WO2019207593A1

WO2019207593A1 - A system to allow compression and alignment of tissue using balloons

Info

Publication number: WO2019207593A1
Application number: PCT/IN2019/050270
Authority: WO
Inventors: Pooja Kadambi; Vijayarajan ALAGUMALAI
Original assignee: Innaccel Technologies Pvt. Ltd
Priority date: 2018-04-27
Filing date: 2019-04-01
Publication date: 2019-10-31

Abstract

A system to allow compression and alignment of tissue using balloons. The balloon system of this invention is composed of medical balloons of a shape suited to the target tissue shape. The balloon system on inflation applies pressure to the target area resulting in tissue compression, retraction, restructuring and bleeding stoppage. Further this balloon system minimizes tissue trauma and is dynamic in that it maintains a firm grip over the target area despite shape changes that occur during the healing process; this is achieved by inflating or deflating the balloon as healing progress.

Description

TITLE OF THE INVENTION

A system to allow compression and alignment of tissue using balloons

PREAMBLE TO THE DESCRIPTION

The following specification particularly describes the invention and the manner in which it is to be performed:

FIELD OF THE INVENTION

The present invention relates to a balloon system composed of medical balloons of a shape suited to the target tissue shape. The balloon system on inflation applies pressure to the target area resulting in tissue compression, retraction, restructuring, bleeding stoppage etc. Further this balloon system minimizes tissue trauma and is dynamic in that it maintains a firm grip over the target area despite shape changes that occur in the target tissue during the healing process; this is achieved by inflating or deflating the balloon as healing progress.

BACKGROUND OF THE INVENTION

Expandable balloons are commonly used in the medical field, some examples of procedures are, in endoscopic or laparoscopic procedures for compression or opening of blocked passages, balloon endoscopy, angioplasty, urinary catheterization, while some examples of products are aortic balloon pumps, and bariatric balloons. Currently tissue compression, retraction, restructuring and bleeding stoppage is done, in most cases, by rigid metal instruments by themselves or with gauze packs or through applying heat/electricity for cauterization. Tissue trauma is a concern in most of these procedures. Further in the field of re-alignment or splinting of a fracture, one practice is to apply a hard cast on a body part at the time of injury or post a surgery. Often, at the time of placing the cast there is inflammation which on subsiding creates a space in between the body part and the cast. This space is undesirable as it compromises the casts grip and could resulting in incorrect setting of the bones.

BRIEF DESCRIPTION OF THE FIGURES

Figure 1A: An embodiment showing balloon on a tubular shaft with a connector manifold

Figure 1B: An embodiment having balloon on a scissor shaped device

Figure 2A: A hollow“cuff’ balloon for expansion of surrounding tissue or crushing a structure within the cuff Figure 2B: A“U” balloon splint with the instrument clip on the outside holding it in place to splint/ re-align tissue within it

Figure 2C: A“cone” balloon probe that allows retraction and expansion of tissue

DETAILED DESCRIPTION OF THE INVENTION

In the following detailed description reference is made to the accompanying drawings that form a part hereof, in which like reference numerals identify the same parts or elements between figures. These embodiments are described in sufficient detail to enable those skilled in the art to practice the invention and it is understood that other embodiments may be utilized and that logical structural, mechanical, electrical changes may be made without departing from the spirit or scope of the invention. To avoid detail not necessary to enable those skilled in the art to practice the embodiments described herein, the description may omit certain information known to those skilled in the art. The following detailed description is, therefore, not to be taken in a limiting sense and the scope of the illustrative embodiments are defined only by the appended claims.

In the context of this specification the term‘balloon’ refers to a single balloon or multiple balloons. The term‘fluid’ refers to liquid or gaseous medium. Further, when‘fluid’ is used in the context of an inflation medium it is to inflate the balloon of this invention. The term “balloon system” refers to the various embodiments described herein as well as devices that in spirit and scope fall within the claimed instant invention. The term‘proximal’ (P) refers to the part of the device outside the body closest to the operator while‘distal’ (D) refers to the part of the device that enters the body farthest away from the operator.

