Abstract:
A linear delivery system and method for deployment of a detachable balloon at a target site in a patient in vivo is disclosed. The system includes a unitary sheath assembly having a retractable shaft and base, and a balloon delivery device configured for insertion through the lumen of the sheath assembly. The linear method of delivery overcomes disadvantages and limitations caused by undesirable movement of the assembly or separation of the catheter from the delivery system during inflation of the balloon. The linear delivery system further includes properties that increase the ease of use and stability of the device so as to reduce the effort required by the physician and discomfort experienced by the patient during deployment of a detachable balloon.

Description:
FIELD OF THE INVENTION 
   The present invention relates generally to a system for deployment of a detachable balloon in medical procedures. The present invention particularly relates to a linear delivery system for deployment of detachable, inflatable balloons in medical procedures involving blood vessels, body cavities, treatment of urinary incontinence, and the like. 
   BACKGROUND OF THE INVENTION 
   Detachable balloons are used for a wide variety of medical procedures where occlusion of a vessel or duct, or compression at a target tissue site is desired. One specific example is in the treatment of urinary incontinence. In patients suffering from this condition, detachable balloons have been used to successfully treat the bladder sphincter deficiency. One or more detachable balloons are implanted into the tissue adjacent to the neck of the bladder of a patient. The inflated balloons aid in the ability of the bladder sphincter muscles to occlude, which improves or resolves the condition. This method of treatment is preferred as it is minimally-invasive, safe and less traumatic to the patient. As such, various systems have been developed for the delivery of balloon catheters to a desired target site. See, for example, U.S. Pat. No. 5,411,475; U.S. Pat. No. 4,802,479; and U.S. Pat. No. 4,686,962. 
   Haber et al., U.S. Pat. No. 4,832,680 describe an apparatus and a non-surgical method for treatment of urinary incontinence. The method entails use of a hypodermic needle to implant a balloon in the tissue adjacent to the urethra. Specialized instrumentation is required to aid in positioning the balloon and protecting the balloon during insertion into the patient&#39;s tissue. A particular disadvantage in this system is that it is cumbersome and difficult to maneuver and requires complicated instrumentation for protection of the balloon during delivery. As a result, more simple and effective balloon delivery systems have been developed. 
   An example of such a device may be found in U.S. Pat. No. 5,830,228, which describe a system for delivering a detachable, inflatable balloon at a target site. The system includes a holder, a protective sheath configured for insertion through the holder and a hub at the proximal end of the sheath; a delivery device for carrying a balloon; and a retractor located on the delivery device for withdrawing the sheath. The retractor includes a head which withdraws the hub of the sheath by movement of the head. Use of the system requires insertion of the protective sheath through the holder and retraction of the sheath by rotating the head of the retractor which is located on the delivery device. Internal threads within the head aid in withdrawing the sheath by engaging in external threads on the hub of the sheath. 
   The above-described delivery systems (and other similar devices not specifically described) offer advantages, including effectiveness and safety to both the user and the patient. However, it has been discovered that an obstacle or disadvantage to such devices is the requirement for specialized instrumentation or that their use is complicated. Additionally, even with the more simple delivery system, the susceptibility of separation of certain component parts, such as the catheter and/or the positioning element, from the delivery system during use in the patient result in major limitations to the reliability of the system. Further, the motion required for retraction of the sheath to expose the balloon is a difficult and more cumbersome motion to perform. Yet still further, the rotational movement necessary to remove the needle (or positioning element) is likely to cause undesirable tissue trauma. 
   In view of the above, it is apparent that there is a need to provide a delivery system with a more reliable and stable delivery of inflatable, detachable balloons. There is also a need to provide a delivery system that is efficient, simpler to use for the physician and easy to implement. A reliable and efficient delivery system would reduce the overall procedure time required and therefore reduce patient discomfort. Such delivery systems include properties that reduce the amount of effort required by the physician prior to and during use of the system as well as properties that ensure the system remain intact during insertion into the target tissue and during inflation of the balloon. 
   OBJECTS AND SUMMARY OF THE INVENTION 
   In view of the foregoing, it is an object of the present invention to provide a balloon delivery device that addresses the limitations and disadvantages associated with prior delivery devices, yet meets the needs of the users. 
