An outer skirt includes a first cuff, a second cuff and an intermediate region. The aforesaid cuffs and the intermediate region are sutured to their respective predefined locations on the outer side of the frame. A leaflet structure having three leaflets is provided. Each leaflet includes two tabs which are attached with each other and to the commissure post to firmly hold the leaflet to the frame. The leaflets are anti-calcified by a process involving low concentration of oxygen.
There is disclosed a process for treatment to avert enzymatic degradation and tissue degeneration of bovine pericardium tissue, used for making bioprosthesis for implant application, comprising the steps of collecting and harvesting raw bovine pericardial tissue; chemically cross-linking the rinsed tissue to generate fixed tissue; laser cutting said fixed tissue to produce tissue leaflet; chemically treating said tissue leaflet with AAS; chemically sterilising and storing the fixed bovine pericardium tissue to maintain the structural integrity and characteristics; and wherein all the above steps are carried out in a low-oxygen and controlled temperature environment.
A composition of multi-layered coating for balloon and process of coating thereof is disclosed. The composition of the multi-layered coating includes a base layer and a top layer. The base layer includes at least one hydrophilic compound in a concentration of 1.0%w/v to 5.0%w/v and at least one crosslinker in a concentration of 0.01% w/v to 0.09%w/v dissolved in at least two solvents. The top layer includes at least one hydrophobic compound in a concentration of 1.0%w/v to 13.0%w/v and at least one hydrophilic surfactant present in a concentration of 0.1%w/v to 1.6%w/v, dissolved in at least two solvents. The process of coating the multi-layered coating includes coating of a base layer followed by a primary heat curing step. Subsequently, the top layer is coated followed by a secondary heat curing step.
Scaffold graft having self-expandable scaffold and method of manufacturing thereof is disclosed. The scaffold graft comprises of a self-expandable scaffold. The scaffold includes an inner surface and an outer surface. The scaffold also includes a first layer coated on at least the outer surface 5 of the self-expandable scaffold resulting in a scaffold graft. The first layer includes at least a polymer dissolved in at least a solvent in the concentration in the range of 0.6%-0.8% (w/v). The thickness of the first layer ranges from 30-60 micron. The reduced profile of the scaffold graft ranges from 1.6 mm-2.4 mm.
A stent-graft assembly is disclosed. The stent-graft assembly is used for coronary applications. The stent-graft assembly includes a stent made of a biodegradable/biocompatible material and has strut thickness of 35-65 µm. The stent graft assembly also includes a graft which is provided with the stent. The graft includes at least one inner slab, at least one middle slab and at least one outer slab. The graft has a thickness of 25-40 µm. The crimp profile of stent-graft assembly is compatible up to 5 French catheters.
Surgical instruments and apparatus; Surgical apparatus and instruments for medical use; Surgical apparatus and instruments for veterinary use; Surgical apparatus and instruments for dental use..
A flow diverter and method of chemically passivating thereof. The process includes immersing the flow diverter in a passivating solution at a passivating temperature for passivating time duration. The flow diverter is then rinsed with an alkalizing solution followed by sonicating the rinsed flow diverter in deionized water at sonicating time duration. The aforesaid steps are repeated till color of the sonicated flow diverter changes. Further, the sonicated flow diverter is soaked in a soaking solution and then the soaked flow diverter is rinsed in a rinsing solution. The present invention also discloses a method for manufacturing the flow diverter which includes braiding, annealing, quenching and chemically passivating the flow diverter. The flow diverter is deployed with the help of a delivery system.
A61F 2/00 - Filters implantable into blood vesselsProstheses, i.e. artificial substitutes or replacements for parts of the bodyAppliances for connecting them with the bodyDevices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
A61L 29/00 - Materials for catheters or for coating catheters
A61L 31/00 - Materials for other surgical articles
59.
SYSTEM AND METHOD OF STERILIZATION AND PACKAGING OF A MEDICAL DEVICE
The present invention discloses a system and a method of integrated sterilization and packaging of a medical device. The present invention discloses a system for simultaneous sterilization of an assembly of a protective package containing a medical device. The protective package includes without limitation a fluid container, a tray and a pouch.