This invention envisions devices and methods that satisfy the earlier mentioned unmet needs with novel devices composed of specially shaped balloons. The instant invention is a balloon system with specialized, shaped inflatable balloons, used to compress tissue within and/or around them that aids in stopping bleeding through surface pressure application or radial pressure, reducing tissue size by compressing out fluid and air from soft tissue, reshape target area by applying pressure to correct anatomical deformity. This instant invention achieves tissue compression, retraction, restructuring and stoppage of bleeding with minimal trauma. It is designed such that it avoids causing trauma to inner layers of tissue due to penetrative injury or scratching. In another embodiment it is used as a long term in-dwelling system, the advantage in such a use is, as healing progresses there are changes in tissue shape which compromise tissue contact with the balloon, the dynamic nature of this system allows continuous firm grip over the target tissue by inflating and deflating the balloon system to conform to the new tissue shape. Another embodiment of this balloon system is its use as a splinting device for re alignment of fractured bones. As healing progresses, the dynamic nature of this system allows the balloon system to be inflated or deflated to conform to the changing shape of the splinted body part. Thus, as healing progresses this splint is adjusted to the altering shape of the body part ensuring that there is no gap between it and the body part.

According to one embodiment the balloon system of this invention is composed of one or more balloons of a shape suited to the target tissue shape having at least one channel for transport of an inflation fluid, which on inflation creates a zone of compression along the target tissue contact area and a tubular shaft having at least one lumen for transport of the inflation fluid. The tubular shaft has a distal end in communication with the balloon and a proximal end connected to a connector manifold. An inflation device is connected to the tubular shaft via a port on the connector manifold. This embodiment of the instant invention is a basic embodiment that functions as a stand-alone device or in another embodiment is combined with an optional instrument.

The balloon of the instant balloon system is uniquely shaped to provide better fit with the target tissue; the specialized balloon shapes being conical, cylindrical, cuff shaped, U-shaped, oval, tear drop and disk. The balloons are single layered or are constructed of more than one layer, said layers being compliant and/or semi-compliant or a combination of rigid and flexible materials like polyurethane (PU), Polyether block amides such as PEBAX, Polyamides (PA) such as Nylon and polyethylene (PE). The use of different materials in the balloon layers makes it possible to keep the size constant yet exert variable hardness and pressure on the target tissue while adjusting the inflation. For instance, semi-compliant balloons will not increase in size but will increase in hardness as pressure increases. Such dynamic change in applied force without surface trauma to tissue and need for excess force from the hands of the user is novel and has utility. In another embodiment the balloon has a further layer being drug coated or porous for administration of therapeutic agents. Drug coated or porous balloons are well known in the art, they function by having a hydrophilic coating to allow delivery or a porous layer that gradually permits passage of the fluid being pushed through it during or after inflation. The balloon is designed to allow residence in-site for an extended period. The balloon is designed according to dimension and pressure requirements to have at least one hollow channel present in the inflated state to allow through flow of inflation fluid. In another embodiment, the balloon further comprises additional channels for another fluid transport, for delivery or suction and/or for insertion of instruments. The balloon when inflated with an inflation fluid creates a zone of compression over the contact surface area i.e. the area of the target tissue in contact with the balloon surface. In the present invention the term fluid includes gases such as air, helium, nitrogen etc. or liquid medium such as saline, water etc. The inflation fluid is of any temperature and may contain therapeutic agents. In the art medical balloons are known to be inflated with saline, distilled water or air infused with the therapeutic agents/ drugs. To reiterate, an additional novelty of this invention is controlling the compressive force exerted over the zone of compression on the target tissue via balloon hardness achieved through inflation control.

The balloon of the instant balloon system is in communication with a single or multi-lumen tubular shaft connected to the balloon at its distal end and a connector manifold at its proximal end. The shaft allows for inflation of the balloon via the connector manifold. The connector manifold has at least one port to allow for inflation via inflation devices like syringe or pressurized endoflator. In another embodiment it has additional ports for insertion of instruments, another fluid transport and/or for suction or delivery. In another embodiment the connector manifold has ports to incorporate design features for single handed advancement and retraction. The tubular shaft core comprises one lumen for transport of inflation fluid. In another embodiment it has additional lumens for transport of other fluids, transport and/ or insertion of an instrument. The tubular shaft is single layered or multi-layered. The tubular shaft material is selected from PA, high density poly ethylene (HTPE), polyvinyl chloride (PVC), Nylon, PEBAX, PU, Acrylonitrile butadiene styrene (ABS), poly carbonate (PC), stainless steel (SS), Titanium, Nitinol or combinations thereof. In another embodiment the shaft is designed to have a layer of material to assist in smooth passage within the body or to provide flexibility.

