US 7018392 B2
Bleeding is controlled on an inner surface of a body cavity by inserting into the cavity an expandable balloon which is covered by a hemostatic shroud, expanding the balloon, and compressing the shroud against the site of bleeding. The balloon may be disposed around a central tube to supply inflation medium. The tip of the device is soft to aid with insertion. The invention includes the corresponding devices and systems for such control of bleeding within a body cavity or passageway, as well as a method of making the devices.
1. A device for controlling bleeding on an inner wall of a body cavity or passageway comprising:
an insertable shaft having a distal end, said shaft comprised of a hemostatic shroud disposed around an inner component, said inner component having a distal end, said shaft having a soft tip on said distal end of said shaft,
and said shroud disposed around said shaft and extending beyond both the distal end of said inner component and the distal end of said shaft.
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14. A device for controlling bleeding on an inner wall of a body cavity or passageway comprising:
an insertable shaft having a distal end, said shaft comprised of a hemostatic shroud disposed around an inner component, said inner component having a distal end and a balloon, said shaft having a soft tip on said distal end of said shaft,
and said shroud disposed around said shaft and extending beyond both the distal end of said inner component and the distal end of said shaft.
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This application is a continuation-in-part of U.S. patent application Ser. No. 09/927,864 filed Aug. 10, 2001 now U.S. Pat. No. 6,706,051, which in turn is a continuation-in-part of U.S. patent application Ser. No. 09/406,166 filed Sep. 27, 1999 now U.S. Pat. No. 6,306,154, which in turn is a continuation-in-part of U.S. patent application Ser. No. 09/057,414, filed on Apr. 8, 1998 now abandoned.
This invention relates generally to medical devices and methods of use, and more specifically, to materials, apparatus, and methods for facilitating hemostasis within a body cavity or passageway.
Nasal passageways, for example, are often susceptible to uncontrolled bleeding caused by various forms of trauma, disease or cellular dysfunction. Methods and devices for controlling, limiting or stopping such bleeding would be useful in a variety of situations, ranging from emergency room care to long term care.
Bleeding is typical after nasal related surgeries or procedures, and epistaxis related to a patient's nasal passageway can be difficult to control. Hemostatic agents, such as carboxymethyl cellulose (CMC) and woven knit or matted fabrics thereof, are known for use in the control of bleeding, such as post-trauma and post-surgical bleeding. CMC is defined as a polycarboxylmethyl ether of cellulose or the sodium salt thereof. It is sometimes referred to as cellulose ether, carboxymethylcellulose, or sodium caramellose. Insertion, application, and subsequent removal of these materials, however, can be difficult in small body passageways, such as nasal cavities.
The present invention comprises methods and devices for the control of bleeding from an inner wall of a body passageway or cavity. Briefly, the invention comprises an inflatable, expandable balloon, usually covered by a hemostatic shroud, which is inserted into a body cavity, such as a nasal passageway. The shroud is composed of a hemostatic agent; that is, the shroud acts to facilitate or enhance blood clot formation. The balloon component of the present invention is expanded, or inflated, within the cavity in order to press the shroud against the site of bleeding, thereby allowing it to absorb blood and facilitate hemostasis. In specific embodiments, the shroud is composed of a woven or knitted fabric of a hemostatic fiber (such as carboxymethylcellulose) or a reinforced hemostatic fiber. Optionally, this shroud may include an “extension” or “tail” fiber, which upon balloon deflation and removal, facilitates the later removal of the shroud which has been intentionally left in vivo.
The device construction, particularly the balloon construction, may vary according to the particular body cavity. Although a range of different materials can be used for any of the embodiments, there are particular materials which work better than others, depending upon the particular application. For a nasal application, one embodiment includes an inflatable balloon made from a relatively inelastic material.
A particular embodiment of the invention comprises a device for insertion of a shrouded balloon into a nasal passageway by a catheter configured such that the balloon encircles the catheter tube. The lumen of the catheter tube thereby serves as a passageway for breathing. The inflated balloon compresses the shroud against the bleeding nasal wall, thereby facilitating or enhancing hemostasis. The balloon is deflatable such that, upon balloon deflation, the shroud may be left in place on the cavity wall and may be removed at a later time, such as by an attached extension on the shroud.
In another embodiment, there is no central lumen. This gives the catheter a much smaller overall diameter. In patients with small nasal cavities, the lack of the breathing passageway is more than compensated for by the small profile which is far less traumatic and painful during insertion.