A61F 2/00 - Filters implantable into blood vesselsProstheses, i.e. artificial substitutes or replacements for parts of the bodyAppliances for connecting them with the bodyDevices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
A61F 2/04 - Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
60.
PROCESS FOR PLEATING AND FOLDING DRUG COATED BALLOON
Process for pleating and folding drug coated balloon is disclosed. A balloon is inflated and an outer surface of the balloon is coated with one or more layers of therapeutic agents and/or excipients. The drug coated balloon is subjected to pleating at a temperature from the range of 25°-60°C and at a pressure from the range of 25-35 psi. The drug coated balloon is then subjected to folding in a predefined direction at a pressure ranging from 80-100 psi and a dwell time ranging of 70-110 seconds. After the pleating and folding, a protective sheath is mounted over the outer surface of the drug coated balloon to hold the pleats of the folded balloon. After mounting, the heat setting process takes place at a temperature of 30-60°C which results in the balloon having a reduced profile ranging from 60% to 70% of the initial balloon diameter.
A drug coated balloon is disclosed. The drug coated balloon includes a balloon having an outer surface coated with a single layer of a solution of an anti-proliferative drug. The single layer includes at least one anti-proliferative drug in the concentration of 60-70 weight % and at least two excipients. In alternate embodiment, the drug coated balloon includes a base layer, a top layer and a middle layer sandwiched between the base layer and the top layer. The base and top layers include at least one plasticizer in the concentration of 8-12 weight % and at least one adhesive binder in the concentration of 0.5-0.8 weight %. The middle layer includes a solid-lipid nanoparticle suspension of at least one anti-proliferative drug, at least one emulsifier and at least one stabilizer in the concentrations of 40-60 weight %, 15-20 weight % and 1-7 weight % respectively.
An expandable endo prosthesis with low crimp profile is disclosed. The expandable endo prosthesis is implantable in a human blood vessel. The expandable endo prosthesis includes an expandable stent with an outer surface, an inner surface, a proximal end, a distal end and a crimp profile of 0.9 mm. The expandable endo prosthesis includes a tissue graft which covers the outer surface of the expandable stent and has a thickness within a range of 0.08 mm to 0.12mm. The tissue graft is anti- calcified. The crimp profile of the expandable stent and the tissue graft assembly is within a range of 1.2mm to 1.3mm.
A biodegradable endoprosthesis for paediatric patients is disclosed. A biodegradable stent includes a plurality of struts and an outer surface, each strut having a thickness in the range of 140 μm to 190 μm and width in the range of 90 μm to 190 μm. The biodegradable endoprosthesis includes a biodegradable graft having a thickness in the range of 30 μm to 100 μm. The biodegradable graft is provided on the outer surface of the biodegradable stent to yield a biodegradable endoprosthesis. The biodegradable endoprosthesis has a deployed diameter in the range of 4mm to 10mm. The biodegradable endoprosthesis is crimped over a balloon having crossing profile 1.6mm to 2.2mm to yield a crimped biodegradable endoprosthesis.
A bilaminated stent with biodegradable mesh and a method of manufacturing thereof is disclosed. The stent-mesh assembly includes a first layer of a polymer coated on the outer surface of the stent, a second layer of at least one drug coated on top of the first layer and a mesh made of a biodegradable material and provided on the outer surface of the stent. The first layer avoids peeling off or delamination of the second layer during mounting and/or knotting of the mesh over the stent.
A biodegradable peripheral scaffold and a method of manufacturing thereof is disclosed. The process includes extruding biodegradable polymer granules to form an extruded tube, deforming the extruded tube to form a deformed tube with high fracture toughness and enhanced strength. The deformed tube is laser cut to yield a scaffold followed by annealing the scaffold in vacuum conditions. The annealed scaffold is coated with a biodegradable polymer in order to impart flexibility to the scaffold.
A braided scaffold and method of manufacturing thereof is disclosed. A process for manufacturing a self-expanding bioresorbable braided scaffold with improved radial and axial flexibility is disclosed. The scaffold comprises a degradable monofilament with shape memory effect, the process includes braiding of the degradable monofilament on a mandrel to form a braided scaffold, subjecting the braided scaffold to two or more stages of heat treatment to stabilize and impart high strength to the braided scaffold, the two or more stages of heat treatment including a primary heat treatment stage and a secondary heat treatment stage, the secondary heat treatment stage melts the braided scaffold at one or more crossover points leading to fusion at the one or more crossover points and imparting high strength and axial flexibility to the braided scaffold.