According to another embodiment the balloon system of this invention is composed of one or more specialized balloons, a tubular shaft connected via a connector manifold to an inflation device and an optional instrument. The balloon system is mounted on the instrument which serves as a guide and placement tool for the balloon device; it may be inserted inside the balloon or connected to the outer surface of the balloon, capable of accessing the target location, inflating the balloon and maintaining target position/location for an extended period of time. The instrument accesses the balloon through the connector manifold on the tubular shaft. The optional instrument may be made of plastic, ABS, PC, metal, SS, titanium or copper. This balloon system can be connected to traditional instruments to allow targeted compression and space creation as well as reshaping with minimal trauma to the tissue it contacts. The type of instrument is not limited to, surgical instruments, drug delivery systems, viewing devices, light delivery systems, electrical delivery systems, ablation systems, scissors, angle probe, suction tube, guide seeker, ball probe, sinus seeker, trochars, probes, dilators, forceps, clips, cameras or combinations thereof.

Thus the present invention is an expandable balloon system that is composed of one or more novel inflatable specialized shaped balloons that are designed according to dimension and pressure requirements to have at least one hollow channel present in the expanded state to allow through flow of inflation fluid and a single or multi-lumen tubular shaft for inflation of the balloon with a single or multi-port connector manifold that allows for connection to devices such as inflation devices, other instruments, elements for single handed advancement and retraction. The afore device is a standalone device or is further combined with an instrument to serve as a guide and placement tool for the balloon device that may be on the inside or connect to the outer surface of the balloon capable of accessing the target location, inflating the balloon and maintaining target position/location for an extended period of time.

The instant devices and methods are to be directly applied to the target site to access and manipulate tissue in the target areas by retracting, pushing, compressing, reshaping or re-aligning with minimal trauma. A method of treating target tissue using the instant balloon system involves bringing the target tissue in contact with the specialized balloon system, inflating the balloon, creating the zone of compression along the tissue surface it is in contact with, resulting in restructuring of the target tissue with minimal trauma. The balloon inflation is adjusted to allow continued firm contact with the tissue as the target tissue resizes over a period of time. A method of re-aligning a fractured bone using the instant balloon system involves placing the target bone in between the specialized balloon. Inflation of the balloon creates the zone of compression around the bone immobilizing the fractured bone. The pressure is varied as healing progresses to provide continued firm contact on the bone fracture. Thus, the balloon is adjusted to conform to the structural changes as healing progresses. A method of crushing a target tissue using the instant balloon system wherein the target tissue is placed within the specialized balloon which on inflation will crush the tissue within with minimal trauma. A method of retracting target tissue using the instant balloon system wherein the specialized balloon is inserted in between the target tissue and the surface from which it is to be retracted, and then the balloon is inflated to push the tissue away from the surface from which it is to be retracted.

The figures are illustrative of the invention but not limitative of the scope thereof. The figures show balloon systems using oval balloon, cuff shaped balloon, U shaped balloon and conical balloon. A basic embodiment of the balloon system of the invention is shown in Figure 1A and the said system comprising an instrument is shown in Figure 1B. The balloon systems illustrated in Figure 2 may have corresponding elements designed for each balloon shape type, and this will become apparent in the drawings and the detailed description that follow. The basic device however is composed of the specialized shaped balloon in communication with the tubular shaft connected to an inflation device which may optionally be further combined with other specific instruments.

The embodiment of the instant invention described in Figure 1A is composed of a balloon (2) a tubular shaft (3) that allows inflation (3 A) as well as in some cases instrument attachment and or passage of fluid through the system (3B). The fluid enters the system through the connector manifold (4) that has at least one port (4A) that is connected to an appropriate inflation device (not shown). There could be more than one port in the manifold (4B) corresponding to other channels or lumens in the balloon or tubular shaft (3). The distal end (D) has the zone of compression (5) located between the balloon (2). The balloon may on the tip (6) of the instrument (1) not shown in in this figure through a dedicated attachment channel or may be fused onto the instrument in cases where the system is completely disposable. The target tissue will be kept between the compression zone (5) to allow the balloon to be inflated to the appropriate size and pressure. Pressure and thus hardness of the balloon can be adjusted through inflation control depending on the therapy required. For instance, a lOatm pressure balloon of 6mm diameter will not increase in diameter but become harder as pressure increases from 2atm. This is useful in fracturing small bones. A foley balloon can be inflated to lOml volume growing from 3mm in diameter to 40mm in diameter as the volume increase. This does not increase pressure and remains soft but changes the space occupied. Thus shape, size, dimension, material and performance characteristics of the system will vary based on applications. The instrument may be disposable or reusable, flexible or rigid based on the application. This embodiment allows tissues like blood vessels, cartilage like the septum, boney structures like turbinates and soft tissue like skin to be gripped post inflation to minimize trauma to the tissue. The embodiment of Figure 1B shows the balloon system shown in figure 1 A mounted on an instrument ( 1), in this case forceps like instrument made of metal or plastic. It is composed of an instrument (1) being an artery forceps or having a scissor like mechanism and handle on the proximal end (P). There is a balloon (2) attached to the distal end of the instrument (D) with a tubular shaft (3) that allows inflation as well as in some cases instrument attachment and passage of fluid into the balloon (2). The fluid enters the system through the inflation port in the connector manifold (4) connected to an appropriate inflation device (not shown). The distal end (D) has the zone of compression (5) located between the balloon (2). The balloon sits on the tip (6) of the instrument through a dedicated attachment channel or may be fused onto the instrument in cases where the system is completely disposable. The target tissue will be kept between the compression zone (5) to allow the balloon to be inflated to the appropriate size and pressure. Pressure and thus hardness of the balloon can be adjusted through inflation control depending on what is desired. The shape, size, dimension, material and performance characteristics of the system will vary based on applications. The instrument may be disposable or reusable, flexible or rigid based on the application. This embodiment allows tissues like blood vessels, cartilage like the septum, honey structures like turbinates and soft tissue like skin to be gripped post inflation to minimize trauma to the tissue.