   A further object of the invention is to provide a linear delivery system that is efficient, requires minimal effort by the user, is easy to assemble and disassemble, and that is reliable. 
   Still another object of the invention is to provide a linear delivery system that minimally obstructs the surgeon&#39;s view of the target site. 
   A further object of the invention is to provide a linear delivery system having flexible guide tabs which prevent separation of the catheter or positioning element from the delivery system during use. 
   A further object of the invention is to provide a linear delivery system configured so that retraction of the shaft is maintained along a longitudinal axis and is accomplished by a single motion. 
   A further object of the invention is to provide a linear delivery system that has a single-unit sheath assembly. 
   In one aspect of the invention, a linear delivery system for deploying a detachable, inflatable balloon to a target site in a patient is disclosed. The system can include a unitary sheath assembly having a retractable shaft portion and a base portion. The retractable shaft portion can have an inner lumen that is between a proximal and a distal end of the retractable shaft. The base portion of the unitary sheath assembly has a lumen that is between a first and second end of the base portion. The proximal end of the shaft portion can be moveably coupled to the second end of the base portion. A retraction tab that is moveable can be located between the first and second ends of the base portion and coupled to the shaft portion of the unitary sheath assembly. The shaft portion of the unitary sheath can be withdrawn toward the first end of the base portion upon movement of the switch. A linear delivery system can also have a balloon delivery device configured for insertion through the lumen of the sheath assembly; the delivery device having a catheter, a hub and a guide tab coupled to the hub. 
   An additional object of the invention is to provide a method of deploying a detachable, inflatable balloon at a target site in a patient in vivo using a linear delivery system. 
   These and other objects not specifically enumerated herein are believed to be addressed by the present invention which contemplates a linear delivery system for deploying a detachable, inflatable balloon that includes a unitary sheath assembly having a retractable shaft and base portion and a balloon delivery device. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
       FIG. 1  is an exploded side view of a preferred embodiment of the present invention including a unitary sheath assembly having a retractable shaft portion and a base portion, and a balloon delivery device. 
       FIG. 2  is an additional side view of a unitary sheath assembly having a retractable shaft portion and a base portion, and a balloon delivery device. 
       FIG. 3  is an exploded side view of unitary sheath assembly having a retractable shaft portion including a retracting tab component, a base portion including a connecting element and a shaft hub, and a shaft portion. 
       FIG. 4  is a detailed view of a retracting tab component of a unitary sheath assembly and a base portion having a slot opening. 
       FIG. 5  is a top perspective view of a unitary sheath assembly with a more detailed view of a shaft portion having visual indicators. 
       FIG. 6  is a view of a base portion of a unitary sheath assembly including a mating receptacle, holding element and slot opening. 
       FIG. 7  is a view of a hub component of a shaft portion of a unitary sheath assembly. 
       FIG. 8  is a side perspective view of a hub component of a shaft portion of a unitary sheath assembly. 
       FIG. 9  is a side perspective view of a unitary sheath assembly including a positioning element. 
       FIG. 10  is a side view of a positioning element of a linear delivery system. 
       FIG. 11  is an additional side view of a positioning element of a linear delivery system. 
       FIG. 12  is a side view of a unitary sheath assembly, with a more detailed view of a connecting element component of a shaft portion ( FIG. 12A ). 
       FIG. 13  is a view of a balloon delivery device having a balloon. 
       FIG. 14  is an exploded side view of a preferred embodiment of the present invention including a unitary sheath assembly, a balloon delivery device and a positioning element. 
   

   DETAILED DESCRIPTION OF THE INVENTION 
     FIG. 1  shows an exploded side view a linear delivery device  10  for deploying a detachable inflatable balloon to a target site in vivo. The device includes a unitary sheath assembly  12  and a balloon delivery device  14 . The unitary sheath assembly  12  has a retractable shaft portion  16  and a base portion  18 . The unitary sheath assembly  12  should be a single unit device in that the retractable shaft portion  16  cannot be removed or separated from the base portion  18 . 