A process for anti-calcification of a tissue is disclosed. The process comprises treating a tissue with a pre-heated solution of fixative agent, treating the tissue with a sterilant, quenching one or more times a tissue in the presence of buffer solution at a predefined temperature and predefined time duration to obtain a quenched tissue, washing of the quenched tissue in the presence of distilled water, reduction of the quenched tissue in the presence of one or more reducing agents to obtain a reduced tissue and washing the reduced tissue with an alcohol to yield an anti-calcified tissue.
A process for anti-calcification of a tissue is disclosed. The process comprises treating a tissue with a pre-heated solution of fixative agent, treating the tissue with a sterilant, masking the tissue with a solution of an alkylamine in phosphate buffer saline to yield a masked tissue, reducing the masked tissue with a solution of lithium aluminum hydride thereby yielding a reduced tissue and washing the reduced tissue with an alcohol to yield an anti-calcified tissue.
A process for anti-calcification of a tissue is disclosed. The process comprises treating a tissue with a pre-heated solution of fixative agent, treating the tissue with a sterilant, refluxing one or more times a tissue in a distillation apparatus in the presence of one or more refluxing agents at a predefined temperature and washing the reduced tissue with an alcohol to yield an anti-calcified tissue.
A bioabsorbable mesh-scaffold assembly is disclosed. The bioabsorbable mesh-scaffold assembly comprises a bioabsorbable scaffold having an outer surface to be implanted in a human arterial vasculature and an expandable bioabsorbable mesh mounted coaxially on the outer surface of the bioabsorbable scaffold. The expandable bioabsorbable mesh is made of a single monofilament. The monofilament is annealed after extrusion and prior to knitting. The extruded monofilament is annealed to increase the strength under vacuum in a range of 115° C to 125° C for a duration ranging from 60-120 minutes. The bioabsorbable mesh-scaffold assembly has a low crimp profile configured for insertion into the human arterial vasculature. The bioabsorbable mesh-scaffold assembly may have a low crimp profile in the range of 1.2 mm to 1.4mm.
An occluder is disclosed. The occluder includes a biodegradable frame and a locking system to lock the occluder at the site of treatment. The locking system comprises a suture and an anchor. One of the ends of the suture is attached to one of the ends of the biodegradable frame and other end of the suture passes through other end of the biodegradable occluder. The biodegradable frame is locked once the suture is pulled till the anchor mates with the other end of the biodegradable frame. The occluder is manufactured by braiding of one or more monofilaments made of biodegradable polymer to form a biodegradable frame. The biodegradable frame is annealed one or more time to form an annealed biodegradable occluder/ frame. The annealed biodegradable frame is welded at two ends and is coated with a layer of polymer on its external surface.
A61F 2/00 - Filters implantable into blood vesselsProstheses, i.e. artificial substitutes or replacements for parts of the bodyAppliances for connecting them with the bodyDevices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
72.
SCAFFOLD GRAFT AND METHOD OF MANUFACTURING THEREOF
A scaffold graft used for treatment of treatment of arterial perforations and/or condition of aneurysm. The scaffold may be made of a biodegradable material. The scaffold is coated with a biodegradable layer of polymer on an outer surface. The biodegradable scaffold is made of poly- L-lactic acid (PLLA). The biodegradable graft may be made of poly-L-lactide-co-caprolactone (PLCL), polycaprolactone (PCL), poly-dl-lactic acid, (PDLLA), polyglycerol sebacate (PGS), Poly L- lactide (PLLA), Poly(glycolic acid) (PGA), Poly L-lactide co-glycolic acid (PLGA) or a mixture thereof. Additionally, the scaffold graft is coated with an antiproliferative drug formulation.