Another embodiment of the invention is shown in Figure 2A, it describes the“Cuff’ balloon embodiment where the instrument (1) is an elongated angled probe/suction tube over which a hollow cylindrical balloon (2) is connected. The inflated balloon (2) applies pressure along the outer surface (7) or inner channel (8). Thus, the compression zone (5) is dual and radial. This hollow“cuff’ balloon can be used for expansion of surrounding tissue or crushing a structure within the cuff. Another application for this is in laparoscopic surgery to serve as a cushion or substitute for the trochar port that allows scopes and instruments into the abdomen without causing irritation or damage to the tissue surrounding the balloon. If a compliant balloon is used in combination with a semi-compliant layer the trochar port size itself (8) can be varied to allow a tight fit thus not requiring multiple port sizes.

Another embodiment of this invention is shown in Figure 2B; the“U” balloon embodiment where the instrument is a clip with a tightening screw (9) that holds the balloon in place by connecting to the outer surface to re-align the tissue within it. The zone of compression (5) is along the outside and inside of the U shape of the balloon. The following example is used to better describe the mode of action of this invention without limiting it to the nasal septum. An example of the invention used to correct a deviated nasal septum is described, however it is not limited to the nasal septum where the compression is used to straighten the cartilage and/or bone and/or splint. The septum would be placed in the inner zone (10) of the U balloon and the instrument (1) tightened with the screw (9) to apply additional force and hold balloon (2) in place post inflation. This embodiment is suitable for correction of the nasal septum post-surgery where the compression will ensure it heals straight and the system will prevent adhesions to surrounding tissue, thus improving healing.

Another embodiment of the invention is described in Figure 2C where the instrument (1) a thin guide seeker or ball probe has a conical shaped balloon (2) connected to its tip (6). This allows force to be applied along the outer cone area in the compression zone (5). Thus, this embodiment is used as a dilator to expand openings or ports, or as a retractor to hold back or push away tissue. A sinus seeker is an example of a device where this balloon at the tip is used to expand blocked openings. Retracting tissue or isolating delicate vessels or nerves could use a device similar to this to minimize trauma to the tissue and move it with inflation control.

Another embodiment is incorporating ablation or thermal systems into the above embodiments. Also envisioned are embodiments of the balloon system with multiple lumens and balloons as part of the same system, balloon system with porous surface for drug or fluid delivery and the instrument containing electrical components to deliver light or ablation. Also envisioned is compatible instrumentation that can deliver electrical, light and heat energy to the target site through, with or around the balloon.

Another embodiment of the balloon systems is incorporating viewing devices such as cameras into the instrument.

Another embodiment of the invention is balloon shapes including but not limited to tear drop, disk, and oval shaped. Yet another embodiment of the balloon system is with multiple balloons arranged on the instrument that have independent inflation and deflation ports.

This invention has applications in but not limited to stopping bleeding through compression, reducing the size of soft tissue, retracting tissue and serving as a splint for shape correction. This has broad clinical applications not limited to ENT, orthopedics and surgery. The device can be used in specific anatomical locations not limited to the nose, throat, colon, abdomen, brain and heart.