The shroud used in the present invention may comprise a woven or knitted fabric combining hemostatic (e.g., carboxymethylcellulose (CMC)) fibers with reinforcing fibers. Alternatively, the shroud may be just a hemostatic agent disposed on the balloon in a film-like covering.
For a better understanding of the present invention, reference may be made to the detailed description which follows, taken in conjunction with the drawings, in which:
The present invention comprises systems, devices, and methods for the control of bleeding in body cavities, such as nasal passageways. Generally, the terms “cavity” and “passageway” may include any bodily cavity, recess, passageway, etc., other than a blood vessel or other component of the vasculature system, and it encompasses those which are healthy and normal as well as those which are abnormal and/or pathological (meaning, diseased or unhealthy).
The term “hemostatic” agent (or material) refers to any agent or material that is capable of arresting, stemming, or preventing bleeding by means other than inducing tissue growth alone. In other words, something other than tissue growth is at least partially responsible for retarding or preventing bleeding. Preferably, the agent or material will be one that enhances blot clot formation. It will, of course, be appreciated that the agent or material may have the beneficial property of inducing tissue growth in addition to retarding or preventing bleeding. Examples of preferred hemostatic agents which enhance blood coagulation include carboxymethylcellulose (CMC), oxidized cellulose, calcium alginate, gelatine, or collagen. CMC can be purchased from Acordis Special Fibres, PO Box 111, 101 Lockhurst Land, Coventry, England, CV6 5RS. Oxidized cellulose such as Tabotamp™, which is sold by Johnson & Johnson, New Brunswick, N.J., U.S.A., is another example of a hemostatic agent. Combinations of different hemostatic agents or materials may be used within the scope of the invention.
The hemostatic agent may be a part of an expansible shroud or may make up the shroud itself. In this later case, the hemostatic agent is either a film or fabric comprised of the hemostatic agent. In the former case, the hemostatic agent is combined with another material, such as a reinforcing fiber material. Typically, the hemostatic agent-containing shroud covers an expansible device such as a balloon. The shroud may be in the form of an expandable tube or in the form of an expandable sheet. In specific embodiments disclosed, the preferred hemostatic agent is a fibrous CMC, which is hemostatic and so will cause blood to clot while at the same time absorbing any exudate. A fabric of CMC fiber is preferred because, aside from its hemostatic properties, it swells and forms a gel, absorbing many times its own weight in fluid when it contacts water (or blood or exudate). Because the CMC material is so hygroscopic, it does not dry into the clotted blood, and therefore can be removed easily without tearing the clot and causing re-bleeding.
Other hemostatic agents which may be used should have absorptive and hemostatic properties similar to those of CMC. In one embodiment, the hemostatic agent fibers are woven or knitted together with reinforcing fibers, such as continuous multifilament polyester or nylon. Such a knitted fabric is illustrated in
Examples of some other hemostatic materials include oxidized cellulose, which is conventionally used in knitted form as a hemostatic agent during surgery, and calcium alginate, which is a textile fiber derived from seaweed and is also commonly used as a wound dressing. Furthermore, there are other polysaccharides which are available with similar chemistry and properties to CMC. For purposes of the present invention, the essential properties of the hemostatic material are the ability to absorb large quantities of liquid without becoming enmeshed in the clotted blood. The material must be non-toxic and biocompatible.
Preferably, the shroud is provided in the form of a woven or knitted, especially a weft knitted, textile fabric in which is incorporated the hemostatic material, and which envelops the balloon. The woven or knitted textile material may be permanently or releasably fixed to the balloon.
In some embodiments, particularly those used in nasal applications, the balloon will be made of a relatively inelastic material, such as polyurethane or PVC. Alternatively, for other uses and embodiments, the balloon can be made from an elastomeric material, such as a thin silicone polymer. These balloons can be made by methods known to those skilled in the art, such as by dip molding. As noted above, it is generally desired in nasal applications that the balloon have a fixed volume and be made of an inelastic material. In such a case, the balloon is effectively a bag that can be filled or emptied with an inflation medium. A fixed volume, inflatable, inelastic balloon does not require the inflating medium to first stretch the elastic material of the balloon (as would be the case where the balloon is made from an elastomeric material). All inflation medium pressure is used to fill the cavity. This is essential when the device is used with a pilot balloon to give a tactile feedback of the pressure inside the catheter balloon. With an inelastic, fixed volume balloon, the tactile feedback is truly representative of the pressure applied to the inner surface of the nasal cavity.