A61F 2/88 - Stents in a form characterised by wire-like elementsStents in a form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
A prosthetic valve has fluoroscopic properties for precise placement of the prosthetic valve in a human stenosed aortic orifice. The prosthetic valve comprises a support frame having a distal and a proximal end, and three adjacently placed rows of hexagonal cells (namely an upper, middle and a lower row). The upper row occupies 50-55% of total length of the support frame. The support frame of the prosthetic valve under fluoroscopy comprises a plurality of light bands and dark bands alternating with each other along the length of the support frame. Further, a second dark band from the distal end of the support frame is bisected by aortic annular plane on placement in orthotopic position of a human stenosed aortic orifice. The prosthetic valve offers advantages such as minimal protrusion in left ventricle and minimal obstruction of prosthetic valve to ostia of coronary arteries.
A dilation instrument particularly a balloon sinuplasty catheter for the treatment of chronic sinusitis is disclosed. The balloon catheter of the present invention is a fixed assembly which is easy to construct and can be delivered to a patient in one go which avoids any injury to epithelial lining of the nasal tissue.
The present invention discloses a multi-stage process for yielding bioabsorbable stents with enhanced shelf life. The process includes annealing a scaffold obtained from the deformed tube, coating the annealed scaffold in low humidity environment, crimping the coated scaffold, packaging the scaffold and then sterilizing the crimped scaffold. The annealing includes heating the scaffold at 100-150° C in vacuum for 10-24 hrs, and cooling the heated scaffold in the presence of an inert gas for 3-6 hrs to ambient temperature to form an annealed scaffold. The annealed scaffold has molecular weight Mw range of 320000 g/mol to 410000, Mn between 190000-250000 g/mol and possesses narrow molecular weight distribution of poly dispersity index between 1.5 to 1.9. Each of the steps of the multi-stage process results in enhanced shelf-life of the bioabsorbable stents.
A conductive ink printed bipolar electrode assembly on the outer surface of an expandable member is disclosed. The bipolar electrode assembly includes one or more electrode and thermocouple traces printed on the outer surface of the expandable member in a pattern for example, spiral, vertical, etc. The bipolar electrodes and thermocouple traces are printed as parallel traces at a fixed distance from each other.
A61B 18/18 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
A prosthetic valve with fluoroscopic properties for precise placement of the prosthetic valve in a human stenosed aortic orifice is disclosed. The prosthetic valve comprises a support frame having a distal and a proximal end, and three adjacently placed rows of hexagonal cells (namely an upper, middle and a lower row). The upper row occupies 50-55% of total length of the support frame. The support frame of the prosthetic valve under fluoroscopy comprises a plurality of light bands and dark bands alternating with each other along the length of the support frame. Further, a second dark band from the distal end of the support frame is bisected by aortic annular plane on placement in orthotopic position of a human stenosed aortic orifice. The prosthetic valve offers advantages such as minimal protrusion in left ventricle and minimal obstruction of prosthetic valve to ostia of coronary arteries.
A vascular closure system Is configured to seal an incision in a vessel of the patient's body. The system includes a slider that is moved from an initial position to a deployed position (that is, towards the puncture of the patient body), until the proximal end of the slider exposes a reference marker on an inner tube. This confirms the deployment of the closure element and completely expands or opens or pivots the closure element in the blood vessel.
A vascular closure system is configured to seal an incision in a vessel of the patient's body. The system includes a slider that is moved from an initial position to a deployed position (that is, towards the puncture of the patient body), until the proximal end of the slider exposes a reference marker on an inner tube. This confirms the deployment of the closure element and completely expands or opens or pivots the closure element in the blood vessel.
A61B 17/00 - Surgical instruments, devices or methods
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
This invention discloses a process for preparation of a balloon expandable biodegradable polymer stent with thin struts (strut thickness 130 μm or less, preferably 100-110 μm) with high fatigue and radial strength. The invention discloses a process for the preparation of a biodegradable polymer stent which involves deforming an extruded biodegradable polymer tube axially at a first predefined temperature by applying an axial force for a first predefined time interval. The process further includes radially expanding the axially stretched tube at a second predefined temperature by pressurizing the tube with an inert gas in one or more stages, the pressure applied in each successive stage being higher than the pressure applied in a previous stage.