   Referring to  FIG. 2 , a more detailed view of a linear delivery device is shown. The retractable shaft portion  16  has an inner lumen  20  between a proximal end  22  and a distal end  24 . The base portion  18  also has an inner lumen  28  between a first end  30  and a second end  32 . As shown in  FIG. 2 , a retractable shaft portion  16  can also include a shaft hub  26  coupled to the proximal end  22  of the retractable shaft portion  16  and the second end  32  of the base portion  18 . The shaft hub  26  resides within  27  the base portion at the second end  32  of the base portion  18  and is therefore, not visible to a viewer externally. 
   As shown in  FIG. 1 , a retracting tab or switch  34  is disposed between the first  30  and second  32  ends of the base portion  18 . Referring now to  FIG. 2 , a retracting tab  34  is coupled to a connecting element  29  located toward the second end  32 , within the base portion  18 . The retracting tab  34  will also include a lower stem region  35  which is configured so as to allow its engagement to the connecting element  29  within the base portion  18 .  FIG. 3  shows additional views detailing the coupling of the connecting element  29  to the retracting tab  34  and proximal end  22  of the shaft portion  16 . 
   As shown in  FIG. 3  and detailed in  FIG. 3B , the connecting element  29  is also coupled  17  to the shaft portion  16  at the proximal end  22  of the shaft portion  16 . This coupling occurs internally within the base portion  18 . During use of the system, the shaft portion  16  of the linear delivery system  10  is retracted backward  33  by retraction of the retracting tab  34  (see  FIG. 2 ).  FIG. 3A  shows an exploded side view of the retracting tab. The connecting element  29  is configured  36  to have a receptacle  80  so as to fit the configuration of the lower stem region  35  of the retracting tab  34 . The coupling of the retracting tab  34  to the shaft portion  16  by a connecting element  29  allows for this feature. Coupling of the shaft hub  26  and the shaft portion  16  to the retracting tab  34  via the connecting element  29 , also prevents separation of the shaft portion  16  from the base portion  18 , which is further detailed below. 
     FIG. 4  shows a side view of an embodiment of the linear delivery device. An enlarged view of a retracting tab  34  component of a unitary sheath assembly is shown in  FIG. 4A . The stem  38  of the retracting tab  34  couples the retracting tab  34  to the hub (not shown) of the shaft portion  16  through a slot opening  40  on the base portion  18  of the unitary sheath assembly  12 . The shaft portion is retracted or withdrawn into the lumen of the base portion by sliding the retracting tab  34  back toward the first end  30  (see  FIG. 1 ) of the base portion  18 . The mechanism of the retraction tab exposes the balloon to the target tissue by a linear delivery method. Use of linear delivery simplifies the motion required for retraction of the shaft and is an ambidextrous motion that can be performed by a physician using one hand. 
   Another aspect of the retracting tab that is advantageous to achieving the goals of the invention is the coupling of the retracting tab  34  to the connecting element  29  by a stem  38  of the retracting tab  34  through the slot opening  40  of the base portion. This coupling prevents separation of the shaft portion from the base portion due to the proximal end  42  of the stem abutting against the proximal end  44  of the slot opening and thus retaining the retraction tab  34  within the slot opening  40 . The stem  38  of the retracting tab  34  can, if desired, be adhesively bonded to a receptacle  80  ( FIG. 12A ) of the connecting element  29 , thereby further securing the shaft portion to the base  18  and retracting tab  34 . Additionally, as shown in  FIG. 4A , the slot opening  40  is configured with a bendable tong  41  to capture the retraction tab in either a full forward or a full backward position. This stabilizes retraction of the shaft during the step of exposing the balloon to a target site. 