For particular non-nasal applications, an elastic material such as silicone rubber can be used for the balloon. Such a balloon may be inflated with a liquid medium such as water or saline solution and the volume controlled by monitoring the volume of fluid inserted. Silicone rubber has the property of being permeable to air but not to water or saline solution.
One specific embodiment of the present invention which is designed for insertion within a nasal passageway is depicted in
In a specific exemplary embodiment, central tube 41 has an approximate outside diameter of 10 mm, and an inside diameter of 4–5 mm. The active length is typically between 40 and 100 mm, although shorter or longer lengths may be required for special applications. One end of catheter 46 may have a reduction in the outer diameter in order to provide a shoulder 40. This shoulder is used to locate and maintain the position of an outer hemostatic shroud, (seen in
In service, balloon 48 is inflated by filling material, typically compressed air, from a syringe in communication with valve 43 and the inflation lumen 42 which terminates in port 52 at the inner surface of balloon 48 between the ends of the balloon which are adhered at tube surface areas 49.
One use of the hemostatic nasal device of
Where the gelled fabric alone has been left in situ, the fabric may be removed at any later time by means of the withdrawal string or “tail” 47. Since the hygroscopic nature of the hemostatic fabric prevents the material from sticking to the clotted blood, removal is simple and with minimal chance of restarting the bleeding process.
In an alternative embodiment, the outer surface of the balloon itself is coated with an agent that facilitates blood coagulation. In such an embodiment, the shroud does not comprise a fabric of any kind, but is the hemostatic agent itself, provided in the form of a flexible film that coats the outer surface of the balloon. Examples of coating material include gelatin and collagen, but the invention is not limited to these. Such an embodiment is shown in
Pilot Balloon Tactile Pressure Indicator
In another embodiment, the device of this invention may include a tactile pressure-indicating pilot balloon in fluid communication with the balloon by which pressure is exerted on the hemostatic shroud. In such an embodiment, both the shroud compressing balloon and the pilot balloon are expandable. Preferably, both balloons are inflatable but made of a non-stretchable material. In this embodiment, the “balloons” are really more like bags or plastic sacks which receive an inflation medium such as air. Once the balloon is fully inflated, its volume no longer changes because the material of which it is made does not stretch. In use the balloon will typically not be inflated to its maximum volume because the cavity into which the balloon is inflated will preferably be smaller than the theoretical maximum volume of the balloon. This is because the maximum volume and dimensions of the balloon are typically chosen to be larger than the cavity in order that the balloon always has the capacity to fill the cavity. In this way, the hemostatic shroud, which surrounds the balloon, is pressed against the complete inner surface of the cavity.
Such a pilot balloon may be disposed at the end of the inflation tube opposite the inflatable balloon of a nasal device as shown in
In order for the tactile pressure sensing pilot balloon to give a more accurate indication of the pressure inside the nasal cavity, it is preferred that the first inflatable balloon (catheter balloon) be non-stretchable. In accordance with this aspect of the invention, the balloon is made of a relatively inelastic material (such as polyurethane or PVC) in order to have the ability of completely filling a cavity without any energy being used to stretch the wall of the balloon. In such a case, the balloon is effectively a bag that can be filled or emptied with an inflation medium. The inflatable, non-stretchable balloon does not require the inflating medium to first stretch the elastic material of the balloon (as would be the case where the balloon is made from an elastomeric material). This is preferred when the device is used with a pilot balloon to give a tactile feedback of the pressure inside the catheter balloon. With a non-stretchable balloon, the tactile feedback is more representative of the pressure applied to the inner surface of the nasal cavity.
In one embodiment, the pilot balloon as illustrated in
In its nasal embodiments, the method comprises the steps of inserting into a nasal cavity a first inflatable balloon surrounded at least in part by a hemostatic shroud comprising a gel-forming absorbent composition. The inflatable balloon is then expanded which compresses the shroud against the inner surface of the cavity where bleeding is to be controlled. Where the device includes a pilot balloon, the pressure inside the inflatable balloon is monitored, during expansion of the inflatable balloon and shroud, by touching the pressure-indicating pilot balloon which is in fluid communication with the first inflatable balloon.