The invention discloses a process for the preparation of a biodegradable stent which involves deforming an extruded biodegradable polymer tube axially at a first predefined temperature by applying an axial force for a first predefined time interval. The process is followed by radially expanding the axially stretched tube at a second predefined temperature by pressurizing the tube with an inert gas in one or more stages, the pressure applied in each successive stage being higher than the pressure applied in a previous stage. The process further comprises laser cutting a specific pattern of scaffold structure on the expanded tube and then crimping the laser cut stent on the balloon of delivery catheter in a sterile environment in multiple stages.
A61L 31/16 - Biologically active materials, e.g. therapeutic substances
A61F 2/915 - Stents in a form characterised by wire-like elementsStents in a form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
This invention discloses a process for preparation of a balloon expandable biodegradable polymer stent with thin struts (strut thickness 130 μm or less, preferably 100-110 μm) with high fatigue and radial strength. The invention discloses a process for the preparation of a biodegradable polymer stent which involves radially deforming the biodegradable polymer tube by applying pressure to it with an inert gas at a predefined temperature in multiple stages with each successive stage having a pressure higher than the pressure applied in a previous stage. The process further involves maintaining the predefined temperature and pressure conditions of each stage for a specified time period after application of the pressure.
B29C 49/00 - Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mouldApparatus therefor
B29C 49/64 - Heating or cooling preforms, parisons or blown articles
A61L 31/06 - Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
A61F 2/915 - Stents in a form characterised by wire-like elementsStents in a form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
A61L 31/14 - Materials characterised by their function or physical properties
B29C 49/08 - Biaxial stretching during blow-moulding
A prosthetic heart valve having a plurality of leaflets formed from a single continuous tissue is disclosed. The leaflets made from a single continuous tissue are seated in a support frame having plurality of expandable cells. Semi-circular arcs of the leaflets are attached to a bottom row of the support frame while attachment nodes of rectangular cross-sections of the tissue are attached to commissures of the support frame. The tissue at the attachment nodes can be sutured to the support frame with leaflet sutures being positioned outside the support frame.
A61B 17/00 - Surgical instruments, devices or methods
A61F 2/00 - Filters implantable into blood vesselsProstheses, i.e. artificial substitutes or replacements for parts of the bodyAppliances for connecting them with the bodyDevices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
This invention discloses method of manufacture of balloon expandable stent made from bioabsorbable polymer with thin struts (strut thickness 130 μm or less, preferably 100-110 μm) with high fatigue and radial strength. The invention further discloses balloon expandable stent made from bioabsorbable polymer with thin struts (strut thickness 130 μm or less, preferably 100-110 μm) with high fatigue and radial strength.
A61L 31/06 - Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
A61L 31/14 - Materials characterised by their function or physical properties
A61F 2/915 - Stents in a form characterised by wire-like elementsStents in a form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
A61L 31/18 - Materials at least partially X-ray or laser opaque
B29C 49/18 - Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mouldApparatus therefor using several blowing steps
B29C 49/42 - Component parts, details or accessoriesAuxiliary operations
B29C 49/64 - Heating or cooling preforms, parisons or blown articles
B29C 55/22 - Shaping by stretching, e.g. drawing through a dieApparatus therefor of tubes
B29C 65/56 - Joining of preformed partsApparatus therefor using mechanical means
B29C 65/00 - Joining of preformed partsApparatus therefor
B05B 13/00 - Machines or plants for applying liquids or other fluent materials to surfaces of objects or other work by spraying, not covered by groups
B29K 667/00 - Use of polyesters for preformed parts, e.g. for inserts
The invention discloses a method for packing and sterilization of bioresorbable scaffold systems without affecting the scaffold characteristics. In accordance to the above objects, the present invention provides an effective method of packing and sterilizing the drug coated scaffold which does not affect the functional and structural characteristics of the scaffold. The present invention also provides a method of packing such that it does not affect the scaffold and the drug coated on scaffold, by maintaining an optimum level of oxygen between 0.01% - 3% and moisture level below 1100 ppm in the packaging system.
This invention discloses method of manufacture of balloon expandable stent made from bioabsorbable polymer with thin struts (strut thickness 130 μm or less, preferably 100- 110 μm) with high fatigue and radial strength. The invention further discloses balloon expandable stent made from bioabsorbable polymer with thin struts (strut thickness 130 μηι or less, preferably 100-110 μm) with high fatigue and radial strength.