   In a preferred embodiment, visual indicators can be disposed on the sheath assembly for providing an indication of a penetration depth of the unitary sheath assembly into a patient.  FIG. 5  shows a view of an embodiment of the invention, detailing a shaft portion  16  of the invention having visual indicators  21 . In addition, a holding means or element  19  (see  FIG. 6 ) can be disposed on the base portion  18  of the sheath assembly for attachment of the assembly to a viewing instrument. Such a holding element can be achieved, for example, by a use of a luer lock type of construction, an internal thread construction, a snap-fit type of construction, or any other means to secure the sheath assembly to a viewing instrument. The holding element could also include a gasket attached to the inner surface of, for example, a luer lock which would assist in eliminating leakage between the delivery device and the viewing instrument. It is preferred that the gasket would be made using a soft, pliable material such as a silicone sheet. A collar can also be disposed at the second end of the lumen of the base portion, thereby preventing separation of the shaft portion from the base portion. 
   As shown in  FIG. 2 , the balloon delivery device  14  is configured for insertion  46  through the lumen  28  of the unitary sheath assembly  12 . Inflation of a balloon can be by means such as a standard syringe, which can be of a variety of sizes such as a 1 cc-, a 5 cc- or a 10 cc-sized syringe, or any other type of fluid delivery means that can be coupled to the hub  52  of the balloon delivery device  14  as shown in  FIG. 8 . The hub  52  of the balloon delivery device can also be threaded  53  to fit with standard syringes. Balloons suitable for use in the present invention can be made of an elastic material, such as silicone, that is capable of being easily stretched or expanded while being resistant to breakage or tearing. The balloon structures preferably are self sealing in that after inflation, the balloon is automatically sealed and detachable from the delivery device. Balloon types useful in the present invention are well known in the art and described, for example, in U.S. Pat. Nos. 5,304,123, 5,411,475 and 4,311,146. 
   A variety of biocompatible fluid materials can be used to fill the balloon depending upon the desired use and preferences of the user. Such materials are well known in the art and include, for example, hydroxyethylmethylacrylate (HEMA), a hydrogel such as polyvinyl pyrrolidone, water, contrast media or saline. 
     FIG. 7  shows a side view of a balloon delivery device. The balloon delivery device  14  includes a catheter  50  component, a hub  52  and a guide tab  54  coupled to the hub  52 . The guide tab  54  is flexible and configured  61  so as to allow for easy insertion and removal of the balloon delivery device  14 . Depression  63  of the guide tab  54  allows for removal of the balloon delivery device from the unitary sheath assembly.  FIG. 8  shows an additional perspective view of a hub  52  of a balloon delivery device  14 , including a guide tab  54 . The top surface of the guide tab  54  can include raised peaks  60  and notches  62 , which when engaged into the base portion  18  of the unitary sheath assembly  12 , ( FIG. 2 ) further aid in locking the delivery device in place. This aspect of the present invention further aids in providing a device that is efficient, simple to engage and reliable in delivering a balloon to a target site. Referring to  FIG. 6 , the base portion  18  of the unitary sheath assembly can have one or more mating receptacle(s)  58  into which the hub  52  of the balloon delivery device  14  slides, ( FIG. 2 ) thereby locking the balloon delivery device  14  in place and preventing possible separation of the catheter from the delivery system during balloon inflation. The location of the mating receptacles can also be designed so as to provide practical versatility to the user. For example, when two mating receptacles are provided, the mating receptacles  58  can be located in direct opposition or at a 180 degree relation to one another. This provides two distinct orientations of the balloon delivery device for insertion into a target site. Additional benefits provided by mating receptacles oriented as such are discussed below in reference to its use with a positioning element. 