When it is desired to use the present invention in a narrow body cavity, such as in a nasal application, several embodiments are particularly advantageous. One such embodiment includes a soft tip to allow easier insertion into the nasal cavity as compared to a device not having a soft tip. The soft tip allows for less damage and irritation to the wall of the nasal cavity during insertion, particularly where the cavity does not exhibit smooth or straight walls. For this purpose, a soft tip can be formed on the distal end of a shaft which is configured to be inserted into a particular body cavity.
In one such soft-tip embodiment, shown in
During manufacture of this embodiment, a cylindrical piece of fabric 232 is slipped over central tube 230 and clamp ring 234 is slid over fabric 232 and part way on to central tube 230. Then, fabric 232 is folded back, and inverted, around tube 230 to create a double layer of fabric along tube 230. After fabric 232 is folded, a folded section 236 is created. This folded region 236, draped over the very soft flexible clamp ring 234, forms a soft tip which reduces trauma as the device is inserted into a body passageway.
In one embodiment, glue can be used to set clamp ring 234 into place. The glue would be placed between fabric 232 and tube 230 where the clamp ring overlaps tube 230. A preferred glue is a cyanoacrylate based glue, a more preferred glue being Loctite 4011. Loctite is a registered trademark of Loctite Corporation.
A second way to achieve the soft tip of the invention is used on the version which does not include a central airway or breathing tube. This involves rolling the balloon around the central tube or rolling the balloon around itself underneath the fabric (See
Film welding techniques (including radio frequency welding) are well known to those skilled in the art and are used in a variety of larger products such as blood bags, intravenous (IV) drug bags, pouches for card or badge protection, etc. Generally, the thinner the material, the better, so long as adequate strength is insured. The preferred thickness for the balloon thin film material is between 0.03 mm and 0.15 mm. The combination of this very thin walled balloon along with a thin inflation tube and thin fabric allows for a very small diameter device. The smaller the diameter, the easier the device can be inserted into a nasal passageway.
The balloon rolling does not have to be rolled around a central tube. As described above, no central tube is present in some embodiments. In such a case, the fabric would be disposed around a rolled balloon where the balloon is simply rolled up on itself. An example of this later embodiment is shown in
Twisted Fabric Construction
In another embodiment, the shroud is attached to the inflation lumen at only the proximal end of the device, as shown in
The present invention also includes a method for manufacture of a device as represented in
The method first requires the placement of shroud 232 over the balloon 240 and central tube 230, as shown in
Glue could also be used with this embodiment. During the step of placing clamp ring 257, a small amount of glue could be injected under the clamp ring at two spots, one each at 180° from the other around the circumference of the inflation tube where clamp ring 257 will be secured. Because the fabric is meshed, in the preferred embodiment, the glue will contact the fabric, the inflation tube, and the inside of the clamp ring, binding all three components together.
This method can also be used to place fabric around a device which has no central inflation lumen, but which has only an inflation balloon attached to the distal end of the inflation tube. Such an embodiment is shown in
In some embodiments of the invention, particularly those not including a breathing lumen, there is a risk that upon deflation, the balloon and/or surrounding fabric will be sucked into the passageway by which inflation medium passes from the central tube into the balloon. This is illustrated in
To prevent this potential problem, a hole may be formed in the central tube wall as shown in
To allow delivery of inflation medium to balloon 302, a hole 304 is provided along inflation lumen 300. The hole could be formed from a number of different techniques. A preferred method of making the hole in this embodiment includes the use of a punch. The punch is a metal tube, with one end sharpened like a circular knife, which is inserted into the side of breathing tube 301 only far enough to create the hole 304. The use of a punch, instead of a conventionally drilled hole, helps insure that a conventional drill does not continue into the breathing passageway and open a hole there during manufacture of the device.
An additional advantage to using the punch, instead of a conventional drill, is that, unlike a conventional drill, the punch cuts a clean hole and does not create loose material or shavings which could be difficult to remove from the device and could cause a contamination hazard during later use of the device. By using the punch, the punched material is removed within the shaft of the punch and discarded.
The foregoing comprises a description of certain exemplary embodiments of the present invention. The invention is not limited to these embodiments, however, and the subjoined claims are intended to be construed to encompass all embodiments of this invention, and equivalents and variants thereof, which may be made by those skilled in the art without departing from the true spirit and scope of the essential concepts disclosed and claimed herein.