Abstract:
A barrel having a sharp cutting end is inserted into an animal body to form a channel connected to a pocket in the target tissue. A piston head mounted in the barrel has a chamber housing a solid element which contains a substance for treating the target tissue. Means associated with the piston head such as a push rod received in the piston bore is utilized to expel the solid element from the chamber into the pocket. The treating substance such as a capsule containing a liquid, gel or other substance is released from the capsule and coats the target tissue in the pocket.

Description:
TECHNICAL FIELD 
       [0001]    This invention relates to a method for delivering substances into the body, and more particularly, the present invention relates to an instrument for delivering the substance to target tissue, preferably while encapsulated in a membrane selected to release the substance to the tissue area. 
       BACKGROUND OF THE INVENTION 
       [0002]    Current methods for delivery of substances into the body, either manually or surgically, are often ineffective or often require careful dosage measuring with each application. There is often a loss of the substance during delivery that results in inadequate dosing. Certain substances need to be precisely and quantitatively measured and delivered completely into body tissue. Actual delivery is often cumbersome, inaccurate, and messy. Delivery into certain cavities is difficult and/or often impossible to administer accurately. 
         [0003]    Current delivery systems include: 
         [0004]    Suppositories are usually inserted into the rectum or vagina. They cannot deliver a liquid, cream or gel effectively or at the correct volume. They may be slow to dissolve and are easily expelled by contractions of surrounding muscle, lack of sphincter control or by gravity before the full amount of the substance to be delivered is administered. Since it is impossible to determine how much of the substance was absorbed, another application of a suppository may result in under or overdosing. Because suppositories are in a partially solid or completely solid form, the dissolution time may be prolonged or not occur at all. 
         [0005]    Hard tablets can irritate tissue, can be easily expelled, dissolve slowly before adequate absorption, or cause inconsistent coating of the directed tissue area. 
         [0006]    Creams, gels and lotions are not only messy and cumbersome to administer, but often a significant portion of the dosage is lost and wasted on the delivery instrument and/or outside the cavity. 
         [0007]    It is difficult to administer an accurate dosage of liquid to most body cavities and tissues. As with the creams and gels, they are often messy and cumbersome to administer, and often a portion of the dosage is lost and wasted on the delivery instrument and/or outside the cavity. 
         [0008]    There is a need for accurate administration of a pre-measured substance into a cavity or tissue area, either manually or surgically, preferably with quick delivery to the target tissue. 
         [0009]    As disclosed in my co pending application Ser. No. ______ filed concurrently herewith entitled “DISPENSING ENCAPSULATED FLUIDS, POWDERS OR MICROSPHERES, SUITABLY TIME RELEASED MICROSPHERES INTO BODY CAVITIES OR TISSUES” (Docket Number 517-20-001) the disclosure of which is completely and expressly incorporated herein by reference, capsules containing liquids, powders or micro spheres, suitably time released microspheres are described which can be inserted into body cavities. The membrane melts, dissipates or dissolves in the cavity to expel the liquid, powder or microsphere, suitably time released micro spheres, onto the walls of the cavity. Insertion of the capsules into natural cavities having exposed tissue such as vaginal, rectal, nasal, etc. tissue can be accomplished by digital insertion through the opening of the cavity. However, administration of capsules into internal tissue is not possible by manual, digital administration. 
       STATEMENT OF THE INVENTION 
       [0010]    In accordance with the invention, a cavity or pocket is formed by a tool which surgically cuts a channel through exterior tissue ending in a pocket or cavity in target tissue such as an organ or a growth either benign or cancerous. A piston head with a chamber formed in the distal face of the head is placed in the barrel of the tool. A cylindrical rod with a hollow bore is connected to the piston head. A capsule is placed in the chamber and a push rod is placed in the bore of the piston rod and pushed until the distal end of the rod traverses a passage through the head, pushes the capsule out of the chamber into the pocket. A central rod is mounted within the bore for axial movement and extends above the piston handle. The end of the rod is pushed to eject the capsules into the pocket. The rod may also be used to fracture the membrane of the capsule to release the encapsulated liquid. The inserter tool is then removed from the pocket and the channel. 
         [0011]    The liquid is quickly released to treat exposed tissue. All of the dose of liquid is dispensed into the cavity and is quickly absorbed into the tissue. 
         [0012]    These and other attendant advantages of the invention will become apparent in the following description when considered in conjunction with the accompanying drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0013]      FIG. 1  is a schematic view of the outer barrel of an insertion instrument for forming a pocket in target tissue; 
           [0014]      FIG. 2  is a schematic view of an insertion piston; 
           [0015]      FIG. 3  is a schematic view of a piston rod; 
           [0016]      FIG. 4  is a schematic view of the outer barrel of  FIG. 1  with the cutting end inserted into target tissue to form a channel pocket; and 
           [0017]      FIG. 4A  is a schematic view of target tissue shown with the barrel removed; 
           [0018]      FIG. 5  is a schematic view of the instrument of  FIG. 2  shown with a piston and in the channel a capsule positioned in a chamber in the distal face of a piston; 
           [0019]      FIG. 6  is a schematic view of an assembly unit with the distal end of the push rod forcing a capsule out of the chamber into the pocket; 
           [0020]      FIG. 7  is a schematic view of the implanted capsule in the pocket after withdrawal of the instrument assembly; 
           [0021]      FIG. 8  is a front view in elevation of a first embodiment of a capsule for delivering a liquid into a body cavity; 
           [0022]      FIG. 9  is a front view in elevation of a second embodiment of capsule suitable for digital insertion; 
           [0023]      FIG. 10  is a sectional view taken along line  10  -  10  of  FIG. 9 ; 
           [0024]      FIG. 11  is a view in section of a capsule within a capsule embodiment; 
           [0025]      FIG. 12  is a schematic view of a capsule divided into two compartments; 
           [0026]      FIG. 13  is a schematic view of an alternative version of a two compartment capsule; 
           [0027]      FIG. 14  is a schematic view of a membrane encapsulated liquid suspension; 
           [0028]      FIG. 15  is a schematic view of a capsule divided into four compartments by membrane walls. 
       
    
    
     DESCRIPTION OF THE INVENTION 
       [0029]    Referring now to  FIGS. 1 ,  4 , and  4 A, the instrument  10  consists of a barrel  12 . The distal end  20  of the barrel  12  terminates in a pointed, tissue cutting or burrowing tool end  22  similar to a biopsy needle. The other end  21  is fitted with a concave topped handle  16 . Referring now to FIGS.  2 , 3 , 4  &amp;  4   a  as the barrel  12  is pushed through a layer of skin  24   FIG. 4  and tissue  26  into target tissue such as a tumor  28 , a channel  30  and pocket  32  are formed by the cutting tool  22 . 
         [0030]    A dispensing piston  34  as shown in  FIG. 2 , including a hollow first rod  36  and a handle  37  is attached to the proximal end  40  end of the rod  36 . The distal end  39  of the rod terminates in piston head  44 . The distal face  45  of the piston head  44  is shaped to contain a detent forming a chamber  46  which holds a capsule  48 . As shown in  FIGS. 3 ,  5  and  6 , a push rod  50  is downwardly mounted in the bore  51  of the rod  36 . The distal end  53  of the rod  50  penetrates a slot  51  through the piston head  44 . The push rod  50  extends into the channel  30  and pocket  32 ,  FIG. 4   a.    
         [0031]    The proximal end of the push rod  50  is connected to a push handle  56  disposed a distance above the piston handles  16  and  37  necessary to traverse the longitudinal length of the channel  30  and pocket  32 . 
         [0032]    Target tissue  28  such as an infected organ is treated by pushing the pointed end  22  of the barrel  12  through skin layer  24  then tissue layer  26  into a tumor  28  to form a pocket  32  and a channel  30  as shown in  FIGS. 4 &amp; 4   a.    
         [0033]    If necessary, an agent to control bleeding can be injected through the barrel  12  or bore of push rod  50  into the pocket  32 . As shown in  FIG. 2 , a capsule  48  is then placed in the chamber  46  in the piston head  44 . The piston head  44  is placed in the bore  15  of the barrel  12  and handle  16  is manually pushed until the head  44  enters the pocket  32 . The push rod  50  is then activated by pressing the push handle  56  to eject the capsule  48  into the pocket  32 . The membrane  60  of the capsule  48  fragments, melts, dissolves or dissipates in the pocket  32  to release the encapsulated liquid  52  which is released into the target tissue area  66  of pocket  32 . The instrument  10  is then withdrawn from the body. 
         [0034]    The capsule utilized with the insertion instrument of the invention can contain any solid material or a dissolving solid, liquid, powder, microspheres, cream or gel encapsulated in a membrane that fragments, melts, dissolves or dissipates in the cavity or pocket formed by the instrument. The solid capsule or encapsulated material can contain a substance treatment unit dosage amount of a medicine suitable to treat and/or cure the affected condition of the target tissue. 
         [0035]    The outer membrane can take various shapes and/or sizes to accommodate the specific need of a substance to be delivered or to accommodate the specific body cavity proportions. 
         [0036]    The membrane may be layered to contain more than one substance for delivery. Outer membrane will melt/dissolve/dissipate to release the first substance, and then the next membrane will melt to release a subsequent substance. This second substance or dosage may be a suspension within the encapsulated liquid or may be a part of a partitioned module. 
         [0037]    Various thicknesses, dissipating temperatures, or chemical compositions of the membrane may be used to vary dissipation timing. 
         [0038]    The specific chemistry of the membrane may have to be altered or coated with an outside layer to prevent premature reactions with substances present in the cavity or entrance to the cavity. 
         [0039]    Capsules may be produced with contents targeting other problems including, but not limited to:
       a) Cavity pH balance   b) Candida control   c) Birth control   d) Tissue health   e) Hormone balance   f) Treatment of sexually transmitted diseases   g) Lactobacillus homeo stasis   h) Treatment of cancerous target tissue   i) Treatment of other medical conditions       
 
         [0049]    The membrane capsule can be produced empty. The physician or pharmacist may inject a therapeutic liquid, gel, powder or other substance into the capsule. 
         [0050]    Referring now to  FIG. 8 , a capsule  100  can take the form of an elongated, thin, oval membrane  102  encapsulating a body  104  of liquid.  FIGS. 9 and 10  illustrate a wide capsule  106  having a convex distal end  108  and a concave proximal end  109  in which the top of a finger  111  can be placed during insertion of the capsule  106 . The distal end  108  can be conically shaped to aid in insertion. 
         [0051]      FIG. 11  illustrates a capsule  112  having an outer membrane skin  114  which encapsulates a first body of liquid  116  and an inner membrane and film  118  which encapsulates a second body of liquid  120 . The liquids  116 ,  120  can be the same and delivery will occur in stages allowing the push rod  50  to breach the outer membrane skin  114  to expel the first body of liquid  116  into tissue, and after absorption the push rod  50  is again pressed to rupture the inner capsule  122  which then expels the second body of liquid  120 . The liquids  116  and  120  can be different such as liquid  116  controlling blood flow and liquid  120  containing a therapeutic substance. 
         [0052]      FIG. 12  illustrates a two compartment capsule  130  in which the interior of an oval-shaped membrane  132  is partitioned into two chambers  134  and  136  by a wall  138 . The liquids  140 ,  142  contained within chambers  134  and  136  will be dispensed simultaneously on breach of the outer membrane film  132  or in sequence if the capsule  130  is positioned with the membrane wall  138  normal to the push rod  50 . The push rod  50  can be advanced stepwise to sequentially disrupt the membranes enclosing chambers  134 ,  136  Release may occur with membrane melting and sequentially release the bodies of liquid  140 ,  142 . 
         [0053]    In  FIG. 13  the first chamber  139  has a thicker membrane  145  than the membrane  147  surrounding the second chamber  149 . The bodies of liquids  144 ,  146  are contained within compartments  148 ,  150 . However, the thickness of the outer membrane  145  connected to a partition wall  156  is thicker than the other portion the membrane  147  also connected to the partition wall  156 . The thinner membrane  147  will be breached first and deliver the contained liquid  146  to targeted tissue. The thicker membrane  145  will breach or dissipate at a later time. 
         [0054]    In  FIG. 15  a capsule  160  having an outer membrane  162  is partitioned into  4  chambers  164 ,  166 ,  168 ,  169  by means of walls  163 ,  165 ,  167  which extend across the membrane  162 . The membrane walls can also be disposed parallel to the central axis of the capsule. 
         [0055]      FIG. 14  shows a capsule  170  in which the liquid suspension or powders  172  encapsulated by the membrane  174  contains a dispersion of microspheres or other particles  176 . 
         [0056]    It is to be realized that the preceding description is for the purpose of enabling one to understand the invention and is not intended to limit the invention, except as defined in the following claims.