     FIGS. 10 and 11  show views of a positioning element. As indicated in  FIGS. 10 and 11 , a positioning element  70  can be included in the linear delivery system. The positioning element  70  has a tip  72  and can be made of a solid wire, configured to allow passage through the lumen  28  of the sheath assembly  12  ( FIG. 2 ).  FIG. 9  shows a view of a sheath assembly containing a positioning element  70  having a tip  72 . Alternatively, the positioning element  70  can be a hypodermic or cytoscopic needle, so long as the positioning element is sufficiently rigid to allow formation of a pocket at the target site by advancement of the positioning element tip  72  to the target site. In a preferred embodiment, (referring to  FIG. 10 ) the positioning element will also include a hub  74 , with a flexible guide tab  76  similar to that described above for the balloon delivery device. The hub  74  with flexible guide tab  76  engages into the mating receptacle  58  ( FIG. 6 ) of the unitary sheath assembly  12 , ( FIG. 2 ) which secures the positioning element in place and as with the balloon delivery device, ensures that the positioning element cannot be displaced from the unitary sheath assembly during insertion into the patient. In the case where two mating receptacles are provided, the receptacles can be positioned to provide two distinct orientations of the positioning element  70  when inserted through the unitary sheath assembly. For example, in the case where the tip  72  of the positioning element is beveled ( FIG. 11 ), the positioning needle is commonly inserted by a physician into the target site with the tip  72  of the positioning element  70  oriented bevel-up or at the “twelve o&#39;clock” position. The guide tab  76  is located on the hub  74  of the positioning element in the same orientation as the tip  72  of the positioning element  70  ( FIG. 10 ). Therefore, the orientation of the guide tab  76  (whether it is in a “twelve o&#39;clock, three o&#39;clock, six o&#39;clock, or nine o&#39;clock” orientation), will also indicate the orientation of the bevel or tip  72  of the positioning element  70 . This embodiment is equally practical and versatile to both a left-handed or a right-handed user. 
   Referring to  FIG. 12 , in an additional preferred embodiment, the connecting element  29  ( FIG. 12A ) of the shaft portion  16  of the unitary sheath assembly  12  can also include a ridge  82  that aids in alignment of the shaft  16  within the lumen of the base portion  18 . The inner surface of the base portion  18  is also configured to correspond to the ridge  82  so that retraction of the shaft is maintained along a track  83  within the base portion  18  that is a fixed linear or longitudinal axis relative to the unitary sheath assembly. 
   In a preferred embodiment of a periurethral system for delivery of a 0.9 cc balloon, the shaft portion  16  has a manufacturing specification of 2.750 inches (69.85 mm) in total length, inserting into the shaft hub  26  ( FIG. 2 ) and connecting element  29  by 0.252 inches (6.401 mm), thereby leaving 2.498 inches (63.449 mm) of exposed or visible shaft length. The internal diameter of the shaft portion is 0.072 inches (1.829 mm), or a size sufficient to allow passage of the catheter  50  portion of a balloon delivery device  14  ( FIG. 2 ). The base portion  18  is greater than 1.794 inches (45.568 mm) in length, has a lumen  28  diameter of 0.397 inches (10.084 mm) to 0.428 inches (10.871 mm) and is configured as shown in  FIGS. 1 and 2 . The slot opening  40  has a length of 0.732 inches (18.593 mm) and is configured as shown in  FIG. 4 . The retraction tab  34  has a base portion that has a curved upper surface, a base height of 0.348 inches (8.839 mm) and a stem height of 0.247 inches (6.274 mm). The material of the base portion  18 , the balloon delivery device hub  52  and flexible guide tab  54 , and the positioning element hub  74  and flexible guide tab  76  is a plastic, such as a medical grade polycarbonate. The material of the shaft portion  16 , catheter  50 , and positioning element  70  is typically made of a flexible material that is sufficiently rigid so as to urge the balloon through the lumen of the catheter  50  and to allow fluid passage. Such a linear delivery system can be provided as a 0.2 cc or a 0.9 cc system that is a disposable, single-use system packaged in individual heat sealed Tyvek® pouches or individual trays. Additionally, the shaft portion  16 , catheter  50 , and/or positioning element  70  can be made of a less flexible material such as a stainless steel. 
   The catheter  50  is a two-catheter system where a first, inner catheter  1  is contained within a second, outer catheter  2  ( FIG. 2 ). The outer catheter  2  is of a shorter length than the inner catheter  1 , thereby allowing a positive stop for attachment of a balloon to the catheter  50 . However, the catheter  50  can also be a single system with an end designed so as to allow relatively easy and stable attachment of the balloon. In some preferred embodiments, the invention contemplates using an inner catheter  1  made of a material such as stainless steel and an outer catheter  2  made from a polymer. In addition, the positing element  70  can be fabricated from a more rigid stainless steel or a more flexible nickel titanium. 