Claims

We Claim:

1. An inflatable balloon system for treating target tissue with minimal

trauma, comprising:

i. at least one balloon of a shape suited to the target tissue shape having at least one channel for transport of an inflation fluid, which on inflation creates a zone of compression along the target tissue contact area;

ii. a tubular shaft having at least one lumen for transport of the

inflation fluid, a distal end in communication with the balloon and a proximal end connected to a connector manifold; and iii. an inflation device connected to the tubular shaft via a port on the connector manifold, said balloon system is inflated or deflated to conform to the changing tissue shape ensuring continued firm grip of the target tissue as healing progresses.

2. The balloon system as claimed in claim 1, wherein a further instrument is in communication with the balloon via a dedicated lumen in the tubular shaft and a port on the connector manifold, for accessing target tissue and maintaining target position.

3. The balloon system as claimed in claim 1, wherein the balloon is

constructed to have more than one layer, said layers being compliant, semi-compliant, drug coated, porous or combinations thereof.

4. The balloon system as claimed in claim 2, wherein the balloon comprises at least one other channel for insertion of another instrument.

5. The balloon system as claimed in claims 1, 2 and 4, wherein the balloon comprises at least one other channel for transport of other fluids.

6. The balloon system as claimed in claim 1, wherein the balloon has the shape selected from the group consisting of, conical, cylindrical, cuff shaped, U-shape, oval, tear drop and disk.

7. The balloon system as claimed in claim 1, wherein the inflation fluid is liquid or gaseous.

8. The balloon system as claimed in claims 1 and 7, wherein the inflation fluid contains therapeutic agents administered at variable temperatures.

9. The balloon system as claimed in claim 1, wherein the balloon maintains its size on adjusting the inflation yet exerts variable hardness and pressure on the target tissue.

10. The balloon system as claimed in claim 1, wherein the balloon is

composed of a material selected from the group consisting of polyurethane, polyamides, polyethylene and combinations thereof.

11. The balloon system as claimed in claim 2, wherein the tubular shaft core comprises at least one other lumen for insertion of another instrument.

12. The balloon system as claimed in claims 1, 2 and 11, wherein the tubular shaft core comprises at least one other lumen for transport of other fluids.

13. The balloon system as claimed in claim 1, wherein the tubular shaft comprises at least one layer which surrounds the core to assist in smooth passage of the balloon system within the body or to provide flexibility.

14. The balloon system as claimed in claim 1, wherein the tubular shaft is composed of polyamide, high density poly-ethylene, polyvinyl chloride, Nylon, acrylonitrile butadiene styrene, poly carbonate, stainless steel Titanium, Nitinol or combinations thereof.

15. The balloon system as claimed in claim 2, wherein the connector manifold has at least one other port for insertion of another instrument.

16. The balloon system as claimed in claims 1, 2 and 15, wherein the

connector manifold has at least one other port for transport of other fluids.

17. The balloon system as claimed in claim 1, wherein the inflation device is a syringe or a pressurized endoflator.

18. The balloon system as claimed in claims 2, 4, 11 and 15, wherein the instrument is selected from the group comprising surgical instruments, drug delivery systems, viewing devices, light delivery systems, electrical delivery systems, ablation systems, scissors, angle probe, suction tube, guide seeker, ball probe, sinus seeker, trochars, probes, dilators, forceps, clips, cameras and combinations thereof.

19. The balloon system as claimed in claim 18, wherein the instrument

material is selected from the group consisting of copper, stainless steel, titanium, acrylonitrile butadiene styrene, poly carbonate and combinations thereof.

20. A method of treating abnormal target tissue using a balloon system,

comprising:

i. at least one balloon of a shape suited to the target tissue shape having at least one channel for transport of an inflation fluid, which on inflation creates a zone of compression along the target tissue contact area; ii. a tubular shaft having at least one lumen for transport of the inflation fluid, a distal end in communication with the balloon and a proximal end connected to a connector manifold; and

iii. an inflation device connected to the tubular shaft via a port on the connector manifold,

comprising bringing the target tissue in contact with the balloon, inflating the balloon to create a zone of compression along the tissue surface it is in contact with for restructuring of the target tissue, and adjusting the balloon inflation to allow continued firm contact with the tissue as the target tissue resizes over a period of time.

21. A method of re-aligning a fractured bone using a balloon system,

comprising:

ii. a tubular shaft having at least one lumen for transport of the inflation fluid, a distal end in communication with the balloon and a proximal end connected to a connector manifold; and

comprising placing the fractured bone in between the balloon, inflating the balloon to create a zone of compression around the bone immobilizing the fractured bone, and over a period of time as healing progresses adjusting the balloon inflation to conform the balloon to the changing shape of the fractured bone.