   In a preferred embodiment of a transurethral system for delivery of a detachable balloon, the longest component will be the positioning element  70 . The total length of the positioning element from the beginning of the tip  72  to the end of the hub  74  is approximately 18.50 inches. The length of the exposed portion of the positioning element when engaged and locked into the unitary sheath assembly  18  is approximately 16.30 inches. 
   The present invention can be used for a variety of medical treatments where implantation of a detachable balloon in a patient is desirable. For example, in the treatment of urinary incontinence, a detachable balloon can be placed in the tissue immediately adjacent to the urethra. The inflated balloon provides pressure external to the urethra, which causes partial closure of the urethra and reduces unwanted fluid leakage from the bladder through the urethra. Alternatively, the present invention can be used in other types of medical treatments where blockage of a duct, vessel, lumen or other tissue is desired, or where the compressive effect of an inflated balloon is desired. 
   Depending upon the target site location and/or physician preference, the linear delivery system can be used in parallel with a viewing instrument or can be passed through a lumen of a viewing instrument. For example, as shown in  FIG. 14 , in the periurethral method of delivery, the positioning element  70  is first inserted  78  through the shaft  16  of the unitary sheath assembly  12  and “locked” into place into the mating receptacle  58 . The unitary sheath assembly  12  and positioning element  70  is then advanced through the patient&#39;s tissue parallel to the urethra to the target site. The desired target site and correct positioning of the assembly is observed using a viewing instrument passed through, for example, the urethra. In transurethral delivery, the positioning element  70  is passed through the shaft  16  of the unitary sheath assembly  12  until the positioning element tip  72  extends beyond the distal end of the sheath assembly  12 , and is locked into place in a mating receptacle  58  by the flexible guide tab  76 . The unitary sheath assembly  12  and positioning element  70  is passed through the lumen of a viewing instrument such as a cytoscope, The viewing instrument, sheath assembly and positioning element, together are advanced to the target site in vivo. 
   Various materials can be used for constructing the shaft portion  16  and positioning element  70 , depending upon the particular method of delivery. For example, if the linear delivery system is to be passed through a viewing instrument, a flexible material such as a nickel titanium alloy is desirable. Alternatively, if the linear delivery system is to be passed directly through a patient&#39;s tissues, a less flexible material such as stainless steel is preferable. 
   Method for Deployment of a Linear Delivery System 
   The present invention also contemplates a method of using a linear delivery system for deployment of a detachable, inflatable balloon at a target site in a patient. The method includes providing a linear delivery system  10  as shown in  FIGS. 13 and 14 . The positioning element  70  is passed through the inner lumen of the sheath assembly  12  until the positioning element tip  72  extends beyond the distal end of the sheath assembly  12 , and is locked into place by the flexible guide tab  76 . The positioning element tip is advanced to the target site in vivo. By depressing the guide tab  76  and pulling back on the hub  74  (not shown) of the positioning element  70 , the positioning element is then withdrawn from the sheath assembly with the sheath assembly remaining fixed at the target site. There is little or no risk of the positioning element separating prematurely from the sheath assembly because it is held securely in place by the flexible guide tab  76  and mating receptacle  58 . 
   Once the positioning element is removed from the sheath assembly, a balloon delivery device  14  with a balloon  39  coupled to the catheter  50  component of the delivery device ( FIG. 13 ) is passed through the sheath assembly. The balloon delivery device is advanced through the sheath assembly until the flexible guide tab  54  ( FIG. 13 ) engages into the mating receptacle  58  ( FIG. 14 ) of the unitary sheath assembly base  18 . This aspect of the invention prevents the catheter of the balloon delivery device from separating from or being displaced from the sheath assembly during balloon inflation. The retraction tab  34  on the base portion  18  of the unitary sheath assembly  12  is then retracted backward toward the first end  30  of the base portion  18  to expose the balloon to the target site in vivo (as shown in FIG,  1 ). The balloon is inflated and detached and the delivery system is removed. 
   The methods and systems of the present invention provide simple, accurate and stable balloon deployment at the target site in vivo. The features of the invention, as described herein, provide a linear delivery system that is less awkward or cumbersome for the physician to use. 
   Although the invention has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the claimed invention. Accordingly, it is to be understood that the drawings and descriptions herein are proffered by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof.